Directive: compliance is mandatory

Policy

Control of Tuberculosis in South Australian Health Services Directive Policy developed by: Public Health and Clinical Systems Approved at Portfolio Executive on: 8 April 2013 Next review due: 31 April 2018

Summary Revisions to the mandatory SA Health Policy Directive ‘Control of tuberculosis in South Australian Health Services’ were approved by Portfolio Executive on 8 April 2013. This policy directive aims to minimise the risk of transmission of tuberculosis (TB) in health care settings through health care worker (HCW) TB screening, infection control, education, surveillance and management. The policy directive mandates each health service to develop and implement a HCW screening program. Revisions include modifications to the HCW screening testing protocols.

Keywords TB control, tuberculosis, health care workers, HCW, TB screening, TB control, TB prevention, TB pre-employment screening, TB infection, TB disease, TB assessment, TB education, directive

Policy history Is this a new policy? N Does this policy amend or update an existing policy? Y Does this policy replace an existing policy? Y If so, which policies? Control of tuberculosis in South Australian Health Services 1 October 2009

Applies to All SA Health Portfolio All Department of Health Divisions All Health Regions AHS, CYWHS, Country Health SA, SAAS

Staff impact All Staff, Management, Admin, Students; Volunteers All Clinical, Medical, Nursing, Allied Health, Emergency, Dental, Mental Health, Pathology

PDS reference D0178

 

Version control and change history Version Date from Date to Amendment 1.0 1/10/2009 31/10/2011 Original version 2.0 8/4/2013 current © Department for Health and Ageing, Government of South Australia. All rights reserved.

SA Health

Directive

Policy for Control of TB in South Australian Health Services

Ref. No.: TBPOL-HCW Effective from: 8 April 2013 Next Review: 31 April 2018

Functional groups Primary and Public Health - Communicable Disease Control Branch - SA Tuberculosis Services

Summary Policy for health services on occupational assessment and screening for tuberculosis in health care workers.

Responsible Division Public Health and Clinical Systems Central Adelaide Local Health Network

Contact person Dr Ann Koehler: 7425 7134 Dr Ral Antic: 8222 5372

Applies to Health services within SA Health

Distributed to

File Number eA779876

Status Active

Chief Executive, Department of Health Compliance with this Directive is mandatory

This policy sets out a framework of measures for monitoring, control and prevention of tuberculosis (TB) in health care workers (HCWs) within SA Health. The framework assists employers of HCWs in establishing appropriate procedures to minimise the risk of transmission of TB within health services. It is mandatory that health services develop and implement a TB control program, which includes a HCW Screening Program, in accordance with this policy. The baseline HCW screening component of the policy applies to all HCWs employed or students on clinical placement within SA Health, including pre-employment screening of all new HCWs prior to entering into an employer-employee relationship and HCW students prior to commencing any clinical placement required as part of their studies. Baseline screening of pre-existing employees should be considered according to risk and available resources. Those HCWs at highest risk (according to individual and work environment risk) are detailed in Table 7.1 of this document, and a list of HCWs requiring screening is provided in Table 7.2. It is the responsibility of health services to monitor TB infection and disease rates within their workplace. This enables ongoing assessment of the risk of transmission and, where necessary, modification of the screening program. This is appropriately done by those who are responsible for Workforce Health and Safety, in consultation with and reporting to SA TB Services.

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1. Policy 1.1 Assessment of TB Risk

A Health Care Worker Screening Program must be developed and implemented by each health service, based on assessment of the service/institutional risk of TB transmission to and from the HCW, including the potential for risk of transmission to patients. Assessment of the service/institutional risks must be monitored over time and reviewed regularly.

The following health services are higher risk settings and must assess the service/institutional risk every two years:

1) institutions with over 200 beds and with ≥ 6 TB patients/year;

2) institutions of less than 200 beds with ≥ 3 TB patients/year;

3) outpatient health clinics that see ≥ 3 TB patients/year;

4) laboratories where clinical specimens that may contain Mycobacterium tuberculosis (MTB) are manipulated; and

5) post mortem suites.

1.2 Infection Control

• Infection control policies of health services must specifically address the risk of TB infection and disease.

• Identified or suspected infectious cases of pulmonary TB disease must be promptly isolated in single rooms under negative pressure.

• HCWs must use correctly fitted particulate filter respirators (P2 / N95) when attending to identified or suspected infectious cases of pulmonary TB disease.

• Timely evaluation of possible transmission of infection to HCW contacts of infectious patients must be conducted.

• HCWs who are HIV-positive or immune-suppressed must be advised not work in an environment with known or suspected infectious TB patients.

