3. ORGANISATION OF SERVICES

The Policy Guidelines has been developed based on previous experience in Peru, current efforts at out-patient MDR-TB treatment in KwaZulu-Natal, and in the Western Cape. The Policy Guidelines describe the roles of the different levels of patient management.

3.1. Types and Functions of DR-TB Units

A DR-TB unit is a health facility where health professionals have been trained to initiate and manage the treatment of DR-TB patients. A DR-TB unit may be a (stand-alone) hospital, a DR-TB ward in a general hospital, or a DR-TB ward in a TB hospital or other specialised hospital.

Hospitalisation provides time for:

• Initiating DR-TB and HIV treatment;
• Monitoring the initial response to treatment and possibly adjusting medication;
• Educating and counselling the patient on MDR-TB and HIV;
• Assessing the household in preparation for discharge; and
• Educating and counselling the family and other household members on DR-TB and HIV to optimise family support for the patient in treatment adherence and implementation of household infection control.

3.1.1. Provincial Level

The centralised DR-TB unit is also known as the “Provincial Centre of Excellence”. Each province has at least one hospital that is a specialised DR-TB unit. This hospital will perform a supporting and supervisory role for the MDR-TB outpatient programme in each province, and as the centre of excellence, provide technical advice to the decentralised MDR-TB sites.

Functions of the Centralised DR-TB Unit

• Initiating treatment of all DR-TB cases after appropriate assessment;
• Admitting DR-TB cases from the geographic area around the unit;
• Ensuring hospitalisation of all XDR-TB cases until there are two successive negative TB cultures;
• Assessing all DR-TB patients attending the clinic each month;
• Providing DOT to all DR-TB patients attending the unit each day;
• Recording and reporting to the provincial Department of Health;
• Providing on-going training, support and supervision for all the facilities in the province;
• Providing social support, rehabilitation, educational and skills building programmes for patients;
• Providing education and counselling to all patients admitted in hospital;
• Preparing a discharge plan for all patients and ensuring effective down referrals;
• Monitoring DR-TB patients post discharge until completion of treatment and two years post treatment completion;
• Monitoring  rational usage of second-line  drugs and ancillary drugs for side effects management;
• Establishing and maintaining functional clinical management teams;
• Compiling monthly, quarterly, six-monthly and annual reports of DR-TB patients started on treatment, their culture conversion and outcomes;
• Providing technical assistance and capacity building to decentralised DR-TB units, and feeder clinics on management of DR-TB; and
• Arranging patients’ evaluations at provincial patient review committees.

 3.1.2. Districts or Sub-Districts

Districts and sub-districts have administrative and management responsibilities in ensuring effective DR-TB services in the area. Their primary functions are to:

• Trace all confirmed DR-TB patients and refer to the DR-TB hospital;
• Ensure availability of drugs for the patient at the clinic or district hospital;
• Establish an efficient patient retrieval system for patients who default DR-TB treatment;
• Arrange transportation for patient evaluation and follow-up at the DR-TB hospital;
• Appoint disease outbreak teams to conduct contact screening programmes for all close contacts of confirmed DR-TB patients six monthly for two years;
• Conduct household assessments prior discharging patients from DR-TB units;
• Monitor and evaluate DR-TB programme performance;
• Ensure continuum of care for patients post discharge;
• Ensure on-going psychosocial support for patients; and
• Increase awareness and education about DR-TB among communities.

Satellite MDR-TB Units exist to complement bed capacity of decentralised sites. They are essentially transitional and should be capacitated to become decentralised sites. Mobile teams are to be attached to PHC services but operate within the community.

3.1.3. Decentralised DR-TB Units

There will be a number of decentralised DR-TB units in each province, depending on the need, but at least one unit per district is required. These units will be responsible for the initiation and management of DR-TB patients in a defined geographical area, initially as inpatients, but then when appropriate, as outpatients. These units may consist of whole hospitals, wards or sections of existing provincial, district or sub- district level hospitals.

