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
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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
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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
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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
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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 audit system. The lack of internal quality audit system has a direct bearing on the accuracy and reproducibility of tests.
SOPs were available in most (70%) of blood centers. How far are the SOPs adhered to in practice is subject to the effectiveness of the internal management and quality audit system? Except for waste management record, over 90 percent of the blood centers surveyed maintained some form of records. Lack of proper handling of the ______6
National Baseline Survey – Evaluation of Blood Screening Systems contaminated blood center waste including sharp materials is a potent risk factor in the spread of infections particularly Hepatitis B and C infections. In addition, improper disposal of the contaminated blood bank waste also contributes to the reuse and recycling of the disposable material which is an important source of spread of hepatitis infections in Pakistan.
External Quality Assurance System (EQAS) at any level is almost nonexistent in public and private sector blood centers contributing to the spread of TTI’s in Pakistan. About half of all blood centers surveyed had an Algorithm for screening donated blood for transfusion transmissible infections. About 70 percent of the private sector and 39 percent of public sector blood centers surveyed use Algorithm for TTI’s prevention.
As accreditation of blood centers is not mandatory in Pakistan, none of the 170 blood centers surveyed were accredited. At the national level, only recently, the Pakistan National Accreditation Council (PNCA) functioning under the federal Ministry of Science and Technology has developed some expertise for accreditation functions.
In the public sector blood centers, 59 percent of the centers (n=64/107) in comparison to 56 percent in the private sector evaluate consumable supplies before procurement. Validation is conducted in only 48 percent of the public sector blood centers surveyed (n=52/107) and none in the private sector. In the absence of any national guidelines for the evaluation and validation of consumable supplies, the risk of procuring poor quality consumables is high.
Screening Processes – Operations and processes of blood centers including screening strategies are; irregular, unsafe and unregulated in the majority of the blood centers. Almost 43 percent of the blood centers had no internal quality audit system and none of the blood centers surveyed had any external quality control system.
About 69 percent or 117 blood centers of the total surveyed, stored test kits and samples in temperature monitored equipment (TME). Sixty seven percent in the public sector centers and 89 percent in the private sector had TME. Seventy five percent of the blood centers surveyed faced power cuts in the range of 5-12 hours daily. The quality and performance of kits is compromised by frequent interruptions in power supply. The use of screening kits not stored at recommended temperatures can also contribute to transfusion of infections through transfusions.
The WHO recommends mandatory screening for five TTI’s namely; HIV, Hepatitis B & C, Syphilis, and Malaria. The findings of the survey indicate that screening is done for only three TTIs (HIV, Hepatitis B & C) in all types of blood centers. Less than 50 percent of the total blood centers surveyed perform screening for Malaria and only three percent for Syphilis.
TTI’s screening is conducted both manually and through an automated system. Almost 73 percent of the total blood centers surveyed perform some form of ______7
National Baseline Survey – Evaluation of Blood Screening Systems internal quality control (IQC) for TTI screening. In the private sector, 18 percent have no IQC in comparison to 32 percent in the public sector.
Procurements – In the public sector blood centers, 95% of the equipment was purchased centrally by the health departments in comparison to the private sector where 80% of the equipment was procured locally. The procurement process involves little input of the technical staff. Almost 92% of the blood centers surveyed (n=157) had a programme or system for equipment maintenance.
About 106 of the 108 public sector centers purchase their supplies through the health departments. While in the private sector blood centers, 80% of the centers (n=50/62) purchase their supplies locally. This is consistent with the findings that most of the private sector blood centers are single center entities.
The situation regarding validation of the supplies is more dismal in the private sector where hardly any center validates their supplies while in the public sector about 48% of the centers validate the supplies.
There is no regulatory control over the import of the consumable supplies including TTI screening kits used in the blood centers resulting in the availability of poor quality and sub-standard cheap options in the market. The criterion for the selection of consumable supplies is predominantly cost rather than quality. As a result, the risks of acquiring infections following transfusion remain significant in Pakistan.
Management Environment – The survey findings indicate the existence of a fragmented blood transfusion system in which blood centers function in isolation and with limited regulatory control. A more integrated blood transfusion system is expected to take effect as the implementation progresses of the Safe Blood Transfusion Programmes in all the provinces and regions which was initiated in 2010 with the support of the German government. One of the objectives of the SBTP is to provide centrally coordinated blood transfusion services at affordable costs to all in consonance with the WHO recommended model. The first phase of the Programme is under way.
Summary Recommendations
The major findings of the study lead to the following recommendations to improve the overall blood transfusion services in the country:
Organization and Management – The findings of the survey underscore the need for Transfusion Medicine and Blood Banking to be recognized as a separate specialty from Pathology with its own specialists and independent career structure. The practice of combining service delivery and regulatory functions should be discontinued. The internationally recommended model of Regional Blood Centers supporting Hospital Based Blood Banks should be adopted all over the country.
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National Baseline Survey – Evaluation of Blood Screening Systems
The Thalassaemia centers need to be established in all the large public sector hospitals. Regulatory authorities should monitor and enforce maintenance of record of TTI exposure of staff and vaccination against Hepatitis B for all blood center staff. Regular voluntary blood donations must be promoted and reliance on ‘Replacement Donors’ should be phased out gradually.
Regulatory Framework – To ensure standardization in services, consistent and uniform regulatory framework should be introduced throughout the country with fully functional blood regulatory bodies. Priority and timely implementation of the German government funded Safe Blood Transfusion Programme would help replace the current fragmented system of blood transfusion that facilitates unsafe blood transfusion.
Physical Infrastructure –All the blood centers should have adequate reliable power back-up services to ensure the quality of consumables and blood components with each blood center having access to dedicated vehicle(s).
Management, Technical, & Financial Capacity – A national level central data base should be developed for blood transfusion services. Adequate resource allocations demand active involvement of the technical staff in the budget development process. Automation should be the preferred mode for laboratory testing. Greater international donor focus is needed to provide comprehensive technical and meaningful financial assistance to national and provincial blood transfusion programmes. Regional collaboration should be promoted to learn from the experience of the neighboring countries.
A comprehensive capacity development program needs to be developed. Licensing of technical staff should be mandatory through a "Medical Technology Council" which should be created to issue licenses to blood center personnel. The regulatory bodies should ensure that each blood center must have an MIS. To ensure consistency in the quality of services, training institutes regulated by respective regulatory bodies in the provinces should be established.
Quality Assurance System & Screening Processes – Minimum standards must be developed and adopted in all blood centers for waste disposal. The comprehensive blood transfusion SOPs developed by the SBTP should be adopted by all blood centers and enforced through the respective regulatory authority. Accreditation mechanism of the blood centers must be institutionalized to ensure consistency in quality of services matching international standards. The organizational structure of each blood center should specify the role and responsibilities of personnel devoted to quality assurance.
The blood regulatory bodies should ensure that each blood center has internal and external quality assurance systems in place which should be mandatory and a condition for approving new or renewal of existing licenses. A national accreditation policy for blood centers needs to be developed which should be implemented in phases. The national testing strategy and algorithms developed recently by the SBTP and WHO should be implemented in all the blood centers. The practice of ______9
National Baseline Survey – Evaluation of Blood Screening Systems storing archive frozen samples of donor plasma for look back studies should be encouraged.
The mandatory screening of all five TTIs recommended by WHO should be adopted by all the blood centers with ELISA screening, the preferred screening technique, instead of the rapid manual kits.
Procurements –The availability of all consumable items including screening kits especially rapid and ELISA kits should be regulated through a licensing regime to ensure quality compliance with internationally accepted standards. Procurement manuals should be developed by the regulatory bodies which should include the guidelines and/or specifications of recommended equipment and supplies including evaluation and validation guidelines. It should be mandatory for all blood centers to comply with the procurement manuals. The regulatory bodies should issue a no- objection certificate for the import of consumable supplies including TTI screening kits.
Management Environment – The progress of the implementation of the German government funded SBTP should be closely monitored and the administrative and constitutional challenges resolved in earnest. And, the second phase of the programme should be initiated in parallel with the first phase. The consensus draft legislation on promotion of blood safety recently developed under the auspices of SBTP should be processed on priority and enacted through the parliament. The lack of credible scientific data on all aspects of blood transfusion is a programmatic gap which should be addressed by conducting a comprehensive national baseline survey on all aspects of blood transfusion.
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National Baseline Survey – Evaluation of Blood Screening Systems
II. Background
1. Purpose
The purpose of the national baseline survey was to encompass all aspects of the blood screening process based on WHO tools and guidelines. The information gathered during the survey provided the basis for developing 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 Azad Jammu & Kashmir, Gilgit- Baltistan, and Federally Administered Tribal Area) and qualitative aspects to the extent possible.
In addition, the staff members of the blood centers, both in the private and public sector, were associated in the survey process which helped build their capacity to comprehend the issues of relevance to the blood transfusion especially the screening process.
2. Rationale
The baseline survey emanated from a process initiated by WHO/OFID Joint Programme in collaboration with the Safe Blood Transfusion Programme that led to the development of an evaluation framework/tool based on WHO framework for assessment, monitoring and evaluation of blood screening systems in Pakistan.
The available data on all aspects of blood transfusion including blood donations, transfusion and screening is incomplete and scattered and cannot be relied on to form any basis of designing interventions to improve the blood transfusion system in the country. It is estimated that more that 1.5 million units of blood are donated each year in Pakistan of which 25% are from voluntary donors, 65% from replacement donors and about 10% from professional donors*. A study documented 570 blood banks in the public and private sector in Pakistan*#. However, a 2009 review by Dr. Nuzhat Salamat estimates 2.8 million bags used in 2008 almost double the official figure of 1.5 million bags##. Since a comprehensive national baseline survey on blood transfusion has never been conducted, so the available information is fragmented and does not present a complete picture on the blood transfusion system in the country.
* National Blood Policy and Strategic Framework 2003-2008 for BTS Pakistan, 2002, National AIDS Control Programme, Ministry of Health, Pakistan.
# A study by Rehman et al Pak. J. Med Sci. 2002.
## Nuzhat Salamat Hematology Updates 2009.
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National Baseline Survey – Evaluation of Blood Screening Systems
It was only in the late 1990s through early 2000s that Pakistan introduced Blood Safety Laws in all the federating units. The policy decision to establish a ‘nationally coordinated’ blood transfusion system in 2010 was put to test by the devolution of the health sector in 2011. The key issue in the blood transfusion sector of Pakistan remains a lack of governance and effective regulation.
The limited regulatory control in blood transfusion is not a feature of the associated professions of medicine, nursing and pharmacy, which have well-developed professional bodies established for the registration and licensing of professional institutes and personnel. In addition, a professional institute, Higher Education Commission (HEC), responsible for the development and implementation of a standard curriculum for all degree programs has been established. But the HEC does not cover medical laboratory technology or blood banking.
As part of the efforts of the Government of Pakistan to establish a national blood transfusion system based on voluntary non-remunerated donation and with every aspect governed by quality management, an analysis of the screening processes in the existing blood transfusion situation was required.
The number of blood centers surveyed (170) meets the WHO guidelines of the minimum number for any survey to be credible. The WHO recommends that minimum of thirty percent of blood centers should be covered by any assessment when the number of such facilities exceeds 100 and all of such facilities if the number is less than 100. With an estimated 570 number of blood transfusion centers in Pakistan as part of a network of national and provincial/regional blood centers supplying blood, the baseline survey included 170 blood centers which formed a representative sample.
The surveyed facilities are performing transfusion services which are hospital based, public or private, and in urban or rural areas throughout the country.
3. Survey Methodology
Interactions with Provincial Programme Managers and other key stakeholders. Literature review. Review of baseline survey tools. Finalize baseline survey tools. Develop work plan. Develop criteria for selection of field survey staff. Selection of field survey staff. Training of field survey staff. Collection of data. Customize data entry & analysis software to the needs of baseline survey. Data Entry. Analysis of data. Report writing. ______12
National Baseline Survey – Evaluation of Blood Screening Systems
The evaluation and baseline survey tools, attached as Annex I, was shared with all the 170 blood centers surveyed and the data collected from all the four provinces of Pakistan including; AJK, GB, and FATA was analyzed. The list of blood centers surveyed is attached as Annex II.
4. Outcome
The national baseline survey and the analysis of the findings of the survey are expected to provide evidence based policy guidelines for policy makers. The analysis includes managerial and technical dimensions for the screening of blood and blood products in the individual facilities with focus on TTI’s.
The analysis emanating from the national baseline survey would help and enable the key stakeholders to have a comprehensive view of all aspects of the existing national blood transfusion situation in general and TTI’s in particular.
The key findings and information gathered from the national baseline survey would help to advocate and develop strategies to strengthen the Safe Blood Transfusion Programme to prevent the spread of TTI’s and improve the quality and safety of blood transfusion in Pakistan.
5. Management
The baseline survey was conducted under the overall management and guidance of the Safe Blood Transfusion Programme. The Project Director (PD), Safe Blood Transfusion Programme, coordinated with the Provincial Managers to facilitate the survey in public sector blood centers. The PD, SBTP also coordinated with the private sector blood centers regarding all aspects of the survey.
6. Schedule
The field work of the survey was conducted between July and November 2012. The data entry process and analysis was completed by February 2013. The draft report was finalized by April 2013.
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National Baseline Survey – Evaluation of Blood Screening Systems
III. Summary of Findings
With a population exceeding 180 million, the estimated total number of blood transfusion centers in Pakistan is believed to be 570. The total annual blood collection in Pakistan is estimated to be 2.8 million units. Blood donors in Pakistan are mostly replacement/family donors influenced by local, social, and cultural traditions that increase the risks of transfusion transmitted infections.
In all, 170 blood banks/centers were surveyed which serve 1,167 hospitals both in the public as well as private sector in all the four provinces of Pakistan including ICT, AJK, and GB. Almost seventy percent of the blood centers surveyed are in the two most populous provinces of Punjab and Sindh.
Types of Blood Centers –The survey findings reflect a high percentage of NGO run blood centers. In the Sindh province, 52 percentage as compared to 31 percentage in Punjab were run by NGOs to meet the growing demands of the transfusion needs of the population. The NGO run blood centers meet the increasing transfusion needs that cannot be met by the public healthcare infrastructure. One of the primary reasons for the growth of private sector blood transfusion centers, particularly the blood transfusion centers, is the estimated more than one hundred thousand transfusion dependent thalassemia patients. These patients are not hospitalized yet require regular transfusions. And there are limited facilities for thalassemia patients in the government managed hospitals. Another factor for the growing involvement of the NGO sector in blood transfusion services is the expansion of the private sector healthcare which offers more surgical and medical treatment options and thus requires more transfusion support.
The proportionate distribution of blood centers surveyed reflects a bias towards the public sector hospital based blood transfusion facilities as a significant amount of the blood transfusion services are provided through public sector hospital based blood banks. The private sector blood transfusion services are offered through blood centers that are hospital based as well as stand alone blood banks and blood transfusion centers.
All blood centers surveyed function as complete units covering all aspects of blood transfusion work including; mobilizing and recruiting blood donors, blood collection, testing, screening, component preparation, and storage under one roof. In the transfusion centers, in addition to all the above, blood transfusion is also administered to the patients.
The 170 blood centers surveyed serve a total of 1,167 hospitals both in the public as well as the private sector. The stand alone blood banks contribute at least partially to meet the needs of a large number of hospitals both in the public and private sector while the hospital based blood banks and the blood transfusion centers primarily meet the needs of their registered patients and contribute only partially to the needs of other patients.
