National Baseline Survey – Evaluation of Blood Screening Systems National Baseline Survey Based on WHO Evaluation Framework/Tool for Assessment, Monitoring and Evaluation of Blood Screening Systems in Pakistan April 2013 Safe Blood Transfusion Programme Ministry of Capital Administration & Development Government of Pakistan ____________________________________________________________________________1 National Baseline Survey – Evaluation of Blood Screening Systems List of Abbreviations AFIP Armed Forces Institute of Pathology AJK Azad Jammu & Kashmir EQAS External Quality Assurance System FATA Federally Administered Tribal Areas GB Gilgit Baltistan GiZ German Agency for International Cooperation GoP Government of Punjab GoB Government of Balochistan GoS Government of Sindh GoKPK Government of Khyber Pakhtunkhwa HEC Higher Education Commission HRA Health Regulatory Authority IBTA Islamabad Blood Transfusion Authority ICT Islamabad Capital territory IQC Internal Quality Control KFW German Cooperation Bank KPK Khyber Pakhtun Khwa (formerly NWFP province) MIS Management Information System OFID OPEC Fund for International Development PBTA Punjab Blood Transfusion Authority PD Project Director PNCA Pakistan National Accreditation Council RPR Rapid Plasma Reagin SBTA Sindh Blood Transfusion Authority SBTP Sindh Blood Transfusion Programme TME Time Monitored Equipment TTIs Transfusion Transmissible Infections WHO World Health Organization ____________________________________________________________________________2 National Baseline Survey – Evaluation of Blood Screening Systems Table of Contents Acknowledgement 4 I. Executive Summary 5 - 10 II. Background 11-13 1. Purpose 11 2. Rationale 11 3. Survey Methodology 12 4. Outcome 13 5. Management 13 6. Schedule 13 III. Summary of Findings 14-25 1. Types of Blood Centers 14 2. Organization and Management 15 3. Regulatory Framework 15 4. Physical Infrastructure 16 5. Management, Technical & Financial Capacity 16 6. Quality Assurance Systems 17 7. Screening Processes 19 8. Procurements 19 9. Management Environment 20 IV. Summary Recommendations 21-25 V. Detailed Quantitative Findings 26-63 1. General Information 26 2. Organization and Management 30 3. Blood Screening Infrastructure 34 4. Blood Screening Technical Capacity 41 5. Procurement of Consumables/Equipment 49 6. Screening for Transfusion Transmissible Infections 52 7. Regulatory Management Environment 61 VI. Glossary 64-71 VII. Annexes 72-95 Annex I - Survey Instruments Annex II - List of Blood Centers Surveyed ____________________________________________________________________________3 National Baseline Survey – Evaluation of Blood Screening Systems Acknowledgement The Safe Blood Transfusion Programme (SBTP) would like to thank the World Health Organization (WHO) for entrusting the task to perform the ‘National Baseline Survey – Evaluation of Blood Screening Systems’ to the SBTP. The Programme would also like to thank the OPEC Fund for International Development (OFID) for providing funding to conduct a range of activities, including the ‘National Baseline Survey,’ for the prevention of Transfusion Transmissible Infections (TTIs) in Pakistan through the WHO/OFID Joint Programme. The findings and recommendations of the survey will help the Programme and policy makers to take necessary corrective actions which are likely to prove beneficial to reduce the burden of the risk of transmission of infections through transfusions in Pakistan. The SBTP is also appreciative of the support extended by the Provincial Blood Transfusion Programmes and the private sector Blood Centers in the collection of data from the respective centers. The cooperation of these partners was critical in conducting the study. The study could not have been successfully completed without the dedication and the commitment of the staff of the Safe Blood Transfusion Programme. Prof. Hasan Abbas Zaheer Project Director ____________________________________________________________________________4 National Baseline Survey – Evaluation of Blood Screening Systems I. Executive Summary The national baseline survey on Evaluation of Blood Screening Systems was conducted between September 2012 and April 2013 as part of a WHO/OFID joint programme in collaboration with the Safe Blood Transfusion Programme (SBTP). The survey tools were based on WHO evaluation framework for assessment, monitoring and evaluation of blood screening systems adapted for application in Pakistan in 2011. The purpose of the survey was to encompass all aspects of the blood screening process. The findings of the survey provide a comprehensive situation analysis of the state of the blood screening process in the country. The survey documented quantitative (sample size 170 blood centers, both in