NOTE: Decentralised  DR-TB  units with adequate human resources and infrastructure capacity may initiate treatment and follow up on XDR-TB cases according to the national and provincial Department of Health’s discretion.At least one decentralised unit is required for each district.

Patients diagnosed with MDR-TB who are smear microscopy positive will be hospitalised at the decentralised DR-TB units for up to eight weeks or until they become smear negative on two consecutive tests. This is important given that most patients in South Africa with MDR-TB are co- infected with HIV and will need to commence treatment for both diseases.

Once a patient’s sputum smear microscopy is negative and they meet the criteria for outpatient treatment (see Figure 2), they may receive treatment while living at home. Smear positive patients who refuse admission but are willing to receive medication should still be treated.

Functions of the Decentralised MDR-TB Units

Districts and sub-districts have administrative and management responsibilities in ensuring effective TB and DR-TB services in their areas. Their primary functions are:

• Initiating treatment of all MDR-TB cases after appropriate assessment;
• Admitting DR-TB cases when indicated;
• Providing transportation for patient evaluation and monthly follow up of all DR-TB cases attending clinic;
• Tracing confirmed DR-TB patients and referring them to the DR-TB hospital;
• Providing DOT to all DR-TB patients attending the unit daily;
• Providing social support, rehabilitation, educational and skills building programmes for patients;
• Providing education and counselling to all patients admitted to hospital;
• Preparing a discharge plan for all patients and ensuring effective down referrals;
• Monitoring DR-TB patients post discharge until completion of treatment and two years post treatment completion;
• Ensuring availability of drugs and monitoring rational usage of second-line drugs;
• Establishing and maintaining functional clinical management teams;
• Recording and reporting to the provincial Department of Health;
• Compiling monthly, quarterly, six monthly and annual reports of DR-TB patients started on treatment, culture conversion and outcomes;
• Monitoring and evaluating DR-TB programme performance;
• Providing technical assistance and capacity building to satellite MDR-TB units and feeder clinics on management of DR-TB;
• Monitoring treatment side effects;
• Ensuring referral of patients with XDR-TB, adverse drug reactions (ADRs) and complicated disease to the centralised DR-TB unit; and
• Tracing all confirmed cases. 

3.1.4. Satellite MDR-TB Units

Satellite units may be based at district or psychiatric hospitals, community health centres, or correctional services facilities. These are transitional structures that should have the capacity to become decentralised sites. Satellite MDR-TB units should exist to:

• Admit and follow up MDR-TB patients initiated on treatment at decentralised sites; and
• Serve patients who refuse to start treatment unless they are closer to home.

After the assessment and initiation of MDR-TB therapy (by a centralised or decentralised DR-TB unit), patients may be referred to a satellite MDR-TB unit where they will receive treatment and are monitored daily. Nurses, with the support of a doctor based at the centralised or decentralised DR-TB sites should monitor the health of the patient.

An improvement in the patient’s medical condition (e.g., weight gain, no fever, no cough, etc.) indicates that s/he is tolerating all MDR-TB drugs and HAART and is smear negative. Patients can be discharged to the community and continue receiving treatment either from the mobile team or their nearest primary health-care facility. At times MDR-TB treatment may be administered in institutions such as prisons, mining health facilities or psychiatric hospitals. The initial period of hospitalisation should be between two and eight weeks.

Initially the patient should return monthly to the decentralised DR-TB site for on-going management of their condition. When the programme is established and the staff at satellite MDR-TB sites are trained, it may be possible for patients in the continuation phase to be monitored monthly at satellite MDR-TB sites. Until then, the patient should travel once bi-monthly or quarterly to the decentralised DR-TB site.

Satellite MDR-TB units should not initiate MDR-TB treatment. They may eventually be upgraded to a decentralised MDR-TB unit if they have adequate and trained staff and infrastructure.