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National Baseline Survey – Evaluation of Blood Screening Systems
Organization and Management–Ninety two percent of the blood centers surveyed had an organizational structure which identified authorities, responsibilities and reporting mechanisms.
Out of the 170 blood centers surveyed, 115 are hospital based blood centers both in the public and private sector. Out of the 115, 94 percent or 108 blood centers are part of the pathology department of the respective hospitals. The high figure is indicative that transfusion medicine is still not considered a speciality in its own right nor is it accorded the priority in view of the public health implications of safe blood transfusion. Although majority of the hospital based blood centers function as part of the Pathology department, and yet 90 percent of these blood centers have their own dedicated staff which clearly indicates that transfusion medicine is an independent specialty and should not be part of the overall organizational set up of the pathology department.
Sixty six percent of the blood centers surveyed had a policy of vaccination of the blood center staff against Hepatitis B. However, only 32 percent of these centers maintain record of its staff for any exposure to transfusion transmissible infections.
Written job descriptions of the staff are available in almost 93 percent of the blood centers surveyed. Whereas, about 70 percent of the blood centers designated specific staff member for quality management.
Regulatory Framework–The findings of the survey indicate that the blood transfusion regulatory framework is inconsistent in different provinces. The Sindh Province in comparison to other provinces has a fully functional blood transfusion authority which has a data base of all, registered as well as unregistered, blood centers in the province. Out of the 170 blood centers surveyed, a total of 80 were granted licenses and 26 blood centers were inspected at least once. So a total of 106 blood centers or 62 percent of the blood centers were covered by the respective Blood Transfusion Authorities. This situation is reflective of the absence or not fully functional status of the blood transfusion regulatory authorities in different provinces. The finding does not imply that the remaining 64 blood centers are providing illegal or unauthorized services. The low number of licensed blood transfusion centers is also a reflection of the limited functional capacity of the blood regulating authorities in most provinces and regions of the country.
The limited regulatory capacity of the regulating authorities is also reflected from the data which shows that 26 blood centers were inspected at least once for registration.
In Sindh province, the regulatory system is most organized and functional. In Punjab province, the blood transfusion authority has been notified and in the process of assuming greater functional status. In KPK province, the blood transfusion regulatory function remains part of the Health Regulatory Authority (HRA) which includes a section to regulate blood transfusion services. In Baluchistan province, the Blood Regulatory Authority has been notified and is in the early stages of formation. In AJK, the blood transfusion regulatory body has been ______15
National Baseline Survey – Evaluation of Blood Screening Systems notified and is functional. In ICT, the blood transfusion authority was functional and due to devolution process, a new management structure is being developed. In FATA and GB, the blood transfusion regulatory authorities are yet to be notified.
In all the provinces, technical support is being provided to the provincial Blood Transfusion Authorities through the Safe Blood Transfusion Program funded by the German Government.
Physical Infrastructure –Out of the 170 blood centers surveyed, 115 were hospital based blood centers in the public and private sector.
The survey findings indicate that the physical infrastructure for various sections of blood transfusion process were properly identified and segregated in 84 percent (n=143) of the blood centers surveyed.
Almost all of the 170 blood centers surveyed had power and water supply connnections. Seventy five percent of the blood centers surveyed faced power cuts in the range of 5-12 hours daily. Backup generation facilities were availbale in 70 percent of the blood centers which are deemed to be adequate by the blood centers to maintain the stored products at recommended temperatures.
Communication tool such as telephone is available in general. However, in the majority of the public sector blood centers surveyed, internet and fax facilities were not available. Dedicated vehicles were available in the private sector stand alone blood banks and blood transfusion centers, while in the hospital blood banks, vehicles from the motor pool were shared. Overall, communication facilities were better and/or functional in private sector blood centers.
Essential and routine blood center equipment was mostly available and functional.
Management, Technical, & Financial Capacity–The management and technical capacity of the blood centers surveyed varied. For example, data management is not accorded priority in almost half of the public and private sector blood centers. This is also reflective of the absence of Management Information Systems (MIS). The lack of data management has serious implications concerning the risk of transmission of infections and in terms of traceability and overall blood safety. The limited use of information technology results in poor management of available resources such as less than credible data, improper storage and stock management, and readily available back up data.
Almost 85 percent of the blood centers surveyed had a system of stock controls which ensured continuous and uninterrupted supply of critical consumable items.
Out of the total of 170 blood centers surveyed, external financial support was only available through local sources and that too only for the private sector blood centers. All the blood centers reported receiving technical support mainly in the form of capacity building of the technical staff through the Safe Blood Transfusion Programme funded by the German grant to the SBTP or through the WHO/OFID ______16
National Baseline Survey – Evaluation of Blood Screening Systems
Joint Programme for the prevention of TTIs in Pakistan. The trainings funded through the WHO/OFID Joint Programme were for the prevention of TTIs through improvements in Quality Management Systems for the benefit of technical and management staff of the blood centers working all over the country. The lack of international financial support to the blood centers both in the public as well as private sector is indicative of the low priority accorded to blood safety in general with relevance other health sector interventions. It also implies the lack of linkages with international and regional counterparts.
The survey findings indicate limited technical support in terms of scale and scope to blood centers. Technical support mainly consists of capacity building of technical staff. Only recently, under the Safe Blood Transfusion Services Program funded by the GiZ and KFW, SOPs, manuals, guidelines, and standards have been developed in consultation with national and international experts. The new technical tools and guidelines are planned to be pre-tested before being adopted by blood centers across the country.
The survey findings indicate limited capacity building of blood center technical staff. To improve the quality of blood transfusion services, there is a critical need for an overall capacity development program for the blood transfusion staff both in the public as well as the private sector.
Out of 170 blood centers surveyed, 26 centers surveyed received external financial support from government and/or private sector donors. The blood centers in the private sector generate resources from charging patients and seeking funds from the general public as well as national institutions. Whereas, in the public sector, external financial support is almost nonexistent as reflected by the overwhelming ‘no response’ from 144 blood centers. Almost all public sector blood centers receive funds as part of the overall budgets allocated by the provincial and federal governments.
Most blood center staff did not have readily available information on budget allocations. There is a general reluctance to share budget related information both in the public and private sector. Even the finance department in public sector hospitals are reluctant to share information with the concerned blood centers about budget allocations. The technical staff 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.
Quality Assurance System-Out of the 170 blood centers surveyed, only 99 have a quality assurance policy.
In terms of implementation of quality assurance policies, both public and private sector blood centers accord low priority. This conclusion is drawn from the survey finding that almost 43 percent of the blood centers surveyed had no internal quality audit system. The situation is worse in public sector blood centers where the majority of the blood centers lack an internal quality audit system. The lack of internal quality audit system has a direct bearing on the accuracy and ______17
National Baseline Survey – Evaluation of Blood Screening Systems reproducibility of tests and the risk of transmission of infections through transfusions.
The majority of the blood centers in public and private sector have SOPs for various blood bank activities. The adherence to SOPs is subject to internal management and the quality of internal audit. The varied responses under separate sections confirm that there is no standard SOP Manual that covers all categories. There is no significant difference among the private and public sector blood centers regarding the availability of SOPs and their usage trend.
Except for waste management record, over 90 percent of the total blood centers surveyed maintained some form of documentation for different types of blood center activities. Lack of proper handling of the contaminated blood center waste including sharp materials is a very potent risk factor in the spread of infections particularly Hepatitis B and C infections. In addition, improper disposal of the contaminated blood bank waste also contributes to the reuse and recycling of the disposable material which is an important source of spread of hepatitis infections in Pakistan.
External Quality Assurance System (EQAS) at any level is almost nonexistent in public and private sector blood centers. EQAS is essential to maintain standards and quality. The lack of any EQAS system is potentially responsible for spread of TTI’s in Pakistan.
About half of all the blood centers surveyed had an Algorithm for screening donated blood for transfusion transmissible infections. In the private sector, 70 percent of the blood centers use Algorithm for TTI’s prevention in comparison to 39 percent in the public sector. In the year 2012, the SBTP with the support of WHO/OPID Joint Programme developed Pakistan specific national Algorithms for the prevention of TTI’s which are expected to be disseminated soon. The Algorithms being currently followed in blood centers, both in the public and private sector, are not uniform.
The accreditation of blood centers is not mandatory in Pakistan. None of the 170 blood centers surveyed was accredited because until recently there was no national level organization which was capable of conducting accreditation of such technical institutions. Only recently, the Pakistan National Accreditation Council (PNCA) functioning under the federal Ministry of Science and Technology developed some expertise of performing accreditation functions which enabled them to conduct the accreditation of the Armed Forces Institute of Pathology (AFIP) in Rawalpindi.
In the public sector blood centers, only 59 percent of the centers (n=64/108) evaluate the consumable supplies before purchase. Similarly, in the private sector only about 56 percent of the centers (n=35/62) evaluate the consumable supplies. The validation of the consumable supplies is conducted in only 48 percent of the public sector blood centers surveyed (n=52/108). In the private sector blood centers surveyed, hardly any center validates the consumable supplies. Overall, the quality of the evaluation and validation is questionable as there are no national guidelines available. ______18
National Baseline Survey – Evaluation of Blood Screening Systems
Screening Processes–The operations and processes of blood banking, including screening strategies, are irregular, unsafe and unregulated as almost 43 percent of the blood centers had no internal quality audit system and none of the blood centers surveyed had an external quality control system.
Out of the total 170 blood centers surveyed, 117 centers (69 percent) stored test kits and samples in temperature monitored equipment (TME). Sixty seven percent of the public sector centers in comparison to 89 percent in the private sector had temperature monitored equipment. Storage of kits at the recommended temperature ensures optimum performance, quality, and credibility of results. The quality and performance of kits can be compromised by frequent interruptions in power supply as seventy five percent of the blood centers surveyed faced power cuts in the range of 5-12 hours daily. About 70 percent of the centers surveyed reported adequate power back-up arrangements. Decrease in the efficacy of the screening kits has a direct impact on the standard and quality of its results. The use of screening kits not stored at recommended temperatures in the blood centers can also contribute to transfusion of infections through transfusions.
Under the WHO guidelines, screening for five TTI’s i.e. HIV, Hepatitis B & C, Syphilis, and Malaria is mandatory. However, the results of the survey indicate that screening is done only for three TTIs (HIV, Hepatitis B & C) in all types of blood centers. Despite the high incidence of Malaria in the country, less than 50 percent of the total blood centers surveyed perform screening for Malaria. Only about three percent of the total blood centers surveyed perform screening for Syphilis.
In Pakistan, TTI screening is conducted both manually and through automated systems. Almost 73 percent of the total blood centers surveyed perform some form of internal quality control for TTI screening. In the private sector, only 18 percent perform no IQC in comparison to 32 percent in the public sector.
Procurements –Most of the equipment available in the blood centers surveyed was purchased locally either by the blood center or centrally by the hospital management or the health departments of the public sector blood centers. The blood center management identifies the equipment needs and the senior hospital management procures the equipment. The blood center technical staff is not involved in the procurement process. Few centers reported receiving some equipment from international donor agencies.
Almost 92 percent of the blood centers surveyed (n=157) had a programme or system of for equipment maintenance.
As 106 of the 108 such public sector blood centers purchase supplies through the health departments or the hospital authorities there is little involvement of the technical staff in the procurement process. Whereas, in the private sector blood centers, 80 percent of the centers (n=50/62) purchase the supplies locally. This is consistent with the finding that most private sector blood centers operate as single center entities.
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National Baseline Survey – Evaluation of Blood Screening Systems
The procurement mechanisms of the supplies differ among the public and private sector blood centers. In the private sector the purchases are mostly at the level of the blood center with more involvement of the technical staff. However, despite this increased involvement of the technical staff in the private sector, about little over half of all the centers evaluate the supplies before selection and procurement. The situation regarding validation of the supplies is more dismal in the private sector where hardly any center validates the supplies while in the public sector about half the centers validate the supplies.
There is no regulatory control on the import of the consumable supplies including TTI screening kits used in the blood centers. The lack of import regulatory controls coupled with low cost as the overriding procurement factor results in the availability of poor and sub-standard cheap options in the market. As a result, poor quality kits are procured without quality evaluation and validation either locally or at the national level. In addition, no national strategy for a testing technique and algorithms is followed in the blood centers. The screening equipment in most centers is not properly calibrated. Limited technical capacity of blood center staff further increases the risks of acquiring infections following transfusion.
Management Environment–A national level blood transfusion programme exists in the country both at the federal and provincial level. The Programme was established in 2010 and the first phase is being implemented and its impact expected in the long term subject to priority implementation by all the provinces. At present, the services are provided through a fragmented blood transfusion system in which all the blood centers function in isolation with little interaction and limited regulatory control. The new Programme however, has leadership at the national and provincial levels which is steering the development of transfusion services in the direction of the WHO internationally recommended model. Under this Programme, blood policy, SOPs, guidelines, manuals have been developed. The objective of this initiative is to provide centrally coordinated blood transfusion services at affordable costs to all in the country along the lines of the WHO recommended model. The first phase of the Programme is under way and the second phase is expected to start by the end of the current year and will extend the coverage of the project. The two phases will thus be implemented together until the completion of the first phase.
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National Baseline Survey – Evaluation of Blood Screening Systems
IV. Summary Recommendations
The major findings of the study lead to the following recommendations to improve the blood screening system in specific and the overall blood transfusion services in general in the country:
Organization and Management
Consistent with international practices, blood transfusion services should not be part of the pathology department as transfusion medicine is a specialty in its own right. The provincial blood transfusion regulatory bodies should recommend the same to the provincial governments to ensure dedicated technical staff and availability of necessary resources to facilitate the separation of the pathology department and the blood transfusion services especially in the public sector hospitals.
The findings of the survey underscore the need for Transfusion Medicine and Blood Banking to be recognized as an entity separate from Pathology, with its own specialists and their career structure.
The practice of blood transfusion service delivery programmes also performing regulatory functions should be discontinued as regulatory functions and service delivery are technically separate responsibilities.
All the blood centers surveyed were providing the complete range of services without functional separation between production and utilization of blood components. The internationally recommended model of centrally coordinated system of Regional Blood Centers supporting Hospital Based Blood Banks should be adopted in the country as planned by the SBTP.
There are little treatment facilities for the management of the thalassaemia patients in hospitals which has resulted in the growth of NGO run transfusion centers to meet the growing demand of transfusion needs of the thalassaemia patients. The thalassemia centers need to be established in the public sector hospitals and the transfusion needs of the Center’s registered thalassaemia patients should be the responsibility of the hospital’s blood center.
Sixty six percent of the blood centers surveyed had a policy of vaccination against Hepatitis B of the blood center staff. Only 32 percent of the blood centers surveyed maintain record of its staff for any exposure to transfusion transmissible infections which is a serious occupational hazard. As part of the regulatory functions, the respective regulatory authorities should monitor and enforce maintenance of record of TTI exposure of staff. Vaccination against Hepatitis B for all blood center staff must be mandatory.
Strategies should be developed to promote regular voluntary blood donations as the regular voluntary blood donors are the safest blood donors. Reliance on Replacement Donors should be discouraged and phased out gradually. ______21
National Baseline Survey – Evaluation of Blood Screening Systems
The implementation of the centrally coordinated Safe Blood Transfusion Programme should be stepped up to replace the current fragmented system of blood transfusion which promotes unsafe blood transfusion.
Regulatory Framework
The key issue in the blood transfusion sector of Pakistan remains a lack of or ineffective governance and regulation. There is a need to have a uniform legal framework for blood transfusion services.
