TUBERCULOSIS PROGRAMME REVIEW (Joint Monitoring Mission)

Checklists to facilitate data collection during field visits to: Provincial and district level health offices Health facilites at all levels

Contents
1. 2. 3. Field visits during a TB programme review/Joint Monitoring Mission (JMM) ...................................... 3 Checklist to facilitate data collection during field visits during the JMM ............................................. 4 Checklist to be used during visits to Provincial and District Health offices .......................................... 6 3.1 TB Programme Management in the province/district .................................................................. 7 4. Checklists to be used during visits to health facilities......................................................................... 18 4.1 TB Programme management at health facilities ......................................................................... 19 4.2 TB case finding - identification of TB suspects in health facilities (all forms of TB including TB-HIV, MDR-TB and pediatric TB) ............................................................................................ 21 4.3 Quality assured laboratory ............................................................................................................ 24 4.4 Management of TB cases at health facilities (Treatment) .......................................................... 28 4.5 Interview with TB patients............................................................................................................ 32 4.6 Management of anti-TB medicines and supplies ......................................................................... 34 4.7 Infection control ............................................................................................................................. 37 4.8 Involvement of all care providers ................................................................................................. 39 5. Tables for data collection .................................................................................................................... 41 5.1 Case detection and laboratory .................................................................................................... 41 5.2 Human Resource Development................................................................................................... 46

This document has been developed by adapting checklists presented in the WHO draft publication
Framework for Conducting a TB Programme Review, WHO Geneva, January 2013 (WHO/HTM/TB/2012) version, as well as checklists used in Joint Monitoring Missions (JMMs) in SEARO and WPRO during the past 7-8 years and experiences gained during JMMs over the same period of time.

1. Field visits during a TB programme review/Joint Monitoring Mission (JMM)

The checklists presented in this document have been developed to facilitate data collection during the field visit part of a TB programme review or a Joint Monitoring Mission (hereafter referred to as JMM). The checklists aim to ensure that all relevant components of the work of the National Tuberculosis Control Programme (NTP) are covered during field visit in a standardized fashion across teams. However, it should be remembered that not all items included in the checklists are applicable everywhere and that the checklist are not supposed to be followed in a too strict way. The checklists are tools to facilitate the work and it is up to each member of the field visit team to use the checklist with care, sensitivity and discretion using his/her professional judgment. In general, each team should check for the following: Consistency Observe TB prevention, care and control services (hereafter called TB control services) and collect quantitative data for agreed upon time periods. Check for consistency between the data they collect and the data reported into the routine NTP reporting system. Quality Confirm their observations and findings, and check the quality of the data with which they are provided. Interviews with key personnel and record review can be used for this purpose.

The teams should verify information obtained from the briefing materials, background documents and presentations by TB programme staff, and data collected and analysed at the national programme level. Team members should record their findings, identify the strengths and weaknesses of the programme, analyze the reasons for these weaknesses, and propose solutions (recommendations). During field visits teams are very likely to be short of time! It is important to be aware of this important challenge. It is easy to get lost in the details of each team members favourite topic at a particular site. Remember that people will be waiting at the next field visit site. For many field visit sites it will be the first time external people visit. Make sure to clearly explain that the visit is not an inspection but that the visit is aiming at helping team members to try to understand what is happening in order to be able to be helpful in recommendations and debriefings. Team members are guests! If a team member has finished reviewing his/her assigned topics see if other team members need any assistance.

2. Checklist to facilitate data collection during field visits during the JMM
This document contains two types of checklists: 1. Checklist for use at provincial and district health offices for reviewing TB programme management. This checklist consists of the following sections: General information TB case detection and treatment outcomes Political commitment, planning and financing Recording and reporting Anti-TB medicines and supplies Supervision Pediatric TB TB-HIV collaborative activities MDR-TB Involvement of all care providers Human Resource Development Advocacy, Communication and Social Mobilization Research 2. Checklists for use at health facilities. Checklists covering the following topics are included: Programme management at the health facility TB case finding (all forms) Quality assured laboratory Management of TB cases (TB treatment)-(all forms Interview with TB patients Management of anti-TB medicines and supplies Infection control Involvement of all care providers The following issues should be noted: There is some repetition between the checklists for Provincial/District and the checklists for health facility level. The same checklist will be used at all heallth facilities irrelevant of size obviously not all questions apply to a small health centre. The reviewer shuld use the checklists with discretion.

Eackh team member should have one copy of the checklist. As the checklist covers all lelvels and all technical areas/programme components, answers to questions/observations should be noted separately. Specific areas assigend to tdifferetnt team memebrs based on thehir expertise Eacjh review member should read through the whoele checklist to be familiar with the scope of the review/assessment for all areas. This will aslso enable each team member to observe services more in general (beyond the scope of their own assigned technical areas). Time permitting (within the time allocated for each specific site visit), technical area experts can do a more detailed assessment using the detailed technical area specific checklists

Please review the checklists below and use those that apply to your assignment.

3.

Checklist to be used during visits to Provincial and District Health offices

The checklist below should be used during visits to Provincial and District Health Offices.

Select the relevant section of the checklist based on your assignment.

3.1 TB Programme Management in the province/district

Objective:
At the end of the mission, the reviewers should comment on: TB programme management in the province/district. What needs to be done to improve TB programme management in the province/district. Provincial/District Health Office (Office of the Provincial/District TB Coordinator) Provincial/District TB Coordinator

Location: Who:

Activities/Questions:

General:
1. Gather information on organization of TB prevention, care and control services in the Province/District. i. What is the size of the population served?

i. ii.

Number of districts (if applicable) List the different health facilities in this area. Include all public providers e.g. health centers and outpatient clinics (including general hospitals, specialty hospitals, medical colleges, health institutions under state insurance schemes, health facilities under public corporations, prison health services and military health services) and private providers (private hospitals and clinics, corporate health services, hospitals and clinics, CSO services, private practitioners, traditional healers, and informal providers). Number of hospital beds (for hospital / lung clinic) Number of out-patients per year Number of admissions per year (for hospitals/ lung clinics) Are all health facilities in the area implementing TB control services based on DOTS? If no, list those that are and explore reasons why some are not

ii. iii. iv. iii.

implementing TB control services based on DOTS (see also detailed checklist on Involvement of all care provides below). iv. v. How are TB control services coordinated between the facilities mentioned above? What are the major health problems in the Province/District?