Functions of Satellite MDR-TB Units

• Admitting all MDR-TB cases referred from centralised or decentralised DR-TB units;
• Ensuring monthly follow up of all DR-TB patients attending the unit;
• Providing DOT to all DR-TB patients attending daily;
• Educating and counselling all patients admitted to hospital;
• Preparing a discharge plan for all patients and ensuring effective down referrals;
• Monitoring treatment side effects; and
• Ensuring referral of patients with XDR-TB, severe ADRs, and complicated disease to the centralised DR-TB site.

3.1.5. Primary Health Care Facilities

Primary health care (PHC) facilities play a significant role in providing injectables at clinics and DOT to all DR-TB patients in their areas. This must be integrated with the treatment of other TB and HIV patients. The existing TB nurses will be trained to handle these activities. It is not necessary to have dedicated DR-TB nurses at the primary health care level.

Patients who have access to a PHC clinic should utilise the health facility for their daily injections and DOT. The facility-based staff will monitor side effects and adherence; provide education on the disease, and monitor household infection control practices. Minor side effects such as nausea, vomiting and diarrhoea should be managed by the nurse at the facility, but the patient should be referred to the decentralised DR-TB unit for management of more serious side effects. In addition, the nurse at the facility should be responsible for contact tracing and serve as the link between the decentralised DR-TB unit and MDR-TB patients treated at the facility.

PHC facilities treating MDR-TB patients will be supported by the nearest decentralised DR-TB unit or the centralised DR-TB unit or provincial centre of excellence if it is closer to the facility.

Functions of Primary Health Care Facilities

• Identifying high risk groups;
• Screening and testing symptomatic high-risk groups;
• Tracing patients with a confirmed diagnosis of DR-TB;
• Notifying the district TB coordinator;
• Providing initial counselling and education of the patient and family;
• Preparing patient for hospital admission when indicated;
• Coordinating referrals to the centralised and decentralised DR-TB units;
• Ensuring monthly follow up of all DR-TB cases attending a clinic;
• Providing DOT to all DR-TB patients attending daily;
• Conducting contact screening of close contacts;
• Following up patients initiated to start community-based treatment or patients who are post discharge from hospital;
• Coordinating follow up visits in hospital;
• Tracing treatment interrupters;
• Collecting monthly sputum and other routine tests;
• Monitoring treatment side effects and;
• Ensuring referral of patients with XDR-TB, severe ADRs, and complicated disease to the centralised DR-TB unit.

Contact Tracing and Monitoring

Contact tracing and monitoring is an important role of the PHC facilities through the mobile teams and DOTS supporters. Measures for contact tracing and monitoring include:

• Listing and examining all contacts and testing those with symptoms in accordance with existing TB protocols;
• Re-testing contacts with symptoms for TB and drug susceptibility six-monthly for two years;
• Ensuring that the MDR-TB patient is continuously screened for signs and symptoms; and
• Offering HIV counselling and testing to contacts.

3.1.6. Mobile Teams

Mobile teams are also called mobile MDR-TB units. These are units based at the PHC facility or a satellite MDR-TB unit. They provide injections to patients at their homes, supervise intake of oral tablets, and educate family about infection control.

Patients who are unable to access a health facility daily should, for the duration of the injectable phase of treatment, be visited daily at home (five times a week) by a mobile team, which should consist of a driver and nurse. During these visits, the team will administer injectable drugs, observe the patient taking their oral drugs, monitor side effects and adherence, provide education on the disease, and monitor household infection control practices. Minor side effects such as nausea, vomiting and diarrhoea should be managed by the nurse on the mobile team, but the patient should be referred to the decentralised DR-TB site for management of more serious side effects. The mobile MDR-TB unit should also be responsible for contact tracing and serve as the link between the decentralised DR-TB site and MDR-TB patients in the community. In some instances the mobile MDR-TB unit will also carry out TB programme activities such as tracing defaulters from the TB programme or giving re-treatment patients streptomycin injections.

Existing TB tracer teams may expand their mandate by taking care of MDR-TB patients. Again, these teams need to take care of all TB and HIV patients. Their scope should not be restricted to MDR-TB care.

