National Blood Policy Strategic Framework 2003-2007 For...

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National Blood PolicyStrategic Framework 2003-2007

ForBlood Transfusion Services in Pakistan

National Blood PolicyStrategic Framework 2003-2007

ForBlood Transfusion Services in Pakistan

Dr. Birjees Mazhar KaziChief

Public Health Laboratories DivisionNational Institute of Health

Islamabad

Ministry of Health, Government of Pakistan

This document is the product of four days National Meeting held from 20-24 September 2002. The meeting was arranged by the National Institute of Health under the auspices of the Ministry of Health and with the technical assistance of the World Health Organization.

Very renowned Blood Transfusion, Haematologists, Public Health Specialists, Development Practitioners, international Consultants/Advisors from the public and private sectors, Armed Forces of Pakistan, Red Crescent, Pakistan Society of Haematology, various Academia and the World Health Organization contributed devotedly and with great zeal in the proceedings of the workshop. The list of the participants is annexed at the end of this manuscript. Dr. Rana Mohammad Safdar, Public Health Specialist from National Institute of Health facilitated the whole strategic planning process and worked for development of the consensus document.

The country Reports compiled by various WHO Consultants who visited Pakistan between 1984 and 2002 provided the foundation for compilation of a strong and comprehensive situation analysis. The Participants developed a consensus on National Blood Policy statement and formulated the National Strategic Framework for Pakistan.

This also provides us a good opportunity to acknowledge the useful and dedicated contributions, hard work and critique by the worthy participants. The WHO Representative in Pakistan provided useful help and devoted his personal time and resources for the success of this meeting. WHO Experts from the Headquarter Geneva and Regional Office, Cairo made it possible to attend and contributed their international experience, which broadened the scope of this gathering. The Executive, NIH provided valuable guidance and assistance for the success of this meeting.

This support and interest by the Federal Ministry of Health was the key to the success of this meeting. The personal interest by the Federal Secretary Health undoubtedly made this endaevour a complete success.

1

Preamable

a. Background

The multifaceted concept of blood safety implies getting blood from healthy voluntary donors, ensuring proper storage of blood, screening donor blood to ensure that it is safe from infections, preparing blood components and avoiding its irrational use.

Like many non-industrialized countries the indifference towards far-reaching public health implication of blood transfusion matters in Pakistan, which prevailed over the years allowed implications of blood transfusion matters in Pakistan, which prevailed over the years allowed tolerance of the extreme fragmentation, rampant commercialism and exceptionally poor quality of transfusion in all but few establishments through the country.

Considering the fact that provision of a safe unit of blood to a needy individual is a basic right, the Government of Pakistan decided to embark upon the issue and launched an organized effort for the development of a National Blood Policy and Strategic Framework for the Blood Transfusion Services (BTS) in Pakistan. The federal Ministry of Health with ample support from the Provincial, AJK and FANA Health Departments, Armed Forces, major private sector organizations and the World Health Organization are spearheading the endeavour. b. Purpose and Guiding Principles:

The basic purpose of the of the exercise is to formulate a national strategic framework in the light of National Blood Policy that could form the basis to revamp the BTS of the country so as the meet to nation's routine and emergency requirements. The document envisions to guide the wide range of partners who are or could be involved in the efforts being made for blood transfusion safety. The document establishes fundamental principles and identifies clear priority areas, which need to be executed in a coordinated manner in order to ensure a successful outcome.

The participation of a wide rang of partners in formulation of the national strategic framework would serve the following key purposes:

i. Enhanced ownershipii. Facilitation of an expanded responseiii. Help in resource mobilization

c. Current status of the Blood Transfusion Services:

The Blood Transfusion Services (BTSs) in the country are mostly hospital based in 170 public and about 450 private blood banks. The annual requirement of blood is approximately 1.5 million bags with 40% demand being met by the public sector. About 80% of the private sector blood transfusions take place in major cities including Karachi and Lahore. Despite efforts to control the practice, around 10-20% blood is still donated by the professional donors.

The concept of Voluntary Non-remunerated Donors (VND) is almost non-existent due to the absence of blood donor recruitment strategy. The cultural and socio-economic factors are associated with the reluctance to donate blood at all, especially without reward. Over 90% of the total blood intake is from relatives of the patient. There is no system in place for the proper recruitment, record keeping and retention of the blood donors except for few centers. Proper blood storage and transportation facilities are also not available in most of the public and private sector blood banks, which leads to wastage of significant proportion of the collected blood.

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Executive Summary

The BTS in the country do not participate in any External Quality Assessment Scheme (EQAS). At the provincial level, the status of development of such services is extremely variable there is inadequate collaboration between the NGOs-BTSs and the provincial governments. The hierarchal organizational structure of Punjab BTSs is the only administrative model available in the country having an Institute for Blood Transfusion Services (IBTS) functional as its nucleus at Lahore.

Over the years, National AIDS Control Programme (NACP) has made significant contributions in improving the screening practices in the country through provision of logistic support and development of the national guidelines on HIV testing. Comprehensive manual viz. “National Standards and Guidelines for Blood Transfusion Services” has been published by the Ministry of Health in 2000, which contains state of the art technical information on all blood banking procedures and rational use of blood and blood products. Some training has also been provided to the laboratory personnel for this matter but the observance of these Guidelines is extremely poor because of the non-existent infrastructure. The HIV and Hepatitis B screening kits are also being provided to the public sector blood banks since 1995. The supply of these kits has not been smooth and suffered interruptions because of myriad reasons.

In Punjab province, blood is also being screened in the public sector for Hepatitis C. the situation in rest of the provinces remains unsatisfactory. In addition to the HIV and hepatitis B & C, the screening for syphilis is also being carried out in some facilities but very few are testing blood for Malaria. The NACP under its enhanced programme, to be implemented during 2003, has included provision of Hepatitis C kits to the provinces with the condition of having proper Quality Assurance and Monitoring System in place.

In Pakistan, the resource limitation is not the only contributing factor towards poor state of the Blood Transfusion Services. Lack of ownership and commitment and neglect to perceive the far-reaching public health implications of a poor blood programme has played a detrimental role for the fragmented services and overall existing scenario with reference to the BTS.

d. Planning Process for National Blood Policy and Strategic Framework: In order to ensure a broad and sound-planning base, the Ministry of Health adopted a systematic and participatory approach, which could ensure to facilitate the integration of the strategic in to the plans of the stakeholders from public and private sector, Armed Forces and internal development agencies.

The model adapted for the development of strategic framework, is a process rather than single planning activity comprising of three important steps namely; i. Situation Analysis, ii. Formulation of National Policy and Strategic Framework and iii. Resource Mobilization.

I. Situation Analysis:

In order to have authenticated baseline for sound future planning, a thorough analysis of the existing situation was carried out through review of the reports of various Missions, which visited the country from 1984 to 2002 for assessment of blood safety situation. Draft statements to this effect were developed under eight (8) Priority Areas for National Blood Policy and Strategic Framework, which were thoroughly reviewed by the senior experts in the field of Haematology and Blood Transfusion during the process of Policy and Framework development.

ii. Formulation of National Blood Policy and Strategic Framework:

The experts, policy and decision makers from the public and private sectors, Armed Forces and international

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development counter part agencies were invited for a four day activity conducted with the financial and technical assistance from WHO Pakistan. In addition to the national participants, the experts from WHO (Pakistan), WHO Regional Office (EMRO) and Headquarters (Geneva) had thorough discussions on eight priority areas and made recommendations that ultimately led to the consensus on the National Blood Policy and formulation of Strategic Framework Document.

The experts reviewed the draft statement on the National Blood Policy, which serves as the foundation for the National Strategic Framework and core-guiding principle for the future blood transfusion services in the country.

In order to facilitate the discussions and ensure uniformity of approach, worksheets were developed on each specific area of Strategic Framework that contained draft (a) situation analysis statement (b) goal and (c) 'proposed' objectives.

Following the development of draft strategic framework, the document was widely circulated to various national and international experts for comments and suggestions that formed the basis of the final document. The expert feedback was obtained on the National Blood Policy during the Workshop (20-23 September) and later on through the official consultations with the provincial Managers of Blood Transfusion Services, private sector and Armed Forces professionals, international development agencies viz. WHO, World Bank, International Consortium for Blood Safety (ICBS), International Federation of the Red Crescent and Red Cross Societies and Organizations a based international experts.

e. Salient Features of National Blood Policy

The aim of this National Blood Policy shall be development and maintenance of a National Blood Programme that strives to meet, in equitable fashion on non-profit basis, all of the rational needs of the patient population throughout the country on a regular basis, at minimal cost, with minimal waste but with optimal safety and efficacy.

