Ontario Ministry of Health and
Long-Term Care
Tuberculosis
Protocol
Issued: September 2006
Version: 1.0
Table of Contents
Preface............................................................................................................................................. i
Acknowledgements......................................................................................................................... ii
1. Tuberculosis (TB): A Brief Background............................................................................... 4
1.1 Tuberculosis in Ontario ............................................................................................................ 5
1.2 Tuberculosis Control Programs: A Definition........................................................................ 6
1.2.1 Tuberculosis Control in Ontario: Current Mandatory Programs and Services Guidelines
(MHPSG) ...........................................................................................................................................................6
1.2.2 Goal.......................................................................................................................................................6
1.2.3 Objectives........................................................................................................................................6
1.3 Roles and Responsibilities in TB Control................................................................................ 8
1.3.1 The Board of Health ...........................................................................................................................8
1.3.2 The Ontario Ministry of Health and Long Term Care...................................................................9
1.3.3 Private Physicians .............................................................................................................................10
1.3.4 The Laboratory/Diagnostic Facility ...............................................................................................10
1.4 Reporting Requirements......................................................................................................... 11
1.4.1 Definitions .........................................................................................................................................11
1.4.2 Definitions Related to Staging of a TB Episode: .........................................................................13
1.5 Duty to Report ......................................................................................................................... 14
1.5.1 Physicians and Practitioners............................................................................................................14
1.5.2 Carriers of Disease............................................................................................................................14
1.5.3 Hospital Administrators and Superintendents of Institutions .....................................................14
1.5.4 School Principals ..............................................................................................................................15
1.5.5 Operator of a Laboratory .................................................................................................................15
1.5.6 Reporting Death due to a Communicable Disease.......................................................................15
1.5.7 Medical Officer of Health Reporting .............................................................................................15
1.5.8 Physician Reporting Refusal or Neglect of Treatment ................................................................15
1.6 Information Collected for Reporting TB: ............................................................................. 16
1.6.1 Regulation 569 of the HPPA...........................................................................................................16
1.7 Roles and Responsibilities....................................................................................................... 18
1.7.1 The Board of Health TB Staff.........................................................................................................18
1.7.2 Retention of TB Records By Health Units...........................................................................................18
1.7.3 The Disease Control Service, Infectious Diseases Branch .........................................................19
1.8 Transferring Information between Public Health Jurisdictions......................................... 20
1.8.1 Transferring Information within Ontario.......................................................................................20
1.8.2 Transferring Information outside Ontario .....................................................................................20
1.9 Legislation ................................................................................................................................ 21
2. Surveillance and Screening ......................................................................................... 32
2.1 Definitions ................................................................................................................................ 32
2.1.1 Surveillance .......................................................................................................................................32
2.1.2 Screening............................................................................................................................................32
2.2 Screening .................................................................................................................................. 33
2.2.1 Purpose of Screening........................................................................................................................33
2.2.2 Components of Screening................................................................................................................33
2.2.3 Indications for Screening .................................................................................................................34
2.3 Tuberculin Skin Testing.......................................................................................................... 39
2.3.1 Mantoux .............................................................................................................................................39
2.3.2 Storage and Handling of the Tuberculin Preparation ..................................................................39
2.3.3 Indications for Tuberculin Testing .................................................................................................40
2.3.4 Contraindications to Tuberculin Skin Testing .............................................................................40
2.4 Tuberculin Skin Testing (TST) .............................................................................................. 42
2.4.1 Mantoux Test Technique .................................................................................................................42
2.4.2 The Two-Step TST ...........................................................................................................................46
3. Diagnostics ........................................................................................................................... 52
3.1 Overview................................................................................................................................... 52
3.2 Tests to Determine Infection................................................................................................... 54
3.2.1 Tuberculin Skin Test ........................................................................................................................54
3.2.2 Interferon-纬 Assays ...........................................................................................................................54
3.3 Tests for the Diagnosis of Pulmonary Disease ...................................................................... 55
3.3.1 Radiology...........................................................................................................................................55
3.4 Non-pulmonary TB ................................................................................................................. 60
3.5 Laboratory Testing for Tuberculosis..................................................................................... 63
3.5.1 Overview............................................................................................................................................63
3.5.2 Types of Laboratory Testing ...........................................................................................................63
3.6 Appendix A............................................................................................................................... 68
A. QuantiFERON-TB TEST (QFT) Fact Sheet.........................................................................................68
4. Tuberculosis Prevention................................................................................................... 71
4.1 Prevention/Health Promotion in the Community................................................................. 71
4.1.1 Health Education...............................................................................................................................71
4.1.2 Community Development/Community Capacity Building.........................................................72
4.1.3 Advocacy ...........................................................................................................................................72
4.1.4 Outreach .............................................................................................................................................72
4.1.5 Evidence-Based Practice.............................................................................................................72
4.2 Early Diagnosis and Treatment.............................................................................................. 73
4.3 Infection Control Measures in Health Care Facilities.......................................................... 74
4.3.1 Administrative and Work Practice Measures in Health Care Facilities....................................75
4.3.2 TB Risk Assessment.........................................................................................................................75
4.3.3 Ventilation, Filters, Ultraviolet Germicidal Irradiation (UVGI) ...........................................76
4.3.4 Local Exhaust Ventilation ...............................................................................................................77
4.3.5 Air Cleaning Methods ......................................................................................................................77
4.3.6 Use of Respiratory Protection .........................................................................................................79
4.3.7 Screening Programs for TB Support, Surveillance and Clinical Care ......................................80
4.4 Resources, Education and Information ................................................................................. 83
4.4.1 Education and Counselling Programs for Health Care Workers ....................................... 83
4.4.2 Local Public Health Unit .................................................................................................................84
4.5 Vaccines .................................................................................................................................... 85
4.5.1 Bacille Calmette-Guerin (BCG) .....................................................................................................85
4.5.2 Other Vaccines against Tuberculosis............................................................................................86
5. Management of Tuberculosis Cases............................................................................ 88
5.1 Clinical Management: Physicians鈥? Roles and Responsibilities............................................ 88
5.1.1 Referral to a Tuberculosis Medical Expert....................................................................................88
5.2 Case Monitoring: Public Health Roles and Responsibilities ............................................... 91
A. Respiratory Cases: Investigation and Case Management ..................................................................91
5.2.1 Initial Investigation:..........................................................................................................................91
5.2.2 Clinical Guidelines for Releasing Patients with Pulmonary/Laryngeal TB from Isolation: 92
5.2.3 Education ...........................................................................................................................................92
5.2.4 Non-Compliance ...............................................................................................................................93
5.2.5 Minimum Requirements for On going Follow-up .......................................................................93
5.2.6 Recommended Protocol for Directly Observed Therapy (DOT) ...............................................95
5.2.7 Management of Tuberculosis in the Homeless and Under-housed............................................95
5.2.8 Discharging Patients from Case Monitoring.................................................................................96
B. Non-Respiratory Tuberculosis ................................................................................................................96
5.2.9 In a Child (鈮? 5 years of age)............................................................................................................96
5.2.10 In Older Children (鈮? 6 years of age) and Adults .....................................................................96
5.3 Appendix A: ............................................................................................................................. 98
Interim Guidance for the Prevention and Control of Tuberculosis (TB) in Homeless Shelters and
Drop-In Centres.................................................................................................................................... 98
5.3.1 Homelessness and TB ......................................................................................................................98
5.3.2 Reducing the Risk of TB Spreading in Homeless Shelters.........................................................98
5.3.3 Proper Documentation in Homeless Shelters..............................................................................100
5.3.4 Resources and Information............................................................................................................100
6. Contact Management ..................................................................................................... 102
6.1 Overview................................................................................................................................. 102
6.1.1 Objectives of Contact Investigation .............................................................................................102
6.1.2 Definitions .......................................................................................................................................102
6.2 Transmission Factors and Risk to Contacts........................................................................ 105
6.2.1 Transmission Factors Relating to the Case .................................................................................105
6.2.2 Transmission Factors Relating to Shared Air Space..................................................................106
6.2.3 Transmission Risk Factors Relating to Contacts........................................................................106
6.2.4 Classification of Contacts ..............................................................................................................107
6.3 Procedure for Contact Investigation.................................................................................... 108
6.3.1 Initiate Investigation.......................................................................................................................108
6.3.2 Establish Limits of Investigation ..................................................................................................109
6.3.3 Contact Tracing Priorities..............................................................................................................110
6.3.4 Contact Interview............................................................................................................................111
6.3.5 Following Contacts Who Live Outside the Health Unit ...........................................................112
6.3.6 Contact Follow-up in Special Settings.........................................................................................112
6.3.7 Managing Contacts who Refuse Follow-up ................................................................................116
6.3.8 Contact Management Recommendations ....................................................................................116
6.4 Appendix A: Sample Contact Letter.................................................................................... 120
6.5 Appendix B: Paediatric TB Contact ................................................................................... 121
7. Latent Tuberculous Infection (LTBI) ....................................................................... 122
7.1 Introduction ........................................................................................................................... 122
7.2 Role of Public Health Units in Treatment for LTBI .......................................................... 123
7.3 Treatment of Latent Tuberculosis Infection ....................................................................... 124
7.3.1 Indications for Treatment...............................................................................................................124
7.3.2 Individuals Who Should Start Preventive Treatment, Regardless of the TST Result...........124
7.3.3 BCG-Vaccinated Person ................................................................................................................125
7.3.4 Individuals Who Should NOT Start Preventive Treatment: .....................................................125
7.4 Patient Management.............................................................................................................. 126
7.4.1 Medical History...............................................................................................................................126
7.4.2 Baseline Liver Function Testing...................................................................................................127
7.4.3 Side Effects......................................................................................................................................128
7.4.4 Treatment Regimens.......................................................................................................................129
7.4.5 Resistance to Isoniazid, and Isoniazid and Rifampin ................................................................130
7.4.6 Pregnancy.........................................................................................................................................130
7.4.7 Children............................................................................................................................................131
7.4.8 Completion of Treatment...............................................................................................................132
8. Treatment of TB Disease ............................................................................................ 134
8.1 Introduction ........................................................................................................................... 134
8.2 Treatment for TB .................................................................................................................. 135
8.2.1 Responsibility for TB Treatment ..................................................................................................135
8.2.2 Treatment Regimens.......................................................................................................................135
8.3 Medications Used To Treat TB ............................................................................................ 137
8.3.1 鈥楩irst Line TB Drugs鈥?.....................................................................................................................137
8.3.2 Availability of 鈥楩irst Line鈥? TB Drugs ..........................................................................................137
8.4 Treatment Regimens (Cases) ............................................................................................... 140
8.4.1 Length of Treatment .......................................................................................................................140
8.4.2 Response to Treatment and Treatment Failure ..........................................................................141
8.5 Drug Resistant TB ................................................................................................................. 144
8.5.1 Acquired Resistance .......................................................................................................................144
8.5.2 Primary Resistance .........................................................................................................................145
8.5.3 Management of Contacts of Person with Drug Resistant TB...................................................145
8.5.4 鈥楽econd Line鈥? TB Medications.....................................................................................................145
8.5.5 How to Obtain 鈥楽econd Line TB Drugs鈥?.....................................................................................146
8.5.6 Reimbursement for Second Line TB Drugs................................................................................147
8.6 Treatment of TB in Special Situations.......................................................................148
8.7 Anti-TB Drugs through the Special Access Program......................................................... 149
8.7.1 How to Request a Drug Through SAP.........................................................................................149
8.8 Dispensing of TB Drugs ................................................................................................................150
8.8.1 Labeling Information to be Included on Each TB Drug............................................................150
8.9 Provision of TB Medications for Persons Leaving Ontario (Cases and LTBI) .....................151
8.10 Need for Referral/Consultation with TB Specialist ...................................................................152
8.11 Directly Observed Therapy (DOT) ...................................................................................... 153
8.11.1 DOT Assessment Guide............................................................................................................153
8.11.2 The Benefits of DOT .................................................................................................................154
8.12 Barriers to Completion of TB Treatment ........................................................................... 155
8.12.1 Challenges to Administration of TB Medications ................................................................155
8.12.2 Administrating TB Drugs with Food .....................................................................................156
8.12.3 Improving Adherence to Therapy............................................................................................156
8.12.4 Dealing with Common Problems Associated with Medication ..........................................156
8.12.5 Completion of Treatment ..........................................................................................................158
Appendix 8-A: MOHLTC Public Health Division Requisition for Drugs..................................... 159
Appendix 8-B: MOHLTC DOT Assessment Form ........................................................................ 160
9. Medical Surveillance for Inactive Tuberculosis............................................................... 161
9.1.1 Citizenship and Immigration Canada (CIC)................................................................................161
9.1.2 Ontario Ministry of Health and Long Term Care.......................................................................165
9.1.3 Local Health Unit............................................................................................................................166
9.2 Follow-up Procedures............................................................................................................ 170
9.2.1 Person Lost to Follow-up or Non-compliant ..............................................................................170
9.2.2 Person Changes Address................................................................................................................170
9.2.3 Discharge from Medical Surveillance..........................................................................................170
9.2.4 Self-referral for Medical Surveillance ...............................................................................................171
9.3 Obtaining Previous Immigration Medical Exam Assessment ........................................... 172
9.3.1 Immigration Medical Exam done outside Canada .....................................................................172
9.3.2 Immigration Medical Exam done within Canada.......................................................................172
9.4 Appendix A: Sample IMM 535 Form .................................................................................. 173
9.5 Appendix B: Sample in Canada Form................................................................................. 175
9.6 Appendix C: Sample Immigration Medical Surveillance Reporting Form ..................... 176
9.7 Appendix D: List of Overseas Medical Offices and Addresses ......................................... 178
9.8 Appendix E: iPHIS Bulletin #8............................................................................................. 180
10. Ventilation Standards in Shelters for the Homeless....................................... 190
11. Tuberculosis Diagnostic and Treatment Services for Uninsured Persons
(TB-UP) Program ................................................................................................................. 191
11.1 Introduction ........................................................................................................................... 191
11.1.1 Purpose of the TB-UP Program ...............................................................................................191
11.1.2 Description of the TB-UP Program .........................................................................................191
11.1.3 Eligible persons covered under the TB-UP program: ...........................................................191
11.1.4 Eligible services and service providers covered under TB-UP: ..........................................192
11.2. Governing Legislation ........................................................................................................... 193
11.2.1 Health Legislation ......................................................................................................................193
11.2.2 Collecting and Releasing Confidential Information..............................................................193
11.3 Roles and Responsibilities for the TB-UP Program ........................................................... 195
11.3.1 Board of Health: .........................................................................................................................195
11.3.2 Service Providers .......................................................................................................................195
11.3.3 Ministry of Health and Long-Term Care, Registration and Claims Branch (RCB):........196
11.3.4 Ministry of Health and Long-Term Care, Public Health Division (PHD):........................197
11.4 Process for Registration into the TB-UP Program ............................................................. 198
11.4.1 Patient Referral to the TB-UP Program ..................................................................................198
11.4.2 Assessment of Potential TB-UP Patient by the Board of Health to Determine Eligibility
for the TB-UP Program ................................................................................................................................198
11.5 Registration of Eligible TB-UP Patients .............................................................................. 200
11.5.1 Application and Consent Procedure for the TB-UP Program:.............................................200
11.5.2 Obtaining Application and Consent for the TB-UP Program ..............................................200
11.5.3 Assigning the TB-UP Registration Number...........................................................................201
11.5 Registration of Eligible TB-UP Patients .............................................................................. 202
11.6 Board of Health Distribution of Claim Forms .................................................................... 205
11.6.1 Information to be included on the Health Care Provider Claim Form prior to distribution
205
11.6.2 Distribution of Health Care Provider Claim Forms ..............................................................205
11.6.3 Health Care Provider Claim Forms for the First and Second Visit to Physician鈥檚
Office/Clinic ..................................................................................................................................................205
11.6.4 Health Care Provider Claim Forms for Subsequent Visits to Physician鈥檚 Office/Clinic.206
11.7 iPHIS TB-UP Screen Data Entry by the Board of Health ................................................. 208
11.7.1 TB-UP Status* ..............................................................................................................................208
11.7.2 Medical Coverage Status at time of registration* .........................................................................208
11.7.3 TB-UP Consent Signed/Start Date*..............................................................................................208
11.7.4 Status Review Date (SRD)............................................................................................................208
11.7.5 TB-UP End Date* .........................................................................................................................209
11.7.6 Reason for Referral* .....................................................................................................................209
11.7.7 Diagnostic Outcome......................................................................................................................209
11.7.8 On Medical Surveillance*.............................................................................................................209
11.7.9 Available Reasons for Discharge ..................................................................................................210
11.7.10 Invoice Number* ..........................................................................................................................210
11.7.11 Invoice Given To* ........................................................................................................................210
11.7.12 Invoice Given Physician ...............................................................................................................210
11.7.13 Invoice Paid Date ..........................................................................................................................210
11.8 TB-UP Data Transfer............................................................................................................ 211
11.9 Submitting and Processing of Claims for the TB-UP Program......................................... 212
11.9.1 Health Care Provider Claim Submission by Service Provider ............................................212
11.9.2 Health Care Provider Claim Payment under the TB-UP Program by RCB.......................212
11.9.3 Returned Health Care Provider Claim Forms by the RCB (Algorithm 4):........................212
11.9.4 Claims for service providers licensed outside Ontario .........................................................215
11.10 Discharge of Patient from TB-UP Program.................................................................... 216
11.10.1 Process for Discharging the Patient from the TB-UP Program ...........................................216
11.10.2 Withdrawal from the TB-UP Program:...................................................................................216
11.11 TB-UP Form Production, Distribution, Control and Retention ................................... 219
11.11.1 Production of TB-UP Forms.....................................................................................................219
11.11.2 Process for the Board of Health to obtain TB-UP Forms.....................................................219
11.11.3 TB-UP Forms Control ...............................................................................................................220
11.12 Dispute Resolution ............................................................................................................ 221
11.12.1 Policy and Program Inquiries ...................................................................................................221
11.12.2 Payment Inquiries ......................................................................................................................221
11.12.3 Final Decision Regarding Unresolved Disputes....................................................................221
11.13 Appendix A: Health Care Provider Claim..................................................................... 222
11.14 Appendix B: Health Care Provider Claim Form Instruction Sheet ............................. 223
11.15 Appendix C: TB-UP Application and Consent Form ................................................... 224
11.16 Appendix D: TB-UP Withdrawal Form.......................................................................... 226
11.17 Appendix E: Claims Form Returned Letter.................................................................. 227
11.18 Appendix F: Sample Exception Letter ............................................................................ 229
12. Use of Orders under the Health Protection and Promotion Act to Control
Tuberculosis............................................................................................................................ 239
12.1 Section 22 Orders .................................................................................................................. 239
12.1.1 Preparing to Issue a Section 22 Order.....................................................................................239
12.1.2 Situations in which a Section 22 Order would be Appropriate to Control and/or Treat
Tuberculosis:..................................................................................................................................................240
12.1.3 Provisions which may be included in a Section 22 Order....................................................240
12.1.4 Process for Completing the Section 22 Order........................................................................241
12.1.5 Process for Serving the Section 22 Order...............................................................................241
12.1.6 Non-Compliance with a Section 22 Order..............................................................................242
12.2 Section 35 Order: Order by the Ontario Court of Justice................................................ 243
12.2.1 Contents of a Section 35 Order ................................................................................................243
12.2.2 Procedures for a Section 35 Order...........................................................................................244
12.2.3 Serving and Enforcing a Section 35 Order.............................................................................244
12.2.4 Appealing a Section 35 Order ..................................................................................................245
12.2.5 Extending a Section 35 Order/Certificate of MOH...............................................................245
12.3 Appendix A: Sample Health Unit Letter ............................................................................ 246
13. West Park Healthcare Centre (WPHC).................................................................. 250
13.1 Introduction ........................................................................................................................... 250
13.2 West Park Healthcare Centre鈥檚 Admission Policy ............................................................. 251
13.2.1 For Patients Not Under S.35 Orders........................................................................................251
13.2.1 West Park Healthcare Centre鈥檚 Admission Policy For Persons Admitted Under a S.35
Order 251
13.2.3 Role of Toronto Public Health (TPH) and WPHC with regard to S.35 Patients ..............252
13.3 Discharge Planning for All Patients from WPHC .............................................................. 254
13.4 APPENDIX A: Letter............................................................................................................ 255
14.1 Legislative Background......................................................................................................... 258
14.1.1 Pending Revisions to Federal Legislation: Bill C-12...........................................................258
14.1.1 鈥淚nfectious or Contagious鈥? versus 鈥淒angerous鈥? Diseases...................................................258
14.2 Management of Persons with Infectious TB Leaving or Entering Canada...................... 260
14.2.1 Person with suspected or diagnosed TB leaving Canada while still infectious.................260
14.2.2 Person with suspected or diagnosed TB attempting to enter Canada while still infectious
261
14.3 Detention under the Federal Quarantine Act ..................................................................... 265
14.3.1 Examples of Recent Situations.................................................................................................265
15. First Nations and Inuit Health Branch (FNIHB) Tuberculosis Control in
Ontario Region....................................................................................................................... 267
15.1 Introduction ........................................................................................................................... 267
15.2 Epidemiology of TB in Ontario First Nation Communities............................................... 268
15.3 Legal Issues ............................................................................................................................ 269
15.4 TB Medication ....................................................................................................................... 270
15.5 Communication between Local Health Unit and FNIHB / Community Health Nurses . 271
15.6 Bacille Calmette-Gu茅rin Vaccine (BCG)............................................................................. 273
Preface
Tuberculosis (TB) continues to be a public health concern in Ontario in 2006. Although the TB rate has
steadily declined, Ontario faces challenges in TB prevention and control. Over 90% of Ontario鈥檚 TB
cases are in the foreign-born. There is also a large pool of latent TB found in persons with HIV, the
elderly, immigrants and refugees who come from areas where TB is endemic. It will be increasingly
difficult to maintain proficiency among those responsible for TB control as the frequency of TB continues
to be less common. On March 24 2006, the Centers for Disease Control and Prevention (CDC) in the
United States warned that there are now reports of multiple cases of TB with resistance to virtually all the
drugs available to treat TB. This is called extensively drug resistant (XDR) TB. XDR TB has emerged
worldwide as a threat to public health and TB control, raising the concerns of a future epidemic of virtually
untreatable TB. There have been persons diagnosed with XDR TB in Ontario 鈥? these cases are costly to
treat and involve complex treatment regimens, posing unique challenges to the public health
management of the disease.
This interim protocol for the public health management of TB in Ontario is based on the recommendations
of the TB Committee of the Canadian Thoracic Society 5th Edition (2000), 鈥淐anadian Tuberculosis
Standards鈥?, as well as the opinions of local and national experts in TB diagnosis, treatment and control. It
is expected that the national standards will be revised in early 2007. Ontario鈥檚 protocol will be finalized
after review of the revised national standards and with feedback received from this interim protocol.
An attempt has been made to develop a comprehensive protocol but it cannot substitute for clinical
judgment. However, if adhered to, it will result in the control of TB in Ontario.
The writing team of this protocol deserves special attention and acknowledgement. There was only one
face-to-face meeting of the team. All the work was done over many months by the Internet and by phone.
Each person on the team functioned as a lead author for at least one chapter as well being a member of
the writing team for other chapters. The protocol would not have been done without this team鈥檚 dogged
determination and constant striving for relevant content and research based evidence.
The reviewers also deserve thanks for their valuable feedback and attention to detail.
A special thank you goes to the editor of the protocol, Gloria Jean Bubba, for her participation in
countless teleconferences and editing sessions and for her insights into helping the team achieve a
cohesive document. She certainly did learn a great deal about TB and public health and she helped
make the document become a reality.
A final thank you to Dr. Barbara Kawa, Senior Medical Consultant of the Vaccine Preventable Disease
Control and Immunization Unit. Dr. Kawa was head of the VPD/TB Control Unit when the first TB protocol
was written in 1998 and she initiated the work on the revision of this protocol (prior to the unit鈥檚
reorganization in June 2006). Her commitment to public health and passion for TB control and
management are the foundation of this protocol.
Joy Marshall
TB Nurse Consultant
September 2006
Acknowledgements
1.1 Writing Team
Pam Chedore MLT
Head TB and Mycobacteriology
Canadian Public Health Laboratory
Ministry of Health and Long-Term Care
Joey Davidson RN, BScN, MBA
Director Infectious Diseases Control Division
York Region Health Services Department
Janice Fackelman RN, BScN
Public Health Nurse
TB Control, City of Hamilton Public Health
Esther Johnson RN, BScN
TB Supervisor
TB Prevention and Control, Toronto Public Health
Jennifer McLean RN
Public Health Nurse
Communicable Disease and TB Control Program, Peel Region
Joy Marshall RN, MN
TB Nurse Consultant
Infectious Diseases Branch
Ministry of Health and Long-Term Care
Dr. Rosana Pellizari
Medical Officer of Health
Perth District Health Unit
Dr. Lilian Yuan
Former A/MOH Peel Region
1.2 Writers of FNHIB Chapter
鈥? Joyce Miazdzyk, R.N., HBScN, Nursing Coordinator for TB Control and Elimination Program,
FNIHB, Thunder Bay Zone
鈥? Debbie Davis-Van Every, R.N., BScN, Nursing Coordinator for TB Control and Elimination
Program, FNIHB, Southern Ontario
鈥? Diane Hunley, R.N., BScN, PHN, Infectious Disease Program, Thunder Bay District Health
Unit
鈥? Paddy Dasno, R.N., TB Control Nurse, SLFNHA, Sioux Lookout Zone
鈥? Cindy McKinnon, R.N., BScN, Infectious Disease Control Program Manager, Northwestern
Health Unit
鈥? Dr. Jean-Pierre Courteau, RCMS, Director of Public Health Unit, FNIHB, Ontario Region
鈥? Joan Edwards, R.N., BNSc, MScN, Regional Nursing Officer, FNIHB, Ontario Region
鈥? Jill Tarasuk, Epidemiologist, FNIHB Ontario Region, Public Health Unit
鈥? Raymonde Hickey, RN BScN, FNIHB Ontario Regional Communicable Disease Control
Manager
1.3 Reviewers
Dr. Lilian Yuan (entire document)
Population Health Strategies
Dr. Elizabeth Rea, A/MOH (entire document)
TB Control Unit Toronto Public Health
City of Ottawa TB Control Public Health Nurses who reviewed the document:
鈥? Lori Royea
鈥? Norah Casterton
鈥? Alana McGeogh
鈥? Andrew Hendricks
Dr. Jae Yang, Assistant Professor of Medicine University of Toronto; Medical Director of the TB
Program and staff respirologist at St. Michael鈥檚 Hospital (Medication Chapter)
Susan Courage, RN, BScN; Operations Coordinator, National Quarantine Service; Public Health
Agency of Canada (Quarantine Chapter)
Gerry Slavin, Legal Services Branch (Orders)
Jane Speakman from legal services of Toronto Public Health (Orders)
1. Introduction Issued: 2006
Tuberculosis Version: 3.0
Protocol
Page: 1 of 285
1. A Brief Background
1. Tuberculosis (TB): A Brief Background
The infectious agent of tuberculosis infection and disease in humans is the Mycobacterium
tuberculosis complex which consists of M. tuberculosis (which is the primary concern of this protocol),
M. africanum, M. canetti and M. bovis 1 . M. bovis includes: M. bovis subsp. caprae, M. bovis subsp.
bovis and the vaccine strain M. bovis BCG. The reservoir is primarily humans, but diseased cattle
(M. bovis) and other mammals are implicated in some areas. Transmission usually occurs by
inhalation of droplet nuclei produced by people with pulmonary or respiratory disease. Healthcare
workers may be exposed during patient care or during procedures such as bronchoscopy, intubation
or autopsy. Bovine tuberculosis, though rare, can be acquired by the ingestion of unpasteurized milk
or dairy products from tuberculous cattle, and sometimes it is spread to farmers and animal handlers
through airborne means.
Primary infection usually goes unnoticed. Early lung lesions heal, leaving no detectable changes
except for occasional calcified pulmonary or tracheobronchial lymph nodes. About 10% of those with
initial infection will develop active disease, 5% within the first two years. Another 5% will go on to
develop active disease sometime in their lifetime. 2 Seventy percent of active tuberculosis disease is
pulmonary; but the disease can affect any organ or tissue. The risk of developing active TB may be
100 times greater in persons infected with HIV than in the general population. 3
Tuberculin skin test sensitivity usually appears within 2-10 weeks of infection. Latent foci of infection
may persist for a lifetime. Mass treatment for latent TB infection is unrealistic and inappropriate for
most communities. However, a risk assessment can determine which infected persons would benefit
most from treatment for latent disease.
The majority of cases of TB disease represent reactivation of latent infection. Virtually any clinical
presentation of tuberculosis is possible and the illness should be considered whenever protracted
febrile illness of unknown origin or undiagnosed coughing of more than three weeks is encountered.
Drug treatment of TB must always include an appropriate combination of antimicrobials and never a
single drug. For respiratory cases, sputum smears are utilized to determine communicability.
Directly-observed, supervised treatment should be used, when possible.
1 th
Heymann D.L. (Editor), Control of Communicable Diseases Manual 18 Edition, American Public Health Association 2004, p. 562
2 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 37
3
Ibid, p. 142
1. Introduction Issued: 2006
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1.1: Tuberculosis in Ontario
1.1 Tuberculosis in Ontario
There were 661 cases of tuberculosis (TB) reported in Ontario in 2004. The annual incidence rate
of 5.3 per 100,000 population was lower than the rate of 5.9 per 100,000 population seen over
the previous 3 years. However, in 1994 the TB rate in Ontario was 8.0 / 100,000 and the rate has
been slowly decreasing annually. The incidence rate of TB in Ontario in 2004 was slightly higher
than that of Canada as a whole, which in 2004 was 4.9 / 100,000. The highest rate of TB in 2004
was in Toronto (14 / 100,000 - 362 cases) followed by Peel (10.2 /100,000 - 119 cases), York (5.3
/100,000- 47 cases), Ottawa (4.8 /100,000 鈥? 40 cases) and Hamilton (2.7 /100,000 鈥?14 cases).
These five urban health units accounted for 88% of TB cases seen in Ontario in 2004. Toronto
alone had 55% of Ontario鈥檚 TB cases in 2004, averaging almost one case per day.
In 2004, just over 1% of TB patients were under 5 years of age. The vast majority of cases
occurred in the 30-49 age group (35%) and those over 60 years of age (27%).
Origin was recorded for 639 of the 661 cases in 2004. Of these 639 cases, 576 (90.1%) were
foreign-born, 45 (7%) were born in Canada and 18 (2.8%) were Aboriginal. Among the foreign-
born cases in 2004, 50% came from four countries: India (19.9% of all foreign-born cases),
Philippines (11.7%), Vietnam (9.8%), and China (8.9 %).
In 2004, 647 cases listed a method of detection. The vast majority of TB cases, 525 (81%), were
culture positive for TB and 122 (19%) showed no bacteriologic evidence and were considered
clinical cases.
There were 705 鈥榮ites of TB鈥? identified for 640 of the 661 cases (some cases had multiple sites).
Pulmonary and primary TB accounted for 55.7% of the sites reported (393 sites) while 44.3%
(312 sites) were extra pulmonary.
Of the 525 culture positive cases, 78 showed resistance to at least one TB drug .The resistance
pattern to any of the first line TB drugs was: isoniazid 45, rifampin 3, ethambutal 5, and
pyrazinamide 4. There were 3 multi-drug resistant TB cases (resistant to at least INH and
rifampin) in 2004, down from 14 in 2002 and 7 in 2003. However, 60 cases showed resistance to
鈥榓ny other鈥? TB drugs, indicating resistance to second line TB drugs.
It is not yet possible to determine the Canadian incidence of TB-HIV co-infection from our existing
surveillance systems. Screenings for HIV in TB cases and the reporting of results have been
identified as essential tasks for the future prevention and control of TB in Canada.
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1.2: Tuberculosis Control Programs: Definition
1.2 Tuberculosis Control Programs: A Definition
1. The first priority of a TB control program is the early identification and the curative
treatment of all infectious cases. This reduces the bacillary burden and decreases the
risk of infection being transmitted to others.
Rapid diagnosis of suspected cases depends on:
the patient entering the health care system when the first signs of TB appear; and,
the health care practitioner鈥檚 ability to recognize TB.
To ensure that both the public -- particularly populations at risk of TB -- and health care
practitioners have the knowledge and awareness to act quickly to diagnose and treat TB, an
effective control program must provide on-going public and health care provider education.
2. The next priority is evaluation and follow-up of close contacts of active cases in order
to identify secondary cases and to provide therapy for latent tuberculosis infection
(LTBI). 4
Three basic strategies critical to the prevention and control of TB in order of priority are:
i) identifying and completely treating all persons with active TB.
ii) Carrying out contact investigations
iii) Screening populations at high risk for TB (infection and/or other
diseases). 5
1.2.1 Tuberculosis Control in Ontario: Current Mandatory Programs and
Services Guidelines (MHPSG)
Under the Mandatory Health Programs and Services Guidelines (MHPSG), published by the
Ontario Ministry of Health in January 1998, each Board of Health is required to provide a
Tuberculosis Control Program. Revised program standard are expected in 2007 and it is
anticipated that objectives will be updated. The current MHPSG are described below:
1.2.2 Goal
The goal of a TB Control Program is to reduce the incidence of tuberculosis.
1.2.3 Objectives
To achieve this goal, boards of health will strive to meet the following objectives:
(a) Reduce the annual incidence rate of active and reactivated TB to 3.5 per 100,000
population by the year 2005.
(b) Reduce the progression of latent TB infection to active TB.
(c) Reduce secondary drug-resistance by the year 2005.
4 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p.175
5
Ibid p. 189
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1.2: Tuberculosis Control Programs: Definition
(d) Achieve the following completion rates by the year 2005:
鈥? 95% of active TB cases will complete treatment as prescribed.
鈥? 90% of individuals on chemoprophylaxis will complete therapy.
鈥? 90% of contacts of active cases of TB will be assessed.
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1.3: Roles and Responsibilities in TB Control
1.3 Roles and Responsibilities in TB Control
1.3.1 The Board of Health
According to the Program Requirements and Standards (TB Control Program, MHPSG), each
Board of Health:
1. Shall have in place an effective program for TB control outlined in a policy and
procedure manual, consistent with the Ontario Ministry of Health Tuberculosis Control
Protocol.
For people with active tuberculosis, the Board of Health program will include case finding,
case holding, treatment and follow-up. Such programs will, at a minimum:
(a) Ensure that all cases/suspected cases are fully investigated, according to the
Ontario Ministry of Health Tuberculosis Protocol.
(b) Ensure the provision of provincially-approved anti-tuberculosis drugs, as
required, at no cost to the patient.
(c) Review drug regimens and sensitivity results for each case to ensure their
appropriateness and adequacy.
(d) Monitor patient compliance with prescribed drug regimens, including the
completion and outcome of therapy, according to the Ontario Ministry of Health
Tuberculosis Protocol.
(e) Ensure that all persons with active (infectious) tuberculosis complete the
prescribed course of chemotherapy through the provision of directly-observed
therapy (DOT), or other appropriate intervention, according to the Ontario
Ministry of Health Tuberculosis Protocol.
(f) Notify the Ontario Ministry of Health immediately in the event that a patient does
not complete the above therapy.
(g) Provide, or ensure the provision of, annual updates to physicians and other
health professionals in the form of written materials and/or presentations on signs
and symptoms, risk factors and reporting requirements to achieve the early
identification and early reporting of active cases.
(h) On an on-going basis and in collaboration with community organizations, local
agencies and institutions, provide to the community written materials and
educational sessions on the signs and symptoms, epidemiology, risk factors and
the benefit of treatment to promote the early identification and treatment of
persons with active tuberculosis.
2. For TB prevention, the Board of Health shall have in place an effective program,
consistent with the Ontario Ministry of Health Tuberculosis Control Protocol. Such a
program will, at a minimum:
(a) Trace and investigate contacts of cases according to the Ontario Ministry of
Health Tuberculosis Protocol.
(b) Trace and monitor individuals placed on medical surveillance for inactive
tuberculosis according to the Ontario Ministry of Health Tuberculosis Protocol.
(c) Promote, through education and selective group screening programs, the
screening of all persons in high risk groups and assessment of those testing
positive to rule out active tuberculosis.
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1.3: Roles and Responsibilities in TB Control
(d) Encourage the prescribing of anti-tuberculosis chemoprophylaxis to those testing
positive, unless medically contraindicated.
(e) Ensure the provision of provincially-approved anti-tuberculosis chemoprophylaxis
drugs at no cost to the patient.
(f) Review the required drug regimens for each person on chemoprophylaxis to
ensure their adequacy and appropriateness.
(g) Monitor patient compliance with prescribed drug regimens and completion of
therapy according to the Ontario Ministry of Health Tuberculosis Protocol.
(h) Monitor the completion rate of the prescribed course of chemoprophylaxis for the
purpose of achieving the above-stated objectives.
(i) Provide or ensure the provision of annual updates in the form of presentations
and/or written materials to health professionals on risk factors for tuberculosis
infection, administration and interpretation of skin tests, indications for and
benefits of chemoprophylaxis and reporting of positive skin test results.
(j) On an on-going basis and in collaboration with community organizations, local
agencies and institutions, provide to the community written materials and
educational sessions on risk factors for tuberculosis infection and benefits of
chemoprophylaxis
1.3.2 The Ontario Ministry of Health and Long Term Care
To support boards of health in their efforts to control TB, the Ontario Ministry of Health will:
(a) Establish provincial standards for Tuberculosis Control Programs and review and
update them, as required.
(b) Design, implement and evaluate provincial TB control strategies.
(c) Administer the TB drug program.
(d) Collect, analyze and disseminate provincial data.
(e) Assist in the interpretation and enforcement of legislation as it relates to TB
control.
(f) Liaise with federal, provincial and territorial TB Control Programs to:
develop and implement national policies
facilitate the administration of TB Control Programs across boundaries (provide inter-
provincial consultation and liaison for case and contact follow-up)
consult with Citizenship and Immigration Canada on policies related to screening and
follow-up of cases of inactive tuberculosis in immigrants, refugees, visitors, visa
students and persons of undetermined immigration status.
(g) Provide consultation to other Ontario Ministry of Health branches (e.g.,
Residential Services Branch) and provincial Ministries (e.g., Ministry of
Correctional Services, Ministry of Education).
(h) Report TB data to the Public Health Agency of Canada (PHAC).
(i) Provide and support educational updates to groups and individuals involved in
TB control.
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1.3: Roles and Responsibilities in TB Control
1.3.3 Private Physicians
For most people, physicians are usually the first point of contact with the health care system and
the health care providers most likely to see people at risk and to diagnose TB.
As part of the TB Control Program, physicians will:
(a) Administer and interpret PPD skin tests.
(b) Assess and diagnose suspect cases of TB.
(c) Report to the local Medical Officer of Health, or designate, all cases of active and
suspect cases of active TB within 24 hours of making the diagnosis and report
positive skin tests within 7 days.
(d) Provide chemoprophylaxis as outlined in the current Canadian Tuberculosis
Standards.
(e) Provide treatment to cases and chemoprophylaxis to contacts of drug-resistant
cases in consultation with an expert in TB management.
(f) Provide treatment and medical follow-up of case until the person has completed
therapy.
(g) Provide information requested by the local Medical Officer of Health as well as
interim and final reports on all cases and contacts on chemoprophylaxis. This
information should, at minimum, include X-ray, smear and culture results as well
as medication changes throughout the duration of treatment.
(h) Monitor and report in a timely fashion to the local Medical Officer of Health any
issues re: non-compliance with treatment, including missed appointments.
1.3.4 The Laboratory/Diagnostic Facility
To support the TB Control Program, the laboratory/diagnostic facility will:
(a) Provide instructions to physicians/patients on collecting and submitting
specimens
(b) Adhere to Laboratory Proficiency Testing Program (LPTP) standards in the
collection, transportation, processing and retention of specimens
(c) Report positive results promptly to the attending physician and the Medical
Officer of Health of the jurisdiction where the laboratory is located and where the
specimen was collected
(d) Refer all culture positive specimens to the Public Health Laboratory (See
Chapter 3: Diagnostics for details in specific health unit jurisdictions)
(e) Interpret results to health professionals and health unit staff
(f) Consult with and educate health care providers.
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1.4 Reporting Requirements
1.4 Reporting Requirements
Ontario鈥檚 TB Control Program depends on maintaining accurate information about TB cases in
the province and having the ability to transfer or share information when appropriate. The Health
Protection and Promotion Act 1990 (HPPA) clearly outlines the requirements of physicians,
practitioners and institutions to report TB. The newly amended Regulation 569 in the HPPA
specifically lists the reportable information required for TB. In order to maintain the integrity of the
reporting system, all parties involved must fulfill their roles and responsibilities.
1.4.1 Definitions
(a) Surveillance Case Definition for Active Tuberculosis
An Individual:
with Mycobacterium tuberculosis complex (i.e. M. tuberculosis, M. bovis
(excluding BCG strain), or M. africanum) demonstrated on culture from
sputum, body fluids, or tissues, or,
without bacteriological proof but with clinical symptoms or signs,
radiological or pathological evidence of active pulmonary or non-
pulmonary disease, preferably with:
a positive tuberculin skin test (as defined by these provincial guidelines),
and/or
demonstration of acid-fast bacilli in smears from sputum, other body fluids or
tissue, and/or
response to anti-tuberculosis treatment.
(b) ICD 10 Coding for Tuberculosis
The new Integrated Public Health Information System (iPHIS), initiated in Spring
2005 in Ontario, is an information system for public health reporting and surveillance
in Ontario. IPHIS replaced the Reportable Disease Information System (RDIS). In
iPHIS, ICD 10 codes are used for TB.
These codes are provided on the following tables:
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Table 1: Respiratory TB
I ICD 10 Code A15.0 Tuberculosis of Lung
ii. ICD 10 Code A15.4 Tuberculosis of Intrathoracic Lymph Nodes
iii. ICD 10 Code A15.5 Tuberculosis of Larynx, Trachea and Bronchus
iv. ICD 10 Code A15.6 Tuberculosis Pleurisy
v. ICD 10 Code A15.7 Primary Respiratory Tuberculosis
vi. ICD 10 Code A15.8 Other Respiratory Tuberculosis
vii. ICD 10 Code 15.9 Respiratory Tuberculosis Unspecific
Table 2: Tuberculosis of Nervous System
I ICD 10 Code 17.0 Tuberculosis Meningitis
ii. ICD 10 Code 17.1 Meningeal Tuberculoma
iii. ICD 10 Code 17.8 Other Tuberculosis of Nervous System
iv. ICD 10 Code 17.9 Tuberculosis of Nervous System Unspecified
Table 3: Tuberculosis of Other Organs
I ICD 10 Code 18.0 Tuberculosis of Bones and Joints
ii. ICD 10 Code 18.1 Tuberculosis of Genitourinary System
iii. ICD 10 Code 18.2 Tuberculosis Peripheral Lymphadenopathy
iv. ICD 10 Code 18.3 Tuberculosis of Intestines, Peritoneum and Mesenteric
Lymph Nodes
v. ICD 10 Code 18.4 Tuberculosis of Skin and Subcutaneous Tissue
vi. ICD 10 Code 18.5 Tuberculosis of Eye
vii. ICD 10 Code 18.6 Tuberculosis of Ear
viii. ICD 10 Code 18.7 Tuberculosis of Adrenal Glands
ix. ICD 10 Code 18.8 Tuberculosis of Other Specified Organs
x. ICD 10 Code 19.0 Acute Miliary Tuberculosis of a Single Specified Site
Table 4: Miliary Tuberculosis
I ICD 10 Code 19.1 Acute Miliary Tuberculosis of Multiple Sites
ii. ICD 10 Code 19.2 Acute Miliary Tuberculosis, Unspecified
iii. ICD 10 Code 19.8 Other Miliary Tuberculosis
iv. ICD 10 Code 19.9 Miliary Tuberculosis, Unspecified
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1.4 Reporting Requirements
1.4.2 Definitions Related to Staging of a TB Episode:
(a) New Active Case:
No documented evidence or history of previously active TB.
(b) Relapsed (Reactivated) Case:
Documented evidence or history of previously active TB which became inactive.
(c) Inactive TB:
Negative cultures of mycobacterium tuberculosis negative for at least 6 months OR,
in the absence of a culture, chest (or other) x-rays that have been stable for a
minimum of 6 months.
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1.5 Duty to Report
1.5 Duty to Report
Under The Health Protection and Promotion Act (HPPA) Revised Statutes of Ontario, 1990
Chapter H.7, the following sections apply:
1.5.1 Physicians and Practitioners
Section 25 requires a physician or a practitioner to report as soon as possible to the Medical
Officer of Health in the health unit in which the professional services are provided if a person, who
is not a patient in or an out-patient of a hospital, has, or may have, a reportable disease. TB is a
reportable disease under the HPPA.
Practitioners include:
Chiropractors,
Dentists,
Nurses,
Pharmacists,
Optometrists, and
Registered drugless practitioners.
The person鈥檚 name, address, date of birth, gender and date of onset of symptoms and additional
information as the Medical Officer of Health (MOH) considers necessary must be provided.
1.5.2 Carriers of Disease
Section 26 requires a physician to report as soon as possible to the Medical Officer of Health in
the health unit in which the professional services are provided if a person is, or may be, infected
with an agent of a communicable disease. This would include carriers of TB; i.e., persons who
have a positive Mantoux skin test or who have an abnormal chest x-ray.
The person鈥檚 name, address, date of birth, gender and date of onset of symptoms and additional
information as the MOH considers necessary must be provided.
1.5.3 Hospital Administrators and Superintendents of Institutions
Section 27 requires hospital administrators and superintendents of institutions to report to the
Medical Officer of Health in the health unit in which the hospital or institution is located, if an entry
in hospital or institution records indicates that a patient or an out-patient:
Has, or may have, a reportable disease; or,
Is infected, or may be infected, with an agent of a communicable disease (i.e., TB
cases and carriers).
The report should be made as soon as possible after the entry is made in the records of the
hospital or institution.
The person鈥檚 name, address, date of birth, gender and date of onset of symptoms and additional
information as the MOH considers necessary must be provided.
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1.5 Duty to Report
1.5.4 School Principals
Section 28 requires the principal of a school to report if a student in the school has, or may have,
a communicable disease (i.e., TB), as soon as possible, to the Medical Officer of Health in the
health unit in which the school is located.
The student鈥檚 name, address, date of birth, and gender, as well as the name and address of the
school that the student attends, must be provided.
1.5.5 Operator of a Laboratory
Section 29 requires the operator of a laboratory to report each case of a positive laboratory
finding in respect of a reportable disease (i.e., TB) within 24 hours to the Medical Officer of Health
in the health unit in which the laboratory is located.
The person鈥檚 name, address, date of birth, gender, and the name and address of the physician or
dentist attending the person, must be provided.
1.5.6 Reporting Death due to a Communicable Disease
Section 30 requires that a physician who signs a medical certificate of death to report if a
reportable disease was the cause or a contributing cause of death, as soon as possible to the
Medical Officer of Health in the health unit in which death occurred.
The deceased person鈥檚 name, address, gender, date of birth, and date of death as well as the
name and address of the physician who attended the deceased, must be reported.
1.5.7 Medical Officer of Health Reporting
Section 31 requires that every Medical Officer of Health (MOH) reports to the Ministry after
receiving a report of reportable diseases or deaths from such diseases that occur in the health
unit served by the MOH.
1.5.8 Physician Reporting Refusal or Neglect of Treatment
Section 34 requires physicians to report the name and residence address of any person who,
while under the care and treatment of a physician in respect of a communicable disease, refuses
or neglects to continue the treatment the physician has prescribed, to the Medical Officer of
Health serving the health unit in which the physician provided the care and treatment.
If the person does not reside in the health unit served by the MOH where the physician provided
the care and treatment, the MOH shall transmit the report to the MOH serving the health unit
where the person resides.
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1.6 Information Collected for Reporting TB
1.6 Information Collected for Reporting TB:
1.6.1 Regulation 569 of the HPPA
This regulation was amended in 2005 to ensure that the necessary information is obtained for
reporting communicable diseases. There is a separate section for TB.
Section 6 Tuberculosis:
1. The date of the diagnosis.
2. The agent of disease.
3. The name and address of the physician attending the person.
4. Medical condition and status of the person including signs, symptoms and site, if any, of
the infection.
5. The clinical history of the person, including:
(a) The name of the hospital, date of admission and the date of discharge from the
hospital if the person is admitted to hospital; or, the name of the hospital if the
person is seen as an out-patient of the hospital.
(b) The date and duration of isolation, if isolated.
(c) Vaccination history.
(d) Reactivation of old disease and years of previous treatment setting out the drugs
and dosages used and the dates treatment commenced and ended.
6. The case classification of the person.
7. Laboratory findings and investigative tests including, without being limited to:
culture and antimicrobial sensitivity,
serological tests,
X-ray examination,
microscopic examination, and
cerebrospinal fluid examination, together with the results of the tests.
8. Current treatment, if any, of the infection, setting out the drugs and dosage used and the
date treatment commenced and ended.
9. Completion of the course of treatment including the major mode of therapy (Directly-
Observed Therapy - daily or intermittent or Daily, self-administered) and the treatment
compliance estimate (80%, 50-79%, less than 50% or unknown).
10. Place where infection is believed to have been acquired.
11. The source of infection including history of exposures.
12. Risk factors for the disease.
13. The immigration status and origin of the person, including:
(a) Country of birth.
(b) Country of last residence.
(c) Immigration Medical Surveillance serial number or Inland Processing Number.
(d) Date of arrival in Canada.
(e) Reported for medical surveillance (has made contact with health unit or equivalent
agency in other jurisdiction.)
(f) Has had medical assessment in Canada for immigration surveillance.
(g) Immigration status at time of arrival in Canada.
(h) Country of birth of parents, if person is under 20 years of age and Canadian-born
but non-Aboriginal.
14. The registered Indian status of the person.
15. The travel history of the person, including:
(a) Date and place of entry into country where disease acquired.
(b) Date of departure from country where disease acquired.
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1.6 Information Collected for Reporting TB
(c) Date and time of entry into Canada and carrier and flight number, if applicable.
(d) Travel within country where disease acquired by date, place and length of stay.
(e) Any other places visited en route to and from Canada.
16. List places and method of travel within Canada prior to and since the onset of illness.
17. The employment details of the person including job title and place of employment.
18. The name and address of the school the person attends, if applicable, including the
classroom.
19. Health unit responsible for identifying contacts.
20. Names of health units with contacts.
21. Number of contacts identified.
22. Number of contacts traced.
23. Number of contacts tested and number of contacts treated.
24. Results of testing of contacts.
25. Outcome:
(a) If the person is deceased: date of death and cause of death.
(b) Complications.
(c) Absconded - lost to follow-up before treatment completion.
(d) Other.
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1.7 Roles and Responsibilities
1.7.1 The Board of Health TB Staff
The Board of Health TB Staff will:
(a) Ensure that information collected on a reported case of tuberculosis or
infection meets the requirements of the HPPA Ontario Regulation 569
(Amended to O. Reg. 1/05).
(b) Establish whether the case of disease/infection meets the surveillance
definition.
(c) Report cases within 7 days to the Disease Control Service (DCS), Infectious
Diseases Branch (IDB), Ontario Ministry of Health and Long-Term Care
(MOHLTC) via the provincial reportable disease information system (iPHIS).
(d) Report to the senior medical consultant or designate, immediately upon
notification, TB cases that are lost to follow-up, including people who have
moved out of province, and cases on whom Section 35 orders have been
written.
(e) Report to the senior medical consultant or designate immediately any TB
cases that involve:
Infants or children
Media releases or have evoked media attention
Outbreaks
Contacts of cases who become active cases
Schools, teachers, health care professionals
Ambulance workers, firefighters or police
TB in the jail or correctional system
A person who has used bus, train or plane transportation for a
journey in excess of eight hours during the infectious period (See
Chapter 6: Contact Management for special forms for notification
of TB on an aircraft.)
Any other situation that you consider important that the MOHLTC
should be made aware.
(f) Ensure that the information reported through iPHIS is complete, accurate,
and updated, as appropriate, including the provision of the final case
disposition.
1.7.2 Retention of TB Records By Health Units
There are two documents that provide guidance for the length of time a health unit should retain
TB records. They are, as follows:
(i) Ministry of Health Records Management
A Guide for Boards of Health in Ontario: Information Analysis and
Development Services Supply and Services Branch September 26, 1986.
This document was sent to Medical Officers of Health on September 26, 1986 to
complete the Records Management Project which was initiated by the Public Health
Resource Service in response to health unit requests for assistance in issues related
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to record retention and filing systems. It provides recommendations for the retention
of records in local public health units; however, local bylaws should also be
considered in the retention schedules used by each Board of Health.
It was recommended that TB records be retained in the health unit office for five
years after the date of the last activity in the file then sent to off-site storage for
35 years (total 40 years), after which the files can then be destroyed.
The Chest Disease patient records that were provided by the Ministry of Health for
skin tests and chest x-rays (3 陆 鈥? x 6鈥? cards) were discontinued after the closure of
the Provincial Chest Clinics in 1982. They should be retained for two years then
destroyed.
(ii) alPHa Records Retention Guidelines for Ontario Health Units November 2000
This document describes and classifies most types of records that are maintained by
each health unit in Ontario and specifies when such records can be transferred offsite
and when they should be destroyed.
