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IBTAAnnualReport2019 22jan2020
IBTAAnnualReport2019 22jan2020
2019
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or
transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise,
without the prior written permission of the publisher
Published by:
Islamabad Blood Transfusion Authority
Ministry of National Health Services, Regulation & Coordination
Government of Pakistan
Website: https://www.ibta.gov.pk
Facebook: https://www.facebook.com/IslamabadBTA
Authors
Prof. Hasan Abbas Zaheer
Dr. Usman Waheed
Kaenat Nasir
Saira Tahir
Cite this publication as: Zaheer, H. A., Waheed, U., Nasir, K., & Tahir, S. (2020). IBTA Annual Report
2019 (1st ed.). Islamabad, Pakistan: Islamabad Blood Transfusion Authority, 978 969 9881 46 6
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
TABLE OF CONTENTS
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
ACKNOWLEDGEMENTS
The Islamabad Blood Transfusion Authority (IBTA) is pleased
to present its Annual Report for 2019. The Report provides a
review of the regulatory functions performed by the Authority
in the Islamabad Capital Territory including the publication of
technical documents and reports. The Report also
documents the support extended to the provincial
counterparts. The IBTA is indebted to Dr. Zafar Mirza,
Special Assistant to Prime Minister, National Health
Services, Regulations & Coordination, for his support and
encouragement. The Authority also expresses gratitude to Dr. Allah Bakhsh Malik,
Federal Secretary, Ministry of National Health Services, Regulations & Coordination,
for his cooperation and guidance. The IBTA is also grateful to Dr. Assad Hafeez,
Director General, Ministry of National Health Services, Regulations & Coordination, for
his support and facilitation to the Authority to enable it to perform its assigned role.
The Authority is also very thankful to the members of the IBTA Governing Board who
have always been very generous in giving their valuable time to the IBTA. Their
technical oversight in developing the vision, strategy and implementation roadmap of
the Authority has been very praiseworthy. The Authority is fortunate to have such
distinguished professionals to guide it. The field work of regulation would not have
been accomplished effectively without the whole hearted support and commitment of
the co-opted team of Inspectors consisting of Prof. M. Farooq Khattak, Prof. Khalid
Hasan, Prof. Javaid Usman, Brig. (R) Dr. Nadir Ali, Prof. Nuzhat Salamat, Dr. Samina
T. Amanat, Dr. Syed Imtiaz Hasan, Dr. Noor e Saba, Wg. Cdr. Dr. Kamran Nazir
Ahmed and Dr. Faiza Fahim.
The Authority would also like to record special appreciation for Dr. Usman Waheed,
Technical Expert SBTP, Ms Kaenat Nasir, Programme Officer, SBTP and Ms. Saira
Tahir, Programme Officer SBTP, who played a key role in the strengthening the
Authority and managing the regulatory work in a professional and committed manner.
The administrative support provided by Mr. Sajid Hussain Shah, Administrative Officer,
SBTP and Mr. Imtiaz Shah, Finance Manager SBTP, is also highly appreciated which
ensured that the technical work proceeded smoothly.
Last but not the least I would be failing in my duties if I do not acknowledge the whole
hearted support, cooperation and encouragement received from the management and
staff of the blood banks that were inspected. Especially acknowledged is the timely
and full compliance of all blood banks in submission of their annual data. The
constructive approach of IBTA in building the capacity of these centres has been very
well appreciated.
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
MESSAGE
The Pakistan Government has embarked on a reform process to ensure access to safe
and efficacious blood for all in the country since 2010. This ambitious goal is being
achieved through structural and functional reorganization of the system with the
assistance provided by the German Government. One of the key elements of this
reform process is the re-activation of blood transfusion authorities to guide and steer
the development of the blood sector in Pakistan. These efforts will help fulfil the
government’s commitment in achieving the Sustainable Development Goals (SDGs).
In Pakistan, various sectors are regulated through single national authorities. However,
the blood sector has separate regulatory bodies in all the provinces and regions. Until
the revival of the Islamabad Blood Transfusion Authority in late 2013, blood regulation
was by and large neglected. But now as a result of the sustained efforts of the IBTA,
blood regulation has been strengthened all over the country and is now being accorded
due priority. The National Blood Policy and Strategic Framework (2014-20) was
revised in 2014 and identified clear priority areas, including regulation, to be pursued
for attaining self-sufficiency in blood products in the country. Indeed, empowered and
effective regulatory systems are an essential pre-requisite for an efficient and reliable
blood transfusion service.
The revived IBTA has in a very short time developed a very successful model of
regulation in Pakistan based on constructive non-punitive approach. I am very pleased
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
I express my special appreciation to the IBTA Chairman, Prof. Hasan Abbas Zaheer,
and his committed team for uplifting the blood regulatory framework not only in
Islamabad but also throughout the country. Indeed the IBTA has performed this
challenging task in a very professional manner and with very limited resources. The
Health Ministry commits its full support to the IBTA and expects continuous
consolidation and strengthening of the blood regulatory system not only in the Federal
Capital but also throughout the country.
January 2020
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EXECUTIVE SUMMARY
Following the devolution of the health sector in June 2011 under the 18th constitutional
amendment, the Islamabad Blood Transfusion Authority was revived by the Ministry of
National Health Services, Regulation & Coordination in September 2013. A new
Chairman and an Advisory Board were also notified. The revived IBTA developed a
plan of action which laid out the framework of the scope of activities including;
development of an evaluation tool for inspection of the blood banks, formation of a pool
of eminent experts to act as IBTA inspectors, announcements in the press for
applications for registration and licensing, processing of applications and organizing
the initial, routine, surprise and annual inspections as well as conducting regular
capacity building activities. Currently 20 blood banks have been granted licenses
following successful inspections (in some cases after more than one inspection) and
six blood establishments have been closed down due to poor standards. Three blood
banks are only registered and not licensed. One initially licensed blood bank is
currently on probation.
The inspection checklist was revised in 2019 on the basis of the Inspectors feedback
and was improved to check compliance of the blood banks with national standards. To
achieve this, each and every standard was assessed through questions in the
inspection checklist. The order of inspection was systematic to ensure that all points
are covered.
Data collection, management, analysis and its publication is the responsibility of blood
regulatory authority. This is essential for improved planning and evaluation of services.
IBTA collects the annual data from all its licensed blood banks regularly in the month
of January every year. This year also the licensed blood banks submitted their 2019
data on the prescribed form to the IBTA. The compliance was 100% and within the
prescribed four weeks period. One of the striking finding of the data remains that many
licensed Blood Banks have insufficient workload and they do not justify their full-
fledged existence. And because of low workload they always have insufficient
inventory and thus have to rely on other blood banks to cover their needs. This
evidence supports the SBTP strategy of consolidation and the concept of large
Regional Blood Centres supporting the linked Hospital Blood Banks.
