National Blood Policy Strategic Framework 2014-20QA Quality Assurance QC Quality Control QMS Quality...

National Blood Policy

&

Strategic Framework 2014-20

Safe Blood Transfusion Programme

Ministry of National Health Services, Regulation and Coordination

Government of Pakistan

Copyright © 2014 by Safe Blood Transfusion Programme, Ministry of National Health Services,

Regulation & Coordination, Government of Pakistan

All rights reserved.

978 969 9881 18 3

Table of Contents

Abbreviations ............................................................................................................ ii

Preamble ................................................................................................................... iii

Message from the Federal Secretary Mo/NHSR&C ............................................... vi

Executive Summary ................................................................................................ 01

Blood Transfusion Services in Pakistan ............................................................... 03

National Blood Policy ............................................................................................ 05

National Strategic Framework ............................................................................... 07

Cluster 1: Governance ........................................................................................... 08

Cluster 2: Resources.............................................................................................. 11

Cluster 3: Core Business ....................................................................................... 15

Cluster 4: Processes Improvement ........................................................................ 20

Annexes

Annex A Objectives and Indicators of NSF 2014-20 .............................................. 24

Annex B Group Photograph Round Table Consultation, May 2014 ....................... 33

Annex C Group Photograph Round Table Consultation, June 2014 ...................... 37

ii

Abbreviations

AATM Asian Association of Transfusion Medicine

AJK Azad Jammu and Kashmir

BTA Blood Transfusion Authority

BTS Blood Transfusion Services

CUB Clinical Use of Blood

EAD Economic Affairs Division

EQAS External Quality Assessment Scheme

FATA Federally Administered Tribal Areas

FFP Fresh Frozen Plasma

GIZ German International Cooperation

GLP Good Laboratory Practices

GMP Good Manufacturing Practices

HBB Hospital Blood Bank

HRA Health Regulatory Authority

HTC Hospital Transfusion Committee

IBTA Islamabad Blood Transfusion Authority

IBTS Institute of Blood Transfusion Service

ICBS International Consortium on Blood Safety

ICT Information, Communication and Technology

IDTM ID Consulting for International Development of Transfusion Medicine

IHN International Haemovigilance Network

ISBT International Society of Blood Transfusion

KAP Knowledge, Attitude and Practices

KfW German Development Bank

KP Khyber Pakhtunkhwa

MoNHSRC Ministry of National Health Services, Regulation and Coordination

NAC National Advisory Committee

PAC Provincial Advisory Committee

PHN Pakistan Haemovigilance Network

PMP Preventive Maintenance Programme

PRCS Pakistan Red Crescent Society

QA Quality Assurance

QC Quality Control

QMS Quality Management System

RBC Regional Blood Centre

SBTP Safe Blood Transfusion Programme

SOP Standard Operating Procedure

SPC Statistical Process Control

TC Technical Cooperation

TTI Transfusion Transmitted Infection

VNRBD Voluntary Non-Remunerated Blood Donor

WHO World Health Organization

iii

Preamble

Driven by the vision of an integrated blood transfusion service structure

across the country, the Government of Pakistan, in 2008 through its

Safe Blood Transfusion Project, embarked on an ambitious reform

process. The reforms included the formulation of a national blood policy

and strategic framework (2008-12) and the establishment of blood

transfusion programmes at the national and provincial levels including

AJK, FATA and Gilgit-Baltistan. Since its establishment, the Project -

with the support of the German partners - has been able to deliver a

series of outputs which have significantly contributed to the

development of the reform process. The scope of the concept of the Project is being

expanded through the establishment of partnerships between the public, private and NGO

sectors. The interaction with the different stakeholders has deepened the SBTP’s

understanding of the existing ´diversity´ in terms of structures, technology, human resource

capacity and overall organization.

In 2014, work was initiated on the new Framework in an effort to refresh and further

harmonize the priorities for the period 2014-20. The revision was also necessitated as the

experiences gained and lessons learnt in the implementation of the first phase of Programme

(2010-14) needed to be incorporated in the future strategy. The second phase of the project

is going to be launched shortly.

An exercise to revise the "National Blood Policy and Strategic Framework (2008-12)" was

conducted based on a joint evaluation of the achievements under this governance tool. This

new document for the period 2014-20 has also taken into account devolution and

decentralization issues surfacing as result of the recent 18th constitutional amendments. The

strategic part of the policy has been formulated in a way to have more precise public-private

partnership models and take into account a new scenario where the provinces have to bear a

greater share of responsibility of the devolved subjects including the health sector.

In order to build consensus on the new draft of NSF 2014-20, two Round Table Working

Group Consultations were conducted in May and June 2014, under the auspices of the Safe

Blood Transfusion Programme. The Consultations were participated by all the provincial

managers of the Blood Transfusion Programmes, transfusion experts from public, private and

NGO sector blood banks and representatives from the Ministry of National Health Services,

Regulation & Coordination, WHO and other development partners.

This Framework document provides fundamental principles and identifies clear priority areas

that need to be focused in a coordinated manner so that the strategy can be implemented

successfully within a set time frame. The overarching priorities regarding blood transfusion

services that are addressed include: equity; the development of leadership, planning and

management capacity; quality of care and monitoring and evaluation. The new strategy will

also encompass and underscore the significance of linkages among the various vertical

health programmes particularly the Maternal, Neonatal & Child Health, Hepatitis Control and

the HIV/AIDS Programmes. The unique challenges posed by the heavy burden of

thalassaemia disease and its impact on the blood system have also been taken into account

in the future strategy. This document will be revised periodically and consolidated by

iii

Prof. Hasan Abbas Zaheer

iv

incorporating suggestions, guidance and critique from the experts and other key

stakeholders.

The revision of this Framework would not have been possible without the technical assistance

from the German International Cooperation (GIZ). Indeed the support of the German Government

for this project through its Technical Cooperation (TC) component implemented by GIZ and the

Financial Cooperation (FC) component funded by KfW has been critical to the successful

implementation of this project of immense public health importance. The role of the GIZ has been

particularly valuable in developing this document as GIZ has been involved with the project since

its conceptual and preparatory planning stages. The Government of Pakistan acknowledges and

appreciates this support from the German government.

It is also pertinent to mention the Technical Assistance provided by the GIZ for the

development of the Strategic Framework 2014-20. Special appreciation is accorded to Dr. JP

Steinmann, GIZ Principal Advisor and his team of experts including Dr. Imran Durrani and Dr.

Aftab Khawaja for their assistance during the NSF development process. The Programme

acknowledges the facilitation provided by Prof. Dr. Cees Th. Smit Sibinga, GIZ Consultant.

The draft document was subsequently circulated among the various stakeholders and their

feedback was incorporated in the document.

The Programme acknowledges the support and encouragement received from our blood

programme managers, including Dr. Muhammad Jafar Saleem (Punjab), Dr. Zahid Hasan

Ansari (Sindh), Prof. Muhammad Tahir Khan (KP), Prof. Nadeem Samad Sheikh

(Baluchistan), Dr. Naveed Ahmed (AJK), Dr. Sartaj Khan (FATA), and Dr. Abdul Latif (Gilgit

Baltistan), whose advice and recommendations were particularly relevant and invaluable.

Mr. Usman Waheed, Technical Expert, SBTP, deserves a special mention for his dedicated

work in developing and editing this document and for his diligence and hard work which made

the finalization of this document possible.

