who - national baseline survey · survey – evaluation of blood screening systems’ to the sbtp....

National Baseline Survey – Evaluation of Blood Screening Systems

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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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List of Abbreviations

AFIP Armed Forces Institute of Pathology

AJK

EQAS

Azad Jammu & Kashmir

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

HRA

Higher Education Commission

Health Regulatory Authority

IBTA ICT IQC KFW KPK MIS OFID PBTA PD PNCA RPR SBTA SBTP TME TTIs

Islamabad Blood Transfusion Authority Islamabad Capital territory Internal Quality Control German Cooperation Bank Khyber Pakhtun Khwa (formerly NWFP province) Management Information System OPEC Fund for International Development Punjab Blood Transfusion Authority Project Director Pakistan National Accreditation Council Rapid Plasma Reagin Sindh Blood Transfusion Authority Sindh Blood Transfusion Programme Time Monitored Equipment Transfusion Transmissible Infections

WHO World Health Organization


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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


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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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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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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


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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


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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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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


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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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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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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.


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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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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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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


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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


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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


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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.


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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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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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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.


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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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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.


____________________________________________________________________________24

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.


____________________________________________________________________________25

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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IV. Detailed Quantitative Findings

1. General Information

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

13 6 4 8 5 14

5169

170

020406080

100120140160180

Province wise distribution of total Blood Centers Surveyed


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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.

Figure 4.2: Type of Blood Centers Surveyed

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

8

107

36

19

0

20

40

60

80

100

120

1

Type of Blood Centers Surveyed

Private Sector Blood Banks

Public Sector Blood Banks

Stand Alone Blood Banks

Blood Transfusion Centers

18132

880

137

0

200

400

600

800

1000

Private Sector Hospital Based

Blood Banks

Public Sector Hospital Based

Blood Banks



Hospitals Served by Type of Blood Centers


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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.

Figure 4.4: Percentage of Licensed/Inspected Blood Centers

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

Licensed/Inspected

62%

Unlicensed/ Uninspected

38%

Licensed/Inspected Vs Unlicensed/Uninspected Blood

Centers

4 0 4 0 0 315

54

1 0 0 0 0 2 8 15

0102030405060

Blood Centers Licensed/Inspected in each Province

Licensed Inspected for License


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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


____________________________________________________________________________30

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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Figure 4.6: Type of Management of Blood Centers

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

8

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40

60

80

100

120

1


Private Sector Blood Banks




0 0 0 0 0 0 0 0

11

52

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34 33

2 1 20 1

3

17

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40Private and Public Sector Blood

Centers in Provinces

Commercial

Govt.

NGO


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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.

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.

5%

63%

21%

11%


Hospital Based Blood Banks (as a part of lab)

Hospital Based Blood Banks

Blood Transfusion Centers Stand Alone Blood Centers


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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.

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

23

147

Respondent Blood Centers with Seperate Costing Heads

Respondents

No Response


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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).

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.

12

7

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6

8

10

12

14


Blood Banks


Blood Banks


Transfusion Centres

Breakdown of 23 Respondents


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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.

Figure 4.12: Province-wise Distribution of Blood Centers as part of Pathology Departments

Blood Centers as part of Path.

Dept. 108

Others 62

Blood Centers as Part of Pathology Departments

11

52

84

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34 33

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40Blood Centers as part of Pathology Departments


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Blood Banks


Blood Banks Stand Alone Blood Banks

Transfusion 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 & testing

1 7 8 99 0 36 2 16

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.

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

95.9

4.1

97.1

2.90

20

40

60

80

100

120

Yes % No%

Water and Power Connection

Continuous Water Supply

Power Supply


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back up generation facilities as part of a critical function in overall health care services provided by the hospitals.

Figure 4.14: Duration of Power Outages at Blood Centers

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

0-4 hrs23%

5-8 hrs50%

9-12 hrs25%

13-16 hrs1%

17-20 hrs1%

Power Cuts / day

96.584.1

12.4

020

406080

100

120

Is emergency power system available?

Electriciy supply and backup generator

sufficient?

Emergency Power System not sufficient

Percentage Availability /Sufficiency of Power Systems


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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 Hospital Based Blood Centers

Public Sector Hospital Based Blood Centers

Stand Alone Blood

Centers

Transfusion 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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Equipment Availability (%)

Functional (%)

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 pure/or pyrogen-free water e.g. distill; deionizer

30.6 100

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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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).

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.

84.7

15.3

System of Stock Controls for Critical Supplies

Yes%

No%

10.0 7.6 5.3 4.1

90.0 92.4 94.7 95.9

0.0

20.0

40.0

60.0

80.0

100.0

120.0

Supply ran out in last 12 months?

Blood Bags ran out?

TTI Kits ran out?

Blood grouping reagents ran

out?