For the blood donations in ICT, as in the previous years, the data indicated heavy
reliance on replacement blood donors (87.25%) with the exception of two centres. The
rate of voluntary blood donors in 2019 was 12.75% compared to 13% in 2018 and
11.3% in 2017. Blood is mostly donated by males (97.7%). Female donations are still
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
very rare. This finding is also consistent with the 2018 and 2017 figures. In 2019, a
total of 7,041 blood components were discarded. About 48.67% blood components
(mostly platelet concentrates) were discarded due to expiry of their shelf life, mostly in
smaller centres while the larger blood banks faced chronic shortages. This
underscores the significance of developing linkages between the blood banks
operating in the ICT.
In contrast to pre-2013 period, most of the blood screening in ICT is now conducted
on automated systems based on NAT, CLIA and ELISA technology. Automation has
been actively promoted by IBTA during the last five years and screening of 99% of
blood collected in Islamabad on good quality automated technology has strengthened
the weakest link of the vein-to-vein blood transfusion. This is an encouraging finding
as automation and use of quality kits on advanced sophisticated equipment ensures
better safety standards. All licensed blood banks reported 100% testing for HIV,
Hepatitis B and C infections, Malaria and Syphilis. In 2014, about 25% of the total
donations were screened for Syphilis and Malaria. This rate increased to about 46% in
2015 and to about 60% in 2016, 77% in 2017 and finally 100% in 2018 and in 2019,
as a result of continuous advocacy and effective regulation by IBTA.
Facilities for component production and storage have been made mandatory by the
IBTA for licensing since 2014. Nearly 95% of the blood units collected in ICT are now
separated into at least three blood components which were much less in previous
years. This is in stark contrast to the practice in the rest of the country where only about
40% of the collections are processed into blood components. In many centres across
the country despite having the required equipment, manpower and resources not all
whole blood donations collected are processed mainly due to physician preference for
‘fresh whole blood’.
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IBTA advocates collaboration between blood banks to reduce duplication and avoid
wastage of blood components due to expiry. In the course of the year strong
collaborations were developed by the PIMS Blood Bank with Sundas Foundation
Thalassaemia Centre and the PRCS Blood Donor Centre. In Sundas Foundation
Thalassaemia Centre, FFPs and platelets are not usually required and are now
provided to the PIMS Blood Bank. The PRCS Blood Centre shares its inventory with
the PIMS Blood Bank and PIMS patients are directed to the PRCS to get blood
components in case of non-availability in PIMS. These patients are provided blood
components by PRCS free of cost if they are Zakat entitled or on nominal charges
otherwise. PIMS is the largest tertiary care hospital in ICT and routinely faces
component shortage as component therapy is widely practiced in PIMS and patients
from other hospitals from Islamabad and Rawalpindi and nearby regions also get blood
components from PIMS Blood Bank. Therefore partnerships with PRCS and Sundas
Foundation Thalassaemia Centre have considerably improved the component
supplies in PIMS especially for platelet concentrates. There are still some hospitals in
ICT where FFP and platelet concentrates remain un-utilized due to non-prescription by
the clinicians. IBTA encourages the licensed blood banks to collaborate with each
other to reduce the wastage of blood, practice rationale use of blood and meet the
demand of components in larger hospital blood banks.
The IBTA continued with the coordination and strengthening of the provincial blood
transfusion authorities in 2019. A meeting was held with the Punjab BTA to share
updates on the implementation of the PBTA Action Plan for strengthening the blood
regulation system in Punjab. The IBTA team visited Peshawar and Karachi to conduct
regulatory activities with BTA Inspectors. The Karachi BTA meeting was very
successful in which the stakeholders from Karachi were briefed about the new reform
agenda and strategy of the new leadership in Sindh BTA. It is expected that the revived
vibrant provincial BTAs will not only strengthen the standard of blood banking but also
streamline the establishment of the linkages between the new RBCs and their attached
HBBs. The BTA meeting in Peshawar was most useful and served to orient the new
blood bank inspectors and the BTA about the best strategy to regulate the sector in
the province in the light of the IBTA experience of the last six years. To ensure smooth
kick-start of the blood bank inspections, the IBTA accompanied the KP team in the
inspections of the blood banks in Peshawar. The inspections were highly appreciated
by all the blood centres inspected. The blood centres deemed the inspections as an
opportunity to reform their systems and highlight the equipment and human resource
deficiencies for rectification as the recommendations of the regulatory authority are
legally binding. The non-punitive constructive approach adopted by the Inspectors was
much appreciated.
In October 2019, a WHO Country Support Mission for Blood Transfusion to Pakistan
came for a week-long assignment. The Mission took place on the special request of
the Health Ministry. The Mission met the Special Assistant to Prime Minster in the
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
beginning to take his guidance and at the end of the Mission for debriefing and his
feedback. The Mission spent a very hectic time and visited Islamabad, Lahore,
Karachi, Hyderabad and Jamshoro, held deliberations with a number of key partners
and visited some large blood centres. The Mission Report has been submitted which
has recorded the achievements of the blood safety reforms ad gives a clear road map
for the future.
The Islamabad BTA has developed a model regulatory system over the last five years
which is well suited to the national needs and is functioning quite effectively. The IBTA
also coordinates with the provincial counterparts and has strengthened their capacity.
The IBTA efforts are widely appreciated by the national stakeholders, provinces and
also the international partners. The World Health Organization has recommended the
Pakistan BT regulation model to the regional countries. The roadmap IBTA followed
was very structured and systematic and had a huge impact on the quality of blood
transfusion services in the federal capital.
The inspection checklist has been revised by the IBTA ‘Task Force on Regulation’
including eminent national experts. The first meeting of the task force was organized
in January 2019. The IBTA plans to generate real time data of the licensed blood banks
on the IBTA website. All the licensed blood banks will be provided a link through which
they can update their blood inventory status online on the IBTA website. The IBTA is
continuously coordinating with the provincial BTAs and it is expected that these efforts
will result in further strengthening of the regulatory authorities in the provinces. Proper
operationalization of the provincial BTAs and their capacity building by the IBTA will go
a long way in reducing the gap in the regulatory standards between the federal capital
and the rest of the country.
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1. INTRODUCTION
The internationally recommended blood system consists of blood regulatory system,
blood supply system and blood transfusion system. The blood regulatory system deals
with legislations, regulations, policies while the blood supply system is responsible for
product liability i.e. blood. The blood transfusion system has to ensure protection of
the rights of the consumers, blood transfusion recipients. The role of regulation in
ensuring the quality and safety of blood supply and transfusion systems has been
recognized by WHO for over 40 years. Accordingly, the SBTP Pakistan has taken
concrete and positive steps in establishing and strengthening the blood regulation to
improve the blood safety standards throughout the country.
The World Health Assembly has passed more than 25 resolutions on various aspects
of blood safety since 1975. The resolutions essentially urge the Member States to
promote the development of national blood transfusion services based on voluntary
non-remunerated blood donors and enact effective legislation which should govern
operations of the blood transfusion services. The World Health Organization also
advocates the need for a standardized Blood Safety Legislation with a policy
commitment to action; communicating government policy; setting the foundation for
executive action; ensuring that policies and strategies are effective and sustainable;
protecting public health, health of donors and recipients of blood; making provisions
for the human, financial and technical resources that are necessary for quality and
safety; and facilitating co-ordination of all activities of the blood transfusion
programmes.