National Blood Policy shall also provide a strategic framework and direction for Blood Transfusion Services both for the public as well as private sector facilities. Under the said policy the Federal Health Ministry and Provincial / Area Health Departments shall:

· Establish Blood Transfusion Services on the pattern recommended by the National Blood Transfusion Committee and establish service cadre for various services tanks at all levels.

· Ensure that adequate funding is available to maintain the standards of transfusion practice / quality management through resource mobilization from all possible sources.

· Establish Reference Centres for the Blood Transfusion Services for training, research and development at the Federal and Provincial headquarters including AJK and FANA.

· Establish and institutionalize Management Information System (MIS) for effective monitoring and evaluation of Blood Transfusion Services.

· Develop technical guidelines and standard operating procedures (SOPs) for the Blood Transfusion Services and ensure that all legislation and regulations are implemented and followed according to national recommendations.

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Within the framework of the National Blood Policy, the blood and blood components would only be collected from voluntary, non- remunerated donors who meet the laid down national standards for the blood donors in such a way that the health and well being of the blood donors, recipients, and health workers are not compromised.

The Federal and Provincial Blood Transfusion authorities will ensure the implementation of the approved laws to ensure thigh quality services and availability of adequate safe blood through monitoring of the Blood Banks according to the mandate given to the respective authorities under the approved Legislation Bills/ Ordinances.

The National Blood Transfusion Committee shall monitor the overall progress of the Blood Transfusion Services in the country according to the mandate given to this Committee.

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f. Salient Features of National Strategic Framework The following eight priority areas were identified along with goals through wide consultations:

Area I: Development, Organization, Management of BTS at national / regional level and Role(s) of the Public/ Private Sectors

Goal: To establish quality National Blood Transfusion Services in the country based upon the most up to date scientific and practical principles to ensure timely and adequate supplies of Safe Blood and Blood Products with maximum efficiency and minimum risk to the donor and recipient

Area II:

Motivation, Recruitment and Retention of Blood Donors, and Blood Collection/ Storage

Goal:

To ensure the adequate supply of safe blood through enhanced voluntary and regular non-remunerated donations and establish proper storage and transportation facilities based upon the most recent recommendations in order to promote its efficient use.

Area III

Capacity Building, Resource Mobilization and Financing

Goal:

To enhance the capacity of the National Blood Transfusion Services in terms of the manpower, skills, and infrastructure.

Area IV: (a) Screening of Transmissible Diseases (b) Biosafety with special reference to infection control practices and

management of infectious waste Goal:

To ensure reliable screening for Transfusion Transmissible Infectious agents and maintain hazard-free environment in and out of the blood Transfusion Services

Area V:

Equipment, Consumables and Laboratory Regents Goal:

To ensure blood safety through adequate and efficient supplies of laboratory equipment and materials

Area VI: Practicing and promoting rational use of Blood and Blood Products / Plasma Expenders

Goal:

To rationalize the use of blood component therapy, thereby reducing the hazards of transfusion through their effective use

Area VII:

Quality Management and Monitoring of the Blood Transfusion Services

Goal:

To Ensure availability of sufficient supply of safe blood and blood components with maximum efficacy and minimum risk to both donors and recipients

Area VIII:

(a)

National Guidelines and Standards

(b) Disaster Management Plan for National and Regional Blood Transfusion Services

Goal: To ensure the adequate and in time supply of safe blood and blood products

g. Key Implementing Partners:

The establishment and strengthening of the National Blood Transfusion Services is a challenging task that requires proportionate efforts on part of all national and international stakeholders. The strategic framework clearly envisions pooled expertise and resources from all the stakeholders, including the government, private sector, armed forces, and international development agencies. The following partners are required to play the proactive role for the purpose:

i. Ministries of Health, Education, Culture & Youth, Municipalities, Women Affairs, Religious Affairs, Law & Justice, Interior,Communication, Labor / Manpower and Industries

ii. Provincial Health Departments and all other Departmentsiii. Armed Forces Institute of Transfusion (AFIT)iv. Private Sector Organizations, such as Agha Khan University (AKU), Baqai University etc.v. Non-Governmental Organizations such as Fatmid Foundation, Hussaini Blood Bank etc.vi. International Organizations such as World Bank, WHO, USAID, International Federation of Red

Cross and Red Crescent Societies, International Consortium for Blood Safety (ICBS) and other development/ donor organizations.

h. Implementation Arrangements:

Implementation of the Strategic Framework for National Blood Transfusion Services would be the joint responsibility of federal Ministry of Health and provincial/ area Health Departments. The federal Ministry would implement the programme through a National Coordinator along with the relevant support staff based at NIH Islamabad while the Coordinator along with the relevant support staff based at NIH Islamabad while the provincial Health Departments, would manage the same through appropriate units established under the concerned Programme Managers.

Due to the multisectoral nature of the project, other Ministries such as Information, Education, Labor and Manpower will play key role in their relevant areas. The National Blood Transfusion Committee and Provincial Blood Transfusion Authorities will be established for continuous monitoring and supervision of the whole effort. Coordination Committees will be established both at federal and provincial levels in order to ensure effective link between the federal and provincial units, Government and private sectors and national and international partners.

The effective role of the private sector will be ensured through its continuous involvement in all development phases of the national blood services including planning as well as the implementation.

I. Barriers:

· Fragmentation in Blood Transfusion Services

· Lack of concrete statistical data to sensitize the policy makers, about the gravity of the situation regarding Blood Safety in the Country

· Sub-optimal Blood Transfusion Services at Federal/ Provincial levels

· Lack of supervisory control by Regulatory Authorities at Federal / Provincial levels to ensure compliance of National Standards and Guidelines

· Inadequate financial support to meet transfusion requirements of the community at all levels and constrained finances for overall health sector

· Lack of identification of responsibilities for Blood Transfusion Services at national/ Private levels.

· Lack of standardized curricula for pre-service training of the manpower

· Grossly deficient quality control and lack of quality assurance in majority of transfusion centres

· Dearth of skilled manpower, state of the art equipment, transfusion related reagent and consumables

· Absence of service structure for the staff of blood transfusion services.

j. Opportunities:

· Availability of a core group of technical experts within the country

· Availability of an administrative structure for BTS in Punjab

· Availability of a model as Armed Forces Institute of Transfusion (AFIT)

· Available National Standards and Guidelines

· Initiation of a new dynamism for the development of a national transfusion service in the country

· Development of the National Strategic Planning Framework for the BTS

· Presence of Programme Managers for Blood Transfusion Services in the Provinces, AJK and Northern Areas

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· Notification of National Blood Transfusion Committee and National Coordinator for Blood Transfusion Services

· Notification for the establishment of National Reference Centre for Blood Transfusion Services at NIH, Islamabad

· Present low incidence of HIV and provision of funding under the enhanced HIV/ AIDS programme for the prevention of transfusion transmitted HIV, Hepatitis B and C infection

· Interest of international funding agencies to support the development of a nationally coordinated blood transfusion service

· Availability of young health population to act as voluntary non-remunerated donors

· Available NGO's support for voluntary non-remunerated donors recruitment

k. Future Course of Action:

The following course would be adopted for the transformation into action and implementation of the National Blood Policy and the Strategic Framework Document:

i. Expert feedback from the Moderators of eight Groups constituted for Strategic Planning Workshop.

ii. Feedback from selected public and private sector and Armed Forces Experts

iii. Feedback from selected WHO (EMRO & Headquarters, Geneva), World Bank, International Consortium for Blood Safety (ICBS), International Federation of Red Cross and Crescent Societies

iv. Official views of all the Provincial Governments, AJK and FANA Governments.

v. Sensitization Seminars for policy and decision makers at the provincial headquarters.

vi. Presentation before the National Blood Transfusion Committee.

vii. Costing of the Strategic Framework

viii. Resource Mobilization campaign.

1. General Information

Pakistan is a country of about 140 million population spread over an area of 852,392 Kms administratively divided in to four provinces i.e. Punjab, Sindh, NWFP, Balochistan and federally controlled Northern/ Tribal Areas (FANA / FATA) and Islamabad Capital Territory (ICT). The state of Azad Jammu and Kashmir (AJK) adjoins Pakistan in the northwest and works jointly with the Federal Government of Pakistan for all the development schemes. Each province consists of districts which in turn comprise of tahsils/ tealukas (sub districts)

Pakistan has primarily an agrarian economy with about 70% of population living in rural areas where socio-economic conditions are generally not conducive to development. With per capita income of about 420 US$, the country is classified among the low-income countries of the world.

The health and population scenario in the country is characterized by high fertility, low life expectancy, and young at structure, high maternal and child mortality, incidence of communicable diseases and malnutritution. Capital investment in health is financed through Annual Development Programme (ADP) that also includes external funding. The federal government substantially finances provinces’ developments budgets but the provinces make decisions regarding allocation of funds over various sectors independently. Existing health services in Pakistan have been inadequate with respect to coverage and effectiveness and resources have mostly been skewed towards curative services rather than the preventive.