Critical Supplies in Last 12 Months

Yes%

No%


____________________________________________________________________________41

4. Blood Screening Technical Capacity

Figure 4.19: Blood Centers with a Quality Policy

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.

9971

Blood Centers with a Quality Policy

Quality Policy

Without Quality Policy

1

48

1 17

59

35

18

0

10

20

30

40

50

60

70


Blood Banks


Blood Banks


Transfusion Centres

Blood Centers have quality policy?

No

Yes


____________________________________________________________________________42

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

80 1 1 2 3

28 28

5 6 3 7 311

23

41

05

1015202530354045

Province-wise Distrubtion of Blood Centers with a Quality Policy

No

Yes


____________________________________________________________________________43

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 Availability

Private Sector Blood

Bank

Public Sector Blood

Banks


Blood Transfusion

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


____________________________________________________________________________44

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.

Private Sector Blood Bank





Blood donors recruitment 7 1 98 9 35 1 17 2

Blood donors selection 8 0 95 12 36 0 16 3

Blood collection & donor care

8 0 98 9 34 2 19 0

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


____________________________________________________________________________45

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).

Figure 4.23: Availability of Data Management Personnel According to the Type of Blood Center

52.447.6

Designated Person for Data Management

YesNo

1

48

2 07

59

3419

010203040506070


Blood Banks


Blood Banks


Transfusion Centres

Type of Blood Center

Designated Person for Data Management According to Type of

Blood Center?

No

Yes


____________________________________________________________________________46

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.

Figure 4.25: Internal Quality Audit System in Blood Centers

7 5 3 7 4 929

176 1 1 1 1 5

22

52

0102030405060

AJK

Balu

chis

tan

Capi

tal T

errit

ory

FATA

Gilg

it-Ba

ltist

an KPK

Punj

ab

Sind

h

Province

Province-wise Distribution of Data Management Personnel?

No

Yes

57.1

42.9

System of Internal Quality Audit

Yes

No


____________________________________________________________________________47

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.

Figure 4.27: Presence of Internal Quality Audit System According to the Provinces

4

62

3 44

4533

15

010203040506070


Blood Banks


Blood Banks


Transfusion Centres


Internal Quality Audit System inType of Blood Centers

No

Yes

6 5 3 7 5 10 16 217 1 1 1 0 4

3548

0102030405060

AJK

BALO

CHIS

TAN

Capi

tal T

errit

ory

FATA

GIL

GIT

BA

LTIS

TAN

KPK

PUN

JAB

SIN

DH

Province

Province-wise Distribution of Internal Audit System

No

Yes


____________________________________________________________________________48

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.


____________________________________________________________________________49

5. Procurement of Consumables’/Equipment

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.

Figure 4.29: Modes of Procurement of Equipment

Yes90%

No10 %

Centres with Adequate Equipment

30.6

70.6

12.9

69.4

29.4

87.1

0102030405060708090

100

Purchased locally by the centre

Purchased centrally or through upper

level agencies

Donated by international development

agencies/donor countries

Yes%

No%


____________________________________________________________________________50

Private Sector Blood Bank



Blood Transfusion

Centers


Purchased locally at the center?

6 2 2 105 29 7 15 4

Purchased centrally or through upper level agencies

2 6 107 0 7 29 4 15

Evaluated before procurement? 7 1 63 44 11 25 18 1

Validated at the centre? 1 7 52 55 0 36 0 19

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


____________________________________________________________________________51

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.

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).

Yes98.2%

No1.8%

Staff training on use of Equipment


____________________________________________________________________________52

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

Yes92.9%

No 7.1%

System of stock control for the critical supplies


____________________________________________________________________________53

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 andprivate 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.

Figure 4.32: Percentage Usage of Algorithm for Testing

Figure 4.33: Usage of Algorithm by Type of Blood Centers

50.649.4Yes %

No %

6

66

6 62

4130

13

010203040506070


Blood Banks


Blood Banks


Transfusion Centres


Use of Alogrithm by Type of Blood Centers

No

Yes


____________________________________________________________________________54

Figure 4.34: Usage of Algorithm According to Provinces

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).

106 3

7 413

19 22

3 0 1 1 1 1

32

47

05

101520253035404550

AJK

BALO

CHIS

TAN

Capi

tal T

errit

ory

FATA

GIL

GIT

BAL

TIST

AN KPK

PUN

JAB

SIN

DH

Province

No

Yes

72.9

27.1

Yes %

No %


____________________________________________________________________________55

Figure 4.36: Percentage Usage of IQC by Type of Blood Centers

International National Provincial Local


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.

3

35

5 35

72

3116

01020304050607080


Blood Banks


Blood Banks


Transfusion Centres


Distribution of IQC byType of Blood Centers

No

Yes


____________________________________________________________________________56

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

Figure 4.37: Test Kits, Reagents Stored in TME

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).

