Amendment 4 to RFP_HE176-09-005.doc

SCHEDULE

1. In the SCHEDULE, under “SECTION J– LIST OF ATTACHMENTS, ATTACHMENT 20 Questions and Answers in regards to the RFP” add the following:

“25. Question: I will appreciate if you can help me to clarify the USAID official rules and regulations regarding the issue of personnel being on more than one proposal. Will it be a problem on USAID’s side if the same person is listed in two different proposals? For example, one contractor plans to recommend the individual for the COP and the other will recommend the individual for a specialized technical or administrative position.

Answer: This issue falls with the contractor and its organization’s policies not the U.S. government

26. I have been asked by former colleague of mine to submit a reference letter for him. He is applying for a job with a XXX for the HIP project in Central Asia. Can I provide a reference based on my previous work with him in Uzbekistan?

Answer: Yes.”

2. In the SCHEDULE, under “SECTION J– LIST OF ATTACHMENTS, ATTACHMENT 24 ASSESSMENT OF THE PREVENTION OF TUBERCULOSIS INFECTION IN HEALTH CARE FACILITIES, WITH SPECIAL CONSIDERATION FOR TB FACILITIES IN KAZAKHSTAN AND KYRGYZSTAN” delete “The entire report will be released by o/a April 22, 2009.” and add the following:

“FULL DRAFT ASSESSMENT OF THE PREVENTION OF TUBERCULOSIS INFECTION IN HEALTH CARE FACILITIES, WITH SPECIAL CONSIDERATION OF TB FACILITIES IN KAZAKHSTAN AND KYRGYZSTAN”

3. In the SCHEDULE, under “SECTION J– LIST OF ATTACHMENTS, add the following:

“ATTACHMENT 25 - PAST PERFORMANCE INFORMATION FOR A GRANT OR COOPERATIVE AGREEMENT”

4. In the SCHEDULE, under section L.6 “INSTRUCTIONS FOR THE PREPARATION OF THE TECHNICAL PROPOSAL" under “Past Performance (suggested 2 pages)” add the following:

“For offerors with past performance experience in Grants and Cooperative Agreements use the form at Attachment 25 in substituted for the lack of contract CPRs.”

FULL DRAFT ASSESSMENT

OF THE PREVENTION OF TUBERCULOSIS INFECTION

IN HEALTH CARE FACILITIES, WITH SPECIAL CONSIDERATION

OF TB FACILITIES IN

KAZAKHSTAN AND KYRGYZSTAN

February - March, 2009

Almaty, Kazakhstan

Bishkek, Kyrgyzstan

USAID/ZdravPlus Project

TABLE OF CONTENTS

Acknowledgements Acronyms Executive Summary Introduction Assessment of TB infection control in Kazakhstan General background Main Findings Epidemiology of TB, MDR/XDR-TB, and HIV/TB in Kazakhstan TB control in Kazakhstan Infection control activities within the TB program

Case finding and diagnosis Treatment Infection control in health care facilities

National Center for Tuberculosis Problems (NTBC)

Talgar Regional TB Dispensary

Summary of recommendations

Laboratory issues Assessment of TB infection control in Kyrgyzstan General background Main Findings Epidemiology of TB, MDR/XDR-TB, and HIV/TB in Kyrgyzstan TB control in Kyrgyzstan Infection control activities within the TB program

Case finding and diagnosis Treatment Infection control in health care facilities

Tokmok Family Medicine Center Tokmok Central Rayon Hospital Kara-Balta Family Medicine Center Kara-Balta TB Hospital Summary of recommendations Laboratory Issues

Glossary

(No Annexes will be available before the closing date)

ACKNOWLEDGEMENTS

This assessment was conducted by the United States Agency for International Development ZdravPlus Project (USAID ZdravPlus Project). The authors would like to thank USAID for the financial support and initiative that made possible this assessment of the prevention of tuberculosis in the health care facilities in Kazakhstan and Kyrgyzstan. We would also like to express our appreciation to the staff of the health care facilities that participated in the assessment.

ACRONYMS

EXECUTIVE SUMMARY

Country assessments on facility-level tuberculosis infection control (TB IC) were undertaken in Kazakhstan and Kyrgyzstan in February and March 2009. The country assessments were based on the conceptual framework outlined in the Health Systems Approach to TB Infection Control in Central Asia paper . The conceptual framework was built on desk research, a literature review, and key informant interviews. The global policies/strategies that support TB IC were used including Expanded Framework for TB; Interim Policy for TB/HIV; Multi-Drug Resistance (MDR); Global Strategy for HIV/AIDS; Occupational Health and Safety; Infection Control, Patient Safety. Available expertise was used to create a map of all conceptual reasons why or how the problems with infection prevention/control could contribute to increases in MDR-TB.