TB case detection and treatment outcomes

1. Review current status and trends in TB case detection (all forms of TB, including pediatric TB, TB-HIV and MDR-TB) 2. Review current status and trends in TB suspect identification. 3. Review current status and trends in treatment outcome for all forms of TB.

Political commitment, planning and financing:

1. Is local government aware of/involved in/supportive of TB control in the district? If yes, how is it demonstrated? 2. Review the District TB Control plan. If there is no plan, explain why not? i. ii. Is there a long term plan as well as annual implementation plans? Does the plan include a specific section on scaling up the management of drugresistant TB? If not how is the scaling up planned? Which local partners have taken part in planning for TB control in the Province/District? Do these plans include a (five-year) budget What is the total health budget from the District government in 2012? What is the operational TB budget out of this total health budget? Which aspects of TB control are inadequately funded? What are the main sources of funding and what are the shares of the different sources

iii.

iv. v. vi. vii. viii.

ix. x.

Has donor funding for TB affected the commitment of local government funds for TB? Are there any activities in the province/district to increase political commitment/resource allocations for TB? 4.

3. Is there a national health security insurance scheme? If yes, has this affected service delivery for TB control? Please describe how. 4. What are the main barriers if any to effective operation of TB control services in your area? 6. How is TB integrated in the overall health plan/health planning in your area?

5.

7. 8. 7. Are TB control indicators featured prominently in routing report form the Provincial/District health department? If not why not?

Recording and reporting

1. Are the following recording and reporting forms available and used in the province/district? TB treatment card; TB laboratory register; District TB register; quarterly report on TB case registration ; quarterly report on TB treatment outcomes and TB/HIV activities; quarterly order form for TB medicines; quarterly order form for laboratory supplies; yearly report on programme management; quarterly report on sputum conversion (optional).

2. If routine culture and drug susceptibility testing are done at province/district, are the following recording and reporting forms available and used in the province/district? TB laboratory register for culture; TB register in BMI using routine culture and DST; quarterly report on TB case registration in the Province/Districts using routine culture; quarterly report on TB treatment outcomes and TB/HIV activities in Province/Districts using routine culture;

quarterly order form for culture and DST laboratory supplies in the Province/District

3. Find out about the reporting process at Provincial and District level. i. ii. iii. iv. v. Who is responsible for compiling quarterly and yearly reports? Where are these reports sent, and to whom? When are they sent? Which day of the month and how often? How are they sent? By mail or by messenger? Does the Province/District use a computer to compile the reports? If so, how is it used? Are reports printed and then sent by mail or by messenger? Is the data sent electronically?

4. Does the Province/District receive any feedback on quarterly reports submitted to regional or central level? If yes, what type of feedback is received? 5. On the quarterly report for TB case registration: i. ii. Are cases designated by age and sex? Are transferred in and chronic cases excluded?

6. Recount the number of TB patients with HIV status known and with HIV-positive status in the TB register, and compare with the last quarterly report for TB case registration. 7. Recount results of treatment on the TB register for the last reporting full quarter, and compare with the last quarterly report on treatment results. Ensure that reporting is complete and each patient is followed through to treatment outcome. 8. Are the number of patients on CPT and ARV recorded?

Management of anti-TB medicines and supplies

1. Who is in charge of receiving TB medicines and supplies? If that person is available, ask what the procedure is for verifying and documenting quantities received. i. Does the facility use a medicines/supplies register to track the delivery, receipt and movement of each item? Where do the TB medicine and supply orders come from (e.g. regional store or central NTP store)?

ii.

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iii.

How are HIV testing kits supplied?

2. What anti-TB first-line medications are available? Are second-line medicines available? 3. Are laboratory supplies and reagents kept in the store? If not, where are they stored? 4. Is there a stock register or card in the facility that keeps track of medicine and supply inventory? i. If yes, does it include information on: ii. quantities of medicines and supplies consumed by patients during the last order period; quantities ordered but not yet received; quantities received from previous orders; quantities loaned to other health facilities that will need to be replaced; expiry dates of medicines in stock.

Count physical stocks and compare with the stock amounts recorded on the stock register or card. If there is no stock register or card, compare quantities with supply order receipt records and patient treatment registers.

5. Inspect the drug storage area: i. What is the temperature of the area? Is the area humid? Are medicines directly exposed to direct sunlight? Inspect the tablets are the colors of the medicines appropriate? Has the color faded? Are the tablets crumbling or do they give off unusual odors Are medicines organized on the shelves so that it is easy to read the product name and expiration date? Is there any air circulation in the storage area? Air conditioner? Open window? Exhaust fan? Space between shelves? Is the storage area secure? Is a lock installed on the door and is it used? If there are windows, are they able to be locked or have bars installed? Are medicines stored on the floor? Are drug containers stacked on top of one another? Are insects, rodents or other pests found in the drug storage area?

ii.

iii.

iv.

v.

vi.

vii.

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viii.

Is there potential for stock to be destroyed by rain or floods?

6. Is stock rotated using the first expiring, first out (FEFO) principle? Inspect a few patient kits to ensure that FEFO is being used for the kits. i. What is done with expired medicines or supplies?

7. Are TB patient kits used? If yes, how are they organized? i. ii. iii. Do they use fixed-dose combination (FDC) blister packs? Can the kits be easily accessed on the shelf or in the storage area? Are syringes and other supplies (e.g. water for injection) included for Category II patients? Is the kit adjusted for the patients weight? Are medications adjusted as weight increases? Is the patients name listed on the outside of the kit? Is the shortest expiry date of all medicines listed on the outside of the kit? What is done with excess medicines from the patient kit?

iv.

v. vi. vii.