The document captures local expertise from provincial programmes, public health specialists

and well-reputed blood bank establishments from all over the country. The stakeholders who

have contributed to the development of this document during the two national consultations

include:

Dr. Ashfaq Ahmed (Capital Administration & Development Division, Government of Pakistan)

Dr. Aftab Ahmed Khan (Kulsum International Hospital, Islamabad)

Mr. Asad Ali (Husaini Blood Bank, Karachi)

Dr. Asad Hayat (Shaukat Khanum Memorial Cancer Hospital, Lahore)

Dr. Ashraf Memon (Sindh AIDS Control Programme, Karachi)

Mr. Ashraf Chattah (EPOS-KfW SBT Project)

Dr. Asma Cheema (German Red Cross, Islamabad)

Mr. Ateeq ur Rehman Memon (Pakistan Nat. Accreditation Council, Ministry of Science & Technology)

Prof. Ayesha Junaid (Shifa International Hospital, Islamabad)

Dr. Faiza Fahim (KRL Hospital, Islamabad)

Dr. Farheen Karim (Aga Khan University Hospital, Karachi)

Dr. Farrukh Hasan (Asian Association of Transfusion Medicine)

Dr. Guenter Merck (EPOS-KfW SBT Project)

Prof. Haroon Khan (Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad)

v

Dr. Huma Qureshi (Pakistan Medical and Research Council, Islamabad)

Prof. Inayat Hussain Thaver (Health Services Academy, Islamabad)

Brig. Javed Usman (Army Medical College, Rawalpindi)

Prof. Khurshid Ahmed (National Institute of Health, Islamabad)

Dr. Kiran Tauseef (Al-Nafees Medical College, Isra University, Islamabad)

Dr. Lubna Tahir Aziz (Fauji Foundation Hospital, Rawalpindi) Dr. Malik Zeb Khan (Institute of Kidney Diseases, HMC, Peshawar)

Dr. Masuma Zaidi (KfW Country Office, Islamabad)

Dr. Muhammad Anwar (Jinnah Postgraduate Medical Centre, Karachi)

Mr. Muhammad Asim Ansari (Kulsum International Hospital, Islamabad)

Prof. Muhammad Farooq Khattak (Quaid-i-Azam International Hospital, Islamabad)

Prof. Muhammad Irfan (Liaqat National Hospital, Karachi)

Dr. Muhammad Imran (Nishtar Hospital, Multan)

Mr. Muhammad Khalid (Blood Transfusion Authority, Khyber Pakhtunkhwa)

Dr. Muhammad Usman Cheema (Islamia University of Bahawalpur, Bahawalpur)

Mr. Muhammad Zakir (Khyber Pakhtunkhwa Safe Blood Transfusion Project)

Dr. Munira Borhany (National Ins. of Blood Disease & Bone Marrow Transplantation, Karachi)

Dr. Nadeem Nusrat (Dow University of Health Sciences, Karachi)

Dr. Naureen Saeed (Holy Family Hospital, Rawalpindi)

Prof. Nisar Ahmed (Children Hospital and Institute of Child Health, Lahore)

Brig. Dr. Nuzhat Salamat (Armed Forces Institute of Transfusion, Rawalpindi)

Dr. Quaid Saeed (World Health Organization)

Dr. Rashid Azeem (Blood Transfusion Authority, Khyber Pakhtunkhwa)

Dr. Roohi Khalil (Federal Government Polyclinic Hospital, Islamabad)

Mr. Rumi Dossal (Fatimid Foundation, Karachi)

Prof. Saba Jamal (Indus Hospital, Karachi)

Dr. Sabeen Afzal (Ministry of National Health Services, Regulation & Coordination)

Dr. Saeed Ahmed (Husaini Blood Bank, Karachi)

Dr. Saif ur Rehman (Pakistan Red Crescent Society, Islamabad)

Dr. Sarfraz Hussain Jaffri (Husaini Blood Bank, Karachi)

Prof. Shahida Mohsin (University of Health Sciences, Lahore)

Dr. Shahtaj Khan (Hayatabad Medical Complex, Peshawar)

Dr. Shamshad Ahmed (Bahawal Victoria Hospital, Bahawalpur)

Dr. Sher Zaman Khan (Blood Transfusion Authority, Baluchistan)

Dr. Syed Imtiaz Hasan (Federal Government Polyclinic Hospital, Islamabad)

Mr. Syed Shahid Ali Zaidi (Ali Zaib Foundation, Faisalabad)

Prof. Tahira Zafar (Peshawar Medical College, Peshawar)

Dr. Wasiq Paracha (Patients Welfare Association, Karachi)

Mr. Zahid Mahmood (EPOS-KfW SBT Project)

Dr. Zahida Qasim (DHQ Hospital, Mirpur Azad Jammu Kashmir)

The SBT Programme is grateful to the Federal and Provincial Health Departments for their

kind patronage and continuous support to implement the Government of Pakistan’s blood

system safety reforms in their respective provinces and regions despite administrative and

constitutional challenges.

Prof. Hasan Abbas Zaheer

National Coordinator


Ministry of National Health Services, Regulation & Coordination


June 2014

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vi

Message from the Federal Secretary Ministry of National Health Services, Regulation & Coordination


The blood transfusion services in Pakistan are fragmented and demand driven, where all

partners work independently with limited regulatory oversight. This heterogeneous state of

affairs makes provision of quality service to the large population a very challenging task. To

improve this state of affairs, in 2008 the Government of Pakistan developed a vision of an

integrated blood transfusion service as recommended internationally and practiced in most of

the countries of the world. This policy decision led to the introduction of an ambitious blood

safety systems reforms process in the country through the platform of the Safe Blood

Transfusion Programme (SBTP), a national project co-funded by the governments of

Pakistan and Germany. The aim of the project is to develop a new infrastructure consisting of

a network of new Regional Blood Centres linked to existing Hospital Blood Banks. The

functioning of the new infrastructure will be in compliance with the international practices,

guidelines and recommendations.

To ensure a sound planning base for the future, the SBTP under the supervision of Ministry

of National Health Services, Regulation & Coordination adopted a systematic and

participatory approach to revise the National Strategic Framework. A number of Technical

Experts from the provincial blood programmes, public and private sectors and the Armed

Forces were invited to review and revise the NSF 2008-12. The well-attended national

consultation, supported by the GIZ Health Sector Support Programme Pakistan, brought

transfusion experts and stakeholders on a single platform to discuss and identify the future

priority areas of the SBTP especially in the light of the experience gained in the

implementation of the first phase of the project which is now nearing successful completion.

The subject document is the output of two rounds of exhaustive national consultations

conducted in May and June 2014.

The Safe Blood Transfusion Programme remains high on the priority of the present

Government and its continued commitment to this vital public health project is again going to

be demonstrated with the signing of the second phase of the project in the very near future.

Consolidating the gains of the first phase of the project and strengthening the Programme as

it enters its second phase will be the key focus and challenge for the future strategy. The

technical support of the German Government implemented through GIZ remains critical for

the project and I would like to thank the German Government for supporting this very

important public health initiative.

The Safe Blood Transfusion Project can truly be termed a success story as despite serious

administrative and constitutional challenges, the Programme implementation was not allowed

to suffer and a solid foundation of a sustainable blood transfusion system has been laid in the

country. Prof. Hasan Abbas Zaheer deserves credit for consolidating and strengthening this

initiative and under his leadership this project was conceived, conceptualized and pioneered.

I am confident that he along with the provincial managers and other stakeholders will

continue to steer the project to greater heights.

Mrs. Rashida Malik

Secretary

Executive Summary

a. Background

The multifaceted concept of blood safety implies collecting blood from healthy voluntary

donors, ensuring proper storage of blood, screening donor blood to ensure that it is safe from

transmissible infections, preparing blood components and avoiding irrational clinical use.