The assessment was implemented in response to the growing multi-drug resistant and extensively drug resistant (MDR/XDR) TB problem and high TB incidence among health care workers and in the Central Asia Region (CAR). There is international understanding that the best way to prevent TB spreading in health facilities is to use systemic strategy based on hierarchy of administrative control, environmental control, and personal protection measures.

The goal of the assessment was to collect and generate reliable data on the TB IC situation in Kazakhstan and Kyrgyzstan and inform decision makers on existing problem areas and a menu of options or possible interventions for future programming. The recommendations generated by the report will be used to strengthen TB IC in the two countries and prevent or minimize the transmission of TB in health care and congregate settings. The facility-level TB IC assessment attempted to identify the strengths and weaknesses of TB IC at the hospital and primary health care (PHC) level, including institutional capacity and every day practices, training of health care personnel, and the patient perspective with regards to access to prompt diagnoses and treatment. The main objectives of the country assessment were to answer the following questions:

· What is the state of infection control in TB facilities and in facilities where TB patients congregate?

· What are the obstacles for proper functioning of the infection control system at the facility level?

· What systemic barriers to facility-level infection control exist, and what are recommendations to address them?

Methodology The country assessment methodology included:

· Analysis of components of TB control program and general health care with emphasis on TB IC in TB and general health care facilities and also population at large.

· Review of reports provided by international organizations and external assessment reports;

· Review of international and national guidelines on infection control;

· Interviewing target groups, such as patients and health care providers (use of standardized data collection tools and checklists to obtain qualitative data and data not available at country level);

· Assessment of the TB IC program in health care facilities using standardized data collection tools and checklists;

· Site visits to selected health care facilities including TB facility diagnosing and treating TB and MDR/XDR-TB, general health care facility participating in TB case finding, diagnoses and follow-up of treatment, and a TB laboratory to assess the implementation of infection control components, and to observe organization and delivery of TB services. The facilities were selected randomly, but accessibility and representativeness of the sites were considered; the balance between urban and rural districts was considered.

· The review focused on the civilian sector

MAIN FINDINGS

It was found during the assessment that there are many similarities but also differences in the TB IC situation in Kazakhstan and Kyrgyzstan. The implementation of TB IC measures in Kazakhstan and Kyrgyzstan is weak. Both countries are guided by the Sanitary and Epidemiological Services (SES) regulations on IC, which need to be revised in-line with international recommendations, such as the 1999 and 2006 WHO guidelines and also the CDC 2005 guidelines and other relevant documents. There is little understanding among health care workers and administration of the ways of transmission of an airborne disease such as TB and, therefore, health care workers tend to disregard the risk of infection and limit themselves to removing visible dirt and dust from surfaces.

Strengths

· The existing MOH/SES regulations on IC include many useful recommendations on preventing transmission of TB in health care facilities.

· The National TB Programs (NTPs) in both countries undertake efforts to strengthen early case finding and prompt treatment of TB cases to stop the spread of infection.

· Both countries have applied to the Global Fund to Fight AIDS, TB and Malaria (GFATM) in order to strengthen implementation of TB activities, including IC measures

· Cooperation between MOH and SES in TB IC is ongoing in both countries and the revision of the current standards on IC is underway in Kazakhstan.

· The persons responsible for IC in health care facilities are appointed

· There is some knowledge of modern approaches in TB IC among health care staff.

· Training of the health care staff (specifically personnel in TB facilities) on IC is planned in both countries

· Refurbishment considering appropriate IC measures is underway in both countries

· Rapid responses for MDR-TB cases are planned to be implemented in both countries during 2010-2011.

· In both countries there are referral or tertiary level TB facilities with appropriate IC measures (Almaty City TB Dispensary MDR-TB Department in Kazakhstan and TB departments in colony 31 and 27 in the penitentiary system in Kyrgyzstan, less so in the TB Institute in Kyrgyzstan)

· In some places appropriate respirators are used

Weaknesses

· The current MOH/SES regulations on TB IC need to be revised in-line with international recommendations

· There are significant budget constraints in TB control, including a lack of funds necessary to implement IC measures

· The existing IC regulations contain many useful points on isolation measures, triage of patients, ultraviolet germicidal irradiation (UVGI), ventilation etc, however, these regulations are not followed partly due to the lack of training but mainly due to the lack of funding.

· Virtually all TB patients are hospitalized for intensive phase of treatment, which in conditions of weak IC increasing the risk of nosocomial infection (every fifth never–previously-treated patient and every second previously treated patient suffer MDR-TB)

· The IC measures are weak overall in TB laboratories

· Safe working conditions are disregarded while carrying out procedures that will probably generate infectious aerosols (e.g., bronchoscopy, sputum induction, endotracheal intubation, suctioning, irrigating TB abscesses, aerosol treatments, autopsies on cadavers with untreated TB disease)

· IC measures are weak in the surgery and intensive care units

· TB diagnoses and treatment is sometimes delayed and patients are defaulting while being infectious

· Health care staff have not received sufficient training in TB IC

MAIN RECOMMENDATIONS

· Revise with partners (NTP, SES, international organizations) the existing standards and guidelines for TB IC in order to ensure that they are in-line with international recommendations

· Ensure there is sufficient funding to implement IC measures in health care facilities, particularly in specialized TB facilities.