8. Is there a buffer or safety stocks of anti-TB medicines? If yes, what is the duration or amount of the buffer stock (e.g. 3 months)? 9. Have there been any medicine stock-outs in the past year? If so, which medicines were affected, and for how long? Explore the reasons for the stock-outs (e.g. incorrect ordering, late deliveries from regional or central store or expired medicines).

10. Have you borrowed any anti-TB medicines from a nearby facility in the past year? Have any facilities borrowed medicines from you over the past year?

11. How are anti-TB medicine orders calculated? How are buffer or safety stock quantities calculated? 12. What anti-TB medicines are available for children? Are pediatric anti-TB medicine formulations available? Alternatively, are adult tablets broken in half for children?

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Supervision
1. Review supervision activities in the province/district

i.

How many TB supervisors are there in the province/district?

ii. iii.

Are supervisory activities organized in collaboration with other programmes? Are there annual plans for supervisory visits? If yes review the plan for the current year. If no plans explain why. Are visits scheduled based on the NTP standard? Have visits been conducted according to plans. If not explain why not. Are standardized checklists used during supervisory visits? If yes review a set of checklists from recent supervisory visit. Are problems clearly described? Are actions to correct problems clearly indicated including who is responsible to do what? If not checklists are used explain why not. What is the most common problem found during supervisory visits in the past 12 months? What has been done to correct this problem?

iv.

v.

Pediatric TB
1. At what level of the health services is child TB diagnosed: Primary Secondary Tertiary

2. Number of cases of child TB managed each month/year? Province District Primary health centre

3. What data are available of child TB in previous year(s)? Year Age groups 0-4 years 5-14 years Type of TB PTB SS+ PTB SSEPTB

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4. What are the common types of EPTB in children? 5. Is child TB managed in the private sector (if yes, try to quantify)? 6. What are the common causes of hospital admission and/or mortality in children?

TB-HIV collaborative activities:

1. Review TB/HIV collaboration in the Province/District: i. Have a mechanism for TB/HIV collaboration been established? If yes, please describe e.g., type of mechanism (coordinating body, working group etc.) Are joint planning activities being carried out? If yes, please describe. Are monitoring and evaluation of TB/HIC collaborative activities being conducted? If yes, please describe. How are TB-HIV collaborative activities being recorded and reported? Are VTCs, ANCs and pother settings where HIV infected people are concentrated screening their clients and patients for sign and symptoms of TB? Is Isoniazid preventive therapy being offered to HIV infected people after active TB has been excluded? Is Cotrimoxazole preventive therapy being offered to HIV-infected TB patients? Are HIV/AIDS care and support services being made available to HIV infected TB patients? Are other organizations/groups involved in TB-HIV collaborative activities in the Province/District? If yes, please list.

ii. iii.

iv. v.

vi.

vii. viii.

ix.

MDR-TB

1. Review management of drug resistant TB (MDR-TB) in the Province/District:

14

i.

Is there a designated Health Facility for MDR-TB management?

ii. iii.

Are patients referred to other facilities designated by the NTP? What is the procedure for managing a patient suspected of having drug-resistant TB? How is communication and referral of patients organized between different health facilities in the Province/District?

iv.

2. If patients are managed in the Province/District, how are lab confirmed MDR-TB patients treated? Are second-line anti-TB medicines available? i. ii. iii. Are MDR-TB patients managed as inpatient or as ambulatory patients? How is DOT organized? In the intensive phase? In the continuation phase? If patients are treated with second-line medicines:

Are treatment adverse effects reported on the TB treatment card or in the TB

register?

Are medicines for management of adverse effects of second-line medicines

available? iv. If culture services are available, are follow-up cultures done on time (every month during the intensive phase and every 2 months during continuation phase) and recorded in the TB register? If MDR-TB patients are treated, is there capacity to provide isolation for the patients while on inpatient treatment?

v.

Involvement of all care providers

1. Are operational guidelines on public-public/public-private collaboration from the NTP available and used? Have they been adapted for the local level and experience? 2. Have local public and non-public providers been mapped out? 3. Have providers been selected for active collaboration and training? If yes, how were the providers selected? 4. Have public/private providers (non-NTP) participated in TB trainings led by NTP?

15

5. Do private/public providers (non-NTP) refer patients to the TB clinic? 6. Do private/public providers (non-NTP) manage TB patients? Do they provide DOT to TB patients? 7. Do private sector laboratories diagnose smear-positive TB patients? How do they collaborate with the NTP or TB clinic? 8. Do private/public providers (non-NTP) use standard NTP forms and registers? 9. Do private/public providers (non-NTP) provide HIV testing for TB patients? 10. Does the TB manager supervise private/public providers (non-NTP) that diagnose, refer or treat TB patients? How often do supervisory visits take place? 11. Does the NTP provide TB medicines and other supplies (i.e. laboratory supplies) to private/public providers (non-NTP)? 12. Is the International Standards for TB Care known? Are the standards used or disseminated to private/public providers (non-NTP)? If yes, have providers been trained on use of the standards?

13. Are professional organizations involved in work with the NTP in the Province/District?

Human Resource Development:

1. Review the staffing situation and the training of staff for all aspects of TB prevention, care and control: i. Which categories of staff and how many of each category, are involved in TB control activities in the province/district (all aspects of TB prevention, care and control)? (E.g.2 nurses, 1 medical doctor, 1 laboratory assistant For each staff member mentioned in question 1 above indicate if they have been trained, and if yes when and where). (E.g. 1 nurse: trained in January 2012 in XX district) Are there any staff positions - for staff involved in TB control - vacant? If yes, please describe which position and for how long the post has been vacant. Are there any unmet training needs in the province/district? Are there any unmet staff needs for TB control? If yes please indicate for what kind of work.

ii.

iii.

iv. v.

16

vi.

Are there up to date training plans addressing on-going training needs for the province/district? If no, please explain. 3.