Considering the fact that provision of a safe unit of blood to an individual in need is a basic

human right, the Government of Pakistan has decided to launch a nationally organized and

coordinated blood transfusion service that would meet the nation’s routine and emergency

requirements of blood. Development of a National Policy and Strategic Framework 2014-20

for Blood Transfusion Services (BTS) is a step in this direction.

b. Purpose and Guiding Principles

The basic purpose of the exercise, to formulate a National Strategic Framework for the years

2014-20 in the light of the National Blood Policy, is to enhance and build up the Blood

Transfusion Services of the country. This document was envisioned to guide the wide range

of partners involved in the BTS strengthening efforts. Based on nationwide Round Table

consensus meetings, held in 2014, the document was further improved and provides

fundamental principles and identifies clear priority areas, which need to be focused in a

coordinated manner in order to ensure a successful outcome of implementation within a set

time frame.

The participation of a wide range of partners in the formulation of the National Strategic

Framework served to enhance ownership, facilitate an expanded response and increase

resource mobilization.

For realistic and practical reasons of implementation, 4 major logical managerial clusters will

be followed:

Cluster 1 – Organization, Structure and Management (governance)

Strategic Areas covered in this cluster deal with:

a) Managerial and governing structure

b) Legal and regulatory affairs

Cluster 2 – Resources (human, education, facilities, consumables, equipment, quality

system and quality management)


a) Facilities, equipment, consumables and laboratory reagents

b) Human capacity building (personnel and education/training)

c) Quality systems and Quality Management

d) Financing, budget and health insurance issues (providing the basic infrastructure

for a sustained blood supply system in the country)

e) Data management and ICT (Information, Communication and Technology)

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2

Cluster 3 – Core business (collection, processing and testing, storage and distribution,

clinical use)


a) Donor management including the community interface

b) Screening for transfusion transmissible infections

c) Processing of blood – component production

d) Biosafety/Waste management (with special reference to infection control practices

and management of bio-hazardous waste).

e) Clinical interface, in-hospital transfusion chain and rational use; haemovigilance

f) Logistics – collection and supply (cold chain, planning) providing the objectives and

related strategies for the day to day operations of the blood supply and clinical use

Cluster 4 – Sustainability and improvement of processes (monitoring and evaluation,

planning, research and development)


a) Monitoring and evaluation

b) Planning (Short and long term)

c) Research and development

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 a proactive

role for the purpose:

1. Ministries of National Health Services Regulation and Coordination, Capital

Administration & Development Division, Ministry of Education, Culture and Youth,

Municipalities, Women Affairs, Religious Affairs, Law & Justice, Communication, Labor /

Manpower and Industries

2. Provincial Health Departments and all other relevant Departments

3. Armed Forces Institute of Transfusion (AFIT), Pakistan Red Crescent Society (PRCS)

4. Private Sector Organizations such as Aga Khan University (AKU), Baqai Medical

University, etc.

5. Non-Governmental Organizations such as the Fatmid Foundation, Husaini Blood Bank,

etc.

6. International Organizations such as GIZ, KfW, WHO, USAID, International Federation of

Red Cross and Red Crescent Societies, International Society of Blood Transfusion, Asian

Association of Transfusion Medicine, International Consortium for Blood Safety (ICBS)

and other development/donor organizations.

3

Blood Transfusion Services in Pakistan

The Islamic Republic of Pakistan is the sixth most populous country in the world with a

population of 180 million. Literacy rate is 49.5% and the population growth rate is 2.03%.

The health care system in Pakistan faces numerous challenges and operates through a

three-tier delivery structure and a variety of public health interventions. The role of private

sector is growing and according to an estimate its share has reached 75%. The overall

health regulatory framework is limited and inadequate. The total expenditure on health is

2.5% of the GDP. Following the implementation of the 18th amendment of the constitution in

June 2011, functions related to health were devolved to the provincial/state health

departments.

The blood transfusion service in Pakistan is fragmented and largely the result of proliferation

of different types of blood establishments with predominant reliance on the ‘Family

Replacement Donors’. The role of the private non-profit sector in blood transfusion has

increased over the past few decades largely as a result of increase in the demand of

transfusion driven to a large extent by the huge burden of thalassaemia disease in the

country. The total number of blood centres is estimated to be 1,830 with a major contribution

by the private/NGO sector.

In 2004, the National AIDS Control Programme (NACP) submitted a proposal to the

Economic Affairs Division (EAD), within the framework of Pakistan-German Official

Cooperation, related to enhanced blood safety in Pakistan. A feasibility study was conducted

in 2007 by a joint mission of GIZ and KfW. The study recommended conversion of the

scattered system of public and private blood establishments to a centralized system of blood

collection and processing that is in line with WHO standards and increase quality and safety

of blood products (through automated processing and quality assurance) and improve cost-

effectiveness. In 2008, blood safety systems reforms were initiated by the government

through this joint project. The reforms included the formulation of a National Blood Policy

and Strategic Framework. In June 2010, the Federal Ministry of Health decided to establish

Blood Transfusion Programmes at the National and Provincial levels as a separate entity

outside of NACP. At the federal level, the Programme performs the role of central

coordinating body to oversee policy planning, provide strategic guidelines, set standards,

monitor and evaluate programmes, liaise with development partners and report on

international commitments.

The Programme is supported by the Government of the Federal Republic of Germany

through its Technical and Financial Cooperation components. The Technical Cooperation

(TC) component is implemented by GIZ [German Agency for International Cooperation] and

is part of the GIZ Health Sector Support Programme. The TC component works to improve

access to safe blood and blood products by providing advisory services concerning

organization and governance of the system including Management Information System,

Voluntary Non-Remunerative Blood Donations, Clinical Use of Blood, Legal and Regulatory

Framework, Quality Management and Capacity Development. The outputs of the TC

component over the last four years have strengthened the national blood safety system

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4

reforms process. The Financial Cooperation (FC) component of the project funded by KfW,

the German cooperative bank, is responsible for the development of the new infrastructure

which consists of constructing and equipping a network of Regional Blood Centres, and

renovation and refurbishment of the existing Hospital Blood Banks. Development of 10

Regional Blood Centers and up-gradation of 60 existing Hospital based Blood Banks through

the FC component is now in its final stages.

The fragmented blood transfusion system in the country lacks a reliable and healthy donor

base and a registry of voluntary non-remunerated regular donors. Blood donors are mostly

replacement donors, as the rate of voluntary blood donations is low. According to the data

collected from 297 blood banks by SBTP for WHO global database on blood safety, there

were 12.35% voluntary non-remunerated blood donations while 87.65% were

replacement/family donations in the year 2012. With the objective of harmonization in donor

management and ensuring blood safety, a national donor policy was developed by SBTP in

2011, for adoption by all institutions involved in blood collection.

The SBTP, operating at the federal level, is providing a facilitation role, while local expertise

is activated and captured and interactive knowledge management processes take place in

lieu of traditional external inputs. The objective is to establish the core elements of an

independent rational structure of a national blood transfusion system that will ensure

adequate, efficient and safe blood supply, in a cost effective manner.

Until the establishment of the Safe Blood Transfusion Programme in 2010, there was no

national voice or platform for blood transfusion in Pakistan. All the stakeholders worked in

isolation in the fragmented system. The SBTP has over the years through its various regular

and diverse activities brought all the stakeholders on a single platform. The various national

consultations to develop operational tools, policies, frameworks, seminars, training

workshops etc. have provided an excellent opportunity for all concerned to interact, share

experiences and learn from each other. As a result of these networking opportunities, the

SBTP is now the recognized national voice of Pakistan on all issues related to transfusion.