There is a need to develop consistent and uniform regulatory framework in all the four provinces and regions of the country. This would ensure uniformity in standards of transfusion services to all the citizens of the country.
There is an urgent need to accord high priority and appropriate allocation of resources in provinces and regions where the blood regulatory authorities are not fully functional.
Capacity building of the technical staff associated with the regulatory authorities should be institutionalized.
Linkages should be developed with the regional and international regulatory bodies.
Physical Infrastructure
It should be mandatory for all blood centers to have adequate power back-up services to ensure the quality of consumables and blood components.
Donor friendly environment should be maintained in all blood centers to encourage voluntary blood donations.
Each blood center should have access to dedicated vehicle for; mobilization of voluntary blood donors, mobile blood camps, transportation of consumables and blood components.
Management, Technical, & Financial Capacity
In the absence of a coherent and centralized system of data collection, transmission, reporting and evaluation, the available data is scattered. There is no mechanism to facilitate the exchange of information and data between blood establishments and blood services. There is a need for central data base which receives information and data from provinces and consolidates and analyzes the data for research, policy and resource allocation guidance.
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National Baseline Survey – Evaluation of Blood Screening Systems
The regulatory bodies should ensure that each blood center must have an MIS to improve; traceability, overall blood safety, data credibility, storage, stock management, research and readily available back up data.
To ensure appropriate resource allocations, the public and private sector management should, as a matter of policy, develop budgets in consultation with the technical staff of the blood centers that are more cognizant of the resource needs.
In the large blood centers, automation should be the recommended mode not only for the screening of blood but also for blood grouping, cross matching etc.
To improve health indicators and meet the Millinium Development Goal targets especially relating to the maternal and child health indicators, there is a need for greater international donor focus on providing technical and financial assistance to blood transfusion initiatives.
To improve the quality of blood transfusion services, there is a critical need for an overall capacity development program for the blood transfusion staff both in the public as well as the private sector. Such a program should include the development of standard curriculum for the diploma and degree programs tailored for the technical staff of the blood centers and also a separate program of ‘Continuing Medical Education’ for the existing technical staff.
There is a need to harmonize the entire system through regulation, standardization and quality control by establishing a "Medical Technology Council" which should issue licenses to personnel educated with the standard curriculum, for working in the Clinical Laboratories and Blood Centers in Pakistan. The functions of this council should be to license or approve University and College Programmes for training and education in all fields of Transfusion Medicine and Medical Technology.
To meet the growing demand of institutionalized capacity building of technical staff both in the public and private sector, uniform curriculum needs to be developed. And, to ensure consistency in the quality of services, training institutes regulated by respective regulatory bodies in the provinces should be established.
Screening Processes & Quality Assurance System
The findings of the survey show that almost 43 percent of the blood centers surveyed had no internal quality audit system which points to a critical gap in blood safety. Uniform SOPs, manuals, guidelines need to be introduced and monitored by the blood regulatory authorities. The SBTP can play a pivotal role of sharing, sensitizing, and capacity building of the technical capacity of blood centers to promote quality assurance.
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National Baseline Survey – Evaluation of Blood Screening Systems
The complete range of blood transfusion SOPs developed by the SBTP should be adopted by all blood centers and enforced through the respective regulatory authority.
Accreditation mechanism of the blood centers must be institutionalized to ensure consistency in quality of services matching international standards.
Quality assurance remains a serious issue. Only about 70 percent of the blood centers had a dedicated staff member responsible for quality management. The organizational structure of each blood center should identify and specify the role and responsibilities of personnel devoted to quality assurance.
The survey findings indicated that public and private sector blood centers accord low priority to implementation of quality assurance policies. The blood regulatory bodies should ensure that each blood center has internal and external quality assurance systems in place which should be mandatory and a condition for approving new or renewal of existing licenses.
To ensure uniformity and consistency in the standards of blood screening, the Pakistan specific national Algorithms for TTI’s recently developed by SBTP and WHO should be adopted by all blood centers.
A national accreditation policy for blood centers needs to be developed which should be implemented in phases.
Minimum standards for waste disposal should be developed and adopted by all blood centers.
The practice of storing archive frozen samples of donor plasma for look back studies should be encouraged.
There is a need to enforce WHO guidelines for testing of all five TTIs. This would only be possible when the blood regulatory authorities are fully functional in all the provinces and regions with effective monitoring capacity.
The survey findings indicate that public sector blood centers rely on rapid kits which undermine blood safety. ELISA technique should be the minimum preferred screening standard process by all blood centers. The respective health departments should allocate adequate resources to procure ELISA kits and equipment and discontinue the procurement of rapid kits.
Procurements
The availability of all blood center consumable items including screening kits especially rapid and ELISA kits must be regulated through a licensing regime to ensure quality compliance with internationally accepted standards.
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National Baseline Survey – Evaluation of Blood Screening Systems
The leadership of blood centers should be sensitized on the significance of conducting evaluation and validation of the consumable items before procurements.
Procurement manuals should be developed by the regulatory bodies which should include the specifications of recommended equipment and supplies including evaluation and validation guidelines. It should be mandatory for all blood centers to comply with the procurement manuals.
The regulatory bodies should issue a no-objection certificate for the import of consumable supplies including TTI screening kits.
Management Environment
The respective provincial governments should give greater priority to blood safety and include it as a core element of the national health policy.
The administrative, financial and constitutional challenges facing the SBTP should be resolved to ensure smooth implementation of the project of national blood safety significance.
Greater collaboration between the national and international stakeholders should be promoted for experience sharing and learning.
The lack of credible baseline statistics on all aspects of blood transfusion remains a programmatic gap. A national baseline survey therefore should be conducted at this stage to monitor the impact and progress of the blood safety systems reforms.
Publications on issues relating to blood safety in Pakistan are few. Research in this field should be promoted to enhance the quality of transfusion services in the country.
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National Baseline Survey – Evaluation of Blood Screening Systems
IV. Detailed Quantitative Findings
1. General Information
Province wise distribution of total Blood Centers Surveyed 180 170 160 140 120 100 80 69 60 51 40 13 14 20 6 4 8 5 0
Figure 4.1: Number of Blood Centers Surveyed in each Province
In all, 170 blood centers were surveyed both in the public as well as private sector in all the four provinces of Pakistan including ICT, FATA, AJK, and GB. Almost seventy percent of the blood centers surveyed are in the two most populous provinces of Punjab and Sindh. The highest number of blood banks surveyed in Sindh province is rationalized as it is the only province in comparison to other provinces that has a functional blood transfusion authority which has a data base of all, licensed as well as unlicensed, blood banks in the province. In Punjab, the blood transfusion authority is notified and in the process of being made fully functional. In AJK, the blood transfusion authority is functional and being strengthened. In other provinces, the blood transfusion authorities are at early stages of becoming functional.
The proportionate distribution of blood centers surveyed reflects a bias towards the public sector hospital based blood transfusion facilities (63%) which were more readily accessible and responsive to the survey (Fig 4.2). The involvement of the private sector in the blood transfusion services is a relatively late phenomenon in Pakistan. The private sector contributes through blood centers that are hospital based as well as stand alone blood banks and blood transfusion centers. In the private sector, usually the larger hospitals have their own blood banks which cater to the needs of the indoor patients. Many private sector hospitals rely on the private stand alone blood banks and the blood transfusion centers which provide services to the general public at large. Another factor that encouraged the growth of private sector blood transfusion centers is the high number, around 100,000 ______26
National Baseline Survey – Evaluation of Blood Screening Systems transfusion dependent thalassemia patients, who have poor access to regular blood transfusion services in the public sector. The thalassemia patients are not hospitalized and yet they require regular blood transfusions. The private sector blood transfusion centers primarily serve the thalassemia patients through the blood centers of the respective blood transfusion centers.
Type of Blood Centers Surveyed 120 107 100 Private Sector Blood 80 Banks Public Sector Blood Banks 60 36 40 Stand Alone Blood Banks 19 20 8 Blood Transfusion Centers 0 1
Figure 4.2: Type of Blood Centers Surveyed
Hospitals Served by Type of Blood Centers 1000 880 800 600 400 200 132 137 18 0 Private Sector Public Sector Stand Alone Blood Blood Transfusion Hospital Based Hospital Based Banks Centers Blood Banks Blood Banks
Figure 4.3: Number of Hospitals Served by Type of Blood Centers
The 170 blood centers surveyed serve a total of 1,167 hospitals both in the public as well as the private sector. Figure 4.3 reflects the relative importance of stand alone blood centers which contribute at least partially to meet the needs of a large ______27
National Baseline Survey – Evaluation of Blood Screening Systems number of hospitals both in the public and private sector as well as the thalassaemia patients in blood transfusion centers. Figure 4.2 and 4.3 analyzed in correlation reflect that 36 stand alone blood centers provide partial coverage to 880 hospitals and blood transfusion centers compared to 134 hospital based blood banks and blood transfusion centers that provide coverage to 287 hospitals and blood transfusion centers. This indicates that most of the hospital based blood banks and blood transfusion centers primarily meet the needs of their own patients and contribute only partially to the needs of patients in other centers.
Licensed/Inspected Vs Unlicensed/Uninspected Blood Centers
Unlicensed/ Uninspected 38% Licensed/ Inspected 62%
Figure 4.4: Percentage of Licensed/Inspected Blood Centers
Blood Centers Licensed/Inspected in each Province 60 54 50 40 30 15 15 20 8 10 4 1 0 0 4 0 0 0 0 0 3 2 0
Licensed Inspected for License
Figure 4.5: Blood Centers Licensed/Inspected by the BTAs in each Province
Out of the 170 blood centers surveyed, a total of 80 were granted licenses and 26 blood centers were inspected at least once. So a total of 106 blood centers or 62 percent of the blood centers surveyed were either regulated or in the process of ______28
National Baseline Survey – Evaluation of Blood Screening Systems being regulated by the respective Blood Transfusion Authorities (Fig 4.4). This does not imply that the remaining 64 blood centers are providing illegal or unauthorized services. The reason for the low number of licensed blood centers is the lack of functional blood regulatory bodies in most of the provinces.
Out of the 90 unlicensed centers surveyed, 26 blood centers in all the four provinces including AJK were inspected at least once for registration (Fig 4.5). These statistics are reflective of weak functional capacity of the provincial regulatory authorities except in the province of Sindh. The low number is also reflective of the process that allows blood centers to make up for the deficiencies identified during inspections before being granted a licence.
In the Sindh province, the regulatory system is most organized and functional. No blood bank can function without registering with the Sindh Blood Transfusion Authority (SBTA). The process for licensing includes, submission of application on a prescribed Performa that includes questions regarding the physical infrastructure, technical qualifications of staff, and type of equipment etc. Once an applicant applies for registration, provisional registration is granted subject to completing all the requirements as prescribed in the Performa. Subsequently, the SBTA inspectors visit the facility and inspect the premises, equipment, interview the personnel, and observe the functioning of the blood center. The information gathered during such visits is then processed into a data base and a SBTA Committee comprising of experts headed by the Health Secretary, Government of Sindh reviews the applicant’s credentials and issues license or advises to address the deficiencies before being issued a license. Once a license is issued, SBTA inspectors perform periodic inspections to ensure compliance with all the technical and physical requirements specified in the application Performa. The license is renewed or cancelled, as the case may be, subject to inspection reports.
In the Punjab province, the regulatory authority has been notified. Some staffing and other management issues continue to be resolved. As a consequence, the Punjab regulatory body is not fully functional. Despite the deficiencies, some blood centers have been inspected, registered and licenses issued. The situation has recently improved with the appointment of a new Secretary and allocation of funds. The Punjab Blood Transfusion Authority (PBTA) has now been housed in new and more adequate premises. The management issues are being resolved. In a recent meeting of the management board of the Authority, a road map has been finalized to promote blood safety in the province by enforcing the regulatory mechanism. The process of registering the existing blood centers has also commenced. Applications have been sought and received from several blood centers, both in public and private sector, to initiate the registration and licensing of the blood centers.
In Khyber Pakhtunkhawa (KPK) only 3 out of 14 or 21 percent of the blood centers surveyed were licensed. In contrast to other provinces where the blood transfusion regulatory authority is stipulated to be an independent entity, in KPK the Health Regulatory Authority (HRA) is also responsible for regulating blood transfusion services. Some blood centers have been registered. The limited staff to regulate the ______29
National Baseline Survey – Evaluation of Blood Screening Systems blood transfusion services is a limiting factor in covering the entire blood transfusion sector in the province.
In the Islamabad Capital Territory (ICT), the Islamabad Blood Transfusion Authority (IBTA) was established in 2005 to regulate blood transfusion services in ICT. The IBTA was fully functional and performed all the regulatory functions until 2009. However, its capacity declined due to management related issues further compounded by the devolution of the Federal health functions to the provinces under the 18th Constitutional Amendment. A new Federal Ministry namely ‘the National Regulation and Services’ has been established and has the mandate to regulate the blood transfusion services in ICT. The final status of the IBTA in terms of a parent Ministry is expected to be decided soon. Once the strategic management issues are resolved, a new Board of the IBTA and its Chairman and Secretary would be appointed. As and when these basic management issues are addressed, the IBTA is expected to regain its functional status.
In Gilgit-Baltistan (GB) and the Federally Administered Tribal Areas (FATA), no regulatory mechanism exists. Plans are in place to develop institutional regulatory mechanisms including the creation of blood transfusion regulatory bodies. Necessary legislation is in process in GB.
In the province of Balochistan, despite the existence of a blood transfusion authority, none of the six blood centers surveyed were licensed. Although the blood transfusion authority has been notified and a Secretary appointed, the Authority is neither staffed nor does it have any functional capacity to perform its mandated regulatory role.
In AJK, out of the 13 blood centers surveyed, only 4 or 30 percent were licensed which are all in the public sector. Until recently, the regulatory authority focused only on the public sector blood centers and to-date had issued 10 licenses. The process of licensing blood centers in the private sector is expected to commence soon.
2. Organization and Management
Out of the total 170 blood centers surveyed, 107 are in the government sector, 63 in the NGO sector and none were commercial blood centers (Fig. 4.6). The private sector blood centers function within private hospitals (as part of or outside the domain of the Pathology departments), as stand alone blood banks, or as part of the blood transfusion centers for the thalassaemia patients.
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National Baseline Survey – Evaluation of Blood Screening Systems
Type of Blood Centers Surveyed 120 107 100 Private Sector Blood 80 Banks Public Sector Blood Banks 60 36 40 Stand Alone Blood Banks 19 20 8 Blood Transfusion Centers 0 1
Figure 4.6: Type of Management of Blood Centers
40 36 Private and Public Sector Blood34 35 33 Centers in Provinces 30
25
20 17 Commercial 15 11 11 Govt. 10 8 NGO 5 4 5 2 2 2 3 0 0 1 0 0 0 0 1 0 0 0 0
Figure 4.7: Distribution of Public/Private Blood Centers in Provinces
The relatively high percentage of NGO run blood centers in comparison to the total blood centers surveyed in Sindh (52 percentage) and Punjab (31 percentage) is a reflection of the growing transfusion needs of the population that has encouraged the private NGO sector to provide blood transfusion services and bridge the services gap that the government run facilities cannot meet (Fig. 4.7). The demand for the ______31
National Baseline Survey – Evaluation of Blood Screening Systems
NGO managed blood centers is also due to the expansion in the health care infrastructure, particularly in the private sector, which has led to increase in the demand of transfusion needs as more advanced forms of surgical and medical treatment options are becoming available in the country. But the main reason for the growing involvement of the NGO sector in blood transfusion services is the limited facilities for thalassemia patients in the government run hospitals. Until 15- 20 years ago, the thalassaemia population was largely neglected but with the passage of time the awareness about the prevention and treatment of thalassaemia has increased which has created a demand for additional blood centers as well as blood transfusion centers. This demand is, to a large extent, being met by the private sector.