· Strengthen early TB case finding and decrease the default rate to decrease TB infection in society and health care facilities

· Implement rapid laboratory techniques to quickly diagnose MDR-TB in order to decrease risk of nosocomial MDR/XDR-TB infection

· Strengthen administrative TB IC measures, such as conduct TB IC risk assessment in health facilities; develop written TB infection control plans; implement effective work practices for the management of patients with suspected or confirmed active TB disease, including separation of patients according to their potential infectiousness and ensuring safe working conditions while carrying out procedures that generate infectious aerosols; and testing, evaluating, and educating health care workers.

· Avoid hospitalizing TB patients and performing aerosol producing procedures in case TB IC measures are not implemented

· Implement environmental TB IC measures maximizing natural ventilation and controlling the direction of airflow. Although many environmental control measures (negative pressure rooms, high efficiency particulate air (HEPA) filters) require resources that are not available in many situations, some inexpensive environmental control measures (e.g., opening windows to increase natural ventilation and use of fans to control the direction of air flow) can be implemented in all settings.

· Where limited funding is available, it is recommended to develop a priority list of environmental IC measures to be implemented. Environmental controls are most important in areas where the risk of exposure is high due to high bacillary loads in air, e.g., wards with infectious TB patients, sputum induction areas, bronchoscopy suites, laboratories performing culture and susceptibility testing, surgery suites, intensive care units, and autopsy rooms.

· Consider obtaining technical assistance in developing the layout of TB facilities (local or international engineers knowledgeable in TB IC measures). An engineer will be helpful in planning the direction of the air flow and the number and location of the UVGI in the health care facilities.

· Implement personal protection measures, such as:

· Respiratory hygiene and cough etiquette for patients

· Appropriate respirators for health care workers. Ensure that all persons coming into contact with an infectious TB patient are wearing an appropriate respirator at all times. Develop, implement and maintain a respiratory protection program (training of health care workers, selection of respirators, and fit testing).

· Implement TB IC measures in TB laboratories based on international recommendations

INTRODUCTION

High rates of tuberculosis (TB), including drug-resistant tuberculosis (DR-TB), and increased prevalence of HIV in the Central Asian Republics (CAR) have led to greater concern about the risk of spread of tuberculosis within health care (HC) settings.

Nosocomial transmission is of obvious concern because it affects not only other patients but also the personal health of health care workers (HCWs) and may result in either temporary or permanent loss of HCWs from the workforce. Nonexistent or ineffective TB infection control (IC) measures facilitate M. tuberculosis transmission in these health care settings

A review of the most common factors contributing to M. tuberculosis transmission in health care facilities at the district and referral levels shows that the situation can be improved with simple and, in many instances, inexpensive control measures. Many of the TB control measures that are likely to have the greatest impact on reducing M. tuberculosis transmission (e.g. rapid diagnosis and isolation of infectious TB patients) can be implemented with minimal additional financial resources

The risk to patients and HCWs of acquiring TB could be significantly reduced if governments, health authorities, and HCWs themselves make infection control a high priority. HCWs are a valuable and often scarce resource, and their expertise cannot be easily replaced.

Effective TB infection control in health care settings depends on:

· Early diagnosis of potentially infectious TB patients;

· Separation of patients according to their potential infectiousness, including separation of drug-resistant TB patients from other TB patients. TB and non-TB patients should be strictly separated;

· Prompt initiation of appropriate anti-tuberculosis treatment.

The primary emphasis of the TB infection control plan should be on achieving these goals.

In all health care facilities – particularly those in which persons who are at risk for TB work or receive care – policies and procedures for TB control should be developed, reviewed periodically, and evaluated for effectiveness to determine the actions needed to minimize the risk of transmission of M. tuberculosis.

TB infection control programs are based on a three-level hierarchy of controls: administrative, environmental, and respiratory protection

Administrative controls are the most important of the three types of controls. At a minimum, administrative controls include conducting a TB risk assessment for the setting; developing a written TB infection control plan; implementing effective work practices for the management of patients with suspected or confirmed active TB disease; testing, evaluating, and educating healthcare workers (HCWs); and conducting problem evaluations as needed.

Environmental controls prevent the spread and reduce the concentration of droplet nuclei in ambient air. Environmental controls include controlling the sources of infection, diluting and removing contaminated air, and controlling airflow.

Respiratory protection controls further reduce risk of exposure to M. tuberculosis in situations that pose a high risk for exposure. Respiratory protection controls include implementation of a respiratory protection program, training HCWs in respiratory protection, and training patients in respiratory hygiene.