The regulation of blood sector implies enactment and enforcement of laws and rules
by the government for safe blood transfusion practices. The independent, autonomous
Blood Transfusion Authority (BTA) performs a steering role to guide the overall
development of the Blood Transfusion Services and regulates the transfusion system
on the internationally accepted blood transfusion system models. In exercise of its
functions, the BTA not only conduct inspections and other control measures, but also
develops, adopts or adapts rules, regulations, standards, guidelines and other tools to
achieve the objective, provides training and education to blood banking professionals
and blood bank staff on how to achieve the standards set by the Authority and
collaborates with other professionals in the field of education, training and other related
purposes.
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The regulatory authorities in the developed countries include the European Blood
Inspection System (EuBIS), Health Sciences Authority-Blood Services Group of
Singapore, National Blood Authority of Australia and Medicines & Healthcare products
Regulatory Agency of the UK, etc. In the developing countries, the common barriers to
the implementation of a legislative framework include insufficient political commitment
and support; absence of or weak blood transfusion policy and strategy; insufficient or
inadequate human, technical and financial resources; inappropriate priority setting;
absence of norms, standards and transparent procedures; lack of inspection and
control mechanisms; poor communication between stakeholders; poor attention to
cultural and religious constraints; and weak consumer and professional associations.
In Pakistan, the blood transfusion laws were developed from 1997-2004. A consensus
uniform updated draft legislation was developed recently by all the stakeholders under
the auspices of the SBTP. Three provinces (KP, Sindh and Punjab) have adopted this
new legislations through their respective legislatures (Figure 1.1). These legislations
intend to regulate collection, testing, processing, storage, distribution, issuance and
transfusion of human blood and blood components, ensuring health protection and
prevention of transfusion transmissible diseases. Approval and enactment of the law
requires a Blood Transfusion Authority to be established as a truly operational
regulatory authority. This BTA regulates all aspects related to safe blood transfusion
structures and processes, including registration and licensing, introduction of
standards, quality systems and haemovigilance. In the Blood Transfusion Law, a
‘Blood Transfusion Authority’ is defined as “a regulatory body” established under the
Department of Health with the objective to regulate the Blood Transfusion Services of
the Region.
The regulatory body for Islamabad, Islamabad Blood Transfusion Authority, was
established in 2005, through the ICT Blood Safety Ordinance promulgated in 2002.
After this Ordinance, the blood banks cannot opt in or out of the law, compliance is
mandatory and to be ensured by the IBTA. In 2005, the Federal Government notified
the establishment of the Islamabad Blood Transfusion Authority and appointed Prof.
Khalid Hasan, Consultant Haematologist, Pakistan Institute of Medical Sciences
(PIMS), Islamabad as its first Chairman. In the absence of a proper structure or
resources, the IBTA secretariat was established in PIMS. An Advisory Committee of
technical experts consisting of haematologists, transfusion medicine experts,
microbiologists, representative of the armed forces and members of private sector and
other stakeholders was notified. The Committee published advertisements in the press
for ICT blood banks registration and licensing. A database of the ICT blood banks was
thus generated and blood banks registered and licenses issued. From 2007-09, Maj.
Gen. (R) Prof. Masood Anwar, Executive Director, National Institute of Health
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remained Chairman IBTA and the IBTA secretariat was shifted to the NIH. During this
period, some inspections were made and licenses issued. In 2009, Dr. Birjees Mazhar
Kazi, Executive Director, NIH, was appointed Chairman IBTA by the Ministry of Health.
The regulatory body for Islamabad, Islamabad Blood Transfusion Authority, was
established in 2005, through the ICT Blood Safety Ordinance promulgated in 2002.
After this Ordinance, the blood banks cannot opt in or out of the law, compliance is
mandatory and to be ensured by the IBTA. In 2005, the Federal Government notified
the establishment of the Islamabad Blood Transfusion Authority and appointed Prof.
Khalid Hasan, Consultant Haematologist, Pakistan Institute of Medical Sciences
(PIMS), Islamabad as its first Chairman. In the absence of a proper structure or
resources, the IBTA secretariat was established in PIMS. An Advisory Committee of
technical experts consisting of haematologists, transfusion medicine experts,
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microbiologists, representative of the armed forces and members of private sector and
other stakeholders was notified. The Committee published advertisements in the press
for ICT blood banks registration and licensing. A database of the ICT blood banks was thus
generated and blood banks registered and licenses issued. From 2007-09, Maj. Gen. (R)
Prof. Masood Anwar, Executive Director, National Institute of Health remained Chairman
IBTA and the IBTA secretariat was shifted to the NIH. During this period, some inspections
were made and licenses issued. In 2009, Dr. Birjees Mazhar Kazi, Executive Director, NIH,
was appointed Chairman IBTA by the Ministry of Health.
After the devolution of the Health Ministry in 2011, the IBTA was revived by the Ministry of
National Health Services, Regulation and Coordination (M/o NHS,R&C) in October 2013.
A new Chairman and a new Advisory Board consisting of eminent transfusion experts,
haematologists, pathologists and public health experts were also notified by the Ministry.
The functions of the IBTA include; registration and inspection of the blood banks; issuing
licenses to the blood banks that fulfil the minimum licensing criteria; annual and surprise
inspections of the licensed blood banks; haemovigilance, surveillance of all components
of the vein-to-vein transfusion chain; compliance with the legislation, bylaws and
regulations; and data management of all the blood banks functioning in the federal capital
(Fig 1.2). In addition, IBTA also coordinates, strengthens and built the capacity of the
provincial BTAs. The IBTA thus performs a steering role to guide the overall development
of the Blood Transfusion Services in the country and promote uniform regulation of the
transfusion sector throughout the country.
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Dr. Syed Imtiaz Hasan (MBBS, MPH, PhD) did his graduation
from the Rawalpindi Medical College and PhD in Pathology from
the University of London. Since 1987, he has served in the
federal government as Medical Officer, Assistant Professor and
now as Consultant Pathologist, working in administrative,
teaching, and research posts in large public-sector hospitals and
institutes in Pakistan and Saudi Arabia. He also completed a
Fellowship in Public Health Resource Management, HIV/AIDS
from CDC, Atlanta. He is a member of the IBTA Advisory Board and has been
instrumental in implementing the inspection tools through inspections with IBTA team.
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Dr. Usman Waheed (BS MLT, MSc, MPhil, Dip. Public Health,
Fellowship Transfusion Medicine, Ph.D.) is serving as
Technical Advisor in the national Safe Blood Transfusion
Programme and the Islamabad Blood Transfusion Authority,
Ministry of National Health Services, Pakistan. Dr. Waheed
holds postgraduate diplomas in Epidemiology (Lon),
Transfusion Medicine (Germany) and Quality Management
(Netherlands).