Blood Transfusion Centers Stand Alone Blood Centers
11% 5%
Hospital 21% Based Blood Hospital Banks Based Blood 63% Banks (as a part of lab)
Type of Blood Centers Surveyed
Figure 4.8: Type of Blood Centers Surveyed
Only 21 percent of the 170 blood centers surveyed were hospital based blood banks functioning independently and not part of the pathology department (Fig. 4.8). While 63 percent of the blood centers surveyed were functioning as part of the Pathology departments of the respective hospitals either in the public or the private sector. A total of 84 percent blood centers were hospital based blood centers. Only 5 percent blood centers surveyed were Stand Alone Blood Centers, all in the private sector. About 11 percent of the blood centers were private sector Blood Transfusion Centers functioning primarily to meet the demand of large number of transfusion dependant thalassemia patients in the country.
None of the blood centers surveyed have outsourced or delegated any of its functions to any other organization. All blood centers surveyed function as complete units covering all aspects of blood transfusion work including; mobilizing and recruiting blood donors, blood collection, testing, screening, component preparation, and storage all under one roof. In the blood transfusion centers, blood transfusion is also administered to patients in addition to the above mentioned functions. ______32
National Baseline Survey – Evaluation of Blood Screening Systems
All the blood centers acknowledged receiving some form of support from national/international sources. All the blood centers surveyed had received technical support in the form of capacity building activities supported by the Safe Blood Transfusion Programme funded by the GIZ and KFW and also the World Health Organization (WHO) through the WHO/OFID Joint Programme. No blood center surveyed had received international financial support.
Secondary data indicates that financial support from national sources is restricted solely to the private sector blood banks ranging from individuals/philanthropists to organizations such as Bait-ul-Maal. The blood centers in the private sector also generate resources by charging patients. Whereas, in the public sector, the cost of recurring expenses is borne by the government and additional external financial support is almost nonexistent. Almost all public sector blood centers receive funds as part of the overall budgets allocated by the provincial and federal governments for hospitals.
The technical support mainly consists of capacity building of technical and management staff. Under the Safe Blood Transfusion Programme funded by the GiZ and KFW, the capacity building process is being augmented by developing SOPs, manuals, guidelines, and standards developed by the national and international experts in consultation with the national stakeholders. The new technical tools and guidelines are to be pre-tested before being adopted by blood centers across the country.
Respondent Blood Centers with Seperate Costing Heads
23
Respondents No Response
147
Figure 4.9: Respondent Blood Centers with Separate Costing Heads
Only 23 out of the total 170 blood centers surveyed shared any information on budget allocations (Fig. 4.9). All the 23 blood centers have separate budgets for donor recruitment, staffing and test processing. Out of the 23 blood centers, 1 was ______33
National Baseline Survey – Evaluation of Blood Screening Systems in the private sector hospitals, 2 in the public sector hospitals, 7 were stand alone blood centers, and 13 were blood transfusion centers (Fig. 4.10).
Breakdown of 23 Respondents 14 13 12 10 8 7 6 4 2 2 1 0 Private Sector Public Sector Stand Alone Blood Transfusion Hospital Based Hospital Based Banks Centres Blood Banks Blood Banks
Figure 4.10 Breakdown of 23 Blood Centers which provided information about Budgeting
The lack of readily available information on budget allocations is the primary reason for not sharing budget information during the survey. Conclusions drawn from observations by the technical staff of the blood centers indicate that there is a general reluctance to share budget related information both in the public and private sector. Even the finance department in public sector hospitals are reluctant to share information about budgetary allocations with the technical staff of blood centers. Discussions reveal that the technical staff of the blood centers is neither consulted nor made part of the budget allocation process in both the public and private sector. The technical staffs’ role is limited to identifying the procurement requirements for consumable items.
The budget figures provided by only 23 blood centers cannot form any basis for a rational analysis in terms of percentage of funding from various sources, the adequacy of funds allocated, nor does it form the basis of any trend analysis regarding allocations by private versus public sector blood centers.
3. Blood Screening Infrastructure
Out of the 170 blood centers surveyed, 115 numbers were hospital based blood centers both in the public and private sector. Out of the 115, 108 blood centers (94 percent) are part of the pathology department of the respective hospitals (Fig. 4.11). The figure is indicative that transfusion medicine is still not considered a speciality in its own right nor is it accorded the priority in view of the public health implications of safe blood transfusion.
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National Baseline Survey – Evaluation of Blood Screening Systems
Blood Centers as Part of Pathology Departments
Others 62 Blood Centers as part of Path. Dept. 108
Figure 4.11: Blood Centers as Part of Pathology Department
Figure 4.12 demonstrates that even in the more populous provinces of Sindh and Punjab where the public health care system is relatively better organized, 66 percent and 48 percent respectively, the blood centers are located within the hospitals are part of the Pathology departments instead of independent blood transfusion centers.
40 34 35 Blood Centers as part of 33 30 Pathology Departments 25 20
15 11 11 10 8 5 4 5 2 0
Figure 4.12: Province-wise Distribution of Blood Centers as part of Pathology Departments
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National Baseline Survey – Evaluation of Blood Screening Systems
Private Sector Public Sector Hospital Based Hospital Based Stand Alone Transfusion Blood Banks Blood Banks Blood Banks Centers No Yes No Yes No Yes No Yes Donor selection 1 7 0 107 0 36 1 18 Blood collection 1 7 6 101 0 36 1 18 Blood processing & 1 7 8 99 0 36 2 16 testing Storage & distributing 1 7 4 103 0 36 1 18
Table 4.1: Suitable Sections in Different Types of Blood Centers
The physical infrastructure for various sections of the blood centers were properly identified and segregated in 96 percent (n=164) of the total 170 blood centers surveyed. The survey results indicate that most blood centers have the necessary arrangements for physical segregation of different blood transfusion functions.
Water and Power Connection 120 95.9 97.1 100
80 Continuous Water 60 Supply 40 Power Supply
20 4.1 2.9 0 Yes % No%
Figure 4.13: Availability of Utilities at Blood Centers
Almost all of the 170 blood centers surveyed had power (n=165) and (n= 163) have water supply connnections (Fig. 4.13). Seventy five percent of the blood centers surveyed (n=127) faced power cuts in the range of 5-12 hours daily (Fig. 4.14). Almost 97 percent (n=165) of the blood centers reported having arrangements for back-up power generation (Fig. 4.15). And, the majority (87 percent) blood centers reported that the power backup arrangements were adequate to ensure that blood products remained at the recommended temperatures. The survey figures confirm that the majority of blood centers located in hospitals (119 out of a total of 170 or 70 percent blood centers surveyed) have
______36
National Baseline Survey – Evaluation of Blood Screening Systems back up generation facilities as part of a critical function in overall health care services provided by the hospitals.
13-16 hrs 17-20 hrs 1% 1%
0-4 hrs 9-12 hrs 23% 25%
Power Cuts / day
5-8 hrs 50%
Figure 4.14: Duration of Power Outages at Blood Centers
Percentage Availability /Sufficiency of Power Systems 120 96.5 100 84.1 80 60 40 20 12.4 0 Is emergency power Electriciy supply and Emergency Power system available? backup generator System not sufficient sufficient?
Figure 4.15: Availability and Sufficiency of Emergency Power Generation
Table 4.2 and Figure 4.16 shows that transport services in hospital based blood centers (27 percent in private sector and 22 percent in public sector) are not available in comparison to almost 100 percent availability of transport in stand alone blood centers and independent transfusion centers. The limited availability of transport for blood centers in hospitals is a reflection of other needs that are met by ______37
National Baseline Survey – Evaluation of Blood Screening Systems limited transport facilities available to the hospital. There is a critical need for dedicated transport facilities for each blood center, whether in the private or public sector hospitals.
Private Sector Public Sector Stand Alone Transfusion Hospital Based Hospital Based Blood Centers Blood Centers Blood Centers Centers
Yes No Yes No Yes No Yes No Transportation 1 7 24 83 2 34 1 18 Telephone 0 8 1 106 0 36 1 18 Fax 4 4 60 47 9 27 2 17 Internet 0 8 67 40 1 35 1 18
Table 4.2: Availability of Communication Facilities According to Type of Blood Center
Figure 4.16: Availability of Communication Facilities According to Type of Blood Center
Other communication tools such as, telephone is available in all the 170 blood centers surveyed. Internet facilities are available to 90 percent of blood centers in the private sector. However, in the public sector, only 38 percent have access to internet facilities. This is also indicative of the lack of MIS systems in public hospitals. With increasing use of internet, fax services are fast losing their utility and hence the declining trend in the use of fax technology as reflected in the findings of the survey.
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National Baseline Survey – Evaluation of Blood Screening Systems
Availability Functional Equipment (%) (%) Donor Beds / Couches 98.2 100 Tube Sealers 95.3 100
Container for safe disposal of sharps 84.7 100 Vehicles for outdoor donor sessions 65.3 100 Electronic Balance 77.6 100 Lab. Bench top centrifuge 82.4 100 Micro plate shaker 70.6 100 Cell washer centrifuge 70.6 100 Binocular microscopes 91.7 100 ELISA plate washers 82.4 100 ELISA plate reader 85.3 100 Automatic pipette 82.9 100 Automated sample processor 32.9 100 Laboratory thermometers 88.2 100 pH Meter 34.7 100 Autoclaves 30.0 100 Water bath 85.3 100 Incubators 78.2 100 Hot Air Ovens 37.6 100 Blood bag mixer 72.9 95 Equipment necessary for producing chemically 30.6 100 pure/or pyrogen-free water e.g. distill; deionizer Blood bank refrigerator 84.7 98 Refrigerated centrifuges 86.5 97 Plasma Freezer -30 C 46.5 99 Deep Freezer -80 C 32.4 100 Laminar Airflow cabinet 23.5 100 Platelet incubator and shaker 72.9 96 Plasma extractors 81.8 100 Plasma thawer 35.3 100 Cryoprecipitate bath (4 C) 22.4 100 Blood transportation box 62.4 100 Voltage stabilizers 59.4 99 PC with accessories and software 40.0 100
Table 4.3: Availability and Functionality of Blood Transfusion Equipment
Table 4.3 indicates that essential and routine blood transfusion equipment was mostly available and also functional. Some advanced equipment was not available in limited number of blood centers.
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National Baseline Survey – Evaluation of Blood Screening Systems
System of Stock Controls for Critical Supplies
15.3
Yes% 84.7 No%
Figure 4.17: Availability of a System for Stock Controls for Critical Supplies
Almost 85 percent of the blood centers surveyed had a system of stock controls which ensured continuous (over 90 percent) uninterrupted supply of critical consumable items (Fig. 4.17 and 4.18).
Critical Supplies in Last 12 Months 120.0 95.9 100.0 90.0 92.4 94.7 80.0 60.0 Yes% 40.0 No% 20.0 10.0 7.6 5.3 4.1 0.0 Supply ran out Blood Bags ran TTI Kits ran Blood grouping in last 12 out? out? reagents ran months? out?
Figure 4.18: Availability of Critical Supplies in the last 12 months
Of the less than 10 percent supplies that did ran out in most blood centers, the shortages were mostly in the public sector blood centers. This reflects a more responsive and flexible procurement system in the private sector compared to the public sector where the system is more cumbersome and rigid.
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National Baseline Survey – Evaluation of Blood Screening Systems
4. Blood Screening Technical Capacity
Blood Centers with a Quality Policy
71 99 Quality Policy Without Quality Policy
Figure 4.19: Blood Centers with a Quality Policy
Blood Centers have quality policy? 70 59 60 48 50 40 35 30 18 No 20 7 Yes 10 1 1 1 0 Private Sector Public Sector Stand Alone Transfusion Hospital Based Hospital Based Blood Banks Centres Blood Banks Blood Banks
Figure 4.20: Availability of a Quality Policy According to the Type of Blood Centers
Figure 4.19, 4.20, 4.21 reflect that out of the 170 blood centers surveyed, 99 or 58 percent have a quality policy, whereas, the remaining 71 do not have a quality policy. In the public sector, 55 percent and in the private sector 95 percent have a quality policy. This reflects a consistent trend of according low priority to quality assurance related issues in the public sector.
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National Baseline Survey – Evaluation of Blood Screening Systems
Province-wise Distrubtion of Blood Centers with a Quality Policy 45 41 40 35 28 28 30 23 25 20 11 15 8 6 7 10 5 3 2 3 3 5 0 1 1 No 0 Yes
Figure 4.21: Province-wise Distribution of Blood Centers with a Quality Policy
In the Sindh province, 40 percent of blood centers surveyed have no quality policy in comparison to 55 percent in the province of Punjab (Fig.4.21).
Organization and Other Policies Yes % No % Does the centre have an organizational structure indicating authority? 91.8 8.2 Does the center have dedicated staff? 90.0 10.0 Is it mandatory for all centre staff to be vaccinated for Hepatitis B? 65.9 34.1 Is the past history of all centre staff to any exposure to TTIs maintained? 32.4 67.6 Are there written job descriptions for all positions within the organization? 92.9 7.1 Has the centre appointed a person responsible for quality management? 70.0 30.0
Table 4.4: Organization and Policies of Blood Centers
Almost ninety two percent of the blood centers surveyed had an organizational structure which identified authorities, responsibilities and reporting mechanisms (Table 4.4). Although the majority of the hospital based blood centers function as part of Pathology departments (Fig 4.12) and yet 90 percent of these blood centers have their own dedicated staff which clearly indicates that transfusion medicine is an independent specialty that requires specially trained and qualified staff.
Almost sixty six percent of the blood centers surveyed had a policy of vaccination of the blood center staff (Table 4.4). However, only about 32 percent of these centers maintain record of its staff for any exposure to transfusion transmissible infections. Written job descriptions of the staff are available in almost 93 percent of the blood
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National Baseline Survey – Evaluation of Blood Screening Systems centers surveyed. And, only 70 percent of the blood centers had a dedicated staff member for quality assurance.
SOPs Availability Yes (%) No (%) Blood donors recruitment 75.9 24.1 Blood donors selection 94.1 5.9 Blood collection and donor care 71.8 28.2 Blood component preparation 76.5 23.5 Screening for TTI 95.3 4.7 Blood group serology 96.5 3.5 Blood storage and transportation 89.4 10.6 Waste management 70.0 30.0
Table 4.5: Percentage Availability of SOPs in the Blood Centers
Table 4.5 reflects that over 70 percent of the blood centers surveyed, both in the public and private sector, have SOPs covering different aspects of blood transfusion functions. How far are the SOPs followed is subject to internal management and quality audit? The varied responses under separate sections suggest that there is no standard SOP Manual that covers all the categories. Similarly, the varied response under each category, critical in its own right, reflects a lack of priority accorded to strict adherence to each SOP which is critical to ensure complete safety in blood transfusion.