2. What regular activities for on-going medical education/continuing education are organized for staff involved in TB control to ensure that staffs are up to date on TB control strategies and interventions?

Advocacy Communication Social Mobilization (ACSM): 1. Is ACSM activities included in your Province/District TB plan? ID yes please describe what activities; if not explain why not. 2. Are any TB-support or patient centred organizations/networks engaged in TB control activities in the Province/District? If yes please describe. 3. Are any other stakeholders engaged in TB control activities in the Province/District? If yes please describe 4. Describe activities on World TB day. 5. Review any advocacy activities (other than Work TB Day) undertaken in the Province/District in the past year. 6. Review availability of IEC material: what material is available and how is it distributed to heath facilities? 7. Describe specific activities undertaken to engage and involve the community in TB control activities. 8. Is there any collaboration with/involvement of Civil Society Organizations in TB control activities in the Province/District? If yes please describe.

Research

1. Describe any operational research activities in the Province/District

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4. Checklists to be used during visits to health facilities

The checklists below should be used during visits to health facilities.

Select the relevant checklist based on your assignment.

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4.1 TB Programme management at health facilities

Objective: At the end of the mission, the reviewers should comment on: TB programme management at health facility level What needs to be done to improve management of TB control activities at health facility level. Provincial/District hospitals, Health centres, Sub health centres or similar Person in charge of the facility and health workers

Location: Who:

Activities/Questions:

1. Gather information about the general situation of the health facility: vi. vii. viii. ix. x. xi. xii. Population of the area served by the institution Other public health services in the area (list types) Other private health services in the area Number of beds (for hospital / lung clinic) Number of out-patients per day/month/year Number of admissions per day/month/year (for hospital / lung clinic) What are the major health problems in the area served by the institution

4. Review trends in TB suspect identification for the facility. 5. Review trends in case detection (TB smear positive and smear negative; EPTB, TB-HIV; MDR-TB and TB in children). 6. Review trends in treatment outcome for all forms of TB. 7. Review supervision, both supervisory visits received from the district level and supervisory visits done by this health facility:

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i.

How often is the District TB coordinator/District supervisor visiting this health facility? When was the last visit? Are standardized checklists used during supervisory visits? If yes review a set of checklists from recent supervisory visit. Are problems clearly described? Are actions to correct problems clearly indicated including who is responsible to do what? If not checklists are used explain why not. What is the main problem(s) found during supervisory visits to this health facility in the past 12 months? What has been done to address the problem(s)? Is staff from this facility supervising community volunteers and/or TB treatment supporters? If yes, please describe who is visiting whom. Are there annual plans for the supervisory visits mentioned in question (viii) above? If yes review the plan for the current year. If no plans explain why. Are visits scheduled based on the NTP standard? Have visits been conducted according to plans. If not explain why not. Are standardized checklists used during supervision of community volunteers and/or TB treatment supporters? If yes review checklists from recent supervisory visits. Are problems clearly described? Are actions to correct problems clearly indicated including who is responsible to do what? If not checklists are used explain why not.

ii.

ii.

iii.

iv.

v.

vi.

8. Review the staffing situation and the training of staff: vii. Which categories of staff and how many of each category, are involved in TB control activities in this health facility? (E.g.2 nurses, 1 medical doctor, 1 laboratory assistant For each staff member mentioned in question 1 above indicate if they have been trained, and if yes when and where). (E.g. 1 nurse: trained in January 2004 in XX district) Are there any staff positions - for staff involved in TB control - vacant? If yes, please describe which position and for how long the post has been vacant. Are there any unmet staff needs for TB control? If yes please indicate for what kind of work.

viii.

ix. x.

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4.2 TB case finding - identification of TB suspects in health facilities (all forms of TB including TB-HIV, MDR-TB and pediatric TB)
Objectives: At the end of the assessment the reviewers should comment on: coverage of TB control services (equity and access); where cases are being missed and estimates of under-reporting, if available; what needs to be done to improve case finding. Specialized and non-specialized outpatient clinic of health facility (hospital, health centre etc.) Health-care workers (doctors, nurses, medical assistants and clinical officers etc.)

Location: Who:

Activities/Questions:
1. Interview health-care workers to find out how they identify TB suspects. What are the clinical criteria for a person suspected of having TB (e.g. cough for more than 2 weeks)? What are the clinical criteria for TB in an HIV-positive patient? 2. Are MDR-TB suspects identified? If yes what are the criteria used?

3. Are children suspected of having TB? If yes, what are the criteria used? 4. If an outpatient register (or similar register) is available, ascertain the proportion of health-care seekers who: i. ii. iii. present with respiratory symptoms; are classified as TB suspects; are referred for sputum examination.

5. Identify the coordination between the outpatient clinic and laboratory services. i. ii. Are Request for sputum examination forms available and used? What is the procedure for sputum collection? Where is sputum collected? Observe whether sputum is collected in well-ventilated areas or outside the building.

21

iii.

If responsible for collecting sputum Are sputum collection containers adequate? How are they labeled? Who is responsible for instructing the suspects on how to produce the sputum? If responsible for collecting sputum What is the procedure for sputum collection, storage and transport to the laboratory? How often are specimens transported? Daily? Weekly?

iv. v.

4. Is the Register of TB suspect used, or a similar register that records name and address of suspect, HIV test result, date sputum collected, date sputum sent to laboratory, date results received from laboratory, and results of sputum examination? 5. Does staff use the suspect register or the laboratory register to monitor suspect screening and to take action?? Determine chest radiography availability and use. If this is not available, are suspects referred elsewhere for chest radiography if it is needed? If so, how does the referral procedure work and how are results communicated back to the referring facility? Is HIV testing provided (provider initiated) for TB suspects? How are results of diagnostic tests provided to the person suspected of having TB? What is the average time between a positive test result and the start of treatment?

6.

7. 8. 9.

10. How are MDR-TB suspects managed? i. Are MDR-TB suspects referred immediately to next referral level or are MDR-TB suspects managed at this facility until a diagnosis has been made? What infection control measures are taken during the diagnostic process?

ii.