TB infection control programs for settings in which patients with suspected or confirmed TB disease are expected to be encountered should include the following steps

1. Assign supervisory responsibility for the TB IC program to a designated person or group in the health care facility. Give the supervisor or supervisory body the support, authority and financial means to conduct a TB risk assessment, implement and enforce TB IC policies, and ensure recommended training and education of HCWs.

2. Train the person responsible for implementing and enforcing the TB IC program.

3. Conduct a risk assessment of the facility. Repeat periodically the risk assessment to evaluate the effectiveness of the TB IC program.

4. Develop written TB IC plan consisting of the risk assessment, management of patients with suspected or confirmed TB disease, training and education of HCWs, screening and evaluation of HCWs, problem evaluation, and coordination.

5. Implement and maintain environmental controls, including room(s) designed to maintain airborne infection isolation precautions (AII room).

6. Implement a respiratory protection program.

7. Outline a protocol for the prompt recognition and initiation of airborne precautions of persons with suspected or confirmed TB disease and update it annually.

8. Create a plan for accepting patients who have suspected or confirmed TB disease if they are transferred from another setting.

9. Conduct a problem evaluation if a case of suspected or confirmed TB disease is not promptly recognized and appropriate airborne precautions not initiated, or if administrative, environmental, or respiratory-protection controls fail.

10. Perform a contact investigation if health care-associated transmission of M. tuberculosis is suspected. Implement and monitor corrective action.

11. Implement and enforce policies and protocols to ensure early identification, diagnostic evaluation, and effective treatment of patients who may have infectious TB.

12. Coordinate activities with the local public health department, emphasizing reporting, and ensuring adequate discharge follow-up and the continuation and completion of therapy.

13. Perform ongoing training and education of HCWs about TB, effective methods for preventing transmission of M. tuberculosis, and the benefits of medical screening programs.

TB FACTS

Tuberculosis (TB) is a disease, caused by Mycobacterium tuberculosis and occasionally by mycobacteria other than tubercle bacilli. The disease caused by Mycobacterium tuberculosis is infectious and is usually spread through the air.

Tuberculosis can infect any organ of the body but it is mainly the patients suffering from TB in their lungs that are infectious. When infectious people cough, sneeze, talk or spit, they excrete TB bacteria into the air.

A person needs only to inhale a small number of TB bacilli to be infected. People infected with TB will not necessarily become sick. In tissues the Mycobacterium tuberculosis can lie dormant for years and causes disease when the immune system is weakened by diseases, such as HIV infection or by stressful conditions, such as those stemming from migration or malnutrition.

Tuberculosis can be successfully treated. However, if the treatment regimens used are wrong, the drugs are taken irregularly, or the anti-TB drugs are of poor quality, a resistance to the anti-TB drugs may develop.

Multi-drug resistant (MDR) TB is defined as a disease caused by Mycobacterium tuberculosis strain resistant to at least isoniazid and rifampicin, the two most powerful anti-TB drugs. Rates of MDR-TB are high in some countries, particularly in the countries of the former Soviet Union. MDR-TB is difficult to treat; the treatment has numerous side effects, is expensive-up to 1,000 times the cost of “regular” TB drugs- and is at least 24 months long.

The emergence of extensively drug-resistant (XDR) TB, defined as Mycobacterium tuberculosis strain resistant in vitro to the effects of isoniazid, rifampicin, a fluoroquinolone and to at least one of three injectable second-line drugs (amikacin, capreomycin or kanamycin), poses a serious threat to TB control as this form of tuberculosis is in most instances beyond cure.

· One-third of the world’s population is infected with the TB bacillus.

· When left untreated, a person suffering from active pulmonary TB infection can infect 10 to 15 people a year.

· 5-10% of people who are infected with TB bacilli become sick with TB at some time during their life.

· 50% of people who are infected with TB bacilli and HIV become sick with TB during their lifetime.

KAZAKHSTAN

GENERAL BACKGROUND

Table 1: Kazakhstan Country Data

(Almaty, Astana, Oral)

Kazakhstan is a middle-income country with an estimated gross national income per person of $5,010 in 2007 (GNI, Atlas method). It is the largest country in Central Asia and one of the most sparsely populated in the world. The country extends from the Volga to the Altai Mountains, and from the plains in western Siberia to oases and desert in Central Asia. The country has considerable mineral wealth and vast areas of arable land.

Kazakhstan inherited significant amounts of infrastructure from the Soviet times and has a relatively well-educated population. Following independence in 1991, Kazakhstan was one of the first and most vigorous reformers among the countries of the former Soviet Union. In the early years of transition, prices were liberalized, trade distortions reduced, and small- and medium-scale enterprises privatized. The treasury and budget processes were significantly improved. Kazakhstan scores much less favorably, however, in the areas of rural land reform, in the creation of an enabling environment for small- and medium-sized enterprises, and in the elimination of corruption.

