Situation Assessment of Public and Private Blood Centres in Bangladesh

Directorate General of Health Services, Ministry of Health and Family Welfare, Bangladesh.

In collaboration with the World Health Organization and the OPEC Fund for International Development (OFID).

This report is the product of a ongoing collaboration between the World Health Organization (WHO) and the OPEC Foundation for International Development (OFID); and the Ministry of Health and Family Welfare, Bangladesh.

World Health Organization 2012

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Table of Contents

Executive Summary ii 1. Background 1 2. Assessment 5 3. Method of Assessment 6 4. Questionnaire Development 6 5. Field Testing 7 6. Sample Determination 7 7. Data Collection 8 8. Supervision 8 9. Data Analysis 8 10. Results 9 11. Discussion 43 a) Organization and management of blood transfusion services in Bangladesh 43 b) National blood donation and collection practices 43 c) National practices in screening of donated blood 44 d) Blood component preparation 44 e) Inventory of blood and blood products and status of the blood cold chain 44 f) Pre‐transfusion practices in hospitals 44 g) Transfusion monitoring and post‐transfusion practices in hospitals 45 12. Conclusion 45 13. Recommendation 47 14. Proposed Action Plan 49 15. Limitations 51 16. Acknowledgements 51 ANNEX I: Assessment Questionnaires 52 Section A: Organization and Management 54 Section B: Blood Donors & Blood Collection 60 Section C: Screening for Transfusion Transmissible Infections (TTI) 63 Section D: Blood Group Serology and Compatibility Testing 64 Section E: Blood Component Preparation 65 Section F: Blood Storage, Transportation, Inventory & Distribution 67 ANNEX‐2: List of blood transfusion centres and hospitals surveyed 75 List of Data Collectors 75 Types of Surveyed Blood Centres 75 List of Blood Centres at District Hospitals 76 ANNEX‐3: Status of Selected Indicators 79 ANNEX‐4: Table of Selected Health and Socio‐economic Indicators 81

Executive Summary Blood Transfusion Service is considered as a major part of the public sector healthcare setting. The service requires quality for safe blood collection and its use for the patients. This report presents the results of situation assessment of blood centres in public and private sectors in Bangladesh. The assessment was carried out in 2011 by experts of blood transfusion and program management personnel of Directorate General of Health Service under the Ministry of Health in collaboration with the World Health Organization (WHO) and the OPEC Fund for International Development (OFID). The objective of the assessment was to review the situation of the existing blood transfusion services that has been established in public and private sectors in Bangladesh, identify gaps and develop a set of recommendations. There are 253 centres in the country and the mainstay of the assessment was a large site survey covering 109 selected blood centres of these 253 centres, from seven administrative divisions of the country. These include public medical colleges, public institutes, district hospitals, Upazila health complexes, standalone private blood centres, private medical colleges, private hospitals and non‐governmental blood centres.

The methodology applied in the assessment was a combination of a desk review of policy documents and looking into the status of organizational management, quality system, training, blood donor recruitment, blood collection, screening for Transfusion Transmissible Infections (TTI), serology and compatibility procedures, blood component preparation, blood storage system, transportation, inventory and distribution. Assessment of the status of transfusion process in the hospital, pre‐transfusion procedure, clinical use of blood and management of the service at central level have been also carried out simultaneously. The blood transfusion services in Bangladesh are managed and regulated by the Ministry of Health under the guidelines of Safe Blood Transfusion ACT, a legal framework for blood safety. The National Safe Blood Transfusion Council has the role of an advisory body and the National Expert Committee is an implementing body for provision of the services. Setting up any private blood centres requires licensing from the Directorate General of Health Service, Ministry of Health.

The Safe Blood Transfusion Program (SBTP), a unit of the Ministry of health supports 203 centres by providing equipment, regular supply of kits, reagents, blood bags and training. 66.8% (169) of blood transfusion centres belonging to the public sector are integrated within the hospitals and located in seven divisions in the country. 5.6% (14) of centres are operated by the Ministry of Defense and 7.91% (20) of centres are supported by the national program but privately operated. In the private sector, 19.76% (50) of blood centres are integrated into the medical college and the specialized hospitals, and also include standalone blood centres. Each of these centres collects, stores and tests the blood. The blood transfusion services are coordinated nationally by the Safe Blood Transfusion Program and give services through the 203 blood centres. There was significant shortage of trained staff in each centre and almost all blood centres surveyed reported to have a shortage of

ii adequate premises, supplies and equipment. Except for two NGO blood centres, all centres reported to have collected blood from patient’s relatives and friends, showing that 85% of blood is collected from relatives/family blood donors and only 15% of blood is donated by voluntary non‐remunerated blood donors. No paid donors were registered during the assessment. No donors were recruited below the age limit of 18; 80% of donors belonged with the age range of 18‐ 24 and 20% with the age range of 25‐44. No donation has been recorded between the ages 44‐60.

In public and private centres, donor assessments were done according to defined donor selection criteria and 95% of the centres have shown hemoglobin test to be performed by the hemoglobin scale method. Follow up of sero‐reactive donors were not observed for blood donor management. SOPs for different processes essential for blood transfusion i.e. for blood screening, ABO & RhD, blood storage, blood component preparation and waste management were non‐existent in majority of the centres. Only in two centres, one private hospital and one private medical college, SOPs were these available and reported as implemented. The system of standard and comprehensive documentation was found only in two public medical college blood centres. In the private sector, documentation was available only in two private medical colleges and in two private hospitals. No centre maintained records of the whole range of procedures carried out. Basic data for patients’ blood grouping were maintained in almost all surveyed centres but were not found in a uniform format. Similarly the donor blood grouping registers were available but not complete in district, Upazila or in medical colleges hospitals of both the public and private sectors. Laboratory documents for patient’ and donor blood grouping and cross matching were found incomplete in the district and Upazila health complexes. These reflect scanty information that could have been generated for the assessment and moreover, most of the vital statistics were missing due to shortage of manpower, according to responders.

The data shows that public centres received most of the training organized by the Safe Blood Transfusion Program as a national training. Out of all district hospitals only 38% responded that they have adequate staff. Out of 14 public medical colleges only 36% and in Upazila 73% have responded that there is adequate staff. Others, in the public sector responded that the staff crisis is considered as one of the major challenges to running the centres smoothly. Screening of all donated blood for markers of five TTI (HIV, HBV, HCV, syphilis and malaria) is mandatory in Bangladesh and 100% donations are screened in all centres except for 20% of district hospitals, 55% of Upazila health complexes, 23% of private medical colleges, 29% of private hospitals and17% of standalone blood centres which do not routinely perform malaria testing. In 98% of the centres, blood screening is carried out using rapid tests. All centres reported to perform blood screening for HIV, HBV, HCV and syphilis. This shows that the prevalence of TTI markers is below 1%. Post‐donation screening was reported in as much as 70% of the surveyed centres, and rest of the centres only did pre‐ donation screening of donors with no screening of donated blood after the blood donation.

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There were no protocol nor algorithm developed and followed for reactive results in either of the centres under assessment. Initial reactive samples were reported as re‐tested by the same kits; no confirmatory facilities have been seen in any of the visited centres. Only 21% of public medical colleges, 50% of private medical colleges and 80% of public institutes reported to run internal quality control during routine testing of TTI.

With regards to External Quality Assessment (EQAS), three public medical colleges and one NGO blood centre reported participation in such a program organized by the Public Health Institute of Thailand. There were records of blood donation deferrals for TTI markers but no other data were available. A blood donor data base was available in NGO blood centres. In public centres there was provision of bulk procurement of kits under the Safe Blood Transfusion Program as well as facilities for validation of kits before their use in centres. All centres reported to have experienced critical supply of blood bags and run out of kits for the 12 last months on several occasions. All private sector and 10% of public sector purchased kits and reagents locally and no validation of these kits was done. 2% of district hospitals, 43% of public medical colleges, 20% of public institutes, 50% of private medical colleges, 57% of private hospital centres and 100% of NGO blood centres reported to produce blood components equal to 10% of total blood collection. 55% of components were produced by the public sector and 45% by the private sector respectively. On average, district hospitals received 93% of blood collected by the centres themselves, 3% from NGO blood centres and 5% from standalone blood centres. In medical colleges, 85% of the blood is collected by the by centres based in the medical colleges and rest 10% is received from NGO blood centres and 5% from standalone blood centres. Patient relatives were reported responsible for transportation of the blood to the patients.

There is wide variation of use of blood grouping techniques using both forward and reverse method. 100% of blood centres in district hospitals, public medical colleges and public institutes used slide method for ABO blood grouping and 18% of district hospitals, 8% of Upazila health complexes, 21% of public medical colleges, 80% of public institutes, 83% of private medical colleges, 71% of private hospitals, and 17% of standalone blood centres reported to carry out reverse grouping along with forward grouping. RhD typing is performed using slide method and cross matching at room temperature. Only one NGO blood centre reported to have performed cross matching by indirect antiglobulin method. Compatibility testing was reported to be carried out and completed by using donor cells and patients serum in 100% of cases. Significantly no centre reported to perform antibody screening for patient’s blood samples. Hospital transfusion committees have been developed in all district hospitals, public medical colleges and public institutes following Safe Blood ACT. SOPs for blood transfusion process have been developed for completing blood request forms, drawing and leveling, blood administration but not for transfusion monitoring and management of transfusion reactions.

The country has a post‐graduate degree started in 1972 as diploma (DBS & T) and currently BSMMU University is providing MD, MTM, DBST and FCPS. Due to extreme shortage of manpower in the licensing authority and Safe Blood Transfusion Program, regular supervision and monitoring of the centres were not adequate for 253 blood centres throughout the country. The assessment shows that a great deal of activities have been undertaken for improving blood transfusion services in Bangladesh by providing blood screening facilities, by regulating the private sector, by reducing paid donations, introducing blood component preparation and containment of TTI markers below 1%. However some areas need more focus for improvement. The main reasons for the lack of SOPs development and implementation and inadequate voluntary blood collections are: lack of comprehensive planning; failures in the delivery system and absence of adequate manpower. The blood transfusion services in Bangladesh thus need more attention from the top level to prioritize for restructuring and development of a comprehensive strategy following the Safe Blood Act. This includes: . National standards for blood transfusion services to be developed for uniform practices. Training should be comprehensive for both the public and private sectors and more emphasis should be given to the importance of SOPs, Quality assurance, importance of documentation for monitoring and evaluation, stock management, TTI algorithms, following standard practices for serology, compatibility testing and pre and post donation counseling. . Facilities of medical colleges’ centres in the public sector need to be strengthened for confirmatory testing for TTI markers. A medical college should be designated as regional blood centre to conduct training, data compilation for the division, support confirmatory testing, conduct motivational and blood collection programs with NGO and set up a haemovigilance system. . There should be provision for adequate and appropriate manpower and equipment in each centre and adequate refrigerators should be provided for segregation of blood units. . The quality of TTI testing and serology should be assessed under EQAS with the Reference Laboratory (RL) or WHO recommended collaborating centres. . There is urgent need for development of strategic planning for voluntary blood donation under National Expert Committees. Efforts should be made to develop a policy for joint collaboration of BT department of medical colleges and non‐ government blood donor organizations for need‐based blood collection and motivational programs. . The Safe BT Council together with National experts should make efforts for the development of National Blood Screening Algorithms. . Local hospital authorities should be oriented about blood safety and encouraged to allocate adequate space for BT centres especially in district hospitals. Hospital Blood v

Transfusion Committees should be oriented and given responsibility to set and define transfusion indications, transfusion alternatives, bedside practices and evaluation of transfusion outcomes including transfusion reactions (haemovigilance). . Regional medical college BT departments should be strengthened with adequate manpower and budget allocations made to initiate supervision and monitoring of BT centres in both sectors. . National expert committee members and experts of higher institutes should visit the different BT centres under the monitoring program to support SBTP in the establishment of quality services throughout the country. . The Reference Laboratory (RL) should function as a national confirmation and reference centre to provide independent responses on repeat reactive TTI donor samples. It should have appropriate and validated confirmation testing facilities in place such as Western Blot technology, Nucleic Acid Amplification Technology (NAT) and PCR as well as competent staff with adequate training to perform the tests. The RL should also monitor training activities in regional centres and compile the TTI data as reported from regional centres. . The reference laboratory should update the national data and report to national authorities. The centre should also have advanced training on quality assurance and EQAS, and perform research. It should have a mechanism of networking with the regional centres.

1. Background A major step in implementing such an integrated blood safety strategy is the need for an effective assessment. It should focus firstly on obtaining information on policy and national operations (organizational and managerial) within facilities. Secondly, information should be collected about managerial and technical parameters regarding blood and blood products in individual facilities along with total “vein‐to‐vein" transfusion. An effective assessment will enable responsible ministries to have a comprehensive view of all aspects of the national blood program and to identify gaps relevant to the implementation of the recommended integrated strategy on blood safety. Key findings and additional information gathered will help to advocate and develop strategies to strengthen the national blood program. The implementation of and progress towards set targets can be monitored by periodic repeat assessments using the same tools.

Bangladesh is a densely populated small country of approximately 156 million people. The country is one of the largest deltas of the world with a total area of 147,570 sq. km (56,977 square miles). Being a low‐lying country it stretches between 20º34' and 26º38' north and longitudinally between 88º01' and 92º41' east. It is mostly surrounded by Indian Territory (West Bengal, Tripura, Assam and Meghalaya), except for a small strip in the southeast by Myanmar. Bay of Bengal lies on the south.