1.3 Pre- employment screening

• All HCWs (as identified in Table 7.2) employed after the implementation date of this directive must undergo pre-employment TB screening.

• Baseline screening of pre-existing HCW employees (as identified in Table 7.2) should be considered according to risk and available resources with the highest priority allocated to those HCWs at highest risk (according to individual and work environment risk as specified in Table 7.1).

• HCWs with an abnormal TB screening result require a medical evaluation by, or in consultation with, a medical practitioner experienced in TB management to determine: (1) the likelihood that the abnormal screening result represents TB infection; and (2) the estimated disease risk and appropriate management.

• This evaluation must include a full clinical assessment of relevant information, including history of possible exposure risk, type and magnitude of abnormal screening result, and individual susceptibility.

• Records of TST/IGRA results must be made available to the HCW and must be kept indefinitely by the SA TB Services.

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• A flowchart to guide pre-employment screening is provided in Tables 7.3 (HCW employees) and 7.4 (HCW students prior to undertaking clinical placements).

1.4 Education

• HCWs must be provided with information and education on infection control procedures by the employing health service and by all other health services where the HCW is assigned to work. HCWs working in higher risk work environments (see Table 7.1) must be provided with detailed information about infection control procedures to minimise the ongoing risk of TB transmission.

• HCWs must be advised by the employer of their obligations under this policy.

• Occupational health advice must be provided to immune-suppressed HCWs with certain predisposing conditions that are at increased risk of developing active TB disease if infected (e.g. transplant recipients, individuals on TNF-α inhibitors, individuals undergoing chemotherapy). These HCWs must be advised that if they are exposed to TB, then TB screening tests (TST and/or IGRA) may be unreliable and produce false negative results. Therefore, these HCWs should avoid high risk work environments.

1.5 Ongoing Screening of HCWs

• HCWs with no evidence of TB infection or disease on baseline screening and who work in high risk work environments where there is potential for ongoing transmission must be screened annually (see Table 7.1).

• HCWs with an abnormal baseline screening result (TST ≥ 10mm diameter) or subsequent converters on immunological testing must have a medical evaluation by a medical officer with experience in TB management and be given appropriate risk-based advice, taking into account the likelihood of the person having TB infection and possible future risk of disease.

1.6 Screening of HCWs after exposure to TB

• HCWs who are deemed to have had significant contact with an infectious TB case must be informed of the risk of acquired infection and offered screening by the SA TB Services or delegate.

1.7 Surveillance of TB Infection and Disease within the Health Service

• Health services must maintain records of notified cases and of TB infection transmission. Where nosocomial transmission of infection is identified, a review, conducted in consultation with SA TB Services, is required.

1.8 BCG Vaccination

• BCG vaccination is not routinely recommended for HCWs1.

• BCG vaccination should be considered in those who may be at high risk of exposure to drug resistant TB cases.

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2. Background

The South Australian Tuberculosis (TB) Services has a statutory obligation in relation to the notification of TB disease (or active TB) and provision of advice and services to individuals and health services. Through these processes, the South Australian TB Services monitor the incidence of TB disease in South Australian health care workers. In South Australia in recent years, there has been a gradual decrease in the notification rate of TB disease among the Australian-born population. The incidence of active disease is highest among new arrivals from high prevalence countries, and is largely dependent on immigration policy. The number of HCWs notified with TB disease from 2003 to June 2012 is:

Year Number of HCWs notified with TB disease

2003 0 2004 3 2005 0 2006 10 2007 4 2008 4 2009 3 2010 7 2011 10 2012 (to June) 7

The pattern of HCW notifications since 2006 is suspected to be due to increased recruitment of overseas-born HCWs, with all but two cases occurring in overseas-born. The two Australian-born HCWs were considered to have acquired their infection overseas whilst living or working in high burden countries. Nearly 50% of these cases have occurred within two years of arrival. The number of HCWs screened has nearly quadrupled since 2010 with the introduction of this policy, and, at the same time, there has been a small increase in the number of active TB cases notified among HCWs, probably reflecting detection bias. Despite pre- and post-migration screening, most cases of TB in new arrivals will be detected at varying times after their arrival, given the natural history of TB. Timeliness of diagnosis in pulmonary TB cases will determine the level of transmission of infection. There have been well documented outbreaks in health care institutions, especially in Intensive Care Units and bronchoscopy and autopsy areas, resulting in significant rates of transmission of infection; as high as 76% in one TB outbreak.3 An enhanced screening program that offers prevention treatment to those with evidence of recent infection, or with risk factors that increase the risk of developing disease, can have significant benefits for the individual and the wider community.