SOPs Private Public Stand Alone Blood Availability Sector Blood Sector Blood Blood Banks Transfusion Bank Banks Centers Yes No Yes No Yes No Yes No Blood donors recruitment 6 2 73 34 35 1 15 4 Blood donors selection 7 1 99 8 36 0 18 1 Blood collection & donor care 7 1 85 22 12 24 18 1 Blood component preparation 7 1 97 10 11 25 15 4 Screening for TTI 7 1 102 5 35 1 18 1 Blood group serology 7 1 103 4 36 0 18 1 Blood storage & Transportation 7 1 91 16 36 0 18 1 Waste management 7 1 58 49 36 0 18 1
Table 4.6: SOPs Availability According to the Type of Blood Centers ______43
National Baseline Survey – Evaluation of Blood Screening Systems
Table 4.6 reflects little significant difference between private and public sector blood centers regarding the availability and adherence to SOPs.
Record Maintenance - SOPs Yes % No % Blood donors recruitment 92.4 7.6 Blood donors selection 91.2 8.8 Blood collection and donor care 93.5 6.5 Blood component preparation 90.6 9.4 Screening for TTI 91.2 8.8 Blood group serology 93.5 6.5 Blood storage and transportation 91.2 8.8 Waste management 55.9 44.1
Table 4.7: SOPs Record Maintenance
Table 4.7 indicates that except for waste management record, over 90 percent of the total blood centers surveyed maintained records for different types of blood center activities. However, only about 56 percent of the blood centers maintain a record of waste management. The survey findings show better record management in the private sector compared to the public sector (Table 4.8).
The findings are consistent with the available secondary data that shows that generally the public and private sector healthcare centers accord low priority to waste disposal. As a result, disposable waste is reused and recycled and is a major contributor to the spread of Hepatitis B and C infections. Improper disposal of sharp waste is also a source of spread of TTIs especially among the blood center staff.
Blood Private Sector Public Sector Stand Alone Transfusion Blood Bank Blood Banks Blood Banks Centers Yes No Yes No Yes No Yes No Blood donors recruitment 7 1 98 9 35 1 17 2 Blood donors selection 8 0 95 12 36 0 16 3
Blood collection & 8 0 98 9 34 2 19 0 donor care Blood component preparation 7 1 96 11 34 2 17 2 Screening for TTI 8 0 96 11 35 1 16 3 Blood group serology 8 0 97 10 35 1 19 0
Blood storage and transportation 8 1 93 14 35 1 19 0 Waste management 7 1 38 69 33 3 17 2 Table 4.8: Breakdown of SOPs Record Maintenance Practices According to Types of Blood Centers ______44
National Baseline Survey – Evaluation of Blood Screening Systems
Designated Person for Data Management No Yes
47.6 52.4
Figure 4.22: Blood Centers with Dedicated Person for Data Management
Figure 4.22 shows that almost half of all the 170 blood centers surveyed do not have any staff designated for data management. In comparison to the public sector where 30 percent have a designated data management staff, 92 percent in the private sector have a designated staff member for data management. In the province of Sindh, 75 percent of the blood centers surveyed had data management staff which is by far the best compared to other provinces and is also a reflection of the more functional nature of its regulatory authority (Fig. 4.24).
Designated Person for Data Management According to Type of Blood Center? 70 59 60 48 50 34 40 30 19 20 7 10 1 2 0 0 No Private Sector Public Sector Stand Alone Transfusion Yes Hospital Based Hospital Based Blood Banks Centres Blood Banks Blood Banks
Type of Blood Center
Figure 4.23: Availability of Data Management Personnel According to the Type of Blood Center
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National Baseline Survey – Evaluation of Blood Screening Systems
Province-wise Distribution of Data Management Personnel? 52 60 50 40 29 30 22 17 20 7 6 5 3 7 4 9 5 10 1 1 1 1 0 AJK KPK No FATA Sindh Punjab
Baltistan Yes - Baluchistan Gilgit Capital Territory Capital
Province
Figure 4.24: Province-wise Availability of Data Management Personnel
Review of secondary data indicates that, in general, data management is not accorded due priority in the public sector blood centers. This is also reflective of the lack of Management Information Systems in public sector hospitals. The lack of data management has serious implications in terms of transmission of transfusion transmissible infections and also traceability and overall blood safety. On the whole, the lack of an Information Technology policy results in lack of credible data, proper storage, and back up of data and consequently increases the risk of TTIs.
System of Internal Quality Audit
No 42.9 Yes 57.1
Figure 4.25: Internal Quality Audit System in Blood Centers
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National Baseline Survey – Evaluation of Blood Screening Systems
Internal Quality Audit System in Type of Blood Centers 70 62 60 45 50 40 33 30 15 20 4 4 3 4 10 No 0 Private Sector Public Sector Stand Alone Transfusion Yes Hospital Based Hospital Based Blood Banks Centres Blood Banks Blood Banks
Type of Blood Center
Figure 4.26: Presence of Internal Quality Audit System according to Types of Blood Centers
According to Figure 4.25, the survey findings show that almost 43 percent (n=73) of the blood centers had no internal quality audit system. The situation is worse in public sector blood centers where the majority (57 percent) of the blood centers lack an internal quality audit system which is consistent with the lack of a quality policy in most of the public sector blood centers (Fig. 4.20). The lack of internal quality audit system has a direct bearing on the risk of transmission of transfusion transmissible infections and also the accuracy and reproducibility of tests. Compared with the other provinces, the blood centers surveyed in the province of Sindh and Punjab have better internal audit systems which may be reflection of the availability of more qualified and trained staff.
Province-wise Distribution of Internal Audit System 60 48 50 35 40 21 30 16 20 6 7 5 1 3 1 7 1 5 10 4 10 0 0 AJK KPK
FATA No SINDH PUNJAB GILGIT Yes BALTISTAN BALOCHISTAN Capital Territory Capital
Province
Figure 4.27: Presence of Internal Quality Audit System According to the Provinces ______47
National Baseline Survey – Evaluation of Blood Screening Systems
The accreditation of blood centers is not mandatory in Pakistan. None of the 170 blood centers surveyed was accredited because until recently there was no national level organization capable of conducting accreditation of technical institutions. Only recently, the Pakistan National Accreditation Council (PNCA) functioning under the federal Ministry of Science and Technology developed some expertise and conducted the accreditation of the Armed Forces Institute of Pathology (AFIP) in Rawalpindi.
Staff Nos. Trainings Obtained National International No Response Medical Officers 277 133 0 0 Nurses 375 0 0 0 Blood Donor Recruiters 473 137 0 13 Laboratory Technicians 1002 290 0 37 Admin & Support Staff 711 392 0 37
Table 4.9: Staff Category and Trainings
Table 4.9 reflects that capacity building or training is a major deficient area in building the capacity of blood transfusion staff. There is a critical need for an overall capacity development program for the blood transfusion staff both in the public as well as in the private sector. This is also a reflection of lack of uniformity and standardization in formal and informal education for blood center staff which has resulted in wide variations in quality of the vein-to-vein transfusion chain. There is a critical need to standardize educational courses across provinces to achieve the goal of blood safety. The training institutes that do exist are not regulated and therefore the quality of the trained staff varies depending on the quality of training received.
The key issue of the Blood Transfusion education sector is lack of governance and regulation. There is a need to harmonize the entire system through regulation, standardization and quality control. Most importantly, a "Medical Technology Council" needs to be created, which should issue licenses to personnel trained on a uniform standard curriculum, for working in the Clinical Laboratories, Blood Centers and Blood Banks in Pakistan. The functions of this council would be to license or approve University and College Programmes for training and education in all fields of Medical Technology.
The findings of the survey underscore the need for Transfusion Medicine and Blood Banking to be recognized as an entity separate from Pathology, with its own specialists and their career structure.
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National Baseline Survey – Evaluation of Blood Screening Systems
5. Procurement of Consumables’/Equipment
Centres with Adequate Equipment
No 10 %
Yes 90%
Figure 4.28: Percentage of Centers with Adequate Equipment
Figure 4.28 co-related with Table 4.2 indicate the availability of routine and essential blood transfusion equipment in over eighty percent of the blood centers surveyed.
100 87.1 90 80 69.4 70.6 70 60 50 40 30.6 29.4 30 Yes% 20 12.9 No% 10 0 Purchased locally by Purchased centrally Donated by the centre or through upper international level agencies development agencies/donor countries
Figure 4.29: Modes of Procurement of Equipment
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National Baseline Survey – Evaluation of Blood Screening Systems
Private Sector Public Sector Stand Alone Blood Blood Bank Blood Banks Blood Banks Transfusion Centers Yes No Yes No Yes No Yes No Purchased locally at the 6 2 2 105 29 7 15 4 center? Purchased centrally or through upper level 2 6 107 0 7 29 4 15 agencies Evaluated before 7 1 63 44 11 25 18 1 procurement? 1 7 52 55 0 36 0 19 Validated at the centre?
Table 4.10: Mechanism of Purchase of Key Supplies in the Blood Centers
The purchase of supplies in the public sector blood centers is predominantly centralized (over 95 percent) through the health departments or the hospital authorities. While in the private sector blood centers, 80 percent of the centers (n=50/62) purchase their supplies locally at the centers. This is consistent with the fact that most of the private sector blood centers are single center entities.
In the public sector blood centers, only 59 percent of the centers (n=64/108) evaluate their consumable supplies before procurement. Price remains the predominant factor that determines the ultimate choice of supplies procured. There is a critical need to add quality as a factor in addition to cost as the evaluation criteria for the procurement of supplies.
In the private sector, only about 56 percent of the centers (n=35/62) evaluate the consumable supplies. The validation of the consumable supplies is conducted in only 48 percent of the public sector blood centers surveyed (n=52/107). In the private sector hardly any center validates supplies.
The supplies procurement mechanism differs between the public and private sector blood centers. In the private sector, the procurement decisions are mostly made at the level of the blood center with more involvement of the technical staff. However, despite this increased involvement of the technical staff in the private sector, little over half of all the centers surveyed evaluate the supplies before selecting and purchasing. But the situation regarding validation of the supplies is more dismal in the private sector where hardly any center validates the supplies in comparison to the public sector where half the centers surveyed validate the supplies. At present there are no national guidelines for evaluation and validation of supplies.
There is no regulatory control over the import of the consumable supplies including TTI screening kits used in the blood centers resulting in the availability of poor quality and sub-standard cheap options in the market. In most cases, the selection of consumables is subject to financial considerations rather than quality. As a result, poor quality kits are procured which have never been properly evaluated and ______50
National Baseline Survey – Evaluation of Blood Screening Systems validated either locally or at the national level. In addition, there is no national strategy for a testing technique and algorithm, the screening equipment in most centers is not properly calibrated. Capacity issues of the technical staff persist. As a result, the risks of acquiring infections following transfusion remain significant in Pakistan.
Almost 92 percent of the blood centers surveyed (n=157) had a programme or system of training staff on equipment maintenance (Fig. 4.30). Most vendors provide training of staff on operation and maintenance of equipment as part of the procurement contract. Similarly, vendors supplying kits also provide training to staff as part of the supply contract. These trainings are conducted on site in the blood centers in most of the cases.
Most of the equipment available in the blood centers surveyed was purchased locally either by the center itself or centrally by the hospital authorities or the health departments. As discussed earlier, the blood center management identifies the equipment needs and the higher authorities then manage the procurement with little involvement of the technical staff. A limited number of blood centers reported receiving some equipment from random international donor.
Staff training on use of Equipment
No 1.8%
Yes 98.2%
Fig: 4.30: Staff training on use of Equipment
In over ninety percent of the blood centers surveyed, a system to maintain critical supplies existed (Fig. 4.31).
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National Baseline Survey – Evaluation of Blood Screening Systems
System of stock control for the critical supplies
No 7.1%
Yes 92.9%
Fig: 4.31: Stock control of supplies
6. Screening for Transfusion Transmissible Infections
Under the WHO guidelines, screening for five TTI’s (HIV, Hepatitis B & C, Syphilis, and Malaria) is mandatory. However, Table 4.11 shows that screening for only three TTIs (HIV, Hepatitis B & C) is routinely conducted in all types of blood centers surveyed. Despite the high incidence of Malaria in the country, less than 50 percent of the total blood centers surveyed perform screening for Malaria. Only about three percent of the total blood centers perform screening for Syphilis. There is a need to enforce WHO guidelines for testing of all five TTIs. This would be only possible when the blood regulatory authorities are fully functional in all the provinces and regions with effective monitoring capacity.
Screening for TTIs Yes % No % HIV I and II 100 0 Hepatitis B 100 0 Hepatitis C 100 0 Syphilis 2.9 97.1 Chagas Disease 0 100 HTLV I/II 0 100 Malaria 44.1 55.9 Others 0 100
Table 4.11: Percentage screening of TTIs at Blood Centers
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National Baseline Survey – Evaluation of Blood Screening Systems
Another factor that affects the relative probability of transmissions of infections through transfusions relates to the quality of kits used and the techniques employed which are variable in different centers.
Figure 4.32 shows that about half of all blood centers surveyed used Algorithms for r screening of donated blood for prevention of transfusion transmissible infections. In the private sector, 70 percent of the blood centers use Algorithms for TTI’s prevention in comparison to 39 percent in the public sector (Fig. 4.33). The SBTP, with the support of WHO, has in 2011 developed Pakistan specific national Algorithms for the prevention of TTIs. These Algorithms have yet to be disseminated nationally. Therefore, the Algorithms being currently followed, both in the public and private sector are not uniform. The national Algorithms developed are expected to be disseminated nationally soon and need to be followed in all the blood centers in the country.
Yes % 49.4 50.6 No %
Figure 4.32: Percentage Usage of Algorithm for Testing
Use of Alogrithm by Type of Blood Centers 66 70 60 50 41 40 30 30 13 20 6 6 6 10 2 0 No Private Sector Public Sector Stand Alone Transfusion Hospital Based Hospital Based Blood Banks Centres Yes Blood Banks Blood Banks
Type of Blood Center
Figure 4.33: Usage of Algorithm by Type of Blood Centers ______53
National Baseline Survey – Evaluation of Blood Screening Systems
50 47 45 40 32 35 30 22 25 19 20 13 15 10 7 10 3 6 3 4 5 0 1 1 1 1 0 No AJK KPK Yes FATA SINDH PUNJAB BALOCHISTAN Capital Territory Capital GILGIT BALTISTAN GILGIT
Province
Figure 4.34: Usage of Algorithm According to Provinces
27.1
Yes % No %
72.9
Figure 4.35: Percentage Usage of IQC Samples
In Pakistan, TTI screening is conducted both manually and through automated systems. Figure 4.35 shows that almost 73 percent of the total blood centers surveyed perform some form of internal quality control for TTI screening. In private sector, only 18 percent perform no IQC in comparison to 32 percent in the public sector (Fig. 4.36).