From the administrative point of view, Bangladesh is divided into seven administrative divisions (Dhaka, Chittagong, Rajshahi, Khulna, Barisal, Sylhet and Rangpur), 64 districts, six city corporations, 308 municipalities, 482 Upazila and 4498 unions. At national level, the Ministry of Health & Family Welfare (MoHFW) is responsible for policy, planning and decision making at macro level. Under MoHFW, there are four Directorates, viz., Directorate General of Health Services, Directorate General of Family Planning, Directorate of Nursing Services and Directorate of Drug Administration. The rural population constitutes the majority (65.4%) of the population; but the urban population is increasing and is currently 34.6%. The number of people living per square kilometer is 939. Male to female ratio is 105:100. The two major religions practiced in Bangladesh are Islam (88.3%) and Hinduism (11%). Other religious groups include Buddhists and Christians. Gross National Product per capita income is US$ 1550 (2009). Dhaka is the capital city of the country. The health care service has been extended up to Upazila level. Distribution of public health care services and facilities follow similar patterns of administrative tiers, viz. national (mostly capital‐ based in Dhaka), regional (in divisions), district, Upazila, union and ward.

Primary health care (PHC), including family planning services in the urban area (city corporations and municipalities), is provided by the Ministry of Local Government; and in the rest of the country by the Ministry of Health and Family Welfare (MoHFW). Provision of secondary and tertiary cares, in both urban divisional directorates with necessary staff and rural areas, is the sole responsibility of MoHFW. The primary level hospital care begins with the 418 Upazila health complexes (153 are 50‐beds and the rest are 31‐beds) with a range

1 of 31 to 50 beds. The 62 district hospitals (59 Sadar district hospitals and two general hospitals) are the secondary level hospitals which provide health care in several specialties with a range of 50 to 375 beds. The tertiary level hospitals are multidisciplinary medical colleges and institutes hospitals with a range of 250 to 1700 beds. At national level there are post‐graduate, specialized hospitals with ranges of 100 to 600 beds. There are four types of static health facilities at union level. These are Rural Health Centres (RHC, 10‐bed hospitals), Union Sub‐Centres (USC), Union Health and Family Welfare Centres (UHFWC) and Community Clinics (CC). There are 18 governmental medical colleges and 41 private medical colleges.

The Government of Bangladesh is implementing the program throughout the healthcare services provided to the people from grass root to central level. The program is entitled Health, Nutrition and Population Sector Program (HNPSP), launched 1998 and extended to June 2010. It was further extended from 2011 to 2016 as Health Population and Nutrition Sector Development Program (HPNSDP). The HPNSDP covers 38 Operational Plans (OP) implemented by 38 Line Directors and 14 Projects/Programs; Safe Blood Transfusion Program is one of them. The Implementing Agency of the program is the Ministry of Health and Family Welfare (MoHFW) with its attached departments.

Blood Transfusion Service (BTS) of Bangladesh was established in 1950 at the Dhaka medical college hospital. A few blood transfusion centres opened later in the then 18 districts. During that period BT activities were mostly limited to only basic grouping and cross matching. More than 70% of annual demands for blood were collected from paid donors till 2001. No blood was screened as mandatory be it in public or private sector. Due to the immense threat of HIV, the government was convinced and committed to ensuring that all patients had access to enough appropriate safe blood and blood products (free from HIV, viral hepatitis and other Transfusion Transmissible Infections (TTI)) whenever needed by hospitals. Under the National AIDS Committee (NAC) on HIV/AIDS, the Blood Transfusion subcommittee (BTSC) was formed to plan Safe Blood Transfusion throughout the country. The committee prepared a three‐year plan. The Ministry of Health and Family Welfare approved the plan and started implementation of National Safe Blood Transfusion Program with the support of UNDP in 1999.

The main objectives of the program were: 1) Establishment of a Reference Laboratory and of blood screening facilities in 99 blood transfusion centres with the provision of reagent kits and equipment for the detection of HIV, hepatitis‐B, hepatitis‐C, syphilis and malaria. 2) Training of doctors and technologists and 3) Enhancement of voluntary blood donation through motivation programs and IEC campaigns. A training module was prepared. However, in 2004 UNDP support was taken over by World Bank and DFID, involving WHO to provide the technical assistance for development of component facilities and the implementation of quality standards under HAPP (HIV/AIDS Prevention Project). In addition, technical assistance of WHO was reinforced by WHO collaborating centre of National Blood

Centre of Thailand. WHO provided support at the National Blood Centre for procurement of equipment and reagents and facilitating overseas training, continuous on‐site technical support through the international centre of excellence WHO Collaborating Centre (WHO CC).

The Blood transfusion service in Bangladesh is under control of the Directorate General of Health services (DGHS) and is coordinated by the National Safe Blood Transfusion Program. Each blood transfusion centre is integrated within the hospital at tertiary (medical colleges, institutes and specialized hospitals) and secondary (district hospitals) levels. However there are blood transfusion centres at primary level hospitals called “Upazila health complexes”. Today there are 203 blood transfusion centres enlisted, supported and coordinated by the National Safe Blood Transfusion Program.

The private sector (50 centres) is being operated by hospital‐based blood transfusion centres and also by standalone blood centres regulated by licensing authorities. Each centre either in the public or private sector reports monthly on blood screening for five TTI and blood components to the reference laboratory of the Safe Blood Transfusion Program. However, there are no national or regional BTS in the country. The National Safe Blood transfusion program has been delegated authority to act as resource mobilization for procurement of equipment, kits, reagents and blood bags for the enlisted centres and training of manpower.

Blood screening facilities developed in 99 blood transfusion centres in the year of 2000 include all public medical colleges, district hospitals, combined military hospitals, medical institutes, Red Crescent blood centres and others as well as two non‐governmental medical college hospitals. From 2008 to 2010 104 new centres were developed in Upazila health complexes and in other hospitals. Today, there are officially a total of 203 blood screening centres. Over a total of 2,440,096 units of blood screened for TTI between 2000 and 2010, 129 HIV, 21,715 HBV, 3,182 HCV, 2,800, syphilis and 1,149 malaria reactive cases were detected, maintaining TTI prevalence almost below 1%. Most of TTI screening is done on rapid tests. Only in some centres of the private sector is blood screening is performed by ELISA.

Approximately 600,000 units of blood are required yearly in Bangladesh. This estimate is based on year 2010 throughout the country as reported by public and private blood transfusion centres. There are mainly two types of blood donors in Bangladesh which are relative/replacement blood donors and voluntary blood donors. The report of SBTP (2010) shows that 70% of blood is collected from directed or relative blood donors the rest being from voluntary blood donors. The blood donation system in Bangladesh is not a centralized system as all blood transfusion centres, mostly hospital based, collect, process and distribute blood. There is no nationally designated organization for recruitment of voluntary blood donors either in the public or private sectors. However there are a few philanthropic

3 organizations who promote voluntary blood donation in the country; Sandhani, a well‐ known medical and dental student' organization, Red Crescent Blood centre, Quantum, Badhan, and Medicine Club etc. are the voluntary blood donor organizations contributing greatly in this area.

Under WHO technical guidance, blood component facilities were developed in 6 centres (Dhaka Medical College, Arm Forces Institutes of pathology, Bangabandhu Sheikh Mujib Medical University, Rajshahi Medical College, MAG Osmani Medical College and Chittagong Medical College). The National Blood Centre of Thai Red Cross trained the staff on blood component preparation and quality assurance. Besides, some private centres are also producing blood components and altogether there are 17 centres which produce blood components for the country. In 2010 a total 40,242 units have been produced which included 2,1254 Red Cell Concentrate (RCC), 11,680 units of Fresh Frozen Plasma (FFP), 7,269 units of Platelet Concentrate (PC) and 39 units of Cryoprecipitate.

The ‘Safe Blood Transfusion Law 2002’ was approved by the parliament. The law was enacted 1st august 2004. The Safe Blood Act focuses on the formation of the National Safe Blood Council and the National Expert Committee for policy development. It also gives emphasis to the implementation of a regulatory system for unauthorized blood transfusion centres, application of good manufacturing practices, and application of appropriate and rational use of blood. Pertinent rules and regulations in connection to implementation of objectives of law have been published as Statutory Regulation Order (SRO) in 2008.

All activities like training, monitoring, program implementation, compilation of data of SBTP are being conducted by the reference laboratory along with a program office situated at Dhaka medical college hospital. The reference laboratory is equipped with modern blood transfusion materials. There are three assistant professors and three medical technologists along with other program staff.

National Safe Blood Transfusion Council is a policy making forum for BTS under MoHFW for developing the policy as per Safe Blood Act. The honorable Health Minister by position is the president and the Director General of Health Service and the member secretary of the Council. Directors of institutes and heads of BT departments are the council members. A number of decisions were taken since the first meeting in 2005 and to date four meetings have been held, among which the establishment of the National Blood Transfusion Centre (NBTC) and the development of national blood policy are the most important. The establishment of the National Blood Transfusion centre is under active consideration of MoHFW.

National Safe Blood Transfusion Expert Committee is the body responsible for implementation of the policy and decisions taken by the National Safe Blood Transfusion Council headed by the Director General of DGHS under MoHFW. It consists of transfusion specialists as members and secretary and the director general as president. Rules for 4 management of public and private blood centres have been developed in 2008 as SRO 145. As per rule public blood centres may collect revenue through imposing charges for blood screening, cross matching and other routine investigations. 50% of the collected funds are kept for purchasing kits and reagents in case of interrupted supply of consumables from the central procurement unit. This system has empowered each blood centre to perform routine activities without interruption. Remuneration of staff working in public blood transfusion centres may be taken from the charges collected as per SRO by this mechanism. However all blood centres are authorized to collect fees of 250/‐ BDT for blood screening in general hospital and charge for 350/‐ for others. As mentioned, 50% of the money collected is diverted to hospitals to be used by blood banks and 50% are distributed as incentives to the blood transfusion centre staff.

A Draft National Policy prepared and approved by the National Safe Blood Transfusion Council is yet to be approved by the cabinet. The major areas cover all the areas of Safe Blood Transfusion Act. This includes strategies for development of the National Blood Program with establishment of the National Blood Transfusion Centre, plan of actions for the improvement of the whole BTS, strategies for staff educational and training programs, strategies for blood screening and donor management and policy for the role of NGOs in voluntary non‐remunerated donor recruitment programs. It also focuses on the needs for implementing and enforcing appropriate regulations necessary to ensure high quality BTS in the private and public sectors. Emphasis is also placed in the draft policy on the development of standard operating procedures (SOPs) and guidelines for appropriate use of blood, introduction of advanced technology, and development of a uniform management information system for the blood program in all blood transfusion centres.

The main goal of the assessment was to develop a National Action Plan for establishment of quality standards for BTS. The scopes of the assessment were to collect data of activities of the existing blood transfusion service in the public and private sectors, physical inspections of the BTSs, in‐depth data review and extraction, cross checking of the data with registers, discussions with key responders and medical technologists of the blood transfusion centres.

The assessment also included a review of the manpower challenges, logistics and equipment, clinical transfusion practices, activities and coordination of voluntary blood donor organization; the existing local constraints and management perspective towards the National Policy and ACT and rules for Safe Blood Transfusion; to reiterate the implementation of standards and SOPs as well as management issues for quality BTS, orientation of the different aspects of variables and importance of indicators identifying existing key capacities and additional capacities needed to reach such objectives.

2. Assessment A national consultative meeting was held on 1 to 2 November 2010 in Dhaka, in collaboration with WHO and OFID, the Ministry of Health, and all other stakeholders in the

5 blood safety program in the country. Thirty‐five participants from the ministry of health, Safe Blood Transfusion Program, blood transfusion experts of hospital based BTSs, representatives of Red Crescent blood centres and non‐governmental blood centres, WHO officials from country office and blood safety experts from WHO‐HQ, Geneva, attended the meeting. During the brief inaugural session, the national authorities and the stakeholders were introduced to the scope and objectives of the WHO/OFID joint project on ‘Prevention of Transfusion Transmitted HIV/AIDS and hepatitis’ in four developing countries namely Bangladesh, Nepal, Bhutan and Pakistan. The meeting concluded with excellent outcomes in identification of local and national barriers in the country.

The priority activities, role and responsibility of stakeholders also discussed the implementation of the proposed blood safety project of WHO/OFID/ Ministry of Health (MoH), Bangladesh. It was prioritized that an assessment should be carried out for existing BTSs in Bangladesh for review and updating of national standards, introduction of algorithms for TTI testing, implementation of Standard Operating Procedures (SOPs), protocol for haemovigilance, waste management, training needs for laboratory staff on TTI testing and quality management. It was recommended that assessment of BTS in the public and private sectors would enable an in‐depth look to identify gaps to make action plan on blood safety by exploring the constraints that preclude establishing quality of blood screening, to identify the needs for strengthening the laboratory and training, to enable responsible stakeholders to have a comprehensive view of all aspects of the national blood program for developing strategic action plans.

3. Method of Assessment The assessment process used is consistent with the process and steps presented in the WHO frameworks for situation assessment used in most countries for BTS. Accordingly the WHO questionnaire has been modified by the expert group of transfusion medicine and the management personnel involved in the national BTS of Bangladesh, considering the country context. The process of development of a questionnaire has been reviewed and revised by the WHO National expertise for its suitability and fitting for the purpose of data collection. The assessment begun with the existing assets (structures, management, practices and critical facilities) pertinent to identify weaknesses and strengths for decision makers to elaborate the relevant action plan Step 1: Identify challenges for a quality blood screening and characteristics. Step 2: Prepare a profile for each important area. Step 3: The findings were evaluated to identify the gaps. Step 4: Preparing a scenario for policy makers to develop action plans for each area.

4. Questionnaire Development The consultative meeting was held 17‐19 January 2011 for development of the questionnaire. The stakeholders were given an introduction of WHO BTS framework of 6 situation assessment tools. Later the resource persons reviewed the draft questionnaire. The group remarked that some questions might not be relevant to the country context of Bangladesh. The questions were considered important as they would reflect the actual situation in the country while filling the global database questionnaire every year. The group finally presented the draft, revised and finalized questionnaires.