TB records are recommended to be kept in the office for two years after
discharge then kept off-site for 18 years.
1.7.3 The Disease Control Service, Infectious Diseases Branch
The Disease Control Service, Public Health Division, Ontario Ministry of Health will:
(a) Report agreed upon data to the Public Health Agency of Canada.
(b) Analyze and summarize provincial TB data and make it available to the
health units in the form of an annual report as well as providing a detailed
epidemiologic review annually in PHERO.
(c) Provide feedback to each health unit on the quality of iPHIS data.
(d) Inform the health units of changes in TB policies and procedures.
(e) Act as liaison in transferring information between federal/provincial/territorial
TB authorities and the health units.
(f) Provide guidance and assistance as required with complex cases or
outbreak management.
(g) Search for old TB records for patients who were in sanatoriums in Canada.
(h) Request the services of a field epidemiologist from the Public Health Agency
of Canada on an as-needed basis.
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1.8 Transferring Information between Public
Health Jurisdictions
1.8 Transferring Information between Public Health Jurisdictions
People with TB and their contacts will often travel from one public health jurisdiction to another
and their case information must follow them. Case information may be sent to the TB Control
Unit by standard mail or by fax. When cases have not received treatment before leaving the
health unit鈥檚 jurisdiction, then notification should be considered urgent and made by telephone
or fax, rather than standard mail. The following describes responsibilities in transferring case
information.
1.8.1 Transferring Information within Ontario
Under the HPPA (S.32), the Medical Officer of Health can provide case details, including names,
to the Medical Officer of Health, or designate, of other (Ontario) health units for the purpose of
administering the tuberculosis control program. Information on cases or contacts that live in
Ontario but outside the health unit should be sent to the appropriate health unit (where the
case/contact resides).
The receiving health unit must notify the referring health unit if the patient is lost to follow-up in
the transfer process. The receiving health unit is responsible for giving the referring health unit
details about the case disposition as soon as they are available.
The referring health unit is responsible for recording the final case disposition through iPHIS.
1.8.2 Transferring Information outside Ontario
Information on cases or contacts outside of Ontario or Canada should be forwarded to the
Disease Control Service, Infectious Diseases Branch, Ontario Ministry of Health, who will be
responsible for notifying the appropriate jurisdiction.
The receiving health unit must notify the referring health unit if a patient is lost to follow-up in the
transfer process. The referring health unit is responsible for providing the final case disposition in
iPHIS.
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1.9 Legislation
1.9 Legislation
Both the federal and provincial governments have legislation to guide TB management and
control, as follows:
Federal legislation attempts to prevent people with active TB from coming into the country
until they have been treated, and to control the spread of TB in federally managed, controlled
settings, such as correctional institutions.
Provincial legislation guides the ongoing prevention, control and management of TB in
Ontario.
Tables 5 and 6 outline the Federal and Provincial legislation in place containing sections
pertaining to TB control or communicable diseases in Ontario. These documents outline the
current statutory requirements but may not reflect the current standards of practice.
Current information for the legislation under the above jurisdictions may be obtained at the
following web sites:
Federal: www.laws.justice.gc.ca
Ontario: www.e-laws.gov.on.ca
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Table 5: Federal Legislation
FEDERAL IMPLICATIONS FOR TB
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鈥? TB is designated as a 鈥榙angerous disease鈥?: note that it is not
QUARANTINE ACT
considered an infectious or contagious disease under this Act.
R.S., c. 33(1st
鈥? Please see Chapter 14 鈥淨uarantining Persons with TB Under
Supp.), s.1.
the Federal Quarantine Act鈥? for the roles and responsibilities of
local public health units and the MOHLTC if a person is
quarantined for TB under the Federal Quarantine Act.
Relevant sections of the act are:
Medical Examination for a Dangerous Disease (TB):
鈥? Section 11 states how a person arriving in Canada from a place
outside Canada with a reasonable suspicion of having a suspected
dangerous disease can be requested to undergo a medical
examination immediately; if the person refuses they can be
detained for a period not exceeding 14 days.
Detention Longer than 48 hours:
鈥? Section 12 states that if a person is to be detained for longer than
48 hours, the federal Minister of Health applies for an order to a
judge of the superior court of the province in which the person is
detained, that the person has a dangerous disease.
Detention of Persons with Dangerous Disease:
鈥? Section 14 says that if the quarantine officer determines the
person has a dangerous disease, the person can be detained,
subject to the Minister, until the quarantine officer is satisfied that
the person is not capable of infecting other persons with that
disease.
The Immigration and Refugee Protection Act requires that all applicants
IMMIGRATION
for permanent residence and some visitors who apply to enter Canada
AND REFUGEE
have a medical examination. Based on this examination, applicants
PROTECTION ACT
might be refused entry into Canada if they have a health condition that
Immigration and
is likely to be a danger to public health or safety, or that could be very
Refugee Protection demanding on health or social services. The Act also requires that
Regulations people with certain medical conditions be placed under medical
SOR/2002-227 surveillance to encourage appropriate treatment and follow-up.
鈥? All potential immigrants, including sponsored refugees (people who
immigrate from refugee camps outside of Canada) and people who
are planning to stay in Canada for a period of six or more months
and who have resided or sojourned, at any time during the one
year period immediately preceding the date of seeking entry, for six
consecutive months, in an area that, in the opinion of the National
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Minister of Health, has a higher incidence of serious communicable
disease (i.e., TB) than Canada, must have a medical examination
before entering Canada.
鈥? See Chapter 9: Immigration Medical Surveillance for details of
the examination, assessment, process and forms.
Table 6: Province of Ontario Legislation
ONTARIO IMPLICATIONS FOR TB
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6(g) An emergency medical attendant and paramedic employed, or
Ambulance Act O.
engaged as a volunteer, in a land ambulance service shall, be free
Reg. 257/100
from all communicable diseases set out in table 1 of the document
Amended to O.
鈥淎mbulance Services Communicable Disease Standards鈥? published by
Reg.317/04
the Ministry, as that document may be amended from time to time.
Section 23:
Animals for
(2) Every non-human primate shall, forthwith upon arrival at a research
Research Act
facility and at such further intervals as may be appropriate, having
(Reg.24)
regard to all of the circumstances, be tested for tuberculosis in a
manner adequate to disclose the presence of tuberculosis in the
primate. R.R.O. 1990, Reg. 24, s. 23 (2).
(3) Every non-human primate found to have tuberculosis by a test
under subsection (2) shall be isolated from other non-human primates
that have not been found to have tuberculosis or shall be humanely
destroyed except only that such steps need not be taken to the extent
that the spread of tuberculosis forms a necessary element in research.
R.R.O. 1990, Reg. 24, s. 23 (3).
(4) No person who is known to have active tuberculosis shall be
employed in the care of non-human primates. R.R.O. 1990, Reg. 24, s.
23 (4).
53 (2) If a Medical Officer of Health determines that remains are those
Cemeteries Act
of a person who died of a communicable disease within the meaning of
(Revised) R.S.O.
the Health Protection and Promotion Act , the remains shall not be
1990, c.C.4
dealt with in any way except as prescribed by the regulations made
under that Act. R.S.O. 1990, c. C.4, s. 53 (2).
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11. (1) No board shall appoint an administrator or person to act
Charitable
temporarily as an administrator or employ a person on the staff of the
Institutions Act
charitable institution maintained and operated by it until the person so
R.R.O. 1990 Reg.
appointed or employed has obtained from a physician a certificate
69 s. 11,18
certifying that he or she is,
(a) free from active tuberculosis or other communicable or contagious
disease;
(2) At least once a year the administrator and each staff member of the
institution shall obtain the certificate prescribed in subsection (1).
R.R.O. 1990, Reg. 69, s. 11 (2).
(3) This section does not apply to a charitable institution that is an
approved charitable home for the aged. O. Reg. 371/94, s. 4.
(1) An approved corporation maintaining and operating a charitable
institution other than an approved charitable home for the aged shall
ensure that each person who is admitted to the institution as a resident
is given a skin test for tuberculosis unless the test is medically contra-
indicated. O. Reg. 371/94, s. 7.
(2) An approved corporation maintaining and operating an approved
charitable home for the aged shall ensure that each person who is
admitted to the home as a resident is given a skin test for tuberculosis
unless,
(a) the person was given the skin test in an approved charitable
home for the aged, a home under the Homes for the Aged and
Rest Homes Act or a nursing home under the Nursing Homes
Act less than one year before the date of admission; or
(b) the test is medically contra-indicated. O. Reg. 371/94, s. 7.
(3) The approved corporation shall ensure that the test required under
subsection (1) or (2) is given,
(a) within 14 days after the person's admission, if the person is
admitted for a period of at least 14 days; or
(b) within the period for which the person is admitted, if the person
is admitted for a period of less than 14 days. O. Reg. 371/94,
s. 7.
18.2 If the Ministry of Health gives an approved corporation
maintaining and operating an approved charitable home for the aged a
surveillance protocol for a particular communicable disease, the
approved corporation shall implement the protocol. O. Reg. 371/94, s.
7.
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93. Every licensee shall ensure that each person in a residence
Child and Family
operated by the licensee who suffers from a communicable disease
Services Act
and for whom isolation is considered necessary by a physician is
R.R.O. Reg.70
isolated from other persons in the residence who have not been
infected. R.R.O. 1990, Reg. 70, s. 93.
This is a lengthy regulation that clearly outlines who is considered a
Health Insurance
resident of Ontario and who is eligible for a health card. The
Act R.R.O. 1990
application for health insurance is outlined.
Reg. 552
The Health Protection and Promotion Act (HPPA), the main legislation for
Health Protection
tuberculosis control, provides the legal basis for controlling communicable
and Promotion Act
diseases, including TB.
R.S.O. 1990,
Chapter H.7
Under this Act, diseases are designated as reportable (O. Reg. 559/91),
communicable (O. Reg. 558/91) or virulent (HPPA, Section 1). Communicable
diseases are a subset of reportable diseases, and virulent diseases are a
subset of communicable diseases.
In the HPPA, tuberculosis is a Reportable, Communicable and Virulent
disease, and both tuberculosis infection (identified by a positive skin test) and
tuberculosis disease are reportable to the Medical Officer of Health (HPPA,
Sections 25 and 26).
The HPPA lists the reporting requirements for communicable diseases. It also
gives the Medical Officer of Health the authority to issue orders against anyone
who has a communicable disease, such as TB, and who is putting others at
risk. It also provides:
a) the Medical Officer of Health the authority to access
personal information that will assist in contact tracing
b) people with a communicable disease the right to appeal an
order issued by a Medical Officer of Health.
Sections in HPPA:
See Chapter 12 for specific information on use of Orders s.22 and 35
under the HPPA:
s.22 Order by MOH re communicable disease
s.23 Order by MOH re persons under 16 years of age
s.24 Directions by MOH
s.25 Duty to Report Disease
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s.26 Carrier of Disease
s.27 Duty of hospital administrator and superintendent of institution to
report disease
s.28 Duty of School principal to report disease
s.29 Duty of Laboratory operator to report disease
s.30 Duty to report death
s.31 Reports by MOH鈥檚 re diseases
s.32 Communication between MOH鈥檚
s.34 Physician to report refusal or neglect of treatment
s.35 Order by Ontario Court of Justice
s.36 Where person withdraws from care and treatment
s.37 Examination of persons under detention
s.38 Confidentiality
s.43 Notice of right to hearing
s.45 Appeal to court
Reg. 544 #4. Camps in unorganized territory 鈥? every operator shall forthwith notify the
medical officer of health for public health inspector of an outbreak or suspected
outbreak of any communicable disease in a camp operated by the operator.
25.1 (1) The municipality, municipalities or board maintaining and operating a
Homes for the
home shall report to the Director in full detail each of the following occurrences
Aged and Rest in the home:
Homes Act R.R.O.
4. A communicable disease outbreak.
1990 Reg. 637
28.1 (1) The municipality, municipalities or board maintaining and operating a
home shall ensure that each person who is admitted to the home as a resident
is given a skin test for tuberculosis unless,
(a) the person was given the skin test in a home, a nursing home under
the Nursing Homes Act or an approved charitable home for the aged
under the Charitable Institutions Act less than one year before the
date of admission; or
(b) the test is medically contra-indicated. O. Reg. 372/94, s. 14.
(2) The municipality, municipalities or board shall ensure that the test required
under subsection (1) is given,
(a) within 14 days after the person's admission, if the person is admitted
for a period of at least 14 days; or
(b) within the period for which the person is admitted, if the person is
admitted for a period of less than 14 days. O. Reg. 372/94, s. 14.
28.2 If the Ministry of Health gives the municipality, municipalities or board
maintaining and operating a home a surveillance protocol for a particular
communicable disease, the municipality, municipalities or board, as the case
may be, shall implement the protocol. O. Reg. 372/94, s. 14.
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9(1)The owner and the operator of a laboratory shall ensure that the staff of
Laboratory and
the laboratory,
Specimen
Collection Centre (b) report the results of a test directly to the person who requested it and
Licensing Act include in the report the name of the laboratory that received the
specimen and the name and address of the laboratory in which the
R.R.O. Reg. 682
test was performed;
(c) report all positive laboratory findings;
(i) that indicate the presumptive presence of any communicable
disease within the meaning of the Health Protection and
Promotion Act to the Medical Officer of Health in the area from
which the specimen originated within twenty-four hours after the
test is conducted, and
(ii) in respect of a reportable disease within the meaning of the
Health Protection and Promotion Act to the Medical Officer of
Health in the area in which the laboratory is located within
twenty-four hours after the test is conducted.
23. Every person employed in the station is free from communicable disease
Livestock and
and for that purpose shall, if so required by an inspector, be medically
Livestock examined.
Products R.R.O.
Reg. 726
13. (7) No person shall milk an animal or handle milking equipment or utensils
Milk Act R.R.O.
that come into contact with milk or cream except a person who is,
Reg.761 (b) free from any communicable disease as defined in the Health Protection
and Promotion Act and the regulations thereunder.
Regulations with respect to the operation of plants:
19. (1) The Commission may make regulations,
23. providing for the pasteurizing of milk or cream used for the manufacture of
a milk product;
17. No employee found to be suffering from active tuberculosis shall be
Mental Health
permitted to work in the institution and the officer-in-charge shall report the
Hospitals Act case within twenty-four hours to the Medical Officer of Health of the
R.R.O. 1990 Reg. municipality in which the employee resides and to the Medical Officer of Health
in the municipality in which he or she is employed. R.R.O. 1990, Reg. 744, s.
744
17.
19. The institution is responsible for all examinations for tuberculosis of an
employee and none of the expenses thereby incurred are payable by the
employee. R.R.O. 1990, Reg. 744, s. 19.
20. No employee shall be detailed to care for a patient believed or suspected
to be suffering from tuberculosis until the employee has received instructions
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as to the necessary technique to protect himself or herself and others against
infection and, where possible, the employee so detailed shall be a positive
reactor to the tuberculin test. R.R.O. 1990, Reg. 744, s. 20.
21. Upon ceasing to be employed, every employee who has been employed
for four or more months shall receive an x-ray film of the lungs and a
nonreactor shall also receive a tuberculin test. R.R.O. 1990, Reg. 744, s. 21.
22. Nothing contained in sections 13 to 21 shall prevent any person from being
employed in an institution when his or her tuberculosis is inactive. R.R.O.
1990, Reg. 744, s. 22.
23. A medical practitioner who believes or suspects that a person admitted to
an institution is suffering from tuberculosis shall notify the officer-in-charge
forthwith. R.R.O. 1990, Reg. 744, s. 23.
Regulations:
Ministry of Health
12. Subject to the approval of the Lieutenant Governor in Council, the Minister
Act may make regulations,
R.S.O. 1990 (h) governing the establishment, maintenance, operation and use of and
the treatment provided in facilities for the diagnosis, surveillance and
Chapter M26
treatment of tuberculosis, and governing the establishment,
maintenance, operation and use of facilities for the diagnosis and
surveillance of other respiratory diseases.
77.1 (1) A licensee of a nursing home shall ensure that each person who is
Nursing Homes
admitted to the home as a resident is given a skin test for tuberculosis unless,
Act
R.R.O. 1990 Reg. (a) the person was given the skin test in a nursing home, an approved
charitable home for the aged under the Charitable Institutions Act or a
937
home under the Homes for the Aged and Rest Homes Act less than
one year before the date of admission; or
(b) the test is medically contra-indicated. O. Reg. 373/94, s. 16.
(2) The licensee shall ensure that the test required under subsection (1) is
given,
(a) within 14 days after the person's admission, if the person is admitted
for a period of at least 14 days; or
(b) within the period for which the person is admitted, if the person is
admitted for a period of less than 14 days. O. Reg. 373/94, s. 16.
77.2 If the Ministry of Health gives the licensee of a nursing home a
surveillance protocol for a particular communicable disease, the licensee shall
implement the protocol. O. Reg. 373/94, s. 16.
Purposes
Personal Health
Information
1. The purposes of this Act are,
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(a) to establish rules for the collection, use and disclosure of personal
Protection Act
health information about individuals that protect the confidentiality of
2004
that information and the privacy of individuals with respect to that
information, while facilitating the effective provision of health care;
(b) to provide individuals with a right of access to personal health
information about themselves, subject to limited and specific
exceptions set out in this Act;
(c) to provide individuals with a right to require the correction or
amendment of personal health information about themselves, subject
to limited and specific exceptions set out in this Act;
(d) to provide for independent review and resolution of complaints with
respect to personal health information; and
(e) to provide effective remedies for contraventions of this Act. 2004, c.
3, Sched. A, s. 1.
Disclosures for health or other programs
2. A health information custodian may disclose personal health information
about an individual,
(a) to the Chief Medical Officer of Health or a medical officer of health
within the meaning of the Health Protection and Promotion Act if the
disclosure is made for a purpose of that Act; or
(b) to a public health authority that is similar to the persons described in
clause (a) and that is established under the laws of Canada, another
province or a territory of Canada or other jurisdiction, if the disclosure
is made for a purpose that is substantially similar to a purpose of the
Health Protection and Promotion Act. 2004, c. 3, Sched. A, s. 39 (2).
24. For the purpose of this Regulation, hospital employees are divided into
Private Hospitals
Group 1 and Group 2. R.R.O. 1990, Reg. 937, s. 24 (1).
Act
R.R.O. 937 (2) Group 1 is composed of,
(a) graduate nurses;
(b) interns;
(c) graduate physiotherapists;
(d) graduate occupational therapists;
(e) nursing assistants, nurses' assistants, ward maids and ward orderlies;
(f) laboratory technicians; and
(g) X-ray technicians. R.R.O. 1990, Reg. 937, s. 24 (2).
(3) Group 2 is composed of all hospital employees not listed in subsection (2).
R.R.O. 1990, Reg. 937, s. 24 (3).
25. (1) Every Group 1 employee shall receive a tuberculin test and an X-ray
film of the lungs within thirty days of employment. R.R.O. 1990, Reg. 937, s. 25
(1).
(2) Every Group 1 employee who has a negative tuberculin reaction shall
receive an additional tuberculin test within six months of the date of the first
test and shall receive an additional test within six months after the date of each
test, where the result of the test is negative. R.R.O. 1990, Reg. 937, s. 25 (2).
(3) Employees referred to in subsection (2) shall receive an X-ray film of the
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lungs annually. R.R.O. 1990, Reg. 937, s. 25 (3).
(4) Every Group 1 employee who is found to have a positive tuberculin reaction
shall not be required to take another tuberculin test but shall receive an X-ray
film of the lungs forthwith and every six months thereafter. R.R.O. 1990, Reg.
937, s. 25 (4).
(5) Every Group 1 employee whose X-ray film shows evidence of abnormal
shadowing shall forthwith receive further examination to determine the nature
of the disease. R.R.O. 1990, Reg. 937, s. 25 (5).
(6) No tests other than the intradermal (Mantoux) test, using one-twentieth of a
milligram of Old Tuberculin, or the patch test shall be used in the test given
under this section. R.R.O. 1990, Reg. 937, s. 25 (6).
(7) Where an employee has received a tuberculin test and an X-ray film of the
lungs within four months before the date of employment, the record of the
result of the test and film may be accepted in lieu of the test and film required
by subsection (1). R.R.O. 1990, Reg. 937, s. 25 (7).
26. (1) Every Group 2 employee shall receive an X-ray film of the lungs within
thirty days of employment and annually thereafter. R.R.O. 1990, Reg. 937, s.
26 (1).
(2) Where an employee has received a tuberculin test and an X-ray film of the
lungs within four months before the date of employment, the record of the
result of the test and film may be accepted in lieu of the X-ray film required by
subsection (1). R.R.O. 1990, Reg. 937, s. 26 (2).
(3) Every Group 2 employee whose X-ray film shows evidence of abnormal
shadowing shall receive forthwith further examination to determine the nature
of the disease. R.R.O. 1990, Reg. 937, s. 26 (3).
27. No employee found to be suffering from active tuberculosis shall be
permitted to work in the hospital, and the superintendent shall report the case
within twenty-four hours to the Medical Officer of Health of the municipality in
which the employee resides. R.R.O. 1990, Reg. 937, s. 27.
28. Where any legally qualified medical practitioner believes or suspects that
any person admitted to the hospital is suffering from tuberculosis, he or she
shall notify the superintendent forthwith. R.R.O. 1990, Reg. 937, s. 28.
29. No employee shall be detailed to care for a patient believed or suspected
to be suffering from tuberculosis until the employee has received instruction as
to the necessary technique to protect himself or herself and others against
infection and, where possible, the employee so detailed shall be a reactor to
tuberculin. R.R.O. 1990, Reg. 937, s. 29.
30. Upon ceasing to be employed, every employee who has been employed
for four months or more shall receive an X-ray film of the lungs. R.R.O. 1990,
Reg. 937, s. 30.
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31. (1) The superintendent shall keep a permanent record of all examinations
and tests of every employee of the hospital and if requested shall send a copy
of every record, including the X-ray films, to the Workers' Compensation Board
or to the Minister. R.R.O. 1990, Reg. 937, s. 31 (1).
32. The hospital is responsible for the examination of the employees and any
expenses thereby incurred. R.R.O. 1990, Reg. 937, s. 32.
33. Where an employee shows evidence of tuberculosis, the superintendent
shall give written notice thereof and a complete report of the medical findings
within seven days after the time of diagnosis to the Workers' Compensation
Board. R.R.O. 1990, Reg. 937, s. 33.
34. Nothing contained in sections 24 and 33 prevents an employee from being
employed in a hospital when his or her disease is inactive. R.R.O. 1990, Reg.
937, s. 34.
4. (1) Every board shall pass by-laws that,
Public Hospitals
e) establish and provide for the operation of a health surveillance
Act
program including a communicable disease surveillance program in
R.R.O. 1990 Reg. respect of all persons carrying on activities in the hospital;
965
2) The program referred to in clause (1) (e) shall, with respect to a particular
communicable disease, include the tests and examinations set out in any
applicable communicable disease surveillance protocol published jointly by the
Ontario Hospital Association and the Ontario Medical Association for that
disease and approved by the Minister. R.R.O. 1990, Reg. 965, s. 4 (2).
SCHEDULE 3: OCCUPATIONAL DISEASES
Workplace Safety
17. Tuberculosis
and Insurance Act
Any employment in a health care facility, a laboratory as defined in the
1997 175/98 Laboratory and Specimen Collection Centre Licensing Act or a reform
institution, any employment in providing health care services or health care
support services or any other employment in which there is a known risk of
exposure to tuberculosis or to the tubercle bacillus.
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2.1 Definitions
2. Surveillance and Screening
2.1 Definitions
2.1.1 Surveillance
Epidemiologic surveillance of tuberculosis is the timely collection, analysis, interpretation and
dissemination of data in order to:
(a) Identify TB trends in the community and
(b) Monitor and improve tuberculosis control activities.
2.1.2 Screening
Screening is the early identification of individuals who may have TB infection or disease.
An individual may be infected by Mycobacterium tuberculosis yet remain symptom free for many
years or for their lifetime. The major screening test for tuberculosis infection is the tuberculin skin
test.
Disease occurs when an infected person develops signs and symptoms of tuberculosis.
Screening for active disease is often referred to as active case finding. Screening tests include
sputum smear (this may include DNA fingerprinting if the patient is culture positive), chest
radiograph or examination of tissue (biopsy) in a non-pulmonary site.
A TB screening program consists of testing, medical assessment and completion of
recommended prophylaxis or treatment.
Testing is discouraged unless a plan has been developed to complete a course of treatment in
persons found to have LTBI or active TB. Such planning should include arrangements for medical
evaluation (e.g., chest radiographs) of persons with positive skin tests and for the medical
supervision of the course of treatment.
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2.2 Screening
2.2 Screening
2.2.1 Purpose of Screening
The purpose of screening is to:
(1) Identify undiagnosed active cases of infectious pulmonary TB in order to
ensure adequate treatment and to prevent transmission to others.
(2) Identify infected people who are at high risk of developing TB in order to
provide prophylaxis.
TB screening should be targeted at groups known to be at high risk for TB. With the exception of
initial testing of persons at low risk whose future activity will place them at increased risk of
exposure (e.g., employment in a setting where TB transmission may occur), screening of low-risk
persons is discouraged because it diverts resources from activities of higher priority.
Each year, health units should review the TB epidemiology within their area, identify populations
at risk of tuberculosis and target screening activities accordingly. Health units should evaluate
their screening programs periodically to determine if they are effective and modify them as
required. 6
2.2.2 Components of Screening
Tests used for screening are determined by the epidemiology, situation and purpose of
screening. All screening for TB should include a symptom assessment. Any person with a
history of symptoms should be investigated for TB disease.
For TB Infection:
Tuberculin Skin Testing (TST) (5TU PPD) is the recommended method of screening for TB
infection. Other methods such as the Tine test should not be used. Further discussion about
Mantoux skin testing may be found in Section 2.3. QuantiFERON庐 is a new blood test for TB
infection which is under evaluation but has not been licensed in Canada. See Chapter 3:
Diagnostics, Section 3.2.2. It is not yet approved by Health Canada and is not available at
any labs in Canada except on a trial basis.
For TB Disease:
Screening for active case finding is rarely done. Focus should be on specific populations.
(See: Section 2.2.3). Active case finding can include direct questioning for the presence of
symptoms associated with active disease, sputum smears, chest radiographs or tissue
examination for non-pulmonary TB. The presumptive diagnosis of active pulmonary TB is
often made on the basis of microscopic examination of a stained sputum smear for acid-fast
bacilli (AFB). Confirmation of the diagnosis usually requires identification of M. tuberculosis in
culture.
6 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 197.
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2.2 Screening
If a large number of sputum specimens are to be collected, prior arrangement needs to be
made with the public health laboratory to ensure sufficient capacity for processing samples.
If chest radiographs are planned, access to radiographic services and timely reading of chest
x-rays need to be arranged.
All screening programs should include:
(a) Clear rationale why a group is being screened
(b) Defined criteria of who is included or excluded (e.g., previous tuberculin skin test
positive) from screening
(c) Written protocol stating how a person who tests positive will be managed (i.e.,
medical referral, further investigation, follow-up regarding prophylaxis or treatment).
(d) Data collection and compilation to track:
the number of eligibles,
the number of tests administered,
the number of positive tests,
the number who completed medical referral, and
the number who completed prophylaxis or treatment.
(e) Adequate resources to support the screening program.
(f) Evaluation of the effectiveness of the screening program.
Operational issues to consider when screening is planned include:
(a) Education of group targeted for screening
(b) Training of staff who will be conducting the screening.
(c) Arrangements with laboratory if specimens e.g., sputum, are to be collected
(d) Written information about TB, translated into other languages as needed.
(e) Informed consent
(f) Relevant history taking. Ask clients about:
their history of BCG,
contact with active TB,
results of previous TB skin tests,
signs and symptoms of TB,
any previous treatment for LTBI or active TB, and,
their general health/current medical conditions.
(g) Referral for clinical evaluation of clients who have a positive test or are
immune-compromised (e.g., HIV-positive) or are 鈮?5 years of age.
(h) Complete and accurate record keeping. Record TB skin test results, in
millimeters of induration, for each person, preferably on the person鈥檚
immunization record (yellow card) and medical chart.
2.2.3 Indications for Screening
High risk individuals who should be considered for screening for LTBI include:
(a) Contacts with recent exposure to a known or suspected TB case (see
Chapter 6 - Contact Management)
(b) Persons with HIV (Human Immunodeficiency Virus) infection
(c) Persons born in countries with a high prevalence of tuberculosis
(d) The poor, especially the urban homeless.
(e) Alcoholics and Injection drug users
(f) Staff and inmates in correctional facilities
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(g) Staff and residents of long-term care homes
(h) Persons with a history of active TB or a chest X-ray suggestive of past TB
and inadequate therapy
(i) Persons with high-risk medical conditions such as chronic renal failure,
diabetes mellitus, immunosuppressive therapy and silicosis as well as
persons who have been prescribed tumor-necrosis factor-alpha antagonists
(i.e., Remicade庐 or Infliximab庐)
(j) Aboriginal communities with high rates of tuberculosis
(k) Persons working in settings in which they may be exposed to TB (e.g., health
care workers, homeless shelter workers, correctional institutions). These
workers should have a two-step TB skin test PRIOR to starting their
training/employment (See: Chapter 5 Case Management: Interim Guidance
for the Prevention and Control of TB in Homeless Shelters and Drop In
Centres) and, annually, depending upon their exposure risk.
(l) Children who are household contacts of HIV-infected persons, adopted from TB
endemic countries, or who have spent more than one month in a TB endemic country
(m) Travelers who are visiting a high-endemic area and who have one of the following
risks:
A medical condition that increases the risk of active disease following infection
Prolonged travel (greater than 1 month)
Intention to work in healthcare, refugee or other high-risk settings
There is NO COST associated with the testing of an individual who has been identified as a
contact of an active case of infectious TB. If you are aware of a physician charging for this
service, please have the individual call:
PROVIDERS SERVICES BRANCH, MONITORING AND CONTROL (extra billing section)
COLLECT at (613) 536-3103
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2.2.4 Screening in High Risk Environments:
This section discusses screening according to risk settings but persons infected with TB
can move from one setting to another; e.g., a person in a shelter enters a correctional
facility. Therefore, timely communication is essential between facilities so individuals
identified through TB screening receive adequate care and follow-up.
(a) Hospitals
The current Tuberculosis Surveillance Protocol for Ontario Hospitals is applicable to all
persons who carry on activities in the hospital, including employees, students, volunteers,
medical house staff, physicians, and contract workers. It does not apply to patients of
these facilities or to visitors. 7
Pre-placement or pre-appointment assessment should include tuberculin skin test status
to determine an accurate baseline. Persons with positive skin tests require further
assessment by the Occupational Health Service, or an appropriate physician.
The frequency of routine surveillance is dependent on the risk for TB transmission. High
risk health care facilities are those with > 6 active TB cases per year or > 1 active case
and the ratio of health care workers to the number of cases of TB annually is
鈮?100. 8 High- risk activities include cough-inducing procedures such as bronchoscopy,
autopsy, pathology examinations, and designated mycobacterium laboratory procedures.
Frequency varies from post-exposure only to every six months. 9
The protocol requires active investigation for anyone who has had contact with a potential
TB transmitter in hospital.
(b) Long-Term Care Homes (LTCH)
Long term care homes include:
homes for the aged
鈥?
retirement homes
鈥?
nursing homes
鈥?
chronic care facilities
鈥?
any other collective living settings for the elderly or infirm.
鈥?
TB skin testing is required for all residents, staff and volunteers in long-term care homes.
Two-step skin testing is recommended for residents and staff within 14 days of admission
or hire. Routine repeat screening is not recommended unless prevalence on employment
screening exceeds 5% or annual conversion rate among staff exceeds 0.5% 10 . All
residents who show symptoms or signs of active tuberculosis should be placed in
respiratory isolation and receive immediate medical assessment.
Instruct employees known to be TST positive to promptly report any symptoms
suggestive of TB; e.g., cough, fever, anorexia or weight loss. Retest individuals who
7
OHA/OMA Communicable Disease Surveillance Protocol, December 2002, p. 4
8
Ibid, pp. 9-10
9
Health Canada. Guidelines for Preventing the Transmission of Tuberculosis in Canadian Health Care Facilities and Other
Institutional Settings. CCDR April 1996: 22S1
10 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 220.
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were initially skin test negative and were subsequently exposed to an infectious case of
TB as part of a contact investigation. Always investigate residents who are symptomatic
for TB. 11
(c) Correctional Facilities
The type of screening program should be influenced by the local epidemiologic data and
whether facilities are short-term or long-term detention settings. All inmates who show
symptoms or signs of active tuberculosis should be placed in respiratory isolation and
receive an immediate medical assessment.
Correctional Service Canada has a protocol for tuberculosis control in penitentiaries. 12
Generally speaking, employees and inmates should receive Two-step tuberculin skin
testing within one month of employment or incarceration. Routine serial skin testing is
recommended until conversion rates are established for each facility. All facilities require
a mechanism for the transfer of screening information when inmates are transferred or
discharged.
(d) Shelters and Drop-In Centres for the Homeless
Tuberculosis screening in urban homeless populations is generally focused on the
detection of persons with active disease (case-finding). All shelter or drop-in centre users
who show symptoms or signs of active tuberculosis should be placed in respiratory
isolation and receive immediate medical assessment. Incentives such as food and transit
vouchers are likely to increase compliance with screening interventions.
Staff and volunteers working in homeless shelters and drop-in centres should be
screened with a Two-step tuberculin skin test initially, for an accurate baseline. The need
for routine or annual screening should be determined by the local public health unit. See
Chapter 5 Appendix A.
(e) Specialized Care Facilities
TB screening in specialized facilities, such as residential drug treatment centres,
hospices, group homes etc., should be determined by the local public health agency and
should be based on local epidemiology, and risk of TB transmission.
(f) Day Care Centres and Schools
A number of factors conspire against the effectiveness of school-based screening
programs to prevent future cases of tuberculosis. These include:
When applying the tuberculin skin test, which has limited specificity in a population at low
risk for tuberculosis, some of the positive skin tests are likely to be false-positive
reactions
Limited rates of utilization of treatment of LTBI result in minimal impact on future cases of
tuberculosis
Such programs have a very low yield of detection of active cases of tuberculosis. 13
11
Ibid
12
Correctional Service Canada, Tuberculosis Prevention and Control in Canadian Federal Prisons, 1998.
13 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 194
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Well-conducted contact tracing of infectious cases and refugee or immigrant testing are more
efficient than non-selective school-based testing for children who have TB infection. 14
Screening of employees working in day care settings should be restricted to those individuals
who are at risk of active tuberculosis and where local epidemiology and resources allow. 15 As
an example, the rate of TB in Toronto is almost 3 times the provincial rate. Toronto Public
Health recommends TB testing prior to employment for all staff and volunteers in daycares
and nursery schools. They recommend that a skin test be done within 6 months prior to
employment. 16
14
MMWR, 1995; 44 (No. RR-11), p. 11
15 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 190
16
Toronto Public Health. Information for Staff/Volunteers in Daycares and Nursery Schools. May 20, 2006.
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2.3 Tuberculin Skin Testing
2.3.1 Mantoux
The major tool to diagnose tuberculosis infection is the tuberculin skin test. The standard
Mantoux skin test is done using 5TU (5 tuberculin units) preparation. Tubersol庐, manufactured by
Sanofi Pasteur, is the skin testing preparation used in Canada. This test consists of the
intradermal injection of a small amount of purified protein derived from M. tuberculosis bacilli. It is
the most accurate, consistent and reliable of the skin tests. Purified protein derivative (PPD)
does not have any live organisms. It is both safe and reliable throughout the course of pregnancy
and during breastfeeding.
Tuberculin skin testing will identify those persons who have developed cell-mediated immunity to
the tuberculin antigens. A reaction consisting of local swelling, or induration, indicates the
presence of delayed hypersensitivity, which peaks in 24 鈥? 72 hours. Newly infected persons will
develop delayed cell-mediated immunity between 2 鈥? 10 weeks after encountering the
mycobacteria.
Conversion occurs when someone who has had previous negative skin test responds to a
tuberculin test with induration and swelling which meets the criteria for a 鈥減ositive鈥? result (See:
Section 2.4.2: Reading and Interpreting the Mantoux Skin test). Conversion is an indicator of
recent infection.
Since a single tuberculin test can stimulate an anamnestic response, yet appear negative, a
second test repeated at least one week after a negative response will differentiate between a true
positive and what is known as a 鈥渂ooster effect鈥?. This phenomenon has been described in various
populations 17 18 19 20 and must be distinguished from a sero-conversion. For more information,
see Two-Step Testing in Subsection 2.4.2, following.
Multiple puncture tests (MPTs), such as the Tine test, should not be used. The MPTs are not
reliable because the amount of tuberculin injected intradermally cannot be precisely controlled.
As a result, these tests may have significant false-negative rates and readings are very difficult to
standardize.
The tuberculin skin test reaction is not specific to M. tuberculosis complex (the mycobacterium
causing tuberculosis in humans). Infection with a variety of non-tuberculosis mycobacteria or with
BCG vaccine (a live, attenuated vaccine derived from M. bovis) may also cause the person to
react to the tuberculin skin test. It is also not possible for the tuberculin skin test to differentiate
between past and ongoing infection.
2.3.2 Storage and Handling of the Tuberculin Preparation
Correct storage and handling of the tuberculin preparation is critical. Failure to do so will result in
a loss of potency and inaccurate test results or false-negative results. (Tubersol product
monograph).
17
Menzies RJ, Vissandjee B, Rocher I et al. The booster effect in two-step tuberculin testing among young adults in Montreal. Ann
Intern Med 1994;120:190-8.
18
Ferbee SH, Mount FW. Evidence of booster effect in serial tuberculin testing. Am Rev Resp Dis 1963;88:118-9.
19
Sepulveda RL, Ferrer X, Latrach C, et al. The influence of Calmette-Guerin Bacillus immunization on the booster effect of
tuberculin testing in healthy young adults. Am, Rev Resp Dis 1990;142:24-8.
20
Knight RA, Kabakjian ME, William H, et al. An investigation of the influence of PPD-B hypersensitivity on the booster effect
associated with multiple tuberculin tests with PPD-S. Am Rev Resp Dis 1963;88:119.
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(a) Store the tuberculin preparation between +20C and +80C. Store it in the dark except when
the doses are actually being withdrawn from the vial. Do not leave it exposed to heat or light.
(b) Do not inject air into the vial prior to the withdrawal of PPD solution into the syringe.
(c) Date the vial of tuberculin when first opened if it is anticipated that all doses will not be used.
Discard a vial of tuberculin preparation that has been opened after one month as the potency
may be reduced due to oxidation and degradation.
(d) Return to Ontario Government Pharmaceutical and Medical Supplies Services (OGPMSS)
any vial of tuberculin preparation that is beyond the expiry date (the last day of the month that
is identified on the box), even if it is unopened.
For mass TB screening clinics, store a syringe filled with tubersol in the dark and use within one
hour of being filled.
2.3.3 Indications for Tuberculin Testing
Refer to Section 2.2.3 Indications for Screening for the list of populations that should be screened
using the TST test. The tuberculin skin testing should be performed to diagnose TB infection in
persons at increased risk of developing the disease. 21
Tuberculin screening of low risk populations is generally discouraged, although testing may be
performed for individuals. 22
23
2.3.4 Contraindications to Tuberculin Skin Testing
(1) When to defer skin testing:
Do not conduct skin testing in:
(a) Any one with a previous severe reaction (e.g., blistering, necrosis, or ulceration) to a TB skin
test.
(b) Anyone with documented active TB or treatment in the past. (The test does not distinguish
between prior and recent infection, and will not provide any useful information in this case.)
(c) People with extensive burns or eczema.
(d) People with viral infections which may temporarily depress the reactivity to the TST. Defer
TST for 4-6 weeks after the infection.
(e) Anyone immunized with a live viral vaccine, (e.g., MMR, varicella), which may temporarily
depress the reactivity to the TST. Refer to the Canadian Immunization Guide for the
complete list of live vaccines. Either administer the Mantoux test before or simultaneously
with the live, viral vaccine or defer TST for 4 to 6 weeks after immunization with a live viral
vaccine.
(2) When not to defer skin testing:
Do not defer skin testing for:
21 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 45
22
Ibid, p. 46
23
Ibid
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(a) People who have been immunized with a non-live vaccine, which does not suppress the
reaction.
(b) Pregnant women.
(c) Anyone who had a previous BCG vaccination.
(d) Anyone who had a history of a positive TST in the past (without a severe reaction/
blistering/ulceration/ necrosis at the site) but the reaction was not documented in
millimetres.
(e) Persons with a common cold.
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2.4 Tuberculin Skin Testing (TST)
2.4.1 Mantoux Test Technique
(a) Use universal precautions during this procedure.
(b) Avoid the use of Emla cream or any other product that might, in and of itself, provoke a local
reaction and interfere with the interpretation of the tuberculin.
Have Epinephrine Hydrochloride 1:1000 readily available for administration. Refer to the
current Canadian Immunization Guide, Anaphylaxis: Initial Management in Non-
Hospital Settings. 24 The current recommendations of the National Advisory
Committee on Immunization (NACI) say the patient who has had a Mantoux skin test
should be monitored for immediate reactions for a period of at least 15 minutes after
the test and for the initial management of anaphylaxis in non- hospital settings.
(c) Obtain an informed consent for the TST from the client.
(d) Use the Tuberculin Purified Protein Derivative (Mantoux) Tubersol preparation 5 TU for the
test. Check expiry date on the vial.
(e) Assess the skin on the volar (flexor) surface of the forearm, about 4 inches below the bend of
the elbow, in an area free of superficial blood vessels and free of skin lesions.
(f) Use a disposable, single-use sterile syringe and needle. The syringe should be a 1 ml.
syringe, calibrated in tenths fitted with a short (陆inch) 26 or 27 gauge needle.
Figure 1: Preparing the Test
(g) Wipe the rubber cap of the vial of the tuberculin preparation with an alcohol swab. Do not
inject air into the vial. Insert the needle gently through the cap and draw 0.1ml. of the PPD
24 th
Health Canada, Canadian Immunization Guide, 6 Edition, 2002, p. 14
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tuberculin preparation into the syringe. Tap the syringe gently and remove any air until fluid
can be expelled from the needle. Ensure that exactly 0.1 ml. still remains in the syringe.
(h) Clean the skin of the forearm with alcohol and allow to dry.
(i) With the bevel of the needle pointing upward, insert the point of the needle into the superficial
layers of the skin (intradermally). If the tuberculin is injected correctly, a definite white bleb or
鈥渨heal鈥? about 10mm in diameter will rise at the needlepoint. This bleb should disappear in 10
to 15 minutes.
Figure 2: TB Correct
Figure 3: Injection and Wheal
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Figure 4: Wheal 鈥? Front View
Figure 5: Wheal 鈥? Side View
(j) If the tuberculin preparation is not injected correctly, repeat on the other arm following the
same procedure and document this clearly.
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Incorrect Administration of TST
Figure 6: TB Deep
Figure 7: TB Shallow
(k) If a drop of blood is present at the injection site, dab it (do not press with cotton ball). Do not
cover with a Band-Aid.
(l) Dispose of needles in puncture resistant hazard container.
(m) Record the time, date, lot number and dose of tuberculin preparation injected and site(s)
(including right or left arm) of injection. Instruct the person to return at a specific date
with 48-72 hours of the test to have the TST read. Remind them that if the test is not
read within the specified time frame, the test will have to be repeated.
(n) Although rare, vesiculation, ulceration or necrosis may appear at the test site in someone
who is highly sensitive. If this occurs, advise the client to see a physician. Some people may
also experience pain, itching, and redness at the site. If the reaction is severe, it must be
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reported as an adverse event (refer to the local health unit protocol for reporting of adverse
events).
2.4.2 The Two-Step TST
(1) The Booster Effect:
A single TST may elicit little response but may stimulate an anamnesic immune response, so that a
second TST given at any time from one week to one year later will elicit a much greater response.
The booster effect was first described in older populations in whom it was felt to represent remote
tuberculosis infection when immunity had waned. It has also been seen in persons with prior BCG
vaccination or with non-tuberculosis mycobateria. 25
Note: Repeat skin testing will not induce a positive skin test reaction
unless the individual has been exposed to the tubercle bacilli.
The two-step testing is recommended for:
Establishing a reliable base line for persons who have not been tested within the past year
and who are going to be re-tested periodically.
Resident of long term care home who may be tested subsequently
Health care professional, staff in correctional facilities, workers in homeless shelters and
drop-in centres
For travellers to high prevalence area for prolonged visit.
The two-step test is NOT recommended for use as a baseline test for people who are contacts
of an infectious case. In contacts, any change from negative to positive must be considered a
conversion and treated appropriately.
(2) Method
The same method and techniques of administration and reading should be used. The second test
should be performed one to four weeks after the first test. Less than one week does not allow
enough time for the 鈥渂ooster 鈥? effect to occur. More than four weeks, the second results may be a
true tuberculin conversion, rather than the 鈥渂ooster 鈥渆ffect.
If the first test is positive (10 mm or more), do not perform the second test.
(3) Interpretation of the Two- Step TST
Consider anyone with a 10mm or greater reaction on the second TST for medical evaluation for their
risk for tuberculosis. The reaction may indicate prior infection and/or disease with M. Tuberculosis
and does not necessarily indicate the presence of active tuberculosis.
A chest x-ray should be done to determine the presence or absence of active pulmonary tuberculosis.
Microbiological examination of the sputum is recommended when the individual is symptomatic.
25 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 51
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(4) Reading and Interpreting the TST
A person who is newly infected with tuberculosis will develop a positive skin test between 2 to 12
weeks after acquiring the infection. Induration is the result of a delayed hypersentivity reaction. T-
cells sensitized by prior infection are recruited to the skin site where they release lymphokines.
Induration is induced through local vasodilatation, edema, fibrin deposition and recruitment of other
inflammatory cells into the area.
(a) Reading the TST
1. Reading the TST should be done by a trained health care professional (never by the
client).
2. Read the TST 48 to 72 hours after administration. Reactions may persist for up to one
week or longer.
3. Measure induration (do not measure redness). Note any blistering, which may occur in
3% to 4% of cases.
Figure 8: Correct Measurement
Figure 9: Incorrect Measurement
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4. To determine the size of the reaction, put the tip of a ball-point pen, at a 45 degree angle,
towards the site of the injection. The tip of the pen will stop at the edge of the induration.
Mark this point and repeat this process 3 times to determine the size of induration on
both the transverse and long axis of the arm. (The four marks will form a rectangle.)
Figure 10: Marking the Site
5. Measure, in millimetres, the length of the transverse diameter (the line that is at right
angles to the long axis of the forearm. This is the size of the reaction. Always record
the size of the reaction in millimetres (even if 0 mm). Do not use terms such as
positive, or negative.
Figure 11: Reading the Test
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Figure 12: Taking Measurement
6. Do not measure the area of redness. Approximately 2 % to 3% of people test will have
localized redness or rash (without induration), which occurs in the first 12 hours. These
are allergic reactions. They are not serious, and do not represent tuberculosis infection.
Figure 13: Tuberculin Measure
7. Document blistering or more serious reactions (e.g. necrosis at the injection site) if they
occur.
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Figure 14: TB Test covered with bandage
8. Record the date and size (in millimetres) of the TST result (induration) on the
immunization record as well as the physician/ health unit chart.
(b) Interpreting the TST
When interpreting the TST, consider the following factors:
Size of the tuberculin reaction.
Purpose for which the test was given.
Possible cause for false-negative and false positive reactions.
Person鈥檚 risk factors for the development of tuberculosis.
Local epidemiology of TB and prevalence of atypical mycobacterial infections.
Tuberculin Reaction
Size in MM Setting in Which the Reaction
Is Considered Significant 26
Induration
HIV infection AND expected risk of tuberculosis
infection is high (e.g., patient is an immigrant from a
country where TB is endemic, is a household contact,
or has an abnormal chest X-ray).
0鈥?4
This reaction size is not normally considered significant
but in the presence of immune suppression may be
important.
HIV infection
Contact of active, contagious infection
5鈥?9
Abnormal chest x-ray with fibronodular disease.
All others (including routine screening).
>10
26 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 50
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(c) Causes of a False Negative TST
False negatives may be caused by the following factors:
(a) Incorrect storage/handling of the Tuberculin (i.e., exposure to heat/light, delayed injection
after filling syringe, use of tuberculin that is outdated, or from vial first opened over one
month ago).
(b) Poor injection technique.
(c) Lack of experience in interpretation, bias in interpretation.
(d) Severe illness, which can include TB.
(e) Immune suppression due to either advanced age or disease (e.g., HIV, lymphoma) or the
effects of treatment (e.g., corticosteroids, oncologic chemotherapeutic agents).
(f) Malnutrition especially if there has been recent weight loss.
(g) Viral infection within the past 4 to 6 weeks.
(h) Recent immunization of a live viral vaccine, in the past 4 to 6 weeks. 27
(d) Anergy Testing in People with HIV Infection
People infected with HIV are at risk for active TB disease. Active TB may also speed the
progression of HIV-related disease. All people with HIV who have clinical symptoms
compatible with tuberculosis should be evaluated diagnostically for TB, regardless of the
results of the tuberculin skin test.
Anergy testing is a diagnostic procedure used to obtain information about the competence of
a person鈥檚 cellular immune system. However, anergy testing is no longer recommended as
a routine component of TB screening among HIV-infected persons because of:
(a) problems standardizing, reproducing and interpreting results with the currently-available
anergy testing methods; and,
(b) the lack of apparent benefit of preventive therapy for groups of anergic HIV-infected
persons. 28
(e) Causes of a False Positive TST
(a) Cross-reactions between the PPD and mycobacteria other than M. tuberculosis.
(b) BCG vaccination. 29
27 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 47
28
MMWR, Vol. 46, No. RR-15, Sept. 5, 1997
29 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 48-49
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3. Diagnostics
3.1 Overview
Diagnostic tests can assist in determining:
The identity of the infecting mycobacteria,
The risk status of an infected person,
Whether TB is latent or active,
The site of TB disease,
The infectiousness of a person with active disease,
Appropriate treatment, and
The extent and nature of a TB outbreak.
The presentation of TB varies according to the host, the environment, the site of infection and the
clinical stage. Before turning to diagnostic studies, it is imperative to undertake a thorough
history, regardless of whether one is investigating a positive skin test, an active case, or a
contact.
Table 1 on the following page outlines the essential components of a diagnostic work-up for TB.
The first two components, the history and the examination, should assist in determining whether
the person of interest has latent or active disease, is at greater risk for TB disease, has a prior
history of disease, and whether treatment was adequate.
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Table 1. Components of a Tuberculosis Diagnostic Work-up
TB history: history of TB exposure, prior tuberculin skin tests, prior TB infection or disease, risk
Medical
factors for drug resistant TB (history of incomplete treatment, foreign birth, incarceration).
History
Demographics: country of origin, occupation, incarceration history and other factors that might
increase the person鈥檚 risk of TB.
Medical conditions: conditions which increase risk for developing TB if infected or may affect
ability to tolerate TB treatment.
TB symptom history: fever, weight loss, cough >3 weeks duration, hemoptysis, chest pain.
Cannot be used to confirm or rule out a TB diagnosis but can provide valuable information about
Physical
the person鈥檚 overall health status.
Exam
Tests can be negative in the presence of active disease or HIV infection. Not needed if disease
Tuberculin
already confirmed with a positive culture.
Skin Test
Posterior / anterior view initially; others as appropriate. Children should routinely have a lateral in
Chest
addition to a P/A.
Radiograph
Because of implications of HIV infection for TB treatment, HIV counseling and testing is the
HIV
standard of care for the initial work-up of TB suspects. If HIV positive, obtain CD4+ and viral
load.
A positive smear indicates mycobacterial infection which may or may not be tuberculosis. Direct
AFB
detection by molecular diagnostic methods (e.g., AMTD, Gen Probe) can identify the AFB in the
Smears,
specimen as Mycobacterium tuberculosis complex (MTBC). Bacteriologic culture for M.
Cultures
tuberculosis confirms the diagnosis of TB; however, clinicians should not wait for culture results
and
before initiating therapy if they suspect active disease.*
Sensitivities
Pathology reports indicating caseating or necrotizing granuloma are presumed to be TB unless
Histology
proven otherwise. Detection by molecular diagnostic methods, such as PCR for MTB in tissue
blocks, is available at the Central Public Health Lab.
* A negative culture for M. tuberculosis does not rule out a diagnosis of pulmonary TB. Patients with abnormal
chest x-rays and symptom histories compatible with TB should be treated presumptively. Individuals on anti-
tuberculosis treatment with CXR improvement and negative cultures are considered to have culture-negative
TB.
Used with permission from Maryland 2003 Guidelines for Prevention and Treatment of Tuberculosis
The symptoms of pulmonary disease include cough, chest pain and hemoptysis. Systemic
symptoms of active TB include fever, chills, night sweats, loss of appetite, fatigue and weight
loss. The clinical presentation of extrapulmonary TB will vary according to the site of disease and
should be considered in the differential diagnosis of persons with systemic symptoms who are at
risk for TB. Other sites of respiratory TB include the larynx, but not the pleura.
HIV testing of persons with suspect and confirmed tuberculosis is the standard of care.
Knowledge of HIV status determines risk, alters presentation of disease and influences
management and treatment. The provider treating the case should offer HIV testing to all
suspects and cases. However, HIV testing should never be done without informed
consent. TB treatment regimens are adjusted according to the CD4+ cells/渭l count.