National and international partners also recognize the SBTP as the national blood

organization that represent Pakistan’s national viewpoint on all issues related to blood

transfusion. As a result of the successful implementation of the project in the last four and a

half years, Pakistan has now firmly secured a place on the world map of blood transfusion.

The Programme leadership is frequently invited to represent the country at international

meetings to share the progress and achievements of its blood safety systems reforms.

5

National Blood Policy

Mission

National Blood Policy will ensure access to safe, efficacious and affordable blood for all

citizens of Pakistan.

Policy

Development, implementation, organization and management of National Blood Transfusion

Services that is able to meet blood demand of the country from voluntary non-remunerated

blood donors in a manner that is safe, effective, equitable, non-profitable, sustainable,

rational, without wastage and protection of donor and healthcare workers’ rights and safety.

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 Blood Transfusion Services at national and

regional levels

2. Define the role(s) of the public / private sector

3. Capacity Building, Resource Mobilization and Financing

4. Procurement of equipment, consumables and laboratory reagents

5. Motivation, recruitment and retention of blood donors

6. Safe blood collection and storage as per national standards

7. Screening of blood and blood products for five Transfusion Transmissible Diseases

(HCV, HBV, HIV, Syphilis and Malaria)

8. Ensure bio-safety with special reference to infection control practices and management

of infectious waste

9. Practicing and promoting rational use of blood and blood products

10. Quality management and monitoring of the blood transfusion services (haemovigilance).

11. Establishment of hospital transfusion committees

12. National Guidelines and Standards for national and regional blood transfusion services

and Disaster Management Plans at the national and regional levels

13. Develop curricula and start diploma / degree programme for blood bank technicians and

doctors

14. Establish reference blood bank center to deal with problem samples

Federal Health Ministry and the Provincial Health Departments shall:

• Establish Blood Transfusion Services on the pattern recommended by the National and

Provincial Advisory Committees.

• 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 Advisory Committee

• Establish reference centers for the Blood Transfusion Services for training, research and

development at the Federal and Provincial Headquarters including AJK and Gilgit

Baltistan.

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• Establish and institutionalize the Management Information system (MIS) for effective

monitoring and evaluation of Blood Transfusion services.

• Educate, motivate, recruit and retain voluntary, non-remunerated blood donors.

• Develop technical manual, quality manual, standard operating procedures (SOPs) and

equipment operating procedure (EOP) for the blood transfusion services.

• Establish facilities for safe plasma fractionation.

• Ensure that all legislations and regulations are implemented and followed according to

national recommendations.

• Resource mobilization from all possible sources.

Safe Blood Transfusion Programmes shall:

1. Aim at safe collection of all blood and blood components only from voluntary, non-

remunerated donors who meet the laid down national standards for blood donors in such

a way that the health and well-being of the donors, recipients and health workers are not

compromised.

2. Be responsible for

a. Collection of whole blood, and then preparation of blood components

b. Ensuring high quality and yield of plasma and platelets derivatives

c. Distribution of blood and blood components to the hospitals under strict quality

control.

d. Haemovigilance

Legislative and Regulatory Control shall:

The Federal and Provincial Blood Transfusion Authorities shall ensure the implementation of

the approved laws, to ensure high quality services and availability of adequate safe blood

and blood products, through monitoring (registration and licensing) of the blood banks

according to the mandate given to the respective authorities under the respective

Ordinances/Acts.

National and Provincial Advisory Committees shall:

The National and Provincial Advisory Committees shall monitor the overall progress of the

Blood Transfusion Services in their respective region, and advice the Provincial Health

Departments and Federal Ministry of National Health Services, Regulation and Coordination

in accordance with the mandate given to these Committees.

7

National Strategic Framework 2014-20

Purpose and Guiding Principles

The basic purpose of formulating a National Strategic Framework for the years 2014-20 in

the light of National Blood Policy is to provide a sound base for future planning of the Blood

Transfusion Services in the country. This document is envisioned to guide the wide range of

partners who are or could be involved in the BTS strengthening efforts. Based on the Round

Table Consultations held in May and June 2014, the document provides fundamental

principles and identifies clear priority areas, which need to be focused in a coordinated

manner in order to ensure a successful outcome of implementation within a set time frame.

The participation of a wide range of partners in the formulation of the National Strategic

Framework ensured enhanced ownership, input from a diverse range of stakeholders and

professionals. The extensive and exhaustive consultations also helped identify existing and

potential sources of resource mobilization.

Clusters

For realistic and practical reasons of implementation, it is decided to consolidate the 4 major

logical managerial clusters as follows:

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Cluster 1: GOVERNANCE

(Organization, Structure and Management of the Blood Transfusion Service) This cluster deals with the organization and structure as well as the management system of the Blood Transfusion Service nationwide. The main fields of attention are the:

a) Managerial and governing structures; and

b) Legal and regulatory affairs

In this cluster, there are 9 priority objectives that are translated into 32 activities.

Objective 1: To establish organizational structures for national, provincial and district

Blood Transfusion Services (BTS) including AJK, ICT, FATA and Gilgit-Baltistan

Activity 1.1 Establish complete and operational management structures in all Provinces

including AJK, ICT, FATA and Gilgit Baltistan

Objective 2: To identify the roles and responsibilities of planning, coordination,

financial management and routine operations at national and provincial levels

including AJK, ICT, FATA and Gilgit-Baltistan

Activity 2.1 Planning, coordination, resource mobilization and quality assurance of

transfusion related reagents and equipment shall be done by the National Coordinator BTS,

guided and advised by the National and Provincial Advisory Committees

Activity 2.2 Management, human resource development, monitoring and evaluation of BTS

by respective BTS Programme Manager of all Provinces including AJK, ICT, FATA and

Gilgit-Baltistan

Activity 2.3 Development and management of routine operations of the Blood Transfusion

Centres at District and Tehsil level under supervision of respective Director and Provincial

Programme Manager.

Objective 3: To establish reference centres/laboratories at national and provincial

level including AJK, ICT, FATA and Gilgit Baltistan

Activity 3.1 Establish state of the art reference centres for solving problems in donor/patient

sample, quality assurance of equipment and transfusion related reagents at the

national/provincial level

Activity 3.2 Arrange periodic training of the relevant professionals on quality assurance and

advance blood banking techniques in centres of excellence locally and abroad

Activity 3.3 Conduct periodic monitoring, surveillance and need assessments of skilled

manpower working in RBCs and HBBs

9

Objective 4: To define the roles and responsibilities and strengthen coordination

among armed forces, public, private and NGO sectors

Activity 4.1 Encourage the private sector for sharing transfusion requirements of the

community with public sector.

Activity 4.2 Conduct surveys for evaluation of the status of the Blood Banks/RBCs and

HBBs in private as well as public sectors

Activity 4.3 Implement the national blood policy in both the public and private sectors to

meet national standards of BTS

Activity 4.4 Arrange and provide technical support to various public and private institutions

through the respective Blood Transfusion Programmes

Activity 4.5 Provide facilities of advanced training to the public and private sector

professional/ technical staff in the Safe Blood Transfusion Programme

Objective 5: To ensure the participation and support of private sector, NGOs and

other institutions for strengthening of blood transfusion services

Activity 5.1 Establish a national network for collection of haemovigilance data from all the

public and private sector centres

Activity 5.2 Organize regular seminars and meetings for all partners

Objective 6: To implement regulatory framework via Blood Transfusion Authorities

Activity 6.1 Activation, capacity building and strengthening of all the Blood Transfusion

Authorities

Activity 6.2 Specialized training of Managers, Secretaries, and Inspectors and the technical

staff

Activity 6.3 Adopt and use the inspection tools (Functional Brief for BTAs)

Activity 6.4 Designate blood banks according to their services. Basic requirements should

be uniformly adopted by all licensed blood banks

Activity 6.5 Conduct regular inspections of Blood Transfusion Centres both in public,

private, NGO sectors, and Armed Forces, in accordance with the formulated technical

Standards for transfusion services and respective Acts/Ordinances

Activity 6.6 Formulate and recommend measures to standardize or improve Blood

Transfusion practices in collaboration with National and Provincial Advisory Committees

9

10

Activity 6.7 Collect haemovigilance data from all blood banks in the public and private

sectors in all the provinces and share it with the SBTP for analysis and compilation of annual

report.