5. Field Testing On 25th January 2011, a field test was conducted in the blood transfusion centre of NICVD (National Institute of cardiovascular Disease) at Dhaka. The group consisted of two experts from Dhaka medical college hospital and DGHS took part in the field test of the assessment tool. The team briefed the procedure of field testing and their findings. The field testing was successful with regards to the preset questions of part one and part two and the responder Assistant Professor was able to give the expected responses for most of the questions asked. The team recommended that questions related to yearly statistics/data were not collected during this short period of interview and recommended that these data should be collected separately by sending the formats to the centre before the assessors’ visits. This would reduce the time taken for assessment during the busy hours of the centre and the assessor would only verify and cross check the prepared data as per format provided beforehand. The team also recommended some modification and rephrasing of questions for understanding and clarification.

6. Sample Determination As per WHO framework for assessment, monitoring and evaluation of the blood transfusion services (FRAME) the number of blood centres and health facilities to be assessed depends on the objective of the assessment; it was advised that attempt must be made to cover as many facilities as possible in doing such an assessment. In general, it is recommended that a minimum of 30% of hospitals (and other health facilities) that received blood from the blood centres must be covered when the number of such facilities exceeds 100 and all of such facilities if the number is less than 100. The sampling methods should be decided and agreed by the assessment team beforehand.

From the report of safe BT program the total number of centres was 203 including blood transfusion centres in public medical colleges, institutes, arm forces institutes, specialized hospitals, district hospitals and Upazila health complexes. It was also reported that there were 50 licensed blood centres in the private sector. It was decided to have an assessment of all centres, but due to limitation of resources and time constraints the program manager decided to visit 59 centres in the first phase and 50 centres in the 2nd phase. Altogether 109 centres were selected for assessment which covered at least 43% of total blood centres out of 253 centres throughout the country. The centres were selected purposely in the stratification of public medical colleges, public institutes, private hospitals, district hospitals, Upazila health complexes, standalone centres, NGO blood centres and others.

7. Data Collection The data collectors were selected among medical doctors from DGHS and Safe Blood Transfusion Program and senior level medical technologists from Safe Blood Transfusion Program. Six teams were constituted with two members in each. The teams that collected the data up to district hospital level were blood transfusion experts and administrative experts from DGHS. However the team that collected data from Upazila level centres i.e. primary level hospitals were senior medical technologists having working experience in monitoring blood centres. The collection of data started in two phases from February to May 2011 and from July to September 2011. 109 centres were selected which include 14 public medical colleges, six private medical colleges, five institutes of the public sector and seven specialized hospitals of the private sector, 50 district hospitals, 11 Upazila health complexes, two NGO blood centres, six standalone blood centres and other eight centres. The data were collected by the preset questionnaire through face to face interviews and on‐ spot inspections of facilities, modes of management of different sized hospitals, discussions with the local authorities, laboratory procedures, equipment and facilities, laboratory records and registers and discussions with blood transfusion staff and clinicians in the hospitals. The teams also reviewed the relevant documents, Safe Blood Transfusion ACT 2002, Rules (SRO) and Draft National Blood Policy. Discussions were held with the program manager and line director, while experts of the reference laboratory, reviewed the yearly reports (January 10 to December10) during data collection. 27 facilities were visited in Dhaka city and the rest were outside and situated on average 250 kilometres from the capital city.

8. Supervision The assessment was initiated jointly by WHO and the program manager of BAN BCT. Dr MK Zaman Biswas, national professional officer (epidemiology), Dr Murad Sultan, technical officer, blood safety, Dr Aminul Hasan DPM BAN BCT, DGHS and Dr Mazharul Hoque, DPM, SBTP coordinated data collection, monitored and supervised the assessment process.

9. Data Analysis The submitted data sheets were checked by a WHO technical officer for verification. Some responses were verified with responders as required. After verification the data sheet were given to data entry operator and to statisticians. A data field was created as per variable of interest and data were entered in the SPSS system for analysis. Mr Hafizur Rahaman, Mr Muhiuddin Ahmed and Mr Golam Kibria Nury in consultation with the technical officer prepared the database in SPSS. The entries were crossed checked and invalid entries discarded. The WHO technical officer assisted in cleaning and verifying the data. Total data of 109 surveyed centres were entered in SPSS. All data were displayed in tables with frequency distribution and graphical presentations were developed. The technical officer, the national consultant of blood safety and the national professional officer in epidemiology and Dr Nazmul jointly analysed the data against the variables and indicators of interest.

10. Results The following are the figures and tables that have been created on the number variables used in the pre‐set questionnaires for the survey of blood centres. The whole questionnaire contains three parts. Part‐1 includes organization and management, quality system, training, equipment & supplies, regulation, health safety, conditions of premises, blood donors & blood collections, screening of transfusion transmissible infections, blood group serology and compatibility testing, blood component preparation, blood storage transportation and inventory distribution. Part two refers to the transfusion process in the hospital which includes pre‐transfusion procedures, SOPs and records, staff training, clinical use of blood, and appropriate use of blood. Part three deals with the assessment of policy and management at the central administrative level and include national policy and coordination, national standards and guidelines, monitoring and assessment at national level, training, contingency plan and preparedness for disasters. The data indicate numbers of blood units, sources of blood by donor types, male/female blood donors, units collected in fixed and mobile sites, number of new donors, number of TTI markers, number and percentage of initial reactive samples, number of repeat reactive samples, types of blood components used, types of patients that received the components. The results are reflected in frequency distribution. As mentioned, the findings are represented according to the questionnaires used to obtain the information from 109 locations.

Part‐1 Types of centre f % District Hospital 50 45 Upazila Health Complex 11 10 Public Medical College 14 13 Private Medical College 6 6 Private Hospital 7 6 Public Institute 5 5 Standalone Blood Centre 6 6 NGO Blood Centre 2 2 Others 8 7 Total 109 100

Table 1: Types of centres surveyed

Out of 109 centres 50 were district hospitals, 11 were Upazila health complexes, 14 public medical colleges, six private medical colleges, seven private hospitals, five public institutes in Dhaka city, six standalone private blood centres, two non‐governmental, Bangladesh Red Crescent blood centre and Quantum Foundation Blood Bank. Other centres included blood centres in combined military hospitals and paramilitary forces, blood centres in the family planning and BGB (Border Guard of Bangladesh) hospital.

Figure 1Distribution of blood centres

Figure 1 shows that 80% of the centres belong to the public sector (ministry of health and other ministry) including medical colleges, institutes, district hospitals and Upazila health complexes, combined military and paramilitary hospitals. 12% of the centres belong to the private sector. Only 6% of the surveyed centres were standalone blood centres.

Almost 73% of total blood centres belong to Ministry of health and 18% to the private sector. However a few centres also get support from Safe Blood Transfusion Program.

Figure 2 Organization and management of blood transfusion services

Delegation of Functions to other Organizations 100 90 80 70 60 50 Yes 40 NO 30 20 10 0 District Upazila Public Private Private Public Standalone NGO Blood Others Hospital Health Medical Medical Hospital Institute Blood Centre Complex College College Centre

Figure 3 Delegation of function

In Bangladesh the BTS is a mixed type system. Public centres are exempted from license where private centres require license from Directorate General of Health Services (DGHS). All centres directly report to National Safe Blood Transfusion authorities. With respect to delegation of authority, none of centres responded to delegate blood transfusion for other organizations. All centres surveyed are attached to hospitals except the standalone blood centres (6).

Figure 4 Types of centres supported by International Organizations

The assessment revealed that blood centres are operated by their own resources. One Upazila reported to have received some logistic support from an international organization like UNICEF. However, Red Crescent blood centres reported to get financial support from several international organizations.

Figure 5 Blood centres that receive support from National Safe Blood Transfusion Program

It has been mentioned that 99 blood centres were enlisted under the Safe Blood Transfusion Program in 1999 when the program was first launched. That includes all public medical colleges, institutes and district hospitals and combined military hospitals and specialized hospitals like children hospitals. Besides, some private medical colleges like Bangladesh Medical College Hospital, national medical hospitals, Red Crescent blood centres, Thalassaemia Foundation Hospital, Holy Family Red Crescent Hospital were also enlisted in the program. These enlisted centres get regular supply of kits, reagents and blood bags from Safe Blood Transfusion Program. In addition, the enlisted centres do receive opportunities for training organized by Safe Blood Transfusion Program. From the assessment it has been noted that 100 Upazila health complexes received basic blood transfusion equipment and laboratory furniture but the function is yet to be started in all of them. During assessment one Upazila blood centre reported to be non‐functional.

Figure 6 Sources of funds for operation of blood centres

All public centres received funds from the government. The public centres reported to collect funds from charge recovery as fees for investigation of blood screening and other serological tests. Red Crescent reported to receive funds from different donor agencies. The proportion of funds from different sources were not calculated and recorded as per data requirement.

Figure 7 Status of quality standards.

The questionnaire for assessing quality standards included whether the centre has a quality policy, organizational structure, job descriptions and availability of a quality manager. The data revealed that out of 109 centres only one of the private sector centres could show quality policy and informed to have received accreditation. Though organization structures were present in most of the centres surveyed, it appeared that it concerned the centre as a

13 whole and not the blood centre. However, written job descriptions were not observed in any of the surveyed centres. For the reason mentioned above, only in one centre (APPOLO Hospital), the survey team could find a quality manager as the centre received JCI (Joint Commission Accreditation).

Figure 8 Status of SOPs in different types of blood centres

Figure 9 Status of SOPs in different types of blood centres

The team looked for SOPs on seven different essential processes including SOPs for blood screening, ABO and RhD blood grouping, blood storage, SOPs for blood component preparation and waste management. Only in two centres‐one private hospital and one private medical college, SOPs were found and reported implemented.

Figure 10 Status of records maintained in different types of centres

Figure 11 Status of records maintained in different types of centres

Figure 12 Status of records maintained in different types of centres

Documentation is an important feature of BTS for tracking and other routine purposes. The survey questionnaire included information on 13 types of documents covering all aspects of BT activities. Standard and comprehensive systems of documentation were found only in two public medical college blood centres. In the private sector it was comprehensive only in two private medical colleges and in two private hospitals. The data collected reveal that record maintenance of transfusion activities is not well organized and uniform. No centre kept records of the whole range of documents as required. Data also revealed that basic data for patients’ blood grouping were maintained in almost all surveyed centres but not in a uniform format. Similarly, the donor blood grouping registers were available but not complete in district, Upazila or in medical college hospitals of both the public and private sectors.

Laboratory documents such as cross matching were found in brief and along with patient blood grouping, donor blood grouping as seen in district and Upazila health complexes. In most of the district hospitals only three registers were found for the whole documentation of BTS. This reflects a paucity of information and most of the vital statistics were missing leading to possible improper monitoring and evaluation. Most of the responders knew the types and formats of documents required from their training program manuals. Lack of maintenance of documents according to responders is mostly due to shortage of manpower. All the data were recorded manually by the medical technologists working in the centres. It has been revealed that none of the centres has a designated person for data management except in one non‐governmental blood centre. In private hospitals like Apollo reported to keep data along with centralized laboratory information system (LIMS) from where data could be retrieved for reporting purposes.

Training 100 90 80 70 60 50 40 30 20 10 0 In‐Service Training National Training International Training

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 13 Status of training in transfusion centres

The data show that Public centres received most of the training organized by Safe Blood Transfusion Program as a national training. Most of the training conducted was basic training to develop laboratory skills.

Figure 14 Status of staff in blood centres

Out of all district hospitals only 38% responded that they have adequate staff. Out of 14 public medical colleges only 36% and in Upazila 73% have adequate staff. Others in public sector responded that the staff crisis is considered one of the major challenges to run the centres. Only in an NGO run centre adequate staff is present. All remaining centres declared to have shortage of staff.

Figure 15 Status of equipment

During the assessment, a list of equipment was shown to each of the centres. None of the centres responded that they have all the equipment as per list provided.

Figure 16 Mechanism of procurement

With regard to procurement of equipment all public centres indicated that almost all major equipment is purchased by a central procurement unit upon request from Safe Blood Transfusion Program whereas in private centres, equipment are purchased locally by the centre itself. Five public medical colleges purchased equipment locally in addition to central procurement. One private medical hospital and one NGO blood centre have received some equipment as grants from donor agencies.

Figure 17 Status of training on equipment maintenance

In response to whether the centre provides training to its staff –almost all centres under assessment responded negatively. In most of the cases the responders mentioned that the vendor provided on spot training when the equipment were purchased and installed. All centres under assessment reported to have equipment maintenance program. The system and practice of stock controls were not developed in either of the centres surveyed. However, it was observed in surveyed centres with varying degree.

Figure 18 Status of procurement of critical supplies

The questionnaires included specific questions as to whether the centre has developed a system for procurement of critical items for blood transfusion centres including blood bags, kits and reagents. It has been reported that blood bags were the critical supplies generally supplied from Central Medical Store and Deport (CMSD), Institutes of Public Health (IPH) and Safe Blood Transfusion Program (SBTP) in the public sector – however not adequate enough to meet the demands of the enlisted centres. In the private sector purchases are made from local market. SBTP generally arranged validation of kits

19 before distribution and use by the centres. There is no validation system for blood bags purchased from local market. Only the bags produced in IPH were reported to be validated.

Figure 19 Status of out of stock critical supplies in different blood centres (blood bags, test kits and reagents)

During assessment almost all centres reported to have experienced all types of critical supply run out. It has been shown that a significant portion of the public centres always suffered from shortages of blood bags where they have no other option than buy through the end user. Shortage of kits and blood group reagents happened to be regular; a major part of public centres suffered shortage with different degrees: 36% of public medical colleges 44% of district hospitals and more markedly 74% of Upazila health complexes and 4% of the public institutes. The private sector reported to keep critical supply ready but has experienced shortages however not in significant proportions. In the public system there is an ad hoc arrangement to buy kits, reagents, and others from local market through funds collected as “investigation fees”, as reported by the responders.