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3.2 Tests to Determine Infection
3.2.1 Tuberculin Skin Test
For a complete discussion of TB skin testing, please see Chapter 2: Surveillance and
Screening.
Since the TST is used to identify infection and not active TB disease, it is not necessary if disease
has already been confirmed with a positive culture. Tuberculin testing is best used to diagnose
latent TB infection or recent seroconversion. Although a positive TST is often the first step in a
diagnostic workup, the test can be falsely negative in the presence of active disease or HIV
infection.
The TST is performed to screen persons at increased risk of developing the disease, especially
contacts of cases and HIV infected persons. A negative TST does not rule out active TB.
Contraindications for skin testing include a previously documented positive TST or treatment of
culture positive TB. For more information on indications and contraindications, refer to Chapter 2:
Surveillance and Screening.
A TST must be interpreted by a trained healthcare provider 48-72 hours after administration.
3.2.2 Interferon-纬 Assays
The QuantiFERON庐 test (Cellestis Ltd) is a test which has FDA (U.S.) approval. The test detects
latent TB infection but cannot differentiate this from active disease. This is a screening test for
latent TB infection that can be used as an alternative to tuberculin skin testing in situations where
skin testing is not feasible or is less desirable.
At present the QuantiFERON庐 test is not available in Canada, unless special
arrangements have been made with the Special Access Program. Further Information may
be obtained at www.cellestis.com.
A similar test, the Elispot (Wellcome, U.K.), measures the cellular response in blood to
MTB antigens.
The test uses a whole blood sample from a patient, which is then incubated in a laboratory with
specific proteins from MTBC as well as with an indicator of immune response, mitogen. The
sample is then tested for gamma interferon, which indicates exposure to MTBC. The test is
invalid if the test for immune response is not positive.
The advantages of the QuantiFERON庐 test are that it:
Requires only one patient visit for blood sampling;
Is not affected by prior BCG immunization;
Provides a quantitative laboratory result rather than the subjective TST reading;
Includes a test for immune response to eliminate possible false negative due to anergy.
A number of published studies have shown that the sensitivity and specificity of the
QuantiFERON庐 and TST tests are similar. However further studies need to be done in specific
populations such as paediatric and HIV patients.
Additional information may be found in: Section 3.6.
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3.3 Tests for the Diagnosis of Pulmonary Disease
3.3.1 Radiology
Radiology is a useful tool to rule out or diagnose active TB. In addition, two
views of the chest may show some abnormality that correlates with diagnosis of latent TB. The
chest x-ray has limits on effectiveness due to the variability of reading/interpretation of results.
Indications include:
Assessment tool if person has pulmonary symptoms.
Assessment tool if person has systemic symptoms; i.e., pain in joint/bone.
Assessment tool if person has positive TB skin test.
Assessment tool for person who is being treated for active pulmonary TB to confirm efficacy
of treatment/indication of improvement from previous exams.
Assessment tool for person presenting with extrapulmonary TB to rule out pulmonary
involvement.
The procedure includes:
Requesting physician provides requisition/order for x-ray.
Technician does the x-ray for a chest, from an anterior/posterior angle and a lateral angle (if
recommended) and for any other portion of the body and confirms adequate view.
Radiologist views the x-ray film and provides interpretation of the results.
Time to Results:
Dependent on availability of radiologist to view and comment on results.
Generally within 48 hours.
Interpretation:
Needs to be viewed/interpreted by experienced radiologist who has received sufficient
information from the requesting physician on why the x-ray is being done; i.e., if active TB is
suspected or if TB skin test is positive.
Table 2: Presentation of Changes on Radiology:
Changes in apices of lungs
(a) In presence of active pulmonary TB:
Volume loss
Infiltrates
Nodules/Densities
Cavities
Pleural effusions
Hilar and/or mediastinal
lymphadenopathy
(3) Granuloma
(b) In presence of latent pulmonary TB:
(4) Fibrosis/scarring
(5) Calcified lymph nodes
(6) Abscess; i.e., bone
(c) In presence of active nonpulmonary TB:
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Special Conditions:
(a) In patients with HIV/AIDS:
The presentation on x-ray may be atypical due to immunocompromised status. Hilar and/or
mediastinal lymphadenopathy are more commonly seen. Completely normal chest x-ray may
be seen in advanced HIV disease.
(b) Children:
Lymphadenopathy more commonly seen-best viewed with a lateral view along with an
anterior/posterior view. Pediatric chest x-rays should be done at a facility equipped to
perform pediatric radiology. This is especially important for children younger than six years of
age.
(c) CT scan:
Computed Tomography allows more precise assessment of both pulmonary and
nonpulmonary disease.
3.3.2. Respiratory Specimen Collection
The collection of respiratory secretions, either via expectoration or during diagnostic procedures,
is an important laboratory tool for the purpose of diagnosing active pulmonary TB and for the
identification of antibiotic sensitivities to cultured MTB complex.
Indications include:
Assessment tool if person has respiratory symptoms
Assessment tool if person has changes on chest x-ray indicative of active or latent TB
Assessment tool if person has history of pulmonary TB with or without treatment
The procedure includes:
Have physician complete requisition for Acid-Fast Bacilli (AFB) smear and TB culture.
Attempt to obtain sputum samples even if person denies having a cough. A series of three
(3) specimens is recommended. A single collection should occur in the early morning on
three (3) consecutive days.
NOTE: In order to collect an adequate sample of secretions and not just saliva, the person
should cough deeply, bringing up sputum from the lungs (not saliva or spit from the throat
or mouth) and deposit the sputum into specimen container.
The container must be fitted with a tight lid and secured well, ensuring the container does not
leak.
The container should be properly labeled with person鈥檚 name and collection date and placed
into the plastic specimen bag, pressing out the excess air and sealing the plastic bag.
Complete the specimen collection form/requisition and place it in the outside slot of the
plastic bag.
The sample must be delivered to the lab as soon as possible and must be refrigerated if
transport is delayed more than 2 hours.
Person collecting the specimen should be wearing an N-95 mask or collect the sample
outside in open air.
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Time to Results:
The AFB smear result is generally available within 24 hours of specimen arriving at the
lab.
The AMTD result, done automatically on the first AFB smear positive sample from a
new patient, is generally available within the next 48 hours, depending on how often the
lab does this testing. (Check with local public health lab to confirm when testing is done.)
The TB culture result is generally available within 9-28 days of specimen arriving at the
lab. (Mycobacteria are slow growing and the growth time for MTBC in the culture depends on
the number of MTB organisms present within the sample. )
A negative culture result is issued at 7 weeks.
Antibiotic susceptibility testing is done on the first MTBC culture isolated from a
patient. Results are generally available within 7 days of culture growth and are only
obtainable on culture positive samples of MTBC.
Special Conditions:
(a) Induced Sputum Collection:
If a patient:
cannot cough to produce sputum; or,
if the sputum sample collected is NOT sufficient,
a saline solution can be inhaled via a nebulizer which will induce the person to cough
up sputum for collection and processing in the same manner as noted above.
Ensure the requisition indicates that the sputum was induced as the sample may
appear watery.
(b) Bronchoscopy:
If person cannot cough or if induced sputum is not available, a bronchoscopy can be done to
obtain sputum samples. However, this procedure is more invasive and expensive.
(c) Gastric aspirate:
This type of aspirate is often indicated when investigating TB in children less than five years
of age, as they cannot cough forcefully enough to bring sputum up. During sleep, sputum
from lungs moves up into the mouth and is swallowed into the stomach. Aspirating the
stomach contents for sampling may reveal TB organisms. Aspiration is done when person
first awakes and requires a special container containing sodium carbonate to neutralize
the stomach acid. The sample is then processed in the same manner as noted above.
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Table 3: Interpretation of Lab reports
Type of Test Results Interpretation Comments
Not Seen/Negative No AFB seen in sample. Sample may not contain
Acid Fast Bacilli
Does not rule out TB-need to enough organism to be seen
smear
have culture results for by microscopy.
(AFB)
diagnosis.
Scarce/Moderate/Numerous AFB seen in sample. AFB level can be indicator of
Indicates amount of bacilli infectiousness. The higher
present. the number of bacilli, the
Indicates either MTB complex or higher the risk the patient is
non-tuberculosis mycobacteria. infectious.
Negative MTB complex rRNA not False negative can occur due
Amplified
detected indicates not TB to low number of MTB
Mycobacterium
organisms. The presence of
Tuberculosis
non-tuberculosis
Direct (AMTD) mycobacteria may cause
interference or there may be
inhibitors present in the
sample.
Positive MTB complex rRNA detected Sample may also contain non-
indicates is TB. tuberculosis organisms as
well.
Indeterminate Unable to interpret result. Possible that not enough
sample was obtained to test,
very low number of MTB are
present, or amplification
inhibitors are present.
Specimen collection should
be repeated.
No growth Indicates MTBC organisms were Case may still be clinically to
Culture
not grown be possible active TB (clinical
case of TB).
MTBC organisms were grown Confirm active case of TB.
Mycobacterium tuberculosis
complex
Various non-tuberculosis Non-tuberculosis mycobacteria Not MTBC, or MTBC may be
mycobacteria (NTM) were grown. overgrown by NTM.
Eg.. Mycobacterium avium
Mycobacterium xenopi
Chart with susceptibilities to first Susceptible Indicates which TB
Susceptibility
line TB medications medications are effective.
Testing
Resistant Indicates which TB
medications are not effective.
Chart with susceptibilities to Susceptible Indicates which TB
second line TB medications medications are effective.
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Table 3: Interpretation of Lab reports
Type of Test Results Interpretation Comments
Resistant Indicates which TB
medications are not effective.
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3.4 Nonpulmonary TB
3.4 Non-pulmonary TB
TB disease of other organs and tissues requires the collection and testing of non-pulmonary
specimens. Table 4 indicates the types of specimens which may be indicated and the specific
instructions which must be followed in order for testing to be carried out.
It is important that all persons with non-pulmonary TB be screened for pulmonary disease,
including chest x-ray and sputum.
The following table is intended as a reference only (for health unit information). Health units are not expected to
obtain these samples.
Table 4: Specimens Other Than Sputum
SPECIMEN SPECIMEN UNACCEPTABLE
SPECIAL INSTRUCTIONS
TYPE REQUIREMENTS SPECIMENS
As much as possible in Cleanse skin with alcohol before Dry swab
Abscess
sterile plastic container aspirating sample. Submit in sterile
contents,
Note: No minimum can be container. If aspiration is not
aspirated fluid
specified here. Pus may possible, collect specimen of swab
arrive on a swab in transport and place in aerobic transport
medium only if volume is
insufficient for aspiration by needle
and syringe.
10-mL SPS (yellow top) or Disinfect site as for routine blood Blood collected in EDTA,
Blood
10 mL heparin (green top) culture. Mix tube contents which greatly inhibits
blood collection tube immediately after collection. mycobacterial growth
5mL blood may be injected directly even in trace
to MycoF/Lytic media, if available. amounts(3). Coagulated
blood. Serum. Plasma.
Blood in bacterial blood
culture medium that is
inappropraite culture
media for TB.
As much as possible (10- Disinfect site with alcohol if Note : bloody specimens
Body fluids
15mL minimum) in sterile collecting by needle and syringe. cannot be tested by
(pleural,
container AMTD.
pericardial,
peritoneal, etc.)
Bone in sterile container Specimen submitted in
Bone
without fixative or formalin.
preservative
As much as possible in Collect aseptically. Mix anti-
Bone marrow
sterile collection tube or coagulant tube contents
SPS or heparin tube immediately following collection.
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Table 4: Specimens Other Than Sputum
SPECIMEN SPECIMEN UNACCEPTABLE
SPECIAL INSTRUCTIONS
TYPE REQUIREMENTS SPECIMENS
>5mL in sterile container Avoid contaminating bronchoscope
Bronchoalveolar
with tap water. Saprophytic
lavage or
mycobacteria may produce false
bronchial
positive culture or smear results.
washing
Sterile container. Add sterile
Bronchial
saline if small amount
brushing
>2mL in sterile container Send maximum volume attainable.
CSF
5-10mL in sterile gastric Collect fasting early-morning Specimen that has not
Gastric lavage
container supplied from the specimen on 3 consecutive days. been neutralized.
fluid (for
Provincial health lab. Collect Laboratory provides gastric
children less
in the morning, before the collection jars containing sodium
than 5 years of patient gets out of bed in carbonate. If gastric container not
age) order to obtain sputum available 鈥? adjust specimen to
swallowed during sleep neutral pH with 100 mg of sodium
carbonate immediately following
collection.
Node or portion in sterile Collect aseptically and avoid Specimen submitted in
Lymph node
container without fixative or indigenous microbiota. Select formalin.
preservative. A small caseous portion if available. Do not
amount of sterile saline may wrap in gauze. Freezing decreases
be added. the yield.
Submit biopsy specimens in Swabs in transport medium (Amies Dry swab
Skin lesion
sterile containers without or Stuarts) are acceptable only if
material
fixative or preservative. biopsy sample or aspirate is not
Submit aspirate in syringe obtainable. For cutaneous ulcer,
with Luer lock cap, needle collect biopsy sample from
removed. periphery of lesion or aspirate
material from under margin of
lesion. If infection was acquired in
Africa, Australia, Mexico, South
America, Indonesia, New Guinea,
or Malaysia note this on the
request because M ulcerans may
require prolonged incubation for
primary isolation.
>1g in sterile, wax-free, Collect specimen directly into Frozen specimen.
Stool
disposable container container or transfer from bedpan Specimen that has been
or plastic wrap stretched over toilet in contact with water in
bowl . the toilet.
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Table 4: Specimens Other Than Sputum
SPECIMEN SPECIMEN UNACCEPTABLE
SPECIAL INSTRUCTIONS
TYPE REQUIREMENTS SPECIMENS
1 g of tissue, if possible, in Collect aseptically and avoid Specimen submitted in
Tissue biopsy
sterile container without indigenous microbiota. Select formalin.
sample
fixative or preservative caseous portion if available. Do not
wrap in gauze. Freezing decreases
the yield.
As much as possible in Do not submit specimens
Transtracheal
syringe with Luer lock cap, in endotracheal tubes.
aspirate
needle removed, or other
sterile container
As much as possible Collect first morning specimen on 3 24-h pooled specimens;
Urine
(minimum 40mL) of first consecutive days. Accept only one urine from catheter bag,
morning specimen obtained specimen/day. Organisms specimens of <40mL
by catheterization or accumulate in bladder overnight so unless larger volume is
midstream clean catch in first morning void provides best not obtainable. Urine
sterile container. For yield. Specimens collected at other specimens should only
suprapubic tap, as much as times are dilute and are not be tested if renal TB is
possible in syringe with Luer optimal. suspected, not as routine
cap or other sterile screening.
container.
Source: Adapted from publication:
Mycobacteriology Laboratory Manual (2005), Laboratories Branch, Ministry of Health and Long-term Care.
Reprinted with permission.
www.health,on.ca & follow the links to Specimen Collection Guide
Note: For queries about specimen collection or to discuss test results, contact the Lab
Head or Microbiologist at the TB laboratory
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3.5 Laboratory Testing for Tuberculosis
3.5 Laboratory Testing for Tuberculosis
3.5.1 Overview
Laboratory testing is an integral part of the diagnosis of tuberculosis (TB). The acid-fast bacilli
(AFB) smear test gives a rapid early indication of possible TB and of a patient鈥檚 infective status.
Nucleic acid amplification tests (NAAT) can assist in the rapid identification of AFB seen in the
smear, as M. tuberculosis complex (MTBC). Culture is more sensitive than the smear and a
culture is required in order to do susceptibility testing. Susceptibility testing provides a guide to
appropriate therapy. Strain typing may be used to assist in outbreak investigations and in tracing
the transmission of TB.
The M.tuberculosis complex (MTBC) tests used to detect MTBC cannot differentiate the species
within this group. The complex consists of M. tuberculosis, M.africanum, M.cannettii, M.bovis,
M.bovis BCG, and several species found only in animals. The first 3 species may be considered
the same, for the purpose of clinical significance. M.bovis will be identified during susceptibility
testing since it is resistant to PZA. The significance is mainly epidemiological. M.bovis BCG will
also be detected during susceptibility testing and is primarily found in patients undergoing BCG
instillation therapy for bladder carcinoma.
3.5.2 Types of Laboratory Testing
(a) The AFB Smear
Specimens are processed in order to achieve decontamination from other organisms that may be
present in the specimen, and for homogenization and concentration. A smear is made from the
specimen concentrate, and is stained to allow visualization of AFB by microscopy.
Some laboratories perform a 鈥榙irect smear鈥? from the specimen, without concentration. The result
from a direct smear should be considered as preliminary, with transfer of the specimen to a
referral lab where a more sensitive, concentrated smear can be performed. A concentrated smear
provides detection of AFB in a specimen when the bacterial load is approximately 10,000 AFB
per ml.
The smear is reported as 鈥? No AFB seen鈥?, or 鈥? AFB seen鈥? with the following quantitation : scarce,
moderate or numerous. Other quantitation systems such as 1+, 2+, are used by some labs.
The smear report is issued within 24 hours of specimen receipt in the lab. All new AFB
positive smear reports are phoned to the ordering physician/health professional. All
positive AFB smear reports are copied to the Medical Officer of Health (MOH) where the
patient resides and to the MOH where the lab is located, as per regulation.
A smear may be performed as a STAT in urgent cases. At Public Health Labs (PHLs), STAT
requests must be telephoned to the lab and a same day, verbal result is given if the specimen
arrives by 2:00p.m. (1400 hours).
AFB smears are not routinely performed on urine samples due to commensal nontuberculous
mycobacteria (NTM) that may be present in the GU tract. Smears are not done on blood
specimens or bloody fluid samples. These specimens are inoculated directly to blood culture
media.
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AFB seen on a smear may be MTBC, NTM or a few other species such as Nocardia spp. which
are semi-acid fast. The specificity of the AFB smear for MTB depends on the demographics of the
patient population. In Southern Ontario the specificity is approximately 50%, since the region has
a high level of NTM. Smear positive specimens may be tested by an amplification test to
determine the identity of the AFB as MTBC or NTM.
Frequency of testing:
For initial diagnosis:
Three sputum specimens, on three consecutive days, should be submitted.
Subsequent to initiation of treatment:
In order to monitor sputum conversion and treatment outcome, all patients with sputum
smear and culture positive disease would have repeat sputum examinations performed at the
end of the second month. To verify treatment success, additional sputum cultures should be
obtained at the end of therapy for both six-month and nine-month regimens. More frequent
monitoring is recommended when the clinical and radiographic response is unfavourable. 30
A referral for sputum induction should be made if the patient is unable to produce a
sputum sample for examination.
(b) Nucleic Acid Amplification Tests (NAAT)
A number of NAAT tests are approved and available commercially. The Amplified Mycobacterium
Tuberculosis Direct (AMTD) by Gen-Probe CA. was selected for use in Ontario due to rapid
turnaround time, sensitivity and the potential to detect active, viable MTBC directly in clinical
specimens. The test is used on concentrated specimens to detect the presence of rRNA from
MTBC.
The AMTD is performed routinely on all new AFB smear positive specimens.
The sensitivity and specificity are high (95%) on smear positive specimens.
Smear negative specimens are only tested upon special request. The sensitivity is significantly
lower (range 65-80%) for AMTD鈥檚 done on AFB negative specimens 31 .
AMTD testing is performed at the Central Public Health TB Lab, Toronto, on Monday,
Wednesday and Friday mornings.
The test takes approximately 4 hours and all results are telephoned to the submitter by
2:00p.m. (1400 hours).
AMTD cannot be done on blood or bloody specimens.
Results are reported as follows:
rRNA of MTBC detected ( positive); or,
rRNA of MTBC not detected ( negative)
30 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 95
31
Public Health Laboratories, Ontario. December 2005. Labstract 鈥淭B and Mycobacteriology Laboratory Update:
Susceptibility Testing of M. tuberculosis complex isolates.鈥?
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Results may be 鈥榠ndeterminate鈥? due to inhibitors in the specimen or because of a very low
bacterial load. In this case, the test will be repeated on the original specimen and, if still
indeterminate, a new specimen may be sent for repeat AMTD testing.
All AMTD results are telephoned to the ordering physician or lab.
All positive results are copied to the MOH where the patient resides and to the MOH where
the lab is located.
AMTD testing is performed only on specimens from untreated patients and cannot be used
to follow therapy.
(c) Culture
All specimens submitted for mycobacterial testing are inoculated to liquid and solid culture media.
Inoculated media are monitored for growth for seven weeks. Culture is more sensitive than the
AFB smear and can detect 10 to 100 viable organisms/mL. Due to the slow generation time of
mycobacteria (18 hours vs. 30 minutes for other bacteria), culture growth and detection may take
several weeks.
The average time for growth of MTBC in a liquid culture from a smear positive specimen of an
untreated patient, is 10 days. Some NTM grow more slowly, for example M. xenopi, which may
take 7 weeks for growth detection.
Identification of growth from cultures: A DNA probe test, AccuProbe ( Gen-Probe), is used
to identify MTBC in cultures. The test is run daily and takes 2 hours.
鈥? All MTBC positive culture results from new patients are telephoned.
鈥? All MTBC positive culture results are copied to the MOH
Cultures which are AFB positive but which are negative for MTBC are identified by AccuProbe or
by high performance liquid chromatography (HPLC) as non-tuberculosis mycobacteria (NTM)
species.
There are currently 113 known species of NTM.
Isolation of NTM from patient specimens may indicate NTM disease or may not be of not clinical
significance. The 1997 American Thoracic Society recommendations on the Diagnosis and
Treatment of NTM may be consulted. 32
(d) Susceptibility Testing of MTBC
The first isolate of MTBCC from each patient, is tested for susceptibility to the 4 first line drugs
(isoniazid, rifampin, ethambutol, pyrazinamide). The test takes an average of 7 days and all
results are phoned to the submitter and copied to the MOH.
If resistance to isoniazid is found at the critical concentration, repeat testing is done using a
higher level of the drug. If resistance is at the lower concentration only, it is reported: 鈥淭est
results indicate low level resistance to INH鈥?. Some experts believe that patients infected with
32
American Journal of Respiratory Critical Care Medicine, 1997, Vol. 156.
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strains exhibiting this level of resistance may benefit from continued therapy with INH. 33 If
resistance is found at both concentrations, a report is issued: 鈥淭est results indicate a high level of
INH resistance鈥?.
Repeat testing to the first line drugs is performed if cultures are still positive at three months. Any
isolate found to be resistant to two of the first line drugs or to rifampin, is tested against a further
panel of seven second-line drugs (streptomycin, amikacin, capreomycin, clofazamine, ofloxacin,
rifabutin, ethionamide).
Only specimens which produce a viable, pure culture of MTBC can be tested.
Mixed cultures, such as MTBCC plus an NTM, cannot be tested for susceptibility. In this
case, more specimens should be submitted in order to enhance the possibility of obtaining pure
growth.
(e) PCR (Polymerase Chain Reaction)
PCR is used at the Central Public Health laboratory to detect MTBC DNA in specimens that have
been fixed in formalin or embedded in paraffin for pathology. These samples cannot be tested by
AMTD or by culture, which require fresh, unfixed tissue or specimens. PCR is an NAAT that can
be used to detect DNA from MTBCC in a specimen. The presence of DNA from MTBCC may not
indicate that the bacteria are viable, or that the disease is in the active phase.
The fixing process can compromise the sensitivity of PCR, when used on these types of
specimens, and therefore only a positive result, in conjunction with histopathology and clinical
findings, can be used to determine whether a patient has active TB.
This testing must be approved by the Microbiologist or the TB Lab Head
(416-235-5993/5841)
(f) Strain Typing of MTBC
Strain typing of MTBC isolates can be used to determine whether patient strains are identical,
related or unrelated to one another. This information must be used as an adjunct to routine
contact tracing and epidemiological information. Strain typing is useful in investigating outbreaks
of TB, patterns of transmission, determining whether a patient has reactivated or been re-
infected, and in investigating possible laboratory cross-contamination.
The most common method of strain typing for MTBCC is restriction fragment length
polymorphism (RFLP) fingerprinting. The method requires extraction of a large amount of DNA,
which necessitates a prolonged incubation of cultures. The resulting 鈥淒NA fingerprint鈥? can be
compared with those of other strains, using computer software analysis. This method is
considered the 鈥済old standard鈥?. Some isolates may require typing by secondary methods such as
spoligotyping or MIRU/VTNR.
These secondary typing methods are quicker to perform but are less discriminatory than RFLP.
MIRU/VTNR may be performed as a rapid, preliminary test, with RFLP typing results being used
for confirmation.
33
NCCLS Approved Standard, 24A. 2003
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3.5 Laboratory Testing for Tuberculosis
Requests for strain typing must be approved by the Medical Microbiologist or
the Head, Mycobacteriology and should be faxed for comparison, with full
patient information and details of which strains are to be used to the lab at:
416-235-6013
Note: Patients can have the same RFLP but have different resistance patterns.
The turnaround time for typing results will depend on the status of the culture (whether actively
growing or frozen). Average time for results is three weeks. The first MTBCC isolate from a
patient is frozen, so that subsequent analysis such as strain typing, is available.
(g) Serum Drug Levels
This test is currently not available in Canada
Samples must be shipped to the National Jewish Medical and Research Center,
Denver, Colorado
Obtain instructions from the Central Public Health TB Laboratory before drawing
blood samples
Serum must be separated from the clot immediately and must be shipped on dry
ice
Serum drug level testing is useful for patients who may be failing therapy despite appropriate
antituberculous medication. Failure to absorb medications may result in sub-optimal
concentrations in the serum. Approximate time for results from serum drug level testing is 3
weeks.
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QuantiFERON-TB Test (QFT) Fact Sheet
3.6 Appendix A
A. QuantiFERON-TB TEST (QFT) Fact Sheet
Last Updated: March, 2006
Note : At the time of publication the QFT test has not yet been approved by Health Canada for use
in Canada
What is it?
The QuantiFERON-TB test (QFT) is a whole-blood test for diagnosing latent tuberculosis (TB) infection
(LTBI). If not detected and treated, LTBI may later develop into TB disease. The QFT measures the
patient鈥檚 immune reactivity to Mycobacterium tuberculosis, the bacterium that causes TB. This test was
approved by the U.S. Food and Drug Administration (FDA) in 2001.
How does it work?
Blood samples are mixed with antigens (protein substances that can produce an immune response) and
incubated for 16 to 24 hours. The antigens are specific for M.tuberculosis. Controls are also included.
If the patient is infected with M. tuberculosis, the blood cells will recognize the proteins and release
interferon-gamma (IFN-g) in response. The QFT results are based on the proportion of IFN-g that is
released in response to specific proteins as compared to that released in response to mitogen in the
controls. Additional tests (such as chest radiograph) are needed to exclude TB disease and confirm the
diagnosis of LTBI.
What are the advantages?
Only requires a single patient visit.
Does not cause the booster phenomenon, which can happen with repeat tuberculin skin tests
(TST).
Is less subject to reader bias and error when compared to the TST.
What are the disadvantages?
1. Blood samples must be processed within 12 hours after collection.
2. Currently, there is limited laboratory and clinical experience with the QFT.
3. The ability of the QFT in predicting a patient鈥檚 risk of progression to TB disease has not been
evaluated.
4. As with the TST, additional tests are needed to exclude TB disease and confirm diagnosis of
LTBI.
When should you use the test?
Testing programs using the QFT should only be implemented if plans are also in place for the necessary
follow-up medical evaluation (such as chest radiograph) and treatment.
Before the QFT is conducted, arrangements should be made with a qualified laboratory to ensure proper
processing of blood within the required 12 hours.
The role of the QFT in targeted testing has not yet been defined, but the QFT can be considered for LTBI
testing as follows:
1. Initial and serial testing of persons with an increased risk of LTBI (such as recent immigrants,
injection-drug users, and residents and employees of prisons, jails, and homeless shelters).
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CDC discourages use of diagnostic tests for LTBI among populations at low risk for infection with
M. tuberculosis. However, initial testing is occasionally performed among certain population
groups for surveillance purposes or where cases of infectious TB disease might result in
extensive transmission to highly susceptible populations, including the following:
2. Initial and serial testing of persons who are by history at low risk for LTBI but whose future
activity may place them at increased risk of exposure, and others eligible for LTBI
surveillance programs (such as health care workers and military personnel).
(a) Testing of persons for whom LTBI screening is performed but who are not considered to
have an increased possibility of infection (such as persons meeting entrance
requirements for certain schools and workplaces).
When should the test not be used?
Because of insufficient evidence on which to base recommendations at this time, the QFT is not
recommended for the following:
Evaluation of persons with suspected TB disease.
Assessment of contacts of persons with infectious TB disease.
Screening of children under 17 years of age, pregnant women, or persons with clinical conditions
that increase the risk of progression of LTBI to TB disease.
Confirmation of TST results, because injection of tuberculin may affect subsequent QFT results.
Diagnosis of M. avium complex disease.
What are the steps in administering the test?
Select an appropriate patient.
Draw a sample of whole blood from patient into a tube with an anti-clotting agent (heparin),
according to manufacturer鈥檚 instructions.
Deliver processed blood to a laboratory within 12 hours.
Schedule an appointment for the patient to receive test results and, if infected, medical evaluation
and possible treatment for LTBI.
How do you interpret test results?
Interpretation of QFT results is influenced by the patient鈥檚 estimated risk for LTBI. Patients at low risk
need to produce a stronger tuberculin response 鈥? as compared to patients at increased risk of LTBI 鈥?
before they are considered infected.
The QFT and the TST do not measure the same components of the immunologic response and are not
interchangeable. However, confirmation of QFT results with a TST is possible because the use of the
QFT does not affect subsequent QFT or TST results. The probability of LTBI is greatest when both the
QFT and TST are positive. Conducting additional tests and assessments for TB signs and symptoms to
rule out TB disease is necessary.
Considerations for confirmation are as follows:
When the probability of LTBI is low, confirmation of a positive QFT result with a TST is
recommended before initiation of LTBI treatment. LTBI therapy is not recommended for persons
at low risk who are QFT-negative, or who are QFT-positive but TST-negative.
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The TST can also be used to confirm a positive QFT for persons at increased risk for LTBI.
However, the need for LTBI treatment when the QFT is positive and the subsequent TST is
negative should be based on clinical judgment and perceived risk.
Negative QFT results do not require confirmation, but results can be confirmed with either a
repeat QFT or a TST if the accuracy of the initial test is in question.
Additional Information:
Centers for Disease Control and Prevention, 鈥淕uidelines for Using the QuantiFERON-TB Test for
Diagnosing Latent Mycobacterium Tuberculosis Infection,鈥? MMWR 2003; 52 (RR-02): 15-18.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5202a2.htm
Food and Drug Administration, 鈥淨uantiFERON: Summary of Safety and Effectiveness Data,鈥?
http://www.fda.gov/cdrh/pdf/p010033.html
Centers for Disease Control and Prevention, 鈥淕uidelines for Using the QuantiFERON-TB Test for
Diagnosing Latent Mycobacterium Tuberculosis Infection,鈥? MMWR 2005; 54 (RR-15)
http://www.cdc.gov./mmwr/pdf/rr/rr5415/pdf
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4.1 Prevention/Health Promotion
4. Tuberculosis Prevention
4.1 Prevention/Health Promotion in the Community
Principles of Health Promotion enable people to increase control over their health and improve
their health status. It is an integral component of an effective and comprehensive approach to TB
prevention and control. Public Health units will provide services that are accessible and equitable
using the following strategies to help prevent TB.
Essential to any health promotion strategy are community participation and access to education
and information. These components serve to empower individuals, promote effective community
participation and establish a sustainable health promotion program.
TB prevention and health promotion should be based on the local epidemiology of TB and the risk
groups present in the population. Health units should target test persons and groups who are the
highest risk for TB (including all health care professionals). In areas that are considered to be low
risk for TB, a more general approach should be undertaken. However all health care workers
should be included in programs and screening.
4.1.1 Health Education
Health education includes communication of information, as well as fostering motivation and skills
necessary to take action and improve health. Health Unit TB programs will:
(a) Ensure that staff of the tuberculosis control program has adequate and current
knowledge and skills related to tuberculosis including, but not limited to:
Diagnosis
Treatment for TB disease and latent tuberculosis infection (LTBI)
Epidemiology of TB, particularly as it relates to the local situation
Socio-cultural factors
Current issues
Risk factors for infection and disease
Risk factors for non-compliance with treatment
The role of public health in tuberculosis control
Drug resistance
TB/HIV
How to order TB medication
Use of iPHIS for TB reporting
TB reporting requirements
Immigration surveillance process
TB specialists in the community
Agencies in the community that can assist in the management of TB
(b) Provide or ensure the provision of on-going tuberculosis education for health
professionals, which includes the topics listed above.
(c) Provide or ensure the provision of on-going tuberculosis education with community
groups, local agencies and institutions at risk for TB.
(d) Make educational materials accessible to the community and relevant to the target
population.
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4.1.2 Community Development/Community Capacity Building
Community development is a process by which the community defines its own health needs,
considers how those needs can be met and decides collectively on priorities for actions. It is a
commitment to equality, community participation, valuing of lay knowledge, viewing problems as
shared and empowerment of individuals/communities through education, skills development and
joint action. 34 TB Programs will utilize principles of community capacity building by enhancing
skills, networking and developing partnerships with community members in order to foster
leadership, empowerment, self-sufficiency and well-being; e.g., homeless populations and
newcomers. 35
4.1.3 Advocacy
Health units will attempt to mitigate the conditions, attitudes and beliefs that could lead to an
increase in the risk of TB infection or its consequences. Health units will:
(a) Support community agencies in improving social conditions such as poverty, homelessness,
and overcrowding, which can be a factor in the spread of TB;
(b) Support and promote public policy aimed at addressing factors that contribute to the
prevalence of TB; and,
(c) Help people with TB to get access to appropriate health care services for follow-up,
regardless of their insurance status, when the cost of tests, drugs or care is a barrier.
4.1.4 Outreach
Health Units will identify and establish relationships to increase the community鈥檚
information and access to TB services especially populations at highest risk.
4.1.5 Evidence-Based Practice
Health Units will utilize evidence-based practice (quantitative, qualitative and experiential
knowledge) which establishes a link between practice and outcome of client care. 36
34 nd
Naidoo, J & Willis, J. (2000). Health Promotion: Foundations for Practice, 2 Edition, pp. 199-217
35
ibid
36
Community Health Nurses Association of Canada. (March 2002). Canadian Community Health Nursing Standards of Practice.
(Draft), p. 114
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4.2 Early Diagnosis and Treatment
Early diagnosis and effective treatment of infectious cases are key to the prevention and control
of TB. Screening of high risk populations and case-finding, rapid diagnostic testing, strong and
enforceable public health legislation, universal and effective therapy, and comprehensive TB
prevention and control programs are all essential components for preventing the transmission of
tuberculosis. For more information on population-based screening, see Chapter 2 Surveillance
and Screening.
Globally, strategies to address co-infection of TB and HIV, including access to basic primary
health care in HIV-endemic countries, are becoming more critical in the context of the HIV-AIDS
pandemic.
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4.3 Infection Control Measures in Health Care Facilities
Tuberculosis remains an important potential occupational hazard in health care facilities serving
populations that are at high risk for tuberculosis. These include health care facilities serving
Aboriginal Canadians, the inner city poor, or immigrants from countries in Asia, Eastern Europe,
Africa and Latin America where tuberculosis is still common. 37 Each facility should have infection
control practices to prevent and detect M. tuberculosis transmission.
For the purposes of discussion, Health Care Workers are defined as all paid and unpaid persons
working in health care settings who have the potential for exposure to M. tuberculosis through air
space shared with persons with infectious TB disease.
These practices should include but are not limited to:
Principles and practices of infection control to decrease the risk of transmission of M.
tuberculosis, including the hierarchy of TB infection control measures, written
policies/procedures, monitoring, and control measures for Health Care Workers (HCW) at
increased risk for exposure to M. tuberculosis.
Rationale for infection control measures and documentation evaluating the effect of these
measures in reducing occupational exposure.
Reasons for testing for M. tuberculosis infection, importance of a positive test result for M.
tuberculosis infection, importance of participation in a TB screening program, and
importance of retaining documentation of previous test results for M. tuberculosis, chest
radiograph results, and treatment for LTBI and TB disease.
Procedures for the investigation of M. tuberculosis infection test conversion in the workplace.
Procedures for the prompt medical evaluation of M. tuberculosis test conversion or
development of symptoms or signs of TB disease in HCWs.
Procedures for the prompt reporting of a suspected diagnosis of TB disease to the setting鈥檚
administration and infection control program.
Procedures for the prompt reporting to the local health unit of a suspected case of TB
disease in a patient (including autopsy findings) or HCW.
Policies, both internal and external, to ensure confidentiality for patients and HCWs with TB
disease or LTBI.
Transportation procedures to protect Emergency Management Services (EMS) staff and
receiving facilities when patients with suspected or confirmed infectious TB disease require
transfer.
Return to Work policies to ensure that a HCW with TB disease is non-infectious before
returning to duty
Proper implementation and monitoring of environmental controls.
Training for safe collection, management and disposal of clinical specimens.
Required record keeping on HCW test conversions for M. tuberculosis infection.
Record keeping and surveillance of TB cases among patients in the setting.
Proper use of and the need to inform the infection control program of factors that might affect
the efficiency of respiratory protection.
Success of adherence to infection control practices in reducing the risk for transmission of M.
tuberculosis in health care settings. 38
37 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 207.
38
鈥淕uidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings, 2005鈥?, MMWR, December
30, 2005/ 54(RR17)
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4.3.1 Administrative and Work Practice Measures in Health Care Facilities
All health care facilities should have a tuberculosis management program. Policies and
procedures should clearly delineate the administrative responsibility for developing,
implementing, reviewing and evaluating the program to ensure that the various program
components identified above are coordinated. Persons with day-to-day responsibility for infection
control and employee health, representatives from the senior administration of the facility, the
laboratory, nursing, medicine, other health disciplines and public health should be part of the
expert committee.
The following activities should be included in the program:
Conducting a TB risk assessment of the setting (see Section 4.3.2 for details).
Developing and instituting a written TB infection control plan to
ensure prompt detection, airborne precautions, and treatment of
persons who have suspected or confirmed TB disease.
Ensuring the timely availability of recommended laboratory processing, testing, and reporting
of results to the ordering physician, infection control team and local public health unit.
Implementing effective work practices for the management of patients with suspect or
confirmed TB disease.
Ensuring the proper cleaning and sterilization or disinfection of potentially contaminated
equipment.
Training and educating HCWs regarding TB, with specific focus on prevention, transmission,
and symptoms.
Screening and evaluating HCWs who are at risk for TB disease or who might be exposed to
M. tuberculosis (i.e., TB screening program).
Applying epidemiologic-based prevention principles, including the use of setting-related
infection control data.
Using appropriate signage advising respiratory hygiene and cough etiquette.
Coordinating efforts with the local health unit. 39
4.3.2 TB Risk Assessment
A TB risk assessment for settings in which patients with suspected or confirmed TB disease are
expected to be encountered should include:
A review of the community profile of TB disease in collaboration with the local health unit.
Consultation with the local health unit to obtain epidemiologic surveillance data necessary to
conduct a TB risk assessment of the health care setting.
A review of the number of patients with suspected or confirmed TB disease that has been
encountered in the setting during at least the previous 5 years.
Determining if persons with unrecognized TB disease have been admitted to or were
encountered in the setting during the previous 5 years.
Identification of areas in the setting with an increased risk of nosocomial transmission of M.
tuberculosis and target them for improved TB infection controls.
Determining which HCWs need to be included in a TB screening program and the frequency
of screening (based on risk classification).
39
Ibid
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Ensuring the prompt recognition and evaluation of suspected episodes of nosocomial
transmission of M. tuberculosis.
Assessing the number of isolation rooms needed for the setting.
Determining the types of environmental controls needed other than isolation rooms.
Determining which HCWs need to be included in the respiratory protection program.
Conducting periodic assessments.
Recognizing and correcting lapses in infection control. 40
An essential part of this program is the annual review of indices of nosocomial transmission (e.g.,
tuberculin test conversion among clinical personnel, number of exposure episodes, number of TB
patients diagnosed only at autopsy). This information should be shared with staff as a means of
increasing their awareness of TB in the patient population served by the facility.
In health care facilities where TB patients are rarely admitted, the management program may
consist only of the capacity to diagnose patients with TB disease, and an arrangement to transfer
all such patients to another centre where the appropriate environmental and personal control
measures have been implemented. 41
4.3.3 Ventilation, Filters, Ultraviolet Germicidal Irradiation (UVGI)
General ventilation dilutes and removes contaminated air and controls airflow patterns in a room
or setting. A single-pass ventilation system is the preferred choice in areas in which infectious
airborne droplet nuclei might be present 42 . In general hospital areas, at least two air changes
per hour are recommended. 43
The great majority of episodes of exposure to unsuspected TB cases and transmission of
infection to HCWs occurs outside of isolation rooms,
making general ventilation the most significant method of preventing airborne
transmission in a hospital. 44
Environmental controls should include technologies for the removal or inactivation of airborne M.
tuberculosis such as local exhaust ventilation, general ventilation, HEPA (High Efficiency
Particulate Air) filtration, and UVGI.
Standards contained in Special Requirements for Heating, Ventilation, and Air Conditioning
(HVAC) Systems in Health Care Facilities: A National Standard of Canada, (CSA) 1991,
outline ventilation requirements for various rooms or areas including:
40
Canadian Standards Association Standards, Ottawa, 1991, pp. 12-13.
41 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 211.
42
鈥淕uidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings, 2005鈥?, MMWR, December
30, 2005/ 54(RR17)
43 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 215
44
ibid
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patient rooms,
operating rooms,
intensive care units,
emergency and other treatment rooms, and
isolation rooms.
The CSA document recommends that isolation rooms should have nine air changes per hour,
ventilation to outside the building and appropriate relative pressurization depending on the
isolation technique. It has also been suggested that newly constructed isolation rooms have
the nine air changes per hour and that those in existing facilities have at least six air
changes per hour. 45
Patients with TB should be isolated in a room where the air pressure is
negative to the corridor, resulting in inward directional air flow.
Air from the room should be exhausted to the outdoors. 46
The exchange of indoor air with outdoor (fresh) air can reduce the risk of infection by diluting the
infectious particles.
The air changes and direction of air flow should be verified at least every six months. Direction of
air flow should be tested with smoke tubes at all four corners of the door. 47
In buildings with sealed windows and mechanical ventilation systems, a high percentage of
recirculation can contribute to nosocomial infection. 48 Therefore, the air should be passed
through a HEPA filter before being exhausted.
4.3.4 Local Exhaust Ventilation
This consists of source-control techniques that are used to capture airborne contaminants (e.g.,
infection droplet nuclei or other infectious particles) before they are dispersed into the general
environment. This type of ventilation should be used for cough-inducing and aerosol-generating
procedures.
4.3.5 Air Cleaning Methods
(a) High-Efficiency Particulate Air (HEPA) Filters
These devices can be used to filter infectious droplet nuclei from the air and must be
used:
45 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 215
46
ibid
47
Ibid
48
Ibid, p. 209
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When discharging air from local exhaust ventilation booths or enclosures directly
into the surrounding room or area, and
When discharging air from negative-pressure rooms into the general ventilation
system (e.g., in settings in which the ventilation system or building configuration
makes venting the exhaust to the outside impossible).
Recirculation of HEPA filtered air can also be achieved by:
Exhausting air from the room into a duct,
Passing it through a HEPA filter installed in the duct, and
Returning it to the room or general ventilation system.
In addition, recirculation can be achieved by filtering air through HEPA recirculation
systems installed on the wall or ceiling of the room or filtering air through portable
room-air recirculation units 49 .
(b) Ultraviolet Light (UVGI)
UVGI can be used in a room or corridor to irradiate the air in the upper portion of the
room and is installed in a duct to irradiate air passing through the duct or
incorporated into room air-recirculation units. There is good evidence that UV light
has excellent germicidal activity against M. tuberculosis and can reduce infectious
droplet concentrations equivalent to ventilation with 20 air changes per hour. UV
light is recommended in bronchoscopy and autopsy areas, particularly if ventilation is
inadequate and cannot be upgraded to meet standards. It may be considered in
areas where exposure is unpredictable, such as emergency rooms in moderate-to-
high risk hospitals. If UV light is used, the units should be installed above head
height with baffles to protect against eye contact. The units should be inspected
every six months. 50
49
鈥淕uidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings, 2005鈥?, MMWR, December
30, 2005/ 54(RR17)
50 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, pp. 216-217
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4.3.6 Use of Respiratory Protection
Standard surgical masks are effective in preventing larger exhaled droplets from falling into
wounds. However, they are less than 50% effective in filtering the much smaller nuclei (1 to 5
microns) containing tubercle bacilli that may be inhaled and reach the alveolus. Current
recommendations call for masks that filter 95% of particles of 1 micron or larger and have less
than 10% leak. Workers should be instructed on how to wear the masks properly (to reduce
facial seal leak) and educated regarding the importance of wearing masks. 51
(1) Indications for Use of N-95 Masks
All persons, including HCWs and visitors, entering rooms in which patients with
suspected or confirmed infectious TB disease are being isolated.
Persons present during cough-inducing or aerosol-generating procedures
performed on patients with suspected or confirmed infectious TB disease.
Persons in other settings in which administrative and environmental controls
probably will not protect them from inhaling infectious airborne droplet nuclei.
These persons might also include persons who transport patients with suspected
or confirmed infectious TB disease and persons who provide urgent surgical or
dental-care to patients with suspected or confirmed infectious TB disease.
Laboratory staff conducting aerosol-producing procedures might require
respiratory protection. 52
(2) Fit Testing
There is a need to determine which respirator fits the user adequately and to ensure
that the user knows when the respirator fits properly. It is important to provide a
means to determine which respirator model and size fits the wearer best and to
confirm that the wearer can don the respirator properly to achieve a good fit. HCWs
should be provided with opportunities to handle and wear a respirator until they
become proficient. 53
The frequency of fit testing should be supplemented by the occurrence of:
(1) Risk for transmission,
(2) Facial features of the wearer,
(3) Medical condition that would affect respiratory function,
(4) Physical characteristics of the respirator, and
Model or size of the assigned respirator. 54
(5)
Note: Each health unit will be required to set up their own arrangement for fit
testing of staff e.g., through EMS or a local hospital.
51 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 217
52
鈥淕uidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings, 2005鈥?, MMWR, December
30, 2005/ 54(RR17)
53
Ibid
54
Ibid.
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4.3.7 Screening Programs for TB Support, Surveillance and Clinical Care
The screening program consists of 5 major components:
(1) Baseline testing for M. tuberculosis infection
(2) Tuberculin testing following unprotected exposure
(3) Serial testing for M. tuberculosis infection
(4) Serial screening for symptoms or signs of TB disease
(5) TB training and education
(1) Baseline Testing for M. tuberculosis Infection
Baseline testing results provide a basis for comparison in the event of a potential or
known exposure to M. tuberculosis and facilitate the detection and treatment of LTBI
or TB disease in a HCW before employment begins and reduces the risk to patients
and other HCWs. 55
Therefore, at the time of hiring, all employees should have Two-step tuberculin
testing unless they have a documented prior tuberculin test. Workers with a reaction
of 鈮? 10mm induration on the first or second test should be considered tuberculin
reactors. They should be referred for chest radiography and medical evaluation, and
consideration of INH preventive therapy.
1. Test results for M. tuberculosis infection for HCWs with a history of BCG
should be interpreted by using the same diagnostic cut points used for HCWs
without a history of BCG. 56
2. A second 2-step TST is not needed if the HCW has a documented 2-step TST
result from any time during the previous 12 months. 57
3. If a newly employed HCW has had a documented negative TST result within the
previous 12 months, a single test can be administered in the new setting. This
additional test represents the second stage of two-step testing. The second
test decreases the possibility that boosting on later testing will lead to
incorrect suspicion of transmission of M. tuberculosis in the setting.
(2) Tuberculin Testing Following Unprotected Exposure
For tuberculin negative workers, a TST should be done immediately and, if negative,
repeated after 8-12 weeks. If the tuberculin test is positive, the worker should be
considered a converter, and consideration should be given to preventive therapy. If
the worker was previously tuberculin positive, a TST should not be done, but chest
55
鈥淕uidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings, 2005鈥?, MMWR, December
30, 2005/ 54(RR17); p. 38
56
Ibid.
57
Ibid.
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radiography should be performed 3 months after the contact or earlier if symptoms
develop, at which time a sputum for AFB testing should also be obtained 58 .
(3) Serial Follow-Up
Annual tuberculin testing is recommended for HCWs involved in moderate risk
activities in moderate to high-risk hospitals, and for workers involved in high-risk
activities in all hospitals. 59
A routine screening program can be discontinued if infection prevalence is <5%
and/or the annual skin test conversion rate is < 0.5% among staff. 60
If possible, stagger follow-up screening so that all HCWs who work in the same area
or profession are not tested in the same month. Staggered screening increases
opportunities for early recognition of infection control problems that can lead to
conversions in test results for M. tuberculosis infection. 61
Health care facilities can be considered to be low risk if there are less than six
admissions of patients with active tuberculosis per year. Health care facilities can be
considered low risk if there are more than 100 health care workers in patient care
areas to which TB patients may be admitted per annual admission of tuberculosis.
Moderate to high-risk hospitals have six or more TB admissions per year, or a ratio of
less than 100 potentially exposed health care workers per TB admission per year. 62
Also see Chapter 2 (2.2.4) Screening in High-Risk Environments.
(4) Chest Radiography
HCWs with a baseline positive or newly positive TST should receive one chest
radiograph to exclude a diagnosis of TB disease (or an interpretable copy within a
reasonable time frame, such as six months). Repeat radiographs are not needed
unless symptoms or signs of TB disease develop. Instead of participating in serial
testing, HCWs with a positive test should receive a symptom screen.
HCWs with extrapulmonary TB usually do not need to be excluded from the
workplace as long as no involvement of the respiratory tract has occurred. 63
(5) Immediate Patient Management
A high index of suspicion must be maintained in order to ensure early identification of
patients with suspected TB. All patients with suspected or confirmed infectious TB
who are admitted to a health care facility should immediately have appropriate
58 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 219
59
ibid p. 219
60
Ibid, p. 220
61
鈥淕uidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings, 2005鈥?, MMWR, December
30, 2005/ 54(RR17)
62 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 210
63
鈥淕uidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings, 2005鈥?, MMWR, December
30, 2005/ 54(RR17)
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isolation precautions initiated. Policies should designate who has the authority to
initiate and discontinue isolation precautions, monitor compliance with isolation
procedures, and manage breaches in isolation precautions. Chest radiography
should be carried out and/or three sputum specimens test for AFB in suspected
cases. 64
Management of Patients with Confirmed TB:
Infection control personnel should be notified of all patients with confirmed TB who
are in the facility.
Patients should remain in an adequately ventilated respiratory isolation room.
Visitors and staff entering the room should wear appropriate respiratory protective
masks.
Visits by children should be discouraged because of their increased susceptibility.
Patients leaving the room should wear a mask. If patients are going to other hospital
departments, those departments should be notified. 65
HCWs that are the first point of contact should be trained to ask questions that will
facilitate detection of persons who have suspected or confirmed infectious TB disease.
64 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 212
65
ibid, p. 213
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4.4 Resources, Education and Information
4.4.1 Education and Counselling Programs for Health Care Workers
All HCWs, including physicians, trainees, and students, should receive initial TB training and
education. The training should be provided before the HCW starts working. In addition, all
settings should conduct an annual evaluation of the need for follow-up training and education for
health care workers based on the number of untrained and new health care workers, changes in
the organization and services of the setting, and availability of new TB infection control
information. 66
The following are suggested components for an introductory TB education program:
(1) Clinical Information
Basic concepts of M. tuberculosis transmission, pathogenesis, and diagnosis,
including the differences between LTBI and TB disease and the possibility of re-
infection after previous infection with M. tuberculosis or TB disease.
Signs and symptoms of TB disease and the importance of a high index of
suspicion for patients or HCWs with these symptoms.
Indications for initiation of airborne precautions of inpatients with suspected or
confirmed TB disease.
Policies and indications for discontinuing airborne precautions.
Principles of treatment for LTBI and for TB disease (indications, use
effectiveness, and potential adverse effects).
How to diagnose TB (physical examination).
Proper treatment using four first-line TB drugs.
HIV/TB risk.
Importance of drug resistance.
How to obtain TB medication and arrange for DOT.
(2) Epidemiology of TB
Epidemiology of TB in the local community, Canada and worldwide.
Risk factors for TB disease.
(3) TB and Public Health
Role of the local health unit鈥檚 TB control program in screening for LTBI and TB
disease.
Availability of information, advice and counselling from community sources,
including universities, local experts and local public health units.
Responsibility of the settings鈥? clinicians and infection control program to promptly
report to the local health unit a case of suspected TB disease or a cluster of TST
conversions.
Responsibility of the setting鈥檚 clinicians and infection control program to promptly
report to the local health unit a person with suspected or confirmed TB disease
who leaves the setting against medical advice. 67
66
鈥淕uidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings, 2005鈥?, MMWR, December
30, 2005/ 54(RR17)
67
Ibid
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The setting should document that all HCWs, including physicians, have received initial TB training
relevant to their work setting and additional occupation-specific education.