Therefore a risk-based approach to control of TB in SA HCWs is appropriate with a focus on HCWs at higher risk of developing TB, and settings of higher risk.

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3. Scope 3.1 Assessment of TB Risk

Environmental risks are classified into two main areas: health service risk and work environment risk, which considers the type of work being undertaken. The risk of TB contact will vary with every health service. Risk will depend upon the number of new TB cases seen each year, timeliness of detection of infectious cases, procedures performed and infection control procedures and practices.

Recommendations for risk assessment are presented in accompanying Tables (7.1 to 7.4). Detailed guidelines for risk assessment have been published by the Centers for Communicable Disease Control, Atlanta.4 Higher risk services include services with over 200 beds and with ≥ 6 TB patients/year; services of less than 200 beds with ≥3 TB patients/year; outpatient health clinics that see ≥ 3 TB patients/year, laboratories where clinical specimens that may contain Mycobacterium tuberculosis are manipulated and post mortem suites.

Work environment risk should particularly be assessed in: respiratory units; bronchoscopy theatres; laboratories handling material that may contain Mycobacterium tuberculosis; and post mortem suites.

• Health services should undertake a health service and work environment risk assessment.

• If the risk assessment identifies a potential for on-going transmission, the health service must have a comprehensive plan for infection control and surveillance.5

3.2 Infection Control

Inadequate infection control procedures can increase the risk of transmission. As transmission is by the airborne route, HCWs are particularly at risk if exposed to an infectious patient not suspected to have TB, or through procedures undertaken that have the potential to generate high concentrations of airborne infectious particles. The level of exposure to Mycobacterium tuberculosis (MTB) in risk areas can be minimised by the combined effects of: TB awareness and early detection of cases, engineering controls to limit the concentration of droplet nuclei and particulate filtration respirators worn by staff.

Information about infection control is provided in the national guidelines ‘Infection control guidelines for the prevention of transmission of infectious diseases in the health care setting’ available at http://www.health.gov.au/internet/main/publishing.nsf/Content/icg-guidelines-index.htm and in the South Australian guidelines ‘South Australian Infection Control Guidelines’ available at http://www.health.sa.gov.au/infectioncontrol.

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• Information and education on infection control procedures must be provided to staff by the employing health service and by all other health services where the HCW is assigned to work, including ensuring that staff members are advised of their obligations to adhere to such a guideline.

3.3 Pre- employment screening

The objective of pre-employment screening is to use a risk management approach to identify HCWs: • at highest risk for infection with Mycobacterium tuberculosis and • most at risk for progression from TB infection to active TB disease.

This includes an assessment to identify active pulmonary TB, latent TB infection and risk factors that increase the likelihood of reactivation of latent TB infection in those with known or possible TB exposure.

• All new HCW employees and HCW students undertaking clinical placements after the implementation date of this directive must have a pre-employment assessment of TB status using a TB questionnaire, and TST and/or IGRA where indicated, as outlined in Tables 7.3 and 7.4.

• Pre-employment screening of HCWs must be initiated prior to commencement of duties in the workplace.

• Baseline screening of pre-existing HCW employees should be considered according to risk and available resources.

• A definition of HCW for this policy is presented in Table 7.2

3.4 Education

In a low-prevalence community such as Australia, experience with TB is limited, and an enhanced awareness of the risks of infection transmission and sentinel symptoms is important. This is intended to ensure early detection of cases, appropriate infection control practices and early presentation for diagnosis if the HCW has symptoms suspicious for TB.

• HCWs must be provided with information, instruction, training and supervision regarding TB infection and disease as is necessary to enable them to perform their work in a manner that is safe and to minimise risk to their health. Information is available from SA TB Services.

3.5 Ongoing Assessment of HCWs at Risk

Annual TST testing is undertaken to monitor the risk and extent of transmission of TB infection to HCW groups in high risk settings. Evidence of TST conversion may indicate inadequate infection control procedures. (Interferon gamma release assay (IGRA) is currently not recommended for serial testing12). Ongoing assessment for up to 2 years may also be offered to HCWs who have lived in or worked in countries where TB is endemic (WHO estimated rate >25/100,000*) with evidence of latent TB infection. Refer to http://www.who.int/tb/publications/global_report/en/ for high prevalence countries.

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• Ongoing screening is not recommended for all HCWs.