Figure 20 Status of regulation /licensing

As mentioned by law, the private blood centres require licensing prior to run a centre whereas public centres do not. The data show that all centres under the private sector obtained licenses. However in response to inspection by licensing authorities, only 50% of private medical colleges and 43% of private hospitals and 100% of NGO blood centres reported inspections by the licensing authorities.

Figure 21 Status of health and safety programme

Figure 21 shows that this area is quite neglected in both sectors. No records of program activities have been shown in the public sector in this regard. Some public blood centres have received training on health and safety program but no documentation was available Data revealed that health and safety program started in some private medical colleges and private hospitals at their own initiative and as an effort to the requirement of accreditation from different international agencies.

Figure 22 Status of suitable premises in the centres

There was significant shortage of spaces in districts hospital and Upazila health complexes surveyed. In district hospitals blood transfusion activities and routine pathology services were seen functioning from the same room, without any separation between the sections. Shortage of space was seen in the standalone blood centres as well as in the private medical colleges and private hospitals. Significantly two NGO blood centres have all types of rooms as reported and observed during the assessment.

Figure 23 Status of suitable premises in the centres

Figure 24 Status of access to differ utilities

Access to facilities like internet, telephone was available in both public and private sectors. Access to power supply varied from centre to centre and most of the public centres have access to central supply from the hospital where it is located.

Figure 25 Status of activities for blood donation

This figure shows 11 types of activities. All centres in both public and private sectors recruit and collect blood from donors. NGO blood centres reported to undertake almost 100% of activities for blood donor education and donor counseling as well as education materials for blood donors and have dedicated units for blood donor programs. This was significantly absent from the rest of the private and public centres. Only 54% of district hospitals and 9% of Upazila health complexes have regular physicians to look at blood donors. Although all centres responded that they have trained donor recruitment staff, materials for donor education and donor pre‐counseling persons were not adequately available.

Figure 26 Status of manpower for blood collection

Figure 27 Status of manpower for blood collection

Data shows that 17% of standalone blood centres and 45% of the Upazila health complexes have the trained personnel for assessing the suitability of blood donors. All other centres show to have trained personnel as well.

Figure 28 Blood donor selection strategies

The data show that there was a mixed type of recruitment strategies in the different centres. It has been noted that changes in recruitment strategies were being adopted in public medical colleges as well as in private centres. The private blood centres and hospitals prefer to perform pre‐donation screening of donors due to high prevalence of seroreactivity. On the other hand NGO blood centres during camp collection usually selected the post donation blood screening. None of the centres have developed a system to follow‐up sero‐

24 reactive blood donors. With regards to pre donation Hb measurement none of the centres responded to have performed it routinely. All centres followed the national criteria for blood donors suitability observed available in all centres surveyed. Except for two NGO blood centres none of the surveyed centres reported to observe World Blood Donor Day.

Figure 29 Method of assessment of blood donor suitability

Figure 29 shows the results of different methods used to assess blood donors’ suitability. All centres responded to use the blood donor assessment form supplied from SBTP as well as the form printed by the centres. Only 36% of public medical colleges, 20% of public institutes, 100% of NGO blood centres reported to hold pre donation counseling and interviews routinely before blood donation. None of the standalone blood centres under assessment reported to hold such activities during routine blood donation. 82% of district hospitals and 55% of Upazila health complexes reported to undertake regular physical checks of the blood donor before donation, however all other centres reported to carry out the physical check in 100% of blood donors.

Method for haemoglobin estimation 100 90 80 70 60 50 40 30 20 10 0 Portable colorimeter Haemoglobin colour scale Other

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 30 Method for Hb estimation Figure 30 shows that estimation of Hb was observed only by use of colour scale technique.

Cumulative Data of Blood Collection by 109 Surveyed Centers

200000 180000 165,816 160000 140000 132,410 (79.85%) 120000 100000 80000 60000 33,406 (20.15%) 40000 0 20000 0 Total No. of blood No. of voluntary non‐ No. of family No. of paid blood donors remunerated blood replacement donors donors donors

Figure 31 Cumulative data of blood collection by 109 centres as surveyed

The data show a yearly total of 165816 units of whole blood collected by the centres which represents 43% of total blood centres in the country. This shows that 15% of blood is collected from voluntary blood donors and 85% from relatives/family blood donors.

Donationby Location 100 90 80 70 60 50 40 30 20 10 0 Static Mobile

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 32 Donations by location

Figure 32 shows that NGO blood centres have the scope to collect blood in equal proportions from fixed and mobile sites, whereas some district hospitals, public medical colleges and public institutes reported to have blood collections done through door

26 campaign which represents on average 10% of collections from mobile sites. On enquiry NGO and standalone blood centres have mobile site donations on different national days. On a turnover basis blood collection was high in public centres in fixed sites though NGO blood centres have shown to have higher numbers of blood donations in mobile sites. Outdoor blood collections were not observed in Upazila health complexes surveyed. Even such an initiative was observed in standalone blood centres as well.

Donation by Age Group

100

90 80 80 70

Percentage 40

30 20 20

10 0 0 0 under 18 years old 18- 24 years old 25-44 years old 46-60 years old

Figure 33 Donation by age groups

The data show there were no paid donors registered during the assessment in any centre. The male/female ratio of the blood donors was not calculated as the data were not recorded in the centres according to the standard format. The records from the centres have shown that no single donor was recruited below the age limit of 18 ; 80% of donors belonged to age limits between 18 to 24 and 20% of donors belonged to age limits between 25 to 44. No donation was recorded between the age from 44‐60 in the surveyed centres.

Number of donor deferrals 1,657 (100% ) 100 90 80 70 60 50 40

Number of Donors 30 20 10 0 No. deferrals due No. of deferrals No. of deferrals No. of deferrals No. of deferrals to low due to their due to high-risk due to travel and due to other haemoglobin medical behaviour other reasons reasons ( TTI ) conditions Figure 34 Number of blood donor deferrals

During donor assessment, deferrals were noted in the centres. However in all centres there were records of blood donation deferrals due to sero‐reactive TTI markers, with no other reasons recorded for deferrals. The figure shows that 100% of donations were deferred due to presence of TTI markers.

Blood donation , reaction record 100 90 80 70 60 50 40 30 20 10 0 One standard volume of Autologous (pre‐ Only s terile , single Records of adverse System of obtaining donation routinely depos itory) blood use plas tic blood blood donor reac tions donor's feedbac k and collected donation collection bags complains

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 35 Blood donation, donor reactions and others

Figure 36 shows that all centres under assessment reported to collect 450ml of blood from the donors routinely and to use blood bags. None of the centres reported to have started autologous blood transfusion and there were no reports available in either of the centres for adverse donor reactions, however they responded to have observed vaso‐vagal reactions during blood donation. No system has been found adapted to record and entertain blood donors for feedback/ complaints either in public or private centres.

Blood Donor Data Base 100 90 80 70 60 50 40 30 20 10 0 B lood donor databas e B udget line item for the donor programme

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 36 Status of blood donor data base

This figure shows the presence of blood donor data bases. The data show that only in two NGO blood centres donor databases were manual and included all donor profiles, status of blood screening and time for next call for blood donation. Moreover, the mentioned NGO blood centres had the specific budget to develop other sections which was absent in the other centres. The data revealed that none of the surveyed centres has shown records for new blood donors each year. NGO blood centres however reported to have the data but not calculated as per specific format required for the assessment.

Collection of Blood through Apheresis Procedure Yes NO 100 90 80 70 60 50 40 30 20 10 0 District Upazila Public Private Private Public Standalone NGO Blood Others Hospital Health Medical Medical Hospital Institute Blood Centre Complex College College Centre

Figure 37 Blood collection by apheresis

Out of 109 centres surveyed only one public institute has record of blood collection for platelet components collected by apheresis. The remaining centres do not have components collection by apheresis.

System to follow up sero‐reactive blood donors 100 90 80 70 60 50 40 30 20 10 0 Results are confirmed by Confirmation is done at the Confirmation is done at a Donor is notified further tes ts centre referenc e laboratory

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 38 System to follow up sero‐reactive blood donors

System to follow up sero‐reactive blood donors 100 90 80 70 60 50 40 30 20 10 0 Post‐donation couns elling is at the centre referred to another centre conducted

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 39 System to follow up sero‐reactive blood donors

Figures 38 and 39 shows the different aspects of management of donors, who are sero‐ reactive for TTI markers. Each of the centres orally reported to provide post donation counseling to blood donors in each case but no protocol was evidenced. Most of the public centres reported to refer the sero‐reactive blood donors from district to medical colleges and to other private diagnostic centres for confirmation. However no feedback results were registered in the centres. Confirmatory testing was not available in the centres and most of blood donors were informed only of ELISA tests for TTI markers when available. There are no national guidelines or written instructions available for processing blood donor deferrals for further evaluations.

Figure 40 Status of TTI screening in the surveyed centres

Figure 40 shows that screening of five TTI tests mandatory in Bangladesh were carried out in 100% of centres except in 20% of district hospitals, 55% of Upazila health complexes, 23% of private medical colleges, 29% of private hospitals, and 17% of standalone blood centres which did not perform malaria testing routinely as evidenced from the assessment.

Quality assessment of TTI tes ting . 100 90 80 70 60 50 40 30 20 10 0 Algorithm for trans fus ion IQC samples used in each P articipate in an EQAS for Perform repeat tes ting in transmissible infections run TTI tes ting case initial reac ting blood sample

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 41 Status of quality control system for TTI markers

Figure 41 shows varieties of information on quality system for TTI markers. The assorted data from the assessment show that none of the surveyed centres (109) has the algorithms for TTI markers; internal quality control (IQC) was not observed in district hospitals and Upazila health complexes. Only 21% of public medical colleges, 50% of private medical colleges, 80% of public institutes reported to run IQC during routine testing of TTI. All NGO blood centres reported to run IQC during testing. With regards to External Quality Assessment (EQAS) three public medical colleges and one NGO blood centre reported to have participated in such a program organized by the Public Health Institute of Thailand.

Temperature‐monitored Equipment for Samples, Kits and Reagents

100

0 Test kits/ Reagents Samples DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 42 Equipment for storage of test kits and blood samples

Figure 42 shows that all kits are kept in temperature monitored refrigerators in 72% district hospitals, 35% in Upazila heath complexes, 100% in public and private medical colleges hospitals and institutes whereas temperature monitored refrigerators for samples storage were absent in varying degrees in all but NGO blood centres.

Screening of blood donations by Elisa Method 100 90 80 70 60 50 40 30 20 10 0 HIV I and II Hepatitis BHepatitis C

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 43 Method of blood screening by ELISA

Figure 43 shows that all surveyed centres carried out TTI testing using rapid method except in two private hospitals and two NGO BC where ELISA and CLIA were seen to be carried out in addition to rapid testing.

Percentage

Repeat testing of initial reacting blood samples

100

0 DH (50) UHC PMC PrMC PrH (7) PInt (5) SBC (6) NGOBC O (8) (11) (14) (6) (2)

Figure 44 Status of repeat testing for initial reactive blood samples

All centres reported to perform repeat testing for initially reactive cases using the same type of kits. The practice of repeat testing was absent in Upazila health complexes. It was 100% in public and private medical colleges and institutes and NGO blood centres. The data also revealed that no centre stored or archived reactive blood samples for look back studies.

Status of blood component production 100 90 80 70 60 50 40 30 20 10 0 Red cell components P latelets Fresh froz en plas ma C ryoprecipitate Any other component component component DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 45 Status of blood component production

Only 2% of district hospitals reported to produce blood components, 43% of public medical colleges, and 20% of public institutes, 50% of private medical colleges, 57% of private centres and 100% of NGO blood centres reported to produce blood components. This figures show that 10% of collected whole blood is converted into blood components by 17 centres in both public and private centres which represent 7% of the total (253 centres) throughout the country. None of the surveyed centres reported to have quality control programs for blood components and no centre reported to have a plasma fractionation plant.

Figure 45 Relative production of blood components

This figure shows that 55% of RCC 26% of FFP and 20% of PRP are produced and distributed.

Status of Blood Component production by apheresis 100 90 80 70 60 50 40 30 20 10 0 Apheres is red cells Aphers is platelets Apheres is plas ma

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 46 Types of centres producing blood components by Apheresis

QC programme for blood components Yes NO 100 90 80 70 60 50 40 30 20 10 0 District Upazila Public Private Private Public Standalone NGO Blood Others Hospital Health Medical Medical Hospital Institute Blood Centre Complex College College Centre

Figure 47 Quality control programme for blood components

None of the centres has a QC program for blood components

Part 2 Assessing the transfusion process in the hospital

Following data are responses to part two of the questionnaire related to pre‐transfusion practices in the hospitals. It is to be mentioned that all blood centres surveyed are integrated within hospitals except for standalone blood centres which are not.

Cold Chain 100 90 80 70 60 50 40 30 20 10 0 Blood storage operating within pre defined temperature

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 48 Blood cold chain management

All centres reported to keep blood in temperature monitored centres except for Upazila health complexes and standalone blood centres where no such system has been developed.

Stock control 100 90 80 70 60 50 40 30 20 10 0 Are SOPs on transport of Stand by generator to Is there a mechanism for Hospital accepted back blood and blood products provide power to the blood monitoring stock of blood into the stock of the center in use at the center storage equipment? and components for reissue DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 49 Stock control

None of the centres has developed SOPs for blood components or blood transportation. The system of stock control monitoring was not adequately developed both in public and private sectors except in the NGO blood centres where stock control of blood bags was available. All centres in the public sector responded that they have mechanisms for accepting the units of

36 blood supplied to the ward of the same hospital but not outside the hospital. It uses criteria though not written when the blood is returned back to the blood centre when not used. In private medical colleges and in private hospitals the same rule is followed where blood issued within the hospital is accepted if returned, under certain criteria. However, NGO and standalone blood centres never accept blood units once supplied from the blood centres even if returned within half an hour of issue.