4.4.2 Local Public Health Unit
The local public health unit can assist health care facilities by providing information and
education sessions about TB and infection control. The local Ministry of Labour office can
provide information on the requirements under the Occupational Health and Safety Act.
Locations for Ministry of Labour local offices can be found at:
http://www.gov.on.ca/LAB/english/about/reg_offices.html
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4.5 Vaccines
4.5 Vaccines
4.5.1 Bacille Calmette-Guerin (BCG)
See also : Chapter 2 : Surveillance, Subsection 2.4.2 4(e) Causes of false positive TST.
Bacille Calmette-Guerin (BCG) is a live vaccine made from a culture of an attenuated strain of
living bovine tubercle bacillus, administered as a single intradermal dose over the deltoid muscle
of the arm. The one vaccine approved for use in Canada is a freeze-dried product produced by
Sanofi Pasteur.
Targeted immunization of some First Nations and Inuit communities in Canada with BCG has
been provided after birth, to reduce hematogenous spread of M tuberculosis from the primary site
thereby preventing serious complications in persons where delay in diagnosis may occur.
Countries experiencing declines in TB rates have discontinued routine BCG programs for a
number of reasons.
In 2004, Canada鈥檚 National Advisory Committee on Immunization (NACI) issued an Advisory
Statement on the use of BCG vaccine 68 . BCG vaccination is recommended in three high risk
groups:
(1) In immunocompetent infants born in First Nations and Inuit communities where
the annual average rate of smear positive pulmonary TB is greater than 15 per
100,000 during the previous 3 years OR the annual risk of TB infection is
greater than 0.1% and early diagnosis and treatment is not available. HIV
antibody testing of the mother and child should be negative. Routine immunization of
First Nations and Inuit communities not meeting these criteria should be
discontinued.
(2) Health care and laboratory workers with repeated exposures to untreated or
drug-resistant TB cases, or to tubercle bacilli in conditions where protective
measures are not feasible. These individuals should have their indications for BCG
vaccination assessed by a TB and/or infectious disease expert.
(3) Travellers planning extended stays in areas of high TB prevalence where
chemotherapy is not possible or drug resistance is high. It is recommended that
an infectious disease or travel medicine specialist be consulted.
(a) Adverse Effects from BCG Vaccination
Worldwide, the use of BCG has been associated with adverse effects documented in both
published and unpublished literature. A survey sponsored by the International Union against
Tuberculosis and Lung Disease recorded over 10,000 complications following almost 1,5
billion BCG vaccinations 69 . The most serious complication, disseminated BCG infection,
occurred in three per million recipients. Dissemination was fatal in 0.02 per million vaccine
recipients due to immunodeficiencies.
68
National Advisory Committee on Immunization. Statement on Bacille Calmette-Guerin (BCG) Vaccine. CCDR 2004 (30) ACS-5
69
Lotte A, Wasz-Hockert O, Poisson N et al. Second IUATLD study on complications induced by intradermal BCG-vaccination. Bull
Int Union Tuberc Lung Dis 1988;63(2):47-59
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In Canada, case reports of disseminated BCG infection identified by IMPACT (Immunization
Monitoring Program-Active) hospital-based surveillance prompted a review of adverse
events by the Public Health Agency鈥檚 Advisory Committee on Causality Assessment
(ACCA). The ACCA report and a First Nations and Inuit Health Branch review, considered in
the 2004 NACI Statement, have estimated that the risk of disseminated BCG infection and
death is much greater for Canadian First Nations鈥? children.
(b) Contraindications
BCG is contraindicated for persons with immune deficiency diseases or impaired immunity
secondary to treatment or malignancy. Extensive skin disease or burns are also
contraindications. Immunization of pregnant women is not recommended. Persons with
positive tuberculin skin tests should not be immunized.
(c) Public Health Issues for BCG vaccination in Canada
The discontinuation of BCG vaccination in populations at high risk of TB outbreaks requires a
cautious and collaborative approach between First Nations stakeholders, providers and policy
makers. An adequate, effective and well-resourced TB Control program must be available at
the community level where ever BCG is withdrawn. In addition, research on resource
requirements and the health impacts of BCG withdrawal have been identified by NACI as
prerequisites for any planned phase-out.
4.5.2 Other Vaccines against Tuberculosis
BCG has up to 80% efficacy in protection against disseminated forms of TB in childhood and
tuberculous meningitis 70 . However, protection against pulmonary TB is extremely variable
(approximately 50% in metanalysis) 71 , and immunity is not life-long. Given the inability of the
existing BCG to control or eliminate tuberculosis, there remains an urgent need for an effective
vaccine.
There are at least three points within the TB disease process at which a new vaccine could be
targeted. First, a vaccine could be given in the neonatal period to prevent primary infection.
Unfortunately, this would not address the millions of people who have latent infection. A post-
exposure vaccine to prevent overt disease in those who have already been infected presents a
second possible intervention point. Although post-exposure vaccines are an area of strong
interest, their development remains largely experimental at this point. And finally, a third possible
intervention would be with a vaccine as an adjunct to chemotherapy; e.g., in people infected with
multi-drug-resistant strains of M. tuberculosis.
The ideal TB vaccine needs to induce high levels of cellular immunity. M. tuberculosis is an
intracellular organism, replicating and residing within human macrophages. Immunity is therefore
dependent on a T-helper cell: specifically, a class II-restricted CD4+ T-cell response. Gamma
delta cells and nonclassically restricted T-cells, such as CD1-restricted T-cells, may also play a
protective role, 72 but how to induce these cells by vaccination is still not yet fully understood.
70
Mcshane H. Developing an improved vaccine against tuberculosis. Expert Rev. Vaccines 2004 3(3): 299-306
71 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 223
72
op cit
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There are two main approaches to vaccine production: either by using the whole organism, as in
the existing BCG, or by inducing immunity to a few immunodominant antigens through a subunit
vaccine.
Attenuated strains of M tuberculosis still require extensive testing to ensure that a return to
virulence is not possible. Several recombinant BCG vaccines are in development and one,
engineered to over express antigen 85B, has entered clinical trials in the USA 73 . These vaccines
are designed primarily for neonates, as a replacement for the existing BCG, with the hope of
generating a better and longer-lasting immune response.
Subunit vaccines can be divided into classes according to which antigen delivery system is used
to induce cellular immunity: protein vaccines, with or without adjuvant; DNA vaccines: and
recombinant bacterial or viral vectors.
Some of the most promising antigens being used for TB vaccine production include the early
secreted antigenic target (ESAT)-6, heat shock protein (HSP)-65, antigen 72F and the antigen 85
complex. These antigens, in conjunction with adjuvant, are at various stages of clinical trials.
DNA vaccines, which induce both cellular and humoral immunity, encoding a variety of genes
from M. tuberculosis, have been developed but have also been shown to induce autoimmune
pathology in animal models. Despite initial promise, no new DNA vaccine against TB has
demonstrated protection superior to BCG to date 74 .
The use of a prime-boost vaccine strategy, to boost a primed T-cell response, is being studied in
TB vaccine research, using nonreplicating poxviruses and adenoviruses as vectors. By using a
DNA-vaccine first, linked to a variety of mycobacterial antigens, and then boosting with a modified
vaccinia virus vaccine Ankara (MVA) with the same antigens, higher levels of T-cells have been
generated in animal models. 75
One interesting development in TB vaccine research is the utilization of mucosal delivery, via a
nasal spray, creating the possibility of needle-less vaccination, which is safer and easier. There
are several of these vaccines under development or entering clinical trials. 76
There are still many unresolved issues in the development of TB vaccines, despite the growing
interest and science. Measurement of efficacy poses a significant challenge, whether the
outcome is infection (which is difficult to measure) or progression to disease (which can take
decades). The identification of proxy markers for use in clinical trials is critical. In addition, the
safety and efficacy of any new vaccine in individuals who are HIV positive will be major
determinants of a vaccine鈥檚 utility. Despite these, and many more challenges, there are over one
hundred new candidates undergoing animal model testing and several now entering, or
approaching, clinical trial evaluations. 77
73
Ibid
74
Mcshane H. Developing an improved vaccine against tuberculosis. Expert Rev. Vaccines 2004 3(3): 299-306
75
McShane H et al. Enhanced immunogenicity of CD4(+) T-cell responses and protective efficacy of a DNA-modified vaccinia virus
Ankara prime-boost vaccination regimen for murine tuberculosis. Infect. Immun. 2002: 70(3), 1623-26
76
Doherty TM. New vaccines against tuberculosis Tropical Med and Int Health 2004:9(7):818-826.
77
Orme I.M. Current progress in tuberculosis vaccine development Vaccine 2005 23:2105-8
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5. Management of Tuberculosis Cases
The basis principles of care for persons with, or suspected of having TB, are the same worldwide: a
diagnosis should be established promptly and accurately; standardized treatment regimens of proven
efficacy should be used with appropriate treatment support and supervision; the response to treatment
should be monitored; and the essential public health responsibilities must be carried out. Prompt,
accurate diagnosis and effective treatment are not only essential for good patient care 鈥? they are the
key elements in the public health response to TB and the cornerstone of TB control. Thus all providers
who undertake evaluation and treatment of patients with TB must recognize that, not only are they
delivering care to an individual, they are assuming an important public health function that entails a
high level of responsibility to the community, as well as to the individual patient. 78
5.1 Clinical Management: Physicians鈥? Roles and Responsibilities
The purposes of TB Management are:
to cure the patient of TB for a lifetime,
to prevent drug resistance,
to minimize the transmission of disease.
Accordingly, physicians who have the primary responsibility for the management of patients with
TB must ensure that all cases have been administered an effective treatment regimen over an
adequate period of time.
5.1.1 Referral to a Tuberculosis Medical Expert
It is recommended that all active or suspect cases of TB be referred to a medical specialist
knowledgeable about TB, especially patients with the following conditions:
(a) Drug resistance and MDR
Resistance is often seen in:
(a) Patients inadequately or inappropriately treated for tuberculosis
(b) Contacts of drug resistant cases
(c) Patients infected in endemic regions (See: WHO website for list of endemic
countries - http://www.who.int/tb/en/; See: Data and country profile; detailed
estimates of TB burden 鈥? data by WHO region and country)
(b) TB treatment failure
If after three months of therapy, cultures remain positive, evaluate the patient carefully
for:
鈥? Non-compliance with recommended treatment regimen
鈥? Presence or emergence of resistant strain
鈥? Inappropriate therapy
鈥? Malabsorption
78
Tuberculosis Coalition for Technical Assistance (TB CTA), International Standards for Tuberculosis Care. The
Hague, 2006. p5.
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(c) Drug intolerance
The elderly, patients with other medical conditions (e.g. diabetes or those on dialysis),
and those taking medications for other medical conditions and patients who have
idiosyncratic drug reactions, may experience reactions to anti-tuberculosis drugs. These
patients may need specialized treatment regimens.
(d) HIV infection
Patients with HIV infection are at higher risk of developing active disease from recent TB
infection and of reactivating any latent tuberculosis infection. TB infection may also
hasten the progression of AIDS. National guidelines recommend that everyone newly
diagnosed with TB be tested for HIV infection. 79
79 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 142
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(e) Pregnancy
Untreated active TB poses a much greater risk to the pregnant woman and the fetus
compared to the medication used for the treatment of tuberculosis. Therefore, treatment
of active disease should be promptly initiated. 80
(f) Pediatric TB
Latent TB Infection in children should not be left untreated because the infection is more
likely to progress to disease. Children with latent infection or TB disease should be
managed by, or under the supervision of, a TB pediatric specialist. Cases of TB in
children should trigger contact investigation for an undiagnosed source case. Children
with TB are typically asymptomatic and are usually non-infectious. 81
80 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 93-94
81
Ibid, p. 127 & 130
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5.2 Case Monitoring: Public Health Roles and Responsibilities
The purpose of case monitoring is to render and maintain the tuberculosis patient non-infectious
through a successful course of treatment and medical follow-up. The TB control staff in public
health units has primary responsibility for monitoring TB cases.
A. Respiratory Cases: Investigation and Case Management
5.2.1 Initial Investigation:
Within three working days of receiving the case report from a physician, lab, etc. contact
the physician by telephone to ascertain the patient鈥檚 medical status.
1. Contact Physician at start of treatment to obtain details for the following:
Tests for Acid-Fast Bacilli (AFBs)
Chest x-ray (within last three months)
Smear, culture or pathology reports (all documentation supporting TB
diagnosis)
Sensitivities
Initial liver function tests (LFTs)
Symptoms and onset date
Level of infectivity (see Chapter 6 鈥? 6.2.1 鈥淭ransmission Factors Related to
the Case鈥?)
HIV status
Medication regimen
2. Contact Patient as soon as possible:
Whenever possible, the first patient contact should be a face-to-face visit and should
cover all of the items listed below as items (a) to (h) and 5.2.3. If the patient is
infectious, an N95 Mask, which has been fit tested should always be used by Health
Department staff. CDC guidelines recommend that Health Care Workers wear
personal respirators in homes of infectious TB patients. 82
Whenever possible conduct the visit in a well ventilated area.
During the initial assessment:
(a) Gather demographic and epidemiological information
(b) Obtain history of any previous TB disease and treatment
(c) Assess symptoms and date of onset
(d) Gather information for contact tracing
(e) Assess the patient鈥檚 understanding and beliefs about TB
(f) Advise about side effects of TB medication
(g) Assess the patient鈥檚 ability to comply with medication and medical follow-up
(h) Assess for directly observed therapy (DOT). See Chapter 8: Treatment of
TB Disease for DOT assessment tool.
(i) If infectious, explain the need for isolation precautions.
82
Core Curriculum on TB. CDC Division of TB Elimination. Chapter 8 Infection Control Personal Respiratory Protection.
www.cdc.gov/nchs/tp/tb/pubs/ssmodules
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5.2.2 Clinical Guidelines for Releasing Patients with Pulmonary/Laryngeal TB
from Isolation: 83
1. AFB Positive
Isolation can be discontinued if:
consecutive sputum smears for AFB on 3 separate days are negative, and
鈥?
there is evidence of clinical improvement, and
鈥?
the medication regimen can be reasonably verified (e.g. patient on DOT).
鈥?
2. AFB Negative
Isolation can be discontinued after two weeks if there is:
clinical improvement
鈥?
adherence to two weeks of a medication regimen where the patient is fully
鈥?
sensitive.
3. MDR TB
Isolation can be discontinued if consecutive smears for AFB and culture on 3
separate days are negative.
Following the initial investigation, it then becomes incumbent upon the TB control
staff to develop a case management plan for each patient. The following
components must be incorporated:
5.2.3 Education
Educate patient and family about:
(a) The disease process of TB
(b) Communicability of TB
(c) The need for isolation in cases of suspected infectious tuberculosis. Note: Those
individuals whose occupation or personal circumstances (work in health care field,
shelter or those who have young children) pose a risk of infection to highly vulnerable
people by virtue of immuno-suppression or age and may require longer periods of
isolation. See above: Clinical Guidelines for Releasing Patients from Isolation.
(d) Treatment protocol and side effects
(e) Necessity of compliance with treatment and patient鈥檚 responsibility for compliance
(f) Purpose of Directly-Observed Therapy (DOT) if indicated
(g) Necessity of continuing public health supervision
(h) The importance of identifying and screening high risk and close contacts
(i) The importance of compliance and how drug resistance may develop if there is poor
compliance.
83 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
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5.2.4 Non-Compliance
Cure rates for TB remain unsatisfactory primarily because patients fail to take their
medication as prescribed by a physician (either not taking the medication as ordered or
not taking the medication for a long enough time period). Therefore, identifying those
patients who are at high risk of non-adherence to treatment and placing them on DOT is
an effective way of achieving a lifetime cure of TB. (See: Chapter 8: Treatment of TB
Disease for tips on improving compliance for TB medication.)
High-risk groups and factors relating to non-compliance include, but should not be limited
to the following:
(a) Biases against treatment
(b) Substance abuse and/or mental health issues
(c) Homelessness
(d) Children and Adolescents
(e) Cultural or socioeconomic barriers
(f) Previous non-compliance with drug therapies
(g) Relapse of TB
5.2.5 Minimum Requirements for On going Follow-up
1. Contact the Patient:
Maintain contact with patients who are not on DOT (as assessed on an individual
basis) no less than the following:
(a) At one month: Interview the patient, preferably in person, or, alternatively, by
telephone. The following should be reviewed:
compliance,
medical status,
attendance at medical follow-up appointments,
treatment side effects, and
DOT reassessment.
(b) Every two months thereafter until discharged from treatment follow-up by
the physician (or on an as needed basis): The patient should be reassessed
using the same criteria as at the one-month interview.
Note: Cases that are more complicated (i.e., have compliance concerns,
experience side-effects) may require additional follow-up and should be
assessed on an individual basis.
2. Contact the Treating Physician to obtain/discuss/review:
(a) At one month:
Smear and culture results
Changes in medication regimen
LFTs (if patient experiencing adverse reactions)
Ensure the treatment regimen is according to the Canadian TB Standards
and is based on the sensitivity testing
X-rays
Culture conversion
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Eye examination
Monitor attendance at follow-up appointment
(b) Every three months or as required to obtain patient follow-up information.
See: One month criteria for contacting physician.
3. Monitor for Culture Conversion
Patients with pulmonary tuberculosis should have sputum specimens collected for
microscopic examination and culture at the end of the second month of treatment.
Additional sputum cultures should be obtained at the end of therapy. 84 More frequent
AFB smears may be useful to assess the early response to treatment and to provide
an indication of infectiousness. Repeat cultures are essential for patients with
documented drug resistance. If a patient鈥檚 symptoms have resolved and the
patient cannot provide a sputum sample, sputum induction may be required to
obtain a specimen.
4. Ensure Appropriate Treatment and Compliance
Ensure that an effective treatment regimen, based on sensitivity testing is
prescribed to and received by the patient. (See Chapter: 8 Treatment of TB
Disease for common medication regimens and side effects). Assess compliance
using the following methods:
Information provided by patient
Information provided by physician
Timely response to treatment
Pill count
Oversee DOT program on a daily, twice or thrice weekly regimen when indicated
for those at high risk of non-compliance. DOT should be the standard of care
unless assessment indicates that the likelihood of compliance is high.
When the medical officer of health has issued a Section 22 or Section 35 order on
a non-compliant patient for whom other voluntary compliance methods have
failed, work in conjunction with the attending physician to ensure that the Health
Protection & Promotion Act, Sections 22 (4) and 35 (2), are applied appropriately.
(See Chapter 12: Use of Orders under the HPPA to Control TB)
Should a patient, who resides outside Toronto, be issued a Section 22/35 Order
and be admitted to West Park Healtcare Centre (WPHC), Toronto Public Health is
to be notified as soon as possible. (See Chapter 12: Use of Orders under the
HPPA to Control TB and Chapter 13: West Park Healthcare Centre).
5. Reporting and Documentation
Report all relevant information to the TB Control Program. The MOHLTC must
be contacted if any patient:
(a) does not fully complete the prescribed treatment;
84 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
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(b) moves outside province;
(c) is lost to follow-up;
(d) is issued a Section 35 Order
Document cases according to health unit protocols and ministry requirements;
ensure that the required data are complete for each case.
Ensure that all relevant information is forwarded to the Ontario Ministry of Health
as required via iPHIS.
5.2.6 Recommended Protocol for Directly Observed Therapy (DOT)
Directly observed therapy (DOT) requires that someone directly observe the patient
taking tuberculosis medication in prescribed doses and regimens. DOT need not be
done by a health professional, but it must be done by an observer trained in DOT.
Because DOT assures the consumption of medications, it can increase compliance to
close to 100%.
(a) Arrange DOT for all patients with respiratory tuberculosis, unless their assessment
indicates that they are highly likely to comply with therapy. This assessment should
be based on interviews with the patient, using the DOT Assessment Tool found in
Chapter 8: Treatment of TB Disease.
(b) Discontinue DOT at any point during treatment ONLY if the patient鈥檚 voluntary
compliance can be assured.
(c) Persons administering DOT should record each observed dose.
(d) DOT can be done in the patient鈥檚 home or in another agreed upon setting, depending
on the best arrangement for the patient and the person observing therapy.
5.2.7 Management of Tuberculosis in the Homeless and Under-housed
(Please see Appendix A Section 5.3 Interim Guidance for the Prevention and Control of
TB in Homeless Shelters and Drop-in Centres. Other useful references include Toronto
Public Health鈥檚 Infection Control Manual for homeless and housing service providers
鈥楤reaking the Chain鈥? 85 ).
The homeless are at a greater risk than the general population in developing infection
and of infection progressing to disease. This is due in part to one or more of the following
circumstances:
The shelter environment, which is often crowded and poorly ventilated;
Delays in patients seeking medical follow-up, which often leads to delays in
medical diagnosis and access to medical care;
Poor nutrition;
Alcohol and substance abuse;
Underlying medical conditions. 86
Therefore,
85
Toronto Public Health, 鈥淏reaking the Chain鈥? 鈥? Infection Control Manual for Homeless and Housing Service
Providers; March 2006; available at www.toronto.ca : search for Infection control.
86 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 193
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Responsibilities
(a) Ensure that the patient is located and placed in isolation until the patient can be
removed from the facility to be medically assessed.
(b) Assess for patient compliance with the recommended medical management.
(c) If the patient is uncooperative, consider preparing a Section 22 order.
(d) The patient must not return to the shelter system until deemed to be non-
infectious by a TB medical specialist and, therefore, should be transferred to
West Park Healthcare Centre or alternative housing..
(e) Once discharged from hospital, DOT should be the standard of care for all
homeless or under-housed patients.
(f) Initiate contact follow-up in shelter system as soon as possible.
Due to the transient nature of this population, regular contact investigation in a shelter can
be difficult. Contact the MOHLTC for guidance prior to embarking on a contact
investigation in a shelter for homeless persons. See MOHLTC and Ministry of Labour letter
to Medical Officers of Health May 11, 2005 for interim guidelines for managing TB in
homeless shelters and for helpful websites for more comprehensive information. (See
Appendix A at the end of this chapter.)
5.2.8 Discharging Patients from Case Monitoring
Patients may be discharged from follow-up once the prescribed treatment has been
completed and all required reporting information has been obtained and transmitted to
the Ministry of Health and Long-Term Care (MOHLTC). Please refer to Chapter 1
Tuberculosis: A Brief Background.
B. Non-Respiratory Tuberculosis
5.2.9 In a Child (鈮? 5 years of age)
Children may develop various forms of TB after exposure, so a diagnosis of non-
respiratory TB in a child should trigger a full contact investigation by public health staff,
including all of the components described for infectious TB, with a goal of locating an
infectious source.
5.2.10 In Older Children (鈮? 6 years of age) and Adults
Non-respiratory TB is usually a later manifestation of primary infection and is not
infectious. Nonetheless, it may be life threatening because of a delay or failure to make
the diagnosis. 87 Follow-up should include:
(a) Documenting and reporting the case to the TB Control Program, MOHLTC,
through iPHIS
(b) Ensuring that the patient is not infectious
(c) Assessing the patient鈥檚 understanding and beliefs about TB
87 th
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(d) Conducting contact investigation for possible source case
(e) Advising the patient (parent/guardian) about side effects of TB medication
(f) Assessing the patient鈥檚 ability to comply with medication and medical follow-up
(g) Assessing for Directly Observed Therapy, using the DOT Assessment Tool (See
Chapter 8: Treatment of TB Disease for DOT assessment tool)
(h) Contacting the patient (parent/guardian) one month after initial visit to assess the
patient鈥檚 health status and compliance and every two months thereafter until
treatment completion (as advised by physician)
(i) Contacting the treating physician every three months or on an as needed basis.
(j) Discharging from case management and ensuring all iPHIS mandatory fields are
complete.
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Prevention and Control of Tuberculosis (TB) in
Homeless Shelters and Drop-In Centres
5.3 Appendix A:
Interim Guidance for the Prevention and Control of Tuberculosis (TB) in
Homeless Shelters and Drop-In Centres 88
5.3.1 Homelessness and TB
Homelessness is a significant risk factor for TB infection and progression to active TB disease. A
homeless person may face an increased risk of TB infection due to: overcrowding in shelters, where
the person may be exposed to a person who has active disease; poor ventilation in shelters that can
result in the concentration of contaminated air; and underlying medical conditions of homeless
persons such as HIV infection, alcohol or drug use and poor nutrition, which make the person more
susceptible to developing TB disease. Persons who are homeless also may have difficulty in taking
medications on a regular basis or attending scheduled medical appointments resulting in their disease
not being recognized or effectively treated.
5.3.2 Reducing the Risk of TB Spreading in Homeless Shelters
Shelters should develop and implement a TB management program based on the
recommendations provided in the references below. The Francis J. Curry National TB Center
(see reference below) has made the following recommendations that will assist shelter
operators and staff to reduce the risk of TB transmission in homeless shelters.
5.3.2.1 General Measures
Education: The shelter should provide education and information on TB to their
staff, volunteers and patients.
Tissues: The shelter should make tissues available. Patients, staff and
volunteers should be instructed to cover their noses and mouths with
tissues when coughing and sneezing.
Bed placement: Beds should be arranged as far from neighbouring beds as possible,
with a head to foot arrangement.
5.3.2.2 Administrative and Work Practice Measures Identifying Suspect Cases of
TB:
TB should be suspected in any homeless person who has a fever and a productive
cough (not a dry cough) that lasts over three weeks. Other symptoms of TB include
coughing up blood, night sweats, weight loss, fatigue and loss of appetite. If a person in
a shelter has a cough and one or more of the other symptoms, they should be
considered a suspect case of TB.
88
This document has been prepared to assist in the prevention and control of TB in Ontario鈥檚 shelters and drop-in centres for
the protection of workers and patients. Employers and other workplace parties are reminded that they have legal duties under
the Occupational Health and Safety Act (OHSA) to protect workers. The Guidance Document is not a statement of the legal
requirements. In this regard reference should be made to the OHSA.
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Prevention and Control of Tuberculosis (TB) in
Homeless Shelters and Drop-In Centres
The shelter staff should:
Immediately separate the suspect case of TB and arrange for medical
care. The person with TB symptoms should be immediately separated from
other staff and residents by placing them in a separate room. A surgical mask
should be placed over the patient's mouth and nose. Medical care should be
arranged as soon as possible. This may mean sending the person to the
Emergency Department of the hospital as persons with suspect TB are often
identified after regular clinic hours.
Notify the local public health unit. The shelter staff should also immediately
notify their local public health unit .
5.3.2.3 Ventilation, Filters, Ultraviolet Germicidal Irradiation (UVGI)
Ventilation can reduce the spread of TB by diluting the concentration of TB particles and
removing contaminated room air. Use of fans, opening windows, and the installation of
High- Efficiency Particulate Air (HEPA) filters and UVGI can dilute the air and/or remove
TB organisms.
5.3.2.4 Use of Respiratory Protection
TB Suspect case
It is most important that the suspect TB case wear a regular surgical mask.
Staff at the shelter
Staff should only use N95 respirator masks when transporting a resident suspected of
having TB or when entering a room in which a suspect case of TB has been placed
temporarily to separate him or her from other staff and residents.
Staff assigned to use an N95 respirator mask should be fit-tested to ensure the mask fits
properly and be trained in the use, care and limitations of the mask. It is generally not
necessary for shelter staff to wear an N95 respirator mask to carry out their duties in
other situations. It is not necessary to have all shelter staff prepared to use an N95
respirator mask. One staff person per shift may be sufficient to meet operational needs
for most shelters.
5.3.2.5 Tuberculosis testing for staff and volunteers pre-placement
Shelter workers and volunteers should be screened for TB infection prior to placement
(post-hire); this provides a baseline in the event of a future exposure. A baseline two-
step Mantoux test should be performed unless there is appropriate documentation of a
previous tuberculin skin test (TST) with the result recorded in mm, not 鈥減ositive鈥? or
鈥渘egative鈥?.
5.3.2.5.1 Contraindications to a Mantoux TST per Canadian TB
Standards, 5th Edition, 2000 and Chapter 2: Surveillance and
Screening
The following persons should not have a TST:
鈥? Persons with severe blistering reactions in the past.
鈥? Persons with documented active TB or a clear history of treatment for
TB infection or disease in the past.
鈥? Persons with extensive burns or eczema.
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鈥? Persons who have major viral infections or who have had live-virus
vaccinations in the past month (this does not include persons with a
common cold).These persons can be tested 4-6 weeks after the viral
infection or the live-virus vaccination.
5.3.2.5.2 Negative Mantoux TST:
An individual who can provide documentation of a Mantoux TST within the
preceding year should have a single initial skin test performed and should
be managed on the basis of that result. There is no need for a second test
(i.e., the second step of the Two-step test) since the earlier test is, in effect,
the first of a two-step test. A history of BCG (Bacille Calmette-Guerin)
vaccine is not a contraindication to TST.
5.3.2.5.3 Routine TST:
Annual routine repeat screening of employees and volunteers would only be
recommended after an assessment by the local public health unit. The
shelter should contact the TB control program staff of their local public
health unit to see if annual screening of employees and volunteers should
be conducted in their shelter.
5.3.2.5.4 Testing Following Contact with an Active Case of TB
Staff, residents, and volunteers should be tested if they are exposed to a
case of TB in the shelter or drop-in centre or elsewhere in the community.
5.3.2.5.5 Previously Positive Mantoux TST:
Persons who have a documented positive Mantoux TB skin test should
have a baseline pre-placement chest x-ray and be medically assessed in
order to rule out active TB disease. They should be instructed to promptly
report any symptoms suggestive of TB (e.g., cough, fever, anorexia, weight
loss).
5.3.3 Proper Documentation in Homeless Shelters
Shelter workers should be reminded to always keep adequate and accurate documentation
including bed logs, patient health history and TB symptoms (such as coughing). In the event that
there is a case of TB in the shelter, adequate and accurate documentation will assist the local
public health unit in carrying out their investigation of the disease, determining the infectious
period of the TB case, and identifying the contacts.
5.3.4 Resources and Information
5.3.4.1 Local Public Health Unit
Your local public health unit can assist you by providing information and education
sessions about TB and infection control. Your local Ministry of Labour office can
provide information on the requirements under the Occupational Health and Safety
Act.
5.3.4.2 Other Resources
TB in Homeless Shelters: Reducing the Risk through Ventilation, Filters, and UV.
Francis J. Curry National Tuberculosis Center.
http://www.nationaltbcenter.edu/catalogue/downloads/tbhomelessshelters.pdf
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Centers for Disease Control. Prevention and Control of Tuberculosis Among
Homeless Persons Recommendations of the Advisory Council for the Elimination of
Tuberculosis. MMWR 1992;41(RR-5).
http://www.cdc.gov/mmwr/preview/mmwrhtml/00019922.htm
Canadian Tuberculosis Standards, 5th Edition, Canadian Lung Association,
Canadian Thoracic Society, Health Canada, 2000
http://www.lung.ca/tb/TBStandards_Eng.pdf
Public Health Agency of Canada. Guidelines for Preventing the Transmission of
Tuberculosis in Canadian Health Care Facilities and Other Institutional Settings.
CCDR Volume: 22S1, April 1996.
http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/96vol22/22s1/22s1n_e.html
Tuberculosis Prevention and Control Guidelines for Homeless Service Agencies in
Seattle-King County, Washington
http://www.metrokc.gov/HEALTH/tb/tbguidelines.pdf
San Francisco Department of Public Health. TUBERCULOSIS (TB) INFECTION
CONTROL GUIDELINES FOR HOMELESS SHELTERS
http://www.dph.sf.ca.us/PHP/TB/TBControl4HomelessShelters.pdf
Ministry of Labour local offices
http://www.gov.on.ca/LAB/english/about/reg_offices.html
Local public health units in Ontario
http://www.health.gov.on.ca/english/public/contact/phu/phuloc_mn.html
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6. Contact Management
6.1 Overview
Contact investigation is a major cornerstone of tuberculosis (TB) control. Its aim is to halt transmission of
M. tuberculosis by treating secondary TB cases, and prevent future cases by identifying and treating
latent TB infections (LTBI).
Contact tracing is also used to locate and treat the source case. This is especially important when the
index case is a child because the source of infection is usually an adult in the same household or another
adult in close contact with the child (e.g. school, daycare, babysitter).
Contact tracing is also an important epidemiological tool in identifying TB disease and infection in a
community.
During the contact investigation, up to 1-2% of close contacts will be found to have active disease. In
addition, 5% to 12% of contacts found to be infected will develop active disease within 2 years of
exposure. 89
6.1.1 Objectives of Contact Investigation
(a) Identify and initiate treatment of secondary cases.
(b) Identify TB-infected contacts in order to offer treatment for LTBI.
(c) Identify the source case if the index case:
is a child,
has primary TB,
has nonrespiratory TB, or
is a new conversion in a high risk environment like a jail or shelter.
6.1.2 Definitions
Contacts are all those who may have been infected by a case of active tuberculosis. Contacts
may be classified as 鈥渃lose鈥?, 鈥渃asual or community鈥? contacts.
Close household contacts are those who live in the same household, prison cell, shelter,
university residence, or army barracks as the infectious case. Household contacts are
considered by definition to share breathing space on a daily basis with the source case.
Close non-household contacts are those who have regular, prolonged contact with the index
case and share breathing space daily, but do not live in the same household. These include
regular sexual partners, close friends, children with whom the index case directly works with,
persons caring for the index case, those with frequent/regular direct face to face exposure at
work, and regular social contacts (bingo, bridge).
89
Greenaway C., Palayew, M., Menzies, D. Yield of casual contact investigation by the hour. Int J Tuberc Lung Disea 7(12): S479-
S485, 2003.
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Casual or Community Contacts are others who spend time less frequently with the index
case or have had less direct exposure to the index case. These may include classmates,
colleagues at work, or members of a club or team, or those sharing large air spaces.
Converter
TB conversion is defined as having a skin test reaction of 10mm or greater when a previous
test reaction was measured as less than 5mm. If the previous skin test reaction was between
5-9mm then an increase of 6mm or more on the subsequent test is considered to be a
conversion.
An individual identified as a contact would be considered a converter if the initial test was 0-
4mm and the subsequent test was 5mm or greater (see situation B).
Conversion, within a two year period, is an indicator of recent infection.
Examples:
Situation A: Patient with a skin test reaction of 12mm; previous reaction was 6 mm.
Interpretation: Considered a conversion as there was an increase of 6mm.
Situation B: Patient identified as a contact, initial skin test reaction was 0-4mm; 8-week
reaction is 6mm.
Interpretaton: Considered a new conversion as the 8-week reaction is > 5mm.
Index Case
The initial patient with active tuberculosis who led to the investigation of contacts.
Source Case
A case of tuberculosis identified as a result of contact investigation and thought to have
infected the index case.
Period of Infectiousness
Period of infectiousness/communicability is defined as the period of time during which a case
of TB can transmit infection to others.
Cases of pulmonary tuberculosis are generally considered to have become infectious at the
time of onset of cough. However, when a case presents with cavitary disease, it is necessary
to go back 1-2 months before cough starts because cavities take time to develop. If no cough
is reported, or if the duration is difficult to determine, the time of onset of other symptoms may
be used to estimate the onset of infectiousness.
For cases that are initially smear-positive, the end of the period of infectiousness is determined
by the demonstration of smear negativity (i.e., negative smears on three consecutive days)
while the case is receiving adequate treatment. During treatment, up to 20% of initially smear-
positive patients will develop a smear-positive, culture-negative state, at which point the
organisms seen on sputum smears are considered non-viable and therefore not communicable
to others. However, at this time there is no commercially available means, other than
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culture, of determining the viability of the mycobacteria, and the demonstration of three
consecutive negative sputum smears is still considered the best determinant of the
non-infectiousness of initially smear positive patients.
Smear-negative cases are generally considered non-infectious after 2 weeks of adequate
therapy. If the index case is suspected or proven to be resistant to one or more of the
medications used in treatment, the period of infectiousness must be reassessed. If active
disease is suspected at autopsy, and culture results are not available, the assessment of the
period of communicability is based on the best available evidence.
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Contacts
6.2 Transmission Factors and Risk to Contacts
The amount of contact necessary for tuberculosis infection to be transmitted is variable and
depends on the infectiousness of the source case and the environment in which contact occurs. In
general, pulmonary or upper respiratory (laryngeal) tuberculosis are considered the most
transmissible by the respiratory route. Cases of laryngeal tuberculosis are considered 4 to 5 times
more contagious than smear-positive pulmonary cases. Cases of non-respiratory tuberculosis, are
with rare exception, considered non-infectious.
TB staff must understand the principles of transmission and risk factors for transmission in order to:
(a) Assess the degree of exposure and risk to contacts;
(b) Establish priorities in contact investigation and follow-up; and
(c) Establish limits of investigation to avoid complicated or costly additions to
existing programs.
In determining the risk of transmission, consider the following factors:
Transmission Factors Relating to the Case
Transmission Factors Relating to Shared Air Space
Transmission Risk Factors Relating to Contacts
Classification of Contacts
6.2.1 Transmission Factors Relating to the Case
(1) Laryngeal TB has a very high risk for transmission.
(2) Presence of acid-fast bacilli in sputum smear indicates that the case is more likely
to be infectious. It has been found that infectiousness is several times greater in
smear-positive than in smear-negative cases. As an indicator of infectiousness, the
ability to culture M. tuberculosis from secretions is less important quantitatively than a
positive sputum smear.
(3) Presence of cough, especially with sputum production, increases the probability of
aerosolization of droplet nuclei.
(4) Cavitary or advanced disease noted on chest X-ray is a presumptive indicator of a
higher transmission risk, with a longer infectious period prior to identification.
(5) Prolonged duration of respiratory symptoms increases the likelihood of
transmission (e.g., delayed diagnosis or delayed recognition of drug resistance)
(6) The use of procedures that may aerosolize infectious droplets (e.g., sputum
induction, bronchoscopy, autopsy, or Pentamidine aerosol treatment) can increase
the risk of transmission.
(7) Lack of adequate chemotherapy or non-compliance with chemotherapy
significantly increases the probability of the case producing acid-fast bacilli.
(8) Singing or shouting increases risk of producing infectious particles.
(9) Patient鈥檚 unwillingness or inability to cover mouth and nose when coughing or
sneezing increases risk of transmission.
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(10)Children< 10 years of age are usually less contagious than adults with the
exception of the rare adolescent with cavitary tuberculosis who produces sufficient
tubercle bacillus to be detected on sputum smears 90 .
6.2.2 Transmission Factors Relating to Shared Air Space
The environment in which the contact occurs is also important in assessing infectiousness.
Transmission is rarely thought to occur outdoors; however, the presence of indoor
environments that are poorly ventilated, dark and damp can lead to increased concentration
and survival of mycobacteria. 91
(a) Volume of air common to the index case and contact is critical (i.e., if the
volume is low 鈥? as in a small shared room, the concentration of infectious
particles is greater). By contrast, a workplace exposure in a large warehouse
type of space is much less likely to lead to transmission.
(b) Ventilation influences the concentration of infectious particles. Exogenous
air introduced will dilute the concentration of potential infected particles,
reducing transmission risk.
(c) Re-circulated air within an essentially closed space may accumulate high
concentration of infectious particles.
(d) Air filtration may efficiently trap droplet nuclei and counteract the tendency
of infectious particles to accumulate within a recirculated air environment.
(e) Ultraviolet radiation used to irradiate air within a shared air space may
reduce the risk of infection by killing bacilli suspended in droplet nuclei.
6.2.3 Transmission Risk Factors Relating to Contacts
(a) The greater the amount of time spent with the index case, the greater the
risk.
(b) Sustained physical closeness or intimacy may increase the risk, although
droplet nuclei eventually undergo random distribution within the shared
space.
(c) Children younger than six years of age and people with impaired
immunity (e.g. HIV positive) have a greater risk of infection. Children and
people with impaired immunity should be thoroughly assessed to rule out
active disease. 92
90 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 130.; MMWR Dec. 16, 2005 Vo.54#RR-15, Guidelines for the Investigation of Contacts of Persons with Infectious
TB. Pp 1-147.
91
Ibid p. 176
92
ibid p. 181
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6.2.4 Classification of Contacts
In identifying and classifying contacts, consider the following factors:
(a) infectiousness of case
(b) frequency and length of exposure to case
(c) physical proximity between case and contact
(d) immune competence of exposed persons
(e) ages of exposed persons
(f) quality of ventilation; i.e., closed poorly ventilated space versus a well
ventilated air space.
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6.3 Procedure for Contact Investigation
6.3.1 Initiate Investigation
(a) Begin contact investigation as soon as the diagnosis of active or
suspected active tuberculosis is made.
(b) Consult with the attending physician and laboratory to establish how
infectious the case is. Also, interview the patient about symptom onset.
(c Identify close contacts within one week of notification and conduct initial
evaluation including skin testing within 1 month. Complete second skin test 8
weeks after last exposure to infectious case.
(d) Make a list of all appropriate contacts from information given by the index
case, the index case鈥檚 relatives, personal physician, or physician, nurse, or
employer at the index case鈥檚 place of work or school principal.
(e) Classify contacts according to risk of exposure (See 6.2.4).
(f) Visit index case's home and, if necessary, school, place of work and
other institutions to assess transmission risks in those environments and
obtain relevant contact information. Ensure confidentiality of index case.
(See: Section 6.2)
(g) Assess transmission risk
(h) Inform patients about the exposure via letter; provide information with
respect to TB infection and disease; inform patients of skin testing clinics if
arranged.
(i) Arrange skin testing for contacts by health unit staff whenever possible, or
refer contacts to their family physician, Community Health Centre, or other
medical facility for investigation and follow-up of possible infection/disease.
See Appendix A for sample letters for contacts.
(j) Request DNA fingerprinting on the samples if TB cases are found during
contact investigation. This would confirm or disprove suspected linkages
between the cases. (See Chapter 3 Section 3.5.2 (f) Strain Typing of
MTBC).
(k) Evaluate the results of the investigation for each circle of contacts to
determine the risk of transmission and the attack rates (See: Figure 1).
(l) Ensure all documentation is completed as required by the health unit and
the College of Nurses of Ontario. Include all fields required by the Ministry of
Health and Long Term care for iPHIS.
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6.3 Procedures for Contact Investigation
Figure 1: Circle of Contacts
Home
CASUAL
Outer
CLOSE
Inner
CASE
Work /
Leisure School
6.3.2 Establish Limits of Investigation
Although sometimes difficult to apply in practice, a systematic, organized approach to contact
investigation is very important in order to best interpret the results in TST testing.
For sputum smear-positive cases the extent and order of contact investigation is
based on the extent of exposure to the case.
Contact investigation must begin promptly with household and non-household close
contacts, especially children, and is expanded if transmission to this circle of contacts
is demonstrated. Transmission is considered to have occurred if a secondary case is
identified, or if the rate of tuberculin reactivity in this circle is greater than expected, or
if there is documented conversion.
Contact investigation should then be extended to those who are in regular, but less frequent,
contact (the 鈥渟econd circle鈥?). This circle often includes classmates or colleagues at work or in
recreational settings that are regularly frequented by the case. The results of the investigation
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of this group of contacts are then used to determine the need to expand the investigation yet
further.
Public health officials should also consider the probability of finding infected individuals
among more casual contacts when deciding whether to extend an investigation. Contacts
who have less exposure have a rate of tuberculin positivity that is usually four to six times
less than that among household contacts.
The prevalence of tuberculosis infection in various Canadian populations and age groups is
not well defined. However, the following broad parameters should assist in providing a
baseline for the interpretation of contact surveys 93 :
Table 1: Expected prevalence of a Positive TST
Among Various Populations
Small children (Canadian born or from low-risk countries) < 5%
Canadian non-Aboriginal adults 10%
Aboriginal Canadians (Age 20-40) 20% - 30%
Foreign born adults who lived for 20 years in a tuberculosis- 50%
endemic country
6.3.3 Contact Tracing Priorities
On diagnosis, all cases of tuberculosis must be classified by degree of infectiousness and
risk to contacts so that TB control staff can establish priorities for contact investigation. (See
Section 6.2 - Transmission Factors and Risk to Contacts.)
Investigating contacts of a highly infectious case and MDR TB cases takes priority
over that of contacts of less infectious cases. When contacts are children or people
who are immunosuppressed, their investigation takes priority, regardless of the status
of the index case.
The following lists priorities for contact tracing.
A. Respiratory Case
1. Highly Infectious (i.e., smear positive, culture positive)
Investigate close contacts immediately
Investigate casual contacts if rates of infection of the close contacts exceed the
expected prevalence rates in the community. Use prevalence data listed above
to guide follow-up.
93 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic Society, Health
Canada, 2000, p. 180.
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6.3 Procedures for Contact Investigation
In some cases of highly infectious tuberculosis, for example, laryngeal
tuberculosis, the contact investigation should include the second circle of regular
contacts from the outset. Similarly, in certain settings (shelters for the homeless,
for example) in which contacts may be difficult to identify or to find, it may be
necessary to do widespread testing from the onset.
2. Less Infectious (i.e., smear negative, culture positive, negative or unknown;
clinical diagnosis with respiratory symptoms but no laboratory evidence)
Investigate close contacts
Investigate casual contacts if rates of infection in close contacts exceed the
projected prevalence rates in the community.
3. Infectiousness Unknown (i.e., diagnosis based on autopsy results; smear
positive, culture not done; smear and culture not done)
Follow contacts based on available information from physician and family.
4. Treatment Failure or non-compliance if sputum remains positive or becomes
positive again:
Restart contact investigation
Investigate newly identified contacts
Retest previously exposed uninfected contacts not on chemoprophylaxis
B. Non-Respiratory Case
1. Extrapulmonary Tuberculosis In Children
Investigate close contacts to find source case
Investigate casual contacts if no source case identified among close contacts.
2. Extrapulmonary Tuberculosis In Adults
Investigate close household contacts as a precaution, to identify possible source
case and to identify previous infection.
6.3.4 Contact Interview
When interviewing contacts, take a complete history, including:
(a) risk factors for acquiring current infection/disease
(b) nature of exposure
(c) socioeconomic factors; e.g., poverty, homelessness, living in a congregate
setting
(d) high risk medical conditions
(e) current symptoms compatible with tuberculosis disease
(f) details of previous contact with tuberculosis
(g) previous tuberculin test dates and results
(h) previous chest X-ray abnormality (including date, place)
(i) details of previous anti-tuberculosis therapy
(j) country of birth and travel history
(k) BCG history
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Advise all contacts to seek prompt medical attention if they develop
symptoms suggestive of tuberculosis, especially coughing that
persists for three weeks or more.
6.3.5 Following Contacts Who Live Outside the Health Unit
A. Within Ontario
(a) Forward information on contacts living in other health units to those health
units for further management.
(b) The receiving unit is responsible for follow-up and must inform the referring
health unit about the results of contact tracing.
(c) The referring unit will use the information on contact follow-up to decide
whether to conclude or expand their contact investigation.
(d) The referring unit is also responsible for recording the results of contact
tracing in iPHIS.
B. Outside Ontario
(a) Forward information on contacts living outside Ontario in writing by fax or
letter to the Nurse Consultant, the TB Control Program, Ministry of Health
and Long-Term Care. Include details about the case such as:
鈥? AFB and culture results
鈥? Sensitivities
鈥? Chest x-ray report
鈥? Last point of contact with index case
The results of the contact follow-up will determine whether to conclude
or expand the contact investigation.
6.3.6 Contact Follow-up in Special Settings
TB control staff should take the steps listed below when following contacts in special settings.
A. Work sites, schools, and institutions
(a) Consult with the program manager, MOH or delegate regarding the plan for
contact follow-up.
(b) Notify appropriate health unit if work site or school is located in that health
unit.
(c) Inform the index case or index case鈥檚 parent/guardian if contact follow-up is
to be done. If you need to release the name of the index case to the
employer or principal in order to identify contacts, please obtain consent from
case or parent/guardian beforehand. If consent is denied, please consult with
Medical Officer of Health or designate.
Obtain the names of designated personnel associated with the setting whose
assistance is necessary to conduct contact tracing or for whom it is their
responsibility to participate in such investigations as outlined by their professional
duties.
(d) Inform the employer, principal/designate about purpose of follow-up.
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(e) Provide the employer/principal with a copy of section 39, HPPA regarding
confidentiality requirements under the Health Protection and Promotion Act.
(f) Offer information sessions on tuberculosis and provide written information to
contacts. A communication plan should be developed including Fact Sheets
and media releases as needed. (Inform the TB Control Unit at the Ministry as
per Section 1.7.1e).
(g) Offer on site Mantoux testing by health unit staff whenever possible.
(h) Forward results of follow-up to the health unit where contact lives, if
applicable.
B. Hospitals and Long-Term Care Facilities (LTCF)
An essential component of TB management within a hospital or long-term care facility is
the identification, assessment and management of patients, visitors, HCWs and other
hospital staff.
Personnel such as infection control practitioners/designate and occupational health
personnel, in consultation with the public health department, should perform the contact
management activities.
Public health should perform these activities for contacts outside the facility; such as:
family members, visitors, and patient contacts who are no longer in hospital.
After receiving notification of an active TB case within a hospital or LTCF setting the case
investigator will:
(a) Consult with the TB manager/designate and/or medical officer of
health/designate regarding the plan for contact tracing investigation within the
setting.
(b) Obtain the names of designated personnel associated with the setting whose
assistance is necessary to conduct contact tracing or for whom it is their
responsibility to participate in such investigations as outlined by their professional
duties (i.e. infection control practitioner/designate, occupational health
personnel).
(c) If possible, co-ordinate a site visit to meet with the designated personnel in order
to:
determine the case management team for the facility; clarify members鈥?
titles, roles and responsibilities
determine the best method in which to communicate with one another to
ensure that communication is clear and consistent to avoid confusion
and inappropriate contact follow-up
establish the limits of the investigation to include, but not limited to:
assessing transmission risk,
鈥?
appropriate classification/identification of close contacts (as per
鈥?
6.2.4),
process for the notification of close contacts,
鈥?
determine contact management recommendations (as per 6.3),
鈥?
assist with the co-ordination of a TB skin test clinic for contacts,
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provide education and counseling as required,
document in order to ensure everyone is aware of expectations and
timelines, and
provide an avenue for reporting results of the contact investigation
conducted within the facility, follow-up meetings as required and/or to
formally close out the investigation with a debriefing session
(d) Ensure all identified staff contacts are actively investigated by the Occupational
Health Service (OHS) and confirm that OHS will notify the supplying
agency/school of the potential exposure (if agency or students involved). In the
case of a contract worker with no supplying agency the OHS should inform the
worker of the exposure and the need for follow-up.
(e) Send a letter to family members as well as former patients identified as close
contacts, indicating that follow-up with a physician is recommended. Include a
fact sheet on TB infection/disease.
(f) Evaluate the results of the investigation for each circle of contacts to determine
the risk of transmission and the attack rates.
(g) Document:
the number of contacts who were evaluated,
number of active cases found,
of those tested, how many converted,
of the conversions, how many received treatment for LTBI, and
number of adverse events following treatment for LTBI.
C. Long distance public transportation
Definition of 鈥淪ignificant Travel鈥?
Significant airline travel is defined as:
a flight of 8 hours or longer in duration.
Significant bus or train travel is defined as:
a journey of 8 hours or longer in length.
(a) Airline contacts
(Refer to 鈥淭uberculosis Air Travel Guidelines for Prevention and Control鈥? 2nd
Edition 2006. Available at: www.who.int/tb/en/; Search for Airline Travel
Tuberculosis.)
(b) Practical Issues in Conducting Investigations Concerning Exposure to TB 94 :
Airline companies do not maintain records of passengers鈥? addresses,
telephone numbers or emergency contact information.
Although a telephone number is requested at booking, this is not an absolute
requirement and the accuracy of the information provided is not known.
94 nd
Tuberculosis Air Travel Guidelines for Prevention and Control, 2 Edition, 2006, p. 9
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In general, contact information maintained in airline records is inadequate in
a high proportion of cases.
Informing passengers and crew of a potential exposure to TB should be
limited to flights that have occurred within the three months before
notification of the TB case to health authorities.
(c) Procedures for Informing Passengers and Crew when Exposure to MTBC is
Suspected 95
Refer to Algorithm, p. 23 of Guidelines.
(d) Criteria for Deciding Whether to Inform Passengers and Crew
(1) Determination of Infectiousness
Laboratory AFB Positive Sputum and/or Positive MTBC Culture AND at
the time of the flight
Clinical: Clinical symptoms including cough and not receiving adequate
TB treatment, or,
Receiving adequate TB treatment for less than two weeks, or,
Receiving adequate TB treatment for more than two weeks but no
evidence of response.
If MDR TB not receiving adequate treatment OR receiving adequate
treatment but no evidence of culture conversion.
(2) Duration of Exposure
If total flight duration exceeds eight hours
(3) Time Elapsed Between Flights and Notification of the Case
Informing passengers and crew should be limited to flights that took place
during the three months before notification of the TB case to the health
authorities.
(4) Proximity of Other Passengers and Crew to the Index Case
Contact examination is required for all passengers in the same row as the
index case and those seated two rows ahead and two rows behind, as well
as cabin crew members working in the same cabin section.
If the health unit determines a passenger meets the above criteria, report this
immediately to the senior medical consultant or designate, TB Control
Program, at the MOHLTC.