Activity 6.8 Disseminate annual report compiled by SBTP

Activity 6.9 Ratify the draft law prepared to harmonize the legal framework

Objective 7: To enhance the political advocacy and commitment at national and

provincial levels (including AJK, ICT, FATA and Gilgit-Baltistan) amongst all partners

Activity 7.1 Increase awareness among the policy and decision makers about the

importance of safe blood transfusion by organizing advocacy seminars, conferences and

workshops at federal, provincial, regional and district levels

Activity 7.2 Collect and disseminate data on Transfusion Transmissible Infections, to

sensitize the policy makers about the significance of blood safety

Activity 7.3 Involve policy makers in blood safety promotion activities

Objective 8: Nationwide Need Assessment Surveys

Activity 8.1 Each regional blood centre shall produce an annual report with relevant

managerial and operational data

Activity 8.2 The RBCs shall provide annual reports to the respective provincial BTA and

BTS

Activity 8.3 BTS shall compile the RBC annual reports into a provincial annual report and

submit to respective DOH and to SBTP

Objective 9: Development of National Thalassaemia Policy and Action Plan

Activity 9.1 Conduct a rapid situation analysis

Activity 9.2 Organize a National Consultation with participation of Thalassaemia Federation

of Pakistan, concerned experts, stakeholders, NGOs, patients etc

Activity 9.3 Formulation of a National Thalassaemia Policy, Strategic Framework and an

Action Plan in the National Consultation

11

Cluster 2: RESOURCES

(Human, education, facilities, consumables and equipment, quality system and quality management) This cluster deals with the key resources needed for the operations of the organization. The main fields of attention are:

a) Human capacity building (personnel and education/training)

b) Facilities, equipment, consumables and laboratory reagents

c) Quality systems and Quality management

d) Financing, budget and health insurance issues (providing the basic infrastructure for a

sustained blood supply system in the country)

e) Disaster management

f) Data management and ICT

In this cluster, there are 7 priority objectives that are translated into 43 activities

Objective 1: To strengthen the human resource of the Blood Transfusion Services in

terms of infrastructural support and competency enhancement (knowledge and skills)

of the human resource

Activity 1.1 Carry out a need assessment / situation analysis of existing capacity

development and academic programmes including infrastructure, their manpower and

curricula etc

Activity 1.2 Calculate the financial requirements based upon the situation analysis

Activity 1.3 Develop standardized and uniform curricula / training materials for teaching and

training of the human resource at all levels (managerial and technical) in coordination with

relevant stakeholders

Activity 1.4 In consultation with the PMDC (Pakistan Medical and Dental Council), medical

colleges may be asked to highlight the importance of transfusion medicine through lectures,

seminars and training workshops for medical students and medical officers. Transfusion

Medicine may be included as a minor subject in the final year MBBS and nursing course. For

young doctors, 4 weeks house job should be mandatory in any blood bank attached with

thalassaemia / haemophilia / blood diseases centre. During internship, doctors should be

posted in blood banks to gain some hands on experience and exposure. Doctors working in

blood centres may be given opportunities to acquire postgraduate qualifications in

transfusion medicine

Activity 1.5 Appoint managers with appropriate qualification for the management of regional

blood centres

Activity 1.6 Develop a service structure for those working in blood transfusion services

including standardized job description, training curricula and career development

11

12

Activity 1.7 Arrange regular on job trainings for relevant professionals at selected quality

blood centres through Blood Transfusion Programmes

Activity 1.8 Continue to seek technical advice from development partners for strengthening

the Blood Transfusion Services

Activity 1.9 Organize academic programmes in coordination with relevant national /

international partners

Objective 2: To carry out need assessment of the blood transfusion facilities with a

view to highlight key deficiencies and identify potentially functional facilities to

transform into regional centers (public and private)

Activity 2.1 Carry out detailed situation analysis of the existing blood facilities(public and

private sector) with reference to their overall location, floor space, demand, workload,

existing equipment, consumables and laboratory reagents, availability of trained manpower

in each province / area including maintenance and repair of equipment, etc.

Activity 2.2 Categorize the blood facilities according to their work load, facilities and

resources

Activity 2.3 Study the existing procurement and storage procedures (both cold chain and

consumables) in detail, and identify and address gaps

Activity 2.4 Assess the existing practices of record keeping, auditing & reporting, monitoring

& evaluation

Activity 2.5 Summarize the findings and present to the Provincial BTS and DOHs

Objective 3: To ensure equipment maintenance, availability of consumables and

laboratory reagents in the facilities

Activity 3.1 The operational tools developed by the SBTP should be finalized on priority.

Pre-testing of developed operational tools should be carried out in selected blood centres.

Finally all EOPs/SOPs may be reviewed and upgraded with corrective and preventive action

Activity 3.2 Arrange critical equipment, consumables and laboratory reagents along with

storage facilities in all blood banks (RBCs and HBBs) according to standards

Activity 3.3 Ensure regular preventive and maintenance programme (PMP)

Activity 3.4 Design and implement proper Quality Assurance (Management) System in each

facility

Activity 3.5 Design a forecasting system for future requirements so as to ensure timely

requisitions and supplies

13

Activity 3.6 Reference laboratories shall validate consumables, in particular TTI and

immunohaematology reagents and related equipment

Activity 3.7 Coordinate with the national and international quality assessment schemes

(QAS)

Objective 4: To establish a national quality management system at all steps of the

blood transfusion services (vein to vein) including procurement and supplies,

processing and testing (QC), design and development

Activity 4.1 Develop a GMP and ISO based National Quality System (QS) and Quality

Management System (QMS)

Activity 4.2 Ensure proper quality and hygiene standards at workplace in accordance with

the international best practices (cGMP, cGLP, cGCP)

Activity 4.3 Establish purchase and procurement systems for selection / purchase of quality

products and services for the blood facilities

Activity 4.4 Prepare product specifications in line with international requirements

Activity 4.5 Establish a Monitoring and Evaluation System (M&E) for tracing vein-to-vein

donors, blood and blood components, laboratory consumables from receipt till use (patients)

/ disposal, and performance outcomes (statistical process control or SPC)

Activity 4.6 Ensure safe transportation, storage and efficient utilization of available

equipment, consumables and laboratory reagents (maintain cold chain)

Activity 4.7 Establish internal QC and participate in the External Quality Assurance

Schemes. After viewing the results take appropriate steps for improvement

Activity 4.8 Build a national and regional network of the blood centres in order to support

each other for anomalies, rare groups and other relevant issues

Objective 5: To ensure prioritized and sustainable allocation of resources for the

blood transfusion services

Activity 5.1 Ensure that sufficient resources are allocated at Federal and Provincial levels

Activity 5.2 Conduct advocacy meetings with concerned national and international agencies

with a view to mobilize additional resources for BTS

Activity 5.3 Plan for contribution / services charges (business plan) based on cost recovery

in order to ensure sustained availability of financial resources

13

14

Objective 6: To formulate a contingency / disaster management team consisting of

blood bank doctors and technicians at national, provincial level to ensure sufficient

and timely supply of reagents / blood bags, etc. in catastrophic areas for safe supply

of blood for transfusion during catastrophes (contingency / disaster management)