Figure 50 Facilities for storage of blood and blood products

In clinical ward there were no separate refrigerators for transit storage of blood. All hospital blood centres used blood bank refrigerators for transit storage of blood. Only five Upazila health complexes and standalone blood centres reported to use domestic refrigerators for blood storage.

Provison of separate storage 100 90 80 70 60 50 40 30 20 10 0 Quarantine/ untested units Ready for issue Discarded units

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 51 Provision of separate storage

In response to facilities for separate storage like quarantine, ready for use and discarded units, 4% of district hospitals, 7% of public medical colleges, 100% of NGO blood centres have separate facilities.

Source of Blood in Hospitals Blood from other centers Blood from NGO blood centers

Blood from Private blood centers Collected by Centre

100 90 80 70 60 50 40 30 20 10 0 District Upazila Public Private Private Public Standalone NGO Blood Others (8) Hospital Health Medical Medical Hospital Institute (5) Blood Centre (2) (50) Complex College College (6) (7) Centre (6) (11) (14)

Figure 52 Source of blood in hospitals

Except for two NGO blood centres all others reported to receive blood from different sources arranged by the patients’ relatives. On average district hospitals received 93% of blood collected by the centres themselves, 3% from NGO blood centres and 5% from standalone blood centres. In medical colleges 85% of the blood is collected by the centres, and the remaining 10% are from NGO blood centres and 5% from standalone blood centres. Patient relatives were reported responsible for the transportation of blood to the patients. There were no transport boxes seen being used in public and private medical colleges and hospitals. Picnic type boxes were common transportation for blood in one centre.

Figure 53 Status of compatibility testing

Compatibility testing was reported to be carried out in all centres surveyed. On inquiry all centres responded to carry compatibility testing by using donor cells and patients serum in 100% of cases. There were mixed responses to ABO cell /serum grouping and RhD typing during cross matching. Significantly no centre reported to perform antibody screening for patients’ blood samples before any compatibility testing.

Methods used for the ABO (Red cell) grouping Forward Grouping Forward + Reverse 100 90 80 70 60 50 40 30 20 10 0 District Upazila Public Private Private Public Standalone NGO Blood Others Hospital Health Medical Medical Hospital Institute Blood Centre Complex College College Centre

Figure 54 Methods of ABO grouping

The data show that 100% of blood centres in district hospitals, public medical colleges, public institutes use slide method for ABO blood grouping and 18% of district hospitals, 8% of Upazila health complexes, 21% of public medical colleges, 80% of public institutes, 83% of private medical colleges, 71% of private hospitals, and 17% of standalone blood centres under survey reported to carry out reverse grouping along with forward grouping. RhD typing using slide method has been seen in all centres.

Figure 55 ABO grouping techniques

Figure 56 Methods of RhD grouping

Figure 57 Techniques of cross matching

The data show that all surveyed centres reported to perform cross matching at room temperature. Only one NGO blood centre reported to perform cross matching by indirect Coombs method as well. None of the centres carried out cross matching in addition to the two methods.

Transfusion Process 100

0 Transport boxes used for Demand of f blood and Separate storage areas Use of domestic System to check the blood transportation shortage of supply for cross matched and refrigerator for storage of patient's previous uncrossed matched blood blood and blood transfusion records as and components products part of the compatibility testing

DH (50) UHC (11) PMC (14) PrMC (6) PrH (7) PInt (5) SBC (6) NGOBC (2) O (8)

Figure 58 Transfusion process

Data show that none of the centres has facilities for segregating cross matched and other blood units. All centres reported to keep the previous transfusion records as part of compatibility testing.

Hospital Transfusion Committee 100 90 80 70 60 50 40 30 20 10 0 District Upazila Public Private Private Public Standalone NGO Blood Others Hospital Health Medical Medical Hospital Institute Blood Center Complex College College Center

Figure 59 Hospital transfusion committee The data show that hospital transfusion committees have been developed in all district hospitals, public medical colleges and public institutes as per rules of Safe Blood ACT.

Percentage Standard operating procedures (SOPs) or local written instructions 100 90 80 70 60 50 40 30 20 10 0 Completing the blood Drawing and labelling Collecting blood and Storage of blood and Administering Monitoring the patient Managing and request form the pre-transfusion blood products from blood products prior to blood/components, before, during and recording transfusion blood sample the blood bank transfusion including patient id after the transfusion reaction check

Figure 60 standard operating procedures for the transfusion process

The figure shows that SOPs for blood transfusion process were developed for completing blood request forms, drawing and leveling, blood administration but not for transfusion monitoring and management of transfusion reactions. There were no national guidelines developed for clinical indications for transfusion, such as Maximum Blood Ordering Schedules (MSBOS), safe blood administration, transfusion reactions. However, during assessment, most of the responders could not show the data because such data were not recorded in the centres. Only in two centres the Red Crescent blood centre and Quantum blood centre have extensive data. But they were not calculated and recorded according to the requirement assessment. For example, these two centres have records of new donors but the number could be not be ascertained as new. Data for the use of blood components were not available as per types of patients in any of the surveyed hospitals.

11. Discussion a) Organization and management of blood transfusion services The Blood Transfusion Service in Bangladesh has been reorganized since 2000 with the implementation of the National Program Safe Blood Transfusion under the Ministry of Health and Family welfare. To regulate and improve the service Safe Blood Act 2002 was approved by the parliament. Safe Blood Transfusion Program is the only implementing authority that has been dealing with facilities development in blood centres up to Upazila level hospitals by providing the logistics, manpower training and regular monitoring. There is National Safe Blood Transfusion Council constituted under the Ministry of Health to direct the National Safe Blood Transfusion Program to develop policy, guidelines and implement the projects for improvement of BTS. Besides, there is an expert committee constituted of the Directorate of Health services for implementation of the resolutions taken in National Safe Blood Council meeting. The overall management of the blood transfusion centres through the health care system is coordinated and implemented by the National Safe Blood Transfusion Program. The assessment does not reflect the whole scenario of BTS in the country but only partially. However, the data represent 43% (109) of the total (253) centres in the country, which is significant.

Each of the centres under survey, collects, processes, screens and distributes blood to the hospital where it is located. Thus there is no central collection system throughout the country. Requirement of licensing is mandatory for the private sector and inspection by licensing authorities was found inadequate. There is no regular system of supervision of transfusion service and no program for implementing quality service. The hospital transfusion committees formed in all public blood centres need activation for addressing and resolving various management issues at the local level. The shortage of manpower in each of the public centres appears to be a major constraint for the implementation of activities. This is applicable to the national program, where there is shortage of manpower to conduct regular supervision and monitoring of the centres. However, there is scope for development of an expert team under the national expert committee to visit the centres on a regular basis for implementing quality standards in the BTS as a decentralized system. b) National blood donation and collection practices From the assessment it is noted that blood collection in BTS is mainly hospital‐based, fixed site collection. The data show that 15% of blood is collected from voluntary blood donors and 85% from relative/family blood donors and that there were no paid donors in any of the surveyed centres. However, there is lack of coordination between the voluntary blood donor organization and the public sector for blood collection and utilization. No national blood donation strategy is yet formulated and no strategic program is yet implemented at national level. The promotion for voluntary blood donation was found inadequate at the national level. No national blood donor data base is yet to be developed for recruitment of blood donors. It is also seen that pre‐donation haemoglobin estimation is not practiced in any of the 109 centres; furthermore, all centres maintain records of donor deferrals due to sero‐reactive TTI markers but not for other reasons. Reliance on replacement donors as a source of blood is seen in all centres. Such donors usually have a higher frequency of infectious disease markers. It is urgent to develop a panel of voluntary donors whose blood is available for any patient. For the recruitment of voluntary blood donors a major effort should be made to develop a national program with an emphasis on training and motivation of 43 young people regarding their eventual responsibility in this matter. Blood donor publicity in adults should be targeted towards middle and upper class persons who have better health standards. This could be done in conjunction with various NGOs. A collaborating blood collection program based on governmental and NGO should be considered under the frame of policy development. c) National practices in screening of donated blood It has been reported that all blood transfusion centres under survey performed 100% blood screening for HIV, HBV, HCV and syphilis. All screening tests for viral markers are done using rapid method and only a few centres perform ELISA tests. However, the quality assessment of TTI testing was found inadequate. No facilities for confirmatory testing for repeat reactive markers have even been reported. Blood donor management, donor notification and deferral are poorly developed in the BTS in either of the systems. Besides, in district blood centres and in the private sector blood is screened as pre‐donation technique however data for sero‐reactive TTI markers were not recorded in the national screening data. How many of them later become false reactive? Or true negative? These data were not available. Single test strategy is being followed for screening in Bangladesh. Due to non‐ availability of referral system most of the sero‐reactive blood donors were not enlisted and followed up systematically to final confirmation. For the same reason no algorithms have been started for blood screening for confirmation for initial reactive and repeat reactions as well as for blood donor notification. There is a general lack of quality control and assurance in all laboratories and in spite of imparted training the concept has not been institutionalized neither in the district hospitals nor in medical colleges and hospital blood centres in both the sectors. There is an urgent need to upgrade serological techniques and to implement SOPs in all transfusion processes. d) Blood component preparation From the assessment it has been learnt that 17 centres throughout the country are producing blood components which convert 10% of total blood collection into blood components. There is no plasma fractionation plant in the country. However, quality control of blood components is yet to be developed in either sector. Use of blood components is not seen as widely practiced in most of the centres; this is due to lack of facilities and lack of orientation on the rational use of blood and blood components and in some centres blood component machines were seen not functioning. e) Inventory of blood and blood products and status of the blood cold chain From the assessment it is seen that in most of the blood centres single type refrigerators are used and all units (cross matched, uncross matched, screened and unscreened blood) were kept in the same refrigerator. It is reported that 4% of district hospitals, 7% of public medical colleges, and 100% of NGO blood centres have separate facilities for quarantine, ready for use and discarded units. This reflects an inadequate storage system for maintaining an appropriate cold chain for blood and blood products. Furthermore, in the public sector no cold chain system was used during transportation of blood from blood centre to the clinical wards of same hospitals. Only in two of private hospitals’ cold boxes were used for transportation of blood. f) Pre‐transfusion practices in hospitals It is to be recalled here that in Bangladesh, blood centres are integrated to each of the hospitals except for the standalone blood centres of the private sector. Due to shortage of blood, each of the hospital collects blood from other sources. Except for two NGO blood centres, all centres reported to receive blood from different sources arranged by patient’s relatives. On average district hospitals

44 received 93% of blood collected by the centres themselves 3% from NGO centres and 5% from standalone blood centres. In medical colleges 85% of blood was collected by the centres and the remaining 10% from NGO blood centres and 5% from standalone blood centres. Patient’s relatives have been reported responsible for transportation of blood to the patients. Consequently, not all centres are sufficient to meet the requirements for their own respective hospitals. The assessment revealed that 100% of blood centres in district hospitals, public medical colleges, public institutes use slide method for ABO grouping and 18% of district hospitals, 8% of Upazila health complexes, 21% of public medical colleges, 80% of public institutes, 83% of private medical colleges, 71% of private hospitals, and 17% of standalone blood centres reported to carry out reverse grouping along with forward grouping. RhD typing is done using slide method in all centres. Compatibility testing was reported to be carried out in all surveyed centres. All carry compatibility testing by using donor cells and patients serum which does not meet the standard criteria for compatibility testing.

Most of the responders particularly mentioned that manpower shortage is one of the reasons for not maintaining the standards for testing. Blood centres are always under pressure to supply blood within a short period of time in most of the cases. No centre reported to perform antibody screening for patient’s blood samples before any compatibility testing. Centres surveyed reported to perform cross matching at room temperature. Only one NGO blood centre reported to perform cross matching by indirect Coombs. Apart from that none of the centres carried out cross matching in addition to the two methods described. Quality standards for blood grouping, serology and compatibility testing need urgent attention for maintaining SOPs. The assessment revealed that none (except only two private hospitals) of the centres have ever developed SOPs for core laboratory process which is one of the challenges for Safe Blood Transfusion Program. The assessment revealed that hospital transfusion committees have been developed in all districts hospitals, public medical colleges and public institutes as per rules of Safe Blood ACT. However, these committees need more orientation about the clinical transfusion process monitoring. g) Transfusion monitoring and post‐transfusion practices in hospitals It is noted that written instructions for the blood transfusion processes were developed for completing blood request forms, drawing and leveling. However, there were no such protocols or instructions for blood administration, transfusion monitoring and management of transfusion reactions. No haemovigilance protocols have been developed in either of the centres. It is to be mentioned here that blood ordering schedule is also not developed in any of the hospitals visited.

12. Conclusion Good progress has been made in Bangladesh, but the pace now should be quickened in view of establishing a quality system in the country, particularly addressing the huge need for blood due to improving medical services and the expansion of the population. However, in spite of imparted training, workshop on clinical use of blood, monitoring of the centres by SBTP and DGHS, the implementation of SOPs was not observed in any of the surveyed centres. The basic procedures of blood typing, cross matching, with exception of a few centres are not followed as per standards which poses great threat to quality service.

The numbers of documents for pre‐transfusion records of patients were scarce and a high variation of format of documentation as well as number of registers to keep vital records related to donor

45 traceability and patients’ transfusion were observed. Similarly, registers for blood donation, cross matching and laboratory procedures were not uniformly followed and documented in centres according to SRO of BTS. Similarly, in the clinical transfusion settings of the visited centres none of centres could produce documents or registers for transfusion monitoring and recording adverse transfusion reactions. As reported, blood screening kits were procured by each centre when the supply from SBTP was inadequate and none of the public centres showed any documents for critical supply of test kits or blood bags purchased by using local funds. All public centres reported staff shortage and showed constraints in delivering quality service especially in medical colleges and district hospitals.