II. Current Status of the Blood Transfusion Services:

Like many non-industrialized countries the situation with regard to Blood Transfusion has remained far from satisfactory over the year. The indifference towards the far-reaching public health implications of blood transfusion has allowed tolerance of the extreme fragmentation, rampant commercialism and exceptionally poor quality of transfusion practices in all but few establishments throughout the country. The blood transfusion services (BTSs) in the country are mostly hospital based in 170 public and about 450 private blood banks. The annual estimated requirement of blood is approximately 1.5 million bags with 40% demands being met by the public sector. About 80% of the private sector blood transfusions take place in major cities including Karachi and Lahore. Despite efforts to control the practice, around 10-20% blood is still donated by the professional donors.

The concept of Voluntary Non-remunerated Donors (VND) is almost non-existent due to the absence of blood donor recruitment and retention strategy. The cultural and socio-economic factors are associated with the reluctance to give blood at all, especially without reward. Over 90% of the total blood intake is from friends and relatives of the patient. The problem is compounded by the fact that there is no coordination between those who recruit blood donors and those who collect blood.

There is no system in place for the proper recruitment, record keeping and retention of the donors except for few centres. The facilities of pre-donation information and appropriate counseling and support are generally not available and donor deferral systems do no exist. The small-scale blood donor programmes lack the adequate human and financial resources to ensure broadening of the donor base and their retention afterwards. The proper blood storage and transportation facilities are also not available in most of the public and private sector blood banks leading to wastage of significant proportion of the collected blood.

The BTSs in the country do not participate in any External Quality Assessment Scheme (EQAS). At the provincial level, the status of development of such services is extremely variable and there is inadequate

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An Overview

collaboration between the NG0s-BTSs and the provincial governments. The hierarchal organizational structure of Punjab BTSs is the only model of its kind in the country with an Institute of Blood Transfusion Services (IBTS) as its nucleus.

HIV/AIDS pandemic has greatly increased public awareness of blood transfusion, thereby generating great interest in the safety and adequacy of the blood supply. The manual “National Standards and Guidelines for Blood Transfusion Services” published by the Ministry of Health contains a comprehensive chapter on the screening of TTIs. Also the National AIDS Control Program (NACP) has made significant contribution in improving the screening practices in the country through provision of logistic support ever since 1994 and development of the national guidelines on HIV testing. Some training has also been provided to the laboratory personnel for this matter but the observance of these guidelines is extremely poor. The HIV and Hepatitis B testing kits are also being provided to the public sector blood banks since 1995. The supply of these kits has not been smooth and suffered interruptions because of myriad reasons. The situation is likely to improve under the enhanced HIV/ AIDS Project (2003-08).

In the Punjab province,blood is also being screened in the public sector for Hepatitis C. the situation in rest of the provinces remains unsatisfactory. In addition to the HIV and Hepatitis B & C, the screening for syphilis is also being carried out in some facilities but very few are testing blood for Malaria. The NACP under its enhanced programme, to be implemented during 2003, has included provision of Hepatitis C kits to the provinces with the condition of having proper Quality Assurance and Monitoring System in place.

In Pakistan, the resource limitation is not the only contributing factor towards poor state of the Blood Transfusion Services. Lack of ownership and commitment on part of all national and international partners and inability to perceive the far-reaching public health implications of a poor blood programme has been detrimental in the existing scenario. Relatively organized blood transfusion services are available only in Punjab, which has been able to maintain the inherited infrastructure through provincial allocations. The situation in remaining provinces including AJK and FANA is feeble where the provincial contributions are very meager and blood programme is limited to only screening for HIV and Hepatitis B and that too out of the federal budgetary allocations through the National AID Control Programme.

III. Planning Process for National Blood Policy and Strategic Framework:

Owing to the unprecedented scale of HIV epidemic more and more attention along with resources is now being diverted towards improving the country blood programmes. The subject of Transfusion Medicine has gained significant attention of the masses in general and the medical community in particular, due to an increased awareness regarding hazards of unsafe blood transfusion. The realization of a properly organized blood although existed since long, it however gained a fresh attention and momentum during the design phase of the enhanced HIV/ AIDS control programme where it was seriously felt that the AIDS prevention efforts couldn't be successful without, being complemented by a sound national blood programme.

The Government of Pakistan therefore, has decided to tackle the issue on priority basis and an organized campaign for the same has been initiated with the development of strategic framework with a future vision. The effort is being spearheaded by the federal Ministry of Health with ample support from the provincial health departments including AJK and FANA. The Ministry has adopted a centralized planning approach because of the fact that it would greatly facilitate the integration of the strategies in to plans of various provincial government departments and ministries.

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The model of strategic planning, which has been followed in the development of strategic framework, is a process rather than a single planning activity comprising three important steps namely: Situation Analysis, Strategic Framework Formulation and Resource Mobilization.

Situation Analysis:

A thorough analysis of the existing situation has been carried out through review of reports by various Missions, which visited the country form 1984 to 2002. Draft statements to this effect were developed which were thoroughly reviewed by the senior experts in the field of Haematology and Blood Transfusion.

Formulation of National Blood Policy and Strategic Framework:

In order to ensure a sound-planning base, the Ministry of Health adopted a systematic and participatory approach. A number of participants from the public and private sectors including those from the Armed Forces were invited for a four days activity conducted with the financial and technical assistance of WHO Pakistan. In addition to the national participants, the experts from WHO (Pakistan), WHO Regional Office (EMRO) and Headquarters (Geneva) had thorough discussions on eight priority areas and made recommendations that ultimately led to the consensus on the National Blood Policy and formulation of Strategic Framework Document.

The experts reviewed the draft statement on the National Blood Policy, which serves as the foundation for the National Strategic Framework and core guiding principle for the future blood transfusion services in the country.

In order to facilitate the discussion and ensure uniformity of approach, worksheets were developed on each specific Area of Strategic Framework that contained draft (a) situation analysis statement (b) goal and (c) some proposed objectives.

Following the development of draft strategic framework, the document was widely circulated to various national and international experts for comments and suggestions that formed the basis of the final document. The expert consensus was obtained on the National Blood Policy during the Workshop (20-23 September) and later on through the official consultants with the Provinces.

National Blood Policy

National Blood Policy for Pakistan shall meet the needs of the community and health programme of Pakistan, for conservation of the donated blood.

The aim of this National Blood Policy shall be development and maintenance of a National Blood Programme that strives to meet, in equitable fashion on non profit basis, all of the rational needs of the patient population throughout the country on a regular basis, at minimal cost, with minimal waste but with optimal safety and efficacy.

National blood Policy shall also provide a strategic framework and directions for Blood Transfusion Services under the following Priority Areas:

1. Development, Organization, Management of BTS at national/ regional levels and respective role(s) of the Public/Private Sectors

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2. Capacity Building, Resource Mobilization and Financing.3. Procurement of the standard equipment, consumables and laboratory regents.

4. Motivation, Recruitment and Retention of Blood Donors, and Blood Collection/ Storage and transportation.

5. a. Screening of Transfusion Transmissible Diseases b. Biosafety with special reference to infection control practices and management of

infectious waste.

6. Practicing and promoting rational use of Blood and Blood Products

7. Quality Management and Monitoring of the Blood Transfusion Services

8. National Guidelines and Standards for National and Regional Blood Transfusion Services and Disaster Management Plans at the national and regional level.

The salient features of National Blood Policy, which are based upon recommendations of the World Health Organization and the International Federation of the Red Crescent and Red Cross Societies, are set out below.

Federal Health Ministry and the Provincial / Area Health Departments shall:

· Establish Blood Transfusion Services on the pattern recommended by the National Blood Transfusion Committee

· Establish service cadre for various services ranks at all levels.

· Ensure that adequate funding is available to maintain the standards of transfusion practice and quality management as recommended by the National Blood Transfusion

· Establish Reference Centres for the Blood Transfusion Services for training, research and development at the Federal and Provincial headquarters including AJK and FANA.

· Establish and institutionalize the Management Information System (MIS) for effective monitoring and evaluation of Blood Transfusion Services

· Educate, motivate, recruit and retain health and voluntary non remunerated blood donors

· Develop technical guidelines and standard operating procedures (SOPs) of the Blood Transfusion Services

· Establish facilities for safe plasma fractionation

· Ensure that all legislation and regulations are implemented and followed according to national recommendations.

· Resource mobilization from all possible sources.

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National Blood Programme

Within the framework of the National Blood Policy, the Blood Programme shall:

· Aim at collection of all blood and blood components only from voluntary, non-remunerated donors who meet the laid down national standards for the blood donors in such a way that the health and well being of the donors, recipients and health workers are not compromised.