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National Baseline Survey – Evaluation of Blood Screening Systems
Distribution of IQC by Type of Blood Centers 80 72 70 60 50 35 40 31 30 16 20 3 5 5 3 10 No 0 Private Sector Public Sector Stand Alone Transfusion Yes Hospital Based Hospital Based Blood Banks Centres Blood Banks Blood Banks
Type of Blood Center
Figure 4.36: Percentage Usage of IQC by Type of Blood Centers
International National Provincial Local Yes No Yes No Yes No Yes No HIV I & II 1.8 98.2 1.8 98.2 0.6 99.4 2.9 97.1 HBV 1.8 98.2 0.6 99.4 0.6 99.4 2.9 97.1 HCV 1.8 98.2 0.6 99.4 0.6 99.4 2.9 97.1 Syphilis 0 100 0.6 99.4 0.6 99.4 2.9 97.1 Chagas Disease 0 100 0 100 0 100 0 100 HTLV III 0 100 0 100 0 100 0 100 Malaria 0 100 0.6 99.4 0.6 99.4 2.9 97.1 Others 0 100 0 100 0 100 0 100
Table 4.12: EQAS Testing Percentage at Blood Centers
As the Table 4.12 shows, External Quality Assurance System (EQAS) for TTIs testing at any level is almost nonexistent in public and private sector blood centers. EQAS is essential to maintain standards and quality. The lack of any EQAS system is potentially responsible for spread of TTI’s. Under the Safe Blood Transfusion Programme, a comprehensive system of EQAS is being introduced for all the blood centers to be established under the Programme. The existing blood centers would be encouraged to adopt the same system for quality assurance. For the first time accreditation process has been introduced by the Pakistan National Accreditation Council under the Ministry of Science and Technology. This needs to be expanded to cover, at the very least, major blood centers both in the public and private sector. ______55
National Baseline Survey – Evaluation of Blood Screening Systems
And in due course of time accreditation from this body must be made mandatory for all the blood centers to ensure minimum risk of transmission of infections through transfusions and to achieve high standards of blood safety
Test Kits, Reagents Stored in TME
20.6
Yes No 79.4
Figure 4.37: Test Kits, Reagents Stored in TME
Test kits/Reagents stored in TME 80 76 70 60 50 40 31 34 30 No 18 20 Yes 7 10 1 2 1 0 Private Sector Public Sector Stand Alone Transfusion Hospital Based Hospital Based Blood Banks Centres Blood Banks Blood Banks
Figure 4.38: Test Kits/Reagents Stored in TME by Type of Blood Centers
Almost 80 percent of the total blood centers surveyed store kits and reagents at recommended temperatures (Fig. 4.37). The storage practices in the private sector blood centers were better and this percentage was almost 94 percent (Fig. 4.38).
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National Baseline Survey – Evaluation of Blood Screening Systems
Samples Stored in TME
31.2
Yes 68.8 No
Figure 4.39: Samples Stored in TME
Test kits/Samples stored in TME 70 61 60 50 46 40 33 30 No 18 20 Yes 10 5 3 3 1 0 Private Sector Public Sector Stand Alone Transfusion Hospital Based Hospital Based Blood Banks Centres Blood Banks Blood Banks
Figure 4.40: Samples Stored in TME by Type of Blood Centers
Almost 69 percent of the total blood centers surveyed store samples at recommended temperatures (Fig. 4.39). Out of the total 170 blood centers surveyed, 117 centers (69 percent) stored samples in temperature monitored equipment. Sixty seven percent of the public sector centers in comparison to 89 percent in the private sector stored samples in temperature monitored equipment (Fig. 4.40). Storage of samples in temperature monitored equipment is critical for the quality of the results of the TTIs screening. Poor storage practices compromise the standard of the results.
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National Baseline Survey – Evaluation of Blood Screening Systems
Donations Screened for TTIs No. of Samples Percentage Screened HIV I /II 1187784 100 Hepatitis B 1187784 100 Hepatitis c 1187784 100 Syphilis 3445 0.29 Chagas Disease 0 0 HTLV I / II 0 0 Malaria 522625 44
Table 4.13: Number and Percentage of Samples Screened
During one calendar year of reporting period (2011) about 1.1 million donations were collected in the blood centers surveyed (Table 4.13). All the donations were screened for HIV, Hepatitis B and C. Screening for Malaria and Syphilis was 44 and 0.29 percent respectively. Different types of test methods (e.g. rapid, ELISA) were used for screening of blood donations for TTIs.
Test methods used for TTI TTI Markers Simple Rapid Test ELISA Others HIV I /II 855745 332039 0 Hepatitis B 855745 332039 0 Hepatitis C 855745 332039 0 Syphilis 3445* 0 0 Chagas Disease 0 0 0 HTLV I / II 0 0 0 Malaria 39038 0 483587** Others 0 0 0
Table 4.14: Number of Samples tested by each Test Method for TTIs (* RPR, **Microscopy)
In the vast majority of the blood centers surveyed (72 percent) screening for the TTIs was usually done only for Hepatitis B, C and HIV and through manual rapid tests and also automated ELISA technique (Fig. 4.14). For malaria screening, 92% of the blood centers rely on direct microscopy which is a laborious technique and also time consuming. Syphilis is screened by the manual Rapid Plasma Reagin (RPR) technique.
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National Baseline Survey – Evaluation of Blood Screening Systems
HIV Hepatitis Hepatitis Chagas HTLV Type of Blood Centers Syphilis Malaria I and II B C Disease I and II
Private Sector Hospital 0 836 727 0 0 0 16 Based Blood Banks
Public Sector Hospital 46 18717 30759 0 0 0 671 Based Blood Banks
Stand Alone Blood Banks 93 1790 1839 0 0 0 27
Transfusion Centers 7 2072 3064 2 0 0 27
Total 146 23415 36389 02 0 0 741
Table 4.15: Number of reactive samples according to the Type of Blood Centers
The HIV prevalence among the donors in the blood centers surveyed was 0.012 percent (Tab. 4.15). The low prevalence of HIV among the blood donors screened is consistent with the national scenario where HIV is found to be restricted mainly among the high risk groups as a ‘concentrated epidemic’. However, until a few years ago, detection of HIV among a blood donor was very rare but now such cases are being detected with somewhat increasing frequency which is a source for concern especially for chronic transfusion recipients.
Hepatitis B and C prevalence among the donors of the blood centers surveyed was 1.97 percent, and 3.06 percent respectively. These findings are also consistent with the recent screening data published where the prevalence of Hepatitis B is lower than that of Hepatitis C. This is probably due to the introduction of the vaccination against Hepatitis B as part of the national EPI campaign and also its easy availability for the general public. The combined high prevalence of the two hepatitis infections means that a significant proportion of the blood collected is discarded with wastage of precious resources and effort.
Co-relating Tables 4.11, 4.14 and 4.15 for the detection of Malaria among the donors in the blood centers surveyed, it is evident that despite the high prevalence of malaria in the country and infection being endemic in parts of the country, the detection rate of the malarial parasite is very low (0.14 percent). The reason for this could be the utilization of the cumbersome and laborious direct microscopy technique for diagnosing malarial infection in addition to lack of trained technicians. The syphilis screening is performed in less than 3 percent of the blood centers screened. The technique used in most of the centers that screen for syphilis is Rapid Plasma Reagin (RPR). Very rarely were a few cases of syphilis detected.
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National Baseline Survey – Evaluation of Blood Screening Systems
HIV I Chagas HTLV I Province Hepatitis B Hepatitis C Syphilis Malaria and II Disease and II
AJK 0 746 541 0 0 0 43 Baluchistan 0 681 497 0 0 0 35 Isl. Capital Territory 0 405 582 0 0 0 23 FATA 0 1755 1187 0 0 0 47 Gilgit Baltistan 0 708 651 0 0 0 16 KPK 1 1838 1219 0 0 0 66 Punjab 90 12097 26475 0 0 0 458 Sindh 55 5185 5237 2 0 0 53 TOTAL 146 23415 36389 2 0 0 741
Table 4.16: Number of reactive samples in each Province
The overall national trend of Hepatitis C being more common compared to Hepatitis B was found in the two most populous provinces of Punjab and Sindh where almost 70 percent of the blood centers surveyed were located. The distribution of Hepatitis B and C in the other provinces is included in the Table 4.16 as is the malaria and syphilis prevalence.
The repeat testing of the initially positive samples is not a common practice in the blood centers surveyed. The samples of the donations tested positive initially are discarded. In some centers, on the request of the donors usually, repeat testing is performed. The blood centers usually do not share the results of the donor screening with the donors. As the donors are mostly the Replacement Family donors and their primary concern is to get the blood components for their patient and thus are usually not concerned to find out their own serological status. On the whole the blood centers as a routine do not conduct confirmatory testing of the reactive samples. Repeat testing of the borderline samples of the ELISA screening is conducted in the centers where ELISA screening is performed. Only scanty figures of routine repeat testing of the borderline / reactive testing thus available cannot be used for any meaningful analysis.
Most of the centers surveyed do not perform repeat testing and discard the initial reactive donations. The centers that do perform repeat testing (usually on the request of the donor) do it at the same centers. None of the centers surveyed sent the samples to other centers for reconfirmation. There is no national reference laboratory for blood transfusion.
The survey results indicate that none of the blood centers surveyed kept any record of the types of its blood donors. However, it is fairly well established that the pre- dominant reliance for blood donations in Pakistan is on the family members of the patients who require blood donations. According to WHO recommendations, the ‘Replacement Blood Donors’ are not the safest donors. So in the presence of a strong cultural practice of receiving blood donations from family members, the risk of acquiring infections is enhanced which is further compounded by quality systems ______60
National Baseline Survey – Evaluation of Blood Screening Systems which are far from ideal and where there is limited evaluation, validation and regulatory control over the availability of sub-standard cheap screening kits.
None of the blood centers surveyed have a policy of issuing blood for transfusion without ever screening it for TTIs first.
None of the blood centers surveyed archive frozen samples of donor plasma and look back studies are not in vogue in the blood centers surveyed.
7. Regulatory Management Environment
The findings of the survey confirm that the blood transfusion services in Pakistan are fragmented with insufficient regulatory oversight. There is limited interaction among the service providers functioning in the public, private and NGO sector in the country. This heterogeneous state of affairs poses serious risks of transmission of infections through transfusions and makes provision of quality service to a population of more than 180 million a serious challenge. Cognizant of these ground realities the Government of Pakistan, in 2008, initiated a process to reform the blood transfusion system. The reforms include the establishment of Blood Transfusion Programmes at the National and Provincial levels including the construction of new infrastructure.
The Safe Blood Transfusion Programme, co-funded by the governments of Germany and Pakistan at the Federal and Provincial levels are responsible for overseeing blood transfusion activities in Pakistan. The overall in charge of the Safe Blood Transfusion Programme is Prof. Hasan Abbas Zaheer, Project Director, SBTP. At present there is no designated National Quality Manager or National Blood Donor Programme Manager. These positions vacant at present and will be filled by 2014 when the new physical and management infrastructure of the Programme is complete.
The National Blood Donor Policy was formulated in 2011 through a national consultation participated by stakeholders and experts from all the regions of the country. In addition, international experts from some regional countries also participated and contributed in this exercise. The WHO provided Technical support through its EMRO and country offices.
A roadmap for the implementation of the envisaged reforms was formulated in 2010 in collaboration with the German partners, GiZ and KfW. The implementation on the Joint Implementation Work plan is proceeding despite financial, political and constitutional challenges.
Since 1997, blood safety legislations have been passed by various provincial assemblies. In 2012, the Safe Blood Transfusion Services Programme conducted an exercise to review all existing legislations in the country on blood safety. The Provincial Governments official Gazettes were examined for blood transfusion acts, laws and ordinances approved and published by the respective governments in the last fifteen years (1997-2012). A synoptical summary was prepared allowing a ______61
National Baseline Survey – Evaluation of Blood Screening Systems comparison of twenty three key concepts in these documents to the European directive.
A considerable degree of diversity between the provincial legislations and the current EU directives was found. The principal findings about current limitations were lack of haemovigilance, quality management, sector diversity, hospital interface, functional separation and considerable latitude in the financial penalties and physical imprisonment. The study resulted in proposing a new law which has been endorsed by all partners and is based on 2005 EU directive. The final draft is now being processed by the respective provincial health departments to be passed by the respective provincial assemblies. Once passed by all the assemblies, essentially the same blood safety legislation will be prevalent throughout the country.
The new law has been drafted with the objective to introduce more cohesion and uniformity in the regulation of quality standards for blood and blood products across the different federating units, which would then be more tuned with the new envisaged system. The proposed new legislation is consistent with modern concepts and trends in transfusion medicine and expected to bring a paradigm shift in the entire system. All the elements which were missing in the existing laws have been addressed including data management, haemovigilance, quality management and functional separation of services provided. In the current post-devolution institutional environment, the Programme is facilitating the passage and subsequent enactment of this law through a series of interventions. Advocacy sessions are directed at health authorities, legislators, policy makers and other important drivers in order to create a new momentum for the implementation of blood safety legislations. In addition to the adoption of new blood safety laws, the reform process includes the development of standards and guidelines, SOPs, quality manuals, introduction of new training modules and curricula and the creation of governance structures at administrative and operational levels.
The National Steering Committee of the Safe Blood Transfusion Programme is responsible for the policy development and decision making for blood transfusion. Similar Committees also exist at the provincial level. The Task Forces and Working Groups of these Committees have representations from a wide pool of national technical experts. All the partners work in close collaboration and harmony to implement the policy and technical decisions.
A National Reference Center Laboratory is planned to be constructed in Islamabad in the complex housing the secretariat of the Safe Blood Transfusion Programme, Islamabad Regional Blood Transfusion Center and the Islamabad Blood Transfusion Authority. The construction of this complex including the National Reference Laboratory for Blood Transfusion will be completed in 2014.
At present there are no plans or strategy to provide for fractionated plasma products. Fractionated products are not available for use in the country.
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The major international partner for blood safety initiative in Pakistan is the Government of Germany which supports the Safe Blood Transfusion Programme through its Technical Cooperation component funded by GiZ. The WHO also provides valuable technical assistance to SBTP through its WHO/OFID Joint Project for the Prevention of Transfusion-Transmitted HIV/AIDS and Hepatitis Infections in Priority Countries (Bangladesh, Bhutan, Nepal and Pakistan). The overall goal of the WHO/OFID Joint Project is to prevent TTIs through universal coverage and quality- assured testing of all donated blood. The WHO has also facilitated procurement for SBTP from USAID of two years support for the provision of HIV, Hepatitis B and C kits for the entire country.
The cost of producing a unit of whole blood / red cells in Pakistan is estimated to be about US$ 350.
The infrastructure of the new centrally coordinated blood transfusion system in Pakistan is being developed. In its first phase 13 Regional Blood Transfusion Centers are being constructed and 78 existing hospital based blood banks will be renovated and equipped. The development work supported by the KfW funded Financial Cooperation component will be completed by 2015. The population covered through the improved infrastructure would be in the range of 15 percent of the total national population. The recurrent cost of managing the new infrastructure is the responsibility of the federal and provincial governments, the funds to which have already been committed and approved. The budget covers all aspects of the transfusion service to ensure highest standards of service delivery. Some cost of the service provided is to be recovered from the patients keeping in mind that the blood components remain affordable to all the population.
In the second phase of the project, the coverage area will be extended by increasing the infrastructure development. The German partners have already confirmed the funding of the second phase which is likely to commence by the end of the current year. The first and second phase will run in parallel until the first phase is completed.
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Glossary
No Term Definition 1 Accreditation Accreditation is a formal process by which a recognized body, usually a non-governmental organization (NGO), assesses and recognizes that a health care organization meets applicable pre-determined and published standards. Accreditation is often a voluntary process in which organizations choose to participate, rather than one required by law and regulation. 2 Algorithm for TTI Document that defines the actual testing process. It includes clear testing statements on :
• Definition of screen non-reactive and decision points for the release of screen non-reactive donations
• Whether initially screen reactive tests should be repeated
• Fate of screen reactive donations
• Subsequent action to be taken with screen reactive donors
3 Apheresis Process by which one or more blood components is selectively obtained from a donor by withdrawing whole blood, separating it by centrifugation or filtration into its components, and returning those not required to the donor 4 Audit Systematic, independent and documented examination to determine whether activities comply with a planned and agreed quality system.
5 Blood bank A laboratory or part of a laboratory, within a hospital which receives and stores screened blood and components, performs compatibility testing and issues blood and components for clinical use. It may be called a hospital transfusion laboratory.