79.4

20.6

Test Kits, Reagents Stored in TME

Yes

No

1

31

2 17

76

34

18

01020304050607080


Blood Banks


Blood Banks


Transfusion Centres

Test kits/Reagents stored in TME

No

Yes


____________________________________________________________________________57

Figure 4.39: Samples Stored in TME

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.

68.8

31.2

Samples Stored in TME

Yes

No

3

46

3 15

61

33

18

0

10

20

30

40

50

60

70


Blood Banks


Blood Banks


Transfusion Centres

Test kits/Samples stored in TME

No

Yes


____________________________________________________________________________58

Donations Screened for TTIs No. of Samples Screened

Percentage

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.

TTI Markers

Test methods used for TTI

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.


____________________________________________________________________________59

Type of Blood Centers HIV I and II

Hepatitis B

Hepatitis C Syphilis Chagas

Disease HTLV I and II Malaria

Private Sector Hospital Based Blood Banks 0 836 727 0 0 0 16

Public Sector Hospital Based Blood Banks 46 18717 30759 0 0 0 671

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.


____________________________________________________________________________60

Province HIV I and II Hepatitis B Hepatitis C Syphilis Chagas

Disease HTLV I and II Malaria

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


____________________________________________________________________________61

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


____________________________________________________________________________62

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 testing

Document that defines the actual testing process. It includes clear 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 blood

Donor whole blood or red cell components matched with the blood of the recipient.

13 District/first-referral level hospital:

A hospital at the first referral level that is responsible for a district or a defined geographical area containing a defined population and governed by a politico-administrative organization such as a district health management team.

14 Donor suitability

criteria It is also called donor selection criteria. Criteria for the selection of 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 assessment scheme (EQAS)

A recognized scheme for organizing EQA. This can be a local scheme or organized at national, regional or international levels


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17 External quality assessment(EQA)

The external assessment of a laboratory’s performance using samples 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 products:

Human plasma protein products prepared under pharmaceutical 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 blood ordering schedule (MSBOS):

A guide to expected normal blood usage for elective surgical procedures which lists the number of units of blood to be routinely cross-matched or grouped, screened and held for each procedure preoperatively.

24 NAT Nucleic acid testing. 25 National blood

programme: A programme under the Ministry of Health with overall responsibility 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

authority/commission

The highest policy formulation and decision-making body under the Ministry of Health for issues pertaining to blood transfusion services in the country. All major stakeholders in the blood transfusion process are usually represented in this authority. May also be referred to as


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National Blood Committee or National Blood Council.

27 National blood

policy: A statement of intent by the Ministry of Health that defines the 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

strategy or strategic plan:

A structured series of steps that provide a pathway for the national blood programme to achieve its policy objectives.

29 National/Regional/P

rovincial Blood Centre

A centre which carries out 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 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 transfusion committee:

A national committee that receives reports from hospital transfusion committees, collates national information on transfusion activity, and 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 panel:

A (national) panel of experts in blood transfusion medicine and/or science that meets on a regular basis to advice on matters associated with the safety, sufficiency and quality of blood transfusion.

32 Organizational

structure Orderly arrangement of responsibilities, authorities and relationships between people – ISO 9000 (2000)

33 Policy A high-level overall document embracing the general goals and intentions of an organization

33 Post-donation counseling

Private face-to-face counseling at which HIV test results and other 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 counseling

The counseling provided to potential donors in privacy before blood is 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 information

Written or oral information given to potential donors, usually groups, 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 management

Coordinated activities to direct and control an organization with regard to quality

43 Quality management system

System to establish a quality policy and quality objectives and to 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 incident:

A case where the patient is transfused with a blood component that 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

reaction: An undesirable response or effect in a patient associated with the 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 Procedure (SOP)

Written instructions for the performance of a specific procedure.

56 Traceability The ability to follow the history of a product or service by means of recorded identification.

57 Unprocessed (pre-processed) blood

Donated blood that has not been processed into components, i.e., 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?


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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

expected Number available

Number 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 number of staff

In-service training

National training course/workshop

International training 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.


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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 and II

HBV HCV Syphilis Chagas disease

HTLV I/ II

Malaria Other, 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:

Infection markers

Test method used (please tick) and the number of donations tested by the different method Simple/Rapid Test ELISA Other, specify

Used? No. Used? No. Used? No. [1]HIV I/II [2]Hepatitis B

[3]Hepatitis 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 (IR)

Number of repeat reactive (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-remunerated donors

Family Replacement Donors

Paid donors

No. of donations tested

No found positive/RR




No found 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

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


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Marker No. of donations tested No found 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

not available Emergency Others,

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


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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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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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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

98 Hamza Foundation Welfare Hospital & Blood Transfusion Services Peshawar

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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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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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

who - national baseline survey · survey – evaluation of blood screening systems’ to the sbtp....

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