· Be responsible for:

· Collection of whole blood, cellular components and plasma;· Ensuring quality and yield of wanted plasma derivatives;· Distribution of blood, blood components, and plasma derivatives of human origin

Legislative and Regulatory Control

The Federal and Provincial Blood Transfusion Authorities shall ensure the implementation of the approved laws to ensure high quality service and availability of adequate safe blood through monitoring of the Blood Banks according to the mandate given to the respective authorities under the constitution.

National Blood Transfusion Committee

The National Blood Transfusion Committee shall monitor the overall progress of the Blood Transfusion Services in the country according to the mandate to this Committee.

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National Strategic Framework

a. Purpose and Guiding Principles

The basic purpose of the exercise is to formulate a national strategic framework in the light of National Blood Policy that could form the basis to enhance and build up the Blood Transfusion Services of the country so as to meet the nation's routine and emergency requirements as well as in emergency situations. The document is envisioned to guide the wide range of partners who are or could be involved in the BTS strengthening efforts. The document fundamental principles and identifies clear priority areas, which need to be focused in a coordinated manner in order to ensure a successful outcome.

The participation of a wide range of partners on formulation of the national strategic framework would serve the following key purposes:

I. Enhanced ownershipii. Facilitation of an expanded responseiii. Help resource mobilization

b. Areas and Goals of the National Strategic Framework:

Based on the available information, the following eight priority areas were identified along with goals through wide consultations:

Area I: Development, Organization, Management of BTS at national / regional levels and Role(s) of the Public/ Private Sector

Goal: To establish quality National Blood Transfusion Services in the Country based upon the most up to date Scientific and Practical Principles to ensure timely and adequate supplies of Safe Blood and Blood Products with maximum efficiency and minimum risk to the donor and Recipient

Aria II:

Motivation, Recruitment and Retention of Blood Donors, and Blood Collection/ Storage

Goal


Area III:


Goal:

To enhance the capacity of the National Blood Transfusion Services in terms of the manpower, skills, and infrastructure.

Area IV:

(a)

Screening of Transmissible Diseases

(b)

Biosafety with special reference to infection control practices and management of infectious waste

Goal:

To ensure reliable screening for Transfusion Transmissible Infectious agents and maintain hazard-free environment in and out of the blood Transfusion Services

Area V:

Equipment, consumables and Laboratory Regents

Goal:


Area VI: Practicing and promoting rational use of Blood and Blood Products / Plasma Expenders

Goal To rationalize the use of blood component therapy, thereby reducing the hazards of transfusion through their effective use

15 16

Area VII:


Goal:

To Ensure availability of sufficient supply of safe blood and blood components with maximum efficacy and minimum risk to both donors and recipients

Area VIII: (a) National Guidelines and Standards(b) Disaster Management Plan for National and Regional Blood Transfusion

ServicesGoal: To ensure the adequate and in time supply of Safe Blood and blood Products

c. Key Implementing Partners:

The establishment and strengthening of the National Blood Transfusion Services is a challenging task that requires proportionate efforts on part of all national and international stakeholders. The strategic framework clearly envisions pooled expertise and resources from all the stakeholders, including the government, private sector, armed forces, and international development agencies. The following partners are required to play the proactive role for the purpose:

I. Ministries of Health, Education, Culture & Youth, Municipalities, Women Affairs, Religious Affairs, Law & Justice, Interior, Communication, Labor / Manpower and Industries

ii. Provincial Health Departments and all other Departments

iii. Armed Forces Institute of Transfusion (AFIT)

iv. Private Sector Organizations such as Agha Khan University (AKU), Baqai University etc.

v. Non-Governmental Organizations such as Fatmid Foundation, Hussaini Blood Bank etc.International Organizations such as World Bank, WHO, USAID, International Federation of Red Cross and Red Crescent Societies, International Consortium for Blood Safety (ICBS) and other development/ donor organizations.

d. Barriers

· Fragmentation and commercialism in Blood Transfusion Services

· Lack of Concerns Baseline Safety in the country

· Sub-optimal Blood Transfusion Services at Federal/ Provincial levels

· Lack of supervisory control by Regulatory Authorities at Federal / Provincial levels to ensure compliance to National Standards and Guidelines

· Inadequate financial support to meet transfusion requirements of the community at all levels and constrained finances for overall health sector

· Lack of identification of responsibilities for Blood Transfusion Service at National/ Provincial levels

· Lack of standardized curricula for re-service training of the manpower

· Grossly deficient quality control and lack of quality assurance in majority of consumables

· Absence of service structure for the BTS staff

e. Opportunities:

· Availability of core group of technical experts within the Country

· Availability of BTS in Punjab with a model administrative structure

· Availability of expertise and infrastructure at the Armed Force Institute of Transfusion (AFIT)

· Availability National Standards and Guidelines

· Initiation of a new dynamism for the development of national transfusion services in the country

· Development of the National Strategic Planning Framework for the BTS

· Presence of Programme Managers for Blood Transfusion Services in the Provinces, AJK and Northern Areas.

· Notification of National Blood Transfusion Committee and National Coordinator for Blood Transfusion Services

· Present low prevalence of HIV and provision of funding under the enhanced HIV/AIDS programme for the prevention of transfusion transmitted HIV, Hepatitis B and C infection.

· Interest of international funding agencies to support the development of nationally coordinated blood transfusion service providing equitable access to safe blood

· Availability of a young healthy population to act as voluntary non remunerated donors with a little motivation

· Available NGOs support for voluntary non-remunerated donors recruitment

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Development, Organization and Management of Blood Transfusion Services at national/regional levels including AJK and FANA, role of the Public /Private Sectors

Situation Analysis

The Blood Transfusion Services in the country are generally fragmented and hospital based in 170 public and about 450 private blood banks. The estimated annual requirement of blood is approximately 1.5 million bags with 4% demands being met by the public sector. However, the private sector mainly caters for the needs of major cities and in this way about 80% of overall sector blood transfusion services are limited to these cities. Despite efforts to discourage the practice, around 10-20% blood is still donated by the professional donors.The indifference towards the public health importance of organized blood transfusion services, prevailing over decades led to blatant fragmentation, poor quality of transfusion practices and commercialism throughout the country leaving few dedicated centres in the public and private sectors and the Armed Forces. The provincial Programme Managers are working on part-time basis in NWFP, Balochistan, AJK, and Northern Areas. Though motivated, they receive absolutely inadequate support from the provincial bodies for administrative, financial and technical aspects. The BTSs in the country do not participate in any EQAS. At the provincial level, the status of development of such services is extremely variable and there is inadequate collaboration between the NGOs-BTSs and the provincial governments.

Although a National Coordinator (NC) has been identified at the national level yet no administrative establishment of support, supervision, training or other technical matters is available to the NC because of the paucity of resources and absence of the subject item on the agenda list.The hierarchal organizational structure of Punjab BTSs is a model establishment in the country with an Institute of Blood Transfusion Services (IBTS) supporting 8 regional centres, 26 district hospitals and 60 Tehsil hospitals Blood Banks (BBs). In the private sector Fatimid Foundation, Hussaini Blood Bank and other NGOs in major cities are the main contributors. In Balochistan, AJK and Northern Areas, the Blood Transfusion Programme is virtually non-existent as a management structure expected for a small central core in Quetta, Balochistan. The same is true for NWFP where the services to the extented of blood components are available in private sector.

In Sindh the private practice evidently dominates ranging from providing excellent services (AKU_BB) to extremely poor Blood Banks. The Sindh Blood Transfusion Authority has now initiated registration, licensing and supervision of the Blood Banks under the Provincial Legislation. The JPMC blood bank, controlled by the federal Ministry of Health, is well developed. The JPMC and AKU BBs are the only two facilities providing service with adequate requirements of QA. There is absolutely inadequate communication between public and the private sectors, including NGOs. The situation outside Karachi is pathetic.

In Islamabad, Red Crescent society owns a facility, which is engaged at a limited level without any plans to play a national role for development, organization and management of Blood Transfusion Services. The public sector BB facilities are working in PIMS and FGSH with a lot of room for improvement.

Area Goal:

To establish quality National Blood Transfusion Services in the Country based upon the most up to date Scientific

and Practical Principles to ensure timely and adequate supplies of Safe Blood and Blood Products with maximum

efficiency and minimum risk to the Donor and Recipien

Objective 1:

To establish organizational structures for national, provincial and district Blood Transfusion Services (BTS)

including AJK and FANA

Strategies to achieve the Objective:

Strategy 1.1 Appoint a full time National Coordinator for the Blood Transfusion Services, having relevant

postgraduate qualifications/ experience in Haematology /Transfusion Medicine and vast managerial

Administrative knowledge

Strategy1.2 Appoint full time Directors cum Provincial Programme Managers BTS (Medical Doctors with

qualifications & experience in transfusion medicine)

Strategy 1.3 Establish complete management structures in all Provinces including AJK and F ANA

Objective 2: .To assign the roles and responsibilities of planning, coordination, financial management and routine operations at

national and provincial levels including AJK and F ANA.