• Annual TST testing must be applied to those working in high risk work environments, e.g. bronchoscopy suites, with potential of ongoing transmission (see Table 7.1).4

• Ongoing clinical assessment must be offered to HCWs who 1) have lived in or worked in countries where TB is endemic (WHO estimated rate >25/100,000) within the previous two years, and 2) have evidence of latent TB infection, and 3) in whom preventive treatment is not undertaken. Clinical assessment at 6 monthly intervals for at least 2 years is advised.

3.6 Assessment of HCWs after Exposure to TB

HCWs may have contact with an unsuspected TB case without adequate protection. When this is identified, assessment and additional screening should be undertaken to identify recent transmission of infection, and treatment instituted when indicated. SA TB Services conducts a public health investigation in all cases of TB notified in this state, to identify individuals who may have been placed at risk and require screening. This is conducted in consultation with the respective health service.

3.7 Management of Tuberculosis Infection

Tuberculosis infection is managed in accordance with national and international standards6,7,8 and must be undertaken by a medical practitioner experienced in TB management. Assessing the risk of disease requires consideration of individual susceptibility and length of time from exposure/infection.

Recent infection (within 2 years) represents the most significant risk for developing disease in the immune-competent HCW. Immune suppression increases risk in those with recent or past infection.

The diagnosis of latent TB infection (LTBI) is reliant on immunological testing. Currently in Australia TST remains the preferred method for screening at risk populations to identify LTBI. The interpretation of the test however depends on BCG vaccination status and immune status. False positive results can also arise from previous exposure to environmental mycobacteria.

Interferon gamma release assays (IGRA) such as the QuantiFERON®-TB Gold test and the T-SPOT®.TB test are now available for the detection of LTBI. Current information on the performance of the IGRA test supports a high specificity in BCG vaccinated populations, particularly if vaccinated after infancy. Therefore IGRAs may be used as a supplementary test in individualised clinical assessment for LTBI where increased specificity is valuable in reducing the confounding effect from prior BCG vaccination or prior exposure to non-tuberculous mycobacteria.1

IGRA is not recommended as the primary screening test for HCW pre-employment screening. IGRA may be an acceptable option where resources, distance or other factors make TST impractical to administer. For further information refer to the National Tuberculosis Advisory Committee’s ‘Position statement on interferon-γ release assays in the detection of latent tuberculosis infection’, Communicable Diseases Intelligence, 36(1), 2012, available at: http://www.health.gov.au/internet/main/publishing.nsf/content/cda-cdi3601i.htm

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HCWs with suggestive evidence of TB infection on screening must undertake a medical evaluation by, or in consultation with, a medical officer experienced in TB management (SA Tuberculosis Services), to assess disease risk, which includes consideration of both individual susceptibility and length of time from exposure/infection.

3.8 Management of Tuberculosis Disease

Tuberculosis disease is an active inflammatory process with the potential to infect close or susceptible contacts and to cause tissue damage and death in the affected individual. Both the individual and public health risk must be managed. The individual should be managed in accordance with national and international standards.6, 7, 8 The public health risk is managed under statutory obligations9 by the South Australian Tuberculosis Services. Treating physicians and health services should be aware of the legal obligations under South Australia legislation requiring that ‘a person who has a controlled notifiable condition that is capable of being transmitted to 1 or more other persons has a responsibility to take reasonable steps or precautions to avoid placing others at risk on account of the controlled notifiable condition.’ 9

A HCW in whom TB disease is suspected or proven is required to be notified to the SA TB Services and treated in accordance with national and international standards11, 12.

A HCW with active TB disease must complete a satisfactory course of treatment and a follow-up period of 2 years with appropriate certification provided to the health service by the treating doctor.

A HCW with active pulmonary TB disease is to be excluded from the workplace until cleared by the medical supervisor nominated by the health service, in consultation with a medical practitioner experienced in TB management.

3.9 Surveillance of TB Infection and Disease within Health Services

Surveillance of TB infection and disease rates enables ongoing assessment of the risk of transmission and, as necessary, modification of the program. This must be undertaken through local services/units responsible for TB screening of staff within health services in consultation with SA TB Services.

Health services must monitor TB infection and disease rates within their workplace.

The following health services must assess the service/institutional risk every two years: 1) services with over 200 beds and with 6 or more TB patients/year, 2) services of less than 200 beds with 3 or more TB patients/year, 3) outpatient health clinics that see 3 or more TB patients/year 4) laboratories/ where clinical specimens that may contain MTB are manipulated and 5) post mortem suites.