Report initially by telephone and then by completing the 鈥淩eporting Form For
A Passenger With Infectious TB On An Aircraft鈥? . This form is available on
the Public Health Agency of Canada web site, as follows;
鈥淩eporting Form for Passenger With Infectious TB On An Aircraft鈥?:
Go to Public Health Agency of Canada www.phac-aspc.gc.ca
Go to A-Z index and type in T
Under Tuberculosis, go to: Tuberculosis Prevention and Control
Click on: Publications and Educational Resources
95
Ibid, pp. 23-27
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Under Travel Health you will find Reporting Form for a Passenger with Infectious
TB on an Aircraft
Fax this form to: TB Control Program, PHD at (416) 327-4687
(b) Train or Bus contacts
Report immediately, to the TB Control Program, at the MOHLTC, any
significant travel via bus or train, by the index case during the period of
communicability/infectiousness (see definitions - 鈥淧eriod of Infectiousness鈥? ).
When determining risk to train or bus contacts ensure transmission factors
have been considered (see 6.2).
6.3.7 Managing Contacts who Refuse Follow-up
(a) Encourage medical follow-up by home visit, telephone contact, or written
request. Notify contact in writing that further follow-up is the responsibility of
the contact and provide information on signs and symptoms of TB. Consult
with medical officer of health or designate to determine if further attempts are
warranted.
(b) If the contact is a child and the parent/guardian refuses follow-up,
immediately consult the medical officer of health/designate who can consider
issuing an order.
(c) If the contact has symptoms suggestive of tuberculosis disease and refuses
follow-up, immediately consult the medical officer of health/designate who
can consider issuing an order.
(d) Ensure that cultural issues have been considered. Translators and
community representatives may be of assistance with contacts who are
refusing follow-up.
6.3.8 Contact Management Recommendations
A. Previous documented TST reported as positive (or 鈮? 10mm induration)
Refer for assessment to rule out active disease and need for
chemoprophylaxis.
(a) Offer INH if indicated for 6 to 12 months if there is no history of
completed chemoprophylaxis.
(b) If index case has INH-resistant organisms, consult an expert in
tuberculosis for management.
(c) If signs and symptoms of TB are evident or contact is
immunocompromised, refer for medical assessment for active
tuberculosis.
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6.3 Procedures for Contact Investigation
B. Previous skin test not done, not documented, or negative (0-9mm)
Do Mantoux skin test as soon as possible after exposure.
HIGH-RISK CONTACT is:
A close contact of a smear positive pulmonary TB case who has:
impaired immunity, such as HIV infection; or,
high probability of infection without skin test conversion yet; or,
鈮?5 years old or an infant born to case with infectious tuberculosis
Note: Infants born to infectious mothers should only be separated from
their mothers if the mother continues to be smear positive or where
compliance with treatment cannot be assured.
1. For high-risk contacts of any age.
If negative (0-4 mm): Do history, physical exam, CXR, assess sputum if
obtained (CTS)
(a) If physical exam reveals no signs of active disease and chest x-ray
is normal:
i. Recommend INH until reevaluated by repeat skin test 8 weeks
after break in contact.
ii. If repeat skin test is negative (<5mm), INH may be discontinued
unless there is continuing exposure to an infectious source or the
contact has HIV infection.
(b) If INH is refused or contraindicated
i. Do Mantoux skin test at 8 weeks after the break in contact. 96
ii. If skin test is positive (鈮?5mm) at any point, proceed as in section
鈥滳鈥? below new positive reactors.
2. Other contacts
i. Repeat skin test 8 weeks after the break in contact.
ii. If skin test is still negative, no further follow-up is required.
iii. If positive (鈮?5mm), proceed as below.
C. New positive reactors and identified converters
Take history, do physical exam, order CXR, sputum exam if indicated.
(a) If physical exam, chest x-ray or sputum (if obtained) are
abnormal
96
Greenaway C., Palayew, M., Menzies, D. Yield of casual contact investigation by the hour. Int J Tuberc Lung Disea 7(12): S479-
S485, 2003.
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Assess for active disease and treat appropriately.
(b) If INH is refused or contraindicated
Advise the contact in writing that he/she is responsible for further
management.
Counsel contact about the signs and symptoms of TB and when to seek
medical attention.
If contact is high risk, advise the contact in writing of the need for
periodic medical follow-up over the next two years, to assess active
disease and provide information on the signs and symptoms of TB.
(c) If physical exam, chest x-ray or sputum (if obtained) are normal
Offer INH if indicated for 6 to 12 months.
If index case has INH-resistant organisms, consult an expert in
tuberculosis for management.
Offer 12 months INH
if the contact is/might be HIV positive
or offer 9-12 months, if contact has abnormal CXR consistent with inactive
TB.
For contact management and follow-up, see the following algorithm. (Figure 2)
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Figure 2: Contact Management Algorithm
NOTE: Any contacts
Tuberculin Skin Test 5 TU PPD who are children
鈮?5years of age or
persons who are
immune
compromised should
Reaction of 鈮?5mm Reaction of 0-4 mm
be given INH during
the 8 weeks between
tests.
Chest x-ray Repeat test in 8 weeks after break in
Symptom Enquiry contact.
Sputum Culture
Reaction of 鈮?5mm Reaction of 0-4 mm
No further follow-up required if
Chest x-ray
immunocompetent.
Symptom Enquiry
If immunocompromised, assess need to
Sputum Culture
continue INH for up to 12 months.
If TB disease ruled If TB diagnosed
out
Offer INH or Treat as active TB
appropriate disease
prophylaxis
ACCEPT:
Follow up for side effects
and compliance
REFUSE:
Advise contact in writing re further management.
Counsel re signs and symptoms of active disease
If contact high-risk advise re follow up for next 2
years and provide info on signs and symptoms of TB
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6.4 Appendix A: Sample Contact Letter
6.4 Appendix A: Sample Contact Letter
You have been named as a 芦type of contact_casual_close_household禄 contact of a person with active
pulmonary tuberculosis (TB). You had contact with this person from 芦Contact_start_date禄 to
芦Contact_end_date禄.
It can take 8 weeks after contact for a TB infection to show up. Depending on an assessment of the
situation by your doctor, you will need one or two TB skin tests.
YOU NEED TO:
Phone the , TB Control Program upon receipt of this letter. Please ask to
talk with a TB Nurse at Monday to Friday between 8:30a.m. and 4:30p.m.
See your family doctor or go to a walk-in clinic to have a TB skin test.
Bring this letter AND the Form to your doctor (TB Contact Follow-up Form).
Ask the doctor/nurse to send the completed form to our health department.
We have sent you a fact sheet on TB infection and TB disease.
YOUR DOCTOR NEEDS TO:
Do a TB skin test and remind you to come back within 48-72 hours later to have the test read.
Complete the Form and FAX it to the
FAX:
Repeat the TB Skin test 8 weeks later if your test is negative.
Sincerely,
PHN/PHI, Designation
Health Protection Branch
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6.5 Appendix B: Paediatric TB Contact
6.5 Appendix B: Paediatric TB Contact
TB Control Program
For ________________, Designation
Medical Officer of Health
City of ___________
RE: D.O.B.:
The above child has been identified as a household/casual contact of a person with active pulmonary
tuberculosis. A tuberculin skin test now and again in 8 weeks (if the first skin test is < 5 mm) is
recommended to determine if infection occurred.
According to the 鈥淐anadian Tuberculosis Standards鈥? (5th Edition 2000) exposed children 5 years of age or
younger who are tuberculin negative on the first skin test should begin preventive therapy with INH until
the second skin test is performed after active tuberculosis has been ruled out. If the second skin test is
negative (<5mm), INH may be discontinued. Should consultation be required please consider calling
either _______________, Pediatrician, at Fax number is or
_______________, Internal Medicine/Infectious Diseases, at Fax number is
number>.
Please complete the attached form and return it to the >>Health Unit<< at the address or fax above. All
residents of Ontario are entitled to medication free of charge for the treatment of active and inactive
tuberculosis. If there are any questions or concerns please call >>Health Unit Phone Number<< , Monday
through Friday, 8:30 a.m. to 4:30 p.m.
Sincerely,
>>PHN/PHI<<
>>Designation<<
For
>>MOH Name<<
Medical Officer of Health
>>City<<
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7.1 Introduction
7. Latent Tuberculous Infection (LTBI)
7.1 Introduction
7.1.1 Definition
Persons who have a positive tuberculin skin test (TST), and have no clinical,
bacteriological, or radiographic evidence of active disease are considered to have
latent tuberculous infection.
Chemoprophylaxis or preventive treatment refers to the treatment after the tuberculous
infection has occurred but before tuberculous disease is present. The term 鈥渓atent
tuberculous infection鈥? replaces 鈥渢uberculous infection鈥? and 鈥渋nactive TB鈥?. The term
鈥渢reatment of latent tuberculous infection (LTBI)鈥? replaces 鈥渃hemoprophylaxis鈥? and
鈥減reventive treatment鈥?. 97
7.1.2 Purpose
The purpose of treating latent tuberculosis infection is to prevent disease in people who
are infected, but who do not yet have active TB. It can also be used to prevent the
initial infection in high- risk contacts (e.g. children <6 years of age and people with HIV)
who have been exposed to an infectious case and who are awaiting follow-up skin-
testing. 98
7.1.3 Rationale
In persons infected with tubercle bacilli there is a variable risk of active tuberculosis.
Without risk factors, about 10% of infected persons develop tuberculosis, 5% within 2
years of infection and 5% after 2 years. 99 An HIV infected person who is also infected
with M. tuberculosis has an 8 鈥? 10% risk of developing active disease each year. 100
The therapeutic effect of INH has been shown to persist for at least 30 years. It is
presumed to endure for the lifetime of the treated patient. 101
97 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 96
98
ibid p. 181
99
Ibid, p. 97
100
Ibid, p. 142
101
Tuberculosis Control in Alaska, July 2001, p. 27
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for LTBI
7.2 Role of Public Health Units in Treatment for LTBI
When treatment for LTBI is prescribed for a patient, the health unit should be notified
by one of the following:
Receipt of a drug order,
Report from a physician,
Result of contact investigation,
Report from other public health units, or
Follow-up of school or worksite screening programs.
Public Health Units will:
(a) Reinforce with physicians the requirement to report TB infection to the medical
officer of health, whether or not treatment is prescribed.
(b) Refer infected individuals for medical assessment and consideration for
treatment of LTBI unless the report is coming from the physician who has
already made the assessment.
(c) Promote the use of treatment for LTBI according to current guidelines.
(d) Educate the patient and family about the purpose of treatment and the possible
side effects of the medications.
(e) Ensure that anti-tuberculous drugs are available free of charge.
(f) Ensure the drugs are appropriate and in the recommended dosage.
(g) Assess the need for directly observed prophylactic treatment (DOPT).
(h) Ensure that baseline liver function testing is done prior to initiation of treatment
for LTBI.
(i) Ensure patients with a history of alcohol abuse, pre-existing liver disease or
age of 鈮? 35 years are monitored for the course of treatment.
(j) Monitor compliance and document completion of treatment.
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7.3 Treatment of Latent Tuberculosis Infection
7.3 Treatment of Latent Tuberculosis Infection
7.3.1 Indications for Treatment
Treatment of latent tuberculous infection is recommended for persons at greatest risk
of tuberculosis disease. Close contacts (those without risk factors) of a case of
infectious TB are at increased risk of active disease. 5% of contacts found to be
infected will develop active disease within 2 years of exposure and another 5% after 2
years. 102
Table 1:
Indications* for Treatment of Latent Tuberculous Infection
In High-Risk Groups
Tuberculin Reaction Size Indication
鈮? 5 mm HIV infection
Recent contact of infectious TB
Presence of lung scar (compatible with old
healed TB but not previously treated)
鈮? 10 mm* Convertors (within 2 years)
Immunosuppression:
鈻? organ transplantation
chronic renal failure
prolonged corticosteroid or immune
suppressive drug therapy
hematologic malignancies: leukemia,
lymphoma
silicosis
diabetes mellitus
鈻? < 90% of ideal body weight
* Consider treatment of LTBI in other persons, particularly those 鈮? 飥?35 years of age, who have a
tuberculin reaction size 鈮? 10 mm and are from one of the following groups: foreign-born from
103
TB-endemic countries, Aboriginals, health care workers, and residents in communal care.
7.3.2 Individuals Who Should Start Preventive Treatment, Regardless of
the TST Result
Individuals recently exposed to TB may have a false-negative reaction to the initial
TST, if tested < 8 weeks after their last exposure, even if they are truly infected. These
individuals should be retested 8 weeks after their last exposure. During the window
period between the two TSTs, the following individuals should start preventive therapy,
even if the first TST is negative:
102 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 97 and 175.
103
Ibid, p. 98
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All household contacts < 5 years of age 104
Contacts with HIV infection or who are otherwise immunocompromised (e.g
persons on dialysis, those with diabetes)
These contacts should undergo a clinical exam and a chest x-ray to rule out TB
disease before starting preventive therapy.
If the second TST result is negative (<5mm), the contact is immunocompetent and no
longer exposed to infectious TB, treatment for LTBI can be discontinued, and further
follow-up is unnecessary. If the second TST result is negative but the contact is
immunocompromised (i.e. HIV infection), a course of therapy for LTBI should be
completed.
If the second skin test result is negative but the person remains in close contact with an
infectious patient, treatment for LTBI should be continued if the contact is: aged <5
years; aged 5-15 years, at the clinician鈥檚 discretion; or HIV-seropositive or otherwise
immunocompromised. 105
7.3.3 BCG-Vaccinated Person
A history of BCG vaccination, with or without a BCG scar, should not influence the
decision regarding LTBI treatment. No criteria can reliably distinguish tuberculin
reactions caused by vaccination with BCG from those caused by natural mycobacterial
infections. Persons at increased risk for recent infections or with medical conditions that
increase the risk of disease should be considered for treatment of LTBI regardless of
BCG vaccination status.
7.3.4 Individuals Who Should NOT Start Preventive Treatment:
Persons who abuse alcohol daily
Persons who are pregnant (see Section 7.4.6)
Persons with acute liver disease
Those who have had an adverse reaction to INH in the past
Those with low likelihood of compliance (consider DOPT if risk of non-
compliance is high)
Persons on medications that may result in serious drug interactions
Persons with peripheral neuropathy of any etiology or a condition that
might predispose him/her to peripheral neuropathy such as peripheral
neuropathy associated with diabetes.
104
Ibid, p. 134
105
MMWR, November 4, 2005, Vol. 54, No. RR-12.
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7.4 Patient Management
7.4 Patient Management
7.4.1 Medical History
Before starting treatment for LTBI, the treating clinician should determine:
Is there active disease?
Pretreatment evaluation must, at a minimum, include a chest x-ray. If the chest x-ray
was taken more than 2 months prior to evaluation or if the language in the x-ray
report is ambiguous, regardless of the date the x-ray was obtained, the patient should
have a repeat x-ray.
If there are symptoms suggestive of either pulmonary or extra-pulmonary
tuberculosis disease, further diagnostic evaluation is needed. Such evaluation may
include comparison of current and previous chest x-rays, bacteriologic examination of
sputum or biopsy of a sample from a non-respiratory site.
Has the individual been treated for LTBI or TB disease in the past?
Does the person have risk factors for the development of TB disease?
Persons who have completed a documented course of preventive treatment in the
past do not need to be treated again, unless there has been recent exposure to TB.
Treatment of LTBI will only remove bacilli currently present in the body; therefore,
subsequent contact with TB disease may require another course of treatment. An
example of this would be:
Subsequent close contact with a person who has AFB smear-positive
pulmonary or laryngeal TB disease and the contact is:
HIV seropositive or has another medical risk factor for developing TB
disease.
Younger than 18 years.
HIV seronegative but has had significant exposure to a patient with
highly infectious TB.
If there is uncertainty whether a person requires treatment for LTBI, consult a TB
specialist.
When preventive treatment is repeated, an entire course should be given on
the assumption that exogenous re-infection may have occurred.
Are there are any pre-existing medical conditions that would be a
contraindication for treatment or are associated with an increased risk of
adverse effects of treatment?
What drugs is the person currently taking?
The patient should inform their family physician that they are on prophylaxis for TB.
Drug interactions may occur between the following drugs, see the Compendium of
Pharmaceuticals and Specialties (CPS) for details:
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7.4 Patient Management
INH and Dilantin/INH and Tegretol - INH blocks the excretion of these drugs by the liver
causing an increase in serum concentration levels. Therefore, serum levels of these
medications should be monitored and the dose of these medications adjusted if
necessary. 106
Aluminum hydroxide gel decreases gastrointestinal absorption of
isoniazid. Isoniazid should be administered at least 1 hour before the antacid.
Rifampin is sometimes used for LTBI. It may accelerate clearance of drugs
metabolized by the liver (e.g., anticoagulants, oral antidiabetics, corticosteroids, digitalis
compounds, oral contraceptives, ethambutol, methadone, estrogen, sulfonylureas,
digoxin, antiarrythmic agents, such as quinidine, verapamil, mexiletine, theophylline,
anticonvulsants, ketoconazole, and cyclosporin). By accelerating estrogen metabolism,
rifampin may interfere with the effectiveness of oral contraceptives. 107
Is there any alcohol abuse or illicit drug use?
The risk of INH-induced hepatitis is increased in persons with daily alcohol
consumption. 108
What is the person鈥檚 HIV status?
All patients should be counseled and offered HIV testing unless they have documentation
of either a positive HIV antibody test or a negative result to an HIV antibody test obtained
< 6 months ago. The identification of latent TB infection and the implementation of
measures to prevent development of active disease are of high priority in the case of HIV
infected individuals. 109
7.4.2 Baseline Liver Function Testing
Baseline liver function (AST, ALT) testing is recommended for all persons prior to starting
treatment for LTBI. Regular monitoring is suggested in those:
with pre-existing liver disease,
with a history of alcohol abuse,
who are 鈮? 35 yrs of age, 110
with a history of substance abuse which would affect the liver.
Baseline and monthly liver function testing is recommended for pregnant and post-partum
women, individuals with liver disease, or those who are malnourished or underweight or
who have clinical evidence of hepatotoxicity.
LTFs should be done, as deemed appropriate, if the patient is taking other medications
with the potential of hepatotoxicity. 111
106 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p.102
107
Ibid, p. 90-91
108
Ibid, p.101
109
ibid p. 142
110
ibid p. 102
111
Indiana State Department of Health Tuberculosis Control and Prevention Manual, 2003 p.33
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7.4 Patient Management
7.4.3 Side Effects
Patients should be advised to notify their physician immediately if they experience any
side effects from INH therapy, 112 such as:
(a) Unexplained anorexia, nausea, vomiting, fatigue, or weakness of more than 3
days duration
(b) Persistent paraesthesia of hands and/or feet
(c) Dark urine
(d) Jaundice
(e) Headache
(f) Rash
(g) Fever of more than 3 days duration
(h) Abdominal tenderness, especially right upper quadrant discomfort
(i) Arthralgia
Toxic effects and, rarely, death have been reported from INH-induced hepatitis. Hepatitis
occurs mostly in adults, but has been reported in children as young as 2 years. Hepatitis
is non-predictable but correlated with age. It has been rare in persons under the age of
20, 0.2% in the 20 to 34 year age group, 1.5% in the 35 to 49 age group and 2.4% in the
over 50 age group. 113
Patients should be advised to discontinue medicines temporarily
(until medical evaluation is possible)
if they experience possible medication-associated side effects and
cannot immediately contact their health-care provider.
It is not necessary to discontinue treatment unless:
鈻? AST exceeds 5 times the upper limits of normal, or when
鈻? clinical jaundice develops, or when
the patient is experiencing symptoms of hepatotoxicity. 114
鈻?
Consideration for Directly Observed Prophylactic Therapy (DOPT):
Persons at high risk of tuberculous disease should be considered for DOPT including:
鈻? Household contacts of patients who are receiving DOT
鈻? Close contacts if compliance is a concern
鈻? Persons attending methadone clinics,
Persons prescribed an intermittent regimen. 115
鈻?
112 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 101
113
ibid
114
Ibid, p. 90
115
Ibid, p. 100
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7.4 Patient Management
7.4.4 Treatment Regimens
Treatment of LTBI is started only after tuberculous disease has been excluded.
Isoniazid (INH) is recommended in a dose of 10-15mg/kg daily for children, up to a
maximum of 300mg daily. For adults, the dose is 300mg daily. The twice weekly dose is
20-40mg/kg, to a maximum of 900mg/dose in children and 900mg/dose in adults.
The addition of vitamin B6 (pyridoxine) in a dose of 25mg is indicated when there is poor
nutrition, alcoholism, pregnancy, diabetes, uremia, or other disorders that might
predispose to neuropathy. It is also recommended in the neonatal period.
The optimal protection is probably achieved by 9 or 10 months, and this is the
recommended benchmark. 116
Table 3
Recommendations for Treatment of LTBI in HIV Seronegative Persons
Drug Duration Interval Mode* Doses
9 months Daily 270
INH SAP
6 months Daily 180
SAP
9 months 2/week 90
INH DOPT
6 months 2/week 52
DOPT
4 months Daily 120
RMP SAP, + DOPT
6 months 2/week 52
INH, RMP DOPT
* SAP: Self-Administered Prophylaxis
* DOPT: Directly Observed Prophylaxis Treatment
For INH resistance or intolerance 117
* +:
Note: A 6 month regimen of INH is not acceptable for children or for persons with
fibrotic lesions visible on their chest x-ray. 118
In situations in which Rifampin cannot be used (e.g., HIV infected persons receiving
protease inhibitors), Rifabutin may be substituted. 119
Pyrazinamide (PZA) and Rifampin (RMP) for a 2 month period are not
recommended for general use.
116 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 97
117
Ibid, p. 98
118
Indiana State Department of Health Tuberculosis Control and Prevention Manual, p. 31
119
MMWR, June 20, 2003 / Vol. 52 / No. RR-11, pp. 735-739
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If the potential benefits significantly outweigh the demonstrated risk of severe
liver injury and death associated with this regimen and the patient has no
contraindications, an expert should be consulted prior to its use 120
7.4.5 Resistance to Isoniazid, and Isoniazid and Rifampin
In persons infected with INH-resistant organisms and a high risk of tuberculous disease,
Rifampin daily for at least 4 months is an acceptable alternative regimen. For preventive
therapy in persons thought to be infected with an isolate resistant to drugs other than
INH, consultation with a tuberculosis specialist is recommended. 121
7.4.6 Pregnancy
(a) Women who are pregnant at diagnosis of LTBI
Except for patients co-infected with HIV or those with recent tuberculous infection,
the recommendation for management of LTBI during pregnancy is to postpone
treatment until after delivery. Pregnancy probably does not increase the risk of
progression to disease and there is a suggestion that pregnant women show a higher
rate of INH hepatotoxicity effects. 122
In some situations, preventive treatment should begin during pregnancy. It should be
started in the first trimester for TST positive (> 5 mm) pregnant women who:
are HIV seropositive or who have behavioral risk factors for HIV infection but
decline HIV testing
have been in close contact with a smear-positive pulmonary TB patient
Preventive treatment should be started promptly after the first trimester of pregnancy
in women who have had a documented conversion in the past 2 years. If preventive
treatment has been restarted, a full course should be given (previous doses ignored).
In pregnant women who are at high risk of tuberculosis, Vitamin B6 is recommended
with INH-containing regimens.
Preventive treatment, if indicated, should be started 2-3 months after delivery for all other
pregnant women, including those with x-ray evidence of old, healed TB.
In pregnant women known or suspected to be infected with a TB strain resistant to at
least INH and RMP, preventive treatment should be delayed until after delivery because
of possible adverse effects of these medications (i.e. ethambutol, pyrazinamide etc.) on
the developing fetus. 123
120
MMWR, August 8, 2003 / Vol. 52 / No. RR-31, pp. 735-739. Adverse Event Data and Revised American Thoracic
Society/CDC Recommendation Against the Use of PZA and RMP for LTBI because of Severe Liver Injury and Death.
121
Ibid, p. 98, 99
122
Ibid, p. 101
123 rd
Clinical Policies and Protocols, Bureau of Tuberculosis Control, New York City Department of Health, 3 Edition, June
1999, p. 23
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(b) Women Who Become Pregnant While Taking Preventive Treatment
In general, treatment should be discontinued in women who become pregnant while
taking INH and/or RMP. To reduce the risk of peri-partum hepatitis, preventive
treatment should not be restarted until 2 or 3 months after delivery. When preventive
treatment is restarted, a full course should be given (previous doses ignored). 124
(c) Perinatal Exposure
If a pregnant woman has LTBI or tuberculosis disease, her newborn will need special
follow-up. The infant should be skin tested at 4-6 weeks of age, and if negative,
retested at 3-4 months and 6 months of age. The infant should not be placed on INH
unless he/she has a positive skin test.
An infant born to a woman being treated for tuberculosis disease should be treated
presumptively with INH unless there is evidence of congenital tuberculosis. The child
should be checked monthly and then be given a TST and chest x-ray at 3-4 months
of age. If the TST is negative, it is recommended that Isoniazid be continued and
the TST be repeated at 6 months. If the skin test is positive at 6 months, the child
should be reassessed for active disease. If disease is absent, an additional 3 months
of INH should be administered. If it is negative, INH may be discontinued.
An infant born to a woman found to have untreated infectious tuberculosis should be
managed the same as an infant whose mother is being treated for tuberculosis with
one additional provision. The mother should be isolated from her infant until
treatment of the mother renders her non-infectious. 125
Breast feeding should not be discouraged, as the very small concentrations of
antituberculous drugs in the breast milk do not produce toxic effect on the newborn. It
should also be emphasized that the small amount of medication that may be found in
breast milk should not be considered effective treatment or prophylaxis in a nursing
infant. 126
7.4.7 Children
A diagnosis of LTBI or tuberculosis disease in a child is a sentinel event usually
representing recent transmission of M. tuberculosis. 127 Active TB disease can be severe
in young children. In children, especially those 鈮?5 years of age, infection is not only more
likely to progress to disease, but to severe forms of disease; e.g., CNS and disseminated
(miliary) TB. 128 Among children, efficacy of treatment approaches 100% with
appropriate adherence. 129
For children with HIV infection or other immunocompromising conditions, a minimum of 9
months of INH preventive therapy is recommended. In situations of uncertain adherence,
124 rd
Clinical Policies and Protocols, Bureau of Tuberculosis Control, New York City Department of Health, 3 Edition,
June 1999, p. 29
125
Tuberculosis Control in Alaska, July 2001, p. 32
126 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 94
127
Ibid, p. 127
128
Ibid
129
Pediatric TB Manual, Hospital for Sick Children, March 2002, pp. 29-30
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7.4 Patient Management
INH can be administered twice weekly (20-40mg/kg/day, maximum 900mg/day) under
Directly Observed Prophylactic Therapy (DOPT). 130
For children infected with what is likely to be an INH-resistant strain, or who are intolerant
of INH, rifampin (10-20mg/kg/day, maximum 600mg/day) is recommended for 6
months. 131
INH may interfere with pyridoxine metabolism and produce peripheral neuropathy and
other significant reactions (i.e. psychotic episodes). B6 (pyroxidine) should be given to
persons with:
diabetes
鈥?
pregnancy
鈥?
renal failure
鈥?
malnutrition
鈥?
substance abuse
鈥?
seizure disorders 132
鈥?
Pyridoxine therapy is generally not indicated except in breast fed infants or malnourished
children.
7.4.8 Completion of Treatment
The important variable is duration rather than continuity. A full course of therapy is
determined more accurately by the total number of doses taken, not solely by the
duration of therapy. 133 Extend INH treatment long enough to ensure the equivalent of 9
months of treatment with 100% compliance. 134
To be considered adequate, the 9 month daily INH regimen, consisting of 270 doses,
should be administered over no more than 12 months. Likewise, to be considered
adequate, the 6 month INH regimens should be administered over no more than 9
months. Regimens of 2 or 4 months should be administered over no more than 3 or 6
months respectively to be considered adequate. 135
Interruptions in treatment may have significant affect on the duration of treatment.
Reinstitution of treatment must take into account:
the bacillary load of the patient
鈻?
the point of time when the interruption occurred
鈻?
duration of the interruption
鈻?
130 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p.135
131
Ibid
132
ibid p. 90
133
MMWR, June 20, 2003/Vol. 52/No. RR-11, p. 8
134 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 97
135
Tuberculosis Control in Alaska, July 2001, p. 36
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7.4 Patient Management
In general, the earlier in the treatment and the longer the duration of the interruption, the
more serious the effect and the greater the need to restart the therapy from the
beginning. 136
136
MMWR, June 20, 2003 / Vol. 52 / No. RR-11
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8.1 Introduction
8. Treatment of TB Disease
8.1 Introduction
Treatment of TB is aimed at achieving a lifetime cure of the disease, preventing drug
resistance, and preventing further transmission of the infection in the community. 137
Therefore, successful treatment of a TB patient benefits the patient and the community.
Cure can be achieved in different ways, all of which include ingestion of drugs to which
the TB organism is susceptible. The medications against TB are always given in
combination for a period of several months. M. tuberculosis is usually slow to produce
disease and equally slow to respond completely to drug treatment. 138 Several factors
must be taken into account in determining which drugs are to be used and the length of
treatment. These include:
The type of disease being treated
The drugs that are available for treatment (Cases due to drug-resistant
isolates will need longer courses of treatment than those due to drug-
susceptible isolates.)
Patient adherence to treatment
Potential drug interactions 139
Patient tolerance of TB medications (because of side effects the treatment
may not always be the most optimal treatment)
137
Alberta TB Control Manual, May 2002, p. 3-8.
138
Ibid.
139
Ibid.
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8.2 Treatment for TB
8.2 Treatment for TB
Treatment for TB should be based on:
Clinical, pathological and radiographic findings;
Results of microscopic examination of acid-fast bacilli smears and cultures for
mycobacteria; and,
Epidemiologic information 140
8.2.1 Responsibility for TB Treatment
In 2002, the American Thoracic Society published their treatment guidelines for TB.
Central to these guidelines is that the responsibility for the treatment of TB is on the
provider or program that provides TB treatment.
鈥溾??. It is well established that appropriate treatment of TB rapidly renders the patient
noninfectious, prevents drug resistance, minimizes the risk of disability or death from TB
and nearly eliminates the possibility of relapse. For these reasons, antituberculosis
chemotherapy is both a personal and a public health measure that cannot be equated
with the treatment of, for example, hypertension or diabetes mellitus, wherein the benefits
largely accrue to the patient鈥ll reasonable attempts should be made to accommodate
the patient so that a successful outcome is achieved, However, interventions such as
detention may be necessary for patients who are persistently nonadherent.鈥? 141
8.2.2 Treatment Regimens
There are two phases of TB treatment:
(a) The Initial or Intensive Phase, and
(b) The Maintenance or Continuation Phase.
(a) Initial or Intensive Phase
The Fifth Edition of the Canadian TB Standards recommends that 3 or 4 drugs
(isoniazid, ethambutol, rifampin and pyrazinamide ) be given daily (using Directly
Observed Therapy [DOT]) for 2 months (60 doses). This phase allows the TB
drugs to kill rapidly replicating populations of M. tuberculosis and to prevent the
emergence of drug resistance. 142
The choice of drugs depends on drug susceptibility testing. If susceptibilities
are not known at the onset of treatment, four drugs are usually prescribed
and adjustments are made once susceptibility test results are available.
The drugs are to be taken daily. The bactericidal effect leads to rapid
bacteriologic sputum conversion and decreasing clinical symptoms. 143
140
TB Control and Elimination, Nunavut Manual, p. 5-1
141
American Journal of Respiratory and Critical Care Medicine, Vol. 167, 2003, American Thoracic Society/Centers
for Disease Control and Prevention/Infectious Diseases Society of America: Treatment of Tuberculosis, p. 614.
142 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 85, 86.
143
Ibid, p. 85
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8.2 Treatment for TB
Because of the relatively high proportion of adult patients with TB caused
by organisms that are resistant to INH, four drugs are necessary in the
initial phase for the 6 months regimen to be effective. 144
This initial phase is important because it:
Results in rapid, symptomatic relief, rapid reduction in infectiousness and
reduced mortality;
Reduces the possibility of the individual developing drug-resistant TB;
and,
Significantly increases the possibility that the client will complete
treatment in 6 months. 145
(b) Maintenance or Continuation Phase.
Two drugs (usually isoniazid [INH] and rifampin [RMP], if the organism is
susceptible) are given daily or twice weekly using DOT for an additional 4 to 7
months. The longer regimen is used if the sputum was AFB positive. This
eliminates any persisting bacteria not destroyed in the initial phase, and reduces
the likelihood of relapse. 146 Medication can be given daily or twice weekly. Any
intermittent delivery MUST be by DOT. The sterilizing effect of therapy eliminates
the remaining bacilli and prevents subsequent relapse. 147
144
American Journal of Respiratory and Critical Care Medicine, Vol. 167, 2003, American Thoracic Society/Centers
for Disease Control and Prevention/Infectious Diseases Society of America: Treatment of Tuberculosis, p. 604.
145
Alberta TB Control Manual, p. 3-8
146
Ibid
147 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p 85
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8.3 Medications Used to Treat TB
8.3 Medications Used To Treat TB
8.3.1 鈥楩irst Line TB Drugs鈥?
Isoniazid (INH), rifampin (RMP), ethambutol (EMB) and pyrazinamide (PZA) are the 鈥榝irst
line鈥? TB drugs. At the present time, they are the most effective drugs with which to
combat TB. They should not be used indiscriminately. If resistance to these drugs
develops, the treatment of TB is often more expensive, more complicated and its duration
much longer. 148 It is also very important that a single drug is not added to a failing
regimen. Doing so can lead to acquired resistance.
ALL DRUGS for the treatment of TB in Ontario are provided free of charge through
the TB Control Program of the Ministry of Health and Long-Term Care. Physicians
should NOT write prescriptions to be filled at a local pharmacy for 鈥榝irst line鈥? TB
drugs unless previous arrangements have been made with the local public health
unit.
All residents of Ontario with TB disease or infection will be provided with drugs free of
charge (including 鈥榮econd line鈥? drugs to treat TB) for the treatment and chemoprophylaxis
of TB infection with M. tuberculosis. These drugs, which are provided by the Ontario
Ministry of Health and Long-Term Care and distributed by public health units, are also
available to visitors (i.e., non-residents) who are unable to pay on a case-by-case basis.
Drugs used to treat atypical mycobacterial infections, also known as MOTT
(mycobacteria other than TB), including M. avium complex, are NOT provided free of
charge. An uninsured person does NOT need to be enrolled in the TB-UP program in
order to get free TB medications in Ontario.
It is important that local public health units ensure that all hospitals, physicians, and
pharmacists in Ontario are aware that the MOHLTC provides TB drugs free of charge to
TB patients and their contacts.
8.3.2 Availability of 鈥楩irst Line鈥? TB Drugs
First line TB drugs can be ordered by local public health units upon the receipt of a
prescription from the health care provider. The drugs are available free of charge from
Ontario Government Pharmaceutical and Medical Supplies Services (OGPMSS) using
the Public Health Division Requisition for Drugs to Treat TB (see Appendix A ).
To obtain these drugs, physicians and hospitals must order their drugs through their local
health unit. In Toronto, some physicians and hospitals may receive drugs directly from
OGPMSS through a special arrangement with their local health unit.
(a) Isoniazid (INH)
Isoniazid is an active bactericidal anti-tuberculous agent that was first used in
1952. Its mode of action is still not completely understood, and it is effective only
against the genus Mycobacterium. 149 The drug is firmly bound to the actively
growing, sensitive tubercule bacilli. 150 It is rapidly and almost completely
148
Alberta TB Control Manual, p. 3-9
149
ibid
150
TB Control and Elimination, Nunavut Manual, p 5-3.
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absorbed, and peak blood levels are reached within 30-60 minutes after
ingestion. Absorption is inhibited by the presence of food in the stomach. 151
There is natural occurrence of resistance to INH in about 1 in a million
organisms. The assumption is made that more than 1 million organisms must be
present before TB disease is seen. Therefore, INH is always used in
combination with another drug when used for treating active TB disease. The
second drug will destroy any naturally occurring drug resistant mutations in the
population of bacteria. If infection has occurred, but NO disease is detected, it is
safe to assume that fewer than 1 million organisms are present, and the use of
INH alone to prevent future reactivation is acceptable practice. 152
(b) Rifampin (RMP)
Rifampin has been in general use since 1970. It acts by inhibiting DNA-
dependent RNA polymerase activity in dividing cells, and it is effective against
mycobacterium as well as some gram positive and gram negative organisms. It
is readily absorbed and reaches peak blood concentrations 2 to 4 hours after
ingestion. Absorption is inhibited by the presence of food in the stomach. There
are many potential drug interactions with RMP and the prescribing physician
should take a careful medication history and consult with a pharmacist to discuss
potential drug interactions. 153
When given intermittently, usual doses are used because intermittent high dose
administration is likely to cause hypersensitivity reactions, including
thrombocytopenia and anaphylaxis. 154
Rifampin is a liver enzyme inducer and increases the metabolism (thus
decreasing the blood levels) of other drugs metabolized in the liver, such as
anticoagulants, oral hypoglycemic agents, corticosteroids, oral contraceptives,
phenytoin etc. Patients on birth control pills will have to use alternate forms of
birth control while on RMP. 155
(c) Pyrazinamide (PZA)
Pyrazinamide has been used since 1952. Its mechanism of action is unknown,
but it is active only at acid ph. 156 The accumulation of pyrazinoic acid (the active
derivative of PZA) through the action of the amidase pyrazinamide by susceptible
M. tuberculosis leads to its intracellular bactericidal action.
Absorption of PZA is not influenced by food intake. 157 Pyrazinamide inhibits the
renal excretion of urates, and will often lead to high levels of uric acid in the
blood. This is usually of no consequence. On rare occasions, it may lead to
151
Alberta TB Control Manual, p. 3-9.
152
Ibid.
153
Ibid, p. 3-10.
154
Ibid.
155
Ibid.
156
Alberta TB Control Manual , p. 3-10.
157
TB Control and Elimination, Nunavut Manual, p. 5-4.
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8.3 Medications Used to Treat TB
acute episodes of gout in persons predisposed to gout; in which case, the drug
may need to be discontinued. 158
(d) Ethambutol (EMB)
The synthesis of ethambutol was reported in 1961. 159 Ethambutol is
bacteriostatic at low dosage (15mg/kg). 160 It diffuses into actively growing
mycobacterium cells where it inhibits the synthesis of one or more essential
metabolites, causing impairment of cell metabolism, arrest of multiplication, and
cell death. 161 It is active only against organisms of the genus Mycobacterium. It
is about 75-80% absorbed after an oral dose, and reaches blood concentrations
about 2 to 4 hours after ingestion. Absorption does not seem to be affected by
food in the stomach. 162
Ethambutol is excreted from the body mainly in the urine. There is a fine line
between the blood level needed to be effective and the toxicity level. In
individuals with impaired renal function, there is marked accumulation of
medication in the system. For this reason, renal function (serum creatinine)
should be measured before beginning treatment. 163
Ethambutol may cause optic neuritis (in about 6% of patients), with decreased
visual acuity and loss of red-green colour discrimination. These effects are
uncommon at the lower dosage (15mg/kg), and for this reason, dosages are
usually reduced after the initial phase of treatment. They are usually reversible
when detected early and the drug is discontinued promptly.
Visual acuity and red-green colour discrimination should be tested
monthly while on treatment, and the patient should be advised to report
promptly any changes in vision.
Because these changes may be unilateral or bilateral, each eye must be
tested separately and both eyes tested together. 164
158
Alberta TB Control Manual, p. 3-10.
159
TB Control and Elimination, Nunavut Manual, p.5-4.
160
Alberta TB Control Manual, p. 3-10.
161
TB Control and Elimination, Nunavut Manual, p.9-4.
162
Alberta TB Control Manual, p. 3-10.
163
Ibid, p. 3-11.
164
Alberta TB Control Manual, p. 3-11.
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8.4 Treatment Regimens
165
8.4 Treatment Regimens (Cases)
8.4.1 Length of Treatment
If fully susceptible, treat for at least 6 months with INH, RMP and PZA (can
be discontinued after 6 months).
INH and RMP can be discontinued after 9 months.
If INH and RMP are NOT used, then extend treatment to a minimum of 12
months
Table 8-1: Duration of Treatment (In Months)
Number
Regimen Intensive Continuing Total of Doses
INH/RMP/PZA 卤EMB 2 4 6 95
INH/RMP 卤EMB 1-2 7-8 9 120
Table 8-2: Dosing Interval Options
Number
Regimen Option of Doses Treatment
INH/RMP/PZA Daily INH, RMP, PZA x 2 months
1 95 doses
Then INH and RMP daily or 2x/weekly for 4
months
Daily INH, RMP and PZA x 2 weeks
2 60 doses
Then INH, RMP and PZA 2x/week for 6 weeks
Then INH and RMP 2x/week for 4 months
INH and RMP Administer daily INH and RMP x 2 months
1 120 doses
Then INH and RMP 2x/week for 7 months
Daily INH and RMP x 1 month
2 100 doses
Follow with INH and RMP 2x/week for 8 months
Daily INH and RMP for 9 months
3 180 doses
All regimens administered intermittently (e.g. 2 x/week) must be administered by DOT.
Ethambutol should be added to the initial regimen until drug susceptibility tests exclude
the presence of resistance. In all cases of suspected drug resistance, the treating
physician should consult a TB specialist prior to starting a treatment regimen.
165 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 86
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166
8.4.2 Response to Treatment and Treatment Failure
In order to monitor sputum conversion and treatment outcome, all patients with
sputum and culture positive disease should have repeat sputum examinations at
the end of the second month of treatment. To verify treatment success, additional
sputum cultures should be done at the end of the 6 and 9 month regimens. However, the
patient must be monitored more frequently if the clinical and radiologic response is
unfavourable. 167 If the patient is unable to cough or produce a sputum sample, consider
arranging for sputum induction.
Treatment failure is defined as two or more positive sputum cultures over an interval of 1
month, after 5 or 6 months of treatment, or two positive sputum cultures in different
months during the last 3 months of treatment. If TB symptoms continue and/or failure of
radiographic improvement in association with persistently positive sputum smears or
cultures should raise the question of treatment failure as early as the third month of
therapy. 168
169
Table 8-3: Doses and Common Adverse Reactions to Antitubercular Drugs
Daily Dose
Usual adult Twice More Less
Adults and
Monitoring Comments
daily dose Weekly Common Common
[children]
mg Dose mg Side Effects Side Effects
Mg/kg
INH Heptotoxicity Peripheral Baseline Exclude interactions
Supplied: (nausea, neuropathy measurement of with other
Tablets: vomiting, (controlled by hepatitis enzymes medications: If
100 & 300 mg abdominal co- for adults. Dilantin is co-
Liquid: discomfort, administration administered with
10mg/1ml anorexia, of pyridoxine) Repeat INH, the Dilantin
fatigue) Arthralgia measurements level will be
accompanied by Convulsions If baseline increased and
(Parenteral
increased Psychotic results are dosage needs to be
formulation
transaminase symptoms abnormal; adjusted accordingly.
also
(AST, ALT ) (rare) If patient is at
available)
Consider overdose
levels Rash high risk from
potential with INH.
adverse
reactions; or,
300 900 If patient has Hepatitis risk
5 [10-20]
symptoms of increases with age,
adverse alcohol consumption,
reaction. and chronic active
hepatitis.
Pyridoxine may
reduce the risk of
peripheral neuropathy.
166
Ibid, p. 95.
167
Adapted from Alberta TB Control Manual, pp. 3-12, 3-13.
168 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 95
169
Ibid, p. 83 and Alberta 3-13.
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8.4 Treatment Regimens
Daily Dose
Usual adult Twice More Less
Adults and
daily dose Weekly Common Common Monitoring Comments
[children]
mg Dose mg Side Effects Side Effects
Mg/kg
INH
(Continued)
RMP Hepatotoxicity Hypersensitivit Baseline CBC Exclude interactions
Supplied (as with INH) y for adults. with other
Capsules 150 Orange Purpura Platelets medications (e.g.,
& 300 mg discoloration of Gastroenteritis Hepatic decreased
Syrup urine and body Renal enzymes effectiveness of birth
formulated secretions shutdown control pills)
from (tears, urine, (rare) Repeat
capsules: saliva, Memory loss measurements if : Orange discoloration
10 mg/ml of tears will stain
perspiration) Leukopenia Baseline results
soft contact lenses;
Once the (rare) are abnormal
syrup is Thrombocytop Patient has sweat can stain
formulated it enia (rare) symptoms of white shirts.
is only good adverse reaction
for 1 month; Significant
keeping it in interactions with
the methadone and
refrigerator is many other drugs.
recommended
Parenteral
formulation
also
available)
10 [10-20] 600 600
PZA Hypeuricemia Hepatotoxicity Baseline Exclude interactions
Supplied: Arthralgia Photosensitivit measurements for with other
Tablets y adults medications
500 mg Gout Uric acid if gout
is suspected Not recommended in
15-30g 1500-2000 2500 Transaminase pregnancy
levels as with
Dosage INH and RMP
adjustment
needs if
patient is on
dialysis
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8.4 Treatment Regimens
Daily Dose
Usual adult Twice More Less
Adults and
daily dose Weekly Common Common Monitoring Comments
[children]
mg Dose mg Side Effects Side Effects
Mg/kg
EMB Retrobulbar Slight uric acid Baseline visual Exclude interactions
Supplied: neuritis elevation acuity and colour with other
Tablets Nausea discrimination medications
100mg & 400 Repeat visual
mg acuity and Report any visual
colour changes
immediately
15-25 800-1200 2400 discrimination
monthly
Avoid in Not recommended
patients with for children who are
renal failure too young to be
monitored for
changes in vision
(unless TB is drug
resistant)
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8.5 Drug Resistant TB
8.5 Drug Resistant TB
Drug resistance is caused by germ mutation following drug exposure. TB germs are able
to alter their structure so that they are able to destroy that drug. The drug can no longer
contribute to cure and active disease may continue or worsen. 170 Multi drug resistance
(MDR) is defined as resistance to INH and RMP. In 2006, the CDC encountered reports
of multiple cases of TB with resistance to virtually all second-line drugs (SLDs).
Extensively drug-resistant (XDR) TB cases are defined as cases in persons with TB
whose isolates were resistant to INH and RMP, and at least three of the six main classes
of SLDs (aminoglycosides, polypeptides, fluroquinolones, thioamides, cycloserine, and
para aminosalicylic acid). 171 XDR has emerged world-wide as a threat to public health
and TB control, raising concerns of a future epidemic of virtually untreatable TB.
Common causes for drug resistance are:
Patients who are inadequately or inappropriately treated for TB (including prior
treatment for TB)
Contacts of drug resistant cases
Patients infected in areas of the world where drug resistance is high e.g., Asia,
Africa, Russia
Persons infected in inner cities and prisons in the United States
If a person with TB disease is given a drug regimen for Latent TB Infection (LTBI), drug
resistance may develop. It is critical that PRIOR to starting treatment for LTBI, a
diagnosis for active TB disease is excluded.
ALL PERSONS WITH DRUG RESISTANT TB SHOULD BE MANAGED BY, OR IN
CONSULTATION WITH, A TB SPECIALIST WHO HAS EXPERIENCE TREATING
DRUG RESISTANT TB. TREATMENT SHOULD BE BY, OR UNDER THE
ADVISEMENT, OF THE TB MEDICAL CONSULTANT AT WEST PARK HEALTHCARE
CENTRE (WPHC). HOSPITALIZATION AT WPHC SHOULD BE CONSIDERED.
PERSONS WITH DRUG RESISTANT TB MUST BE ON DOT.
THE BASIC PRINCIPLE FOR TREATMENT OF DRUG RESISTANT TB IS THAT IF
THERE IS RESISTANCE TO ONE OR MORE TB DRUGS, THEN AT LEAST 2 OTHER
DRUGS THAT THE PERSON IS SUSCEPTIBLE TO, SHOULD BE PRESCRIBED.
8.5.1 Acquired Resistance
Persons whose initial culture show sensitive bacilli and then develop resistance during
treatment are said to have acquired resistance. Resistance develops from taking fewer
than 2 drugs to which the bacilli are sensitive. This may be due to inadequate,
inappropriate, or irregular treatment or non-adherence to drug taking. 172
170
Regional Tuberculosis Control Manual FNIHB Ontario Region March 2002, p. 91.
171
MMWR, March 24, 2006, Vol. 55/ No. 11.
172 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 112.
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8.5 Drug Resistant TB
8.5.2 Primary Resistance
This type of resistance occurs in persons previously untreated for TB who have drug
resistant organisms, presumably since they have been infected from an outside source of
drug resistant bacilli. 173
8.5.3 Management of Contacts of Person with Drug Resistant TB
The management of these contacts should be discussed with a TB specialist to
determine the best treatment regimen. Contacts of MDR TB should be followed for at
least 2 years, irrespective of treatment. This may include evaluating the contact every 6
to 12 months and, if symptoms warrant, obtain chest x-rays and sputum specimens for
culture and sensitivity.
8.5.4 鈥楽econd Line鈥? TB Medications
Second line TB medications are used to treat patients who are resistant to one or more of
the first line TB drugs or those who cannot tolerate the regular first line TB medications.
The prescribing of 鈥榮econd line鈥? TB drugs should be done ONLY by a TB specialist or by
a provider who has consulted with a TB specialist. These drugs are available free of
charge (see procedure for reimbursement in Section 8.5.6, following). The following
information with regard to the most commonly used second line TB drugs is for basic
information only. Please consult the Compendium of Pharmaceuticals and Specialties,
the prescribing pharmacist and the product monograph for complete drug information.
(a) Streptomycin (SM) 174
Streptomycin was discovered in 1944. It works by interfering with bacterial cell
proteins. It is not absorbed in the gut and is, therefore, given only in parenteral
form. Peak blood concentrations are reached about 1 to 2 hours after
administration.
It is excreted from the body mainly through the urine. If a person has impaired
renal function, SM will accumulate and may reach dangerously high blood levels.
For this reason, persons with any renal impairment need to be monitored very
closely.
There is also the risk of 8th nerve toxicity when using SM (especially if the patient
has renal impairment). This may lead to permanent loss of inner ear function.
Symptoms include: nausea, vomiting, vertigo, nystagmus and ataxia, tinnitus,
and varying degrees of hearing impairment. Monthly audiograms are necessary.
SM is also teratogenic to the fetus鈥? 8th cranial nerve and should not be used in
pregnancy.
(b) Fluroquinolones 175
The most common fluroquinolones used are: levofloxacin, gatifloxacin and
moxifloxacin. These drugs should not be considered as first line TB agents
for the treatment of drug susceptible TB, except in patients who are
intolerant or resistant to the first line drugs. The most commonly used drug
is levofloxacin. The adult dose is 500 鈥? 1000mg/day. Antacids and other
173
Ibid.
174
Alberta TB Control Manual, p. 3-11.
175
American Journal of Respiratory and Critical Care Medicine, Vol. 167, 2003, American Thoracic Society/Centers
for Disease Control and Prevention/Infectious Diseases Society of America: Treatment of Tuberculosis, p 626,638
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medications can cause a marked decrease in the absorption of the
fluroquinolones and may cause treatment failure. It is important to caution the
patient not to take this drug within two hours of a dose of antacids, the chewable
tablet form of didanosine, sucialfate, iron, magnesium, calcium, zinc or vitamins
or other dietary supplements (e.g. Ensure, Sustical).
In 2006, the Product Monograph for Tequin庐 (gatifloxacin) was revised. Serious
cases of both hypoglycemia and hypercalcemia were reported in persons
receiving Tequin庐. Tequin庐 is now contraindicated in patients with diabetes
mellitus.
(c) Rifabutin (RIF) 176
This drug is often substituted for RMP due to drug resistance. It is generally
reserved for those patients receiving medication with unacceptable interactions
with RMP or those who experience intolerance to RMP. The maximum adult
dose is 5mg/kg to a total of 300mg daily, 2 times or 3 times a week. The dose
may need to be adjusted with concomitant use of protease inhibitors or
nonnucleoside reverse transcriptase inhibitors. Persons taking RIF may
experience hemotologic toxicity (neutropenia), gastric symptoms, uveitis,
polyarthralgias, hepatoxicity, skin discolouration with normal bilirubin, rash, flu-
like symptoms and orange discoloration of bodily fluids.
(d) Aminogycosides (Amikacin and Kanamycin) 177
These two drugs are closely related and are given IM or IV. The maximum adult
dose is 15mg/kg/day (1.0g/day IV or IM). The drug is usually given in a single,
daily dose for 5-7 days/week then reduced to 2-3 times per week after the initial
first 2 to 4 months or depending on culture conversion. It is important that
patients on these drugs have audiology testing as ototoxicity is a side effect and
deafness can result.
(e) Cycloserine 178
The adult maximum dose is 10-15 mg/kg/day to 1000 mg. The usual dose is 500
-750 mg/day given in 2 doses. Patients may complain of CNS effects such as
headache and restlessness. This drug may exacerbate underlying seizure
disorders or mental illness.
8.5.5 How to Obtain 鈥楽econd Line TB Drugs鈥?
鈥楽econd line TB drugs are provided free of charge for patients infected with M.
tuberculosis complex. These drugs are not stocked at OGPMSS and must initially be
purchased by the patient, the health department, hospital or physician. The PHD will
reimburse the cost of the drug and the dispensing fees.