Functions of Mobile Teams

• Provide DOT to all DR-TB patients in the area;
• Provide patient, family and community education on TB;
• Monitor treatment side effects and referring to the nearest health-care facility when necessary; and
• Maintain appropriate records.

3.1.7. Community Level: DOTS Supporters/Caregivers

Depending on the local situation, the DOTS supporters may be community caregivers, community DOTS volunteers or family members. It should be noted that training is very important for this cadre of supporters, and compensation should be considered because DOT is the department’s core business. Family members should only be used as a last option because they may be coerced by other family members, making them less objective as community caregivers.

Patients and their designated household treatment supporters must be trained on the natural history of MDR-TB and HIV as well as in basic infection control (e.g., cough hygiene and the basic principles of isolation), MDR-TB medications, common side effects/toxicity, and the role of HIV in TB infection. Family planning during MDR-TB treatment should be encouraged. Community caregivers should provide on-going daily support to MDR-TB patients who are treated on an outpatient basis.

If the patient is on HAART, the patient and treatment supporter should receive literacy training according to current practice. This must be given by staff trained in MDR-TB and integrated TB and HIV care. Any training that takes place in the clinical setting will be separated in space and time from the HAART programme to avoid nosocomial transmission. In addition, education for the patient, household supporter, and possibly even the treatment supporter should be given at individual patients’ home by the mobile MDR-TB unit.

Given the important role of the treatment supporter, s/he should preferably be HIV-negative and have access to a support group and regular TB screening.

Functions of Community Level Services

• Provide DOT to all DR-TB patients in the area;
• Provide patient, family and community education on TB;
• Monitor treatment side effects and referring to the nearest health-care facility when required; and
• Maintain appropriate records.

Table IX describes the responsibilities of staff working at various levels of MDR-TB care.

3.2. Management Teams/Committees at Different Levels

The provincial TB directorates are responsible for setting up management teams and committees to oversee the clinical management of DR-TB patients in the province.

3.2.1. Provincial DR-TB Review Committee

Each province should establish a management team to support and advice in difficult clinical cases, medico-legal and ethical issues such as termination of MDR-TB treatment in a patient who does not respond to treatment. This committee must be multi-disciplinary and should include medical officers and/or professional nurses from the DR-TB hospital, physicians, pathologists, paediatricians, cardio-thoracic surgeons, public health specialists, radiologists, civil society representatives, social workers, provincial management and a specialist in legal and ethical issues. Other representatives from government departments such as Social Development, Correctional Services, Military Health Services, South African Social Security Agency, and the mining industry may be included in this committee.

This committee advises and recommends on the following:

• Appropriate clinical management of individual MDR- and XDR-TB patients;
• Use of salvage regimens in individual patients with high-grade resistance;
• Management of chronic drug resistant TB regarding termination of treatment and palliative care;
• Management of patients who refuse treatment;
• Management of infectious patients who do not cooperate with the health professionals and those who abscond from hospital or refuse to be admitted; and
• Development of provincial criteria on pass-outs.
• Identification and resolutions to health systems issues contributing to poor service delivery such as delays in culture results or shortages of medication.

3.2.2. District and Sub-District Level

At a district and sub-district level co-ordination of DR-TB activities will be done by the district and sub-district TB co-ordinators and the district TB team if there is one. This team will be responsible for:

• Informing (PHC) staff of the latest developments regarding DR-TB;
• Disseminating and training PHC staff on the latest guidelines regarding when sputum cultures should be taken so that patients with DR-TB are diagnosed as soon as possible;
• Referring patients diagnosed with DR-TB to the decentralised unit for initiation of treatment;
• Ensuring that PHC staff feel supported in their treatment of patients with DR-TB;
• Ensuring that there are no interruptions in treatment as the patient moves from being an inpatient to receiving care in the community; and
• Monitoring and referring patients receiving treatment in the community.

Patient support groups should be formed at all levels of care to enhance adherence.