3.10 BCG Vaccination

There is a lack of evidence supporting a protective benefit from Bacille-Calmette-Guérin vaccine (BCG) in adults. Further, BCG does not prevent transmission of infection and is no longer recommended as the primary means of HCW protection.1 The use of BCG is carefully considered according to individual circumstances e.g. in those HCWs who may be moving to an overseas country to work in an area where

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multi-drug resistance is more common. BCG is contraindicated in immunocompromised persons.

Further information on BCG is contained in the document “The BCG Vaccine: Information and Recommendations for Use in Australia”1 available at http://www.health.gov.au/internet/main/publishing.nsf/Content/cda-cdi3001e.htm

4. Responsibility

Preventing TB transmission is the shared responsibility of HCWs and employers. A combination of staff education, awareness, early diagnosis, environmental controls and screening procedures is required to minimise the risk of transmission to HCWs and from HCWs to patients.10 Local Health Networks

Local Health Networks have a responsibility to:

• assess the service level risk of TB transmission to HCWs

• develop local procedures and work practices in line with this policy appropriate to the service level risk of TB transmission to HCWs;

• educate staff about TB infection and disease;

• implement infection control procedures that are appropriate to manage the TB risk;

• ensure all new HCWs undergo pre-employment screening with a TB questionnaire, and , where indicated, administration of TST and/or IGRA and ensure results are forwarded to SA TB Services monthly for collection in a centralised database

• monitor rates of TB infection and disease within the health service in conjunction with SA TB Services

• conduct ongoing surveillance of HCWs at higher risk of becoming infected, through annual screening of those HCWs exposed to a high risk work environment;

• ensure that HCWs undergo assessment (including screening where appropriate) of HCWs after exposure to TB in consultation with SA TB Services;

• ensure management of HCWs with TB disease or infection is undertaken including referral to SA TB Services; and

• monitor rates of TB infection and disease within the health service.

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Workforce Health Branch, Workforce Directorate, Systems Performance Division (Department for Health and Ageing)

Work Health Branch, Workforce Division, has the responsibility to:

• develop procedures for use across SA Health

• develop processes to ensure that HCWs who work across different health care facilities comply with the policy directive

• provide a tuberculosis screening program for HCWs and annual screening services for metropolitan health services which includes:

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o employment screening,

o annual screening for staff working in high risk areas, and

o screening (where indicated) after exposure to active pulmonary tuberculosis as determined by SA TB Services in consultation with the local health service

• provide consultant advice in relation to pre-employment screening, annual screening services and assessment/screening after exposure to TB for country health services as required

• oversee implementation of the policy including a gap analysis (through the Workforce Health Strategy, Policy and Governance

• conduct audits of monitoring and compliance (via Workforce Health Performance Review and Continuous Improvements)

HCWs HCWs have the responsibility to:

• comply with the policy and to ensure maintenance of adequate infection control standards in the workplace; and

• present urgently for medical assessment at the onset of any signs suspicious of TB.

SA TB Services SA TB Services has a responsibility to:

• contribute to development of policy with CDCB;

• provide public health advice to health services when TB disease or infection is detected in HCW and when HCW are exposed to TB;

• provide consultancy in clinical and public health management of TB disease and infection;

• provide screening expertise and advice including the provision of training and on-going accreditation in screening for relevant health service staff that are responsible for Workforce Health;

• facilitate implementation of the policy by providing a model screening questionnaire and other protocols to the Workforce Health Branch ;

• maintain a centralised database to monitor the frequency of TB infection in HCWs and assess risk over time;

• conduct ongoing surveillance of TB disease in health services; and

• report at least annually to the Workforce Health Branch, Department of Health on TB disease in health services included in this policy directive.

Communicable Disease Control Branch (Department for Health and Ageing) The Communicable Disease Control Branch has the responsibility to:

• provide policy direction in consultation with SA TB Services;

• provide additional public health advice and assistance to SA TB Services where required for TB control across SA; and

• provide administrative services to the health services to enable the distribution of TST and BCG.

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5. Risks

As outlined in the Background above, the increasing trend towards attracting HCWs from countries with a high burden of TB is likely to increase the number of notified active cases among this group and potentially cause personal, community and employer dilemmas. Documented outbreaks of TB in health services have resulted in high rates of transmission of infection. A risk management approach, as detailed in this Policy, is needed.