Strategy 2.1 Carryout detailed situation analysis of the existing blood facilities in the country including AJK and

FANA with reference to their overall demonic workload, existing equipment, consumables and laboratory

reagents, availability of trained manpower etc.

Strategy 2.2 Planning, coordination, resource mobilization and quality assurance of transfusion related reagents

and equipment by the National Coordinator BTS with the help of National Blood Transfusion Committee

(NBTC) for all Provinces including A]K and FANA.

Strategy 2.3 Management, human resource development, monitoring and evaluation of BTS by respective

Director cum Provincial Programme Manager (PM) BTS of all Provinces including AJK and FANA

Strategy 2.4 Development and management of routine operations of the Blood Transfusion Centers at District

and Tehsil level under supervision of respective Director cum Provincial Programme Manager (BTS)

Strategic Areas

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Objective 3:

To aim at induction and retention of 100% voluntary non-remunerated blood donors for safe transfusion of blood

and blood products


Strategy 3.1 Organize Blood Donor Motivation Committees at all levels including health professionals, religious

scholars, notables and well-reputed people of that community, teachers, councilors, Nazims, philanthropists and

Strategy 3.2 Conduct regular motivational activities for the promotion of voluntary blood donation including

walks and other cultural events

Strategy 3.3 Disseminate messages for the general public through frequent use of print and electronic media

Strategy 3.4 Arrange motivation lectures and donation camps at educational institutions, industrial units and

public places

Objective 4:

To enhance the political commitment at national and provincial levels including AJK and FANA amongst all partners


Strategy 4.1 Organize symposia, seminars, conferences and workshops on various aspects of Blood Transfusion

Services with participation of policy and decision makers

Strategy 4.2 Arrange visits of concerned officials to various Blood Transfusions Centers.

Strategy 4.3 Collect and disseminate concrete data of Transfusion Transmissible Diseasies ' to sensitize the

policy makers about Blood Transfusion Services.

Strategy 4.4 Conduct studies at various public and private Blood Banks to assess the prevailing practices and

standards

Objective 5:

To establish reference centers /laboratories at national and provincial levels including AJK and FANA


Strategy 5.1 Establish a state of the art reference centre for quality assurance of equipment and transfusion

related reagents at the national level

Strategy.5.2 Establish state of the art reference laboratories in all the Provinces including AJK and FANA for

quality assurance of BTS and other transfusion related issues

Strategy 5.3 Arrange periodic on the job training of the relevant professionals on quality assurance and advance

blood banking techniques in centers of excellence abroad

Strategy 5.4 Conduct periodic monitoring, surveillance and need assessment of skilled manpower working in

blood banks

Objective 6: Teaching and training of professionals and staff of blood banks


Strategy 6.1 Arrange regular on the job trainings for the relevant professionals at Armed Forces Institute of

Transfusion (AFIT) Rawalpindi, Agha Khan University (AKU), Karachi and Institute of Blood Transfusion

Services Punjab (lBTS), Lahore.

Strategy 6.2 Conduct periodic refresher courses as part of Continued Medical Education (CME) in transfusion

medicine at various centres.

Strategy 6.3 Organize training courses for blood bank staff from all the Provinces including AJK and FANA, for

both public and private sectors.

Strategy 6.4 Motivate and encourage the Directors cum Provincial Programme Managers BTS and other blood bank officers to improve their qualifications and expertise in the field of transfusion medicine.

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Objective 7:

To enhance and strengthen the capacity of the public sector to meet blood transfusion requirement of the

community


Strategy 7.1 Establish network of the Blood Transfusion Services up to District and Tehsil level in all the four

Provinces including AJK and F ANA

Strategy 7.2 Categorize Blood Banks at various levels according to the needs of the community and build their

capacity accordingly

Strategy 7.3 Provide the facilities of component preparation at Provincial/Regional Transfusion Centres

/Institution including AJK and F ANA

Objective 8:

To promote and practice rational use of safe blood and blood products


Strategy 8.1 Establish Hospital Transfusion Committee (HTCs) with representation from Blood Banks

.

Strategy 8.2 Create awareness among the users of blood products through frequent lectures, seminars and workshops with full participation of clinicians

Objective 9:

To define the roles & responsibilities and strengthen coordination amongst Defense, public and private sectors


Strategy 9.1 Encourage the private sector for sharing transfusion requirements of the community with public

sector.

Strategy 9.2 Conduct surveys for evaluation of the status of the Blood Banks in private as well as public sectors.

Strategy 9.3 Define and implement a uniform policy in both the public and private sectors to meet national

standards of BTS.

Strategy 9.4 Arrange and provide technical support to various public and private institutions through the AFIT

Rawalpindi and IBTS Lahore.

Strategy 9.5 Provide the facilities of advance training to the public and private sector professional/ technical staff

at AFIT and Punjab IBTS.

Objective 10:

To define and strengthen the role of Federal, and Provincial Regulatory Authority for Blood Bank Services.


Strategy 10.1 Ensure legal entitlement of respective Control Authorities to exercise regulatory role as applied to

Blood Transfusion Services.

Strategy 10.2 Specialized training of Inspectors with reference to Blood Transfusion Services.

Strategy 10.3 Conduct inspection of Blood Transfusion Centres both in public and private sector, and Armed

Forces in accordance with recognized technical Standards for wins fusion services.

Strategy 10.4 Formulate and recommend measures to standardize or improve Blood Transfusion practices in collaboration with National Blood Transfusion Committee.

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Motivation, Recruitment, Retention of Blood Donors and Collection, Storage of Blood

Situation Analysis:

The concept of Voluntary Non-remunerated Donors (VNDs) is almost non-existent due to the absence of blood donor recruitment and retention strategy. The cultural and socio-economic factors are associated with the reluctance to donate blood at all, especially without reward. Many people are not motivated towards voluntary blood donation because they do no have a set of attitudes and beliefs to support it. Even though there are voluntary student groups prepared to donate in emergencies, very few are regular established donors. Over 90% of the total blood intake is from friends and relatives of the patient. Huge size of the private sector is another factor responsible for dearth of the VNDs since these services do not operate basically with a holistic approach towards the BTSs. As most of the donations are hospital based, proper facilities are generally lacking. The hospital/ blood bank premises are also not user friendly. The problem is compounded by the fact that there is no coordination between those who recruit blood donors and those who collect the blood.

There is no system in place for the proper recruitment record keeping and retention of the donors. The facilities of pre-donation information and appropriate counseling and support are not available and donor deferral systems do not exist. The small-scale blood donor programs lack the adequate human and financial resources to ensure broadening of the donor base and their retention afterwards.The proper blood storage and transportation facilities are also not available in most of the public and private sector blood banks leading to wastage of significant proportion of the collected blood.

Although the National AIDS Control Program has included the component of safe blood transfusion in its public messages yet there is no organized health education campaign aimed at establishing the voluntary donors base. There is therefore, an urgent need of a major campaign directed toward public education, donor motivation and recruitment in order to gradually move away from the hospital and coercion as the mainstay of blood provision.

Area Goal:


Objective 1

To establish Department of Donor Recruitment within National Blood Transfusion ServicesStrategies to achieve the Objectives:

Strategy 1.1 Devise a comprehensive and multidimensional national blood donor recruitment programme

Strategy 1.2 Appoint suitable staff with allocation of funds for the propose

Strategy 1.3 Provide the requisite orientation and training to the relevant staff

Strategy 1.4 Encourage the participation of volunteers in donor recruitment efforts

Strategy 1.5 Develop the SOP s for voluntary donor recruitment

Strategy 1.6 Establish proper information system and database

Strategic Area II

Strategy 1.6 Establish proper information system and database

Objective 2:

To carry the Need Assessment and set targets accordingly

Strategy to achieve Objective

Strategy 2.1 Conduct suitable studies with a view to correctly assess the blood demand

Strategy 2.2 Establish and maintain a fool proof Inventory system for blood and blood products

Strategy 2.3 Train the relevant staff on optimal use of blood

Strategy2.4 Computerization of all relevant information

Objective 3:

To enhance the level of public awareness on Blood Safety


Strategy 3.1 Develop socially acceptable and motivating messages and IEC material using mass media, aiming at target population groups

Strategy 3.2 Coordinate with the Ministries of Health, Education, Culture & Youth, Municipalities, Women Affairs, Religious Affairs, Law & Justice, Interior, Communication, Labor/Manpower and Industries

Strategy 3.3 Appoint and train the Motivators

Strategy 3.4 Provide the necessary Equipment and Transport

Objective 4:

To prepare the future generation of Blood Donors


Strategy 4.1 Introduce the Blood Safety concept in school curricula

Strategy 4.2 Establish Societies for awareness about Blood Safety

Strategy 4.3 Arrange various socio-cultural and academic activities and events on special days in routine in order to highlight the importance of safe blood

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Objective 5:

To recruit the Voluntary Non-remunerated Blood Donors and ensure their Retention


Strategy 5.1 Select and motivate the appropriate Target Groups for voluntary non-remunerated blood donation

Strategy 5.2 Define and adhere to Donor Selection Criteria

Strategy 5.3 Ensure the Donor Care Satisfaction and Safety

Strategy 5.4 Launch an appropriate mechanism for appreciation and recognition of VNRDs

Strategy 5.5 Involve VNRDs in planning, implementation and routine operations and ensure transparency in Procedures

Strategy 5.6 Computerize the relevant record and establish Re-call System

Strategy 5.7 Establish proper counseling facilities for the voluntary donors and mechanism for Information of Screening Results taking care of the confidentially issues

Strategy 5.8 Ensure appropriate management of the Deferred Donors

Strategy 5.9 Motivate and convert the replacement donors into VNRDs

Objective 6:

To establish a proper Monitoring, Supervision and Evaluation mechanism


Strategy 6.1 Appoint internal and external Monitoring Teams

Strategy 6.2 Develop and establish proper Auditing & Reporting system in the blood banks

Strategy 6.3 Carry out periodic evaluation of the blood facilities by third party and share the results with all partners

Objective 7:

To develop linkages among various stakeholders with a view to ensure efficient and optimal use of Blood and Blood Products

Strategic Area II


Strategy 7.1 Identify all Partners

Strategy 7.2 Establish a mechanism for periodic Information Sharing

Strategy 7.3 Arrange frequent Meetings and Seminars involving all partners from public as well as the private sector

Objective 8:

To ensure Safe Collection, Storage and Transportation of Blood


Strategy 8.1 Introduce a mechanism for Authorization and Licensing of Blood Banks

Strategy 8.2 Define and implement the SOPs for collection, storage and transportation of blood and blood products

Strategy 8.3 Provide the requisite infrastructure along with appointment of suitable staff and ensure regular finances for the purpose

Strategy 8.4 Standardize the Equipment, Consumables, & Transportation System

Strategy 8.5 Introduce and monitor the regular Recording and Reporting System

Strategy 8.6 Put in place proper storage system for blood and blood products having uninterrupted power supply and after sale service arrangements

Strategy 8.7 Ensure provision of vehicles/refrigerated lories and all other equipment required for transportation of blood, blood products, blood bags, reagents etc.

Strategy 8.8 Ensure Quality Assurance system at every step of collection, storage and transportation of donated blood

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Situation Analysis:

An essential component of the organization and its efficient functioning depends upon the availability of resources; human and all others. For efficient management of the blood transfusion services and ensuring safety of blood supply, availability of trained manpower and of infrastructural facilities including supplies and equipment is essential.

The requisite modern physical infrastructure for the management of organized Blood Transfusion Services is virtually absent in the country. Lack of manpower is the major constraint in development and strengthening of the blood transfusion services. This is basically due to lack of training opportunities of the professionals. The IBTS, Lahore is running a one-year diploma course in Transfusion medicine but the same has not been recognized by the PMDC as yet. Postgraduate training facilities for M.Phil and FCPS are available in the disciplines ofTTransfusion / Haematology in the private and public sector for medical graduates. The facilities up to B.Sc and M.Sc are also available for the laboratory technicians and technology. An exposure to foreign training is however necessary after training in the country. The continued training programmes for the Blood Transfusion personnel do no exist.

BTS in Sindh province are extremely variable. The private practice has some of the state of the art services (AKU BB) to the Blood Banks in shambles operating with our licensing and supervision. The JPMC blood bank, controlled by the federal Ministry of Health, is well developed. The JPMC and AKU BBs are the only two facilities providing service with adequate requirements of QA. The situation out side Karachi is however, pathetic. In Balochistan AJK and Northern Areas, the Blood Transfusion Programme is virtually non-existent for a small central core in Quetta, Balochistan. The same is true for NWFP where the best services are available in tow teaching hospitals in Peshawar and Abbotabad respectivelyThe supply of the requisite equipment, consumables and laboratory reagents at various blood centres is far from satisfactory, leading to improper processing and storage. Appropriate premises and facilities need to be built and established for effective and safe service delivery.

As regards financial resource, the situation is grossly variable from province to province. In Punjab, the government is significantly contributing towards BTSs and is managing Hepatitis C screening out of its own regular allocations. The government of Sindh approved a PC-1 for strengthening the Blood transfusion services, which expired in June 2002. The PC-1s need to be developed and approved in Sindh, NWFP, Balochistan and FANA. The contributions of other provinces and AJK are however very meager and need to be grossly enhanced.

The organization like Red Crescent Society, Fatmid Foundation, Hussaini Blood Bank etc are providing services mainly in the major cities. Their resources are however, limited and the organizations work under the control of respective system, in a rather secluded manner.

Area Goal:

To enhance the capacity of the National and Provincial Blood Transfusion Services in terms of the manpower, skills, and infrastructure.

Objective 1:

Strategic Area III

To enhance the political advocacy and commitment at the national level


Strategy 1.1Increase the awareness of Policy Makers about the role and importance of provision of safe blood to the needy population.

Strategy 1.2 Organize advocacy seminars and conferences o safe blood transfusion at federal, provincial, regional and district levels

Strategy 1.3 Publicize widely the need for an efficient blood transfusion programme at federal, provincial, regional and district levels

Strategy 1.4 Hold individual meeting with the concerned authorities regarding the need of safe blood transfusion services in the country

Objective 2:

To ensure the participation and support of private sector, NGOs and other institutions for strengthening of blood transfusion services

Strategy 2.1 Establish a network of all NGOs and private sector for sharing of information

Strategy 2.2 Organize regular seminars and meetings for all partners at appropriate level

Strategy 2.3 Initiate news bulletin on regular basis to update about the information on transfusion medicine

Strategy 2.4 Involve members of professional medical & paramedical organizations, for utilization of health outlets in private sector /NGOs on rational use of blood

Objective 3:

To strengthen the Blood Transfusion Facilities in terms of infrastructural support and skills enhancement of the manpower


Strategy 3.1 Establish a National Directorate for Blood transfusion Programme having an autonomous status

Strategy 3.2 Establish a Technical Advisory/ Expert Committee from public and private sector/ NGOs to help and advise on technical matters related to Blood Transfusion Services

Strategy 3.3 Carry out an exercise on need assessment /situation analysis of existing infrastructure and available manpower

Strategy 3.4 Workout the financial requirement based upon the situation analysis

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Strategy3.5 Develop standardized and uniform curricula/ training material for training of the manpower at all levels

Strategy 3.6 Highlight the importance of increased awareness about transfusion medicine through lectures, seminars and training workshops for medical students, medical officers at appropriate level

Strategy 3.7 Develop a special cadre for those working in blood transfusion services for standardized training curricula, job description and career development

Objective 4:

To ensure prioritized and sustainable allocation of resources for the blood transfusion services


Strategy 4.1 Develop and process the Project document (PC-1s) at Provincial, AJK and FANA levels on priority basis

Strategy 4.2 Conduct advocacy meetings with concerned national and international agencies with a view to secure enhanced allocations for BTS

Strategy 4.3 Plan for some contribution / services charges in order to ensure sustained availability of financial resources

a) Screening of Transmissible Diseasesb) Biosafety with special reference to infection control practices and management of

infectious waste

Situation Analysis:

The screening of blood for transfusion transmissible infections (TTIs) is mandatory for blood safety. HIV/AIDS pandemic has greatly increased public awareness of blood transfusion, thereby generating great interest in the safety and adequacy of the blood supply. The Manual National Standards and Guidelines for Blood Transfusion Services contains comprehensive chapter on the screening of TTIs. Also the National AIDS Control Programme has made significant contribution in improving the screening practices in the country through development of the national guidelines on HIV testing. Some training has also been provided to the laboratory personnel for this matter but the observance of these guidelines is extremely poor. The HIV and Hepatitis B testing kits are also being provided to the public sector blood banks since 1995. The supply of these kits has not been smooth and suffered interruptions because of various administrative reasons. The situation is likely to improve under the enhanced HIV Project.

In Punjab province, the blood is also being screened in the public sector for Hepatitis C. The situation in rest of the provinces remains unsatisfactory. In addition to the HIV and Hepatitis B & C, screening for Syphilis being carried out in some facilities but almost none is testing blood for Malaria. The NACP’s enhanced programme, likely to be implemented from December 2002, has included provision of Hepatitis C kits to the provinces with the condition of having proper monitoring system in place.