176
American Journal of Respiratory and Critical Care Medicine, Vol. 167, 2003, American Thoracic Society/Centers
for Disease Control and Prevention/Infectious Diseases Society of America:Treatment of Tuberculosis, p. 620, 621
177
Ibid, p. 624
178
Ibid, p. 623
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8.5.6 Reimbursement for Second Line TB Drugs
To obtain reimbursement for these drugs, the local public health unit should send an
invoice to the TB Control Unit PHD together with:
A photocopy of the prescription (all identifying information of the patient must be
removed, including the name, address and phone number);
The iPHIS TB identifier (to ensure that the drugs are being used only for the
treatment of TB cases) should be written on each prescription; and,
The total amount to be reimbursed and the address where the reimbursement
should be sent.
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8.5 Drug Resistant TB
8.6 Treatment of TB in Special Situations
The treatment of TB is special situations such as:
Persons who are HIV+ve,
Pediatric cases,
Persons with extrapulmonary TB,
Pregnancy and breastfeeding,
TB in persons with liver disease, and/or
TB in persons who have renal failure
is beyond the scope of this protocol. Information for these special situations can be found
in the Canadian TB Standards 179 and the American Thoracic Society Treatment of
Tuberculosis 180 .
179 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 92-94
180
American Journal of Respiratory and Critical Care Medicine, Vol. 167, 2003, American Thoracic Society/Centers
for Disease Control and Prevention/Infectious Diseases Society of America ::Treatment of Tuberculosis, p. 642-650
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Program
8.7 Anti-TB Drugs through the Special Access Program
Practitioners occasionally require drugs that are not approved in Canada to treat TB. The
Therapeutic Products Directorate of Health Canada has a mandate to authorize the sale
of these drugs to practitioners. This mandate is managed by the Special Access
Program (SAP). SAP is responsible for authorizing the sale of pharmaceutical, biologic,
and radiopharmaceutical products that are not approved in Canada.
8.7.1 How to Request a Drug Through SAP
Practitioners may fax, phone or write to SAP to request the medication. Most requests
can be handled by fax but urgent requests should be followed up by telephone. After
consideration, an authorization may be granted. The manufacturer has the final word on
whether or not the drug will be supplied.
The SAP request forms are available on line at (www.hc-sc.gc.ca; Drugs and Health
Products; Special Access to Drugs and Health Products). The following information must
be supplied when requesting a drug from the SAP:
Practitoner鈥檚 name and phone number
Address of physician鈥檚 office or hospital pharmacy where the drug is to be
delivered
The name of the drug and the dosage
Manufacturer鈥檚 name
Total quantity of the drug requested
Intended dosage
Patient鈥檚 initials, date of birth and sex
The medical indication for the drug
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Program
8.8 Dispensing of TB Drugs
The OGPMSS cannot legally label drugs with dispensing instructions. To ensure that the
patient receives proper instructions, boards of health have three options at the present
time:
(a) The public health unit can make arrangements with a local pharmacy to
dispense the TB drugs at the pharmacy (including proper labeling,
repackaging, and blister packing as required). All costs incurred will be paid
for by the local public health unit.
(b) The physician or clinic who orders the drug, labels the drugs and gives them
to the patient along with the relevant drug information sheets, including signs
and symptoms of adverse drug reactions.
(c) A nurse at the local public health unit can provide the drugs directly to the
patient, giving the patient the relevant drug information sheets, including
signs and symptoms of adverse drug reactions. Any repackaging of the
medication is considered dispensing and can only be done under the
delegation of the Medical Officer of Health.
Current information about nurses鈥? responsibility in dispensing drugs can be
obtained at the College of Nurses of Ontario鈥檚 web site: www.cno.org;
Publications and Services; Documents; Medication 鈥? dispensing.
8.8.1 Labeling Information to be Included on Each TB Drug
Name of patient
Name of the drug, the tablet size and the quantity of medication dispensed
The dose, frequency, and duration of medication
The expiry date for the medication
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Program
8.9 Provision of TB Medications for Persons Leaving Ontario (Cases
and LTBI)
Persons with TB disease can only leave Ontario with the permission of their treating
physician. They must NOT be infectious at the time of travel. Only one month鈥檚 supply
of medication is to be given to a person with TB disease or infection who is leaving
Ontario. Treatment details must accompany the patient. The TB Control unit can assist
the health unit in contacting the health authority or practitioner where the person is going
to ensure there is no disruption in treatment. If the patient is not able to make these
arrangements, the PHD will contact PHAC to assist in locating a practitioner in the region
where the patient will be located.
If the TB patient DOES NOT return to Ontario when expected, the local public health
unit should notify the PHD immediately. The patient may have run out of medication and
become infectious (or resistant to the existing treatment). PHD can alert the necessary
public health authorities (PHAC, CDC, Quarantine Office), as deemed necessary. The
patient may be denied re-entry into Canada until the person has documented proof of
treatment and proof that they are not infectious.
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8.10 Need for Referral/Consultation with TB Specialist
A referral with a TB specialist should be sought for any TB patient who has, or may:
Have resistance to more than one TB drug
Have resistance to INH and RMP (MDR TB) 鈥? in this situation, treatment
should be by, or under the advisement of, the TB specialist at West Park
Healthcare Centre (see Section 8.5)
Have cavitation on initial or subsequent chest x-rays
Have a positive TB culture after 2 months of treatment
Be HIV-positive
Have a condition such as end stage renal disease which could make
treatment fail
Be a child < 18 years of age. Because of the high risk of disseminated TB in
infants and children < years of age, treatment must be started as soon as the
diagnosis of TB is suspected. Treatment should be by (or under the
advisement of) a pediatric TB specialist.
Have liver disease
Be pregnant or breastfeeding
Have relapsed/reactivated TB/ treatment failure:
Relapse: Patient becomes and remains culture negative during therapy
but becomes culture positive again; or has evidence of radiographic
deterioration consistent with active TB. This usually occurs within the
first 6-12 months after completion of therapy
Treatment Failure: continued or recurrently positive cultures during the
course of anti-tuberculosis therapy. This may be due to non adherence,
drug resistance, malabsorption of drugs, or extreme biological variation
in response. 181
181
American Journal of Respiratory and Critical Care Medicine, Vol. 167, 2003, American Thoracic Society/Centers
for Disease Control and Prevention/Infectious Diseases Society of America: Treatment of Tuberculosis, p. 612.
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8.7 Directly-Observed Therapy (DOT)
8.11 Directly Observed Therapy (DOT)
Directly observed therapy (DOT) is the most effective strategy available for
ensuring adherence to treatment. DOT means that all doses of medications are
swallowed in the presence of a trained observer.
DOT is the recommended method and is considered the standard of medication
delivery in Ontario for all cases of TB. DOT should be the standard of care unless
assessment indicates that the likelihood of compliance is high.
Recommendations for DOT are not based on the assumption that any particular patient
may be non-compliant with treatment. Nevertheless, treatment regimens are always
long, require the patient to take more than one drug, continue long after the patient feels
well, and may even make them feel a little unwell. Even the most motivated individual
often has difficulty completing a full treatment regimen under these circumstances. 182
DOT is a strategy which is supported by the World Health Organization. It is becoming
widely used worldwide, as more countries develop the capacity to detect TB and provide
medications to all who need it. 183
8.11.1 DOT Assessment Guide
An assessment tool has been developed by the Ministry and several health units to
determine those persons who should be on DOT. (See: Appendix B). DOT must always
be considered for any person who scores 鈥榊ES鈥? on any category in this assessment tool.
184
However, DOT must always be used when the person :
Has sputum smear positive pulmonary TB. This person is considered to be
very infectious and is therefore a public health risk.
Has TB and HIV co-infection.
Is on an intermittent drug regimen.
Is known to be non-adherent with treatment regimens. This person is at
higher risk of developing drug resistant TB.
Shows relapse of disease (documented)
Is an Intravenous drug user
Is a homeless or under-housed person
Is a child
Has mental health problems which would lead you to question either the
ability of the person to be adherent, or the safety of the self-administered
therapy.
Has multi-drug resistant TB.
182
Alberta TB Control Manual, p. 3-14.
183
ibid
184
Ibid
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8.7 Directly-Observed Therapy (DOT)
8.11.2 The Benefits of DOT
Use the following to explain the benefits of DOT to a patient:
DOT encourages successful completion of treatment by providing assistance
with taking the medication.
With DOT, intermittent dosage is an option, and most patients need only take
their medication 2 or 3 times each week in the continuation phase and often
the regime will often be shorter than for the daily, self-administered
treatment.
The person providing DOT ensures that the patient keeps their MD or clinic
appointments; and they watch for side-effects and provide information.
DOT gives the patient the opportunity to ask questions and reduce fears
about TB and the treatment regime.
DOT improves the likelihood of a permanent cure.
DOT will reduce the likelihood of acquired drug resistance. 185
185
Alberta TB Control Manual, p 3-14
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186
8.12 Barriers to Completion of TB Treatment
The circumstances surrounding each patient that may affect their ability to complete
treatment becomes the most important consideration in completing TB treatment.
Factors that interfere with adherence to the treatment regimen include:
Cultural and linguistic barriers to cooperation
Lifestyle differences
Homelessness
Substance abuse
For the patient, a large number of other conditions and circumstances are priorities that
compete with taking their TB treatment. For example:
(a) Patient Related Barriers:
Conflicting health beliefs
Alcohol or drug dependence
Mental illness
Immigration and resettlement issues.
(b) System Related Barriers:
Lack of transportation
Inconvenient MD or clinic hours for follow up appointments
Lack of interpreters
187
8.12.1 Challenges to Administration of TB Medications
Cannot readily predict who will or who will not adhere to the treatment
regimen.
Adherence to therapy is not related to education, socioeconomic status, race,
gender etc.
TB treatment is lengthy and adherence to therapy decreases as treatment
length increases.
Problems with compliance are likely to increase as the number of TB drugs
changes or increases.
Patients may feel well or be in denial and not perceive the need to take any
medication.
There may be mild side effects, especially in the beginning of the treatment
regimen.
Treatment may cause disruptions to the patient鈥檚 life style, especially when
he/she has to be available at a scheduled time for DOT.
186
American Journal of Respiratory and Critical Care Medicine, Vol. 167, 2003, American Thoracic Society/Centers
for Disease Control and Prevention/Infectious Diseases Society of America: Treatment of Tuberculosis, p. 615.
187
TB Control and Elimination, Nunavut Manual, p 5-10.
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188
8.12.2 Administrating TB Drugs with Food
Taking TB drugs with food can delay or moderately decrease their absorption. However,
the effects of food are of little clinical significance. Therefore if a patient has epigastric
distress or nausea with their first line TB drugs, dosing with meals, or changing the time
of the administration of the medication is recommended. This is preferable to splitting a
dose or changing to second line TB drugs. Note that the absorption of INH can be
substantially decreased when the drug is given with glucose or lactose.
8.12.3 Improving Adherence to Therapy
鈥淚t is important to make clear to the patient that the treatment is to keep them, their family,
and the community healthy. By agreeing to take the medication the patient is helping
themselves and everyone they know. Health workers must be sensitive to patient needs
and beliefs, which may affect adherence to therapy. The patient may think that tuberculin
skin reaction means disease. They may relate treatment to the days of the sanatoria
when people were removed from their home and community for months to years and
many died away from home. The stigma attached to TB may lead to fear of being
rejected and ostracized by family, work and community, which may give rise to feelings of
isolation and depression. Patients need reassurance, support, and accurate information
about TB. As well, they must trust that confidentiality will be maintained.鈥? 189
Tips to Improve Adherence 190
Develop a trusting relationship with the patient and family over time using the
daily period of medication delivery to get to know the family.
Indulge and accommodate the patient鈥檚 needs whenever possible.
Consider using incentives (i.e., anything that motivates the patient) such as
transit tokens, food vouchers, toys for children, phone cards. Providing cash
to patients for compliance at appointments is especially useful with certain
clients e.g. the homeless.
191
8.12.4 Dealing with Common Problems Associated with Medication
(a) Nausea/Vomiting
Nausea may be related to drug-induced hepatitis especially if it related to
abdominal pain. The prescribing MD should be informed. If a patient vomits
within one hour of ingesting the medication, the dose is counted as missed.
Try giving the medication at mealtime or with food
Ask the prescribing MD if dimenhydrinate or other anti-nausea
medication would be helpful before meals
Try giving medications during the late afternoon or evenings as some
patients tolerate this better
(b) Fatigue
This can be a problem that interferes with the patient鈥檚 work/school.
188
American Journal of Respiratory and Critical Care Medicine, Vol. 167, 2003, American Thoracic Society/Centers
for Disease Control and Prevention/Infectious Diseases Society of America: Treatment of Tuberculosis, p. 636.
189
TB Control and Elimination, Nunavut Manual, pp. 5-10 - 5-11
190
Ibid, p. 5-11
191
Ibid, pp. 5-11 - 5-14
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Adjust the time of day medications are given to suit the patient鈥檚
schedule
An evening dose may be necessary if fatigue is severe and interfering
with daytime activities
(c) Difficulty Swallowing Pills
This can be a significant problem for patients who have nausea and gagging.
Try giving the medication in applesauce or with juice/soda/or crackers
Sometimes the medication can be crushed but Rifampin has a bitter
aftertaste
Some medications are available in liquid form
(d) Infants/Toddlers
Often there is a 鈥淔ear of Strangers鈥?, especially at the beginning of the treatment.
Usually the problem is not with the taste of the medication but the unfamiliarity
with the medication. It is important to take time to develop a trusting relationship
with the infant and the family.
Expect the child to spit out the medication!
Try to select the best time of day for the infant, avoiding nap times or
after meals when they are full.
Learn the infant鈥檚 routine and be prepared before the visit with toys etc.
Small doses of liquid medication may be mixed with baby food. DO NOT
put the medication in the baby鈥檚 bottle because that means you have
to stay and watch until the baby finishes the bottle.
Distraction works very well!
(e) Younger Children
May behave better at the beginning of treatment because the health care worker
is providing a lot of attention. This may wear off!! 鈥淐ontrol鈥? is important at this
stage.
Try crushing pills or using liquid forms.
Give choices such as medication cup, syringe, favorite snack, spoon.
Let them take the medications themselves if trustworthy. They may like
squirting the syringe in their mouths.
Use incentives such as stickers, treats etc.
Alternate the incentives.
Be attentive and creative, taking time to make the visit fun.
Remember their birthday.
(f) Older Children
Can be the most problematic age group for TB medications; embarrassment can
be an issue.
Let them choose liquid or tablets/capsules
Can be given with food or drink
Use incentives
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8.8 Barriers to Completion of TB Treatment
Try reasoning/rewards. Involve them in the plan of care and provide
basic information on treatment and disease.
Always be discreet if giving medications at school 鈥? offer different options
for place of delivery of medication.
(g) Missed Doses
The treating MD must be aware of the number of doses the patient has missed
so these doses can be added to the end of the treatment to complete the
treatment regimen.
(h) Interruptions in Treatment 192
Interruptions in treatment may have a significant effect on the duration of therapy.
Reinstitution of treatment must take into account the bacillary load of the patient,
the point in time the interruption occurred, and the duration of the interruption. In
general, the earlier in the treatment and the longer the duration of the
interruption, the more serious the effect and the greater the need to restart
therapy from the beginning. This decision should be made by the treating
physician in consultation with a TB specialist as deemed necessary.
8.12.5 Completion of Treatment
Treatment is completed when the patient has taken all the drugs prescribed.
A full course of treatment is determined more accurately by the total number of
doses taken, not solely on the duration. 193
Treatment protocols should continue for 6-9 months or until an absolute minimum of 80%
of the prescribed doses have been taken. 194 If there are missed doses or if there is a gap
in treatment, all missed doses should be made up. If MORE than 50% of doses have
been missed, or if treatment is not completed within the recommended time, consultation
with a TB expert is recommended to determine the appropriate action to be taken: either
the continuation of the treatment for a longer duration OR restarting treatment from the
beginning.
192
American Journal of Respiratory and Critical Care Medicine, Vol. 167, 2003, American Thoracic Society/Centers
for Disease Control and Prevention/Infectious Diseases Society of America: Treatment of Tuberculosis, p. 610.
193
Ibid, p. 634.
194 th
Long, R. Editor, Canadian Tuberculosis Standards, 5 Edition, Canadian Lung Association, Canadian Thoracic
Society, Health Canada, 2000, p. 96.
Issued: 2006
8. Treatment of TB Disease
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Protocol 8.9 Appendix 8-A: MOHLTC Public Health
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Division Requisition for Drugs to Treat TB
Appendix 8-A: MOHLTC Public Health Division Requisition for Drugs
Issued: 2006
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Protocol 8.10 Appendix 8-B: OMHLTC DOT
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Assessment Form
Appendix 8-B: MOHLTC DOT Assessment Form
Assess the need for DOT initially and on ongoing basis (at least monthly or as often as
necessary).
Use these assessment factors as well as your comprehensive assessment.
The presence of any of these assessment factors is an indication that the person should be
considered for DOT.
The HIGHER the risk of non-adherence or the potential for disease progression, the more
important it is for the person to be on DOT.
IF YES,
ASSESSMENT FACTOR FOR DOT NO YES DOT IS A
PRIORITY
1. MDR resistant (resistant to INH and Rifampin)
2. Resistant to more than one TB drug
3. Resistant to one TB drug
4. AFB+ve and culture +ve (pulmonary)
5. AFB-ve culture +ve pulmonary TB
6. Noncompliant with treatment
7. Substance abuse (alcohol e.g. alcohol or drugs)
8. Slow progress with treatment (e.g. person with repeat +ve culture on treatment)
9. Transient/homeless/underhoused
10. Persons who are too frail, elderly, impaired or forgetful to manage own care; no
caregiver; mental illness
11. Previous long term treatment failure e.g. diabetes or hypertension medication
non compliance
12. Prescription for intermittent therapy
13. Flight risk
14. Child/adolescent
15. Person whose TB has reactivated
16. Person who denies diagnosis of TB
17. Person recently discharged from correctional facility
18. Person who has difficulty swallowing pills
19. Person who avoids gov鈥檛 or authorities for fear of revealing immigration status
20. Person under S.22 or 35 order under the Health Protection and Promotion Act
21. Non compliant with appointments
22. Side effects with TB medications
23. HIV+ve
24. Lack of trust of health care professionals
25. No family MD or consistent care provider
26. Immune Compromised e.g. diabetes or cancer
27. Inadequate social supports; financial difficulties
28. Language and/or cultural issues
鈥淒OT should be the standard of care unless assessment
indicates that the likelihood of compliance is high.鈥? Ontario鈥檚
TB Protocol
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Surveillance
9. Medical Surveillance for Inactive Tuberculosis
TB prevention and control is a public health responsibility. The purpose of Medical
Surveillance is to provide new immigrants to Canada with appropriate medical follow-up to
rule-out active TB disease and to determine the ongoing follow-up if either active or inactive
TB is confirmed. By screening new arrivals for TB, persons can be offered treatment and
therefore prevent the spread of TB in Canada. 195
9.1 Roles and Responsibilities in Medical Surveillance
9.1.1 Citizenship and Immigration Canada (CIC)
(a) Outside Canada Procedure:
All immigrant applicants to Canada, those who come as refugees and certain visitors,
are required to undergo an Immigration Medical Examination (IME) prior to entry. The
IME, completed in the country of origin before arrival in Canada for those who apply
from abroad consists of:
Medical history
Physical examination
4 age-related routine tests:
Urinalysis for applicants > 5years of age
Chest x-ray for applicants > 11 years of age
Syphilis serology for applicants > 15 years of age
HIV test
If active TB disease is found, the person is denied entry until they have received
adequate treatment and have been reassessed. If there is no active disease, but the
x-ray appears abnormal or the person has a history of previously treated TB or the
report of a positive skin test (TB skin tests are not undertaken routinely as part of the
immigration medical examination) the person receives medical clearance to go to
Canada with a condition of entry, that they contact their local public health authority (in
Ontario, this is the local public health unit in the area they reside) within 30 days of
their arrival. The person is provided with a copy of the Medical Surveillance
Undertaking Form (IMM 535) (See: Appendix A for a sample form) which notes the
type of medical surveillance in Box 8 with an 鈥淪鈥? code of 2.02 for inactive TB. The
person may also present with a Permanent Residency form which notes the 鈥淪鈥? code
in Box 28 and Field 43.
Citizenship and Immigration Canada (CIC) notifies the TB Control Program, Ministry of
Health and Long Term Care (MOHLTC) of these persons by faxing a copy of the IMM
535 form for each individual placed on medical surveillance. The MOHLTC then
forwards the forms to the respective health unit so that medical surveillance for TB can
be initiated.
195
Heywood, N; Kawa, B.; Long, R.; Njoo, H.; Panero, L; Wobeser, W., 鈥淕uidelines for the Investigation and Follow-up of
Individucals Under Medical Surveillance for Tuberculosis After Arrivng in Canada: A Summary鈥?, Canadian Medical
Association Journal, June 10, 2003, p. 1563.
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Surveillance
(b) Urgent Immigration Medical Surveillance Referrals
CIC will notify PHD by phone if a person is deemed to be an urgent referral. An urgent
medical referral means that a person had a chest x-ray during their immigration
medical overseas that was rated 4.3 to 4.6. The ratings are described below:
4.3 Isolated hilar or mediastinal mass/lymphadenopathy (noncalcified).
4.4 Single/multiple pulmonary nodules/masses greater than or equal to 1cm.
4.5 Non-calcified pleural fibrosis and/or effusion.
4.6 Interstitial fibrosis/parenchymal lung disease/acute pulmonary disease.
4.7 ANY cavitating lesion OR 鈥淔luffy鈥? or 鈥淪oft鈥? lesions felt likely to represent
active TB.
PHD will notify the TB Manager of the public health unit where the person resides by
phone that an urgent referral has been received and then will fax the referral to the
health unit. The health unit should attempt to contact this patient as soon as possible
and arrange for the person to be medically assessed. PHD will follow up with a phone
call to the health unit and notify CIC when the person has been medically assessed.
(c) In-Canada Procedure:
Some individuals have their initial Immigration Medical Examination (IME) and chest x-
ray done while in Canada by Designated Medical Practitioners (DMPs).
A list of Designated Medical Practitioners (DMPs) is on the
Canadian Citizenship and Immigration (CIC) web site: www.cic.gc.ca .
On the main menu, click on: 鈥楳edical Practitioners in your area鈥?.
Examples include:
refugees,
students or visitors who decide to stay longer than 6 months, or,
family members who were visitors and have applied for permanent residency
to stay in Canada.
Following the IME, the person is provided with an In-Canada Public Health Follow-up
form and instructions on contacting their local public health authority.
A sample In-Canada Public Health Form is found in Appendix B.
Persons placed on medical surveillance after arrival in Canada must be followed up
with a medical assessment and chest x-ray the same as those persons who arrive
from outside Canada (see algorithm). Remember: the DMP is under contract by CIC. It
is the physicians at CIC who decide if a person is placed on medical surveillance. ALL
in Canada referrals must follow the same process as those who apply from
outside Canada and who are placed on medical surveillance.
Due to the fact that these persons are being screened after arrival in Canada, active
TB disease may be detected. Accordingly, the following happens:
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Surveillance
Citizenship and Immigration Canada (CIC) notifies the MOHLTC by
forwarding an In-Canada Public Health Follow-up Form, noting whether the
medical surveillance is for inactive TB ( by 鈥淪鈥? code 2.02) or if the medical
surveillance is for active TB ( by 鈥淪鈥? code 2.01).
Upon receipt of an In-Canada report of active TB, the Public Health Division
will telephone the health unit involved directly, notifying them of the person
with active TB disease in their jurisdiction.
The notification will be faxed immediately to the health unit.
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Surveillance
Algorithm 1:
196
Follow-up of individuals placed under medical surveillance for TB
History of active TB not previously treated
Inadequate treatment of active TB
Abnormal chest x-ray suggestive of inactive TB
Recent contact with infectious TB
Rule out active TB
Consult with infectious disease
History specialist/respirologist/TB expert
Physical examination Consider possibility of drug
Chest x-ray resistance
Active TB
Smear/cultures, as Treat according to Canadian TB
appropriate Standards
Latent TB infection
Consider treatment of LTBI according to
If treatment for LTBI refused/not
Canadian TB Standards
tolerated, counsel regarding signs
If likely multidrug 鈥? resistant TB infection,
and symptoms of TB; follow-up for
consult with an infectious disease
3 to 5 years
specialist/respirologist/TB expert
Once treatment of LTBI satisfactorily completed, Symptoms suggestive of TB
counsel regarding signs and symptoms of TB, and should be evaluated immediately
discontinue follow-up to rule out active TB
196
Ibid, CMAJ, p. 1564
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Surveillance
9.1.2 Ontario Ministry of Health and Long Term Care
The TB Control Program, Ministry of Health and Long Term Care (MOHLTC) is
responsible for ensuring that the IMM 535 forms have complete, accurate information.
IMM 535 forms that have complete information (i.e., an address and an accurate 鈥淪鈥?
code) are forwarded to the appropriate health unit for follow-up via an iPHIS referral.
If a health unit receives a IMM 535 form from a person that has with missing data, contact
the TB Nurse consultant at the MOHLTC for clarification (e.g. no 鈥淪鈥? code noted, no
address noted).
The MOHLTC will notify CIC of any information received from the health units on the
Reporting Forms (see Appendix C) e.g. person cannot be located, documentation that
the person has been medically assessed, etc.
Once the person has been medically assessed in Ontario, the condition of entry is
removed by CIC.
The following algorithm outlines the procedure to be followed, which is explained further
in this document.
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Surveillance
Person placed under
medical surveillance for
TB has 1 month, after
arrival in Ontario (or after
applying in-land), to
contact health unit.
9.1.3 Local Health Unit
The local health unit initiates and continues medical surveillance for a period of up to five
years from the date of the initial clinical evaluation for medical surveillance, or until the
person has been discharged. (See section 9.2.3 for conditions of discharge). Although
there are no specific regulations for the length of follow-up, the highest incidence of
active tuberculosis in recent arrivals to Canada develops within the first 3 to 5 years of
their immigration. 197
Priorities of Medial Surveillance
197
Ibid, CMAJ, p. 1564
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Surveillance
A greater priority should be placed on the identification and TB testing of persons at
increased risk of progression to active disease if infected. Factors that increase the risk of
progression to active disease include the following 198 :
HIV
Recent TB infection
Upper lung zone fibronodular changes on chest x-ray
Previously inadequately treated active TB
Organ transplantation
Prolonged use of corticosteroids or other immunosuppressing agents
Chronic renal failure
Hematologic malignancies
Silicosis
Diabetes
Malnutrition
When the health unit receives a referral from iPHIS or a complete IMM 535 form from the
person under medical surveillance, the health unit shall:
(a) Contact the person by letter, telephone or in person.
If the person is contacted by letter, attach a medical assessment form to be
completed by the physician. (Note: Each health unit is to develop its own
form for use in its health unit jurisdiction).
(b) Advise the person of the following:
The signs and symptoms of active disease which would include cough, weight
loss, fatigue, fever, night sweats or hemoptysis
Requirements of medical surveillance
Instructions about obtaining OHIP coverage
The need for the person to contact the health unit to provide any change of
address as well as the name of the family physician
(c) Information to be included on the medical assessment form:
The requirements of medical surveillance
Complete history and physical examination results
Dates and results of chest X-ray and other appropriate radiological investigation
At least one but preferably three sputum specimens for smear and culture for
Mycobacterium tuberculosis
Other appropriate laboratory tests as deemed necessary by the treating
physician
Medical information and chest x-rays from the country where immigration medical
assessment was carried out (if requested/obtained)
Written recommendations regarding prophylaxis for clients with inactive TB
Current recommendations if chemoprophylaxis is refused or is medically
contraindicated
198
Ibid, CMAJ, p. 1564
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Surveillance
Reporting to MOHLTC using the Reporting Form (that is faxed to the MOHLTC):
(a) When a person has made contact with the health unit, report to MOHLTC as
soon as possible indicating that contact has been made
(b) If no contact has been made with the person within 4 months of notification of
the person being under medical surveillance, report to MOHLTC
(c) When documentation is received by the health unit that medical
assessment has been made, report to MOHLTC. This information should be
received at the MOHLTC no longer than 6 months after notification that
contact has been made.
(d) Upon discharge from medical surveillance: When follow-up is
complete/person is lost to follow-up/person moves within Ontario or Canada
or person is deceased.
No Contact Made with Person:
(a) If the unit receives no response from the person by one month after
the first contact attempt (by letter, phone or in person), the health
unit will make a second attempt to contact the client.
(b) If person cannot be located, notify the MOHLTC by faxing the
Immigration Medical Surveillance Reporting Form (Reporting Form)
(Sample of form in Appendix C)
(c) Complete iPHIS Medical Surveillance episode (see appendix E-
Bulletin #8)
(d) MOHLTC will notify CIC that the person has not been found.
(e) If CIC has new information on the person, it will be forwarded to
MOHLTC.
(f) MOHLTC will forward any update to health units.
Contact Made with Person:
(a) Advise person of the requirements of medical surveillance.
(b) Determine current immigration status (i.e. permanent resident,
visitor, student, temporary worker).
(c) Counsel person regarding TB disease, transmission, treatment and
chemoprophylaxis.
(d) Assess person for active TB by reviewing a checklist of signs and
symptoms.
(e) If there is an indication of active TB or if person is a contact of a case
of TB and the person has no health insurance coverage, refer
him/her to Tuberculosis Diagnostic and Treatment Services for
Uninsured Persons Program (鈥淭B-UP鈥?) for immediate medical
assessment. (See Chapter 11 for TB-UP procedures).
(f) If there is no indication of active TB, refer person for medical
assessment once Ontario health insurance coverage has been
obtained.
(g) Request name of person鈥檚 family physician.
(h) If contact is made by phone, send letter and medical assessment
form to person.
(i) As soon as possible, notify MOHLTC that person has been
contacted by faxing the Reporting Form to the MOHLTC.
(j) MOHLTC will notify CIC.
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Surveillance
(k) Complete iPHIS Medical Surveillance episode.(see attached iPHIS
Bulletin for Immigration Medical Surveillance Appendix E)
Medical Assessment Completed
Once the local health unit receives documentation of the completed medical assessment
report, TB control staff will:
(a) Review the results of the medical assessment
(b) If active TB is diagnosed, fax the Reporting Form to the MOHLTC
indicating that the person has newly diagnosed active TB. Do NOT
send if the individual had TB diagnosed in the past; send only the
current episode of TB.
(c) Contact physician or person, if necessary, for further information.
(d) If person is on treatment or chemoprophylaxis for LTBI, monitor as
per guidelines.
(e) If person is not on treatment or chemoprophylaxis, follow-up should
be individualized.
(f) Notify MOHLTC of assessment done, using Reporting Form.
(g) Update iPHIS medical surveillance episode.
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9.2 Follow-up Procedures
9.2 Follow-up Procedures
9.2.1 Person Lost to Follow-up or Non-compliant
If, prior to discharge, the person:
moves to an unknown area or moves back to their country of
origin,
is lost to follow-up,
is non-compliant with requests for repeat examinations, or,
is deceased,
then, inform the MOHLTC by faxing the Reporting Form and update
iPHIS (see appendix E)
9.2.2 Person Changes Address
(a) If person changes jurisdictions with Ontario:
Notify the receiving health unit with a referral form including all
pertinent information.
Notify the MOHLTC by faxing the Reporting Form and update
iPHIS
(b) If the person moves out of Ontario but within Canada:
Notify the MOHLTC by faxing Reporting Form and a referral form
including all pertinent information and update iPHIS and
discharge (see appendix E)
The MOHLTC will forward the referral to the appropriate
provincial authority.
(c) If the person moves out of the country for more than a month:
Notify the MOHLTC by faxing Reporting Form and discharge the
person in iPHIS.
The MOHLTC will notify the CIC.
(d) If the person comes back into Canada:
It is the responsibility of the individual to notify the local public
health unit of their location so Medical Surveillance can
recommence.
9.2.3 Discharge from Medical Surveillance
1. Discharge persons from public health medical surveillance follow-up when:
(a) The person鈥檚 chest X-ray is normal;
(b) The person has completed an adequate course of
chemoprophylaxis;
(c) TB control staff can obtain reliable documentation of
previous treatment and compliance;
(d) There is no change in the person鈥檚 chest X-ray over the
follow-up period (usually 3 to 5 years);
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9.2 Follow-up Procedures
(e) The person has died.
2. Notify the person that their medical surveillance is complete.
3. Notify MOHLTC, by faxing the Reporting Form of discharge.
4. Update iPHIS medical surveillance episode and close.
9.2.4 Self-referral for Medical Surveillance
1. With Copy of IMM 535
If an individual has the IMM 535 or In Canada notification form and contacts with
the health unit directly:
(a) Ask the person for a copy of IMM 535 form (this ensures
accurate information is entered in iPHIS)
(b) Send a referral to PHD via iPHIS
(c) Conduct surveillance as described above.
2. Without Copy of IMM 535
If the person has a Permanent Residency form but does not have a copy of the
IMM 535 form, then:
(a) Ask the person for a copy of the Permanent Residency form.
(b) Check Field 28 for the 鈥淪鈥? code.
(c) If confirmed as inactive TB (i.e., 鈥淪2.02鈥?), conduct surveillance
as described above.
(d) if 鈥淪鈥? code is missing, contact the MOHLTC TB nurse consultant
by telephone or fax (not by email) with the name, date of birth
and country of origin of the individual. The MOHLTC will request
the specific disease code from Citizenship and Immigration
Canada and will then notify the health unit.
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9.3 Obtaining Previous Immigration Medical Exam Assessment
The Immigration Medical Exam assessment information done prior to arrival in Canada or
done within Canada as an In-Canada processing can be obtained for review.
9.3.1 Immigration Medical Exam done outside Canada
Fax the office where the medical assessment was performed, noting the information in
Box 9 of IMM 535 (IMS file #). When a referral is sent in iPHIS, the IMS file number from
Box 9 is entered by PHD in the 鈥楴otes鈥? tab of the person鈥檚 demographic section. A
package of information will be sent by CIC which may include actual x-ray films. These
films should be returned to the originating office.
A list of international Immigration offices is found in Appendix D.
9.3.2 Immigration Medical Exam done within Canada
Fax Citizenship and Immigration Canada, Ottawa, at 613-952-3891. CIC will forward a
copy of the medical assessment. If x-ray films are included, they must be maintained at
the requesting Health Unit or returned to CIC (they should not be sent to MOHLTC)
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9.4 Appendix 9-A: Sample IMM 535 Form
9.4 Appendix A: Sample IMM 535 Form
Appendix A:
Sample IMM 535 Form
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9.4 Appendix 9-A: Sample IMM 535 Form
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9.5 Appendix 9-B: Sample In-Canada Forms
9.5 Appendix B: Sample in Canada Form
Appendix B:
Sample In-Canada Form
Public Health Authority Notification Letter for Medical Surveillance
(In Canada Public Health Follow-Up)
The following is for your information and action as deemed necessary.
An immigration medical examination conducted in Canada has recently been completed
on the following individual who is currently residing in your jurisdiction.
This examination has revealed the presence of a condition which would normally result in
a medical susrveillance notification by Citizenship and Immigration Canada.
As the individual resides in Canada, this notification is being issued before the
immigration application is completed.
The client has been provided with an informational handout entitled 鈥淚N-CANADA PUBLIC
HEALTH FOLLOW-UP鈥?
FAMILY NAME: Doe
GIVEN NAMES: JOHN
DATE OF BIRTH: 01/JAN/1952 (DD/MMM/YYYY)
SEX: MALE FEMALE
鈥淪鈥? CODE: S 2.02
ADDRESS: 1 ANY STREET
OTTAWA, ONTARIO
POSTAL CODE: K1A 1A1
TELEPHONE: (613) 925-1234
IMS FILE NO.: 7001-123456
UPON INITIATION OF MEDICAL SURVEILLANCE, PLEASE RETURN THIS SHEET BY FAX
TO CIC MEDICAL SURVEILLANCE UNIT. FAX: (613) 952-3891
DATE SURVEILLANCE INITIATED: PUBLIC HEALTH AUTHORITY STAMP:
(DD/MMM/YYYY)
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Medical Surveillance Reporting Form
9.6 Appendix C: Sample Immigration Medical Surveillance Reporting Form
NOTIFICATION TO TB CONTROL UNIT AT THE MOH FROM HEALTH UNIT
Complete this form and fax to the Ministry of Health each time information is received about a patient who is under Medical
Surveillance.
Please fax this to the Ministry of Health and Long-Term Care c/o Joy Marshall 416-327-4687.
(If you have any questions please call Joy at 416-327-7053)
_____INITIAL REPORT from Health Unit to PHD _____UPDATE from HU to PHD
Health Unit______________________________________Date (YYYY/MM/DD)______________________
Contact Person at Health Unit: Name_____________________Tel.: _(___)___________________
Patient鈥檚 Immigration Serial Number (Box 10 on IMM form)______________________
OR
Inland Processing No.: _______________________Date IMM 535 Form Rec鈥檇 at Health unit____________________
(YYYY/MM/DD)
Family Name_____________________Given Name_______________________Middle Name____________________
DOB : YYYY_________MM____DD_____ Country of birth______________________
Citizenship and Immigration Canada (CIC) has advised the Ministry of Health and Long Term Care (MOHLTC) that the above named
person arrived in Canada with a diagnosis of inactive Pulmonary Tuberculosis (IMM 2.02) and agreed to medical surveillance
undertaking.
The person has: (check as many as apply)
CONTACT: (please complete this section especially if any medical assessment done)
Had personal contact (by phone or in person) with this or another Health Unit in Ontario.
Date of initial contact___________________
Had personal contact (by phone or in person) with health unit outside of Ontario.
Date of initial contact___________________
ASSESSMENT FOR TB:
Has gone for medical assessment and initial chest x-ray DATE____________________
Follow-up chest x-ray done or requested
Has been recommended for annual chest x-ray for 3-5 years (no need to send updates annually)
LTBI:
Has started prophylaxis for tuberculosis infection. ____Has completed LTBI
ACTIVE DISEASE:
Has active disease and has been reported in RDIS
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Medical Surveillance Reporting Form
HAS NOT BEEN LOCATED:
Has never been located at (indicate address)_________________________________
Was located but now Lost To Follow Up
HAS MOVED:
Has moved to :______________________________________________________
Has moved (no available address)
HEALTH UNIT DID NOT RECEIVE 535 FORM FROM PHD FOR THIS PATIENT:
(please send a copy of IMM 535 to PHD with this reporting form)
Patient self reported from Ontario
Patient self reported from another province
Patient self reported from outside Canada
Other_________________________________________________________________________
HAS BEEN DISCHARGED FROM MEDICAL SURVEILLANCE AT HEALTH UNIT
Date____________________ File #_______________________
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Offices and Addresses
9.7 Appendix D: List of Overseas Medical Offices and Addresses
Address and Fax Number(s)
City
Overseas Medical Services
Beijing
International Region
The Canadian Embassy
19 Dongzhimenwai Dajie
Chaoyang District
Beijing, PRC 100600
Fax: 011-86-10-6532-6148
Overseas Medical Services
London
International Region
The Canadian High Commission
MacDonald House
1 Grosvenor Square
London, England
W1X 0AB
Fax: 011-44-20-72-58-6358
Overseas Medical Services
Manila
International Region
The Canadian Embassy
Level 7 Tower 2, RCBC Plaza
6819 Ayala Avenue cor. Sen. Gil J. Puyat Avenue
Salcedo Village, Makati City
1200 Philippines
Fax: 011-632-843-1103
Overseas Medical Services
Nairobi
International Region
The Canadian High Commission
Limuru Road
Gigiri, Nairobi
Kenya
Fax: 011-254-20-366-3445
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Tuberculosis Tuberculosis Version: 1.0
Protocol 9.7 Appendix 9-D: List of Overseas Medical
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Offices and Addresses
Address and Fax Number(s)
City
Overseas Medical Services
New Delhi
International Region
The Canadian High Commission
7/8 Shantipath
Chanakyapuri
New Delhi 110021, India
Fax: 091-011-4178-2033
Paris Overseas Medical Services
International Region
The Canadian Embassy
35, Avenue Montaigne
75008 Paris, France
Fax: 011-33-1-44-43-29-83
Overseas Medical Services
Port of Spain
International Region
The Canadian High Commission
Maple House, Tatil Centre
3-3A Sweet Briar Road
P.O. Box 1295
Port of Spain, Trinidad, W.I.
Fax: 1-868-628-6993
Overseas Medical Services
Singapore
International Region
The Canadian High Commission
1 George Street #11-01
Singapore 049145
Fax: 011-65-6854-5911
Overseas Medical Services
Vienna
International Region
The Canadian Embassy
Laurenzerburg 2/3A-1010
Vienna, Austria
Fax: 011-43-1-531-38-3912
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9.8 Appendix E: iPHIS Bulletin #8
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10. Ventilation Standards in Shelters for the Issued: 2006
Tuberculosis Homeless Version: 1.0
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10.1
10. Ventilation Standards in Shelters for the Homeless
Note: This chapter will be available in a subsequent version of this protocol.
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11.1: Introduction
11. Tuberculosis Diagnostic and Treatment Services for
Uninsured Persons (TB-UP) Program
11.1 Introduction
11.1.1 Purpose of the TB-UP Program
The purpose of the Tuberculosis Diagnostic and Treatment Services for Uninsured
Persons (TB-UP) Program is to:
(a) Reduce the public health risk due to transmission of tuberculosis (TB) from
uninsured persons within Ontario;
(b) Ensure that TB diagnostic and treatment services are available for all persons
residing in Ontario who are not covered by the Ontario Health Insurance Plan
(OHIP), Interim Federal Health (IFH) or any other provincial/territorial/private health
insurance plan; and,
(c) Eliminate the financial barrier for uninsured persons in Ontario, as well as facilitate
the early diagnosis and initiation of treatment (as required) of all persons with
active/suspect TB.
11.1.2 Description of the TB-UP Program
The TB-UP program consists of processing payments to physicians, laboratories and
radiology service providers for services provided to uninsured individuals who require
assessment and/or treatment for active/suspect or latent TB infection (LTBI), including
contacts of infectious TB. The program is intended to facilitate prompt diagnosis and
treatment for the uninsured group of persons, thus reducing the risk of transmission of TB
from uninsured cases to other Ontario residents, as well as the related costs to Ontario鈥檚
health insurance plan (OHIP).
The TB-UP program will ensure that all uninsured persons in Ontario have access to
diagnostic and treatment services required to determine whether they have TB disease or
latent TB infection (LTBI), to prescribe the required treatment, and to provide the required
follow-up so that the appropriate course of treatment is completed.
11.1.3 Eligible persons covered under the TB-UP program:
The TB-UP program will be implemented in two phases at the local level, through the TB
Control Program staff of the board of health.
Phase 1 includes persons who are uninsured and one of the following:
(i) an active case or potential/suspect case of TB (pulmonary or extra-pulmonary);
(ii) a contact of an active TB case; or
(iii) any other person at high risk of developing active TB as determined by the TB
Control program staff of the board of health.
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11.1: Introduction
Phase 2 includes uninsured persons referred under the medical surveillance process
who have LTBI, but who do not meet the other criteria listed above (i.e., case/suspect
case or contact).
11.1.4 Eligible services and service providers covered under TB-UP:
The following services and service providers will be covered under the TB-UP
program:
Out-patient Services:
Out-patient medical clinical (physician) services (provided by physicians who are
paid on a fee-for-service basis), as well as laboratory and radiology services for the
diagnosis and treatment of TB disease or LTBI; or
In-patient Services:
Medical clinical services which are provided by a physician who is a specialist paid
on a fee-for-service basis (e.g., respirologist, ID physician, internist, paediatrician,
etc.) for services related to the diagnosis or treatment of TB or LTBI.
The following services and service providers will not be covered under the TB-UP
program:
any services/expenses for uninsured persons who receive hospital in-patient
services; or
services provided by physicians or other service providers (i.e., laboratories and
radiology facilities) who are normally compensated through a global budget or an
alternative payment process through an organization/agency and are not paid on a
fee-for-service basis.
NOTES REGARDING SERVICE PROVIDERS FOR TB-UP PROGRAMS
Service providers must be licensed within their province of practice to be eligible
for payment under the TB-UP program (Section 94, Claims for service providers
licensed outside Ontario).
Physicians who have opted out of OHIP can participate in the TB-UP program;
however they must submit the Health Care Provider Claim form (Appendix A) to the
Ministry of Health and Long-Term Care, Registration and Claims Branch (RCB) for
payment. These physicians should not bill the patient directly, as RCB will not
reimburse the individual TB-UP patient.
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11.2: Governing Legislation
11.2. Governing Legislation
11.2.1 Health Legislation
TB is a reportable disease. Therefore, under Sections 25 to 31 of the Health Protection
and Promotion Act (1990), physicians, laboratories and others are required to notify their
local medical officer of health of any suspect and active TB cases, as well as of any
persons infected with TB. In addition, persons who are identified with suspect latent TB
on immigration medical examination are referred to their local health unit for follow-up as
part of the medical surveillance process.
Tuberculosis control activities are mandated under Sections 5 and 7 of the HPPA and are
set out in the Tuberculosis Control program portion of the Mandatory Health
Programs and Services Guidelines, December 1997. Under these requirements, every
board of health in Ontario is required to have in place an effective program for persons
with active tuberculosis and for TB prevention. This will include:
case finding, case holding, monitoring of drug treatment, and follow-up of contacts
and infected individuals for TB prevention;
ensuring the provision of TB drugs for persons with TB disease or infection at no cost
to the patient; and
ensuring that patients who are placed under medical surveillance (as a result of their
immigration medical examination) are referred to a physician for follow-up
assessment.
It is important from a public health perspective to render all persons (regardless of their
medical insurance status) with active TB non-infectious as soon as possible to reduce the
further transmission of the disease to the public. The early diagnosis and treatment of all
cases/suspect cases of TB disease and TB LTBI are critical to achieving this objective.
11.2.2 Collecting and Releasing Confidential Information
The TB-UP program is authorized pursuant to the following provisions of HPPA:
Section 2 Purpose
Section 4 Duty of Boards of Health
Section 5.2 Control of Disease
Section 5.4.1 Collection and Analysis of Data
Section 7 Guidelines for Provision of Mandatory Programs
Sections 25 to 31 Reporting of Disease
and under the Ministry of Health and Long-Term Care Act:
Section 6 Duties and Functions of the Minister
The application for coverage through the TB-UP program and the provision of consent to
collect, use, share and disclose a patient's personal health information among the
patient's local board of health, health care provider and the MOHLTC is covered when
the patient signs the TB-UP Application and Consent Form. The authority for obtaining a
minor's consent from a person who has the lawful custody of that individual, who is less
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11.2: Governing Legislation
than sixteen years old, is under Section 66 of the Freedom of Information and Protection
of Privacy Act.
Collection of personal information is only for the purpose of determining eligibility
registration in the TB-UP program and the provision of TB-UP health services. This
personal information is required to support TB-UP program administration in the provision
of the patient's health care, payment of provincially funded compensation to the patient's
health care providers under the TB-UP program, and the evaluation and planning of the
program. The authority for the collection and use of this information is the Ministry of
Health and Long-Term Care Act, Section 6, and the HPPA, Sections 2, 4, 5.2, 5.4.1, 25
to 31.
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11.3: Roles and Responsibilities for the TB
UP Program
11.3 Roles and Responsibilities for the TB-UP Program
11.3.1 Board of Health:
The board of health will:
(a) Be notified of uninsured persons requiring TB services either from the patient
themselves, or from a service provider or service agency (Section 4.1, Patient
Referral to the TB-UP Program);
(b) Assess if the patient is eligible for coverage under the TB-UP program (Section
4.2, Assessment of Potential TB-UP Patient by the Board of Health to Determine
Eligibility for the TB-UP Program);
(c) Verify the patient鈥檚 identification (Section 5.2.1, Registration into the TB-UP
program by the board of health);
(d) Obtain the TB-UP Application and Consent for the TB-UP Program (Appendix C)
from the patient and manage the TB-UP Withdrawal from the TB-UP program as
required (Appendix D);
(e) Register eligible individuals into the TB-UP program and assign a TB-UP
registration number (Section 5.3, Assigning the TB-UP Registration Number);
(f) Notify the Ministry of Health and Long-Term Care, Registration and Claims
Branch (RCB) of TB-UP program registrants on a monthly basis (Section 8 : TB-
UP data Transfer);
(g) Ensure the appropriate number of Health Care Provider Claim forms have been
issued for each TB-UP patient (Section 6, Board of Health Distribution of Claim
Forms); and
(h) Collect and submit TB-UP data to the Ministry of Health and Long-Term Care,
Public Health Division (PHD) for the purposes of program monitoring and
evaluation (Section 8.1.2, Provision of TB-UP program data to the PHD).
11.3.2 Service Providers
If a patient presents at the office of a service provider (e.g., due to symptoms from
TB) and has not notified the board of health, the attending physician will:
(a) Verify the patient鈥檚 OHIP status and personal identification (Section 5.2.2,
Registration into the TB-UP program from the service provider鈥檚 office/clinic);
(b) Notify the board of health of the uninsured person who has either suspect/active
TB or who is a contact of an active TB case and request a TB-UP Application and
Consent form (Appendix C) for this patient;
Note: All persons who are infected with TB or who have TB disease are to
be reported to the local medical officer of health, as required under the
requirement of the Health Protection & Promotion Act (1990).
(c) Return (fax/mail) the patient signed TB-UP Application and Consent form to the
board of health (TB Control Program staff), who will then register the patient into
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11.3: Roles and Responsibilities for the TB
UP Program
the TB-UP program, assign a TB-UP Registration Number and initiate first
mailing of Health Care Provider Claim forms (Appendix A).
For all TB-UP patients registered in the TB-UP program (i.e., who have a TB-UP
registration number and claim form), the attending physician will:
(a) Ensure the TB-UP registrant鈥檚 Name, Date of Birth, Gender, Registration Number
and Eligibility Expiry Date (i.e., Part A of the claim form) has been completed by
the board of health on all Health Care Provider Claim forms. Incomplete Health
Care Provider Claim forms will be returned to the service provider by the RCB
(Section 9.3, Returned Health Care Provider Claim Forms by the RCB);
(b) Complete Part B of the Health Care Provider Claim form and include only those
services which are related to the investigation and/or treatment of TB
disease/infection or complications that arise as a result of treatment for TB
disease/LTBI. The diagnosis and treatment of unrelated diseases are not
covered for payment under the TB-UP program;
(c) Submit completed Health Care Provider Claim form(s) to the RCB, for
assessment for payment and processing of payment under the TB-UP program
(Section 9.1, Health Care Provider Claim Submission by Service Provider);
(d) Notify the board of health (TB Control Program staff) of the patient鈥檚 treatment
plan and request the required number of Health Care Provider Claim forms to
cover subsequent visits for the next four week period. Claim forms will be issued
monthly by the board of health on a request basis (Section 6, Board of Health
Distribution of Claim Forms); and,
(e) Return all Health Care Provider Claim forms that have not been used to the local
board of health.
11.3.3 Ministry of Health and Long-Term Care, Registration and Claims
Branch (RCB):
The Registration and Claims Branch will:
(a) produce and control the distribution of the Health Care Provider Claim form to
boards of health (Section 11, TB-UP Form Production, Distribution, Control and
Retention);
(b) act as the claims payment-processing agent for the TB-UP program;
(c) check each claim received to determine whether the patient is eligible for
payment through OHIP and, if so, advise the service provider;
(d) verify claims received to ensure the following:
(i) patient eligibility (as per the TB-UP registration information received
from boards of health);
(ii) OHIP eligibility;
(iii) service claim code eligibility (claim code is listed in the OHIP
Schedule of Benefits);
(iv) service eligibility (e.g., service is rendered prior to the eligibility expiry
date on the claim form);
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11.3: Roles and Responsibilities for the TB
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(v) provider eligibility (as per the Corporate Provider Database); and
(vi) completeness of claim (i.e., claim form includes all required
information).
(e) assess and process claim payments for services rendered under the TB-UP
program. Services provided will be paid at same rate as the Schedule of
Benefits fee value for the same service provided to an insured person.
11.3.4 Ministry of Health and Long-Term Care, Public Health Division
(PHD):
Public Health Division will:
(a) establish provincial standards (i.e., TB-UP policies and procedures) for the TB-
UP program, and review and update as required;
(b) produce and distribute the following forms to the board of health:
(i) TB-UP Application and Consent form; and
(ii) TB-UP Withdrawal form.
(c) cover costs of monies paid to service providers by RCB for all eligible claims
through the TB-UP program;
(d) utilize the information received monthly from RCB for the financial monitoring
of the TB-UP program expenditures;
(e) provide program consultation to boards of health, other Ontario Ministry of
Health branches (e.g., Registration and Claims Branch) and other stakeholders
(e.g., Ontario Medical Association) as needed;
(f) monitor and evaluate the TB-UP program, based on information received from
boards of health and RCB;
(g) provide the final decision in a dispute resolution process if the board of health
or the RCB is unable to resolve disputes related to their respective areas of
responsibility with respect to the TB-UP program (Section 12.3, Final Decision
Regarding Unresolved Disputes); and
(h) provide support and educational updates to groups and individuals involved in
TB control.
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11.4: Process for Registration into the TB-
UP Program
11.4 Process for Registration into the TB-UP Program
11.4.1 Patient Referral to the TB-UP Program
(a) Registration into the TB-UP program at the board of health (Algorithm 1)
The board of health may be notified of a potential TB-UP patient through one of
the following:
Patient contacts the board of health directly: either by coming in person
to the health unit or by phone; or,
Board of health is notified by way of service provider or service agency.