6. Definitions

Abnormal baseline refers to a TST result greater than or equal to 10mm diameter (irrespective of BCG status). Contact refers to a person who has shared air with a person who has been notified with active tuberculosis disease. Health care workers refer to all health care workers, including trainees, students, and employees of health services, who have contact with patients or certain laboratory specimens (details in Table 7.3). Health service refers to a centre that delivers health care services (e.g. hospitals, general practice, domiciliary nursing and ambulance services) within SA Health. High prevalence countries refer to countries that have a TB notification rate greater than 25 cases per 100,000 population 2. IGRA – Interferon gamma release assay refers to an in vitro blood test to detect latent TB infection based on interferon-gamma release after stimulation by TB specific antigens. Immune-suppressed refers to a situation where the immune response of the body is weakened, for example in transplant recipients, individuals on TNF-α inhibitors, individuals undergoing chemotherapy. In such a situation there is an increased risk to the individual of reactivation of latent TB infection. Negative baseline test result refers to a TST result that is less than 10mm diameter (except in the immune-suppressed). New arrival refers to a person who has arrived in Australia from overseas in the previous 2 years with the intention of remaining in Australia for a specified period of time or indefinitely. Pre-employment refers to health care workers prior to entering into an employer-employee relationship and health care worker students prior to commencing any clinical placement required as part of their studies. Surveillance refers to the ongoing, systematic collection, analysis, interpretation, and dissemination of data regarding a health-related event for use in public health action.10 Tuberculosis (TB) refers to an infectious disease caused by the Mycobacterium tuberculosis complex.

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Tuberculosis infection (latent tuberculosis infection) refers to a subclinical infection with M. tuberculosis without clinical, bacteriological or radiological features of disease. Tuberculosis (TB) Screening is a public health process for establishing the presence of infection or suspicion of disease and uses a combination of a TB questionnaire, TST and/or IGRA and CXR. Tuberculin Skin test (TST) refers to a diagnostic test that measures a cell-mediated immune response to identify possible infection with M. tuberculosis. TST conversion refers to an increase from a negative baseline of greater than or equal to 10 mm diameter within a 2 year period. Such an increase indicates recent infection.

7. Tables 7.1 Risk Assessment of Health Facility (work environment) and of HCW 7.2 Definition of HCW for the purposes of this TB pre-employment screening policy 7.3 Flow-chart for pre-employment assessment – new HCW employees 7.4 Flow chart for pre-clinical placement assessment – HCW students

Table 7.1: RISK ASSESSMENT OF HEALTH SERIVCE (WORK ENVIRONMENT) AND OF HCW

WORK ENVIRONMENT INDIVIDUAL HCW

High Risk

• Bronchoscopy suites* • Work areas where staff are regularly involved in

supervising sputum induction for suspected cases of pulmonary TB*

• Laboratories where clinical specimens which may contain Mycobacterium tuberculosis (MTB) are manipulated

• Post mortem suites

• HCW born in a high prevalence TB country* • HCW who trained or worked for 3 months or

more in a high prevalence TB country* • Previous history of TB disease • Evidence of TB infection as indicated by a

history of positive TB screening test (e.g. TST or IGRA) result

• Previous or current contact with an active TB disease case

• Immune-suppressed

*High prevalence TB countries are those where TB is endemic (WHO estimated rate >25/100,000) http://www.who.int/tb/publications/global_report/en/

Low Risk

• Laboratories where clinical specimens that may contain Mycobacterium tuberculosis (MTB) are not manipulated

• All other work areas

• No TB exposure risk factors or other evidence of TB infection identified with the TB screening questionnaire

• Health care workers who do not have any patient contact

*Note: Bronchoscopy suites and sputum induction areas should be negative pressure rooms

TABLE 7.2: DEFINITION OF HCWs FOR THE PURPOSES OF THE TB SCREENING POLICY

HCWs requiring TB screening Staff not requiring TB screening Doctors Catering staff Nurses Cleaning staff Dentists, Dental Nurses/Assistants Store persons Allied Health staff with direct care of patients (Physiotherapists, Occupational Therapists, Speech Pathologists, Social Workers, Dieticians, Pharmacists, Radiographers, radiation therapists, etc.)

Laundry staff Orderlies Sterilisation Services staff

Staff working in bronchoscopy suites Medical Records staff Maintenance staff working with ventilation systems

Maintenance staff (other)

Administrative staff in respiratory/infectious diseases wards

Administrative staff (other)

Laboratory staff who may be manipulating clinical specimens which may contain Mycobacterium tuberculosis (MTB)

Volunteers

Staff working in post mortem suites HCW students required to undertake clinical placements in SA Health facilities or workplaces (see Table 7.4)

TABLE 7.3 FLOW-CHART FOR PRE-EMPLOYMENT ASSESSMENT – HCW EMPLOYEES

HEALTH SERVICE HCW SCREENING

HIGH RISK HEALTH SERVICES

• Over 200 beds who see ≥ 6 TB patients/year (including large metropolitan tertiary hospitals) OR