Kazakhstan has enormous economic opportunities. The projected expansion of oil production, an abundance of other natural resources, strong oil prices, responsible macroeconomic policy, and other policy improvements set the stage for a very promising future. However, the country also faces significant risks, both in the shorter and medium term, and for the longer term (maintaining macroeconomic and financial sector stability).

MAIN FINDINGS

Epidemiology of TB, MDR/XDR-TB, and HIV/TB in Kazakhstan

After Kazakhstan gained independence from the Soviet Union in 1991, tuberculosis re-emerged as an important public health problem and its burden remains high in the country. The case notification rate (new cases and relapses) for 2006 was 155 per 100 000 population – the highest among the 53 countries of the WHO European Region (see Table 2: Key indicators of TB control, and Figure 1: Surveillance and epidemiology in Kazakhstan, WHO Global TB Report 2008). The disease is affecting the most productive age group – people between 15 and 65 years of age.

Table 2: Key indicators of TB control in Kazakhstan, WHO Global TB Report 2008

Estimates

Surveillance and DOTS implementation

Figure 1: Surveillance and epidemiology in Kazakhstan, WHO Global TB Report 2008

Figure 2: TB among health care workers

Based on data from the National Tuberculosis Program (NTP), TB incidence among health care workers working in TB facilities was 463.5 per 100 000 in 2006, which is 3.5 times higher than in the population at large. The most affected were nurses, assistant nurses and other paramedical personnel. TB incidence was 444.4 per 100 000 among doctors, compared to the 788.4 per 100 000 among nurses and 778.6 per 100 000 among assistant nurses and other paramedical personnel (see Figure 2: TB among health care workers).

Unfortunately data on nosocomial TB infection among patients has not been collected in the country, mainly due to the lack of modern laboratory techniques necessary to confirm nosocomial infection.

MDR/XDR-TB

The national drug resistance surveillance data for 2007 revealed extremely high prevalence of MDR-TB: 20.0% among new smear positive cases and 52.9% among previously treated cases (See Table 3: Drug resistance surveillance data in Kazakhstan, 2007). This form of TB is as transmittable as drug-sensitive TB, but has much lower chance of being cured due to complicated diagnoses and treatment, numerous side effects, and also the high cost of the treatment course.

Representative data on XDR-TB are not available in Kazakhstan. However, based on the reports from the National Reference Laboratory (NRL), resistance to second line anti-TB drugs (SLDs) is present.

TB/HIV co-infection Data on TB/HIV co-infection are not available in the NTP due to confidentiality issues. [Note: Additional data from Republican AIDS Center to be included here.] Systematic TB/HIV collaborative activities were initiated in 2004 when a joint coordinating body was established that focused on development of national guidelines and protocols and training of staff for further provision of HIV counseling and testing for TB patients.

Table 3: Drug resistance surveillance data in Kazakhstan, 2007

TB CONTROL IN KAZAKHSTAN

In 1997, the Directly Observed Treatment-Short course (DOTS) was introduced in Kazakhstan and expanded to cover the entire country in 1998, including the penitentiary sector. TB control interventions are guided by the:

· National Intersectoral Action Plan for Implementation of the TB Control Program for 2008-2012;

· Ministry of Health Order No. 245, April 23 2007, “On further strengthening TB control interventions in the Republic of Kazakhstan;” and

· Other regulatory acts. (Acts on infection control are listed in Annex E: Legal framework.)

The Ministry of Health has the overall responsibility for TB control in the country. The implementation of TB activities within the NTP is coordinated by the NTP Central Unit, represented by the National TB Center (NTBC). The NTP Central Unit also involves the Ministry of Justice (MOJ) and other governmental entities, and collaborates with nongovernmental organizations and international partners in planning, implementation, and monitoring and evaluation of activities.

TB control interventions are implemented through a network of specialized TB facilities and Primary Health Care (PHC) services. Since 2000, PHC providers have been increasingly involved in TB control within the ongoing reform of the national health system.

[Note: Additional information on the structure, role and responsibility of SES to be included here, incl. detail on Prikaz 245 and 452] The Ministry of Health (MOH) summarized the main achievements in TB control for the Round 8 GFATM grant application as the following:

· Strong political commitment to TB control resulting in substantially increased funding of TB control;

· Comprehensive regulatory framework established by the Ministry of Health and the NTP for all components of the national program;

· Improved program monitoring and evaluation with regular NTP supervision at central and regional levels, and upgraded reporting and recording system;

· Increasing involvement of Primary Health Care in TB control incorporated in the overall health system transformation process;

· Uninterrupted supply of first-line anti-TB drugs (FLDs) (procured with domestic resources) in all territories and strengthened system of drug management;

· Improved integration and cooperation between TB control services in the civilian and penitentiary sectors;

· Effective collaboration between the NTP and international partners; successful implementation of the Round 6 GFATM grant.