Note: If the TB-UP patient does not have a physician, the TB Control
Program staff of the local board of health will assist him/her in finding a
physician.
(b) Registration into the TB-UP program from the service provider鈥檚
office/clinic (Algorithm 2)
The initial service provider may see an uninsured person in their office or clinic
(i.e., a person may present due to symptoms of TB). The attending physician will
call the board of health to determine if this person would be eligible for coverage
under the TB-UP program.
11.4.2 Assessment of Potential TB-UP Patient by the Board of Health to
Determine Eligibility for the TB-UP Program
To be eligible for coverage under the TB-UP program, the patient must meet the
following criteria, with respect to both their:
TB status, and
medical insurance coverage status.
The TB Control Program staff will interview the patient, in person or by phone, to
determine the patient鈥檚 eligibility for coverage under the TB-UP program by:
(a) Assessing the patient鈥檚 TB status (i.e., risk of TB disease/LTBI). The TB-
UP patient must be one of the following:
an active/suspect case of TB (pulmonary or extra-pulmonary);
a contact of an active case of TB;
any other person at high risk for developing active TB as
determined by the TB Control Program staff; or,
Person under immigration medical surveillance for TB (Phase 2).
(b) Determining the patient鈥檚 medical insurance coverage status (i.e., patient
does not have coverage under OHIP, IFH, or other
provincial/territorial/private health insurance). Patients are eligible if they
are currently in Ontario, meet one of the TB status requirements above
and are not covered by any medical health insurance for TB services.
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11.4: Process for Registration into the TB-
UP Program
These persons would not have coverage for TB diagnostic or treatment
services under OHIP, the IFH program, medical insurance plan of
another province/territory, private medical insurance or other medical
insurance plan. This includes persons such as the following:
persons currently in the 3 month waiting period for OHIP (e.g.,
landed immigrant, live-in caregiver such as a nanny);
homeless and do not have OHIP coverage, IFH or other medical
insurance coverage for TB services;
foreign student without OHIP coverage, IFH or other medical
insurance coverage for TB services
visitor without medical insurance coverage for TB services*;
persons who do not have legitimate immigration status (long-
term visitor); or
persons who have been discharged from prison but are not
currently eligible for OHIP.
* Some private medical insurance plans do not cover TB services if these services are
considered to be for a pre-existing medical condition. This may include persons such as
visitors or foreign students who require TB services while in Ontario. The TB-UP
program will cover eligible TB services provided to these persons.
NOTE: The TB-UP program will not issue retroactive payments for persons who
receive TB diagnostic and/or treatment services prior to registration in
the TB-UP program.
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11.5: Registration of Eligible TB-UP
Patients
11.5 Registration of Eligible TB-UP Patients
11.5.1 Application and Consent Procedure for the TB-UP Program:
In order to obtain coverage under the TB-UP program, eligible patients must first apply
for coverage and provide consent to share information among health units, service
providers and the Ministry of Health and Long-Term Care.
11.5.2 Obtaining Application and Consent for the TB-UP Program
(a) Registration into the TB-UP program at the board of health (Algorithm 1):
The TB Control Program staff of the board of health will review the TB-UP Application
and Consent form (Appendix C) with the patient by phone or in person. The patient must
sign the TB-UP Application and Consent form to be registered in the TB-UP program.
The patient can sign the form either at the office of the board of health or at the office of
the attending physician. The patient must be informed that by signing the TB-UP
Application and Consent form, the patient:
confirms that they do not have OHIP, IFH or any other form of health insurance to
cover TB related diagnostic or treatment services;
requests to be registered in the TB-UP program;
provides authority to the board of health, health care providers providing services
under the TB-UP program and the Ministry of Health and Long-Term Care
(MOHLTC) to collect, use, share and disclose the TB-UP patient鈥檚 personal
health information among themselves for the purposes of the TB-UP program;
and
agrees to the release of their health number to health care providers providing TB
diagnostic and treatment services in the event that they are or become insured
under OHIP.
Once the patient has signed the TB-UP Application and Consent form they will be
registered in the TB-UP program and assigned a TB-UP Registration Number. The
Board of Health TB Control Program staff must enter the TB-UP Registration Number on
each Health Care Provider Claim form (Appendix A) prior to issuing to the service
provider or TB-UP patient. The board of health cannot issue a TB-UP Registration
Number without a signed TB-UP Application and Consent form. The signed TB-UP
Application and Consent form will be retained by the board of health in the patient鈥檚 file.
The board of health will also need to verify the individual鈥檚 personal identification before
the patient signs the TB-UP Application and Consent form for the TB-UP Program.
Acceptable forms of personal identification include:
(a) passport;
(b) landed immigration papers/student visa/work permit; or
(c) confirmation/referral from service agency (e.g., homeless persons).
(b) Registration into the TB-UP program from the service provider鈥檚 office/clinic
(Algorithm 2):
In general, the eligible patient should register at the board of health office during regular
business hours. However, under exceptional circumstances (e.g., a highly infectious TB
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11.5: Registration of Eligible TB-UP
Patients
case) the patient may register while at the physician鈥檚 office/clinic. In this situation, the
attending physician will verify with the patient that they are not covered under OHIP, IFH
or any other provincial/territorial or private health insurance. The physician will call the
local board of health to notify of uninsured persons with either suspect/active TB or
contact of active TB and request a TB-UP Application and Consent form (Appendix C).
The board of health can fax a blank TB-UP Application and Consent form to the attending
physician鈥檚 office or hospital out-patient clinic. The TB Control Program staff at the board
of health should confirm that the physician or their support staff verified the individual鈥檚
personal identification (Section 5.2.1 above for acceptable forms of personal
identification). The attending physician or their support staff will review the TB-UP
Application and Consent form with the patient and request the patient鈥檚 signature.
Once the consent form is signed it can either be mailed or faxed to the board of health for
retention in the patient鈥檚 file. A faxed TB-UP Application and Consent form with the
patient鈥檚 signature will be adequate for the board of health to register the patient in the
TB-UP program and initiate first mailing of the Health Care Provider Claim forms
(Appendix A).
(c) Process if patient declines signing the TB-UP Application and Consent form for
the TB-UP Program
The patient cannot be registered in the TB-UP program if they do not sign the TB-UP
Application and Consent form for the TB-UP Program. The board of health cannot assign
a TB-UP program registration number or provide any Health Care Provider Claim forms
without a signed TB-UP Application and Consent form. Without a signed TB-UP
Application and Consent form, there is no mechanism for the RCB to pay the claims
submitted by service providers.
11.5.3 Assigning the TB-UP Registration Number
Once the board of health has received the signed TB-UP Application and Consent form
and the patient meets the eligibility criteria, the TB Control Program staff can proceed
with registering the patient in the TB-UP program and assigning a TB-UP Registration
Number. The board of health will:
(a) Search for and select the patient in iPHIS TB module; then
(b) Enter the detailed information about the TB-UP registration in the iPHIS TB
Uninsured Person Registration Details screen and save.
The system will auto-generate a TB-UP registration number after the information in the
TB Uninsured Person Registration Details screen is saved (i.e., by clicking on the SAVE
button). The iPHIS TB-UP registration number is in numeric format, the health unit letter
code is no longer required as part of the registration number. The 8-digit TB-UP
registration number should be entered on each Health Care Provider Claim form (Part A)
prior to issuing to the service provider or patient.
The board of health will notify the RCB of the patient鈥檚 registration in the TB-UP program
(Section 8.1.1, Provision of TB-UP registration data to RCB).
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11.5: Registration of Eligible TB-UP
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11.5 Registration of Eligible TB-UP Patients
Algorithm 1: Enrolment & Registration into the TB-UP Program
at the Board of Health
A. Board of Health TB Control program
NOT ELIGIBLE
staff will assess TB status :
Active /suspect TB case;
Patient referral to TB-UP Program Contact of case of TB; or
If patient does not meet
(Section 4): Person at high risk of developing TB
eligibility criteria for TB-
Self reports in person or by (as determined by TB program staff).
UP then no need to
phone; Person on Immigration medical
enroll in TB-UP
By service provider; or surveillance (phase 2)
program.
By service agency.
Eligible TB status, now determine medical health insurance coverage
NOT ELIGIBLE
B. Board of Health TB Control program staff will determine medical
insurance coverage:
If patient HAS
Patient has NO health insurance e.g. OHIP, IFH or private health
Health Insurance
If patient HAS insurance.
health insurance
then service
provider can bill
through patient鈥檚 If patient does not have health insurance coverage and meets one of the TB
insurance (i.e., status requirements then the Board of Health TB Control program staff will
OHIP, IFH or proceed with registration.
other health
insurance).
C. Registration into the TB-UP Program (Section 5):
Verify patient鈥檚 personal identification.
TB-UP Application & Consent form signed by patient for TB-UP registration.
Patient assigned TB-UP registration number.
Notify the RCB of TB-UP registrants.
NOT ELIGIBLE D. Issuing Health Care Provider Claim forms (Section 6):
Health unit TB Control program staff can either:
Give a package of 7 forms to patient to provide at first physician visit;
or
Mail a package of 7 forms to the attending physician.
If patient does
(All claim forms must have TB-UP registration #; expiry date, board of
NOT sign the
health address, name of pt, DOB & gender. This information must appear
consent form,
on each page of the claim forms).
they cannot be
registered in TB-
UP program and
no TB-UP
registration
E. Subsequent visits to service provider and issuing claim forms UNUSED CLAIMS FORMS
number will be
(Section 6): Service provider must
assigned.
Service provider contacts TB Control program staff at the board of health to return to board of
discuss treatment plan and request additional claim forms as needed. health
Board of health will
destroy unused claim
forms and update
iPHIS TB-UP Claims
screen.
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11.5: Registration of Eligible TB-UP
Patients
Algorithm 2: Registration into the TB-UP Program from the Service
Provider鈥檚 Office/Clinic during regular business hours.
NOT ELIGIBLE
Patient referral to TB-UP
If patient does not meet
A. Service provider will notify the board of
Program (Section 4):
eligibility criteria for TB-
health if patient鈥檚 TB status is one of the
Self reports in person; or
UP then the patient will
following (Section 4):
By service agency.
not be enrolled in TB-
Active /suspect TB case; or
UP program.
NOT ELIGIBLE Eligible TB status, now determine medical
health insurance coverage.
Patient HAS Health
If patient HAS Insurance B. Service provider will verify no medical health
health insurance
insurance:
then provider can
Patient has NO health insurance e.g. OHIP, IFH or
bill through
private health insurance.
patient鈥檚
insurance (i.e.,
OHIP, IFH or
other health
insurance).
If patient does not have health insurance coverage and meets one of the
TB status requirements, then the service provider contacts board of
health.
C. TB-UP Registration from service provider鈥檚 office/clinic
(Section 5):
Submitting Claim Forms
Service provider contacts the board of health to fax the TB-UP
to RCB (Section 9):
Application & Consent form.
NOT ELIGIBLE Service provider
Service provider verifies patient鈥檚 personal identification.
sends completed
Signed consent form can be faxed to the board of health to initiate
claims forms to the
TB-UP program registration.
Registration &
Original consent form will be mailed to the health unit for retention
Claims Branch of the
If patient does in the TB-UP patient鈥檚 file.
MOHLTC (RCB) for
NOT sign
payment under the
consent form,
TB-UP program.
they cannot be
registered in
TB-UP and no
TB-UP D. Board of health registers patient in the TB-UP program and
registration issues claim forms to service provider (Section 4 & 6):
number will be Once the board of health has received the signed consent form, the
assigned. patient will be registered into the TB-UP program and assigned a
RCB verifies claim forms
TB-UP registration number. and will process the
The board of health will mail required number of claims forms to the payment.
service provider.
Service provider will E. Subsequent visits to service provider and issuing claim forms
forward laboratory and (Section 6):
radiology requisitions with Service Provider contacts the TB Control program staff at the board of
the claims forms to the health to review the treatment plan and request additional claim forms as
Laboratory and Radiology needed.
departments or send Additional claim forms mailed out to service provider.
along with the patient.
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11.5: Registration of Eligible TB-UP
Patients
NOTE: The preferred method for registration is at the board of health. However, if the
patient presents at the office/clinic of a service provider and has not previously contacted
the board of health, this procedure should be followed.
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11.6: Board of Health Distribution of Claim
Forms
11.6 Board of Health Distribution of Claim Forms
11.6.1 Information to be included on the Health Care Provider Claim Form
prior to distribution
The board of health TB Control Program staff must complete Part A on ALL Health Care
Provider Claim forms before claim forms are issued. This includes the following:
(a) Program Identification Code (i.e., TB-UP);
(b) Disease under Investigation/Treatment (i.e., TB);
(c) Referring Health Unit, Name of TB Control Staff Person, Telephone Number;
(d) Patient鈥檚 Name, Date of Birth and Sex;
(e) Registration Number (i.e., TB-UP Registration Number); and
(f) Eligibility Expiry date (i.e., TB-UP End Date).
NOTE: A new claim form will be required if the board of health staff should
make a mistake in recording the registration number on the claim form. The
RCB will not accept any claim forms in which the registration number shows
signs of being altered (i.e., if white-out was used or if number has been crossed
out and a new number written over) (Section 9.3, Returned Health Care Provider
Claim Forms by the RCB).
11.6.2 Distribution of Health Care Provider Claim Forms
Once the patient is registered in the TB-UP program (i.e., assigned a TB-UP Registration
Number), the board of health will distribute a package of Health Care Provider Claim
forms to the attending physician. The board of health will either:
(a) give the package of Health Care Provider Claim forms to the patient (in person)
to take to their physician; or
(b) mail the package of Health Care Provider Claim forms directly to the attending
physician鈥檚 office/clinic.
11.6.3 Health Care Provider Claim Forms for the First and Second Visit to
Physician鈥檚 Office/Clinic
As noted above, the board of health will provide the required number of the Health Care
Provider Claim forms to the patient directly or send by mail to the attending physician.
This initial claim form package will consist of 7 Health Care Provider Claim forms and a
Health Care Provider Claim Form Instruction (Appendix B) sheet for each claim form. The
7 Health Care Provider Claim forms will cover the following services:
3 Health Care Provider Claim forms for physician services (2 forms to cover first
and second (follow-up) visit with the attending physician and 1 form to cover
radiologist services);
3 Health Care Provider Claim forms for laboratory services (a separate claim
form must be submitted for each date of service, 3 claim forms may be required if
3 sputum specimens are obtained and tested on different days); and,
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11.6: Board of Health Distribution of Claim
Forms
1 Health Care Provider Claim form for the radiology facility.
An Instruction sheet should accompany each Health Care Provider Claim form. The
Instruction sheet will provide assistance to the service provider as to how each claim form
should be used.
(a) At the first visit, the attending physician will keep two Health Care Provider
Claim forms for billing services for the first and second (follow-up) visit (note: a
service provider must use a separate claim form for each date of service). The
attending physician should order the required laboratory tests or x-rays using the
standard requisition form. The following claim forms should be attached to the
standard requisition form for:
(i) Laboratory requisitions attach:
鈥? 3 Health Care Provider Claim forms to bill laboratory services and
the Health Care Provider Claim Form Instruction sheet.
(ii) Radiology requisitions attach:
鈥? 1 Health Care Provider Claim form for radiologist (physician)
services and a Health Care Provider Claim Form Instruction sheet;
and
鈥? 1 Health Care Provider Claim form for the radiology facility and a
Health Care Provider Claim Form Instruction sheet.
The TB-UP patient will take the remaining 5 Health Care Provider Claim forms and the
Instruction sheets along with the standard requisition to the laboratory and/or radiology
facility as required.
(b) The attending physician can bill the second (follow-up) visit using the
additional Health Care Provider Claim form for physician services. On the
second visit the physician will review the results of the initial diagnostic testing
(e.g. TB skin test, chest x-ray, laboratory tests) with the patient and determine
whether further follow-up is required. The physician鈥檚 office/clinic will contact the
local board of health - TB Control Program staff to provide an update of the TB
status and treatment plan for the patient. At this time, the physician鈥檚 office will
need to provide the board of health with an estimate for the number of Health
Care Provider Claim forms needed to cover physician visits and/or further
laboratory/radiology services for the next four week period.
11.6.4 Health Care Provider Claim Forms for Subsequent Visits to
Physician鈥檚 Office/Clinic
(a) Once the attending physician has provided an update of the patient鈥檚 TB
status and treatment plan, the board of health will mail out the estimated
number of additional Health Care Provider Claim forms requested by the
physician鈥檚 office/clinic. The board of health can send out additional claim
forms on a monthly basis as requested by the attending physician.
(b) For all other subsequent physician visits, the board of health may provide
Health Care Provider Claim forms to the physician鈥檚 office directly. The
number of claim forms provided each time should only be the number
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11.6: Board of Health Distribution of Claim
Forms
required to cover the next four week period of visits, as outlined in the
treatment plan or updates from the attending physician.
(c) The board of health TB Control Program staff must include the information
listed in Section 6.1 above on all Health Care Provider Claim forms before
issuing to the physician鈥檚 office/clinic.
(d) The board of health should advise the physician鈥檚 office/clinic that only
original Health Care Provider Claim forms not photocopies* must be
submitted to the RCB for assessment and payment under the TB-UP
program.
(e) The service provider will return all Health Care Provider Claim forms that
have not been used to the local board of health. The board of health will
retain these unused claim forms in the TB-UP patient鈥檚 file for further use
until the patient is discharged from the TB-UP program. Once the TB-UP
patient is discharged, the board of health will destroy all unused Health
Care Provider Claim forms made out to the specific TB-UP patient. The
board of health should delete unused and/or destroyed Health Care
Provider Claim Forms that were recorded as issued on the iPHIS TB-UP
Claim Form Details screen.
* Photocopies of the Health Care Provider Claim form may be accepted by the RCB in
exceptional circumstances (e.g., lost in mail). However, the copy must clearly state 鈥渄uplicate鈥?
and be resigned by the service provider.
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11.7: iPHIS TB-UP Screen Data Entry by
the Board of Health
11.7 iPHIS TB-UP Screen Data Entry by the Board of Health
Board of health staff will first open a TB episode for the patient by entering the required patient
information into the integrated Public Health Information System (iPHIS) TB module. The
following information must be entered into iPHIS: patient鈥檚 name, address, telephone number,
date of birth, gender as well as status at time of arrival (i.e., immigrant, visitor, etc.) as per regular
iPHIS reporting and management of a TB case.
Board of health TB Control Program staff will obtain the following information from the patient and
record the information into the iPHIS TB Uninsured Person Registration Details screen. This data
will be included in the regular iPHIS reporting to the PHB for the purpose of monitoring and
evaluating the TB-UP program (Section 8.1.2, Provision of TB-UP program data to the PHB).
Below is a detailed description of the data to be collected and entered by the board of health TB
Control Program staff.
NOTE: All fields marked with (*) are mandatory.
Please ensure these are completed in the
鈥淭B Uninsured Person Registration Details鈥? screen.
11.7.1 TB-UP Status*
鈥? not eligible for program
鈥? eligible/active patient
鈥? discharged
11.7.2 Medical Coverage Status at time of registration*
鈥? persons in the 3 month waiting period for OHIP
鈥? homeless without OHIP, IFH or other health insurance for TB services
鈥? persons who have been discharged from prison but are not currently eligible
for OHIP
鈥? visitor without health insurance for TB services
鈥? foreign student without OHIP, IFH or other health insurance for TB services
鈥? persons who do not have legitimate immigration status (long-term visitor)
11.7.3 TB-UP Consent Signed/Start Date*
Enter the date when the patient signed the TB-UP Application and Consent form and was
registered in the TB-UP program.
11.7.4 Status Review Date (SRD)
The status review date (SRD) is the date when the insurance status of the patient should
be checked by board of health staff to determine ongoing eligibility for the TB-UP
program. The SRD:
(i) will default to 90 days from the date on which the patient was registered in the
TB-UP program (i.e., 90 days for the date indicated in the Consent Signed/Start
Date field) ; this date must be 30 days prior to the TB-UP End Date.
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11.7: iPHIS TB-UP Screen Data Entry by
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(ii) can be set at one year from the program registration date for active/suspect TB
cases (e.g., visitors or foreign students), since active TB treatment may take
one year or longer.
The board of health staff will review the TB-UP patient file two weeks prior to the SRD to
determine if the patient is now covered by OHIP or any other health insurance. Once the
patient is covered for TB service under OHIP or any other health insurance plan, they will
no longer be eligible for coverage under the TB-UP program. The patient will then be
discharged from the TB-UP program (Section 10.1, Process for Discharging the Patient
from the TB-UP Program).
NOTE: The SRD can be extended at the discretion of the board of health, for
example if the patient has not received OHIP coverage within 90 days and/or
treatment for TB has been extended beyond the review period. The new SRD must
be reported to the RCB by updating the list of TB-UP registrants (Section 8.1.1,
Provision of TB-UP registration data to the RCB). The board of health must also
update the Health Care Provider Claim form if extending the SRD results in the
extension of the end date (i.e., expiry date). The board of health will indicate the
extended SRD and if necessary the revised TB-UP End Date in the iPHIS TB
Uninsured Person Registration Details screen.
11.7.5 TB-UP End Date*
Enter the date when it is anticipated the patient should be discharged from the TB-UP
program (i.e., expiry date). When the patient is actually discharged from TB-UP program
this will become the discharge date and should be updated appropriately. The TB-UP
End Date should be entered as a date 4 months from the start date during the initial save
in iPHIS.
11.7.6 Reason for Referral*
active case
suspect case
contact of case
medical surveillance
LTBI (other)
11.7.7 Diagnostic Outcome
active pulmonary TB
active extra pulmonary TB
LTBI on treatment
LTBI without treatment
assessment complete findings negative
assessment not complete, further assessment results required
11.7.8 On Medical Surveillance*
yes
no
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11.7.9 Available Reasons for Discharge
medically assessed 鈥? no further follow-up
medically assessed 鈥? on treatment
medically assessed 鈥? treatment completed
consent withdrawn
deceased
moved outside Ontario
patient covered by OHIP, IFH or other medical insurance for TB services
In the TB Uninsured Person Claim Form Details screen:
11.7.10 Invoice Number*
Enter pre-printed number on claim forms in the TB Uninsured Person Claim Form Details
screen.
11.7.11 Invoice Given To*
patient
initial physician
subsequent physician
parent/guardian
11.7.12 Invoice Given Physician
Only appears if 鈥榠nitial physician鈥? or 鈥榮ubsequent physician鈥? is selected from the Invoice
Given To drop list above. Select the name of physician to whom claim forms were sent.
11.7.13 Invoice Paid Date
Enter the date when the invoice was paid from the claim forms returned to the board of
health from RCB (i.e., pink copy).
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11.8: iPHIS TB-UP Screen Data Entry by
the Board of Health
11.8 TB-UP Data Transfer
(a) On a monthly basis, the PHD will submit a list of TB-UP registrants to the RCB in MS
Excel Spreadsheet format that can be generated from ReportNet. This spreadsheet
is saved on a password-protected diskette and sent to RCB by the first of every
month.
(b) A cumulative list of all TB-UP registrants, both current and discharged, will be
included in the file sent to RCB. The RCB will use the TB-UP registrant information
from the MS Excel Spreadsheet (i.e., ReportNet) to confirm that the TB-UP patient
information on the submitted claim form corresponds to the patient information
provided in the spreadsheet from the PHD. This information will assist the RCB staff
in verifying patient registration in the TB-UP program by a board of health.
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11.9: Submitting and Processing of Claims
for the TB-UP Program
11.9 Submitting and Processing of Claims for the TB-UP Program
11.9.1 Health Care Provider Claim Submission by Service Provider
Claims will be submitted by service providers to the RCB for assessment for payment
under the TB-UP program using the Health Care Provider Claim - Diagnostic and
Treatment Services for Uninsured Persons form (Appendix A).
11.9.2 Health Care Provider Claim Payment under the TB-UP Program by
RCB
RCB will assess and process claim payments for services rendered under the TB-UP
program. Services provided will be paid at same rate as the Schedule of Benefits fee
value for the same service provided to an insured person. Service providers will receive
payment for processed claims on a regular schedule. Payments for services under the
OHIP and the TB-UP programs will be included in a single remittance to the provider.
The payment details for the amount paid under the TB-UP program will be included in
detail line under TB-UP. Best efforts will be made on behalf of the RCB to ensure that
claims will be paid to service providers who provide services under the TB-UP program
within 8 weeks of receipt.
Service providers must submit all claims to the RCB within 6 months of the date of
service. This includes original claims and resubmitted claims (e.g., if original was lost).
Payment for claims submitted more than 6 months following the date of service
will be refused unless the RCB service manager is satisfied that there are
extenuating circumstances.
Once the RCB has processed the Health Care Provider Claim forms submitted by service
providers, a copy (pink) of the claim form will be sent to the appropriate board of health.
This copy of the paid form will be retained by the board of health in the TB-UP patient鈥檚
file.
11.9.3 Returned Health Care Provider Claim Forms by the RCB (Algorithm
4):
1. Reasons for a Health Care Provider Claim form to be returned:
The RCB may return a claim submitted by a service provider for reasons such as the
following:
Patient was not enrolled in the TB-UP program at the time the TB service
was rendered;
Patient is covered under OHIP;
Claim form is not complete or information is missing;
TB-UP Registration Number has been altered;
More than one date of service is listed on the claim form (NOTE: A separate
claim form must be used for each date of service);
Claim form is a photocopy;
Claim is stale dated (i.e., claim received more than 6 calendar months after
date of service);
Service code submitted does not correspond to the service code in the OHIP
Schedule of Benefits; or
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Service provider is not listed in the ministry provider database (NOTE: An
exception letter (see Appendix F) from the Medical Officer of Health/
designate must accompany a claim for services that are rendered outside the
province of Ontario by a service provider licensed within their province of
practice) (Section 9.4, Claims for service providers licensed outside Ontario).
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11.9: Submitting and Processing of Claims
for the TB-UP Program
Algorithm 4: Returned Health Care Provider Claim Forms by the RCB
A. Health Care Provider Claim Form returned by RCB (Section 9.3)
RCB may return a claim form to the service provider for reasons such as the following:
Patient is not enrolled in the TB-UP program at the time the TB service was rendered;
Patient is covered under OHIP;
Claim form is not complete or information is missing;
TB-UP Registration number has been altered;
More than one date of service is listed on the claim form. NOTE: A separate claim form must be used for each date of service;
Claim form is a photocopy;
Claim is stale dated (i.e., claim received more than 6 calendar months after date of service);
Service code submitted does not correspond to the service code in the OHIP Schedule of Benefits; and
Service provider is not listed in the ministry provider database. NOTE: A letter from the Medical Officer of Health/designate(see
Appendix F) must accompany a claim for services that are rendered outside the province of Ontario by a service provider licensed
within their province of practice.
B. RCB returns claim form to the service provider:
If claim form is returned, RCB will send the returned claim form to the service provider along
with a 鈥淐laim Forms Returned鈥? letter(see Appendix E) that outlines reasons for returned
claim.
D. If the service provider cannot provide the information then the
C. Service provider receives returned claim form from service provider will:
the RCB:
contact the board of health where the patient is registered for
Service provider is notified of the reasons for the assistance; or
returned claim form in the 鈥淐laim Forms Returned鈥? letter send the returned claim form to the board of health for them to
(see Appendix E) provide the required TB-UP patient information.
Once conditions outlined in the 鈥淐laim Form Returned鈥? NOTE: The service provider may return claim form to the board of health
letter are met, service provider can re-submit the for exception letter, extension of expiry date or to add missing/correct TB-
completed/corrected claim form to RCB for payment. UP patient information (e.g., registration number).
E. Board of health receives returned claim form from service
provider:
A service provider may send their returned claim form (along with
鈥淐laim Form Returned鈥? letter 鈥搒ee Appendix E)) to the board of
health for inclusion of missing information or an exception letter as
required.
Once conditions outlined in the 鈥淐laim Form Returned鈥? letter are
met, the service provider can re-submit the claim form to RCB for
payment.
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11.9: Submitting and Processing of Claims
for the TB-UP Program
2. Process for re-submission of returned Health Care Provider Claim forms:
If a Health Care Provider Claim form is not eligible for payment, the RCB will return the
claim form to the service provider along with a Claim Forms Returned letter (see
Appendix E). The Claim Forms Returned letter will outline the reason RCB returned the
claim. The service provider will provide the necessary information or correct the claim
and re-submit to the RCB for payment under the TB-UP program.
If the service provider cannot provide the necessary information then the service provider
will need to contact the board of health for assistance. Once the conditions outlined in
the Claim Form Returned letter are met, the service provider can re-submit the
corrected/completed Health Care Provider Claim form to the RCB.
NOTE: If the service provider has questions related to claim payments they can
contact the Ministry of Health and Long-Term Care, Toronto District Office (TDO)
of the Registration and Claims Branch by phone at (416) 314-7770.
11.9.4 Claims for service providers licensed outside Ontario
(a) In order to receive payment through the TB-UP program, claims submitted by
service providers licensed outside the province of Ontario must include an
original letter signed by the local Medical Officer of Health (MOH) or
designate authorizing the out of province TB related service(s) for the
uninsured patient (see Appendix F). Service providers must be licensed
within their province of practice to be eligible for payment under the TB-UP
program (Section 1.2.2, Eligible service providers for payment under the TB-
UP program).
(b) In the event that a service provider disagrees with the decision from the
MOH/designate regarding non-approval of TB-UP services rendered outside
Ontario, the MOH/designate will consult with the Senior Medical Consultant
at the Public Health Branch (PHB) to discuss the specific issue (Section 12,
Dispute Resolution).
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11.10: Discharge of Patient from TB-UP
Program
11.10 Discharge of Patient from TB-UP Program
11.10.1 Process for Discharging the Patient from the TB-UP Program
(a) Patient may request to be withdrawn from the TB-UP program (Section
11.2.1: Withdrawal from the TB-UP Program) or the board of health may
initiate discharge due to one of the following reasons, patient:
completed treatment;
is deceased;
moved outside Ontario;
completed assessment and findings were negative; or
is covered under medical insurance such as OHIP or IFH.
(b) The board of health must ensure the following fields in the iPHIS TB
Uninsured Person Registration Details screen are completed, if the TB-
UP patient is to be discharged (Section 7, iPHIS TB-UP Screen Data
Entry by the Board of Health):
TB-UP End Date
TB-UP Diagnostic Outcome
Reasons for Discharge
(c) The board of health TB Control Program staff should ensure that claim
information (i.e., invoice paid date) from all paid claims sent by RCB for
services rendered prior to the patient鈥檚 discharge is entered into the TB
Uninsured Person Claim Form Details screen.
(d) The TB Control Program staff must notify the RCB of the patient鈥檚
discharge from the TB-UP program through the TB-UP registrant report
sent monthly to the RCB (Section 8.1.2. Provision of TB-UP Registration
Data to RCB). The TB Control Program staff must also contact the
attending physician to inform of TB-UP patient鈥檚 discharge from the TB-
UP program.
11.10.2 Withdrawal from the TB-UP Program:
Patient withdraws from the TB-UP program (Algorithm 5)
The patient may withdraw from the TB-UP program in either one of the following ways:
(a) At the board of health:
The TB-UP patient may contact the board of health directly to request to be
withdrawn from the TB-UP program. The TB Control Program staff will review
the TB-UP Withdrawal form with the patient (Appendix D). The patient must be
informed that once they have signed the TB-UP Withdrawal form the patient is
agreeing to withdraw:
registration from the TB-UP program;
authorization for the board of health, health care providers providing
services under TB-UP and the MOHLTC to collect, use, share and
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11.10: Discharge of Patient from TB-UP
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disclose personal information among themselves for any purpose
relating to the TB-UP program; and
coverage under the TB-UP program for diagnostic and/or treatment
services for TB.
Once the patient has signed the TB-UP Withdrawal form, the board of health TB
Control Program staff will proceed with discharging the patient from the TB-UP
program (Section 10.1, Process for Discharging the Patient from the TB-UP
Program). The signed TB-UP Withdrawal form will be retained by the board of
health in the patient鈥檚 file. The board of health will update the iPHIS TB
Uninsured Person Registration Details and the TB Uninsured Person Claim Form
Details screen. Notification of the patient鈥檚 withdrawal/discharge from the TB-UP
program must be sent to the RCB as well as the attending physician (Section
10.1, Process for Discharging the Patient from the TB-UP Program and Section
8.1.2, Provision of TB-UP registration data to RCB).
(b) At the service provider鈥檚 office:
The TB-UP patient may request to withdraw from the TB-UP program while in the
service provider鈥檚 office. The attending physician may direct the TB-UP patient
to the board of health for withdrawal. Alternatively, the attending physician may
contact the local board of health to inform of patient鈥檚 wish to withdraw from the
TB-UP program and request a TB-UP Withdrawal form (Appendix D). The board
of health will fax a blank TB-UP Withdrawal form to the attending physician鈥檚
office. The attending physician or their support staff will review the form with the
patient and explain that by signing the TB-UP Withdrawal form the patient agrees
to withdraw:
registration from the TB-UP program;
authorization for the board of health, health care providers providing
services under TB-UP and the MOHLTC to collect, use, share and
disclose personal information among themselves for any purpose
relating to the TB-UP program; and
coverage under the TB-UP program for diagnostic and/or treatment
services for TB.
The signed TB-UP Withdrawal form can be mailed or faxed to the board of health
for retention in the patient鈥檚 file. A faxed withdrawal form with patient鈥檚 signature
will be adequate to initiate discharge from the TB-UP program (Section 11.1,
Process for Discharging the Patient from the TB-UP Program). The board of
health will update the iPHIS TB Uninsured Person Registration Details, the TB
Uninsured Person Claim Form Details screen and send notification to the RCB
(Section 10.1, Process for Discharging the Patient from the TB-UP Program and
Section 8.1.2, Provision of TB-UP registration data to RCB).
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11.10: Discharge of Patient from TB-UP
Program
Algorithm 5: Patient Withdraws from the TB-UP Program
PATIENT WITHDRAWS
OR
IS DISCHARGED FROM TB-UP PROGRAM
Reasons for discharging TB-UP patient from the TB-UP program (Section 10):
The board of health may discharge a TB-UP patient due to the following reasons, patient:
Medically assessed 鈥? no further follow-up
Medically assessed 鈥? treatment completed
Medically assessed 鈥? on treatment
Consent withdrawn
Deceased
Moved outside Ontario, or
Covered under medical insurance such as OHIP or IFH.
(Board of health will update the iPHIS TBUninsured Person Registration Details screen for discharging patient and
notify RCB.)
OR
TB-UP Patient may request to be withdrawn
from the TB-UP program (Section 10.2.1):
AT SERVICE PROVIDER鈥橲
AT BOARD OF HEALTH
OFFICE/CLINIC
Patient requests to withdraw from TB-UP
Program:
Signs TB-UP Withdrawal Form.
Patient requests to withdraw from
Patient requests to
TB-UP Program:
withdraw from TB-UP
Service provider calls the board
Program
of health and requests a TB-UP
Service provider has
Patient is discharged from TB-UP
Withdrawal form.
patient go to board
Program:
Board of health faxes withdrawal
of health.
Board of health updates iPHIS TB
form to service provider.
Uninsured Person Registration and
Provider faxes the signed TB-UP
Claim Form Details screens and
Withdrawal form to the board of
notifies the RCB via monthly report (i.e.
health.
diskette).
Board of health proceeds with
Board of health notifies service
discharging patient from TB-UP
provider that patient has withdrawn
program.
from TB-UP Program.
Service provider mails original
signed TB-UP Withdrawal form
to the board of health.
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11.11: TB-UP Form Production, Distribution,
Control and Retention
11.11 TB-UP Form Production, Distribution, Control and Retention
11.11.1 Production of TB-UP Forms
(a) The RCB will manage the stock and on-going production of the Health
Care Provider Claim 鈥? Diagnostic and Treatment Services for Uninsured
Persons form (Appendix A).
(b) Each Health Care Provider Claim form will have a pre-printed unique
sequential number called the "invoice number" which will be used for
monitoring and tracking of claim forms within the iPHIS TB Uninsured
Person Claim Form Detail screen. This number should not be altered by
the board of health or service provider.
(c) The PHD will manage the stock and on-going production of the TB-UP
Application and Consent form and the TB-UP Withdrawal form (Appendix
C & D).
11.11.2 Process for the Board of Health to obtain TB-UP Forms
(a) Health Care Provider Claim forms can be ordered from the Ministry of
Health and Long-Term Care. The board of health staff can order these
forms using either one of the following methods:
(i) complete a Stationery and Publications Requisition form 0350-93
which is available in paper copy or can be obtained online at:
http://intra.forms.ssb.gov.on.ca/mbs/ssb/forms/FormsReposit
ory.nsf/ Forms/MOH-014-0350-93/$File/0350-
93_.pdf?OpenElement
The electronic form can be filled in and then mailed to address on
form or faxed to the number on the form; or
(ii) call the Adesso warehouse customer service line with the
information at (416) 327-0837 or fax (416) 327-0329 the ordering
information on board of health letterhead.
The following information is required:
form number which is 3977-84
catalogue number which is 7530-5626
form title which is Health Care Provider Claim form
The board of health will need to provide the quantity, budget code to ship
under (individual board of health budget code for shipping forms), board of
health address for shipping as well as contact name & telephone
information.
(b) TB-UP Application and Consent and TB-UP Withdrawal forms for the TB-
UP program:
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11.11: TB-UP Form Production, Distribution,
Control and Retention
These forms can be obtained from the Ministry of Health and Long-Term
Care. The board of health can request a supply of these forms by quoting
the catalogue number (see bottom right side of the form, e.g., 7530) and
faxing the request to (416) 327-0329 on board of health letterhead.
Further ordering information can be found on the web site at
http://www.gov.on.ca. The board of health can search the web site by
form name or by form number.
11.11.3 TB-UP Forms Control
The board of health offices will control the distribution of claim forms to
service providers. Each Health Care Provider Claim form has a pre-printed
unique invoice number. The board of health will enter this unique invoice
number into the iPHIS TB Uninsured Person Claim Form Details screen for
each claim form issued (Section 7.11, Invoice Number). The board of
health will also indicate (in the iPHIS TB Uninsured Person Claim Form
Details screen) the person they gave the claim forms to (Section 7.12, TB-
UP Invoice Given To). For example, if the board of health issued the claim
form to the attending physician then the name of physician receiving the
claim form must be included in the iPHIS TB Uninsured Person Claim Form
Details screen (Section 7.13, TB-UP Invoice Given Physician).
The individual TB-UP Application and Consent form and the TB-UP
Withdrawal form will not be tracked by the PHD.
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11.12: Dispute Resolution
11.12 Dispute Resolution
11.12.1 Policy and Program Inquiries
(a) Inquiries relating to the TB-UP policy or program procedures will first be
directed to the local boards of health for resolution.
(b) For escalated inquiries the board of health will discuss with the PHD
(Senior Medical Consultant: VPD/TB Unit) by phone at (416) 327-7419.
11.12.2 Payment Inquiries
Inquiries relating to claim payment will be directed to the Ministry of Health and Long-
Term Care, Toronto District Office (TDO) of the Registration and Claims Branch by phone
at (416) 314-7770.
11.12.3 Final Decision Regarding Unresolved Disputes
The PHD will provide a final decision in unresolved disputes. This would include
escalated disputes which the board of health or RCB is unable to resolve.
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Claim
11.13 Appendix A: Health Care Provider Claim
Health Care Provider Claim:
Diagnostic and Treatment Services for Uninsured Persons
See Section 11.2 for process for Board of Health to obtain TB-UP Forms.
A sample cannot be produced in this protocol
but a supply should be available at the local public health unit.
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Claim Form Instruction Sheet
11.14 Appendix B: Health Care Provider Claim Form Instruction Sheet
This instruction sheet should accompany each Health Care Provider Claim form in the initial
claim form package. Service providers who provide out-patient services to TB-UP patients can
bill for these services by submitting the completed Health Care Provider Claim forms to the
Registration and Claims Branch of the Ministry of Health and Long-Term Care for payment under
the TB-UP program. Detailed submission instructions including Terms and Conditions for billing
through the TB-UP program can be found on the Health Care Provider Claim form.
The initial claim form package contains 7 Health Care Provider Claim forms that will cover the
following services:
1. Physician Services:
鈥? 2 Health Care Provider Claim forms to cover first and second physician visits; and
鈥? 1 Health Care Provider Claim form to cover the radiologist service.
2. Laboratory Services:
鈥? 3 Health Care Provider Claim forms for laboratory services (a separate claim forms must
be submitted for each date of service, 3 claim forms may be required if 3 sputum
specimens are obtained and tested on different days).
3. Radiology Services:
鈥? 1 Health Care Provider Claim form to cover radiology facility.
At the initial TB-UP patient visit, the attending physician will retain 2 Health Care Provider Claim
forms and give the remaining claim forms to the patient to provide to laboratory and radiology
service providers as required. The attending physician should order the required laboratory tests
or x-rays using the standard requisition forms and attach the standard requisition form(s) to the
appropriate Health Care Provider Claim form(s).
Ordering additional Health Care Provider Claim forms:
The attending physician should contact the local public health unit to obtain additional Health
Care Provider Claim forms.
NOTE: A service provider must use a separate claim form for each date of service.
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Consent Form
11.15 Appendix C: TB-UP Application and Consent Form
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Consent Form
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11.16 Appendix D: TB-UP Withdrawal Form
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Letter
11.17 Appendix E: Claims Form Returned Letter
Dr
Dear Service Provider:
Your Tuberculosis for Uninsured Persons Program (TB-UP) Claim Form is being returned for the
following reason(s):
Form is not complete (or TB-UP Registration number has been tampered with or
changed)
Claim contains more than one service date.
Form is not an original form (or clearly marked DUPLICATE containing an original
provider signature, or an original faxed copy from a PHU containing an original provider
signature).
Claim is stale dated (claim service greater than 7 calendar months from date received by
the processing site). No Public Health Unit exception letter authorizing payment
attached.
The Client has Ontario Health Insurance (OHIP).
The OHIP number is ______________.
Fee Code submitted is invalid. No Public Health Unit exception letter authorizing payment
attached.
.
Service provider is ineligible (not listed in the provider database). No Public Health Unit
exception letter authorizing payment attached.
Service provider is ineligible (ineligible on the provider database).
Patient not listed on TB-UP Registration Report, or not enrolled in program at time of
service (service date is prior to program start date, or after program end date as listed on
the TB-UP Registration Report). No Public Health Unit exception letter authorizing
payment attached.
Other _________________________________________________________
Please return the completed/corrected form as soon as possible. Your claim cannot be
processed without your completed/corrected claim form.
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Letter
Continued
The fee submitted on your TB-UP claim is not equal to the amount in the Schedule of
Benefits. Your claim is being processed, but the amount paid will not be as billed
(photocopy of claim attached).
If you have any questions, please contact our office.
____________________________________
Ministry of Health and Long-Term Care
47 Sheppard Ave East Suite 505
Toronto ON M5W 1G9
(416) 314-7770
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11.18 Appendix F: Sample Exception Letter
Dear
The Tuberculosis Diagnostic and Treatment Services for Uninsured Persons (TB-UP) program
enables health care service providers licensed in Ontario to receive payment for services they
provide to uninsured individuals who have been identified as requiring follow-up for tuberculosis
infection or disease. Under this program, physicians, laboratories and radiology clinics will be
paid for specific outpatient services rendered to individual patients registered in the TB-UP
program. Specific outpatient services are listed on TB-UP claim forms.
Claims for 'exceptional' services (i.e., services not indicated on the claim forms) require prior
approval by the local Medical Officer of Health indicating that the 'exceptional' service was
required for the diagnosis/treatment of the particular client. Claims by service providers' licensed
outside the province of Ontario also require prior approval in order to receive coverage through
the TB-UP program for services rendered for the diagnosis/treatment of the particular client.
Please accept this 'exception' letter granting approval for the following:
Claims for specific 'exceptional' service (specify the service(s) required and the
corresponding code from the OHIP fee schedule along with the current fee, and
provide rationale)
Claims by service providers licensed outside the province of Ontario to receive
coverage through the TB-UP program for services rendered for the
diagnosis/treatment of the particular client.
The above indicated approval has been determined by the local Medical Officer of Health as
required for the diagnosis/treatment of TB for the particular client and can receive coverage
through the TB-UP program.
Thank you,
________________________________
Medical Officer of Health/Designate
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12.1 Section 22 Orders
12. Use of Orders under the Health Protection and Promotion
Act to Control Tuberculosis
The purpose of the Health Protection and Promotion Act (HPPA), as set out in Section 2, is to
provide for the organization and delivery of public health programs and services. The goal of such
services is the prevention of the spread of disease, and the promotion and protection of the
health of the people of Ontario..
The Medical Officer of Health (MOH) is an important statutory official under the HPPA and
possesses authority under HPPA to act, among other things, to prevent the spread of disease,
decrease the effects of health hazards and protect the public鈥檚 health.
The HPPA lists the reporting requirements for communicable diseases (See Chapter 1). It also
gives:
(a) The medical officer of health the authority to issue orders against anyone who has a
communicable disease, such as TB, and who is putting others at risk;
(b) The medical officer of health the authority to access personal information that will assist
in contact tracing and;
(c) People with a communicable disease the right to appeal an order issued by a medical
officer of health, however the order remains in force pending the appeal.
Where the public鈥檚 health and safety are at risk and the situation is urgent, or if other
measures to achieve compliance have failed, an MOH may rely on the more intrusive
provisions of the HPPA. It has been customary practice for an MOH to use all reasonable
measures to obtain voluntary compliance before using the more intrusive statutory
powers of the MOH to ensure appropriate treatment and medical follow-up for
tuberculosis.
12.1 Section 22 Orders
The following considerations reflect common public health practice relating to the
issuance of a Section 22 Order:
Any intervention should be the 鈥渓east intrusive, most effective鈥? option.
More intrusive interventions should be adopted only after less intrusive
alternatives have been unsuccessfully attempted.
12.1.1 Preparing to Issue a Section 22 Order
For diseases designated as communicable under O. Reg. 558/91, a MOH has the power
under Section 22(1) of the HPPA to issue a written order requiring an individual to take or
to refrain from taking certain actions. A Section 22 Order can be issued when the MOH is
of the opinion, based upon reasonable and probable grounds, that:
(a) A communicable disease exists or may exist or that there is an immediate
risk of an outbreak of a communicable disease in the health unit served by
the MOH.
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12.1 Section 22 Orders
(b) The communicable disease presents a risk to the health of persons in the
health unit served by the MOH and that the requirements specified in the order
are necessary in order to decrease or eliminate the risk to health presented by
the communicable disease.
(c) A Section 22 Order may specify the time or times when or the period or periods
of time within which the person to whom the order is directed must comply with
the order R.S.O. 1990, c.H.7, s.22(3).
12.1.2 Situations in which a Section 22 Order would be Appropriate to
Control and/or Treat Tuberculosis:
The following situations illustrate (but do not limit) the situations appropriate for issuing a
Section 22 Order.
Explicit refusal or demonstrated inability to comply with isolation measures as
directed by the attending physician and/or Public Health staff during the period of
communicability;
Explicit refusal to co-operate in providing names and contact information for
identifiable household and close non-household contacts;
Explicit refusal to comply with medical appointments and/or diagnostic tests
as recommended by the attending physician or other specialist involved in the
client鈥檚 care;
Explicit refusal to comply with taking anti-tuberculous medication therapy as
prescribed;
Explicit refusal to comply with directly observed therapy arrangements;
Explicit refusal, by a symptomatic contact, to follow-up with a physician to rule
out active TB disease; and/or
Explicit refusal, by parents of a child contact, to follow-up with a physician
to rule out active TB disease.
12.1.3 Provisions which may be included in a Section 22 Order
Pursuant to Section 22(4), an order pertaining to a communicable disease, may include,
but is not limited to, the following:
(a) Requiring the person to whom the order is directed to submit to an examination
by a physician and to deliver to the MOH a report by the physician as to whether
or not the person has a communicable disease or is or is not infected with an
agent of a communicable disease;
(b) Requiring the person to isolate himself/herself and remain in isolation from other
persons until such time the person is deemed non-infectious;
(c) Requiring the person who has or may have TB (a virulent disease) to
immediately place himself/herself under the care and treatment of a physician,
and to attend medical appointments and appointments with public health
departments (i.e. DOT appointments);
(d) Requiring the person to comply with taking the prescribed anti-tuberculous
medication therapy;
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12.1 Section 22 Orders
(e) Requiring the person to identify all contacts and provide comprehensive contact
information;
(f) Requiring the person to conduct himself/herself in such a manner as not to
expose another person to infection; and/or,
(g) Any other requirement that will decrease or eliminate the risk of tuberculosis
infection to the public.
Pursuant to subsection 22 (5) of the HPPA, an order may be directed to a person or a
class of persons who reside, or are present in the health unit served by the MOH. Notice
of the Order made to a class of persons must be delivered to each member of the class
where it is practicable to do so in a reasonable amount of time, pursuant to Section
22(5.2) of the HPPA.
12.1.4 Process for Completing the Section 22 Order
Once reasonable measures to obtain voluntary compliance are attempted, the TB Control
program manager/designate and the case investigator in consultation with the
MOH/designate and legal services should prepare the Order for the signature of the
MOH/AMOH. A copy of the signed Order should be included in the client鈥檚 file. (Refer to
Section 22 Template). A Section 22 order should:
Contain the full name (ensure correct spelling), date of birth and most current
address of the individual to whom the Order is being issued;
State the reason(s) why the Order is being issued; include all the measures that
were taken by the health department to obtain voluntary compliance;
Include the specifics of the evidence (e.g. chest x-ray results, laboratory results
and dates of these tests) identifying that the individual has or is suspected of
having a communicable, virulent disease;
Detail action to be taken and in what time frame; and
Clearly identify what is expected of the person with regard to action and time
frame; for example: person to keep appointment with Dr. X at (specified street
address) on (specified date and time). Please note: specific details and the
requirements are important here.
Inform the person that he/she has the right to a hearing before the Health
Services Appeal and Review Board (HSARB) (HPPA Section 44).
12.1.5 Process for Serving the Section 22 Order
Whenever possible, public health staff should serve the Section 22 Order in person to
explain and discuss the Order鈥檚 requirements. A process server may also be engaged by
the health department to serve the Section 22 Order in circumstances where the address
of the client being served is known.
If it is not possible to serve the Order personally by health unit staff, then it may be sent
by regular mail. An Order issued by regular mail is effectively served on the seventh
day after the date of mailing. Health unit staff must contact a person who has been
served an order by mail, to ensure that he/she understands the Order.
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12.1 Section 22 Orders
If a client has difficulty understanding English, the services of a professional interpreter
(not a family member) should be used to ensure that the person understands the
contents of the Order.
The Order takes effect on the date it has been served, even if there is a request for
a hearing by the individual to whom the Order is directed.
12.1.6 Non-Compliance with a Section 22 Order
Any person who fails to obey an Order made under the HPPA is guilty of a provincial
offence and upon conviction, may be liable to a fine of up to $5000 for every day or part
of a day on which the offence occurs or continues R.S.O. 1990, c.H.7 s.101(1).
Appeal Process
Health Services Appeal and Review Board (HSARB) is a tribunal of record and all written
documentary evidence is available to anyone who is a party to the proceedings. Any
person against whom an order is issued must be informed of his/her right to appeal
R.S.O. 1990, c.H.7 s.44(1).
The person may request a hearing by the Health Services Appeal and Review
Board (HSARB) by written notice to the MOH within 15 days after the Order is
served. Anyone served with an order by a MOH can request a hearing from the
HSARB.
The hearing must occur within fifteen working days after receipt by the Board of a
notice requiring the hearing.
Although the Order takes effect when served, a person who requests a hearing
may seek a stay of the Order from HSARB to prevent the Order from taking effect
until the hearing has taken place and a determination has been made as to its
validity.
The person may appeal the decision of the HSARB to Divisional Court and that
right to appeal is broad, allowing the Divisional Court:
To confirm, alter or rescind the decision of HSARB;
To exercise all of the powers of HSARB to confirm, alter, or rescind the
Order as the court considers proper; or
To refer the matter back to the HSARB for re-hearing in whole or in part,
as the court considers proper.
In situations where there is non-compliance with a Section 22 Order:
Legal services should be consulted to determine if further action is warranted, which may
include but is not limited to:
Issuing another Section 22 Order
Fine (HPPA Section 100)
Initiating a proceeding to restrain the contravention (HPPA Section 102)
Making an application for an Order by the Ontario Court of Justice 鈥? Section 35
Order
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12.2 Section 35 Order: Order by the Ontario
Court of Justice
12.2 Section 35 Order: Order by the Ontario Court of Justice
When a person who has a communicable disease that is designated as a virulent
disease, and continues to pose an infectious disease risk, such as TB, and fails to
comply with a Section 22 order requiring the person to:
(a) Isolate themselves and remain in isolation from other persons;
(b) Submit to an examination by a physician;
(c) Place themselves under the care and treatment of a physician; and/or
(d) Conduct themselves in such a manner as not to expose another person to
infection,
the MOH may apply to a judge of the Ontario Court of Justice to issue an order under
Section 35 of the HPPA.
12.2.1 Contents of a Section 35 Order
Under Section 35, a judge may order that the person who has failed to comply with the
Section 22 order of the MOH:
(a) To be taken into custody and admitted to and detained in a hospital or other
appropriate facility named in the order;
(b) To be examined by a physician to ascertain whether or not the person is
infected with an agent of a virulent disease; and
(c) To be treated for the disease if found, on examination, to be infected with an
agent of a virulent disease.