11. Are any risk groups (e.g. migrants, refugees or ethnic minorities) systematically screened for TB? 12. Is NTP collaborating with other programs (other than HIV/AIDS), such as MCH, diabetes control etc. for TB screening of clients? 13. Review management of children suspected of having TB: i. What are the common clinical presentations of TB in children?

ii.

Assessment of children with suspected TB: a. where? by whom? How?

22

iii.

What routine investigations are ordered for child TB suspects? a. Is sputum sent for microscopy? Sometimes Never

b. If taken, by what method(s) is sputum taken? b. Do you have tuberculin solution available? c. CXR available Y Y N N

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4.3 Quality assured laboratory

Objective: At the end of the assessment, the reviewers should comment on: coverage of laboratory services; quality assurance (QA) of diagnosis; what needs to be done to strengthen the laboratory network. Microscopy centre or laboratory facility Laboratory manager or director, laboratory technicians

Location: Who:

Activities/questions:
1. Determine information on general laboratory operations, workload, tasks and staff. i. ii. What is the catchment area and population served? How many technicians work in the laboratory, and what qualifications do they have? What is their workload? What is the proportion of time each technician devotes to processing of AFB specimens? How many microscopy centres are there? What is the number and percentage of population coverage? How many sputum specimens are processed daily? Weekly? Monthly? How many smears (number) are performed during the reporting period? Have the technicians received special training on AFB sputum collection and microscopy? If yes, when was the training and who provided it? Observe general biosafety conditions of the laboratory. Is airflow appropriately directed? Are the smears prepared and stained, and reagent stored, in an appropriate area?

iii.

iv.

v.

2. Are standardized laboratory guidelines and standard operating procedures (SOP) for AFB (and culture and DST, if appropriate) specimen processing available and used? If yes, ask to see a copy;. Are the guidelines prepared by the national reference laboratory? 3. Are laboratory technicians or staff responsible for collecting sputum from patients? If yes:

24

i.

Review specimen collection procedures. Are specimens collected using spot, early morning, spot timing (depending on whether the policy is two or three sputum samples) Where is sputum collected? Observe whether sputum is collected in wellventilated areas or outside the building. Are sputum collection containers adequate? How are they labeled? Who is responsible for instructing the suspects on how to produce the sputum?

ii.

iii. iv.

3. If the laboratory receives sputum specimens from an outpatient clinic or facility: i. ii. iii. How is the specimen delivered to the laboratory? What times is the laboratory open to receive the specimen? What is the usual turn-around time from when a specimen is received to reporting of results? How are results reported back to the clinic of the health-care facility?

iv.

4. Observe the equipment: i. What type of microscope is used standard light or fluorescent? If standard light, what is the quality of the microscope? How old is it? Is it monocular or binocular? What is the light source? Ask the technician to show you a positive AFB slide and observe the quality under the microscope. Are microscope slides re-used? Observe how the slides are labeled and stored. How long are the slides kept for?

ii.

5. Review quality and supply of laboratory reagents. Are the reagents prepared centrally or locally? Please describe the process. 6. Review the laboratory register. (Ask to use the register for the remainder of the visit as it will be needed to cross-check patients in the TB register): i. Are the following fields available and used: date specimen received, name and address of patient, name of referring facility, reason for sputum smear microscopy exam, result, District and TB register number (for new diagnosed and registered patients)? Does each patient have at least three sputum smear examination results?

ii.

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iii.

Are results quantified as: (NEG): 0 AFB/100 fields; (19) exact number if 19 AFB/100 fields; (+): 1099 AFB/100 fields; (++): 110 AFB/ field; (+++): > 10 AFB/ field? Count the number of smears done during the last month and compare with the same month smears done one year previously, to measure the workload. If there is a significant difference, discuss this with the laboratory technician. What is the proportion of positive suspects (i.e. people with at least one positive smear) out of all suspects examined? Does the laboratory participate in any QA procedures? If so, describe these. Is feedback on results of QA provided to the laboratory technician in a timely manner? Review any recent QA results. For less-than-adequate results, was refresher training or supervision offered to the laboratory technician?

iv.

v.

vi.

For laboratories performing culture or culture/DST: [Note:. If the advisor is presented with a laboratory that is performing culture or DST (or both), the following general questions can be asked in preparation for a more thorough review by an expert at a later time. 1. Is a laboratory expert performing the monitoring and supervision of these laboratories? Are any other tests besides smear microscopy/culture/DST are being implemented. If yes, which ones? 2. What is the general organization of the laboratory? What is the link with the national reference laboratory (NRL) or supranational reference laboratory (SNRL)? 3. How many technicians are designated for culture? How many for DST? Have the technicians received special training on culture and DST? If yes, when was the training provided and who provided it? 4. Review infrastructure and environment conditions of laboratory including water source, electricity, general maintenance, safety and management of wastes. 5. What is the quantity and quality of equipment, supplies and reagents? 6. Are there contracts and logbook for maintenance available? If so, review. 7. Is a manual or SOPs for culture and DST available? If so, are the SOPs ones recommended by NRL or SNL? If so, please attach them to the mission report. 8. What infection control procedures are in place for: i. transportation and management of specimens;

26

ii. iii. iv.

maintenance of biosafety cabinet and culture room; ventilation, negative pressure, control and maintenance of high-efficiency particulate air (HEPA) filters; ensuring adequate stock and use of personal protection including respirators and masks.

9. Are external quality assurance procedures in place with a reference laboratory? Please describe the procedure.

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4.4 Management of TB cases at health facilities (Treatment)

Objective: At the end of the mission, the reviewers should comment on: management of treatment of TB, including TB/HIV co-infected patients. what needs to be done to improve management of TB cases at the facility. Health facilities managing TB patients Health workers (any category) responsible for patient management

Location: Who:

Activities/questions:
1. How many patients are on DOT and what type of DOT (health facility, community, family)? 2. Are treatment supporters trained? If so, how? Are they supervised? If so, how? Do treatment supporters receive any incentives? 3. Are fixed-dose combination anti-TB medicines used? Are patient kits used? 4. Do patients receive incentives or enablers (e.g. food, transport vouchers or money) during their treatment for TB? If yes, what do they receive? Who provides it (TB clinic, local CSOs, etc.)? 5. Are the following recording and reporting forms available and used at the health facility? request for sputum smear microscopy examination; request for sputum smear microscopy examination, culture, DST (if relevant); TB treatment card; TB identity card; TB treatment referral or transfer; register of TB suspects; register of TB contacts; register of referred TB cases.