The heightened public and professional perceptions over the risk of transfusion-transmitted diseases has substantiated the need to have a Quality Management Programme with the primary goal of transfusion of safe unit of blood.

The Biosafety practices in both the public and private sector blood banks require immediate attention. The necessary training and refresher courses on the subject are scanty. Most of the laboratory staff is not vaccinated against Hepatitis B. Necessary training facilities on the subject are also lacking. Expert for some of the major centres, the management facilities for accidental exposure are not available. Most of the medium and small-scale facilities even lack the basic requirements like gloves. The disposal of waste of the Blood Banks is also variable from facility to facility.

The scenario demands comprehensive safety programme for all categories of the staff based upon the universal safety precautions. Some assistance is likely to be made available for this important area out of the resources being allocated for the enhanced HIV/AIDS Project, which needs to be utilize in an exceptionally well-planned manner.

Area Goal:

To ensure reliable screening for Transfusion Transmissible Infectious agents and maintain hazard-free environment in and out of the Blood Transfusion Services

Objective 1


Strategy 1.1 Development of adequate and well-trained human resource to ensure proper screening of blood for

TTIs

Strategic Area IV:

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Strategy 1.2 Perform screening of blood for transfusion transmittable infections according to the National

Standards and Guidelines

Strategy1.3 Ensure sustained availability of quality controlled screening assays at affordable cost

Strategy 1.4 Establish internal quality control systems and participate in external quality assessment schemes

(EQAS)

Strategy 1.5 Resource mobilizations for adequate and sustainable supply of screening assays and required

accessories

Equipment, Consumables and Laboratory Reagents

Situation Analysis:

rdAccording to the report published by the Global Burden of Disease Study, the roadside accidents could be the 3 leading cause of the morbidity and mortality by the year 2020. Safe Blood Transfusion is the first and the foremost and immediate medical intervention that surely contributes in saving precious human lives after accidents. The sheer existence of proper BTSs with all the requisite back up equipment and laboratory material is therefore of paramount importance for effective and safe service delivery in an hour of need.

Punjab has a well-managed administrative infrastructure for the Blood Transfusion Services in Pakistan. The structure has its nucleus in Lahore as Institute of Blood Transfusion Services having divisional and district units. The services in rest of the provinces are extremely fragmented without proper administrative control and back up services / equipment etc. The system of procurement of equipment, consumables and laboratory reagents is inappropriate resulting in frequent interruptions in supplies.

The blood transfusion facilities in the private and public sector lack proper equipment and remain short of the consumables and laboratory reagents due to the limitation of resources. The situation in private sector accounting for 60% of the total blood requirement is even worst since a great majority of these centres work without proper equipment, licensing and supervision. The facilities of plasma fractionation are not available in the country.

The proper blood storage facilities are also not available in most of the public and private sector blood banks leading to wastage of significant proportion of the collected blood. Moreover due to the lack of the kits storage facilities in the blood banks, the quality deteriorates rather quickly making the results highly doubtful. Similarly interrupted supplies of the materials like disposable syringes and gloves etc. leave the facility users and staff highly vulnerably to the transfusion transmissible infections.

The equipment, consumables and reagents are mainly imported and are subject to all kind of duties imposed by the Government for the subject matter. The importers have monopoly on some items, which create problems for the users. There is a need to develop uniform policies for equipment, reagents in the public sector hinder the working badly and a significant proportion of the allocated budget is wasted in taxes. Long-term vision for procurement of equipment, reagents and maintenance of equipment needs to be worked out including plans to replace the old items. There should be service and maintenance facilities for quick replacement of the faulty and worn out parts of the equipment. Proper trained staff is not available for handling the equipment, which cuts down its life. Trained core of engineers should be developed for this purpose or else service/ maintenance contracts should be managed at the time of procurement of all instruments and equipment.

Area Goal:


Objective 1

To carry out need physical assessment /verification of the blood transfusion facilities with a view to highlight key deficiencies

Strategic Area V:

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Strategies to achieve the objective:

Strategy 1.1 Carry out detailed situation analysis of the existing blood facilities in the country including AJK and FANA with reference to their overall demand, workload, existing equipment, consumables and laboratory reagents, availability of trained manpower etc.

Strategy1.2 Categorize the blood facilities according to their workload and define minimum standards for each category

Strategy1.3 Study the existing procurement and storage procedures in detail and identify gaps

Strategy1.4 Analyze the availability of trained manpower in each province / area for maintenance and repair of the equipment

Strategy1.5 Assess the existing practices of record keeping, auditing & reporting, Monitoring & Evaluation

Objective 2

To make all requisite equipment, consumables and laboratory reagents in the facilities

Strategy2.1 Lay down the Standard Operating Procedures (SOPs) for the blood facilities based upon the situation analysis / need assessment

Strategy 2.2 Negotiate with the relevant authorities to rationalize the taxes / duties on the laboratory materials to bring the cost at reasonable level

Strategy 2.3 Arrange the requisite equipment, consumables and laboratory reagents along with storage facilities in all blood banks as per minimum acceptable standard for the category

Strategy 2.4 Ensure availability of properly trained manpower for running the facilities

Strategy 2.5 Design and implement proper Quality Assurance System in each facility

Strategy 2.6 Design the forecasting system for the future requirements so as to ensure timely requisitions and supplies

Strategy 2.7 Arrange courses in the field of biomedical engineering in order to ensure the availability of skilled manpower

Strategy 2.8 Share information on quality of the equipment, consumables and laboratory reagents with all partners

Strategy 2.9 Coordinate with the national and international agencies with a view to learn from the experiences of each other

Strategy 2.10 Arrange refresher courses and on job training facilities for the relevant staff

Strategic Area VI

Practicing and promoting rational use of Blood and Blood Products

Situation Analysis:

Rational use of blood means providing the right blood product, in the right quantity, for the right patient. It can help the gap between and supply of the precious blood and surely reduce the transmission of TTIs. The patients who require blood or blood products whether in life threatening acute situations or as a supportive therapy must receive the required component only The concept in Pakistan is still in its infancy where approximately 98% of the blood is used as whole 'fresh' blood and more than 70% as single blood unit. The inventory system in the blood is not maintained and the blood components are not generally available.

Although the manual National Standards and Guidelines contains separate chapter on the Rational Use of Blood and Blood Products, which was developed in broad based Guidelines. The decision of giving blood or its product depends upon the clinician. The prescribes of blood / medical professionals need to be therefore made aware of the potential hazards of the irrational use of the transfused blood. A lot of work in terms of equipment provision, manpower training and awareness creation regarding the subject matter remains to be accomplished. The Blood Banks generally lack the requisite equipment for component preparation and storage therefore, proper training of the blood bank staff could not be managed. The users of blood and blood products should therefore be made part of the technical training programmes.

The Hospital Blood Transfusion Committees (HTCs) are non-existent, which serve as the most important monitoring mechanism for the subject mater. Simultaneously the misconceptions regarding the issues like: fresh blood and the use of whole blood need to be addressed. Introduction of the concepts of transfusion medicine and the appropriate use of blood products; promulgation of the clinical guidelines and carrying out clinical audit against these guidelines, all are lacking. For instance, better antenatal care may reduce the incidence of life-threatening obstetric conditions and obviate the need for emergency transfusions.In addition to the above, the availability and accessibility of blood/ plasma substitutes such as pharmacological agents for patients with diathesis, crystalloids/ colloids, haematinics, genetically engineered recombinant products and blood substitutes is also not uniform across the country which leads to inappropriate use of blood and blood products.