Activity 6.1 Develop contingency / disaster management plan in consultation with National

and Provincial Disaster Management Authorities (N/PDMA), National Health Emergency

Preparedness and Response Network (NHEPRN) and all relevant stakeholders from the

public and private sectors after identification of the potential emergency requirements of

blood and blood products

Activity 6.2 Develop a mechanism, which could ensure mobilization of donors during

emergency for proper contingency / disaster management

Activity 6.3 Computerization of the available blood/blood products and donor base so that

the information could be readily made available, when required

Activity 6.4 Strengthen the coordination between national, provincial and regional blood

banks, NGOs, voluntary donors, private and armed forces hospital blood banks

Activity 6.5 Continuously update the list of voluntary donors, especially rare and Rhesus D

negative donor groups

Activity 6.6 Ensure sufficient storage and transportation capacity for donated blood during

emergency/catastrophes

Activity 6.7 Availability of sufficient consumables required for blood processing and testing,

before embarking on to the blood donations during emergency

Activity 6.8 Staff training to deal with a disaster situation

Objective 7: To develop a computer based harmonized management information

system

Activity 7.1 Development of data management tools

Activity 7.2 Development of information system and database

Activity 7.3 Computerization of all existing relevant information in the database

15

Cluster 3: CORE BUSINESS

(Collection, processing, testing, storage, distribution and rational clinical use of blood

and blood products)

This cluster deals with the core business of blood supply and clinical use of blood and blood components. The main fields of attention are:

a) Donor management including the community interface

b) Screening for transfusion transmissible infections

c) Processing of blood – component production

d) Biosafety/Waste management (with special reference to infection control practices and

management of bio-hazardous waste).

e) Clinical interface, in-hospital transfusion chain and rational use; haemovigilance

f) Logistics – collection and supply (cold chain, planning) providing the objectives and

related strategies for the day to day operations of the blood supply and clinical use

In this cluster, there are 9 priority objectives that translate into 61 Activities.

Objective 1: To establish a Department of Donor Management within Blood

Transfusion Services

Activity 1.1 Design a comprehensive and multidimensional nationwide blood donor

motivation, mobilization and retention programme

Activity 1.2 Implement the National Blood Donor Policy

Activity 1.3 Appoint adequate number of competent staff with allocation of funds for their

capacity building.

Activity 1.4 Encourage the participation of voluntary donor associations and NGOs in donor

motivation efforts

Activity 1.5 Develop the process description and related SOPs for voluntary donor

motivation, mobilization and retention

Activity 1.6 Establish and maintain proper information system and database on voluntary

donors

Objective 2: To aim at motivation and retention of 100% voluntary non-remunerated

blood donors, preferably on a regular basis, for safe transfusion of blood and blood

products

Activity 2.1 The Donor Departments shall organize motivation and retention programmes at

all levels

15

16

Activity 2.2 Conduct regular motivational activities for the promotion of voluntary blood

donation

Activity 2.3 Identify appropriate (low risk) target groups for voluntary non-remunerated blood

donation by proper counseling facilities

Activity 2.4 Define and adhere to internationally accepted (WHO) donor selection criteria

Activity 2.5 Ensure adequate and appropriate donor care, satisfaction and donor safety

Activity 2.6 Ensure proper appreciation and recognition of VNRBDs

Activity 2.7 Involve VNRBDs in promotional activities

Activity 2.8 Organize Club 25 in all major cities

Activity 2.9 Strengthen university based BDOs, establish their network and exploit their true

potential

Activity 2.10 Computerize donor registry and establish a regular call-up system

Activity 2.11 Establish a mechanism to provided pre-donation information as well as

information and guidance of screening results, ensuring proper confidentiality

Activity 2.12 Ensure appropriate management and counseling of deferred donors

(temporary and permanent) and introduce a nationwide register of permanently deferred

donors

Activity 2.13 Motivate and convert family/replacement donors into regular VNRBDs

Activity 2.14 Promote the concept of BDO network

Activity 2.15 Introduce the blood safety concept in school curricula

Activity 2.16 Establish Societies and Clubs for awareness about blood safety

Activity 2.17 Arrange motivation lectures and donation camps at educational institutions,

industrial units and public places

Activity 2.18 Celebrate World Blood Donor Day and reiterate Government commitment to

provide safe and adequate blood and blood products in addition to promoting regular

voluntary blood donations

Activity 2.19 Develop socially and culturally acceptable motivational messages and

promotional material by professional experts using mass media for the general public

17

Activity 2.20 Coordinate with the Ministries of Health, Education, Culture & Youth,

Municipalities, Women Affairs, Religious Affairs, Law & Justice, Interior, Communication,

Labor/Manpower, Industries, and Social Welfare Departments

Activity 2.21 Appoint and train motivators, to coordinate with BDOs, NGOs

Activity 2.22 Identify potential low risk groups in the community

Objective 3: To carry out regular nationwide KAP surveys and studies to allow design

of a well-focused and sustained public oriented donor motivation and mobilization

programme

Activity 3.1 Involve Faculties of Sociology, Behavior Sciences, and Psychology in

Universities to design and structure an appropriate and targeted KAP surveys and studies

Activity 3.2 Utilize the earlier studies conducted by the Safe Blood Transfusion Programme

Objective 4: To ensure 100% screening of donated blood for Transfusion

Transmissible Infections (TTIs)

Activity 4.1 Ensure appointment of adequate, competent and well-trained human resource

to ensure proper screening of blood for TTIs

Activity 4.2 Implementation of National Standards on TTI screening (HCV, HBV, HIV,

syphilis and malaria)

Activity 4.3 Ensure resource allocation for adequate and sustainable supply of validated

screening assays and required accessories

Objective 5: To establish the facilities for component preparation, storage, adequate

transportation and quality control

Activity 5.1 Develop capacities to ensure 100% component preparation and discourage the

routine use of whole blood

Activity 5.2 Ensure availability of quality assured blood components in sufficient amount

Activity 5.3 Design and implement process descriptions and related SOPs/EOPs for

collection, processing, testing, storage and distribution (transportation) of blood and blood

products, in-hospital ordering, compatibility testing and transfusion

Activity 5.4 Ensure provision of necessary equipment along with backup services and

maintenance (backup power supply, spare parts)

17

18

Activity 5.5 Establish a proper Quality Control System for all steps involved in processing of

blood, i.e. component preparation, testing, storage, issuance, transport, inventory control,

recall coordination / communication to reduce wastage of blood components

Activity 5.6 Harmonize equipment, consumables and transportation system for blood

collection, processing, testing and storage and distribution

Activity 5.7 Establish a proper storage system for blood and blood products (cold chain)

having uninterrupted power supply and back up, and after sales service agreements

Activity 5.8 Ensure provision of proper transport containers and vehicles, and all other

equipment required for transportation of blood, blood products, blood bags, reagents, etc.