6. Review a cohort of TB treatment cards, including patients currently on treatment and patients who have completed treatment. Cross-check the TB treatment cards with the TB register and the Laboratory register to ensure that information is properly recorded on the TB treatment card.

28

i.

Are TB treatment cards being used that include information on referrals, Cotrimoxazole and antiretroviral treatment (ART), date and result of HIV test, date starting CPT and ART, X-ray date and results, and HIV care information? Review the procedure for ticking boxes on TB treatment card, recording that medicines have been administered. Are treatment cards of TB patients treated in peripheral or satellite units returned and archived in the main TB unit?

ii.

iii.

7. Review TB treatment cards for a selection of patients who defaulted or failed treatment, to verify that patients were appropriately managed. 8. Is there a system to retrieve patients who have not collected their medication or presented to the health facility when required (default tracing)? If so, how is it carried out? By whom? 9. What is the process for patients who transfer to another District? Is the TB treatment referral/ transfer form used? Is the treatment outcome of all transferred patients communicated to their initial District? 10. Are contacts of smear-positive patients investigated and screened for TB? 11. Review treatment of TB-HIV co-infected patients: i. ii. Is co-trimoxazsole preventive therapy being offered to HIV-infected TB patients? Is there a referral mechanism for HIV-positive TB patients who need HIV care and support? Are patients co-infected with TB and HIV systematically offered ART irrelevant of CD4 count? How is TB treatment managed in an HIV positive patient already on ART?

iii.

iv.

12. Review treatment of MDR-TB patients i. ii. Are MDR-TB patients managed as inpatient or as ambulatory patients? How is DOT organized? In the intensive phase? In the continuation phase?

29

iii.

If patients are treated with second-line medicines:

Are treatment adverse effects reported on the TB treatment card or in the TB

register?

Are medicines for management of adverse effects of second-line medicines

available? iv. If culture services are available, are follow-up cultures done on time (every month during the intensive phase and every 2 months during continuation phase) and recorded in the TB register? If MDR-TB patients are treated, is there capacity to provide isolation for the patients while on inpatient treatment? How many patients are on DOT and what type of DOT (health facility, community, family)? Are treatment supporters trained? If so, how? Are they supervised? If so, how? Do treatment supporters receive any incentives? Do patients receive incentives or enablers (e.g. food, transport vouchers or money) during their treatment for TB? If yes, what do they receive? Who provides it (TB clinic, local CSOs, etc.)?

v.

vi.

vii.

viii.

13. Review treatment of children with TB: i. ii. iii. What regimens are used to treat children with TB? Are medicines available to treat TB in children? What are common problems with adverse events/tolerance?

iv. v. vi. vii.

What are outcomes and adherence Pediatric TB/HIV (data, services, screening for HIV, screening for HIV) Pediatric MDR TB (data, management issues, outcomes, challenges) Are children treated for TB routinely registered with the NTP? Always Sometimes Rarely

viii.

What are the main challenges for the management (diagnosis or treatment) of TB in children?

30

14. Review availability of health education material on TB (posters, pamphlets etc.) 15. Review contact investigation procedures: i. Are TB patients routinely asked about contacts? If yes, where is information recorded? How are contacts screened? Among all the TB cases registered in the last year, how many were identified through TB contact investigation? Is chemoprophylaxis provided to TB contacts? If yes, to which category of TB contacts? and which chemoprophylaxis How many TB contacts were administered chemoprophylaxis within the last year? How many of them completed the chemoprophylaxis?

ii. iii.

iv.

v.

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4.5 Interview with TB patients

Objective: At the end of the mission, the reviewers should comment on: information and management of patients by health staff from the patients perspective; cost to patient for diagnosis and treatment; what needs to be done to improve accessibility to and quality of care. Hospital ward, TB outpatient clinic, health centres Current TB patients

Location: Who:

Activities/Questions:
1. Interview, if possible, a selection of patients, both inpatient and outpatient, and if possible, with their treatment cards. The patient should be told that the interview is voluntary, any information provided will remain confidential, and permission will be asked before taking photographs. The interview should be a dialogue with the patient, and the patient should be told why these questions are being asked. i. ii. iii. Do you know that you are undergoing treatment for TB? Do you know the correct duration of treatment for their TB disease? Do you take your medication under direct observation? Is it convenient in terms of time and location? Do you pay for TB medicines or other health facility fees? Are you taking public or private transportation to the clinic; if so what is the cost? Do you incur other costs directly related to their TB disease? Have you ever been treated for TB in the past? Do you have any thoughts as to how you were infected with TB? Where did you go to seek care when they first became ill? How much time passed between the first onset of symptoms and the first seeking care?

iv.

v.

vi. vii.

32

viii.

How much time passed between the first contact between the health services and the diagnosis of TB? How much time passed between the diagnosis and the start of treatment? Have you received any information about your TB disease and treatment? Do you receive any incentives or enablers (e.g. food, transport vouchers or money)? What are attitudes in your family and your community concerning TB? Do you feel stigma or discrimination because of the disease?

ix. x. xi.

xii.

2. Do you have any questions or concerns that you would like to discuss? Remember to thank the patient for their time and their willingness to answer the questions and provide information to help improve TB control services.