6 Blood centre A facility which carries out all or part of the activities for donor recruitment, blood collection (whole blood and, in some cases, apheresis), testing for transfusion-transmissible infections and blood groups, processing into blood components, storage, distribution to hospital blood banks within a defined region, and liaison with clinical services. Blood centers may be stand alone or hospital-based. The following should NOT be categorized as blood centers:
• Mobile or fixed blood collection sites/rooms which are operated as part of a blood centre
• Hospital blood bank which only stores, performs compatibility
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testing and issues compatible blood.
7 Blood cold chain The maintained storage and transportation of blood and blood components at the appropriate storage temperature and conditions from the point of collection to the point of use. 8 Blood component A separable part of whole blood obtained usually using centrifugation or filtration, e.g. red cells, platelet concentrates or fresh frozen plasma.
9 Blood donors Voluntary non-remunerated blood donor: An altruistic donor who gives blood freely and voluntarily without receiving money or any other form of payment.
Family/replacement blood donor: A donor who gives blood when it is required by a member of the patient’s family or community. This may involve a hidden paid donation system in which the donor is paid by the patient’s family.
Paid donor: A donor who gives blood for money or other form of payment.
Autologous donor: A patient who donates his/her blood to be stored and re-infused, if needed, during surgery. 10 Calibration The sect of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or valued represented by a material measure, and the corresponding known values of a reference standard 11 Contingency plan A form of risk management which involves the anticipation of problems that might occur and the preparation of protocols/plans that will be put in place should an event occur. 12 Cross-matched Donor whole blood or red cell components matched with the blood of blood the recipient.
13 District/first-referral A hospital at the first referral level that is responsible for a district or a level hospital: defined geographical area containing a defined population and governed by a politico-administrative organization such as a district health management team.
14 Donor suitability It is also called donor selection criteria. Criteria for the selection of criteria donors which are designed to ensure that the giving of blood will not harm either the donor or the recipient. 15 Evaluation The specific selection process to determine the suitability of a procedure or material (e.g. reagent, blood pack, equipment) 16 External quality A recognized scheme for organizing EQA. This can be a local scheme assessment scheme or organized at national, regional or international levels (EQAS) ______65
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17 External quality The external assessment of a laboratory’s performance using samples assessment(EQA) of known, but undisclosed, content and comparison with the performance of other laboratories. An external quality assessment scheme is a recognized scheme for organizing EQA. This can be a local scheme or may be organized at national, regional or international level. 18 Fractionated plasma Human plasma protein products prepared under pharmaceutical products: manufacturing conditions. Plasma products include albumin, immunoglobulin and coagulation factors VIII and IX. 19 Job description A statement of the duties and working conditions for a particular job. It defines the job holder's authority and responsibility within the organization as well as the skills, abilities, qualifications and experiences required for the job. 20 Haemovigilance The monitoring, reporting and investigation of adverse incidents/near- misses related to all blood transfusion activities. 21 Inventory A systematic listing of stock (or assets) held. An annual inventory is prepared at the end of each year following a physical inspection and count of all items owned by an organization. The list gives details, such as location, reference number, description, condition, cost and the date the inventory was taken. 22 Licensure Licensure is a process by which a governmental authority grants permission to an individual practitioner or health care organization to operate or to engage in an occupation or profession. Licensure regulations are generally established to ensure that an organization or individual meets minimum standards to protect public health and safety. Organizational licensure is granted following an on-site inspection to determine if minimum health and safety standards have been met. Maintenance of licensure is an ongoing requirement for the health care organization to continue to operate and care for patients. 23 Maximum surgical A guide to expected normal blood usage for elective surgical blood ordering procedures which lists the number of units of blood to be routinely schedule (MSBOS): cross-matched or grouped, screened and held for each procedure preoperatively. 24 NAT Nucleic acid testing. 25 National blood A programme under the Ministry of Health with overall responsibility programme: for the planning, implementation and monitoring of all activities related to blood transfusion throughout the country. Responsibility for the implementation of the blood programme may be fully or partially delegated to a governmental or non-governmental organization designated as the national blood transfusion service.
26 National blood The highest policy formulation and decision-making body under the authority/commissio Ministry of Health for issues pertaining to blood transfusion services n in the country. All major stakeholders in the blood transfusion process are usually represented in this authority. May also be referred to as ______66
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National Blood Committee or National Blood Council.
27 National blood A statement of intent by the Ministry of Health that defines the policy: organizational, financial and legal measures that will be taken to ensure the quality, safety, availability and accessibility of blood transfusion within the country.
28 National blood A structured series of steps that provide a pathway for the national strategy or strategic blood programme to achieve its policy objectives. plan:
29 National/Regional/P A centre which carries out donor recruitment, blood collection (whole rovincial Blood blood and, in some cases, apheresis), testing for transfusion- Centre transmissible infections and blood groups, processing into blood components, storage, distribution to other blood centers and hospital blood banks within a defined region, and liaison with clinical services. Blood centers usually operate at national and regional/provincial level as part of the National Blood Transfusion Service. 30 National clinical A national committee that receives reports from hospital transfusion transfusion committees, collates national information on transfusion activity, and committee: may determine national guidelines for clinical transfusion practice. The NCTC may also have a role in liaison with educational institutions and the preparation of educational materials. 31 (National) expert A (national) panel of experts in blood transfusion medicine and/or panel: science that meets on a regular basis to advice on matters associated with the safety, sufficiency and quality of blood transfusion.
32 Organizational Orderly arrangement of responsibilities, authorities and relationships structure between people – ISO 9000 (2000)
33 Policy A high-level overall document embracing the general goals and intentions of an organization
33 Post-donation Private face-to-face counseling at which HIV test results and other counseling types of information are given. When bad news is being given, counseling aims to give the donor enough time to ask questions, to help with immediate practical and emotional impact f the result and to offer options for extended follow-up and care (including for loved ones and family) by appropriate referral to complementary organizations and facilities. Because of the possible need to recognize and manage acute psychological reactions in the post-donation phase, this service should be provided only by staff specifically trained in counseling.
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34 Pre-donation The counseling provided to potential donors in privacy before blood is counseling taken. It usually involves an explanation of the test of HIV and other transfusion transmissible infections; the possible consequences of learning one is infected, the need to stay uninfected if one is currently uninfected; encouragement to self-defer to an alternative counseling and testing sites if there is a recent risk history and the potential donor wants a test; information on how test results can be received and securing informed consent to proceed with donation (and testing) if appropriate. 35 Pre-donation Written or oral information given to potential donors, usually groups, information by recruiting teams some time before the donation. Information may also be given by teachers, educators and mass media, and includes discussion of the need for regular, safe donations; the fact that blood is tested for HIV, what HIV is and how it may be avoided; the possible consequences of learning that one has HIV; procedures for confidentiality in information management; and where to go if a potential donor requires a test for HIV. 36 Processed blood Blood that has been processed into components. Generally refers to the red cell component. The essential tests may or may not have been done. 37 Procurement The process of obtaining good and services in any way, such as through purchase, donation, loan or hire.
38 Quality Totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs; Ability of a set of inherent characteristics of a product, system or process to fulfill requirements of customers and other interested parties 39 Quality assurance The overall range of activities and systems that provide confidence within the organization and authorities that all quality requirements are met; as part of the overall quality management programme, the range of activities and systems that provide confidence within the organization and for the authorities that all quality requirements are met. 40 Quality control Checks put in place to ensure that processes, procedures and products meet the quality requirements; Part of quality management focused on fulfilling quality requirements 41 Quality department The identified and authorized department within an organization responsible for the overall development, organization and management of quality and quality systems. 42 Quality Coordinated activities to direct and control an organization with management regard to quality
43 Quality System to establish a quality policy and quality objectives and to management system achieve those objectives
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44 Quality manager The appointed, responsible and authorized individual within an organization with the responsibility for developing and managing the quality system 45 Quality officer An individual who works within the quality department of an organization and who is primarily concerned with the day-to-day operation and maintenance of the quality system 46 Quality policy 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.
47 Quality system Organizational structure, processes, procedures and resources needed to implement quality requirements.
48 Quarantine(2) To place in isolation. For example, unprocessed blood is kept in isolation (not accessible for use) until all essential tests are completed.
59 Record Document stating results achieved or providing evidence of activities performed – ISO 9000 (2000).
50 Release Authorization to proceed to next stage of a process – ISO 9000 (2000).
51 Serious adverse A case where the patient is transfused with a blood component that incident: did not meet all the requirements for a suitable transfusion for that patient, or was intended for another patient and that might lead to death or a life-threatening, disabling or incapacitating condition or which results in, or prolongs, hospitalization or morbidity.
A serious adverse incident may be due to transfusion errors, deviations from standard operating procedures or hospital policies that have led to mistransfusion. It may or may not lead to an adverse reaction.
52 Serious adverse An undesirable response or effect in a patient associated with the reaction: administration of blood or blood component that is fatal, life- threatening, disabling or incapacitating or which results in, or prolongs, hospitalization or morbidity.
53 Specification Document stating requirements – ISO 9000 (2000)
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54 Standard Minimum level required
55 Standard Operating Written instructions for the performance of a specific procedure. Procedure (SOP)
56 Traceability The ability to follow the history of a product or service by means of recorded identification. 57 Unprocessed (pre- Donated blood that has not been processed into components, i.e., processed) blood whole blood received from a donor. The essential tests have not yet been carried out. 58 Validation That part of a QA system that evaluates in advance the steps involved in operational procedures or product preparation to ensure quality, effectiveness and reliability (GMP); confirmation and provision of objective evidence that the requirements for a specific intended use or application have been fulfilled
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VI. Annexes
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Annex I. Evaluation and Survey Tools
General information about the Centre
Name of the Centre ______
Address ______
City/District/Province ______
Name of officer in-charge ______
Designation ______
E-mail: ______Telephone ______
Fax ______Cell ______
Date of report ______
Reporting period: From ______To ______
Type of blood centre
Public Sector Hospital Based Blood Banks Private Sector Hospital Based Blood Banks Stand Alone Blood Banks Transfusion Centers Misc. Quasi Legal Blood Banks
The number of hospitals served by the blood centre: ______
Name of the hospitals served: ______
The estimated population size served by the blood centre: ______
Geographic area of the country covered: ______
Is the centre registered/ licensed? ______72
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Yes No
If yes, under what national body/ authority/ agency is the centre registered /licensed? ______
Is the centre inspected for the purpose of registration / license? Yes No
If yes,
When was the last inspection carried out? ______Date/month/year
Organization and Management
Under which management responsibility does the blood centre operate (please tick):
[1] Government
[2] Non-governmental organizations
[3]Commercial (for profit) organizations
What type of facility does the centre belong to? (please tick)
[1]Standard alone blood centre [2]Hospital based blood centre [3]Hospital based blood bank (as part of the laboratory) [4] Transfusion Center
[5] Misc. Quasi Legal Blood Banks
Has the blood centre delegated/outsourced any of its functions to another organization? Yes No
If yes, is there a formal contract /agreement/Memorandum of Understanding (MoU) signed between parties involved? Yes No
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Name of the organization : ______Role of the organization : ______
Is there any national/ international source supporting the blood centre? Yes No
If yes, [1] Technical (please specify names):______[2] Financial (please specify names):______
What is the total annual O&M cost of the blood centre?
[1]What is the total annual cost of operating for donor recruitment and blood collection ______Local currency/ USD
[2]What is the total annual cost of operating for testing, processing, storage and distribution? ______Local currency/ USD [3] What is the total annual cost for staffing? ______Local currency/ USD
Any other expenses including overhead? Yes No
If yes, what are the total annual overhead costs? ______
Please provide the information on the funding for operations of the blood centre in the current budget year.
[1] Percentage of funding from the government: _____% [2] Percentage of funding from the non-governmental organization: _____% [3] Percentage of funding from fees and/ or cost recovery: _____% [4] Percentage of funding from the external donors: _____%
Blood Screening Infrastructure
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1. Buildings
Is the centre located separately or part of the pathology department ______
______
Does the centre have suitable premises for:
Yes No
[1]Donor selection
[2]Blood collection
[3]Blood processing and testing
[4]Storage and distributing Does the centre have access to:
Yes No
[1]Continuous water supply
[2]Power supply
What is the duration of electricity power cuts per day ______
Is emergency power generation available ______
Is electricity supply and backup generator sufficient to ensure that products can be safely maintained at their storage temperature ______
[3]Transportation system
[4] telephone
[5]fax
[6]internet
2. Equipment
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Equipment Number Number Number expected available functioning
Donor beds/couches
Tube sealers
Container for safe disposal of sharps Vehicles for outdoor donor sessions Electronic balance
Laboratory bench top centrifuge for separation of samples Micro plate shaker
Cell washer centrifuge
Binocular microscopes
ELISA plate washers
ELISA plate reader
Automatic pipette
Automated sample processor Laboratory thermometers pH Meter
Autoclaves
Water bath
Incubators
Hot Air ovens
Blood bag mixer
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Equipment necessary for producing chemically pure and /or pyrogen-free water (e.g. still; deionizer ) Blood bank refrigerator
Refrigerated centrifuges Plasma freezer –300C
Deep freezer -80 C
Laminar Airflow cabinet Platelet incubator and shaker Plasma extractors
Plasma thawer
Cryoprecipitate bath (40C) Blood transportation box Voltage stabilizers
PC with accessories and software
3. Consumable Items
Is there a system of stock control for the critical supplies? Yes No
Have any of following supplies run out in the last 12 months? Yes No
(Please tick and indicate number of days affected with-out supply)
Item No Yes If yes, please
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indicate number of days [1]Blood bags [2]TTI kits [3] Blood Grouping Reagents [4]Others (Pl. specify)
Blood Screening Technical Capacity
Does the centre have a quality policy?
Yes No
Does the centre have an organizational structure indicating authority, responsibility and reporting relationships?
Yes No
If yes, please provide a copy of the organogram.
Does the center have dedicated staff or is it shared with the pathology department ______
______
Is it mandatory for all centre staff to be vaccinated for Hepatitis B: Yes No
Is the past history of all centre staff to any exposure to TTIs maintained Yes No
Are there written job descriptions for all positions within the organization?
Yes No
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Has the centre appointed a person responsible for quality management?
Yes No
Does the centre have Standard Operating Procedures (SOPs) or local written instructions for following area of the centre? (Please tick as appropriate)
Yes No
[1]Blood donors recruitment
[2]Blood donors selection
[3]Blood collection and donor care
[4]Blood component preparation
[5]Screening for TTI
[6]Blood group serology
[7]Blood storage and transportation
[8]Waste management
[9]Others (Specify) Do the centre maintain records of the following: (Please tick as appropriate)
Yes No
[1]Blood donors recruitment
[2]Blood donors selection
[3]Blood collection and donor care
[4]Blood component preparation
[5]Screening for TTI
[6]Blood group serology
[7]Blood storage and transportation
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[8]Waste management
[9]Others (Specify)
Has the centre designated a person responsible for the data management?
Yes No
Does the centre have a system of internal quality audit?
Yes No
Is the centre accredited?
Yes No
15.1 If yes, please indicate against what standard is the centre accredited? ______
15.2 By which agencies is the centre accredited? ______
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 training International number training course/workshop training of staff course/workshop [1]Medical officers [2]Nurses [3]Blood donor recruiters [4]Laboratory technologist [5] Administrative and support staff
Does the centre have adequate staff for its operations?