In their summary of the main challenges in TB control, the MOH stated that the country lags far behind the target in terms of treatment outcomes. For the last two years, the treatment success rate in new smear positive cases was only around 70%, and as low as 47% in smear positive re-treatment cases. One of the most important reasons for this is the very high burden of drug resistance.

[Note: Additional information on structure of collaborative TB/HIV activities, and challenges and recommendations for collaborative TB/HIV activities to be included here]

[Note: Additional information on collaborative TB/drug rehabilitation dispensary services to be included here] Infection control activities within the TB program

TB infection control has been neglected until lately. Under the Soviet Union, there was little understanding of the modes of transmission for airborne diseases such as tuberculosis. Therefore, infection control measures for TB focused on removal of visible particles, such as dirt and dust, from surfaces. It was believed that a TB patient can transmit disease with his hands and personal belongings. Also, the home of a TB patient was considered contaminated, even if the rooms were well ventilated after isolation of the patient. Activities to control TB infection were planned based on these beliefs (i.e. mainly disinfecting surfaces in health care facilities and the homes of TB patients).

While implementing modern approaches to TB control, HCWs’ understanding of the modes of TB transmission has deepened and the MOH/NTP has recognized the need to revise the existing regulations for infection control. Revision of the IC standards and regulations is planned for 2009, in close collaboration with SES, which has traditionally played an important role in infection control matters in the country.

The MOH/NTP has applied to the GFATM Round 8 for financial support to bridge gaps in financing for the TB control program. Several activities to strengthen IC in facilities will be focused on, including 1) training of personnel; 2) procurement of respirators, and 3) refurbishment of TB facilities and TB laboratories in order to ensure safe working conditions and to decrease nosocomial infection among patients, particularly considering high MDR-TB rates in the country.

Case finding and diagnosIs

Effective TB infection control in health care settings depends on:

· Early diagnosis of potentially infectious TB patients.

· Separating patients according to their potential infectiousness, including separation of drug-resistant TB patients from other TB patients. TB and non-TB patients should be strictly separated.

· Prompt initiation of appropriate anti tuberculosis treatment.

The primary emphasis of the TB infection control plan should be on achieving these goals

Early case finding and diagnosis of TB is a very effective measure to prevent spread of infection in the society at large, but also in health care facilities. Delays in diagnosis can be caused by problems at different levels:

· Patient perspective – delaying seeking care for such reasons as low awareness of TB disease, stigma, social and financial problems;

· Health care perspective – problems such as poor training in TB, clinical misconduct, poor quality of TB laboratories, and financial issues;

· System perspective – administrative, legal, and financial issues.

Existing policy in Kazakhstan

According to MOH Prikaz No. 466, August 3, 2007, case finding is conducted by primary health care services in collaboration with specialized TB services. Case finding is mainly passive (patients presenting to health care facilities with TB symptoms.) Active case finding is conducted among high-risk groups, including prisoners, health care workers, and patients with chronic diseases.

[Note: Additional information on delay in diagnosis, if any, based on patient questionnaire to be included here]

Diagnosis of TB is confirmed by sputum smear microscopy (supported by x-ray) and culture. In order to diagnose drug-resistant TB (MDR/XDR-TB) drug sensitivity testing (DST) is conducted for all patients at start of treatment.

The result of the sputum smear microscopy is reported to a clinician within 24 hours, the culture result is reported within two months or ten days (depending on the method used), and the DST result is available within [Note: timing to be confirmed]. As such, patients with MDR/XDR-TB might stay in the hospital for three or more months without being diagnosed with drug resistant TB. This creates additional risk of nosocomial infection, as they are not isolated from the other patients during this period.

Rapid diagnostic tests for MDR-TB (e.g. HAIN) allow for diagnosis of resistance to rifampicin (and isoniazid) in one to three days. Quick techniques allow prompt isolation and treatment of MDR/XDR-TB patients, therefore decreasing the duration of infectiousness. These techniques were not available in Kazakhstan at the time of this assessment, but are planned to be implemented in 2010.

Strengths

· Overall, there is good access to health care services in Kazakhstan. Patients present with cough to the local feldsher-accusher point (FAP) or general practitioner, depending on which is closer to their place of residence.

· Diagnosis of TB is free of charge for the patient.

· There is a well-functioning network of TB doctors/facilities, with good cooperation with PHC services.

· The TB laboratory network has been revised and is quality assured (internal and external quality assurance (QA) at all levels), able to confirm TB diagnoses and potential infectiousness of a patient.

· Kazakhstan is planning to obtain quick rifampicin testing technique in 2010, thus, prompt diagnosis, isolation and treatment of a MDR/XDR-TB patient could become a reality.

Challenges

· The TB treatment can be started only by a TB doctor, which is often far away from the home of the patient.

· Infectious patients with MDR/XDR-TB occupy same rooms together with TB patients for many months before being diagnosed due to the laboratory methods currently in use (solid media).