As a founding member of the national blood programme, his
contributions to the Blood Transfusion sector in Pakistan are
diverse. His strong academic and professional background allowed him to competently
address all areas of the blood system reforms project co-funded by the German and
Pakistan governments. Dr. Waheed is involved with the teaching and training of under-
and post-graduate students in the field of medical laboratory sciences, transfusion
medicine and virology. As a keen researcher, he has authored more than 90 research
publications besides authoring four handbooks, 13 technical manuals and co-authoring
a millstone joint publication by SBTP and WHO – the National Blood Policy and
Strategic Framework. He also supervised the team formulating the HIV testing strategy
for Pakistan.
Dr. Waheed was awarded the prestigious ‘Young Investigator’ award by the
International Society of Blood Transfusion in 2014 (South Korea) and 2015 (UK). He
is also the Editor of three peer-reviewed international journals. A member of many
professional bodies and international expert working groups, Dr. Waheed has
represented Pakistan in many scientific conferences abroad and is serving on Advisory
Boards of American Society for Clinical Pathology, USA Science Advisory Board,
South Asian Association of Medical Laboratory Scientists and Asian Association of
Transfusion Medicine.
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The Mission held deliberations in Islamabad and met the Special Assistant to the Prime
Minister on Health Dr. Zafar Mirza and the Acting WR. In addition to the briefings from
SBTP and IBTA the Mission also met the CEO, KPBTA, Dr. Jamal Nasir, RBC
Manager, Dr. Noor e Saba, and the KP BT Programme Manager Dr. Shams ur Rehman
Afridi. A skype meeting was held with the Balochistan BT Programme Manager. The
Mission then proceeded to Lahore and met the Director General Health, Punjab, Dr.
Haroon Jehangir Khan; Secretary, Punjab Blood Transfusion Authority and Director,
Institute of Blood Transfusion Services, The Mission also visited the Mayo Hospital
Blood Bank. In Karachi, the Mission met the Provincial Secretary Health, Director,
Sindh Blood Transfusion Authority, Representative of Sindh Health Care Commission.
The Mission also visited the blood banks in Civil Hospital, Jinnah Post Graduate
Medical Centre and the Indus Hospital. The Mission also visited the Jamshoro RBC
and its attached HBB in Civil Hospital Hyderabad.
The Mission recorded the achievements of the SBTP and evaluated the progress of
the blood safety reforms, identified operational and systemic gaps and outlined the
recommendations for scaling up the reform program. At the end of the Mission, a
detailed debriefing was given to the Health Advisor in which the WHO representative
was also present. The Advisor appreciated the efforts of the Mission and the
performance of the SBTP and offered valuable recommendations and suggestions.
Soon afterwards the Mission submitted its report outlining the operational plan for the
future.
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Chairman, IBTA, Prof. Zaheer in his address said the Authority is very thankful to the
Inspectors who have always been very generous in giving their valuable time to the
IBTA. Their technical oversight in developing the vision, strategy and implementation
roadmap of the Authority has been very praiseworthy. The Authority is fortunate to
have such distinguished professionals to guide it. The field work of regulation would
not have been accomplished effectively without the whole hearted support and
commitment of the co-opted team of Inspectors. The Chief Guest highly appreciated
the IBTA efforts in strengthening the regulation of the blood transfusion sector in the
federal capital and also in rest of the country. The IBTA efforts have been
acknowledged at the international level also by WHO and other partners which is a
source of pride for the Health Ministry as well as the country. He acknowledged the
contribution of the IBTA leadership in promoting the cause of blood safety at the
national and international forums.
Brig. (R) Dr. Nadir Ali, Prof. Javaid Usman, Wg. Cdr. Dr. Kamran Nazir Ahmed, Dr.
Noor e Saba, Dr. Shawana Kamran and Col. Mehreen Ali Khan receiving souvenirs from
the Chief Guest, Maj. Gen. Prof. Saleem Ahmed Khan, HI (M), and Prof. Hasan Abbas
Zaheer, Chairman IBTA
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
The meeting started with a welcome address by the CEO, KP BTA, Dr. Jamal Abdul
Nasir who acknowledged the presence of all Inspectors. He also thanked the IBTA
team for sparing time to attend the meeting. He retreated the commitment of KP
government to ensure the safe blood transfusion practices in the provinces through a
robust blood transfusion authority.
Mr. Ali Khan, Assistant Director, KP BTA, presented the progress made by the KP BTA
and the future plans for the implementation of regulation in the province of KP.
Prof. Zaheer, Chairman IBTA, updated on the operationalization of the Islamabad BTA
in 2013 and the progress made in last six years. He informed that in Pakistan various
sectors are regulated through single national authorities. However, the blood sector
has separate regulatory bodies in all the provinces and regions. Until the revival of the
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
Islamabad Blood Transfusion Authority in late 2013, blood regulation was by and large
neglected. But now as a result of the sustained efforts of the IBTA, blood regulation
has been strengthened all over the country and is now being accorded due priority.
The revived IBTA has in a very short time developed a very successful model of
regulation in Pakistan based on constructive non-punitive approach. The model of
regulation developed for Islamabad is well suited to the needs of the system in
Pakistan and needs to be replicated in the provinces through the provincial authorities.
International partners including WHO and senate standing committees have highly
admired the functioning of IBTA.
Dr. Usman Waheed, Technical Expert IBTA, presented the Inspection Checklist used
for inspection in Islamabad. He informed that the inspection checklist was formulated
in 2013 and later revised in January 2019 on the basis of the Inspectors feedback and
was improved to check compliance of the blood banks with national standards. To
achieve this, each and every standard was assessed through questions in the
inspection checklist. The order of inspection was systematic to ensure that all points
are covered. The same Checklist has been adopted by provincial/regional authorities
in Punjab, Balochistan, AJK and Gilgit and KP. The Inspection Checklist is key for
successful and uniform implementation of regulatory model throughout the country as
it eliminates any chances of biasness. The presentations were followed with a detailed
question and answer session where the Inspectors were informed about the
assessment of blood banks through the checklist.
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In the second phase, the Authority inspected 10 blood banks from May 27-30, 2019,
in Peshawar including Shaukat Khanum Memorial Cancer Hospital; North West
General Hospital; Fatimid Foundation Thalassaemia Centre; Mercy Teaching Hospital,
Frontier Foundation Thalassaemia Centre; Kuwait Teaching Hospital; Hamza
Foundation Thalassaemia Centre; Govt. Naseerullah Babar Memorial Hospital; Moulvi
Ameer Shah Memorial Hospital; and Naseer Teaching Hospital.
The KPBTA was notified in 2017 and a Board of Governors formed which appointed
Dr. Jamal Abdul Nasir as its first Chief Executive Officer. The BTA secretariat was
established in the premises of the Peshawar Regional Blood Center and the first
meeting of the Board of Governors was held soon afterwards. On the basis of the
decisions taken by the Board, some technical and administrative staff was hired,
budget developed and funds released and some provincial experts identified to act as
its honorary Inspectors. An advertisement was also placed in the press to invite
applications for registration of all public and private sector blood banks functioning in
the province.
The CEO also established regular coordination with Prof. Hasan Abbas Zaheer,
Chairman, IBTA to seek technical assistance to establish the KPBTA on strong
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
footings. Accordingly, the IBTA has shared all its technical tools (Inspection forms,
Checklists, Reporting formats, etc) with KPBTA, briefed its panel of Inspectors and
prepared them to perform their assigned role with optimum efficiency. On the request
of the KPBTA, the IBTA team (Prof. Zaheer and Dr. Usman Waheed) participated in
the inspections conducted in two phases on April 8-9, and May 27-30, 2019 in
Peshawar.