Procurement of Consumables/Equipment
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Does the centre have adequate equipment for its work?1 Yes No
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) Do you provide staff training of the use of equipment? Yes No
Does the centre have a programme for equipment maintenance? Yes No
How key supplies2 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] Validated at the centre?
Is there a system of stock control for the critical supplies? Yes No
2 Key supplies include blood bags, TTI test kits, blood group serology reagents, etc. ______81
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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)
Screening for Transfusion Transmissible Infections
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Does the centre screen the donated blood for following TTIs (please tick)?
Screening for Yes No HIV I and II Hepatitis B Hepatitis C Syphilis Chagas Disease HTLV I/II Malaria Others, specify______
Note: 1) If your answer to all the above is "No", skip all questions of section "C". 2) If your answer to any of the above is "Yes", please answer all relevant questions on that screening test.
Does the centre have an algorithm for screening donated blood for transfusion transmissible infections?
Yes No
2.1 If yes, please provide a more detailed description of the algorithm
Is internal quality control (IQC) samples used in each run in order to validate the test run?
Yes No
Does the centre participate in an external quality assessment scheme (EQAS) for TTI testing? Yes No
4.1 If yes, in which area and at which level does the centre participate in EQAS? Please tick:
Level HIV I HBV HCV Syphilis Chagas HTLV Malaria Other, and II disease I/ II specify International National Regional/ provincial Local
Are test kits/reagents and samples stored in temperature-monitored equipment?
Yes No
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[1]Test kits/ Regents
[2]Samples [1] Please indicate the number and percentage of donations screened for transfusion transmissible infections (TTIs) during the reporting period.
TTI markers Number of donations screened % [1] HIV I and II [2]Hepatitis B [3]Hepatitis C [4]Syphilis [5]Chagas disease [6]Malaria [7]HTLV I/II
Are different types of test methods (such as simple/Rapid and ELISA methods) used for the screening of blood donations for TTIs?
Yes No
7.1 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 by the Infection different method markers Simple/Rapid Test ELISA Other, specify Used? No. Used? No. Used? No. [1]HIV I/II [2]Hepatiti s B [3]Hepatiti s C [4]Syphilis [5]Chagas Disease [6]HTLVI/ II [7]Malaria [8]Others, specify
[1] Please indicate the number of donations that were reactive in the screening test. TTI markers Screening test reactive No of initial reactive Number of repeat reactive (IR) (RR) [1]HIV I/II [2]Hepatitis B [3]Hepatitis C [4]Syphilis
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[5]Chagas Disease [6]HTLVI/II [7]Malaria
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.
TTI markers Reactive results confirmed? Confirmatory test positive Yes No Number % [1]HIV I/II [2]Hepatitis B [3]Hepatitis C [4]Syphilis [5]Chagas Disease [6]HTLVI/II [7]Malaria
Does the centre keep records of screening tests performed for TTI marker, by type of donations?
Yes No
8.1 If yes, please complete the following table and indicate the total number of donations tested and number of donations found to be positive for TTI markers for different types of donors:
Marker Voluntary non- Family Replacement Paid donors remunerated donors Donors No. of No found No. of No found No. of donations No found donations positive/RR donations positive/RR tested Positive/RR tested tested [1]HIV I/II [2]Hepatitis B [3]Hepatitis C [4]Syphilis [5]Chagas Disease [6] HTLVI/II [7]Malaria [8]Others, specify
Does the centre keep records of screening tests performed for TTI marker by different type of voluntary non-remunerated donations? Yes No
11.1 If yes, please complete the following table and indicate the total number of donations tested and number of donations found to be reactive for TTI markers for different types of voluntary non- remunerated donors: Voluntary non-remunerated donors New Donors Repeat Donors ______85
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Marker No. of donations tested No found No. of No found positive/RR donations tested positive/RR [1]HIV I/II [2]Hepatitis B [3]Hepatitis C [4]Syphilis [5]Chagas Disease [6]HTLVI/II [7]Malaria [8]Others, specify
Is blood ever issued without screening for the transfusion transmissible infections that was required by the policy?
Yes No
12.1 If yes, please complete the following table and provide the numbers and major reason(s) responsible for that?
Reasons (Tick as appropriate) Numbers Marker Test kits/reagents Emergency Others, not available specify [1]HIV I/II [2]Hepatitis B [3]Hepatitis C [4]Syphilis [5]Chagas Disease [6]HTLV [7]Malaria [8]Others, specify
Does the centre archive frozen samples of donor plasma?
Yes No
10.1 Are these used for look-back studies?
Yes No
Regulatory Management Environment
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Is there a unit within the relevant Ministry (or other government department) with responsibility for overseeing blood transfusion activity?
If yes, name of the unit: ______
Name of the officer in charge______Is there a designated national blood program manager? Is a national quality manager/officer nominated Is a national blood donor programme manager/officer nominated? Is there a national blood policy?
If yes, Year of adoption______
Please obtain a copy Is there a national strategy or strategic plan?
If yes, has its implementation been initiated? Is there specific national legislation covering safety and quality of blood transfusion?
If yes, obtain the document reference number and a copy. Has the relevant Ministry 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. Are there (national) expert panel (s) to advice on technical and medical issues related to transfusion safety, availability and quality? Is there a national reference centre? (Is there a national blood transfusion service?)?
If yes, what was the year of its establishment? ___ 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)------Is there a national strategy for the provision of fractionated plasma products?
Please indicate how fractionated plasma products are supplied in the country? Please tick.
[1] Importing from abroad
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[2] Fractionation in-country by the public (not-for-profit) sector
[3] Contract fractionation by a profit making organization
[4] Other, specify Does any international agency/organization/institution provide technical support to blood centre/blood transfusion services
If yes, name of the agency______Does any international agency/organization/institution provide financial support to blood centre/blood transfusion services
If yes, name of the agency______What is the appropriate cost (in US dollars) of producing a unit of whole blood/red blood cells (including donor recruitment, collection, testing, processing, storage and distribution)? Is a specific budget provided for the national blood programme?
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 Is there a national cost recovery policy/system for the blood centre/blood transfusion services?
If yes, obtain detailed information. National standards and guidelines 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
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[6]Testing of Blood donated for TTIs
[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 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
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Annex II: List of Blood Centers Surveyed
Center Name City
1 A.H.Q Hospital SWA Wana
2 A.H.Q.H Parachinar
3 Abbottonians Medical Association Abbottabad
4 Agha Khan Medical Centre Ghizer
5 AHQH Kurram Agency
6 AHQH North Waristan Agency Miran Shah
7 AJK Central Blood Transfusion Service AIMS Muzafarabad
8 Al Mehboob Blood Bank Barkhan
9 Al Sheikh Bin Zayed Hospital Muzafarabad
10 Ali Zaib Blood Transfusion Services Faisalabad
11 Al-Shifa Blood Bank Mirpur
12 Bahawalpur Victoria Hospital Bahawalpur
13 Benazir Bhutto Hospital Rawalpindi
14 BINO Cancer Hospital Bahawalpur
15 Blood Bank Jinnah Post Graduate Medical Centre Karachi
16 Blood Bank Nishtar Hospital Multan
17 Blood Bank Services Ahmed Medical Center Rawalpindi
18 Blood Bank Services-Bilal Hospital Rawalpindi
19 Blood Bank Services-MEDICSi Islamabad
20 Blood Transfusion Services, Lyari General Hospital Karachi
21 Blood Unit (Emergency) Mayo Hospital Lahore
22 Blood Unit Sir Ganga Ram Hospital Lahore
23 Blood Unit(Main) Mayo Hospital Lahore
24 Blood Unit, Jinnah Hospital Lahore
25 Blood Unit, Allied Hospital Faisalabad
26 Blood Unit, Govt. Kot Khawaja Saeed Hospital, DHQ-II Lahore
27 Blood Unit, Govt. Mian Munshi Hospital Lahore ______90
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28 Blood Unit, Lady Aitchison Hospital Lahore
29 Blood Unit, Lady Willingdon Hospital Lahore
30 Blood Unit, Punjab Institute of Cardiology Lahore
31 Blood Unit, Services Hospital Lahore
32 Blood Unit,Govt. Mian Nawaz Sharif Hospital, Yakki Gate Lahore
33 Bolan Medical Complex Quetta
34 Burhani Blood bank and Thalasseamia Centre Karachi
35 Burhani Blood bank and Welfare Association Rawalpindi
36 CH Kalaya-Type-D Kalaya Orakzai
37 CITI Lab and Blood Bank Layyah
38 Civil Hospital Multan
39 Civil Hospital Badin
40 Civil Hospital Khairpur
41 Civil Hospital Mirpurkhas
42 Civil Hospital Tando Allahyar
43 Civil Hospital Chaman
44 Civil Hospital Dadu
45 Civil Hospital Jacobabad
46 Civil Hospital Mastung
47 Civil Hospital Mithi
48 Civil Hospital Naushero Feroz
49 Civil Hospital Pishin
50 Civil Hospital Sanghar
51 Civil Hospital Tando M.Khan
52 Civil Hospital Thatta
53 Civil Hospital Zarghukhel
54 Civil Hospital Darazinda Dera Ismail Khan
55 Civil Hospital Karachi
56 Civil Hospital Jandola Tank
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National Baseline Survey – Evaluation of Blood Screening Systems
57 Civil Hospital Mirpur Mathelo Ghotki
58 CMC Hospital Larkana
59 CMH Muzafarabad
60 CMH Rawalakot
61 CPE Cardiology Hospital Multan
62 DHQ Bhimber
63 DHQ Hattian Bala
64 DHQ Hospital Rawalpindi
65 DHQ Hospital Kamber
66 DHQ Hospital Umarkot
67 DHQ Hospital Lakki Marwat
68 DHQ Hospital Neelum
69 DHQ Hospital Sudhnoti
70 DHQ Hospital Kandhkot
71 DHQ Hospital Kotli
72 DHQ Hospital Bagh
73 DHQ Hospital Gilgit
74 DHQ Hospital Khanewal
75 DHQ Hospital Lodhran
76 DHQ Hospital Muzaffargarh
77 DHQ Hospital Skardu
78 DHQ Hospital Chilas Gilgit
79 DHQ Hospital Ghanche Gilgit
80 DHQ Hospital Ghotki Sukkur
81 DHQ Hospital, Mirpur
82 DHQ(T) Hospital Dera Ismail Khan
83 District Blood Unit Sheikh Zaid Hospital Rahim Yar Khan
84 District Blood Unit BV Hospital Bahawalpur
85 District Blood Unit, DHQ Hospital Faisalabad
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National Baseline Survey – Evaluation of Blood Screening Systems
86 District Hilal – e – Ahmer Hyderabad
87 F.G Ploy Clinic Hospital Islamabad
88 Fatimid Foundation Karachi
89 Fatimid Foundation Karachi
90 Female Jubilee Hospital Bahawalpur
91 FJ Chest and Central Hospital Quetta
92 Frontier Foundation Peshawar
93 Gen Mushtaq Baig Memorial Hospital Chakwal
94 GMC Hospital Khanpur Khanpur
95 Government Maternity Hospital Peshawar
96 Govt Nasirullah Babar Memorial Hospital Peshawar
97 Haidri Blood Bank and Welfare Society Parachinar Hamza Foundation Welfare Hospital & Blood Transfusion 98 Peshawar Services 99 Hayatabad Medical Complex Peshawar
100 Hayatabad Medical Complex, Peshawar Peshawar
101 Holy Family Hospital, Rawalpindi Rawalpindi
102 Husaini Blood Bank (Soldier Bazar) Karachi
103 Husaini Blood Bank (Nazimabad) Karachi
104 Husaini Blood Bank (Dadan Shah Road) Hyderabad
105 Husaini Blood Bank (North Nazimabad) Karachi
106 Husaini Blood Bank Jacobabad
107 Husaini Blood Bank Lahore
108 Husaini Blood Bank (Main Sharae Faisal) Karachi
109 Husaini Blood Bank (Sukkur Road) Shikarpur
110 Husaini Blood Bank (Clifton) Karachi
111 Husaini Blood Bank (Mehmoodabad) Karachi
112 Husaini Blood Bank (Godra) Karachi
113 Husaini Blood Bank (Chand Bibi Road) Karachi
114 Husaini Blood Bank (Dhoraji Colony) Karachi
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National Baseline Survey – Evaluation of Blood Screening Systems
115 Husaini Blood Bank (Shaheed-e-Millat Road) Karachi
116 Husaini Blood Bank (Korangi SITE Area) Karachi
117 Husaini Blood Bank (Garden Road) Karachi
118 Husaini Blood Bank (Korangi Colony) Karachi
119 Husaini Blood Bank (Kharadar) Karachi
120 Husaini Blood Bank (Gulshan-e-Iqbal) Karachi
121 Husaini Blood Bank (City Branch) Hyderabad
122 Husaini Blood Bank (New Karachi) Karachi
123 Husaini Blood Bank (City Branch) Shikarpur
124 Husaini Blood Bank Thatta
125 Husaini Blood Bank Jacobabad
126 Husaini Blood Bank (Gulshan-e-Maymar) Karachi
127 Husaini Blood Bank Badin
128 Institute of Blood Transfusion Service Lahore
129 Institute of Kidney Diseases Peshawar
130 Institute of Medical Sciences Shahdapur
131 Jamila Sultana Foundation Thalassaemia Centre Rawalpindi
132 Kashif Iqbal Thalassaemia Care Karachi
133 Khyber Teaching Hospital Peshawar
134 Kulsum International Hospital, Islamabad Islamabad
135 Lady Reading Hospital Peshawar
136 Lahore General Hospital. Lahore
137 Liaquat National Hospital Karachi
138 Mehran Clinical Lab and Blood Bank, Rajana T.T Singh
139 Muhammadi Blood Bank (F.B. Area Branch) Karachi
140 Muhammadi Blood Bank (Head Office) Karachi
141 Muhammadi Blood Bank (Korangi Branch) Karachi
142 Muhammadi Blood Bank (NICVD Branch) Karachi
143 Nishtar Hospital Multan
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National Baseline Survey – Evaluation of Blood Screening Systems
144 Pakista Institute of Medical Sciences (PIMS) Islamabad
145 Pakistan Thalasseamia Welfare Society Rawalpindi
146 Pakistan Red Crescent Society Rawalpindi
147 Pir Baqadar Shah Taluka Hospital Matiari
148 PWA Voluntary Blood Bank Karachi
149 RBUT Civil Hospital Shikarpur
150 Sindh Government Hospital, Ibrahim Hydri, Karachi Karachi
151 Sindh Government Hospital, Korangi, Karachi Karachi
152 Sindh Government Hospital, Liaquatabad Karachi
153 Sindh Government Hospital, New Karachi Karachi
154 Sindh Govt Hospital Qasimabad Hyderabad
155 Sindh Govt Hospital, Saudabad Karachi
156 Sindh Govt Lyari General Hospital Karachi
157 Sindh Govt Qatar Hospital Karachi
158 Sindh Govt Shah Bhitai Hospital Hyderabad
159 Sundas Foundation Sialkot
160 Sundas Foundation Faisalabad
161 Sundas Foundation Mirpur
162 Sundas Foundation Lahore
163 Sundas Foundation Gujranwala
164 Sundas Foundation Daska
165 Sundas Foundation Gujrat
166 THQ Hospital Ahmedpur East
167 THQ Hospital Kabirwwala
168 THQ Hospital Hangu Kohat
169 THQ Hospital Yazman Bahawalpur
170 Waqar Clinical Lab and Blood Bank Services, Kamalia Toba Tek Singh
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