[Note: Additional information on challenges expected to be included here based on results of patient questionnaire] Recommendations

· Strengthen early case finding in order to decrease time of infectiousness and stop transmission of TB in society but also in the health care facilities

· Ensure that infectious patients are promptly isolated and referred for appropriate treatment once they enter health care facility

· Look into possibilities to implement quick diagnostic methods for MDR-XDR-TB in order to decrease nosocomial infection

[Note: Additional recommendations expected to be included here based on results of patient questionnaire]

TB treatment

It is known that once they have started treatment, TB patients will cease being infectious after approximately two weeks . Patients with MDR-TB remain infectious for longer periods of time. It is also known that by the time a TB case is diagnosed the patient already may have infected close contacts, as a patient with pulmonary TB is infectious for prolonged periods prior to diagnosis (see Table 4: Guidelines for estimating…).

Table 4: Guidelines for estimating the beginning of the period of infectiousness of persons with TB, by index case characteristic

Chest radiograph Recommended minimum beginning of likely period of infectiousness

Existing policy in Kazakhstan

Once a patient is diagnosed with TB in Kazakhstan he/she is hospitalized in a specialized TB facility for the duration of the intensive phase (at least two to three months). The network of TB facilities is as following:

· Civilian TB services: 138 specialized TB dispensaries (at the republican, oblast and district levels), out of which 76 in-patient facilities with a total capacity of 14,895 beds, and 115 TB cabinets in general outpatient health facilities (polyclinics). In recent years, 785 beds in 19 facilities were re-profiled for MDR-TB treatment. There are a total of 16,023 health care staff in TB facilities, including 1,425 TB doctors (phthisiatricians), 5,906 nurses, 57 laboratory doctors (bacteriologists), 302 laboratory technicians and 8,669 ancillary staff (out of these, approximately 340 are assigned to MDR-TB departments).

· Penitentiary TB services (PS): TB treatment is provided in 8 institutions with 2,340 beds, out of which 200 beds are planned to be for DR-TB patients. There are a total 343 persons working in TB facilities in the PS. Penitentiary facilities were not assessed during current assessment.

Treatment regimens used in Kazakhstan are, overall, based on the WHO recommendations. However the treatment regimens for Category I, II and III patients are somewhat longer in duration for regular TB (see Table 5: Treatment regimens, Kazakhstan). The given explanation for this was that high drug-resistance, stronger treatment regimens are needed. However, it is known that first-line anti-TB drugs will not cure MDR/XDR-TB. Furthermore, unnecessarily prolonged treatment regimens bring additional costs for the health care system and increase the possibility of side effects for the patient. Treatment is delivered mainly (estimated 85%) under direct supervision of health care staff of the TB facilities (intensive phase) or primary health care services (continuation phase). There have been no gaps in the supply of FLDs for the last five years.

Table 5: Treatment regimens, Kazakhstan

4HRE

In 2007, the treatment success of pulmonary new SS+ TB patients was 70.7 %; 11.5 % failed the treatment and 4.7 % defaulted in Kazakhstan. The treatment success in Talgar was 86.2%, which was higher compared to the whole country; failure rate was 11.5% and 4.7% defaulted (see Table 6: Treatment outcome of TB cases Kazakhstan, country-wide and in Talgar, 2007). Based on these data one can conclude that more than 11 % of the patients remain infectious because they do not get cured. Unfortunately, most of them are spreading MDR-TB infection. (See also Annex J: Quarterly reports 2007 - Talgar, Almaty Oblast, Kazakhstan.)

Table 6: Treatment outcome of TB cases Kazakhstan, country-wide and in Talgar, 2007

TOM Talgar, Almaty Oblast, 2007

The SLDs for treatment of MDR-TB are not available for everyone. In 2008, the NTBC launched a DOTS-Plus pilot project and started treatment of first 70 patients with SLDs procured through the Green Light Committee (GLC) mechanism. The NTP is planning to apply for the expansion of the DOTS-Plus project in 2009. The MDR-TB patients also have been treated to some extent with locally procured SLDs. The treatment success of MDR-TB patients enrolled in the NTBC in 2005 was 77.0%, while as many as 17% defaulted and 3.7% failed – possibly spreading infection (see Table 7: Treatment outcomes for MDR-TB patients according to NTBC, 2005).

Table 7: Treatment outcomes for MDR-TB patients according to NTBC, 2005

Strengths

· FLDs are available and free of charge to patients. Overall, the treatment regimens used are in line with international recommendations

· The Green Light Committee (GLC)-approved DOTS-Plus program has been launched and the NTP is planning to apply for its expansion, thus providing a possibility that patients with MDR/XDR-TB may be cured.

· Treatment success rates reached the target (85%) in Talgar, which means that the chain of infection is more or less successfully interrupted for drug sensitive TB patients.

· The penitentiary system (PS) is collaborating with the civilian TB services and the link between the PS and the civilian TB services has been strengthened with the support of the international organizations.