Area Goal:

To rationalize the use of blood and blood component therapy thereby reducing the hazards of transfusion through their effective use

Objective 1:

To promote and practice the appropriate clinical use of blood and blood products


Strategy 1.1 Educate the relevant health professional on rational use of blood

Strategy 1.2 Increase the awareness level regarding appropriate use o of blood among general population

Strategy1.3 Training of the prescribes of the blood according to the national guidelines on rational use of blood and blood products

35 36

Strategy 1.4 Disseminate National Standards and Guidelines widely to the relevant health professionals

Strategy 1.5 Ensure the availability of intravenous replacement fluids / plasma expands

Strategy 1.6 Establish Hospital Transfusion Committee to monitor and regulate the practices regarding transfusion medicine

Strategy 1.7 Carry out regular audit using requisite tools

Objective 2:

To discourage the use of whole blood and promote the use of appropriate amount of require component


Strategy 2.1 Carry out the IEC activities with the objective of educating the health professionals as well as community at large

Strategy 2.2 Ensure regular monitoring, supervision and evaluation by the Hospital Transfusion Committee every month

Strategy 2.3 Ensure availability of blood components in appropriate amount and at all levels

Objective 3:

To establish the facilities of component preparation, storage, safe transportation and quality control


Strategy 3.1 Up builds the capacity of blood facilities in a stepwise fashion starting from the tertiary hospitals

Strategy 3.2 Ensure provision of necessary equipment along with backup service

Strategy 3.3 Develop human resources for the purpose

Strategy 3.4 Establish proper Quality Control System in various steps involved in Blood Transfusion i.e. Component Preparation, Storage, Issuance, Transport, Effective use, Inventory control, Recall coordination / communication to reduce wastage of various blood components

Objective 4:

To remain abreast of the future developments and build the capacity accordingly


Strategy 4.1 Coordination with the national and international partners with a view to share

information regarding latest developments

Strategy 4.2 Discuss, develop and implement the national recommendations regarding upcoming developments in transfusion medicine viz. Cell separators Aphaeresis products, Autologus donations, Leuko-depleted products, Irradiated products and use of inexpensive and effective alternatives

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Situation Analysis:

The Quality Assurance / Control is a delicate and essential task of all transfusion centres designed to ensure maximum biological potency and safety of blood and blood products. Quality Management begins with the proper construction of premises and covers the continuous monitoring of equipment and competence of personnel, and the testing of a defined number of units of each product for the appropriate parameters. When unfavorable results are obtained, the procedures must be reviewed and corrective measure taken. The basic aim of quality management is to prevent errors and ensure that every step of the procedure is correctly carried out resulting in the final product of satisfactory quality.Proper quality management is practiced only in a few blood facilities. The BTSs in the country however, do no participate in any External Quality Assessment Scheme. Even the best hierarchal organizational structure of Punjab BTSs in the country with a nucleus (IBTS) supporting 8 regional centres, 26 district hospitals and 60 Tehsil hospitals BBs requires lot of support improvement and sustainability of its quality management system. In Balochistan AJK and Northern Areas, the Blood Transfusion Programme is virtually non-existent except for a small central core in Quetta, Balochistan. The same is true for Peshawar and Abbotabad respectively. The JPMC and AKU BBs are the only two facilities providing service with adequate requirements of QA. In most of the blood centres, there is an inadequate understanding of the most basic principle of Quality Assurance, GLPs and GMPs. There is absolutely inadequate communication between public and the private sectors, including NGOs.

The Quality Management System needs to be developed with the main objective to ensure availability of sufficient supply of a high quality blood and blood components for transfusion with maximum efficacy and cost-effectiveness and minimum risk to both the donors and recipients. The desired Quality Management System should be observed at all the levels of blood transfusion services.Similarly there is no system in place for monitoring by the Blood Transfusion Services. The BTSs in Pakistan will be provided with Hepatitis B and C screening Kits by upcoming enhanced HIV/AIDS Control Programme. This is however subject to the establishment of proper QA and BTS Monitoring System by the respective provinces, AJK, FANA and Federal Capital BTS.

Area Goal:

To ensure availability of sufficient supply of safe blood and blood components with maximum efficacy and minimum risk to both donors and recipients

Objective 1:

To motivate and build quality consciousness among all blood programme staff through appropriate training, total quality management.


Strategy 1.1 Establish the requisite infrastructure catering for the blood needs of the community at all levels

Strategy 1.2 Recruit suitable staff for the blood banks and arrange appropriate training facilities

Strategy 1.3 Arrange facilities of continued training, education / refresher courses and motivational visits to the developed countries with organized blood services

Strategic Area VII:

Objective 2:

To establish quality management system at all steps of the blood transfusion services including procurement & supplies, processing & preparation, design & development


Strategy 2.1 Ensure proper environment at workplace in accordance with the international best practice on the subject

Strategy 2.2 Establish purchase and procurement department for selection / Purchase of Products and service for the blood facilities

Strategy 2.3 Prepare product specification in various steps of blood transfusion services

Strategy 2.4 Adopt advance technologies in various steps of blood transfusion

Strategy 2.5 Establish Monitoring System capable of tracing the laboratory materials from receipt till use/ disposal

Strategy 2.6 Ensure proper transportation, storage and efficient utilization of the available equipment, consumables and laboratory reagents through human resource development

Objective 3:

To coordinate between the public or private sector for broader participation in the quality manage system


Strategy 3.1 Establish internal QC and fully participate in the External Quality Assurance

Strategy 3.2 Arrange reciprocal training of staff at all levels

Strategy 3.3 Build a national and regional network of the blood facilities in order to support each other for anomalies, rare groups and other relevant issues

Strategy 3.4 Maintain a pool of qualified / experienced professionals as advisory panel

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a. National Guidelines and Standards for the Blood Transfusion Servicesb. Disaster Management Plan for National and Regional Blood Transfusion Services

Situation Analysis:

(a) The Ministry of Health has developed very useful and comprehensive manual: “National Standards and Guidelines for Blood Transfusion Services, which was launched on World Health Day 2000. The document is based upon the standard international recommendations adopted in the local context and has three Chapters, which cover all-important aspects contain the state of art instructions for all procedures and practices of Transfusion Medicine including the rational use of blood and blood components.The Guidelines are however, not being observed across the board through a proper mechanism in place. Both the Blood Bank staff and the blood prescribers are not trained on these guidelines nor there does any system for the continuous training programme exist. There is an urgent need to put in place a mechanism through which these Standards & Guidelines could be reviewed after every two years. National Guidelines or General Quality Assurance and Biosafety are also lacking.

The present status of BTSs leaves lot to be desired because of the neglect prevailing over decades towards the transfusion services, which allowed poor quality of practices. Most of the transfusion services, which allowed poor quality of practices. Most of the donations are hospital based where proper facilities are generally lacking. The hospital/ blood bank premises are also not user friendly. The comprehensive observance of the National Standards and Guidelines would essentially depend upon infrastructural support. The suitable premises, trained workforce, requisite equipment, uninterrupted supply of the reagents and strong back up services for blood banks would be essential to complement the implementation of this manual. As an important step, the sensitization and training of blood bank staff and that of the prescribes of blood should be initiated through tailor-made programmes

(b) Blood saves life and the importance of blood transfusion is enhanced manifold during natural or man-made disaster as first line of life saving therapy. The blood under such circumstances is required urgently and in massive quantity. The blood supply should however be managed without and in massive quantity. The blood supply should however be managed without a compromise on the quality otherwise one should be ready to face the consequences of transfusion transmissible infections and wide range of other accidents associated with mismatched blood etc. The management of affectees under such circumstances would cast shadows on the health exchequer creating socio-economic crises.

rdAccording to the report published by the Global Burden of Disease Study, the accidents could be the 3 leading cause of morbidity and mortality by the year 2020. Safe blood transfusion is the foremost and immediate medical intervention, which is required soon after accidents, and surely contributes in saving precious human lives.

The situation demands that the Disaster Management Plans should be developed and made available at all levels of blood transfusion services so as to mitigate the emergency and disaster situations.

Area Goal:

To ensure the adequate supply of Safe Blood at all levels and on all times

Objective 1:

Strategic Area VIII:

To develop and implement uniform instructions and SOPs for all steps of General Laboratory Procedures and Goods Manufacturing Practices involved in transfusion medicine


Strategy 1.1 Review biannually and widely disseminate the guidelines to all Blood Banks in Public and private sector

Strategy 1.2 Develop specific training programme for various categories of Blood Bank staff and the Clinicians (prescribes of blood and blood products)

Strategy 1.3 Arrange and run regular training programmes based on the National Guidelines for the relevant staff of the Blood Banks

Objective 2:

To ensure Implementation of guidelines at all levels and in all procedures


Strategy 2.1 Establish national and provincial Blood Transfusion Authorities and Hospital Blood Transfusion Committees to monitor implementation of the national guidelines

Strategy 2.2 Provide necessary Legislative support for implementation at National/ Provincial level

Strategy 2.3 Training / skills enhancement of the Inspectors on monitoring and supervision

Strategy 2.4 Establishment of proper Quality Assurance in the private and public sector blood facilities

Objective : 3

To ensure sufficient and timely supply of safe blood for transfusion during catastrophes


Strategy 3.1 Develop disaster management plan in consultation with all relevant stakeholders from the public and private sectors after identification of the potential emergency requirements of blood and blood products

Strategy 3.2 Develop a mechanism, which could ensure mobilization during emergency for proper disaster management

Strategy3.3 Computerization of the available blood/blood products and donor base so that the information could be readily made available, when required

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Strategy 3.4 Strengthen the coordination between national, provincial and regional blood banks, NGOs, voluntary donors, private and CMH Blood Banks

Strategy 3.5 Update list of voluntary donors especially rare and negative donor groups

Strategy 3.6 Ensure sufficient storage capacity for donated blood during emergency/ catastrophes

Strategy 3.7 Availability of sufficient consumables required for blood processing before embarking on to the blood donations during emergency.

National Blood Policy Strategic Framework 2003-2007 For...

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