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
The invited experts included the representatives from all the leading public, private and
NGO sector blood banks in Karachi. Dr. Durrenaz informed that the SBTA is now
regulating the provincial blood banks in a very methodical and recommended manner
and adopting a non-punitive constructive approach to strengthen the standard of
services of the large and medium sized reputable blood centres. At the same time the
smaller blood banks operating from miscellaneous settings (clinics, pharmacies,
laboratories etc.) without proper human resource and facilities are being dealt strictly
according to the legislation. It is expected that with this new approach very soon the
commercially oriented smaller centres providing unsafe and poor quality of services
will be legally eliminated or will cease to exist. She also shared the data of 147 licensed
blood banks in Sindh and its analysis. This is the first time that Sindh BTA has collected
detailed proper and authentic data from all the licensed blood banks in Sindh.
Chairman IBTA thanked the SBTA for coordinating with the IBTA and reaffirmed full
support from IBTA and SBTP to reform the BT regulation in Sindh. He informed that
all the tools and technical documents developed by IBTA and SBTP were now being
used and implemented by the SBTA. He stressed the need to ensure the presence of
minimum standards (human resource, equipment and facilities) as a basic pre-
requisite for licensing. Any blood bank, public or private sector, not fulfilling the
minimum standards should be provided reasonable time to address the deficiencies
and then re-inspected before being granted a license. After ensuring this primary
objective, subsequent inspections should focus on improving the technical standards,
practices, donor management, voluntary blood donations, quality of consumables,
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
Since its revival in September 2013, IBTA has received registration applications from a
total of 26 blood banks functioning in the Islamabad Capital Territory. Until December 2019,
licenses were granted to 20 blood banks fulfilling the minimum criteria under the Islamabad
Blood Safety Ordinance (Table 10.1). Some of these blood banks were initially only
registered and subsequently upon addressing their deficiencies were granted licenses.
Currently three blood banks are registered, two of which yet to become operational (Table
10.2-10.3). Six blood banks have been closed down in last six years as they did not fulfil
the licensing criteria (Table 10.4). The licensed blood banks are routinely inspected on
annual basis and their licenses renewed for one year if the inspection is successful. In
addition, surprise checks and formal and informal coordination is also maintained with the
ICT blood banks by the IBTA.
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
PIMS Hospital
14.
PNS Hafeez Naval Hospital
15.
PRCS Blood Donor Centre
16.
Quaid-i-Azam International Hospital
17.
Rawal Institute of Health Sciences
18.
Shifa International Hospital
19.
Punjab Employees Social Security Institution
20. (PESSI) Hospital
1. NORI Hospital
1. Capital Hospital
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
With the revival of the IBTA in 2013, applications were invited from the blood banks
functioning in Islamabad Capital Territory to apply for registration through announcement
in the local newspapers. Some blood banks applied in response to the newspaper
advertisements. Other non-applicant known blood banks were encouraged to apply for
registration. Some blood banks were identified during inspections through referrals and
contacted for registration. A proper mapping of blood banks in Islamabad has not been
carried out due to resource constraints but is planned for the future subject to availability
of funds. A few diagnostic centres and laboratories that perform part time blood banking
were later identified through miscellaneous sources and were directed to close down as
they were not fulfilling the minimum criteria of licensing of blood banks under Islamabad
Blood Safety Ordinance LXXIII of 2002.
A comprehensive performa was designed by the IBTA in 2013-14 for the collection of data
from the licensed blood banks on the various aspects of their work. The performa is
periodically reviewed and revised. The IBTA shared the performa with the 20 licensed
blood banks and one registered blood bank (Capital Hospital) in the first week of January
2020 for the collection of 2019 data. All the blood banks returned the filled forms within two
weeks.
Collection of data from the licensed blood banks in the ICT was carried out to review the
situation and status of different aspects of blood transfusion services in the ICT blood
banks, individually and collectively. The data was collected through a pre-tested tool which
was based on the questionnaire of the WHO Global Database on Blood Safety. The
questionnaire was adapted to the local requirements. Data entry errors and inconsistencies
were frequent in the beginning and were corrected after rigorous follow up. The data were
subsequently aggregated and analyzed in order to improve service and quality of care in
the ICT blood banks.
Out of the 21 blood banks, 12 are in public sector and nine in private/NGO sector (Fig.
10.1).
14
12
12
10 9
0
Public Private/NGO
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
In 2019, 75,348 blood donations were collected from the 21 blood banks (Table 10.5). The
2019 data shows an uneven distribution of the burden of work, a finding consistent with the
data of the past six years. In ICT, ~ 60% (n=43,976) of the blood donations was collected
by the two large blood banks (PIMS and Shifa Int’l Hospital). Two medium sized blood
banks (FGPC and PRCS) collected 16.7% (n=12,649) blood donations.
The contribution of the remaining 17 blood banks was about 24% (n=18,725). The number
of donations in these 17 smaller blood banks ranged from 134 to 3,027 donations in 2019.
Out of these 17 blood banks, 10 centres collect less than 1,000 donations per year. Some
centres collect less than one donation per day. In other words, most of the blood banks
functioning in the Federal Capital do not justify their existence as full-fledged blood banks.
These blood banks can better serve as hospital based blood banks relying on a larger
blood bank or a Regional Blood Centre for their supply of blood and blood components.
Currently, irrespective of the workload, all the 21 blood banks (private and public sector)
have to maintain minimum standards (expensive equipment, costly HR and other facilities)
to fulfil the licensing requirements. Full-fledged existence of the small blood banks also
means that they and their host hospitals remain dependent on the larger blood banks as
they cannot possibly ever have sufficient inventory of the blood components of all the blood
groups.
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
The uneven workload in the ICT blood banks strongly supports promotion of the
internationally recommended centralized model of blood transfusion services. This model
is being introduced in the country through the German government funded Safe Blood
Transfusion Programme. The model is based on the functional separation between
production units (Regional Blood Centres) and utilization units (Hospital based Blood
Banks). A Regional Blood Centre will be established in Islamabad in 2019 which will be
responsible for mobilizing voluntary blood donors, recruiting and retaining them, collecting
donations, processing, screening and testing the collected blood and preparation and
storage of the prepared blood components for distribution to the existing hospital based
blood banks in Islamabad. These hospital blood banks will then no longer be required to
do all these functions and will instead serve as “Consumption Units‟ and receive the
prepared components from the Islamabad Regional Blood Centre according to their needs
and store them until transfusion to the patients.
The same model already existed in Pakistan at the Armed Forces Institute of Transfusion
in Rawalpindi which serves as a Regional Blood Centre supplying blood to the adjoining
army hospitals, e.g. CMH, MH and AFIC, etc. The physical infrastructure developed by the
SBT project in Phase I (10 RBCs and up-gradation of 59 HBBs) is now functional. This
infrastructure also follows the centrally coordinated model with functional separation
between production (RBCs) and utilization (HBBs). At their full capacity, the Phase I
infrastructure will cover approximately 15% of the national coverage. In Phase II the scope
and scale of the coverage is being further expanded which is expected to cover 20-25% of
the coverage.