Over the past decade since the creation of SBTP, blood collection and donor recruitment has only changed from paid donation system to donations by relatives and there is rarely any stock seen in public centres of blood collected from voluntary donation and no stocks of blood were seen in the Upazila health complexes during the survey. Nonetheless, Safe Blood Transfusion Program has been successful in lowering the rate of TTI markers in blood donors (below 1%) through the introduction of mandatory blood screening backed by the Safe Blood Act. The isolated success would need to be consolidated through gap analysis and lessons learnt between the sector wide program and the findings of the assessment. The SBTP from the very outset focused on prevention of TTI, rather than total improvement of coordinated BTS. Consequently, time bound strategic planning like immediate, midterm and long term action plans need to be formulated and implemented. The experts recommended assessment of all centres in order to get more information. The questionnaires set which was prepared and developed after consultation was exhaustive however many of the responses were not well registered due to paucity of systematic records; in many instances it was also difficult to retrieve full information within the short period of time allowed for assessment.

The assessment findings can serve as input for formulating a capacity development response for capacities that could be strengthened and optimize the already strong and well founded ones. It can also set the baseline for continuous monitoring and evaluation of progress against relevant indicators and help create a solid foundation for long‐term planning, implementation and sustainable results. The collected data can be used, for instance, when preparing national action plans for blood transfusion services and implementation strategies. In the context of any of the situations just described, the collected data will act as a catalyst for action, confirm priorities and provide insight into operational hurdles experienced in the last program from 2000 to 2010. It is to be noted that the conducted assessment opened an opportunity to educate and update program personnel and the responders at the centres on the importance of data series required for updating the global data base of blood safety. The assessment has introduced and put emphasis on use of benchmark which needs to be considered for adaptation and implementation of quality assurance. It was learned from the assessment that the blood transfusion service (2000 and onward) in Bangladesh had been largely successful in establishing mandatory blood screening in public and private sectors, initiating blood components production, institutionalizing training, data collection, and regulation of private blood centres. The assessment has encouraged prioritizing the use of different indicators.

13. Recommendations  The infrastructure of blood transfusion services especially in district hospitals under the public sector needs more attention in providing physical space required for proper functioning of the blood centres. The blood transfusion services should be separated from diagnostic laboratories. Each blood centre in district and Upazila health complexes should also have suitable facilities and preferably separated from pathology departments.

 There should be deputation of additional staff such as medical technologists in each blood centre. Medical officers working in blood centres should get frequent training along with medical technologists on procurement, SOPs, quality assurance, record keeping, documentation, stock management, TTI algorithms, standard practices for serology, compatibility testing, and pre‐ and post‐donation counseling.

 The overall management personnel in each centre require management training and training on quality management for implementing SOPs in BTS.

 Safe Blood Transfusion Program should consider training for the private sector so that the uniform standards are being followed in each centre, which would assist the licensing authority to conduct regular monitoring and supervision of standards.

 National standards should be developed for blood transfusion including SOPs. National authority should train the personnel on the basis of national standards of blood transfusion.

 The national voluntary blood donation program should be structured with participation of potential stakeholders and policy should be adopted for GOVT–NGO collaboration for organizing motivational and blood collection programs to build up blood stocks in the centres. There should be policy adopted for equal distribution and exchange of blood between public and private sectors in order to have optimum utilization of blood.

 Regional basis blood collection should be initiated jointly by medical colleges and voluntary blood donor organizations for more blood components production and replacing the use of whole blood in all cases.

 Safe Blood Transfusion Program with collaboration of reference laboratory should take initiative for the development of TTI algorithms and conduct regular quality of TTI testing and serology with recommended WHO collaborating centres.

 Regional medical colleges should be strengthened with adequate facilities and manpower for acting as regional referral centres for confirmatory testing of TTI markers.

 National guidelines should be developed for blood donor deferral, confirmatory testing, management and notification.

 Clinicians need more orientation on rational use of blood and should be encouraged to develop SOPs for blood administration, monitoring transfusion and reporting hazards of blood transfusion.

 Local level hospitals transfusion committees should be oriented proactively in developing local blood transfusion guidelines for monitoring and supervision of BTS including development of haemovigilance protocols.

 There should be provision for adequate and appropriate equipment in each centre and adequate refrigerators provided for segregation of units of blood before and after testing.

 Members of national expert committee and experts of higher institutes should visit the different types of centres under monitoring program to support SBTP in establishing quality services in a large number of centres throughout the country.

 The Reference Laboratory (RL) should function as a national confirmation centre to provide an independent opinion on repeat reactive TTI donor samples. It should have appropriate and validated confirmation testing facilities in place such as Western blot technology, Nucleic Acid Amplification Technology (NAT), PCR, CLIA and competent staff with adequate training to perform the tests. RL should also monitor training activities in regional centres and compile data of TTI and blood components, update the national data and report to national authority. Besides, the centre should take any advance training, like quality assurance, EQAS and research. It should have a networking system with regional centres.

14. Proposed Action Plan

Activities / Timeline Month 1 2 3 4 5 6 7 8 9 10 11 12 1 .Situation Assessment

Assess the existing facilities/ practices and identify gaps for screening donated blood 2. Develop National Action Plan and Baseline indicators Develop national action plan (workshop) Develop baseline indicators 3. Review / develop national standards, strategies and algorithms Develop / Review and revise National Blood Policy, National Guidelines, Strategies, SOPs and related documents Dissemination of the above guidelines to stakeholders and regular CME for updates 4. Develop equipment, reagent management system Review procedures in current use in the procurement of equipment and kits/reagents Develop a system (procurement guideline) for development and evaluation of specification for blood banking logistics including reagents/kits/blood bags; printing of the guideline & dissemination Streamline evaluation procedure for procurement of equipment/kits/reagents 5. Identify, designate and build capacity of national reference laboratory Establishment of regulatory mechanism for Blood Banking (EQAS, Proficiency Panel Preparation and validation, Evaluation of diagnostic kits/ reagents/ blood bags/blood bank equipment; import/export of reagents/kits) Training for staff in management of NEQAS, Proficiency panel preparation, TTI screening,

Activities / Timeline Month 1 2 3 4 5 6 7 8 9 10 11 12 6. Capacity Building Develop capacity on investigation of transfusion reactions and haemovigilance protocol Training of staff in Transfusion medicine (Fellowship) Networking of Central, Regional, District and Hospital based Blood centres Review Meetings* and monitoring 7. Training for laboratory personnel Hands on training on TTI screening

Hands on training on waste management

Hands on training on proper use of the SOPs 8. Training and support to develop quality systems Develop Quality Policy and manual

Hands on training workshop on quality assured screening of donated blood including IQC, QA, EQAS, Waste Management Development and distribution of SOPs

Training workshop for recording, reporting and maintenance of Blood Banking information system 9. Strengthen information management systems

Develop and operationalize a web based Information Management System Expansion of the web based Blood Banking Information Management System linking with MIS. Technical support for maintenance of Blood Banking data management system Regular evaluation of the program Implementation by experts of MoHP/WHO country office/ HQ through visits, review meetings, etc.

15. Limitations The used toolkit was very comprehensive and it would have been very useful for introduction of WHO framework for monitoring. However, the assessment suffered a considerable time due to non‐ availability of data collectors for conduction of the assessment. There were other administrative problems in the program management like changes of program managers which ultimately led to delay in timely conducting of the assessment. Due to considerable number of variables the analysis by SPSS also took time to prepare the final report.

16. Acknowledgements The assessment has been successfully completed with the assistance of Safe Blood Transfusion Program team and resource persons of DGHS under the leadership of program director, program manager and deputy program manager of BAN‐BCT and SBTP. During the visits of the centres, responders cordially supported the team in inspection of the centres showing the records and statistics which greatly contributed in the assessment. It is nevertheless to acknowledge the technical assistance of WHO country office, Dr Neelam Dhingra, WHO HQ, Dr Rajesh Bhatia, SEARO, WHO for which such assessment could have been conducted. Dr MK Zaman Biswas, National Professional officer (epidemiology), Dr Murad Sultan, technical officer, blood safety, national consultants CSR, EHA and data analyst and statistician are greatly appreciated for their contribution in making the assessment successful. Dr SM Alamgir, Dr Muzaddeed Ahmaed, Dr Syeda Masooma Rahman, Dr Enamul Haque, Dr Zahidur Rahim and Dr Selina Khatun of WHO and Dr Md Ashadul Islam of blood transfusion and Dr Mazharul Hoque, DPM, SBTP, Dr Aminul Hassan, DMP, DGHS have been acknowledged for their continuous and pro‐active support that enlightened with valuable guidance during the assessment. Collaboration and support of OFID is highly appreciated.

References 1. Aide Mémoire: Blood Safety, 2002 2. WHO Aide Mémoire: Good Policy Making Process for blood safety and availability, 2008 3. WHO Aide Mémoire: Quality System for Blood Safety, 2002 4. WHO Aide Mémoire: Safe Blood Components, 2005 5. WHO Aide Mémoire: Clinical Use of Blood, 2003 6. WHO, Framework for Assessment, Monitoring and Evaluation of the Blood Transfusion Services, 2010 7. Safe Blood transfusion Act 2002 8. Safe Blood Transfusion Rules 2008 9. Screening Report of Safe Blood Transfusion 2010 10. Bangladesh Health Bulletin, 2011

ANNEX I: Assessment questionnaires

The assessment tool for Blood Transfusion at Public and Private sector DGHS and WHO

Name of the DATA collectors with Designation with contact number:

…………………………………………………………………………………. …………………………………………………………………………………. ………………………………………………………………………………….

Date of visit: …………………………..

Date of Reporting and submission: …………………………

Signature: ……………………………

Center Code …………......

District…………………………. .

Division ………………………. .

Part 1: Assessing the blood centre1

General information about the Centre Name of the facility

Address

City/ town District

Name of officer in‐charge

Designation E‐mail Telephone Fax Other

Date of report ‐

Reporting period: From To

Name of responder/s With contact number

Signature

Type of blood centre

National Blood Centre Regional/ Provincial Blood Centre District level Blood Centre/Blood Bank Other (Please specify)

1 It can be standalone blood center that collects, screens, processes and distributes blood or a hospital‐based blood center that collects, screens, processes and issues (or distributes) blood. Hospital blood banks that only store blood and check compatibility should not be regarded as a blood center. 53

Section A: Organization and Management General management 1 Under which management responsibility does the blood centre operate (please tick): [1] Public (under MOHFW) [2] Public (other than MOHFW) [3] Non‐governmental/non‐profit organizations such as the National Red Cross Society [4] Private Blood centre

2 What type facility does the centre belong to? (please tick) [1] Standalone blood centre [2] Hospital based blood centre [3] Hospital based blood bank (as part of the laboratory) [4] Other (Please specify)

3 Is the National authority (SBTP) supporting the blood centre? Yes No If yes, Types of support Financial : Yes No Reagent : Yes No Blood Bag : Yes No Equipment : Yes No Others specify : Quality System 4 Does the centre have a quality policy? Yes No

If yes, please obtain a copy A document that defines the goals and objectives of a blood transfusion service or blood centre with regard to quality, a commitment to meeting stated requirements, and an undertaking to drive continuous improvement throughout its activities. It must be suitable for the organization and provide a framework for establishing, communicating and monitoring performance against agreed quality objectives.

5 Does the centre have an organizational structure indicating authority, responsibility and reporting relationships? Yes No

If yes, please provide a copy of the organigram.

6 Are there written job descriptions for all positions within the department /centre? Yes No

7 Has the centre appointed a person responsible for quality management? Yes No

The appointed, responsible and authorized individual within an organization with the responsibility for developing and managing the quality system 8 Does the centre have Standard Operating Procedures (SOPs) or local written instructions for following areas of the centre? (Please tick as appropriate) Yes No [1] Blood donors selection [2] Blood collection and donor care [3] Blood component preparation (RCC, FFP, PRP) [4] Screening for TTI [5] Blood group serology and Cross matching [6 ] Waste management

9 Do the centre maintain records of the following: (Please tick as appropriate) Yes No [1]Blood donors selection [2]Blood collection and donor care [3]Blood component preparation [4 ]Screening for TTI [5]Waste management [6] Patient blood grouping register [7]Donor blood group register [8]Cross Matching register [9]Blood Supply register [10]Blood Stock register

Training 10 How many staff work in the centre in following categories and how many of them have been trained during the reporting period? (Please specify numbers)

Category of Staff Total In‐service National International number training training training of staff (departmental course/work course/worksho on blood shop (SBTP) p SBTP) transfusion) Professor Associate professor Assistant Professor Consultant Medical officer Medical Technologist

Nurse Counsellor Administrative staff Others specify

11 Does the centre have adequate staff for its operations2?

Equipment & Supplies 12 Please provide information on the availability and functioning of the equipment in the centre based on the list at the end of the section.