Activity 5.9 Ensure documentation of every step of collection, processing, testing, storage

and distribution of donated blood

Objective 6: To promote and practice appropriate clinical use of blood and blood

products

Activity 6.1 Educate the relevant health professionals on rational use of blood and the use

of alternatives

Activity 6.2 Ensure implementation of guidelines on clinical use of blood at all levels

Activity 6.3 Establish a mechanism for periodic information sharing

Activity 6.4 Establish Hospital Transfusion Committees to monitor, evaluate and regulate

the in-hospital practices regarding transfusion medicine

Activity 6.5 Ensure regular meetings of the Hospital Transfusion Committees (HTCs) to

evaluate the implementation of the CUB guidelines and occurrence of all untoward event

(haemovigilance)

Activity 6.6 Review regularly and disseminate the guidelines

Activity 6.7 Arrange frequent meetings and seminars involving all partners and stakeholders

from public as well as the private sector

Activity 6.8 Ensure the availability of intravenous replacement fluids

Activity 6.9 Carry out regular internal audits using available tools

Objective 7: To carry out a nationwide Clinical Needs Assessment and set targets

accordingly

19

Activity 7.1 Review of annual data with a view to correctly assess the blood demand. All

blood banks shall also submit their whole blood, red cell concentrate, FFP, Platelets and

Cryoprecipitate storage capacity

Activity 7.2 Establish and maintain an inventory system for blood and blood products (stock

management)

Activity 7.3 Registration of hospitals/clinics prescribing transfusions. These hospitals or their

hospital transfusion committees shall submit previous years and current month blood

consumption data

Objective 8: To develop a comprehensive nationwide haemovigilance system to

monitor, evaluate and improve clinical transfusion practice

Activity 8.1 develop data collection tools/reporting system

Activity 8.2 Develop a simple and uniform reporting system for adverse transfusion events

Activity 8.3 Ensure data collection by BTAs/HTCs and sharing with SBTP

Activity 8.4 Publication of annual Haemovigilance report on national level

Activity 8.5 Coordination with International Haemovigilance Network (IHN) for technical

assistance

Objective 9: To promote biosafety and safe disposal of bio-hazardous waste at blood

transfusion centers

Activity 9.1 Ensure implementation of National/International Guidelines for infection control

practices at Blood Transfusion Centres

Activity 9.2 Human resource development in infection control practices and waste

management

19

20

Cluster 4: SUSTAINABILITY AND IMPROVEMENT OF PROCESSES

(Monitoring and Evaluation, Planning, Research and Development) This cluster focuses on improvement as an ultimate goal of quality management. Key elements are:

a) Monitoring and evaluation

b) Planning (Short and long term)

c) Research and development

This cluster contains 3 objectives that translate into 8 strategies:

Objective 1: To establish a comprehensive Monitoring and Evaluation system

Activity 2.1 Internal and external Monitoring and Evaluation shall be the responsibility of QM

department

Activity 2.2 Develop, monitor and evaluate proper documentation system (document

control)

Activity 2.3 Carry out regular evaluation (internal and external) of blood facilities by licensing

authorities

Objective 2: To develop medium and long term planning of blood supply

Activity 2.1 Advocacy of policy makers for resource allocation

Activity 2.2 Discuss, develop and implement the national recommendations regarding latest

developments in transfusion medicine viz. cell separators (aphaeresis products), autologous

donations, leukocyte-depleted products, irradiated products and use of inexpensive and

effective alternatives, preoperative autologous blood donation, intra operative blood salvage,

pre-operative haemodilution and post-operative blood salvage

Objective 3: Research and Development

Activity 3.1 Promote evidence based research in the field of transfusion medicine.

Activity 3.2 Take appropriate measures to encourage research and development in

transfusion medicine, e.g. coordinate with Faculties of Biosciences in partner universities to

assign their research students transfusion related topics for dissertation writing, publication

of a research journal in the field of transfusion medicine, etc

Activity 3.3 Ensure easy access to current literature on transfusion medicine and related

bioscience fields

22

ANNEXES

24

Annex A: Objectives and Indicators of the National Strategic Framework 2014-20

Cluster 1: GOVERNANCE

Objective 1: To establish organizational structures for national, provincial and district Blood Transfusion Services (BTS) including AJK, ICT, FATA and Gilgit-Baltistan

Process Indicators Outcome Indicators

Appointment of BTS Programme Managers Number of provinces/regions having BTS

Programme Managers

Operationalization of BTS Programme (Federal

and Provincial)

Number of provinces/regions with operational

BTS Programmes

Objective 2: To assign the roles and responsibilities of planning, coordination, financial management and routine operations at national and provincial levels including AJK, ICT, FATA and Gilgit-Baltistan


Development of processes for planning,

coordination, financial management and

routine operations of BTS

Number of provinces/regions who have

developed processes for planning, coordination,

financial management and routine operations of

BTS

Objective 3: To ensure prioritized and sustainable allocation of resources for the blood transfusion services


Conduct advocacy meetings with national

policy makers/international partners

Number of advocacy meetings held with national

policy makers/international partners

Approval of resource allocation for BTS Approved PC-1s for BTS (federal and provincial

level)

Objective 4: To establish reference centres/laboratories at national and provincial level

including AJK, ICT, FATA and Gilgit-Baltistan


Approval of PC-1s with resource allocation for

reference laboratories

Number of provinces/regions with approved PC-

1s having resource allocation for reference

laboratories

Establishment of reference laboratories at

federal and provincial level

Number of reference laboratories established

Number of functional reference laboratories

Capacity building of professional and technical

staff of reference laboratories on advance

blood banking techniques and quality

assurance

Number of capacity building workshops

organized

Number of staff trained in advanced blood

banking techniques and quality assurance

Development of international collaborations by

reference laboratories

Number of international collaborations/linkages

developed by each reference laboratory

Objective 5: To define the roles and responsibilities and strengthen coordination among armed

forces, public, private and NGO sectors

25


Conduct coordination meetings for the stakeholders

Number of coordination meetings held for the stakeholders

Development of collaborations/partnerships among stakeholders

Number of collaborations/partnerships developed

among stakeholders

Collaborative trainings held for professional and technical staff of public and private sectors

Number of staff from public and private sectors

trained with increase knowledge and expertise to

solve problems

Objective 6: To ensure the participation and support of private sector, NGOs and other

institutions for strengthening of blood transfusion services


Conduct coordination meetings Number of coordination meetings and increased

knowledge management

Advocacy through mass communication

Number of news item published in print media

Number of spots/programmes in electronic

media

Advocacy through focus targeted communication

Number of e-newsletter, annual reports and

World Blood Donor Day reports etc. published

with coverage of all BTS stakeholders

Objective 7: To implement regulatory framework via Blood Transfusion Authorities


Notification of regulatory authorities Number of provinces/regions with notified

regulatory authorities

Operationalization of the regulatory authorities Number of provinces/regions with operational

regulatory authorities

Conduction of training workshops/capacity

building activities for regulatory authorities staff

Number of training workshops conducted

Number of regulatory authorities staff trained

Conduction of inspections at federal and

provincial level

Number of licensed blood banks at federal and

provincial level

Objective 8: To enhance the political advocacy and commitment at national and provincial

levels (including AJK, ICT, FATA and Gilgit-Baltistan) amongst all partners


Conduction of advocacy meetings, workshops,

seminars and conferences held to create

political awareness about blood safety, TTIs,

and clinical use of blood

Number of decision makers having awareness

about blood safety, TTIs, and clinical use of

blood

Objective 9: Nationwide Need Assessment Surveys


Conduction of comprehensive baseline survey Number of provinces/regions who have

conducted a comprehensive baseline survey

25

26

Development of baseline survey report


developed and disseminated the baseline survey

report

Objective 10: Development of National Thalassaemia Policy and Action Plan


Conduction of national survey to assess the

current scenario

National survey conducted to assess the current

scenario

Conduction of consultations to formulate a

national action plan on thalassaemia

Number of consultations held to formulate a

national action plan on thalassaemia

Formulation and dissemination of national action

plan on thalassaemia

27

Cluster 2: RESOURCES

Objective 1: To strengthen the human resource of the Blood Transfusion Services in terms of

infrastructural support and competency enhancement (knowledge and skills) of the human

resource


Designing and development of new BT

degree/diploma programmes from universities

Number of universities who have initiated new

degree/diploma programmes in transfusion

medicine

Development of training materials for technical

and professional staff of BTS

Number of training materials developed for

technical and professional staff of BTS

Conduction of capacity building workshops by

blood transfusion programmes for all cadres

Number of capacity building workshops

conducted by the blood transfusion programmes

Conduction of surveys for need assessment of

skilled manpower in BTS

Number of surveys conducted for need

assessment of skilled manpower in BTS

Calculation of cost involved in human resource

development/strengthening

Number of provinces/regions with a business

plan for human resource strengthening

developed

Objective 2: To carry out need assessment of the blood transfusion facilities with a view to

highlight key deficiencies and identify potentially functional facilities to transform into regional

centers (public and private)