The ICT licensed blood banks support the concept of the SBTP model of centralized
services through large RBCs. The current management of the smaller blood banks also
realize that it does not make economic sense to maintain a full blood bank if their
transfusion requirements are low. A number of these blood banks exist in the private
medical college hospitals. And as per the PMDC requirements they are bound to establish
a full-fledged blood bank in their teaching hospitals. However, if they are allowed by the
PMDC, they are willing to enter into agreements with the larger blood banks and function
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
only as hospital based blood banks as per the SBTP model. The IBTA intends to write to
the PMDC to revise their policy in this regard when the Islamabad RBC is established and
functional.
A similar situation exists in the armed forces blood banks (PNS Hafeez and PAF Hospital).
As per rules the armed forces hospitals in Category A-C must have fully functional blood
banks. IBTA also intends to write to the Surgeon General Pakistan to revise their policy in
this regard and encourage their collaboration with the Armed Forces Institute of
Transfusion (AFIT) in Rawalpindi and other larger hospitals in other regions.
Currently the blood safety legislations do not have any provision to close down any blood
bank due to insufficient work load. But with the emergence of modern Regional Blood
Centres in the country and their reliance on regular voluntary blood donors, the full-fledged
existence of unsustainable and unsafe smaller and medium sized blood banks dependent
on the patients to provide blood donors should eventually fade out.
Out of the total of 75,348 whole blood donations collected in ICT in 2019, 73,612 (97.70%)
were donated by male blood donors and only 1,736 (2.30%) were donated by female
donors (Figure 10.2). The percentage of female blood donors is slightly more in 2019 in
ICT as compared to last year (in 2018, it was 2.0%).
Low female donation rates in a high literacy region like the federal capital is a source of
concern. It is believed that lack of female friendly facilities, poor privacy, misconceptions,
nutritional status, cultural and social factors contribute to low female donation rates.
However, the response in mobile camps in female educational centres is encouraging.
Females
2.3%
Male
97.7%
Out of the 75,348 whole blood donations collected in ICT in 2019, 87.25% (n=65,736)
donations were collected from family replacement donors while only 12.75% (n=9,6102)
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
donations were collected from voluntary donors (Figure 10.3). Blood collection from
paid/professional donors was not reported by any blood bank in ICT.
VNRBC 12.75%
Family
Replacement
Donars
87.25%
Out of the 21 blood banks, the Sundas Foundation Thalassaemia Centre collected highest
percentage of voluntary blood donations 98.3% (n=2,977) followed by PRCS Blood Donor
Centre 64.5% (n=5,119). The remaining blood banks have very low number of voluntary
blood donations. Most of the voluntary blood donations in ICT were collected in mobile
blood camps. Sundas Foundation Thalassaemia Centre and PRCS collect almost all
donations in mobile camps. Voluntary donation in blood bank setting is not very common.
The World Health Organization recommends that all countries should be self-sufficient in
all blood products and that every blood donation should be voluntary, anonymous and non-
remunerated. The collection of blood from voluntary, non-remunerated blood donors is an
important indicator of safety and quality. The situation in ICT regarding the source of blood
supply is similar to the rest of the country. The IBTA 2018 data reveals that the pre-
dominant reliance continues to be on the patients’ friends and relatives, the “Family
Replacement Donors”. Despite the increase in the voluntary blood donations, the overall
share of voluntary blood donations is still not sufficient. This is despite the fact that
Islamabad has the highest literacy rate in the country and also possibly the most sensitized
populace. And in times of national crisis, droves of volunteers throng the blood banks for
blood donations to save the lives of unknown recipients as witnessed in many natural and
man-made calamities in the recent past. This implies that lack of voluntary blood donors in
routine times is due to lack of a proper system to manage the voluntary donors and
channelize the spirit of altruism in the society. Another main contributing factor for the
shortage of voluntary blood donors and our reliance on the “Replacement Donors” is the
lack of a proper donor friendly infrastructure in our blood centres.
In Islamabad, except for Sundas Foundation Thalassaemia Centre and Pakistan Red
Crescent Society, all the remaining blood banks are housed within the premises of
hospitals of various size. These hospital premises are invariably congested and crowded.
And the blood banks functioning within these settings also have similar issues. The young
and healthy people, the potential voluntary donors, are not inclined to visit such settings
unless their family member or a friend requires blood. We thus have a situation where the
potential voluntary donors invariably present to the system as “Replacement Donors”. As
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
these blood banks have basically evolved as “blood manufacturing units” so due attention
is not paid to the needs of the blood donors, the most important element of the transfusion
chain. Therefore, in the absence of donor friendly environment and conditions, the
experience of the individual donors is often not very pleasant. However, under compelling
circumstances, the “Replacement Donors”, accept these inconveniences. But the net result
of the prevailing poor conditions for the blood donors in our blood bank settings is that we
lose out on the opportunity to convert the suitable “Replacement Donors” into regular
voluntary non-remunerated blood donors.
Some ICT blood banks, however, do rely very significantly on VNRBDs, e.g. Sundas
Foundation Pakistan Thalassaemia Centre and PRCS Blood Donor Centre. Due to its
conventional and historical role, the PRCS has a particularly strong background of
mobilizing voluntary donors. But almost all their donors are first time donors as most of
their blood donations take place in mobile blood camps in universities and colleges where
the student population is not static. In the other centres also the voluntary donors are first
time donors who are as safe or unsafe as the family replacement donors. The safest
voluntary donors are the regular donors who donate blood two or three or more times a
year and are screened for suitability each time through behavioural, physical and
serological screening. The regular voluntary donors are thus the safest donors.
Unfortunately, the number of such donors in Islamabad is still very small.
Islamabad, a comparatively small city, has a large number of universities which have a
huge combined enrolment. All these universities as well as many colleges have their own
blood donor organizations (BDOs), which organize mobile blood camps infrequently often
in collaboration with a blood bank. Collectively these BDOs are the single largest source
of voluntary blood donors in Islamabad. The same pattern is evident in the rest of the
country. Until recently all these BDOs worked in complete isolation and without proper
technical guidance or supervision. The true potential of these youth organizations thus
remained locked. Recently, the SBTP formed an Association of the blood transfusion
stakeholders including BDOs called “PakBLOOD” which aims to bring all the BDOs on a
single platform, build their capacity and strengthen them to become the main force to
mobilize voluntary blood donors in their respective areas. These efforts have yielded
promising results and sporadic increase in voluntary blood donations have been witnessed
through donations in mobile and blood bank settings. The strategy however needs to be
institutionalized to wean away the blood bank’s dependence from the patients’ families to
the voluntary donors.