• Less than 200 beds who see ≥ 3 TB patients/year OR

• Outpatient health clinics that see more than ≥ 3 TB patients/year

• Laboratories manipulating specimens that may contain Mycobacterium tuberculosis (MTB)Post mortem suites

High risk work environment as

assessed by Table 7.1

Low risk work

environment as assessed by Table

7.1

Baseline TB screening

questionnaire required No baseline TST

test required

No annual TST test required

High risk HCW as assessed by Table

7.1

Low risk HCW as

assessed by Table 7.1

Baseline TST test required

No annual TST test

required

No annual TST test

required

Annual TST test

required if previous TST reaction

negative

Base line TB screening

questionnaire required

AND

Baseline TST test required

ALL OTHER HEALTH SERVICES AND SETTINGS

No baseline TST

test required

No annual TST test required

Baseline TST test

required

No annual TST test required

TABLE 7.4 FLOW-CHART FOR PRE-CLINICAL PLACEMENT ASSESSMENT - HCW STUDENTS

High risk HCW student as

assessed by Table 7.1

Base line TB screening questionnaire required

Low risk HCW student as

assessed by Table 7.1

HCW students required to undertake clinical placements in SA Health facilities/workplaces Note: Screening required at least 2 weeks prior to first clinical placement

8. References 1. National Tuberculosis Advisory Committee. The BCG Vaccine: Information and Recommendations for use in Australia. Communicable

Diseases Intelligence 2006; 30(1):109-115. Available at http://www.health.gov.au/internet/main/publishing.nsf/Content/cda-cdi3001e.htm

2. Broekmans, JF et al. European framework for tuberculosis control and elimination in countries with a low incidence. European Respiratory Journal 2002; 19: 765-775.

3. Griffith, DE. Tuberculosis outbreak among health care workers in a community hospital. American Journal of Respiratory and Critical Care Medicine 1995; 152: 808-811.

4. Jensen, PA et al. Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings. MMWR Recommendations and Reports 2005; 54: RR17. Available at http://www.cdc.gov/mmwr/PDF/rr/rr5417.pdf

5. American Thoracic Society, Centers for Disease Control and Prevention, Infectious Diseases Society of America. Treatment of tuberculosis. American Journal of Respiratory and Critical Care Medicine 2003; 167:601-662.

6. Centers for Disease Control and Prevention. Treatment of Tuberculosis. Morbidity and Mortality Weekly Report 2003; 52:1-74. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5211a1.htm

7. Centers for Disease Control and Prevention. Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection. Morbidity and Mortality Weekly Report 2000; 59:1-71. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4906a1.htm

8. Tuberculosis Coalition for Technical Assistance. International Standards for Tuberculosis Care (ISTC). The Hague: Tuberculosis Coalition for Technical Assistance, 2006.

9. South Australian Public Health Act 2011 Part 2, Section 14(3) and Part 10. Available at http://www.legislation.sa.gov.au

10. Centers for Disease Control and Prevention. Updated Guidelines for Evaluating Public Health Surveillance Systems. Morbidity and Mortality Weekly Report 2001; 50:1-35.

11. Centers for Disease Control and Prevention. Treatment of Tuberculosis. Morbidity and Mortality Weekly Report 2003; 52:1-74.

12. Canadian Tuberculosis Committee. Updated Recommendations on Interferon gamma release assays for latent tuberculosis infection. An Advisory Committee Statement (ACS). Canada Communicable Disease Report 2008; 34(ACS-6):1-13.