Conduction of need assessment surveys in the

country


conducted needs assessment surveys

Identification of centres which can be upgraded to regional centres

Number of centres identified for up-gradation into

regional centres

Objective 3: To ensure equipment maintenance, availability of consumables and laboratory

reagents in the facilities


Development of SOPs and EOPs for all processes of BTS

Number of blood banks having SOPs and EOPs

for all processes of BTS

Development of storage facilities Number of blood banks with adequate storage

facilities

Conduction of trainings for professional and technical staff in the field of biomedical engineering

Number of professional and technical staff

trained in the field of biomedical engineering

Organizing tax subsidy for laboratory materials Notification of Tax exemption certificate from the

FBR

Objective 4: To establish a national quality management system at all steps of the blood

transfusion services (vein to vein) including procurement and supplies, processing and

testing (QC), design and development


27

28

Promotion of certification for BTS Number of blood banks with ISO certification

Development of an efficient monitoring and

evaluation team

Number of blood banks having monitoring and

evaluation teams

Objective 5: To formulate a contingency / disaster management team consisting of blood bank

doctors and technicians at national, provincial level to ensure sufficient and timely supply of

reagents / blood bags, etc. in catastrophic areas for safe supply of blood for transfusion

during catastrophes (contingency / disaster management)


Development of disaster management plans Number of Provincial/regional Blood Transfusion

Programmes with disaster management plans

Development of VNRBD donor database Number of blood banks with VNRBD donor

database

Arrangement of adequate storage facilities for

donated blood during emergencies

Number of blood banks with adequate storage

facilities for donated blood during emergencies

Maintenance of adequate stock of

consumables

Number of blood banks with adequate stock of

consumables

Objective 6: To develop a computer based harmonized management information system


Development of standardized data collection

tools

Number of blood banks using the standardized

data collection tools

Conduction of trainings for staff in blood

transfusion information systems

Number of staff who received training in blood

transfusion information systems

29

Cluster 3: CORE BUSINESS

Objective 1: To establish a Department of Donor Management within Blood Transfusion

Services


Development of a donor management department in all blood banks

Number of blood banks with a donor

management department

Development of donor database Number of blood banks with donor database

Objective 2: To aim at motivation and retention of 100% voluntary non-remunerated blood

donors, preferably on a regular basis, for safe transfusion of blood and blood products


Establishment of blood donor motivation committees

Number of blood banks with blood donor motivation committees

Organizing motivational events for general

public

Number of motivational events held (e.g. walks,

live theatres, seminars, etc.)

No. of counseling facilities established to

recruits voluntary non-remunerated blood

donors (VNRBDs)

Percentage increase in volunteer donor base

Establishment of donor clubs and BDO

networks

Number of donor clubs and BDO networks

established

Objective 3: To carry out regular nationwide KAP surveys and studies to allow design of a

well-focused and sustained public oriented donor motivation and mobilization programme


Conduction of KAP studies to guide donor motivation and mobilization programmes

Number of studies conducted to guide donor

motivation and mobilization programmes

Conduction of studies to assess the prevailing

practices and standards at various public and

private blood banks

Number of studies conducted to assess the

prevailing practices and standards at various

public and private blood banks

Objective 4: To ensure 100% screening of donated blood for Transfusion Transmissible

Infections (TTIs)


Allocation of adequate resources for development of TTI screening facilities

Resources allocated for the development of TTIs screening facilities

Conduction of on-job trainings for professional and technical staff on proper screening of blood

Number of on-job trainings held for professional and technical staff on proper screening of blood

Establishment of QC system for TTI screening Number of blood banks having quality controlled

screening assays

Objective 5: To establish the facilities for component preparation, storage, adequate

transportation and quality control


29

30

Promotion of concept of component preparation

Number of blood banks preparing blood

components

Provision of equipment for component preparation in all blood banks

Number of blood banks having equipment for

component preparation

Development of SOPs and EOPs for

component preparation

Number of blood banks using SOPs and EOPs

for component preparation

Development of a proper transportation

mechanism of blood components

Number of blood banks transporting blood

components according to appropriate

temperatures

Establishment of QC system for component

preparation

Number of blood banks having quality controlled

blood component preparation

Objective 6: To promote and practice appropriate clinical use of blood and blood products


Establishment of hospital transfusion

committees (HTC) Number of hospitals having HTCs

Conduction of regular meetings of HTC Number of hospitals having regular meetings of

HTC

Development of guidelines on rational clinical

use of blood

Number of hospitals who have implemented

guidelines on rational clinical use of blood

Conduction of trainings for doctors/nurses on

clinical use of blood (CUB)

Number of doctors/nurses trained on CUB

Increase in component therapy and alternatives to blood

Objective 7: To carry out a nationwide Clinical Needs Assessment and set targets accordingly


Conduction of studies/surveys to assess the blood demand

Number of studies/surveys conducted to assess

the blood demand

Development proper inventory system for

blood and blood products in blood banks

Number of blood banks with developed inventory

system

Objective 8: To develop a comprehensive nationwide haemovigilance system to monitor,

evaluate and improve clinical transfusion practice


Development of reporting system for haemovigilance

Number of blood banks with developed reporting

system for haemovigilance

Generation of haemovigilance data from blood

banks

Number of blood banks sharing haemovigilance

data

Conduction of trainings on haemovigilance Number of provinces/regions having trained

haemovigilance coordinator

Objective 9: To promote biosafety and safe disposal of bio-hazardous waste at blood transfusion centers


Development and dissemination of national

guidelines on infection control and waste

Number of blood banks following national

guidelines for infection control and waste

31

management management

Conduction of trainings for professional and

technical staff on infection control and waste

management

Number of on job trainings held for professional

and technical staff on infection control and waste

management

31

32

Cluster 4: SUSTAINABILITY AND IMPROVEMENT OF PROCESSES

Objective 1: To establish a comprehensive Monitoring and Evaluation system


Development of proper recording, auditing and reporting system in blood banks

Number of blood banks with proper recording,

auditing and reporting system

Capacity building of staff on proper recording,

auditing and reporting system in blood banks

Number of staff trained in proper recording,

auditing and reporting system in blood banks

Appointment of a monitoring and evaluation

officer

Number of blood banks who have appointed a

monitoring and evaluation officer

Objective 2: To develop medium and long term planning for sustainability


Generation of credible data on all aspects of

vein-to-vein transfusion chain

Number of need assessment survey conducted

in the provinces/regions

Planning and coordination of BTS Number of coordination meetings held among

the provinces/regions

Objective 3: Research and Development


Promotion of research oriented activities in transfusion medicine

Number of blood banks carrying out research in

transfusion medicine

Research projects under process Number of research projects completed

Publication of research work in

national/international journals

Number of research publications in

national/international journals

Participation in national/international

conferences

Number of presentations (oral and poster) made

at the national/international conferences

Annex B: 1st Round Table Consultation, May 2014

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Annex C: 2nd Round Table Consultation, June 2014

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Ministry of National Health Services, Regulation and Coordination


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