public and private sector in all the four provinces and AJK, GB, and FATA) and qualitative aspects to the extent possible. Summary of Findings Regulatory Framework – The findings of the survey indicate that the blood transfusion regulatory framework is inconsistent in different provinces. Sindh is the only province that has a functional blood transfusion authority. The conclusion about the weak regulatory environment is supported by the data that shows 80 of the total of 170 blood centers surveyed were granted licenses and 26 blood centers were inspected at least once or a total of 106 blood centers or only 62 % of the blood centers surveyed were licensed and/or inspected by the Blood Transfusion Authorities at least once. Physical Infrastructure – The physical infrastructure for various sections of blood transfusion process were properly identified and segregated in 84% (n=143) of the blood centers surveyed. Almost all the blood centers surveyed had power and water supply connnections. Seventy five percent of the blood centers faced power cuts in the range of 5-12 hours daily. Backup generation facilities were availbale in 70 percent of the blood centers. Most public sector blood centers surveyed lacked internet and fax facilities. Overall, communication facilities were better and/or functional in private sector blood centers. Dedicated vehicles were only available in stand alone blood centers and transfusion centers as compared to public and private hospital based blood centers where vehicles from a motor pool provide support to blood services in addition to performing other functions. Essential and routine blood center equipment was mostly available and functional. Management, Technical, & Financial Capacity – In the absence of MIS, both in the public and private sector, data management is not accorded priority in almost half of the blood centers surveyed. Almost 85 percent of the blood centers surveyed ____________________________________________________________________________5 National Baseline Survey – Evaluation of Blood Screening Systems had a system of stock controls which ensured continuous and uninterrupted supply of critical consumable items. The survey findings indicate limited scale and scope of technical support to blood centers. The Safe Blood Transfusion Programme funded by a grant from the German government and the WHO/OFID Joint Programme is the main driving force to support technical trainings. The lack of wider international financial support to the public/private blood centers is symptomatic of the limited priority accorded by donors to blood safety in general. A total of 26 centers received any external financial support from government and/or private sector donors. Almost all public sector blood centers receive funds as part of the overall budgets allocated to public hospitals by the provincial and federal governments. The technical staff of the blood centers is neither consulted nor is it part of the budget allocation process in the public sector. Their role is limited to identify the procurement requirements for consumable items and equipment. Besides the lack of donor funding of blood centers in the public sector inhibiting their capacity to provide more extensive range of services, the growth of private sector blood transfusion centers is directly related to the growth in demand of services. For example, to meet the demand of an estimated more than one hundred thousand transfusion dependent thalassemia patients the private sector healthcare infrastructure offers dedicated service for the management of the thalassaemia patients. The expansion in the private sector healthcare infrastructure, offering more advanced medical and surgical treatment options, has also generated demand for transfusion services. Out of the 170 blood centers surveyed, 115 are hospital based with 108 (94%) part of the pathology department, an indication of the lack of priority accorded to transfusion medicine as a separate speciality. Sixty six percent of the blood centers surveyed had a policy of vaccination against Hepatitis B of the blood bank staff with only 32% maintaining any record of its staff for any exposure to transfusion transmissible infections. Almost 93% of the blood centers maintain records of staff job descriptions and 70% had a dedicated staff member for quality management. Ninety two percent of the blood centers surveyed had an organizational structure which identified authorities, responsibilities and reporting mechanisms. Quality Assurance System - Only 99 (58 %) of the total blood centers surveyed have a quality assurance policy as compared to 71 (42 %) that had none. The situation is worse in public sector blood centers where the majority (55%) of the blood centers lack an internal quality