Attachment A Preventive treatment in the individual who has evidence of 'latent' TB infection but no TB disease As a general rule recommending treatment to a healthy person with latent TB infection (who poses no infection risk to others) must balance their potential future disease risk against the more immediate risk of harm to them from the isoniazid preventive therapy (IPT). Also requiring consideration is the potential public health benefit i.e. the secondary benefit to others in preventing possible future cases. The first dilemma is accuracy in diagnosing latent TB infection. The imprecision of the tests in current use (Mantoux and IGRA) is an important issue. Sensitivity is very much dependent on the population being screened. Sensitivity of these tests is at best 70-80%; however it is much less in the immune-suppressed. Furthermore, unless a person has been having regular Mantoux tests over time to identify when a conversion occurs; it is often very difficult to pinpoint time of infection. If an individual develops TB infection, the lifetime risk of developing disease in an immune-competent person is on average 8-10%. Most of this risk is contained within the first 2 years post exposure (~ 50%). The residual risk is spread out over the lifetime of the individual. At about 10 years post infection the risk is estimated to be approximately 1 case of TB disease developing for every 1000 cases of TB infection/year. The risk is significantly higher if immune-suppressed e.g. HIV positive 10% per year compared to 10% lifetime for immune-competent. The expert consensus is that once 5-7 years has lapsed since exposure and the time of infection, then any benefit from IPT is marginal unless there are immune-suppressing health considerations. Due to the difficulty in assessing when exposure causing primary infection most likely occurred, assigning individual risk is difficult. The risk of isoniazid-induced hepatitis is the most concerning risk of harm to the individual. This risk increases with age. It is approximately 1/1000 in those aged 20-35 years, 1% in those aged 35-50 years and 2-3% in those aged more than 50 years. Deaths from liver failure, although rare, have been reported. Side effects of a less serious nature occur in 5-10% of those taking IPT and can be significant in terms of day to day "quality of living". Not surprisingly these unwanted side effects often impact upon compliance, and treatment therefore requires careful monitoring including monitoring of liver function. IPT is not absolute in preventing development of disease. It reduces the chance of TB developing by 75-90% and does not prevent disease if subsequent re-infection occurs. There is also a risk that an overseas-born HCW is infected with an INH resistant strain (~10%) or a primary multi-drug resistant strain (~ 4%, based on the latest WHO drug surveillance estimates). It is not possible to determine which infected individuals are carrying a drug resistant strain unless that individual develops active disease. The evaluation of an individual deemed to have been TB infected requires careful consideration of all of the above risks and benefits in reaching a recommendation about the use of isoniazid preventive therapy. Those people who do not participate in the therapy are monitored and followed up at six-monthly intervals for a minimum of two years by SA TB Services.

As described above there are significant impediments to creating a risk-free scenario. These include the imprecision of available screening tests, the natural history of TB infection and the risk of harm to individuals from taking preventive treatment. Individual decision making by an expert is invariably based on probabilities and a consensus-based best practice approach to evaluation.

Attachment 2

1. In South Australia all cases of Tuberculosis (TB) are reported to the South Australian TB Services. SA TB Services routinely manage all notified cases using established protocols and according to national and international standards of care. The protocols cover both clinical and public health management and involve the person infected with TB as well as other people identified through contact tracing who may be at risk of infection.

TUBERCULOSIS CASE MANAGEMENT COORDINATION PROTOCOL

2. The public health management is routinely conducted by SA TB

Services. It involves identifying close or susceptible contacts (people who have had contact with a case and may be at risk of infection) and instituting strategies to manage those risks. Time is required to identify contacts, undertake risk assessment procedures and institute appropriate management strategies.

3. Both cases and contacts have a right to be informed by their health care

provider or another appropriate person rather than learning of their status through a third party.

4. Occasionally SA TB Services identifies TB cases that may be of

particular public health or community significance. Assessment of public health or community significance requires consideration of a range of individual and contextual factors. Examples of cases that may be of significance include: cases with higher potential for transmission particularly in the service setting, cases with highly drug resistant infection, cases where unusually large numbers of contacts are identified, and two or more cases occurring in one setting. These cases require coordinated action by a range of stakeholders and on occasion there may be a need to communicate information to the public.

5. Consistent with the above, the following protocol is to be followed by SA

Health in managing TB notifications of public health/community interest:

I. Where a case of public health interest is identified, the Director of SA TB Services (or nominated delegate) notifies the Director, Communicable Disease Control Branch (CDCB), Department for Health and Ageing (DHA).

II. The Director, CDCB (or the person designated by the Director, CDCB) assumes responsibility for all communication between the SA TB Services, or any involved Health Region, and DHA.

III. The Director CDCB, in conjunction with SA TB Services medical staff, prepares a notification to the Chief Executive (CE), DHA and the Minister for Health and Ageing via the Executive Director, Public

Health and Clinical Systems, that a case of public health interest has occurred and that further information on potential contacts will be available once the risk assessment is completed. The anticipated timeframe for this is documented in the TB clinic case pro forma.

IV. SA TB Services completes contact identification and advises the Director CDCB of the proposed management plan and liaises with the Media Manager, Media and Communications Branch, DHA regarding the communication plan.

V. A case conference of all relevant parties is called by the Director CDCB as soon as possible following notification of the case, and at appropriate times to ensure accurate information is shared and that the communication strategy is aligned with the principles above. The case conference should include representatives from SA TB Services, CDCB, Media and Communications, ED PHCS and others as appropriate.

VI. The CE and Minister are advised promptly of the agreed public health management and communication plan following the initial case conference and updated promptly following subsequent case conferences if required.