One of the main barriers in the promotion of voluntary blood donations remains the
absence of dedicated blood centres where lines do not cross between the patients and the
healthy voluntary blood donors. This issue is being addressed in the country with the
development of a network of modern Regional Blood Centres which are independent of
hospitals. Such a Centre for Islamabad with a capacity of more than 50,000 donations per
year will be developed in third quarter of 2020 and should be able to cater to the needs of
all the blood banks in Islamabad. The Regional Blood Centre and attached Hospital Blood
Banks will be obliged to build a network with BDO’s and all partners involved in voluntary
blood donation. Within this network, common activities to inform broader parts of the
population about blood and blood donation and to promote VNRBD will be tuned. A donor
management strategy including a registry of Blood Donors will be implemented through the
Islamabad Regional Blood Centre.
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
In 2019, 71,591 (95.01%) blood collections in ICT were processed into at least three blood
components, i.e. Red Cell Concentrates (RCC), Fresh Frozen Plasma (FFP) and Platelet
Concentrates (Figure 10.4).
Components
Not
Prepared
4.99%
Components
Prepared
95.01%
Out of 21 ICT blood banks, 19 blood banks reported nearly or more than 95% component
preparation rate in ICT. The remaining two blood banks prepare components variably from
45% to 70% mostly due to lack of awareness among the hospital’s clinicians about
component therapy.
When the revived IBTA initiated the regulation work in Islamabad in the last quarter of
2013, the situation regarding blood component preparation was very unsatisfactory and
only a few blood banks processed the whole blood donations into blood components. Many
blood banks did not even have the required equipment and facilities. However, the situation
has improved considerably since then due to the IBTA advocacy and capacity building of
the management and technical leadership of the blood banks. Facilities for component
production and storage are now a mandatory requirement for licensing. During the initial
phase of licensing many blood banks had to make substantial investments in their centres
to procure ultra-centrifuges, freezers, incubators and other essential equipment to prepare
and store blood components. However, there are still a few blood banks which keep
substantial percentage of their collections as whole blood. The reason is mainly the
pressure from clinicians to issue whole blood or extremely low workload and absence of
demand of blood components by clinicians. Formation of effective hospital transfusion
committees are expected to improve this situation. Steps to promote rationale use of blood
and component therapy needs to be taken for the benefit of the hospitals where the
clinicians still prefer whole blood transfusions.
The common reason cited by the blood banks for not preparing blood components is lack
of demand for blood components by the clinicians and wastage particularly of the platelet
concentrates. IBTA advocates collaboration between blood banks to share the surplus
components prepared with the other licensed blood banks where there is shortage. Such
collaborations now exist between PIMS and Pakistan Thalassaemia Centre and PIMS and
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
PRC Blood Centre. In Pakistan Thalassaemia Centre, FFPs and platelets are usually not
required. These two components are thus provided to PIMS Blood Bank. PRC Blood
Centre shares its inventory with the PIMS Blood Bank and PIMS patients are directed to
the PRCS to get blood components. These patients are provided components by PRCS
free of cost if they are Zakat entitled or on nominal charges. PIMS is the largest tertiary
care hospital in ICT and routinely faces component shortage as the PIMS clinicians
practice component therapy. Therefore, partnerships with PRCS and PTC have
considerably improved the component supplies in PIMS especially for the platelet
concentrates.
Among the five TTIs tested, 70 (0.09%) were reactive for HIV, 807 (1.07%) for HBV and 941
(1.24%) were reactive for HCV. 0.02% (n=19) were reactive for Malaria and 0.76% (n=576) for
Syphilis (Figure 10.6).
1.24%
1.07%
0.76%
0.09% 0.02
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
The reactivity for all TTI markers decreased in 2019 from the previous year. Only malaria
reactivity is almost same as the previous year. The collective TTIs prevalence is still high
and unacceptable and needs to be curtailed through more effective behavioural and
physical screening of the blood donors.
In 2019, for HBV and HIV screening, 85.01% of the total donations were screened by CLIA
and 14.99% of the total donations were screened by ELISA. In addition, 18.02% of the total
donations were further screened by NAT while only 0.4% of the total donations were
screened using manual kits. For HCV screening, 69% of the total donations were screened
by CLIA, 31% of the total donations were screened by ELISA, 18% of the total donations
were screened by NAT while only 0.4% of the total donations were screened using manual
kits. For screening against Malaria, 16.4% of the total donations were screened by CLIA
and 83.6% of the total donations were screened using manual kits. For Syphilis, 27.8% of
the total donations were screened by CLIA, 1% of the total donations were screened by
ELISA and 71.2% of the total donations were screened using manual kits.
IBTA strongly recommend the use of automated serological screening and use of quality
kits recommended by WHO or EU or approved by FDA. The IBTA Advisory Board has
recommended the use of TPHA or anti-TP (ELISA/CLIA) for syphilis screening. The rapid
devices are used for the screening of HIV, HBV and HCV in one centre as compared to 6
centres in 2014. SIH is screening all its donations by two technologies,
Chemiluminescence followed by pooled NAT screening of the non-reactive samples. The
application of advanced technology and internationally certified kits for serological
screening in blood centres in ICT augurs well for blood safety for the residents of
Islamabad.
Out of the 21 ICT licensed blood banks, nine blood banks use a computerized data
management system which collect about 75% of the total blood donations in Islamabad
Capital Territory (Figure 10.7). The remaining 12 blood centres have manual system and
collect about 25% of blood donations.
14
12
12
10 9
0
Figure 10.7: Data Management
MIS Methodology used by Manual
number of Blood Banks
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
10.10 Haemovigilance
In 2019, 283 Adverse Events (AE) in donors were reported in the 75,348 blood donations.
Most common events were Vasovagal 112 (39.5%), hypotension 91 (32.1%), and
haematoma 21 (7.42%). (Figure 10.8).
The IBTA strongly advocates haemovigilance practices in its licensed blood banks to
promote transfusion safety. The Authority strongly highlighted the significance of this
surveillance work. Training workshops organized for the capacity building of the blood
banks comprehensively covered haemovigilance and guidance was provided to the blood
bank management to initiate this practice in the blood banks and hospitals. A precondition
of blood bank licensing was establishment of a Hospital Transfusion Committee (HTC) with
representation of the senior management of the hospital and medical and surgical
specialist as well as the nursing staff.
Others
Vasovagal with
40%
LOC
2.1%
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
Others Allergy
20.4% 20.4%
TACO 4.08%
FNHTR 55%
FNHTR
Anaphylaxis/ Hypersensitivity
Immunological Haemolysis due to ABO Incompatibility
Others
The HTC is responsible for ensuring blood safety standards and monitoring the
haemovigilance system. The blood banks were advised to conduct at least three HTC
meetings every year and share minutes of the meeting with IBTA. One of the IBTA licensed
public sector blood bank (KRL Hospital) has developed a model system for
Haemovigilance and conducts HTC meetings regularly. Even the complete blood request
form is sent through the MIS based system to the blood bank for cross-match and issuance.
Over the past few years, IBTA has made significant progress in promoting the culture of
donor and patient vigilance. This has enabled IBTA to collect Haemovigilance data from
all the licensed blood banks. The annual data generated provides very useful information.