13 Does the centre have adequate equipment for its work?3 Yes No

14 How are equipment procured? Please tick as appropriate Yes No [1]Purchased locally by the centre [2]Purchased centrally or through upper level agencies [3]Donated by international development agencies/donor countries [4]Other (please specify) 15 Does the centre provide staff training of the use of equipment? Yes No

16 Does the centre have a program for equipment maintenance? Yes No

17 How key supplies4 in the centre were purchased? Please tick () whenever applicable.

Yes No [1] Purchased locally at the centre? [2] Purchased centrally or through upper level agencies [3] Evaluated before procurement? [4] Validation of kits, reagent and blood bag carried out? If yes

2 this question should be answered based on the national criteria if there is one, otherwise the answer can only reflect the perceptions of the directors/managers of the blood center 3 Same as above 56

Whether in practice (reagent, kits and blood bag)

18 Is there a system of stock control for the critical supplies? Yes No

If yes Blood Logistics Blood Bag Kits Reagent Others specify Critical stock items are all items that directly or indirectly affect the ability to collect, test, process and distribute blood and blood products 19 Have any of following supplies run out in the last 12 months? Yes No

(Please tick and indicate number of days affected without supply) Item No Yes If yes, please indicate number of days [1]Blood bags [2]TTI kits [3] Blood Grouping Reagents [4]Others (Pl. specify) Regulation 20 Is the centre registered/ licensed (private organization)? Yes No

20. 1 If yes, under what national body/ authority/ agency is the centre registered /licensed? ______

21 Is the centre inspected for the purpose of registration / license? Yes No

If yes, 21. 1 When was the last inspection carried out? ______Date/month/year

Health and Safety 22 Is there a program for Health and Safety in the centre? Yes No

Detailed information on the program

4 Key supplies include blood bags, TTI test kits, blood group serology reagents, etc. 57

Premises 23 Does the centre have suitable premises for5: Yes No [1]Donor selection and collection [3]Blood processing and testing [4]Storage and distributing [5] Wash room /Bath room for donors [6]. Store room [7] Room for Blood Transfusion staff [8] Autoclave

24 Does the centre have access to: Yes No [1]Continuous water supply [2]Power supply [3]Transportation system [4] telephone [5]fax [6]internet

5 The questions should be adapted based on the country‐specific guidelines about work area regulations. 58

Equipment in the blood centre6: Equipment Number Number Number expected available functioning Donor beds/couches Weighing scale Blood collection monitor (bio Mixture) Sphygmomanometers Tube sealers Container for safe disposal of sharps Oxygen supply equipment (e.g. cylinder) PC with accessories and software bench top centrifuge for samples Blood transportation box Double pan balance Cell washer centrifuge Binocular microscopes Laboratory thermometers ELISA plate washers ELISA plate reader Automatic pipette pH Meter Autoclaves machine Water bath Incubators Hot Air ovens Deep freezer‐750C‐80 0C Plasma extractors Platelet incubator and shaker Haematology autoanalyzer Refrigerated centrifuges Haemocue/instrument for Hb Estimation Voltage stabilizers Distill water Plant Blood bank refrigerator

6 The list of equipment should be adapted to be used for the blood centres in various levels in the country where assessment is conducted. If a national standard for the equipment requirement at various level of blood services is available, this list should be based on the standards.

Pharmaceutical refrigerator Air conditioner Blast freezer

Section B: Blood Donors & Blood Collection 25 Are following activities undertaken by the centre (please tick)?

Activities Yes No Blood donor recruitment Pre‐donation counselling Blood collection from donors

Note: If your answer to all the above is "No", skip section "B" of the questionnaire completely. If your answer to any of the above is "Yes", please answer all relevant questions on that topic.

26 Does the centre have dedicated unit and staff for the blood donor program? Yes No

27 Is there a physician in the centre with responsibility for medical matters such as donor health and safety? Yes No

28 Does the centre have trained donor recruitment staff? Yes No

29 Is there a specific budget line item for the donor program? Yes No

30 Are educational materials for donor information available? Yes No

If yes, at what level were these materials developed By the centre______; Regional/______; national______. 31 Are there criteria for assessing the donor suitability to give blood? Yes No

32 How do you assess donor suitability? (Please tick.)

Method Yes No [1]Donor questionnaire [2]pre‐donation counselling & interview [3]Physical check [4]Other, specify

33 Does the centre estimate donor's haemoglobin or haemtocrit before donation? Yes No

34 Is there a blood donor database/registry in the centre? Yes No

34. 1 If yes, how is it maintained? Manual Electronically

35 Among the total number of DONATIONS from voluntary non‐remunerated blood donors who donate during the period, how many are from new donors

Please indicate the number of DONATIONS that were collected in different locations. (last one year) Nº

‐ Static location ‐ Mobile sites

36 Is only one standard volume of donation routinely collected in the centre? Yes No

36. 1 If yes, what is the standard volume of a whole blood unit collected in the centre?

36. 2 If different volumes are routinely collected in the centre, please indicate the number of BLOOD DONATIONS different volumes? Volume of Collection (ml) Nº (write "E" if it s estimated)

37 Does the centre collect blood through apheresis procedures?

Yes No 38 Does the centre collect autologous (pre‐depository) blood donation? Yes No

If yes, please indicate the total number of autologous DONATIONS (pre‐depository) collected in the centre during the reporting period.

39 Are records of adverse blood donor reactions maintained? Yes No

39. 1 Please indicate the number of donations with adverse reactions for the reporting period? You may give an estimated% if the exact number cannot be provided.

Type of reactions Number of donations with % adverse reactions [1]Total [1. 1]Mild reaction [1. 2]Modest reaction [1. 3]Severe 40 Is there a system to follow up sero‐reactive blood donors (please tick)? Yes No

40. 1 If yes, answer the following by ticking as appropriate Yes No [1]Results are confirmed by further tests [1. 1]Confirmation is done at the centre [1. 2]Confirmation is done at a reference laboratory [2]Donor is notified [3]Post‐donation counselling is conducted [3. 1]at the centre [3. 2]referred to another centre

40. 2 If donor counselling is conducted in the centre, is it conducted by trained personnel? Yes No

Section C: Screening for Transfusion Transmissible Infections (TTI)

41 Does the centre screen the donated blood for following TTI (please tick)?

Screening for Yes No HIV I and II Hepatitis B Hepatitis C Syphilis Malaria

Note: If your answer to all the above is "No", skip all questions of section "C". If your answer to any of the above is "Yes", please answer all relevant questions on that screening test.

42 Does the centre have an algorithm for screening donated blood for transfusion transmissible infections? Yes No

42.1 If yes, please provide a more detailed description of the algorithm (Document of procedures and Protocol for testing and interpretation of result specially for initial reactive case, repeat reactive case and confirmatory testing) 43 Does the centre participate in an external quality assessment scheme (EQAS) for TTI testing? Yes No

44 Are test kits/reagents and samples stored in temperature‐monitored equipment? Yes No [1]Test kits/ Regents [2]Samples 45 [1] Please indicate percentage of donations screened for transfusion transmissible infections (TTI) during 2010 (Jan‐December). TTI markers % [1] HIV I and II [2]Hepatitis B [3]Hepatitis C [4]Syphilis [5]Malaria 46 Are different types of test methods (such as simple/Rapid and ELISA methods) used for the screening of blood donations for TTI? Yes No

46. 1 If yes, please indicate the types of test methods used in the centre and the total number of donations tested by each method during the reporting period:

Test method used (please tick) and the number of donations tested Infection by the different method markers Simple/Rapid ELISA Other, specify Test Used No. Used No. Used No.

[1]HIV I/II [2]Hepatitis B [3]Hepatitis C [4]Syphilis [5]Malaria [6]Others, specify

47 Does the centre perform repeat testing in case of initial reacting blood sample

48 Are reactive results in the screening tests confirmed (either by the centre or through reference laboratories)? If yes, please indicate the number of donations that were positive in the confirmatory test.

49 Does the centre keep records of screening tests performed for TTI marker by different type of voluntary non‐remunerated donations? (Voluntary donors are new and repeat) Yes No Others, specify

Section D: Blood Group Serology and Compatibility Testing

50 Which of following tests were performed on blood donations for determination of ABO and Rh (D) groups and what techniques were followed? (Please tick)

Red cell/ Serum/ RhD Forward Reverse Grouping Grouping Grouping [1]Slide [2]Tube [3]Micro‐plate [4]Column agglutination

[5]Magnetic bead technology [6]Others

51 Do you perform irregular antibodies screening on blood donations? Yes No

52 Does the centre participate in an external quality assessment scheme (EQAS) for Blood Grouping Serology assay? (see the EQAS for TTI) Yes No

52. 1 If yes, at which level does the centre participate in EQAS?

Level Please tick. International National Regional/ provincial Local 53 Does the centre provide compatibility testing for other hospitals/clinics? Yes No

If yes, what is the total number of cross‐match procedures performed by the centre?

Section E: Blood Component Preparation

54 Does the centre prepare blood components? Yes No

Note: If your answer to all the above is "No", skip this section ("B") of the questionnaire completely. If your answer to any of the above is "Yes", please answer all relevant questions on that topic. 55 What is the number of whole blood donations that were separated into component during the reporting period? (number of donations)

56 What type of components does the centre prepare? How many units were prepared during the reporting period?

Please tick “yes or “no” and, if the answer “yes” is chosen, indicate the total units of blood components prepared during the reporting period. 56. 1 Whole blood derived components

Components Yes No Nº [1]Red cells [2]Platelets7 [3] plasma [4]Fresh frozen Plasma (FFP) [5]Cryoprecipitate [6]Others, specify 56. 2 Components collected through apheresis procedures 57 Is there a QC program to monitor the quality of final blood components? Yes No

In built process for checking 1%

1. 67

Section F: Blood Storage, Transportation, Inventory & Distribution

58 Is blood storage operating within the pre‐defined temperatures for storage of blood and blood components according to the SRO? Yes No

WB +20C to + 6 0C Platelet concentrate +200C to + 24 0C FFP (fresh Frozen Plasma‐300C Cryoprecipitate‐300C 59 Is the temperature of the blood storage equipment in the centre monitored? Yes No

If yes, describe how it is monitored. Temperature chart Report of inspection 60 What types of freezers does the centre use for storage of blood or blood products? Yes No [1] Blood Bank Refrigerator [2] domestic refrigerator for whole blood/red cell [3] domestic freezer for FFP/Cryoprecipitate If yes, please provide the number of domestic refrigerators and freezers used and (if possible) the estimated percentage of blood/blood components stored in the domestic refrigerators or freezers. (Is the temperature monitored? How is it monitored?)

61 Does the centre have separate storage areas for following purposes?

Yes No [1] Quarantine/ untested units [2] Ready for issue to patients [3] Discarded units

62 Does the centre use equipment for blood transportation? Please tick "Yes" or "No" appropriately. If "yes" is ticked, indicate the numbers of equipment the centre have for transportation?

Yes No Number [1] Picnic type boxes [2] locally made boxes [3] Standard cold boxes [4] Refrigerated vehicle [5] Other, specify

63 Is the temperature of blood monitored during transportation? Yes No

If yes, describe how it is monitored. 64 Do you have stand‐by generator to provide power to the blood storage equipment? Yes No

65 Is there a mechanism for monitoring stock of blood and components? Yes No

If yes, please describe how the stock of blood and components are monitored

66 Please provide the total units of blood and blood components distributed during the reporting period

Units [1]Whole blood [2]Red cells [3]Platelets [4]Fresh frozen Plasma (FFP) [5]Cryoprecipitate [6]Others, specify

67 Is the blood not used by the transfusing hospital accepted back into the stock for reissue? Yes No If yes 67. 1, what is the total number of units (whole blood or red blood cells) accepted back in the stock during the reporting period?

67. 2 Are there criteria to receive blood back for stock rotation? Yes No

Written document or SOP for Criteria or condition indicating under which it will be accepted and not accepted)

68 Do you maintain records of the following: (Please tick as appropriate) Yes No [1]Request blood and components for transfusion [2]Drawing and labelling the pre‐transfusion blood sample [3]Collecting blood and blood products from the blood bank [4]Storage of blood and blood products prior to transfusion [5]Administering blood/components, including patient id check [6]Monitoring the patient before, during and after the transfusion [7]Managing and recording transfusion reaction

69 Which of these are available or used as alternatives to blood transfusion? Yes No [1]Crystalloids [2]Colloid [3]No information available

70 Is there a system for monitoring post transfusion incidence or reactions in the health facility? Yes No

[1] system for monitoring post transfusion incidence [2] system for monitoring post transfusion reactions

71 What was the number of serious adverse transfusion incidents or reactions reported during the reporting period? [1] Number of serious adverse transfusion incidents [2] Number of serious adverse transfusion reactions

72 Do the medical records in the facility permit differentiation of blood usages for any of the following categories of patients requiring multiple transfusions? Yes No

72 1 If yes, please specify the number of the patients and number of blood, blood components and blood products transfused in the reporting period.

Condition No of Whole Red Platelets FFP Crpt patients blood Cells [1] Thalassaemia

[2] Haemophilia

[3] Sickle Cell Anaemia [4] Aplastic Anaemia [5] Haematological and other malignancies [6] Chronic renal failure [7] Others (Specify)………….. …………………….

IN PLACE Policy and management at the central administrative level (Tick) Yes No

National Policy and coordination

1 Is there a unit within the MoH (or other government department) with responsibility for overseeing blood transfusion activity? If yes, name of the unit: ______Name of the officer in charge______

2 Is there a designated national blood program manager? 3 Is a national quality manager/officer nominated ? 4 Is a national blood donor program manager/officer nominated? 5 Is there a national blood policy? If yes, Year of adoption______Please obtain a copy 6 Is there a national strategy or strategic plan?

If yes, has its implementation been initiated? 7 Is there specific national legislation covering safety and quality of blood transfusion? If yes, obtain the document reference number and a copy. 8 Has the Ministry of Health constituted a national body responsible for policy development and decision making for blood transfusion? If yes, please provide a list showing the membership of this body. 9 Are there (national) expert panel (s) to advice on technical and medical issues

related to transfusion safety, availability and quality? 10 Is there a national reference centre? (Is there a national blood transfusion service?)? If yes, what was the year of its establishment? ___ 11 Has the government delegated any responsibility for NBTS/blood transfusion services to a nongovernmental organization?

If yes, name of the organization(s):‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐, Roles of the organization (s)‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ 12 Is there a national strategy for the provision of fractionated plasma products?

13 Please indicate how fractionated plasma products are supplied in the country? Please tick.

[1] Importing from abroad [2] Fractionation in‐country by the public (not‐for‐profit) sector

[3] Contract fractionation by a profit making organization

[4] Other, specify

14 Is a specific budget provided for the national blood program? Are there specific budget line item for (1) national supervision (2) training (3) donor recruitment (3) equipment maintenance and spare parts (4) other, please specify 15 Is there a national cost recovery policy/system for the blood centre/blood transfusion services? If yes, obtain detailed information.