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4.6 Management of anti-TB medicines and supplies

Objective: At the end of the mission, the reviewers should comment on: availability of medicines (including for children and 2d line medicines) and past medicine shortages; availability of supplies and stock out; overall medicine management system and supplies management system; what needs to be done to improve medicines and supplies management. TB clinic pharmacy or drug store Private pharmacies Pharmacists/drug storage workers

Location: Who:

Activities/Questions:
1. Who is in charge of receiving TB medicines and supplies? If that person is available, ask what the procedure is for verifying and documenting quantities received. iv. Does the facility use a medicines/supplies register to track the delivery, receipt and movement of each item? Where do the TB medicine and supply orders come from (e.g. regional store or central NTP store)? HIV testing kits and how are they supplied?

v.

vi.

2. What anti-TB first-line medications are available? Are second-line medicines available? 3. Are laboratory supplies and reagents kept in the store? If not, where are they stored? 4. Is there a stock register or card in the facility that keeps track of medicine and supply inventory? iii. If yes, does it include information on: quantities of medicines and supplies consumed by patients during the last order period; quantities ordered but not yet received; quantities received from previous orders;

34

 iv.

quantities loaned to other health facilities that will need to be replaced; expiry dates of medicines in stock.

Count physical stocks and compare with the stock amounts recorded on the stock register or card. If there is no stock register or card, compare quantities with supply order receipt records and patient treatment registers.

5. Inspect the drug storage area. ix. What is the temperature of the area? Is the area humid? Are medicines directly exposed to direct sunlight? Inspect the tablets are the colors of the medicines appropriate? Has the color faded? Are the tablets crumbling or do they give off unusual odors Are medicines organized on the shelves so that it is easy to read the product name and expiration date? Is there any air circulation in the storage area? Air conditioner? Open window? Exhaust fan? Space between shelves? Is the storage area secure? Is a lock installed on the door and is it used? If there are windows, are they able to be locked or have bars installed? Are medicines stored on the floor? Are drug containers stacked on top of one another? Are insects, rodents or other pests found in the drug storage area? Is there potential for stock to be destroyed by rain or floods?

x.

xi.

xii.

xiii.

xiv.

xv. xvi.

6. Is stock rotated using the first expiring, first out (FEFO) principle? Inspect a few patient kits to ensure that FEFO is being used for the kits. ii. What is done with expired medicines or supplies?

7. Are TB patient kits used? If yes, how are they organized? viii. ix. x. xi. xii. Do they use fixed-dose combination (FDC) blister packs? Can the kits be easily accessed on the shelf or in the storage area? How many months of treatment are included? Are syringes and other supplies (e.g. water for injection) included for Category II patients? Is the kit adjusted for the patients weight? Are medications adjusted as weight increases?

35

xiii. xiv. xv.

Is the patients name listed on the outside of the kit? Is the shortest expiry date of all medicines listed on the outside of the kit? What is done with excess medicines from the patient kit?

8. Is there a buffer or safety stocks of anti-TB medicines? If yes, what is the duration or amount of the buffer stock (e.g. 3 months)? 9. Have there been any medicine stock-outs in the past year? If so, which medicines were affected, and for how long? Explore the reasons for the stock-outs (e.g. incorrect ordering, late deliveries from regional or central store or expired medicines). 10. Have you borrowed any anti-TB medicines from a nearby facility in the past year? Have any facilities borrowed medicines from you over the past year? 11. How are anti-TB medicines orders calculated? How are buffer or safety stock quantities calculated? 12. What anti-TB medicines are available for children? Are pediatric anti-TB medicine formulations available? Alternatively, are adult tablets broken in half for children?

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4.7 Infection control

Objective: At the end of the mission, the reviewers should comment on: the administrative measures in place, especially for enabling early detection of active TB cases; measures in place at facility level for reducing the transmission of Mycobacterium by infectious cases; existence of measures implemented in relation to health-care workers. Outpatient clinic of health facility, hospital ward, any health facilities with TB suspects or patients Health workers, TB manager

Location:

Who:

Activities:
1. Is the facility implementing workplace and administrative infection control measures? i. Does the facility have an infection control plan? Is there a person in charge of infection control in the facility? (If yes, this person should be interviewed). What coordination or communication is there between the TB and HIV programmes in regards to infection control? Is there a triage plan in place, to separate people with TB symptoms from other patients in the health facility? Are HIV-infected people and other at-risk patients separated from TB suspects and patients? Is cough hygiene taught to and practiced by TB patients? Does the facility try to minimize the time that an infectious patient is at the facility? Are patients provided with TB educational materials Are the staff knowledgeable about the signs and symptoms of TB, and about TB infection control

ii.

iii.

iv.

v. vi. vii. viii.

37

2. Is the facility implementing environmental infection control measures (waiting areas, treatment rooms, ventilation, and flow of patients)? i. ii. Is there ventilation in the facility? If yes, what kind (natural or mechanical)? Is there evidence of air filtration (air cleaners, HEPA filters in high-risk areas such as isolation rooms, sputum induction rooms, bronchoscopy and surgical suites, and autopsy suites)? Is ultraviolet germicidal irradiation (UVGI) used?

iii.

3. Is the facility implementing personal protective infection control measures? i. Are respirators available and used? If yes, what kind, where are they used, and who uses them? Do health-care workers undergo a fit testing programme, and perform regular fit checks when using the respirators Do patients use surgical masks? Are surgical masks used by health-care workers or staff?

ii.

iii.

4. Does the facility regularly record the proportion of health workers who developed TB in a given time period? Is there a health worker TB registry? 5. Are health workers provided with a package of prevention and care interventions for including HIV prevention, ART and IPT for HIV-positive health workers? 6. Are health workers engaging key implementation partners (including Civil Society Organizations) to increase awareness of infection control in congregate settings, especially in communities with a high burden of TB to reduce risk of TB transmission. 7. Review procedures for waste disposal including syringes and needles.