The information gained from the investigations and analysis of haemovigilance facilitate
corrective and preventive actions to be taken to minimize the potential risks associated
with safety and quality in blood processing and transfusion for donors, patients and staff.
Each and every incidence reported must be investigated fully to ensure that lessons are
learned and shared with all to avoid repetition of the errors. It is expected that with the
passage of time the HTC functioning would improve and along with it the standard of
reporting of adverse events. Currently, it appears that the adverse events are under-
reported mainly due to the fear of reprisals and lack of recognition of adverse signs and
symptoms. A landmark achievement in many blood banks is the return of empty blood bag
after the transfusion.
The objective of donor haemovigilance (DHV) is to continuously improve donor safety and
satisfaction through monitoring, analyzing, and researching adverse events associated
with blood donation just prior to, during, and after the donation event. The activities of
prospective and continuous surveillance of donation related complications are largely
voluntary in Pakistan but are mandated in the ICT through the ICT Blood Safety Ordinance.
The donor haemovigilance data of 2019 indicated that majority of the AE were vasovagal.
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
These events are often avoidable, provided trained, vigilant and committed staff is
available. Such vigilance systems allow monitoring of donor safety and assessment of the
success of interventions designed to further improve donor safety. It is crucial that all blood
banks adopt a systematic approach to monitor the rates of donor adverse reactions.
Recording of these events and their analysis and corrective measures will ensure that the
donor experience in the blood centre improves. This practice is likely to increase the trend
of voluntary blood donations.
The patient haemovigilance data showed very low number of immediate adverse events if
compared with anecdotal evidence from other developing countries. No haemolytic
transfusion reaction and delayed transfusion reaction took place during the reporting period
in ICT. Majority of the reactions were febrile, anaphylactic/ hypersensitivity allergic
reactions. This is probably due to under reporting because of fear of reprisal or lack of
awareness about the signs and symptoms of transfusion reactions. The figure may rise
with more stringent follow up from individual blood banks with the transfusion wards.
Out of 75,348 blood collections in 2019, 7,041 blood units were discarded. About 2,501
(35.52%) blood units were discarded due to TTI positivity, 3,427 (48.67%) blood
components discarded due to expiry date and 1,113 (15.80%)due to other miscellaneous
causes.
The question was not properly phrased in the questionnaire due to which clear response
could not be received. The discard of blood components was not requested separately due
to which a mix discard of RCC, FFPs and Platelets is provided by some blood banks in the
expiry section. The percentage of blood being discarded due to expiry is very high in some
small-sized blood banks due to insufficient demand in their hospitals. Wastage of the
scarce blood resource can be avoided by centralization and better coordination with large
centres.
TTI Positivity
35.52%
Expiry
48.67%
Misc
15.80%
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
Out of the 21 ICT blood banks, manual cross-matching is done in nine blood banks while
12 perform cross-match through semiautomatic or automatic Gel-Card technology (Figure
10.11). Use of Gel Card technology is recommended especially in the larger blood banks
where the existing workforce cannot possibly manage this work manually. In addition,
permanent record is also maintained with this technology and quality of work assured.
12
Gelcard Manual
Figure 10.11: Cross-Match Technology in ICT Blood Banks
Permanently
Deffered
16.75%
Temporary
Deffered
83.25%
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
Gastroenteritis 2 0.04%
Typhoid 15 0.36%
Fever 55 1.35%
Fasting 18 0.44%
Asthmatics 8 0.19%
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
The Programme is also very fortunate to avail the professional guidance and expertise of
eminent national and international experts who have contributed effectively in reviewing this
document. The document has been edited by Prof. Hasan A. Zaheer, Dr. Saeed Ahmed, Dr.
Usman Waheed and Akhlaaq Wazeer.
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
The Functional Brief provides guidelines for the functioning of BTA as regulators of a modern
Blood Transfusion System as sanctioned by the new Safe Blood Transfusion Law and may be
used as a communication tool with the Health Department to explain which resources are
required to conduct the actions defined. This would include the identification of BTA staff
requirements, the elaboration of registration documents to be filled by all Blood Establishments
operating in the province/state/ICT and the mapping of all these facilities. On the basis of this
first overall data collection BTA and DOH will have more clarity about expected workloads and
the resources to be allocated.
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Zaheer HA, Waheed U, Nasir K, Tahir S. IBTA Annual Report. 1st Ed. 2019
The document is divided into sections providing the reader a clear and comprehensive
knowledge of regulatory framework of BTS, the structure and functioning of BTA, and the step
by step approach in registration and licensing of a blood establishment and management of
post inspection data. The inspection checklist is elaborated in such a way that the inspector
knows the significance of each question and how each question should be presented during
inspection in order to get maximum and relevant information from the blood establishment
Therefore it will serve as a useful tool for guiding blood transfusion inspectors in conducting
inspection of Blood Establishments in a systematic manner.
This book also gives the inspector an insight on their rights and responsibilities which
accompany their optimal training. Well trained inspectors are the backbone of safe blood
transfusion practice in the country and ensure progress of blood safety.
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The SBTP appreciates Prof. Syed Muhammad Irfan, Consultant Haematologist, Liaquat
National Hospital and Medical College, Karachi, and Executive Board Member, Pakistan
Society of Haematology, for motivating the Programme to compile this Handbook and also
for reviewing and endorsing the adopted document. The SBTP technical team (Dr. Usman
Waheed, Kaenat Nasir and Saira Tahir) also deserve special acknowledgement for their
tireless efforts to adopt the original WHO document into a Handbook well suited to the
national needs and requirements.
It is expected that the use of this document in the Pakistan healthcare system will
significantly improve the blood transfusion practices in our hospitals. It will also help
overcome to a large extent the chronic shortage of blood and blood components in our
blood centres and promote the rational and judicious use of blood and blood components.
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IBTA is a unique authority that helps the institution in its true spirit
to organize the Blood Banks with excellent quality and efficiency.
I really appreciate and in addition suggest that there is a need for a
hub where blood banks can share their experiences and data and
also that hub can provide information with reference to availability
of products in different blood banks. This can be physical or online.
An online option will be more helpful.
Best wishes for all IBTA team members.
Babar Hameed Awan
Senior Manager Diagnostics, Ali Medical Centre, Islamabad
The way they inspected is very positive and their suggestions and
recommendations are very encouraging that helped us a lot in
reviewing and upgrading of operational tasks of our blood bank. The
best thing that I felt during the entire inspection process is, there is
no undue pressure of being inspected. I would like to extend my
profound wishes to IBTA team so that their core mission of safe
blood transfusion will come true.
Dr. M. Sharif Astori
Administrator, Federal Government Polyclinic Hospital Blood Bank
Islamabad
During my visit to Pakistan, I was pleased to see the progress made by the
Islamabad Blood Transfusion Authority (IBTA) by implementing the blood
safety legislation inhet Islamabad Capital Territory. The IBTA has developed
a very practical model of regulation suitable for the needs of developing
countries. I appreciate the IBTA team for this endeavor. Best wishes!
Dr. Yetmgeta Abdella, MD, MPH
Medical Officer for Blood and Transfusion Safety
Regional Office for the Eastern Mediterranean, World Health Organization
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