National standards and guidelines

16 Are there national standards/guidelines for: [1] Criteria for assessing the suitability of donors for blood donation [2] Standardized donor interview questionnaire [3] Blood collection [4] Technical specification for blood components [5] Preparation of Blood and Blood components [6]Testing of Blood donated for TTI [7] Storage of Blood and Blood Components [8] Transportation of Blood and Blood Components [9]Issue of Blood [10]Quality management for blood transfusion services [11]Waste management in blood transfusion services? [12]Occupational health and hygiene to prevent the transmission of blood borne infections

17 Are there national standards/guidelines for: [1]Clinical indications for transfusion [2]Standardized blood request form [3]Maximums blood ordering schedules (MSBOS) [4]Pre‐transfusion testing [5]Safe Blood administration [6]Transfusion reaction form

Monitoring and Assessment at the National Level

18 Is there a system of centralized data collection and analysis for the blood transfusion services in the countries

19.1 If yes, how frequent are the national data collection and analysis conducted?

19 Is scheduled supervision program available for: (1) blood centre (2) blood banks in hospitals or other health facilities When was the latest supervisory visit? What activities are conducted during the supervisory visits? Is there a standard supervision checklist? If yes, pl provide a copy?

20 Is there a national external quality assessment scheme for blood group serology? If yes, please provide the name of the provider, or how it is provided:______

21 Is there a national haemovigilance system? If yes, please provide the start year______and the number of participating facilities______

22 Mechanism for the regulation of the blood centre/blood transfusion services?

(A) Is there a system for mandatory registration or licensing of blood transfusion services?

(B) Is there a system of regular inspection of the blood transfusion services?

(D) Is there a national regulatory authority for blood transfusion services? If yes, name of regulatory authority______

Equipment and supplies

23 Is procurement of equipment conducted centrally at the national level?

24 Is there a separate budge line item for equipment maintenance and spare parts?

25 Is there a national inventory maintained for equipment and spare parts

26 Is there a national program to evaluate test kits and reagents used for blood transfusion? If yes, who conducts the evaluation? ______

Education and training

27 At the national level, is there a program to provide continuing education for personnel involved in blood transfusion?

If yes, obtain more detailed information, such as providers/organizer/fields.

28 During the reporting period, how many national training courses were provided? Please fill in the following tables

No. of courses Total No. of Major purpose of the training organized participants [1] Donor education, recruitment, and selection

[2] Blood collection and donor care

[3] Quality management [4] Laboratory practices and skills relating to blood safety

[5] Processing and component preparation [6] Cold chain management (storing, handling, transportation)

[7] Transfusion and blood utilization

[8] Blood administration procedures

[9] Bio‐safety and waste management

[10] Blood service management

[11] Others, please specify______

29 Are there educational programs in blood transfusion medicine/science leading to a nationally recognized university degree/diploma?

ANNEX‐2: List of blood transfusion centres and hospitals surveyed

List of Data Collectors  Dr Md Mumtaz Uddin Bhuiyan, Director hospital, DGHS  Dr MAJ Musa, Deputy Director Planning, DGHS  Dr Md. Mazharul Hoque, Assistant professor, DPM SBTP  Dr Lutfor Kabir, Deputy Director, Hospital DGHS  Dr Md Alamgir Ahmed, Assistant Director, DGHS  Dr Shamsuzzaman, Assistant Director, DGHS  Dr Md Nazmul Haque, Assistant Director  Dr Aminul Hassan, DPM BAN BCT, DGHS  Dr Masum, DPM, DGHS  Prof. Dr Husne Ara Begum, Blood Transfusion Department , DMCH, Dhaka  Dr Moon Mon Rahman, Assistant Prof, Blood Transfusion, NITOR, Sher‐e‐Bangladesh Nagar  Dr Hosne Ara, Associate professor, Blood Transfusion Dept., DMCH, Dhaka  Dr Munshi Md Habib Ullah, Associate prof., Blood Transfusion, SSMC, Dhaka  Dr Zereen Mosfeqa Rahman, Blood Transfusion, NICVD, Sher‐e‐Bangla Nagar, Dhaka  Dr Syeeda Masooma Rahman, Assistant professor, SBTP  Dr Farhana Islam, Blood Transfusion, NIDCH, Mohakhali, Dhaka  Dr Md Khairul Islam, Blood Transfusion NITOR, Sher‐e‐Bangla Nagar, Dhaka  Dr Sheikh Daud Adnan, Assistant Prof Blood Transfusion, NICVD, Dha  Dr Mizanur Rahman, Assistant Professor, Blood Transfusion, SSMC, Dhaka  Dr Zubaida Nasreen, EMO Blood Transfusion, DMCH, Dhaka  Dr Daulatun Nahar, Associate professor, Safe Blood Transfusion Program, DMCH, Dhaka  Dr Md Asadul Islam, Associate Professor, Transfusion Medicine, BSMMU, Dhaka  Md Faruque , Medical Technologist Lab , SBTP  Shakhawat Hossain , Medical Technologist Lab , SBTP  Md Mollah Amirul Islam Medical Technologist Lab , SBTP

Types of surveyed Blood Centres

Centre Type Number of Centres District Hospital 50 Upazila Health Complex 11 Public Medical College 14 Private Medical College 6 Private Hospital 7 Public Institute 5 Standalone Blood Centre 6 Standalone NGO Blood Centre 2 Others 8 Total 109

List of Blood Centres at District Hospital

Sl Name of Centre 1 Adhunik Sadar Hospital, Bagerhat 2 Adhunik Sadar Hospital, Feni 3 Adhunik Sadar Hospital, Kishoregong 4 Adhunik Sadar Hospital, Magura 5 Adhunik Sadar Hospital, Rajbari 6 Adhunik Sadar Hospital, Thakurgaon 7 Barisal Sadar Hospital 8 Chittagong Sadar Hospital 9 General Hospital Noakhali 10 General Hospital, Jamalpur 11 General Hospital, Jessore. 12 General Hospital, Kushtia. 13 General Hospital, Meherpur. 14 General Hospital, Narayanganj. 15 General Hospital, Pabna. 16 General Hospital, Patuakhali. 17 General Hospital, Rangamati. 18 General Hospital, Sirajgonj 19 General Hospital, Tangail. 20 Modernized Sadar Hospital, Jhalokati 21 Mohammad Ali Sadar Hospital, Bogra 22 Sadar Hospital, Bandarban 23 Sadar Hospital, Barguna 24 Sadar Hospital, B‐Baria 25 Sadar Hospital, Bhola 26 Sadar Hospital, Brahmanbaria 27 Sadar Hospital, Chandpur 28 Sadar Hospital, Chapai Nowabgonj 29 Sadar Hospital, Comilla 30 Sadar Hospital, Cox's Bazar 31 Sadar Hospital, Faridpur 32 Sadar Hospital, Gaibandha 33 Sadar Hospital, Gazipur 34 Sadar Hospital, Gopalgonj 35 Sadar Hospital, Habiganj 36 Sadar Hospital, Hobigonj 37 Sadar Hospital, Jhenaidah 38 Sadar Hospital, Jhenaidah 39 Sadar Hospital, Khulna 40 Sadar Hospital, Laxmipur 41 Sadar Hospital, Madaripur 42 Sadar Hospital, Munshigonj

Sl Name of Centre 43 Sadar Hospital, Narile 44 Sadar Hospital, Natore 45 Sadar Hospital, Nilphamari 46 Sadar Hospital, Panchagor 47 Sadar Hospital, Sariatpur 48 Sadar Hospital, Satkhira. 49 Sadar Hospital, Sunamgonjl 50 Shahid Shamsuddin Sadar Hospital 51 Blood Banks Quantum Foundation, Dhaka 52 Red Crescent Blood Centre, Dhaka 53 Anser & VDPHospital, Gazipur 54 Azimpur Maternity Hospital Dhaka 55 BBF Hospital, Peelkhana Dhaka 56 CMH, Bogra Cantonment, Bogra. 57 CMH, Chittagong Cantonment, Chittagong. 58 CMH, Comilla Cantonment, Comilla. 59 CMH, Rangpur Cantonment, Rangpur. 60 Port authority Hospital 61 AFIP, Dhaka Cantonment, Dhaka 62 National Institute of Cancer Hospital Dhaka 63 National Institute of kidney Hospital Dhaka 64 NIDCH, Mohakhali, Dhaka 65 IC& MH Matuil Dhaka 66 Chittagong Medical College Hospital, Chittagong 67 Comilla Medical College Hospital, Comilla. 68 Dhaka Medical College Hospital, Dhaka 69 Dinajpur Medical College Hospital, Dinajpur 70 Faridpur Medical College Hospital, Faridpur 71 Khulna Medical College Hospital, Khulna 72 MAG Osmani Medical College Hospital, Sylhet 73 Mymensingh Medical College Hospital, Mymensingh 74 Rajshahi Medical College Hospital, Rajshahi 75 Rangpur Medical College Hospital, Rangpur 76 S.Sh.Medical College Hospital, Sher‐e‐Bangla Nagar, Dhaka 77 Shaheed Ziaur Rahman Medical College Hospital, Bogra 78 Sher‐e‐Bangla Medical College Hospital, Barisal 79 Sir Salimullah Medical College Hospital 80 Ad‐din Hospital 81 Appolo Hospitals 82 Dhaka Shishu Hospital 83 Lab Aid Hospital 84 National Heart Foundation Hospital Dhaka 85 Square Hospital

Sl Name of Centre 86 United Hospital, Dhaka 87 Bangladesh Medical College Hospital Dhaka 88 BIRDEM Hospital, Dhaka 89 Holy family Red Crescent Medical College Hospital 90 Kwaza Younis Ali Medical College 91 National Medical College Hospital, Dhaka 92 Sikder Womens Medical College and Hospital, Dhaka 93 Brati Blood Bank Chata Kalibari, Ankur, Tangail 94 Crossmatch Blood Centre, Dhaka 95 Dhaka City Blood Bank and transfusion Centre, Dhaka 96 Fatema memorial Diagnostic Medical Services, Dhaka 97 New Save Life Blood Bank and Diagnostic Centre, Comilla 98 Shebika Blood Bank, Dhaka 99 Bheramara Upazila Health Complex 100 Borolekha Upazila Health Complex, Moulivi Bazzar Sylhet 101 Chaugasha UHC 102 Fakirhat UHC, Bagherhat, Khulna 103 Gurudashpur Upazila Health Complex 104 Kolapara UHC 105 Loha Gora UHC 106 Parshuram Upazila Health Complex 107 Patnitala UHC 108 Sakhipur Upazila Health Complex 109 Shibgonj Upazila Health Complex

ANNEX‐3: Status of selected indicators

Indicator(s) Unit of Benchmark (with Outcome in 2010 Measurement Year and Data Source) 1999 Number of Blood Transfusion centre Number of Blood 18 centres 203Centres Transfusion Centres *SBTP DATA functional Number of Blood Transfusion centre at Number of Blood NA 50 private sector Transfusion centre

Units of blood screened Units of blood supply 99653 *SBTP DATA 3.8 lac

Blood component Facilities centres Number of centres No DATA 17 centre Number of New Regional centres for blood Number of centres No DATA No target collection Establishment of National Blood centre Number No DATA 1 centre

Number of blood collected per year Number of facilities 0.9 lac 3.8 lac

Donation per 1000 population ratio NA 4.2

Types of blood donor Percentage

Voluntary 10% 30%

Replacement /family 20% 70%

Paid 70% 0%

Unit Screened Percentage

HIV NA 100%

HBV NA 100%

HCV NA 100%

Syphilis NA 100%

Malaria NA 80%

Percentage of donation screened for TTI in Percentage quality assured manner HIV NA NA

HBV NA NA

HCV NA NA

Syphilis NA NA

Malaria NA NA

Prevalence of TTI in blood donation Percentage

HIV NA 0.002%

HBV NA 0.862%

HCV NA 0.097%

Syphilis NA 0.047%

Malaria NA 0.01%

Percentage of units discarded due to TTI Percentage NA 0.99%

Number of staff trained on national Number NA NA standard , guidelines, algorithm and SOPs on screening of blood for TTI

ANNEX‐4: Table of selected health and socio‐economic indicators

Name of indicator Source A. ADMINISTRATION Division 7 Bangladesh City corporation 9 datasheets Metropolitan city 4 Municipality 308 District 64 Upazila 483 Union 4,501 Ward 40,509 Village (approximately) 87,310 Household 25,490,822 B. EDUCATION and ECONOMY Per capita GDP (in US$) 2010‐11 664 Bangladesh Economic GDP growth rate (%) 2009‐10 6 Review 2010

C. DEMOGRAPHY Population Total 142. 32 BBS 2011 (in million) Male 71. 26 (2011 Female 71. 06 Census) D. HEALTH STATUS Infant mortality rate (per 1000 live 39 SVRS 2009, births) BBS Maternal mortality ratio (per 194 BMMS 2010 100,000 live births) Neonatal mortality rate (per 1,000 28 SVRS 2009, live births) BBS E. HEALTH SERVICES PROVISION Government hospitals at Upazila 463 DGHS 2011 Government hospitals of secondary 120 Total no. of government hospitals 583 No. of non‐government hospitals 2,501 (Regd. by DGHS) No. of beds in MOHFW 39,639 (functioning)

Name of indicator Source No. of beds in private sector (Regd. 42,237 by DGHS) No. of registered physicians 53,063 BMDC 2011 Estimated no. of doctors available 43,537 HRD Data in the country Sheet 2011 Doctors working under MOHFW 38% Doctors working under other org. 3% Health Bulletin 2011, Page‐5