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4.8 Involvement of all care providers

Objective: At the end of the mission, the reviewers should comment on: collaboration of publicpublic and publicprivate providers; scope and quality of collaboration;

what needs to be done to improve collaboration among different providers. Location: Private-public facilities that refer, diagnose, or manage TB patients

Who:

Private/public providers, staff at these facilities

Activities/questions
1. Are operational guidelines on public-public/public-private collaboration from the NTP available and used? Have they been adapted for the local level and experience? 2. Have local public and non-public providers been mapped out? 3. Have providers been selected for active collaboration and training? If yes, how were the providers selected? 4. Have public/private providers (non-NTP) participated in TB trainings led by NTP? 5. Do private/public providers (non-NTP) refer patients to the TB clinic? 6. Do private/public providers (non-NTP) manage TB patients? Do they provide DOT to TB patients? 7. Do private sector laboratories diagnose smear-positive TB patients? How do they collaborate with the NTP or TB clinic? 8. Do private/public providers (non-NTP) use standard NTP forms and registers? 9. Do private/public providers (non-NTP) provide HIV testing for TB patients? 10. Does the TB manager supervise private/public providers (non-NTP) that diagnose, refer or treat TB patients? How often do supervisory visits take place?

39

11. Does the NTP provide TB medicines and other supplies (i.e. laboratory supplies) to private/public providers (non-NTP)? 12. Is the International Standards for TB Care known? Are the standards used or disseminated to private/public providers (non-NTP)? If yes, have providers been trained on use of the standards? 13. Are professional organizations involved in work with the NTP in the Province/District?

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5. Tables for data collection

5.1 Case detection and laboratory

Health Facility Level

Number of TB patients treated in 2012 Patients diagnosed in 2011 History of previous TB treatment Results of smear microscopy No of cases No of sputum specimens collected and sent to DHC + No + Yes + Patients diagnosed in 2012 No + Yes

District Level
Case-finding (2012) Previous history of TB treatment Total No No of persons investigated for TB Smear positive(+) No of TB cases found Smear negative() Subtotal No of smears examined No of AFB positive smears found Case notification
New cases Year SM+ 2012 2011 PTB SM Both EPTB Others SM+ Retreatment cases PTB SM Both Total EPTB Others

Yes

41

PTB= pulmonary TB; EPTB= extra pulmonary TB; SM+= smear positive; SM= smear negative The figures in gray shade may not be available or exist, but obtain the data if any. Diagnostic and follow-up smear microscopy (2012)
No of smears examined 3 Diagnostic smear microscopy 2 1 All 2 Follow-up smear microscopy 1 All Total Cases with positive smear(s) 3 2 1 All Cases with all negative smears No of smears examined Positive Negative Both

Follow-up smear microscopy of the patients (2011 cohorts) by month

Patient categories No of cases Smear microscopy No examined SM+ new cases No positive SM+ retreatment cases No examined No positive No examined SM cases No positive Follow-up smears by month 2 3 5/6 6/8

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Provincial level:
Case-finding in the province (2012) Previous history of TB treatment Total No No of persons investigated for TB Smear positive(+) No of TB cases found Smear negative() Subtotal No of smears examined No of AFB positive smears found In the provincial hospital/ laboratory (2012) Previous history of TB treatment Total No No of persons investigated for TB Smear positive(+) No of TB cases found Smear negative() Subtotal No of smears examined No of AFB positive smears found Yes Yes

Notified TB cases in the province

New cases Year SM+ 2012 2011 PTB EPTB SM Both Others SM+ SM Both Retreatment cases PTB EPTB Others Total

PTB= pulmonary TB; EPTB= extra pulmonary TB; SM+= smear positive; SM= smear negative The figures in gray shade may not be available or exist, but obtain the data if any.

43

Diagnostic and follow-up smear microscopy in the provincial hospital/ laboratory (2012)
No of smears examined 3 Diagnostic smear microscopy 2 1 All 2 Follow-up smear microscopy 1 All Total Cases with positive smear(s) 3 2 1 All Cases with all negative smears No of smears examined Positive Negative Both

Follow-up smear microscopy of the patients (2011 cohorts) by month in the province
Patient categories No of cases Smear microscopy No examined SM+ new cases No positive SM+ retreatment cases No examined No positive No examined SM cases No positive Follow-up smears by month 2 3 5/6 6/8

44

Follow-up smear microscopy of the patients (2011 cohorts) by month in the provincial hospital
Patient categories No of cases Smear microscopy No examined SM+ new cases No positive SM+ retreatment cases No examined No positive No examined SM cases No positive Follow-up smears by month 2 3 5/6 6/8

Quality assurance - How many DHC laboratories have been assessed in 2012? - How many labs showed 1 or more major errors by EQA in 2012? - What action and how many times have undertaken at DHC labs shown major error(s)? - Provide EQA data sets (2012)
Name of DHC lab SM volume Total + The slide sample for EQA Total + *Action taken

HFN

LFN

HFP

LFP

QE

*Number of supervisory visits

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5.2

Human Resource Development

Staff Positions and Training for TB-related Activities1

Category of staff involved in 2 NTP

Number of positions established/ 3 sanctioned (a)

Of them (a), number of positions filled

Of them (a), number trained in NTP in the past 12 months

4

Total trained in NTP

A. ALL HEALTH FACILITIES Medical Officer Registered Nurse/Registered Midwife/Enrolled Nurse/Enrolled Midwife Health Assistant/Medical Assistant/Clinical Officer Laboratory Technician/ Microscopist Pharmacist Counsellor Other staff categories (specify 5 below)

46

B. District LEVEL District TB Coordinator TB/HIV Coordinator Laboratory Supervisor Supervisor Drug Store Manager Statistical Assistant Other staff positions (specify below)

1 Health facility to fill in section A; District Level to fill in Section A with cumulative data for all health facilities in District plus district-specific positions. 2 Including private providers, community workers, etc. 3 Part time posts are considered as one position. 4 Trained in NTP is defined as having attended a standardized competency (skills)-based training course designed by NTP for the specific job functions according to the NTP manual. 5 If TB-HIV collaborative activities are part of NTP, add additional staff categories as relevant based on job functions.

Note Similar form for Provincial Level should be filled with cumulative data for all health facilities in province, Section B with cumulative data for all BMU in province plus province-specific positions.

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48