A Section 35 order is valid only if it is signed by the judge. Section 35 orders are often
signed by the court at the conclusion of the Section 35 application and provided to legal
counsel for the MOH and the respondent.
A copy of the Order should be served on the respondent.
The order to detain someone in a hospital or other facility takes effect when the order is
served. The person may be detained for not more than four months R.S.O. 1990, c.H.7,
s35 (7) however the order may be extended by a judge following an application for
extension by the MOH.
The MOH in the health unit where the hospital (or other facility) is located must apply to
the Ontario Court of Justice to extend the period of detention. The judge must be satisfied
that the person continues to be infected and that discharging him/her from hospital would
present a significant risk to the health of the public R.S.O. 1990, c.H.7 s35(11).
Any MOH considering an order under Section 35 should advise the
TB Control Program,
Ontario Ministry of Health and Long-Term Care (MOHLTC).
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12.2 Section 35 Order: Order by the Ontario
Court of Justice
12.2.2 Procedures for a Section 35 Order
When considering a Section 35 order, the health unit should:
(a) Clearly document the patient鈥檚 failure to comply with a Section 22 order.
(b) Discuss the situation with a legal representative for the health unit who is
familiar with the provisions of the Health Protection and Promotion Act.
(c) Discuss the decision to proceed with a Section 35 application with the TB
Control Program, Ontario MOHLTC.
(d) Identify a hospital that meets the following criteria:
Can provide the required medical care/expertise and treatment;
Has a secure bed where the patient may be kept without the
possibility of leaving; and,
Can provide negative pressure ventilation.
A judge may not sign an order unless s/he is satisfied that the
hospital is able to provide detention, care and treatment. Therefore,
it is critically important to discuss the security, care and treatment
arrangements with hospital administration and the attending
physician before applying for the order.
West Park Healthcare Centre (WPHC) is the only provincially-designated
in-patient treatment facility for complex TB patients. It is also the only
healthcare facility in Ontario that is able to detain persons with TB that
are held under a Section 35 Order under the HPPA. Please refer to
Chapter 13 for details of admitting a patient who is under a S. 35 order
to WPHC. WPHC will only admit patients during the week during
business hours. If a patient is apprehended under a S.35 order outside of
these times, the health unit will have to make alternative arrangements to
detain and isolate the patient until WPHC is able to admit him/her.
(e) Prepare the Section 35 application. Ensure that a lawyer knowledgeable
about Section 35 orders prepares the application and has the relevant
information on the case from the patient鈥檚 chart and from the
professionals involved to draft the application. This may be done in
consultation with public health unit lawyers who are experienced in
preparing orders under the HPPA.
12.2.3 Serving and Enforcing a Section 35 Order
Any notice, order, or other document under the HPPA is sufficiently given, served
or delivered if delivered personally or sent by ordinary mail addressed to the person at
the person鈥檚 last known address.
A process server can also be engaged by the health department to deliver the Section 35
Order in circumstances where the address of the client being issued is known.
Section 35 orders may also be directed to a police force to do what is reasonably
necessary to locate, apprehend and deliver the person in accordance with the order.
Health units may request the police to escort the patient to the hospital or other facility.
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12.2 Section 35 Order: Order by the Ontario
Court of Justice
To ensure a smooth patient transfer:
(a) Speak with the police prior to bringing the court application and advise
their assistance may be required.
(b) Provide a copy of the signed order to the police.
(c) Ensure that police personnel take appropriate infection control
measures.
(d) Ensure that all parties are aware e.g. the MOHLTC, Toronto Public
Health (if applicable) and West Park Healthcare Centre (WPHC). A
teleconference is very useful to inform all involved.
12.2.4 Appealing a Section 35 Order
Section 35 applications take priority over appeals before the HSARB. An appeal before
the HSARB is stayed if the subject matter of the appeal is elevated to a Section 35
application however the order remains in effect pending the judge鈥檚 decision in appeal.
12.2.5 Extending a Section 35 Order/Certificate of MOH
A Section 35 order is in force for a period of up to four months from the date it is served. It
may be extended by a judge, upon application by the MOH serving the health unit in which
the hospital or appropriate facility is located. An order may be extended if the court is
satisfied that:
The person continues to be infected with an agent of a virulent disease; and,
The discharge of the person from the hospital or appropriate facility would present
a significant risk to the health of the public [HPPA 35 (11)].
A Section 35 order may be extended for not more than four months. Further motions to
extend the order may be brought by the MOH who has jurisdiction where the person is
detained. These extensions must not exceed four months
A MOH having jurisdiction where the individual is detained may release a patient
from the hospital or other facility prior to the expiry of the order. An attending
physician does not have this authority.
The release and early discharge of the individual is authorized by a Certificate of the
Medical Officer of Health provided two conditions are met:
1. The individual is no longer infected; and,
2. The individual does not present a significant risk to the community.
Before discharging a patient from hospital, notify the MOH of the health unit where the
patient will reside after discharge to ensure continuity of care and follow-up. If the person
is in WPHC, see Chapter 13: West Park Healthcare Centre concerning discharging a
patient from WPHC under a Section 35 order.
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12.3 Appendix 12-A: Sample Health Unit
Letter
12.3 Appendix A: Sample Health Unit Letter
SAMPLE (CAN BE ADAPTED)
HEALTH UNIT LETTERHEAD
ORDER
Made pursuant to Section 22 of the
Health Protection and Promotion Act, R.S.O. 1990, c.H.7
(DATE)
(PATIENT NAME)
(ADDRESS)
I, DR. _______________________, MEDICAL OFFICER OF HEALTH (or delegate) FOR THE CITY OF
__________________, ORDER YOU TO COMPLY WITH THE FOLLOWING ACTIONS:
1. Attend (West Park Healthcare Centre/TB clinic/ physician鈥檚 office) and submit yourself to an
examination by Dr. (Name), insert specific date and time as recommended by the (Name of) Public
Health Department, and cooperate fully with the recommended investigation and treatment for your
(multidrug resistant or pulmonary tuberculosis), and
2. Conduct yourself in such a manner as not to expose another person to infection from a
communicable and virulent disease, namely tuberculosis, by following instructions given to you by
the nursing and medical staff at (Name of Facility) and/or (Name of Health Unit) TB staff, and
3. That you continue to be treated by Dr. (Name) including submitting to any diagnostic tests deemed
to be necessary by Dr. (Name) or his/her delegate, in order to assess whether your pulmonary
tuberculosis is/has/had again become infectious, as a result of your failure to comply with
antituberculous therapy; and
4. That you continue to report each week, by 鈥︹??.a.m., on each day of treatment to the (Public Health
and Community Services Department or specify location) for directly observed therapy for your
tuberculosis at the frequency prescribed by Dr. (Name) or his/her delegate until your treatment
regimen has changed and Directly Observed Therapy (D.O.T.) can be reduced. Your treatment will
not be considered completed prior to (month/year) unless explicitly stated by Dr. (Name) or his/her
delegate. If therapy is required beyond this date according to the judgment of Dr. (Name) or his/her
delegate, you must continue to comply with the recommended treatment; and
5. That you provide the staff at the (Public Health Department) as well as staff at the (TB clinic/treating
physician鈥檚 office) with complete and up-to-date information regarding your current address and
telephone number at least 72 hours prior to move, and that you continue to update this information
in the event of future changes so long as you are requiring therapy for active pulmonary
tuberculosis (as per (__) above); and
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6. That as long as you are considered to require therapy for active pulmonary tuberculosis (as per
(__) above), you inform staff at the (Public Health Department) as well as staff at the (TB
clinic/treating physician鈥檚 office) of any and all plans to travel outside the City of (Name of City), at
least 72 hours prior to departure, that would prevent your receipt of antituberculous therapy
according to section (__) above, and to develop a plan, acceptable to public health, for treatment
while away, including providing said staff with a means of contacting you while you are outside of
the City; and
7. Isolate yourself at home, do not go to work, do not have visitors come to your home until you are
advised by (Public Health Department staff or attending physician Dr. .. or delegate), that your
pulmonary tuberculosis no longer poses a risk to others; and
8. Do not leave (West Park Healthcare Centre or other treatment facility) to which you may be
transferred until you are advised by (Public Health Department staff or attending physician Dr. ..)
that your multi-drug resistant pulmonary TB or pulmonary TB no longer poses a risk to others.
THE REASONS FOR THIS ORDER ARE THAT:
1. Based on medical examinations and laboratory evidence, including that outlined below, you have a
communicable and virulent disease, namely active pulmonary tuberculosis:
鈥? Many/Moderate/Few AFB (acid fast bacilli) in a sputum sample obtained from you on
(Date), and laboratory results received (Date) that report the presence of MTBC Complex;
sensitive to all first line drugs or resistant to (Name of Drugs) .
鈥? An initial chest x-ray on (Date) showed bilateral pulmonary infiltrates, one infiltrate
occupied the (Location). There was evidence of cavitation within the infiltrate. There was
also an additional infiltrate within the midzone of the left lobe.
鈥? Medical assessments completed by (TB clinic/ Physician/Infectious Disease Services) at
the (Name of Facility) resulting in a diagnosis of active pulmonary tuberculosis (date) and
consequent isolation and treatment with a full-regimen of anti-tuberculosis medication from
(Date) to (Date) while in hospital.
2. Since your diagnosis, I have received reports pursuant to the Health Protection and Promotion Act
indicating that:
(a) A repeat chest x-ray taken on (Date) showed bilateral pulmonary infiltrates with two ill-
defined cavities in the right upper lobe. The upper cavity measures 4 cm in greatest
dimension and the lower one 5 cm in diameter. As per the radiology report, all the changes
represent active tuberculosis with bronchogenic spread.
(b) Upon follow-up by the public health nurse (PHN) managing your case, the importance and
necessity of your full compliance with medical follow-up and appropriate antituberculous drug
therapy was explained to you. You failed to comply with D.O.T. as noted by the following:
Your failure to attend DOT (Directly Observed Therapy) appointments at
(Location) on (Provide Dates).
(c) On (Date/s), you could not be reached at your address by telephone or in person.
(d) On (Date), you were advised by (Physician鈥檚 name) of your diagnosis of tuberculosis, started
on TB medication and informed to isolate yourself at home until you were deemed no longer
infectious.
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(e) On (Date/s) health department TB staff was informed that you had gone to work even though
you were informed that you were infectious and therefore posed a risk to others.
3. The nature of your disease requires that you be treated for a prolonged duration with multiple drugs
to which the infecting organism is susceptible. The required duration of therapy for your disease
has been estimated by Dr. (Name), a physician expert in the treatment of tuberculosis, to be
approximately 鈥︹??.months. Premature interruption of therapy, as represented by your failure to
attend DOT appointments at the Health Department, poses the following risks to persons in the
health unit that I serve:
(a) Because your active pulmonary tuberculosis is not completely treated, it is considered possible
that your disease will reactivate, and that you will become infectious to those around you. The
likelihood that you pose a risk to those around you increases as your time without medical
therapy increases; and
(b) Because of your failure to arrive at the Health Department for scheduled DOT appointments
and the possibility that on those days you are not taking your TB medication, it is possible that
infection transmitted by you would be resistant to the antituberculous agents that you have
been receiving namely Isoniazid and Rifampin, two of the most powerful medications in the
control of tuberculosis.
THIS MEDICAL OFFICER OF HEALTH is of the opinion, on reasonable and probable
grounds:
1. That a communicable disease exists, or may exist, or that there is an immediate risk of an
outbreak of a communicable disease in the health unit served by me; and
2. That the communicable disease presents a risk to the health of persons in the health unit
served by me; and
3. That the requirements specified in this order are necessary in order to decrease or eliminate
the risk of transmission of this communicable disease from you to others.
NOTICE
TAKE NOTICE THAT you are entitled to a hearing by the Health Services Appeal and Review Board if you
deliver to me and to the Health Services Appeal and Review Board, 151 Bloor Street West, 9th Floor,
Toronto, Ontario, M5S 2T5, notice in writing, requesting a hearing within 15 days after a copy of this Order is
served on you.
AND TAKE FURTHER NOTICE THAT although a hearing may be requested, this Order takes effect when it
is served upon you.
FAILURE to comply with this Order is an offence under the Health Protection and Promotion Act
R.S.O. 1990, for which you may be liable, on conviction, to a fine of not more than $5,000.00 for every
day or part day on which the offence occurs or continues to occur.
__________________________________
Name and Designation of Medical Officer or Health or Delegate
Medical Officer of Health
Name of Public Health Department
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Address of Public Health Department
OFFICE USE ONLY:
Served upon: ________________________________________________________________
Time: _________________ On: __________________________________________
Hand delivered by: ____________________________________________________________
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13.1 Introduction
13. West Park Healthcare Centre (WPHC)
13.1 Introduction
Toronto鈥檚 West Park Healthcare Centre Tuberculosis Service is the only provincially-
designated inpatient treatment facility for complex TB patients. It is also the only
healthcare facility in Ontario that is able to detain persons with TB that are held
under S. 35 orders under the HPPA.
The types of patients that are usually seen at WPHC would include persons who:
Have a multi-drug resistant form of TB (MDR TB);
Are co-infected with TB and HIV or other complex medical conditions;
Have experienced side effects from TB medication and are unable to take
regular first-line TB drugs;
Are not responding to treatment;
Have had a Section 35 order served to them under the Health Protection and
Promotion Act (HPPA) to be confined to hospital under guard; and/or
Live in congregate settings or who are under-housed (i.e. homeless persons).
West Park Healthcare Centre is located at:
82 Buttonwood Avenue,
Toronto, M6M 2J4
Telephone Number: (416) 243-3600
Fax Number: (416) 243-8947
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13.2 WPHC Admission Policy
13.2 West Park Healthcare Centre鈥檚 Admission Policy
13.2.1 For Patients Not Under S.35 Orders
(a) Inpatient
WPHC should have the most up to date and accurate information possible about
persons being considered for admission to their facility. The admission form for
WPHC is available at www.westpark.org. On the left side of the page click on
鈥淧atient Services鈥? and then click on 鈥淎dmission Forms鈥?. The TB inpatient referral
form is located at the bottom of Page 4 on the web site and is also available in
Appendix A at the end of this chapter. You may also contact WPHC for admission
forms. Once the forms are completed, fax them to WPHC at (416) 243-8947 prior
to the patient being admitted.
(b) Outpatient
For outpatient referrals, a physician or public health nurse letter with pertinent
information should be faxed to WPH鈥檚 Care Coordinator or their nurse practitioner at
416-243-8947.
13.2.1 West Park Healthcare Centre鈥檚 Admission Policy For Persons
Admitted Under a S.35 Order
It is important that WPHC be notified in advance that a TB patient is being
considered for a S.35 order under the HPPA to be detained and treated at the
healthcare centre.
The following admission policy ensures that the necessary planning and
communication have taken place in order that WPHC can arrange the care and
services for TB patients detained there.
1. The Medical Officer of Health (MOH) of the jurisdiction applying for a S.35 order
contacts the WPHC TB Service Physician in Charge or delegate and advises of
the pending order.
2. The WPHC TB Service Physician in Charge or delegate provides the MOH with
the contact information of the TB Service Care Coordinator at WPHC who acts as
the single designated contact person for all persons being admitted under a S.35
order.
3. The referring MOH will arrange a teleconference to alert the TB Control Unit of
the MOHLTC, Toronto Public Health, the physician currently treating the patient
and the TB Service Physician in Charge of the impending admission.
4. A formal intake process is initiated. The referring health unit is advised of the
information and documentation required by WPHC to assess whether the TB
service is the most appropriate facility to detain and treat the patient at the current
time.
5. The information/documentation required to organize a plan of care includes:
History of facts leading to the issuing of the S.35 order
History of previous TB
Patient demographic information (i.e., gender, age)
Patient鈥檚 first language
If the patient is apprehended and is found intoxicated, injured, or in an
acute psychiatric state, then assessment at an acute care
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facility/emergency room will be necessary to determine the patient鈥檚
medical stability and immediate need for treatment (injuries, withdrawal
prevention). Copies of any relevant information from this assessment
must be forwarded to WPHC.
Patient鈥檚 housing status/homelessness, current living arrangements,
presence of children or elderly persons in the household
Information on any pre-existing conditions or known history of:
(a) Mental illness
(b) Cognitive impairment
(c) Substance abuse and current management
(d) Violent or criminal behaviour.
(e) Previous incarceration
Current mental status and evaluation of any current psychiatric
symptoms
Forensic psychiatric assessment, if indicated
Patient鈥檚 willingness to undergo TB assessment and to take TB
medications as prescribed by the WPHC TB Service Physician
Potential for discharge barriers (e.g. homelessness, financial problems)
The Care Coordinator receives this information and/or documentation and
forwards this to WPHC鈥檚 TB physician.
6. The WPHC physician:
reviews this information,
determines if the patient being served with the S.35 order can be cared
for at WPHC, and
advises the MOH accordingly.
If it is determined that the psychiatric status of the patient cannot be managed
appropriately at WPHC, the physician at WPHC will discuss this with the referring
MOH so alternative plans can be made.
7. Once the patient is accepted for admission, WPHC is listed as the detaining
facility in the S.35 order. The physician at WPHC and the public health unit
arrange for the actual admission. A copy of the S.35 order will be faxed then
mailed to West Park.
13.2.3 Role of Toronto Public Health (TPH) and WPHC with regard to
S.35 Patients
All patients at WPHC who are under a S.35 order become the responsibility
of Toronto Public Health (TPH) as the hospital is within TPH鈥檚 jurisdiction.
Therefore, if a patient being detained under a S.35 order leaves hospital
property without permission, WPHC must notify TPH. TPH will then attempt
to locate the patient.
If located, the patient will be isolated and returned to the hospital. If unable to
locate the patient TPH will notify both the health unit who initiated the S.35
order and the Ministry of Health.
TPH also becomes the health unit responsible for applying for an extension of
the order or the rescinding of the order.
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Therefore it is essential that TPH be informed and aware of all S.35 order persons
being detained at WPH as soon as admission is being considered (see: Admission
Policies above). TPH will review S.35 orders that are nearing expiry and arrange
extensions of the orders if necessary (in consultation with the originating health unit).
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13.3 Discharge Planning for all Patients from
WPHC
13.3 Discharge Planning for All Patients from WPHC
Discharge planning must begin as soon as a person is admitted to WPHC. Most
persons are admitted due to complex medical and/or social problems that render TB
treatment more difficult. Discussions with WPHC and the health unit where the
patient is going to live after discharge should begin when the patient is
admitted so that there is ample time to arrange for the patient鈥檚 care once in the
community again. The care of complex TB patients can sometimes take a year or
more AFTER discharge, so it is important that planning start early to ensure that the
person鈥檚 treatment after discharge is not interrupted.
Because such care is often complex, it is essential that the MOH of the jurisdiction in
which the person is going to reside is:
Involved with the discharge planning, and
Agrees to provide the necessary treatment in its jurisdiction.
The patient should not be discharged from WPHC until the accepting health
unit is able to make the necessary arrangements for medical follow-up, DOT,
housing, etc.
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13.4 Appendix 13-A: Letter Page: 11-1
13.4 APPENDIX A: Letter
West Park Healthcare Centre
TB Service
Inpatient Referral Form
Addressograph:
Name of Referring Physician:
____________________________________________________
Unit Patient Coming From: ________________________ Unit Tel. #: __________________
Diagnoses:
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
Reason for Transfer: (Check all that apply)
Infectious and living with at risk individuals
Advanced Disease
Drug Resistance
Drug Toxicities
Co-morbidities
Other:________________________________
Level of Nursing Care Required:
(Check all that apply)
Independent
Ambulatory. Some assistance needed with ADLs
Non-Ambulatory. Assistance needed with ADLs
Bedridden. Full care required
Behavioural Challenges
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Medications
Date of Last Time of Last
Name Dose Date Started
Dose Dose
Drug Allergies: ____________________________________________________________
First Language: ____________________________________________________________
Patient鈥檚 English: None__ Some__ Fluent__
Interpreter Required? Yes__ No__
Please complete this form and attach the following documents.
Admission History
Course in Hospital
Copy of MAR
Copies of consultants鈥? reports
Chest x-ray/CT scan reports
Most Recent Blood Work
HIV Test Submitted? Yes__ No__ If yes, date: _________________________
Result: Neg__ Pos__ Pending__
Sputum AFB submitted? Yes__ No__
If yes, date: ____________________ PHL #(s): ______________
Treatments: (Check all that apply)
O2 @_____L/minute
IV/Saline lock. Date inserted: _______________________
G-Tube. Date Inserted: ________________________
Formula and Rate: ____________________________________
Special Diet: _________________________________________
Wound Care: _________________________________________
Blood Sugar Monitoring: ______X per ________
Is patient booked for any external appointments in the next 8 weeks?
Date: ____________________ Location: ____________________________________
Reason:
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
Other Information:
_____________________________________________________________________
_____________________________________________________________________
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____________________________________________________________________
Signature: ____________________________________________________________
Date: ____________________________ Tel: ________________________________
Fax Referral and required documents to:
The Care Coordinator or Nurse Practitioner, at:
(416) 243-8947
Patients will not be accepted for transfer
until referral and required documents are received.
West Park does not accept admissions after 2:00p.m. (14:00h),
Monday to Friday (excluding statutory holidays).
Please make ambulance bookings accordingly.
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14. The Quarantining of Persons with Tuberculosis Under the
Federal Quarantine Act
14.1 Legislative Background
The Federal Quarantine Act of 1872 is the federal legislation that is designed to prevent
the introduction of infectious or contagious diseases into Canada. Under the Quarantine
Act, persons arriving in Canada from outside of the country who are suspected of
having a disease that could constitute a danger to Canadian public health can be sent for
a medical assessment or they can be detained.
For more information with regard to the sections of the Quarantine Act that impact on
Tuberculosis management, please see Chapter 1, SS 3.1: Federal Legislation.
14.1.1 Pending Revisions to Federal Legislation: Bill C-12
Bill C-12, the new federal Quarantine Act, received royal assent on May 12, 2005. The
intent of this federal public health legislation is to prevent the introduction and spread of a
communicable disease in persons arriving in or departing from Canada. This new law
will provide the Public Health Agency of Canada (PHAC) with new authorities and
modern tools to respond to public health risks.
BILL C-12 WILL NOT COME INTO FORCE
UNTIL NEW QUARANTINE REGULATIONS HAVE BEEN DRAFTED AND APPROVED.
PHAC anticipates that this legislative process will be completed late fall, 2006.
14.1.1 鈥淚nfectious or Contagious鈥? versus 鈥淒angerous鈥? Diseases
A person may be detained under the Quarantine Act, if he/she has any of the five
diseases that are deemed to be infectious or contagious. Each of these diseases has
a known incubation period. They are as follows:
Table 1: Diseases Deemed to be Infectious or Contagious
Under the Quarantine Act
Disease
Cholera
Plague
Smallpox
Yellow Fever
SARS
If a person has a disease that is considered infectious or contagious under the
Quarantine Act, he/she can be prevented from entering or leaving Canada.
A dangerous disease is any disease that the federal Quarantine Officer suspects may
pose a risk to public health. TB is considered under the Quarantine Act to be a
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dangerous disease. If a person has a dangerous disease (i.e., TB), then he/she can
only be prevented from entering the country. The person cannot be legally
prohibited from leaving Canada.
Under the federal Quarantine Act in Canada,
tuberculosis (TB) is considered to be a dangerous disease.
It is NOT deemed to be infectious or contagious.
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14.2 Management of Persons with Infectious
TB Leaving or Entering Canada
14.2 Management of Persons with Infectious TB Leaving or Entering
Canada
14.2.1 Person with suspected or diagnosed TB leaving Canada while still
infectious
If the local public health unit is aware that a person with infectious pulmonary TB is
planning on leaving the country, the health unit should educate the person and try to
persuade him/her to change the travel plans until he/she is no longer infectious.
However, if these attempts fail, then the person may continue to plan to travel while still
infectious.
There is no jurisdiction under the federal Quarantine Act to prevent a person with
infectious pulmonary TB from leaving the country. The local public health unit can
use Section 22 and 35 orders under the Health Protection and Promotion Act (HPPA)
(See Chapter 12 Use of Orders) to prevent the person from leaving.
A S.22 order should be prepared and served to the person immediately. The
order should clearly specify that the person has infectious TB and is considered
to be a public health risk and that the person should not be traveling by public
conveyance.
If the person declares intent to travel despite the S. 22 order, the health unit can
ask a judge for a S.35 order under the HPPA, as the person is deemed to be a
flight risk and a public health risk.
The Tuberculosis Control Unit of the Ministry of Health and Long-Term Care (MOHLTC)
should be notified as soon as the health unit considers writing a S.22 order. A
teleconference will be arranged by the MOHLTC which will include representatives from
the following:
The local public health unit
The MOHLTC
Peel Regional Health Department
(Note: Peel is the jurisdiction in which Pearson Airport is located.)
Toronto Public Health Department if the person requires hospitalization or is to
be detained under a S. 35 order.
(Note: Toronto is the jurisdiction in which both William Osler Hospital, where
persons requiring isolation are taken from Pearson Airport, and West Park
Hospital are located.)
Quarantine Station at Pearson Airport or border crossing point that person is
expected to use
As each situation is unique, the teleconference allows all concerned parties to be aware
of the specific details of the situation and to formulate a plan of action.
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14.2 Management of Persons with Infectious
TB Leaving or Entering Canada
If a S.35 order is issued, then the following procedure is used:
1. A copy of the S.35 order is sent to Peel Regional Health Department.
2. Peel Regional Health Department then notifies Peel Regional Police (who also
need a copy of the order). This will depend on the unique circumstances in each
situation. The procedure of 鈥榳ho does what 鈥? is decided upon during the
teleconference.
3. The Quarantine Medical Officer at Pearson can email conveyance operator desk
agents to be on the lookout for 鈥淧erson 'X' - for communicable disease
reasons" and indicate that this person should not be allowed to leave the
country or board the plane. Although the Quarantine Act may not prevent a
person leaving Canada with TB, individual airlines may decide not to allow a
person with infectious TB to board the plane. Under International Health
Regulations, an air carrier should not board a traveler known to be ill with an
infectious communicable disease. This action is at the discretion of the airline.
Note: although the Quarantine Act cannot prevent a person with infectious TB
from leaving the country, a S. 35 order under the HPPA can. The Quarantine
Division (NHQ Ottawa) can work with the air carrier industry networks for wider
notification if required.
4. If the person is apprehended at Pearson airport, Peel Regional Police or EMS
with the support of a Peace Officer would be instructed to bring the person to
either William Osler or West Park Healthcare Centre, depending on the situation
or when the detention takes place.
14.2.2 Person with suspected or diagnosed TB attempting to enter Canada
while still infectious
Persons with infectious TB can detained at a Canadian port of entry under the
Quarantine Act. If a traveler is identified as having a communicable disease, or is
displaying symptoms of a communicable disease by a public health authority, then the
traveler will be assessed at the port of entry by the Quarantine Service and referred for
medical examination and treatment.
If the Quarantine Service has been notified and has knowledge of a traveler, ill with a
communicable disease wanting to return to Canada, they will work with Foreign Affairs
Canada, PHAC, international public health partners and air carriers to ensure the
individual has appropriate treatment before traveling on a commercial aircraft.
Outside Canada
PHAC (Quarantine Divison/NHQ) will notify the affected airlines that a person who may
pose a public health risk is planning on traveling to Canada. Under International Health
Regulations, an air carrier should not board a traveler known to be ill with an infectious
communicable disease. This action is at the discretion of the airline, The person may be
required to provide documentation that he/she is not infectious (proof that at least two
smear negative sputum specimens have been obtained). The Quarantine Division may
post an alert in the Border Advance Passenger Notification system through the Canadian
Border Agency National Risk Assessment Center- see Algorithm 1.
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14.2 Management of Persons with Infectious
TB Leaving or Entering Canada
Arrival at an airport or border crossing in Canada
Algorithm 2 summarizes the steps that can be taken when a person with known or
suspected infectious TB attempts to enter Canada at a Canadian airport or border
crossing. As stated above, the best course of action is for the parties involved to have an
initial planning teleconference.
If advance notification information is available, the Public Health Agency of Canada
(PHAC) will alert the MOHLTC that a person with suspected TB is on an aircraft. The
MOHLTC will contact all the jurisdictions involved. The teleconference is important for all
jurisdictions involved (i.e., PHAC, MOHLTC, Peel Regional and Toronto Public Health
Departments, and the destination health unit).
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14.2 Management of Persons with Infectious
TB Leaving or Entering Canada
Algorithm 1
Person with infectious TB attempts to enter Canada
MOHLTC notifies PHAC that a person with
infectious disease is planning on traveling to
Canada.
PHAC communicates with airlines and with health
authorities in country where patient currently is residing.
PHAC posts an alert with CBSA.
鈥? Person must produce documentation that they are
not infectious (usually 3 negative smear
specimens or that they have been on an approved
TB treatment regimen for at least 2 weeks).
鈥? PHAC sends a letter to the family of the person (if
address in Canada is known) or to address where
person currently residing outside Canada notifying
them of conditions of entry into Canada
If person is deemed to be infectious
If person deemed to be non infectious
鈥? PHAC will work with
鈥? PHAC notifies MOHLTC who informs
medical personnel, air
health unit
carriers, and public health
鈥? Once person has arrived in Canada, the
to have the traveler treated
health unit arranges for medical follow-up
before returning to Canada.
and appropriate case management
鈥? If the person does manage
to elude officials in their
country of origin they may
be detained by Quarantine
Officials in Canada 鈥? see
Algorithm 2.
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14.2 Management of Persons with Infectious
TB Leaving or Entering Canada
Algorithm 2:
Person at Canadian Border Crossing with Infectious TB
PHAC is notified that
person suspected of
having TB is on
board plane or at
border crossing
Person not detained at airport or
border crossing and arrives home
Local health unit to manage the
Person arrives at Pearson case
Person arrives at other MOHLTC will liaise with PHAC and
border crossing health unit
PHAC will detain and Health unit may have to issue
transport to local hospital orders under HPPA to detain
MOHLTC notifies local person for diagnosis and treatment
health unit
ROLE OF HEALTH CANADA
Detained (by PHAC)
Detains person, transports to
Quarantine Officer will board
hospital and secures under federal
plane and assess person.
Quarantine Act until person is
Person detained at
Quarantine Officer (QO)
deemed to be non infectious until
customs
makes brief announcement
the local public health unit issues
Person is detained,
to the other passengers and
a S. 35 under the HPPA
transported and secured,
gets contact information in
Issues statement to the media as
as in airport procedure.
the event contact tracing is
necessary
needed (2 rows in front and
2 rows behind where TB
ROLE OF THE MOHLTC
suspect sat on the plane)
Communication liaison between
PHAC and local public health units
Transported (by PHAC)
Passenger removed by QO
ROLE OF PUBLIC HEALTH UNITS
to ambulance (prearranged
Toronto or Peel to obtain a S.22 or
to be waiting on tarmac)
S.35 order as necessary under
Person will be brought to
HPPA in order to ensure person is
West Park or William Osler detained and treated as needed
Hospital) Contact investigation as
necessary
Secured (by PHAC) Arrange for AMTD testing of
sputums at William Osler
Passenger will be secured by
Communication between hospital
a peace officer for 48 hrs.
and MOHLTC
under Quarantine Act. Local
Issue statements to media, as
public health unit to start
necessary
proceedings for S. 22 & S.35
orders if infectious.
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14.3 Detention under the Federal Quarantine
Act
14.3 Detention under the Federal Quarantine Act
Depending on the situation, PHAC can detain a person with a dangerous disease
(i.e., TB) under the federal Quarantine Act from 48 hours to indefinitely. If PHAC
suspects a person with infectious TB is traveling on an airplane or is at a border
crossing, they can immediately detain that person for 48 hours until initial test results
are obtained. If a longer period of detention is necessary, PHAC can apply for an
extension, but this can be a lengthy process. Once the person is safely isolated in
hospital, the local public health unit should initiate a S. 22 order (and a S.35 order, if
necessary) after consulting with all levels of authority involved.
14.3.1 Examples of Recent Situations
The algorithm above outlines the responsibility of the various levels of authority.
However, every situation is unique. This is illustrated in the following situations. They
underline the need for communication among all jurisdictions involved to ensure that
the necessary interventions are in place to reduce the risk of exposure of infectious
TB.
(1) MOHLTC notified by PHAC that a person is at Customs at Pearson Airport
with an immigration file that indicates that this individual left Canada three
years earlier with a diagnosis of untreated infectious pulmonary TB.
The MOHLTC verified with the local public health unit that this person had left
Ontario when the initial diagnosis of infectious TB was made. The person was
now willing to seek immediate assessment and treatment for TB in Ontario. The
normal 30-day immigration condition of landing was shortened to one week. The
local public health unit arranged for the immediate medical assessment of this
person.
(2) A person leaves Canada not knowing they have infectious TB.
This person saw their local physician who did preliminary tests for cancer of the
lung. The patient left for a previously arranged vacation in South America. The
next day test results showed that the person had highly infectious pulmonary TB.
The local public health unit was able to contact the patient and inform him/her of
the diagnosis. PHAC was able to locate a TB specialist in the visiting country and
treatment was started immediately. PHAC also arranged for contact tracing on
the aircraft for the trip to South America. After the person was on treatment for 3
weeks, the physician treating the patient provided a letter that indicated the
person could safely return to Canada. The local public health unit arranged for
medical care in their jurisdiction.
(3) A person arrived at Pearson airport with several bottles of TB medication
that had been prescribed in the country of origin.
This person told Customs Agents that he/she had been diagnosed two months
earlier with pulmonary TB and had been provided with enough medication for the
duration of the visit. The person had no obvious symptoms of TB. PHAC notified
the MOHLTC who contacted the health unit where the person was visiting. The
health unit made arrangements for the person to be followed by a local TB
specialist who confirmed that the person was not infectious and the prescribed
medication was appropriate.
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14.3 Detention under the Federal Quarantine
Act
(4) A physician in Russia notified the Canadian Consulate in Russia that a
person visiting as part of a Canadian tour was suspected of having
pulmonary TB. This person became ill during the tour and was brought to the
physician who suspected TB after doing a chest x-ray. The person was advised
not to proceed on the tour but to remain in isolation, be tested for TB and start
treatment at a local hospital. The person declined and left with the tour to return
to Canada. PHAC notified the MOHLTC and the person was removed from the
plane at Pearson and detained in hospital under guard until TB was ruled out.
(5) A landed immigrant from Ontario with active, untreated, infectious drug
resistant TB disease (with cavitary lesion on chest x-ray) left Canada
against the attending physician鈥檚 advice, and against health unit orders.
The MOHLTC notified PHAC. Arrangements were made with the airline that the
person shows proof of freedom from TB before being allowed to board the
aircraft. The Canadian Consulate in the country of visitation notified this
individual of the conditions for returning to Canada. An attempt to return to
Canada without the required documentation was unsuccessful. This person was
able to return to Canada several months later, once the necessary proof of
freedom from infection was produced. This situation required tremendous co-
operation among staff of PHAC, the airlines, the MOHLTC and several local
public health units.
(6) A patient on treatment for drug resistant TB left Ontario to visit a sick
relative in another province 鈥? then returned to their country of origin
A person with drug resistant TB pleaded with their physician to be allowed to visit
a sick relative in another province. The physician provided two weeks worth of
medication to an accompanying family member with instructions on how to
observe the administration of the medication (intermittent doses). The person and
their family member left for their country of origin. After two weeks the local health
unit discovered that the person was not in Canada. They notified the MOHLTC
who notified PHAC. PHAC was able to determine which airline the person left
Canada on and the expected date of departure to Canada and issued an alert
that this person was not allowed to enter Canada without documentation that they
were free of infectious TB. A letter was sent by PHAC to the person鈥檚 address in
Ontario with this information. The relatives in Ontario called the health unit with
information where the patient was staying. PHAC provided the family with the
name and location of a local physician who would provide TB care. PHAC and
the MOHLTC held regular discussions about this situation and monitored the
situation closely. Once documentation was provided that stated the person was
on adequate treatment and was not infectious, the person was allowed to return
to Canada.
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15.1 Introduction
15. First Nations and Inuit Health Branch (FNIHB) Tuberculosis
Control in Ontario Region
Multi 鈥? Jurisdictional Partnerships in Tuberculosis Control
15.1 Introduction
Although health care is a provincial responsibility, First Nations and Inuit Health Branch
(FNIHB) of Health Canada is responsible to ensure that the mandatory programs of
Communicable Disease Control, Environmental Health and Emergency Response are in
place for health protection in First Nations鈥? communities.
Across Canada, there are seven regions in FNIHB of Health Canada. The province of
Ontario, known federally as Ontario Region, is comprised of 134 First Nations
communities (population approximately 80,000) and divided into four Zones:
(1) Southern Ontario Zone,
(2) Thunder Bay Zone,
(3) Moose Factory Zone, and
(4) Sioux Lookout Zone.
Each Zone has unique characteristics and challenges regarding geography, demography,
health status, and access to services. Each First Nations community receives nursing
services by Community Health Nurses (CHN) who are either employed by FNIHB or
Band employed by a First Nations community.
For further details as to the Ontario FNIHB regional TB Control program, please contact
the FNIHB regional office at (613) 954-8574.
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15.2 Epidemiology of TB in Ontario First
Nation Communities
15.2 Epidemiology of TB in Ontario First Nation Communities
First Nations TB rates remain 8 to 10 times higher than overall Canadian rates and 20-30
times higher than Canadian-born, non-Aboriginal rates. Despite this, 2000 national TB
case tally of 86 is the lowest ever reported in the First Nations, on-reserve population.
The notification rate in 1999 was very high, due to the occurrence of several large
outbreaks. Of the areas where Health Canada鈥檚 First Nations and Inuit Health Branch
(FNIHB) provides TB programs, TB rates are highest in the four western provinces
(British Columbia, Alberta, Saskatoon and Manitoba) and in northwestern Ontario (the
communities of the Sioux Lookout zone). 199
199
FNIHB web page; www.hc-sc.gc.ca; First Nations and Inuit Health; Diseases and Health Conditions;
Topics TB.
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15.3 Legal Issues
15.3 Legal Issues
Public health information must often be shared between the province and the federal
government. General authority is found in the (Federal) Privacy Act, under section 8. For
routine matters, consent (whether verbal, written or implied) is usually required.
However, section 8 does provide for situations in which consent is not necessary for
example, sharing information about a TB client who lives on a First Nations reserve.
Subsection 8 (a):
鈥? Permits disclosure 鈥渇or the purpose for which the information was obtained or
compiled by the institution or for a use consistent with that purpose鈥?.
Subsection 8 (b):
鈥? Permits 鈥渇or any purpose in accordance with any Act of Parliament or any
regulation made there under that authorizes its disclosure鈥?.
Subsection 8 (m):
鈥? Allows disclosure, where 鈥渋n the opinion of the head of the institution, the public
interest in disclosure clearly outweighs any invasion of privacy that could result
from the disclosure or disclosure would clearly benefit the individual to whom the
information relates鈥?.
This authority is reinforced by Ontario鈥檚 Personal Health Information Protection Act, 1990
further to section 38 which details how personal health information may be disclosed and
shared by health information custodians. For example, if it is not reasonably possible to
obtain the individual鈥檚 consent in a timely manner, this information may be disclosed if it
is necessary for the provision of health care to a patient living on a reserve and being
cared for by the community nurse, provided the individual has NOT expressly instructed
the custodian not to make the disclosure.
In practical terms, this legislation allows disclosure of a client鈥檚 personal medical
information between FNIHB community health staff and their provincial counterparts,
under communicable diseases regulations or on a need-to-know basis for disease
control.
When dealing with a challenging case, the CHN and/or attending physician, working in
consultation with the TB Control Nurse and the Regional Community Medical Specialist
(RCMS) may request the support from the community Chief and Council, elder or family
member to influence the individual to cooperate. When all possibilities to encourage
cooperation have failed, the Medical Officer of Health (MOH) for each health unit has the
authority, in collaboration with the Zone Medical Officer (ZMO) /RCMS, to invoke the
Health Protection and Promotion Act (HPPA) (section 22 first, followed by section 35).
This provincial legislation provides the legal basis for controlling communicable diseases,
including TB. 200 The MOH signs and enforces Orders under the HPPA on the reserve.
200
Dr. Roger Johnson, RCMS, Memorandum, The Legality of Sharing Public Health Information Between Federal and
Provincial Jurisdictions, April 7, 1997.
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15.4 TB Medication
15.4 TB Medication
TB medication is available free of charge to people diagnosed with either active TB or
LTBI. The medication can be obtained through the local health unit, or in the case of
remote isolated communities, through local pharmacies at no charge.
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15.5 Communication between Local Health
Unit and FNIHB / Community Health Nurses
15.5 Communication between Local Health Unit and FNIHB / Community
Health Nurses
Communication between the respective federal and provincial partners is essential to
ensure the appropriate and complete follow up of active TB cases or LTBI. Many First
Nations people who are diagnosed with either active TB or LTBI live both on and off-
reserve during their course of treatment and, as such, can easily be lost to follow up.
This applies to a non-First Nations individual living on-reserve, e.g., teachers or nurses.
Therefore, communication between FNIHB and TB Control staff of the local public health
unit is critical.
The follow up of TB cases and LTBI are the same both on and off reserve. FNIHB does
not collect TB case and contact information through the provincial iPHIS data base. As
such, exchange of information can only occur through verbal or written reports.
All individuals living on-reserve and assessed on-reserve as being TST positive (LTBI)
and all probable/suspected and confirmed cases of active pulmonary and extra-
pulmonary tuberculosis are to be reported to the respective health unit by the Zone TB
Control Nurse as soon as possible.
All individuals living on-reserve and assessed off-reserve as being TST positive (LTBI)
and all probable/suspected and confirmed cases of active pulmonary and extra-
pulmonary tuberculosis are to be reported by the health unit to the respective Zone TB
Control Nurse, who will forward the information to the respective Community Health
Nurse.
All infectious cases of active disease living off-reserve but known to have resided for a
period of time on-reserve are to be reported to the respective Zone TB Control Nurse.
The mechanism used for reporting is by telephone (especially for active cases)
followed by a faxed laboratory report and /or radiological report.
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15.5 Communication between Local Health
Unit and FNIHB / Community Health Nurses
Zones and Public Health Units in Ontario with Regional Ontario Contacts
* Indicates health unit has a First Nation Community within its jurisdictional boundaries
Zones Public Health Units
Moose Factory Zone Porcupine*
Zone TB Nurse : (705) 658-4544 Ext. 2313
Thunder Bay Zone Algoma *
Zone TB Nurse: (807) 343-5353 North Bay-Parry Sound*
Northwestern *
Porcupine *
Sudbury District *
Thunder Bay District *
Timiskaming *
Sioux Lookout Zone Northwestern *
Zone TB Nurse: (807) 737-1802 Thunder Bay District *
Southern Ontario Zone Brant *
Zone TB Nurse: (519) 751-6526 Durham *
Grey Bruce*
Eastern *
Elgin - St. Thomas*
Haldimand-Norfolk*
Haliburton, Kawartha, Pine Ridge *
Halton
Hamilton-Wentworth
Hastings and Prince Edward *
Huron Perth
Chatham-Kent*
Kingston, Frontenac, Lennox & Addington
Lambton *
Leeds, Grenville, Lanark
Middlesex-London*
Niagara
North Bay-Parry Sound*
Ottawa
Oxford
Peel
Peterborough*
Renfrew*
Simcoe-Muskoka*
Toronto
Waterloo
Wellington-Dufferin-Guelph
Windsor-Essex
York *
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15.6 Bacille-Calmette-Gu茅rin Vaccine (BCG)
15.6 Bacille Calmette-Gu茅rin Vaccine (BCG)
BCG vaccination of newborns has been discontinued in most of Ontario鈥檚 on-reserve
population. The National Advisory Committee on Immunization (NACI) provided new
recommendations in December of 2004 to continue the use of BCG only in specific
circumstances. At the present time, First Nations communities in Ontario are looking to
move towards the discontinuation of this routine vaccination where appropriate in support
of these new recommendations. BCG vaccine is presently being used only in northern
Ontario First Nations communities.
Issued: 2006
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INDEX
A F
First Line TB Drugs ............................................... 148
Acid-Fast Bacilli (AFBs)....15, 39, 59, 64, 65, 66, 71,
First Nations and Innuit Health Branch (FNIHB)
72, 73, 90, 91, 101, 102, 104, 115, 122, 125, 137,
...........................................155, 289, 290, 291, 293
146, 147, 172, 268, 277
Advocacy ................................................................. 80
H
Air Cleaning..............................................................86
Ambulance Act O. Reg. 257/100 Amended to
Health Care Facilities..36, 41, 82, 83, 84, 85, 91, 93,
O. Reg.317/04...................................................27
111
Animals for Research Act (Reg.24) .................27
Health Care Workers.. 40, 41, 77, 79, 82, 89, 90, 92,
101, 135, 168
B Health Insurance Act R.R.O. 1990 Reg. 552.. 29
Health Protection and Promotion Act 1990
Bacille Calmette-Guerin (BCG)8, 15, 39, 44, 46, 51,
(HPPA). 15, 18, 20, 22, 24, 29, 105, 123, 208, 209,
57, 61, 71, 89, 94, 95, 96, 110, 122, 136, 295
258, 260, 261, 262, 263, 264, 265, 271, 272, 281,
282, 291
C Health Protection and Promotion Act R.S.O.
1990, Chapter H.7 ........................................... 29
CDC ......................................... 77, 101, 141, 155, 162
Homeless 40, 42, 51, 77, 80, 106, 108, 110, 111, 121,
Cemeteries Act (Revised) R.S.O. 1990, c.C.4 27
164, 167, 172, 204, 215, 217, 224, 271
Charitable Institutions Act R.R.O. 1990 Reg.
Homes for the Aged and Rest Homes Act
69 s. 11,18 .........................................................28
R.R.O. 1990 Reg. 637..................................... 30
Chemoprophylaxis .... 11, 13, 14, 121, 127, 133, 148,
180, 181, 182, 184
I
Child and Family Services Act R.R.O. Reg.70
.............................................................................29
Child(ren).... 22, 29, 40, 43, 59, 64, 65, 69, 77, 91, 94, IMMIGRATION AND REFUGEE PROTECTION
ACT .................................................................... 26
95, 100, 102, 103, 107, 112, 116, 119, 120, 121,
Immigration Medical Examination (IME)... 174, 175
126, 132, 133, 139, 140, 141, 142, 143, 152, 154,
Infection Control 82, 83, 84, 90, 92, 93, 101, 106, 111,
163, 164, 167, 168, 172, 259, 273
123, 265
Citizenship and Immigration Canada (CIC)...174, 175,
176, 178, 181, 182, 183, 185, 188, 190 Interferon-纬 Assays .................................................. 61
Contact Investigation ...... 10, 42, 100, 106, 107, 112, iPHIS15, 22, 23, 24, 79, 105, 107, 118, 122, 158, 178,
113, 115, 118, 119, 120, 121, 122, 124, 128, 134 180, 181, 182, 183, 184, 185, 194, 218, 223, 224,
Contact Management ..... 22, 40, 112, 123, 124, 127, 225, 232, 233, 234, 237, 238, 293
128
L
D
Laboratory and Specimen Collection Centre
Directly-Observed Therapy (DOT).. 12, 20, 92, 102, Licensing Act R.R.O. Reg. 682.................... 31
103, 104, 105, 106, 107, 139, 146, 147, 151, 155, Laboratory Testing ................................................ 71
164, 165, 166, 172, 173, 259, 268, 269, 275 Latent Tuberculous Infection (LTBI) ..................... 133
Drug Resistant TB...9, 59, 92, 94, 98, 103, 104, 115, Liver Function Test (LFT) ....................101, 134, 138
145, 146, 151, 155, 156, 157, 163, 164, 165, 287 Livestock and Livestock Products R.R.O. Reg.
726...................................................................... 31
E
M
Early Diagnosis and Treatment........... 81, 94, 205, 208
Elispot ......................................................................61 M. africanum ..................................................... 8, 15
Evidence. 9, 15, 17, 34, 44, 77, 80, 86, 102, 114, 121, M. bovis........................................................ 8, 15, 44
125, 133, 139, 142, 163, 260, 261, 268 M. bovis BCG.......................................................... 8
M. bovis subsp. bovis .......................................... 8
M. bovis subsp. caprae ........................................ 8
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R
M. canetti..................................................................8
M. tuberculosis ......................8, See M. tuberculosis
Mandatory Programs and Services Guidelines ...10, 12 Radiology ................................................. 62, 222, 241
Mantoux..... 18, 34, 38, 44, 46, 47, 109, 110, 123, 127, Respiratory Protection...................83, 84, 88, 101, 109
128 Respiratory TB ..............................8, 16, 59, 101, 107
Mental Health Hospitals Act ..............................32
Milk Act R.R.O. Reg.761......................................32
S
Ministry of Health Act .........................................32
Ministry of Health and Long Term Care......13, 22, 26, Screening13, 37, 38, 39, 41, 42, 43, 45, 56, 57, 61, 70,
105, 106, 107, 126, 148, 170, 172, 174, 176, 178, 77, 79, 81, 82, 83, 84, 89, 90, 92, 103, 110, 134,
181, 182, 183, 184, 185, 190, 209, 216, 233, 234, 174
263, 264, 265, 272, 281, 283, 286, 287 Screening Programs ..............13, 38, 39, 43, 89, 134
MTBC..59, See Mycobacerium tuberculosis complex, Second Line TB Drugs........................................... 158
See Mycobacterium tuberculosis complex Section 22 Orders....................258, 259, 260, 261, 262
Multi-Drug Resistant Tuberculosis (MDR) .....9, 98, Section 35 Order...................105, 262, 263, 264, 265
102, 120, 125, 155, 156, 163, 165, 172, 271 Special Access Program (SAP)........... 61, 140, 160
Mycobacterium tuberculosis complex 8, 15, 61, Sputum .... 8, 15, 37, 38, 39, 52, 64, 65, 68, 69, 72, 90,
65, 66, 67, 71, 72, 73, 74, 75, 118, 125, 268 91, 102, 104, 113, 115, 116, 119, 121, 125, 127,
128, 137, 147, 152, 156, 164, 180, 222, 241, 268,
N 277, 283
Surveillance.... 9, 12, 15, 20, 22, 26, 28, 30, 32, 33, 35,
Non-Compliance......14, 79, 103, 104, 115, 121, 136, 37, 41, 77, 79, 82, 84, 95, 174, 175, 176, 177, 179,
261 180, 181, 182, 183, 184, 190, 206, 208, 215, 225
Non-pulmonary TB ....................................37, 38, 68
Non-Respiratory TB .......................................107, 115
T
Nursing Homes Act .............................................33
TB Episode............................................................... 17
O TB Risk.... 10, 42, 59, 80, 83, 84, 92, 94, 95, 108, 214
Transmission Factors...............101, 115, 116, 120, 126
Outreach................................................................... 80 Tuberculin Preparation............................45, 48, 49, 50
Tuberculin Skin Testing ...15, 37, 38, 39, 41, 42, 43,
P 44, 45, 47, 57, 59, 61, 76, 95, 109, 132, 133
Tuberculin Skin Testing (TST) .....38, 42, 44, 45, 46,
Personal Health Information Protection Act 47, 50, 51, 52, 55, 57, 61, 62, 76, 77, 78, 89, 90,
2004 ....................................................................33 92, 94, 109, 110, 119, 120, 127, 133, 135, 136,
Pregnancy .... 44, 46, 77, 95, 100, 136, 138, 140, 141, 141, 142, 293
142, 143, 153, 156, 159, 163 Tuberculin Testing ................................44, 45, 89, 90
Prevention/Health Promotion.............................79, 80 Tuberculosis Diagnostic and Treatment Services
Preventive Treatment .. 133, 135, 136, 137, 141, 142 for Uninsured Persons Program (TB .. 148, 182,
205, 206, 207, 208, 209, 210, 211, 212, 213, 214,
Private Hospitals Act...........................................34
Public Health Unit.... 23, 26, 42, 83, 92, 93, 101, 109, 215, 216, 217, 218, 219, 221, 222, 223, 224, 225,
110, 111, 134, 148, 158, 161, 162, 174, 175, 183, 227, 228, 231, 232, 233, 234, 235, 237, 238, 239,
240, 241, 246, 264, 273, 281, 286, 287, 293, 294 240, 241, 242, 244, 246, 247, 248
Two-Step TST.......................................................... 51
Public Hospitals Act............................................35
Pulmonary Disease............................ 9, 62, 102, 190
U
Q
Ultraviolet Germicidal Irradiation (UVGI) . 84, 85, 86,
QuantiFERON庐.............................. 38, 61, 62, 76, 78 109
Quarantine.............. 26, 162, 279, 280, 281, 282, 286 Use of Orders under HPPA.................105, 258, 281
st
QUARANTINE ACT R.S., c. 33(1 Supp.), s.1.
.............................................................................26
V
Vaccines ..........................................46, 94, 95, 96, 97
Index Issued: 2006
Tuberculosis Version: 1.0
Protocol
Page: 276 of 285-
Ventilation & Filters .... 84, 85, 86, 108, 109, 111, 116, X
117, 204, 264
X-ray .......................................................14, 17, 18, 20
W
Workplace Safety and Insurance Act 1997
175/98.................................................................36
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