3.3. Treatment Follow Up

DR-TB treatment should be monitored closely through daily DOTS and recording of patients taking their drugs and receiving injections. Sputum for smear microscopy and culture should be collected every month for the duration of treatment. Depending on where the patient receives care, daily DOTS and recording of patients taking their drugs and receiving injections should be done by the decentralised DR-TB site, mobile team or the satellite unit administering medication. Sputum collection and the monitoring of smear microscopy, culture and DST results should be conducted at the decentralised DR-TB site.

Adverse drug reactions should be monitored continuously by the facility where the patient receives treatment or the mobile team and DOTS supporters. ADRs should be assessed using a check-list and where necessary reported without delay to supervising unit. ADRs must be treated aggressively as this will enhance treatment adherence.

Details of the patient’s HIV status and HAART, including the commencement date and treatment regimen must be recorded in the patients’ notes. The clinical and laboratory evaluations that should be conducted monthly are listed in Table XI.

3.4. Infection Control

3.4.1.  Home Infection Control

Mobile teams including DOTS supporters should educate patients and household members. Home infection control will be encouraged and monitored. Home infection control includes the following:

• Ensuring adequate ventilation/open windows;
• Isolating patient (own bedroom where possible);
• Promoting cough hygiene;
• Ensuring that patients use surgical mask during waking hours while at home or when meeting with others;
• Refraining from close contact with children;
• Maximising time in open-air environment (e.g., receiving visitors outside);
• Advising all household members and regular contacts to undergo HIV tests;
• Minimising contact with known HIV positive patients; and
• Ensuring that household members are screened for TB and DR-TB every six months.

Infection Control during Home Visits

Mobile teams should decrease the risk of contracting DR-TB by adhering to the following infection control measures:

• Wearing an N95 respirator (health workers and DOTS supporters);
• Keeping home visits or clinical evaluations brief, and whenever possible, conduct these outside or in a well-ventilated room with as much distance as possible from the patient;
• Educating the patient on cough hygiene and avoiding close contact;
• Providing the patient with a surgical mask when close contact is required; and
• Collecting sputum outside, observing prescribed infection control precautions.

3.4.2. Infection Control during Patient Transport

When transporting DR-TB patients, the following infection control measures should be observed:

• Use compartmentalised vehicles separating the airspace of the driver from that of the passengers;
• Open vehicle windows;
• Provide surgical mask for patient;
• Provide N95 masks for medical staff and driver; and
• Educate patient.

Health workers who have contact with DR-TB patients should know their HIV status. If they do not, they should be encouraged to be tested for HIV. Health workers who are HIV-positive should commence ART when appropriate and be screened every six months for TB and have a TB culture done at the time of ART initiation and on an annual basis.

3.5. Building Treatment Capacity to Meet the Increasing Burden of MDR-TB

It is clear that cases of MDR-TB are on the rise in South Africa. To meet this need, treatment services are being expanded to decentralised treatment facilities and community-based programmes are being developed and expanded. It is imperative that innovative approaches to expand access to MDR-TB treatment are explored.

Nurse-initiated treatment programmes are an important option that has proven successful for HIV management throughout the world. Data on nurse-initiated TB/HIV treatment are beginning to emerge in conference proceedings. South African researchers have documented the successful integration of a nurse-based screening algorithm for pulmonary TB compared with physician diagnosis, and a randomised controlled trial is now underway to evaluate PALSA-Plus nurse-led management strategies throughout primary health-care clinics.

The mounting evidence for nurse management coupled with the continued expansion of community-based MDR-TB programs compels key stakeholders to consider the most appropriate approaches to address the epidemiologic circumstances facing the country.

3.6. Conclusion

Issues addressed in this Section, Organisation of Services, are also covered in the Multi-Drug Resistant Tuberculosis: A Policy Framework on Decentralised and Deinstitutionalised Management for South Africa. Our MDR-TB services are still medical practitioner-driven. All MDR-TB patients are being initiated on treatment by medical practitioners. Given the high burden of MDR-TB in the country, we will gradually phase in nurse-initiated MDR-TB component to address this challenge.