Challenges

· There are not enough of SLDs for all patients with MDR-TB, thus a significant proportion of patients remain infectious and transmit disease to society at large and health care facilities.

· Treatment failure and default rates for MDR-TB patients are high.

Recommendations

· Ensure that the treatment regimens used and treatment delivery follow the International Standards of Care in order to reach high cure rates to stop the transmission of infection in the society and health care facilities.

Infection control in TB facilities in Kazakhstan

TB infection control programs are based on a three-level hierarchy of controls:

· Administrative controls

· Environmental controls

· Respiratory protection controls

Administrative controls Administrative controls are the most important of the three types of controls. At a minimum, administrative controls include 1) conducting a TB risk assessment for the setting; 2) developing a written TB infection control plan; 3) implementing effective work practices for the management of patients with suspected or confirmed active TB disease; 4) testing, evaluating, and educating healthcare workers (HCWs); and 5) conducting problem evaluations as needed.

Effective TB infection control in health care settings depends on:

· Early diagnosis of potentially infectious tuberculosis (TB) patients;

· Separating patients according to their potential infectiousness, including separation of drug-resistant TB patients from other TB patients, and strict separation of TB and non-TB patients; and

· Prompt initiation of appropriate anti-tuberculosis treatment.

The primary emphasis of the TB infection control plan should be on achieving these goals

A TB risk assessment using the standard TB risk assessment worksheet was carried out for the NTBC in Almaty City and the Talgar TB Dispensary in Almaty Oblast (see Annex A: Risk assessment checklist.)

MAIN FINDINGS

The National Tuberculosis Center (NTBC)

The National Tuberculosis Center (NTBC) is a national-level hospital that receives the most complicated cases from throughout the country. It also serves as the NTP Central Unit for the country. The NTBC is the main training facility for graduate and postgraduate health care personnel and is a center for research.

Based on the risk assessment, the NTBC is a high-risk specialized TB facility, where not only TB patients, but also MDR/XDR-TB patients, are diagnosed and treated. The NTBC houses the National Reference Laboratory (NRL) – currently situated in a separate building – which is discussed below. The NTBC was built in 1932 as a dormitory and later rebuilt into the TB facility. Newer buildings were added from 1962-1968.

A team consisting of an epidemiologist, clinician and an infection-control nurse has been assigned supervisory responsibility for infection control, including TB IC in the NTBC. This team is also active in developing policies and guidelines, and communication with SES. It also has authority over the implementation of TB IC measures in the country. The team has support from the administration and the central level of the NTP, but unfortunately lacks the means to implement and enforce TB infection control policies. In 2008, the IC team assessed the availability of some environmental infection controls in TB facilities in the country (see Annex I: Assessment of Infection Control Measures, National Plan 2008-2012, Kazakhstan).

The IC team has been trained in IC issues (via an international training in Murmansk, Russian Federation) and is aware of international recommendations on IC. Unfortunately, very little training is provided by the NTBC to the HC staff in IC.

The infection control program, together with a plan for monitoring and evaluation, was available in the facility. The IC plan is based on existing national regulations (see Annex F: List of the points addressing TB IC in MOH Prikaz No. 629, August 19, 2004). There are some weaknesses and misunderstandings in the national recommendations, such as the protective value of face masks and UVGI, and also the time needed to elapse for clearing the air of a room after an infectious patient. However, if followed, the guidelines would generally be helpful in controlling TB infection in the facilities.

The national regulations underline the necessity for prompt isolation (isolation rooms) and triage of infectious patients, and regulate patient flow, direction of airflow, and movements of the health care staff. They also deal with the use of UVGI lights and face masks. The national recommendations are currently under revision in order to make them consistent with the international standards.

Summary of the findings in the departments assessed

The NTBC is composed of many separate buildings situated on the campus. TB patients are admitted into two of them, which are both “H” shaped, with four floors and a basement. The total capacity of the hospital is 455 beds (see table 8: Structure of the NTBC).

In 2008, there were 66 doctors, 214 nurses, 166 assistant nurses, and 175 other staff working at the NTBC.

The NTBC has an outpatient reception and inpatient departments (including surgery), an MDR/XDR-TB department, department for pediatric TB, clinical laboratory, TB laboratory, diagnostic facilities, and a training Center. (See Annex L: Layout of the NTBC). The division of TB beds by department is outlined in Table 8: Structure of the NTBC.

In 2008, 1558 patients were admitted to the NTBC. Of them, only 28.4% (442/1558) were SS+ (see Annex K: Patients by categories admitted to the NTBC). The proportion of patients diagnosed with MDR-TB out of all hospitalized was [Note: proportion to be confirmed]. Surgery was performed on 13.3% (207/1558) out of all patients hospitalized. Mean length of stay in the hospital for all patients was approximately three months (Kazakhstan overall = 103.9 days; NTBC = 86 days).