Ebook Blood Transfusion Guideline PDF

TRANSFUSION
PRACTICE GUIDELINES
for Clinical and
Laboratory Personnel
NATIONAL BLOOD CENTRE

Ministry of Health Malaysia
4TH EDITION 2016
National Blood Centre
Ministry of Health, Malaysia
Jun 2016
Transfusion Practice Guidelines

for Clinical and Laboratory Personnel
National Blood Centre

Ministry of Health, Malaysia
Jalan Tun Razak,
50400 Kuala Lumpur, Malaysia
Tel: 03-2613 2688 | Fax: 03-2698 0362
Web: http://www.pdn.gov.my
© National Blood Centre 2016

Any copy or reprint for
commercial purpose is forbidden
without consent from the
National Blood Centre.
Foreword by the Director General of Health, Malaysia
Foreword by the Director General of Health, Malaysia

The Blood Transfusion Service (BTS) has contributed significantly to the progress of
health care in Malaysia by providing adequate, safe and high quality blood and blood
products . The demand for a reliable transfusion service is ever increasing. Despite
technological and medical advances blood transfusion risks still exist and blood
safety remains a major concern to medical personnel, patients and communities.
One of the efforts to address this concern was the publication of Transfusion Practice
Guidelines for Clinical and Laboratory Personnel. It has been utilised as a practice
guideline both in the government and private hospitals in Malaysia.
With rapid development in transfusion medicine, there is a need to provide an
updated guidance document to facilitate standardisation and consistency of current
technical and clinical transfusion practices throughout the country. Thus I am pleased
to see that the 4th edition has materialised with improvements in presentation as well
as technical and clinical contents.
This edition has been extensively revised by a group of technical and clinical experts.
All personnel involved in BTS must be well versed with its content and adhere to the
requirements in this guideline. I urge all hospital directors and head of BTS to ensure
that appropriate and adequate training is provided to their personnel. Elimination of
errors and achieving safer and more effective blood transfusion shall be a priority for
all healthcare facilities.
For safe and appropriate transfusion practices, each hospital must have a functionally
active Hospital Transfusion Committee (HTC). One of its many roles shall be the
surveillance of adverse transfusion events through an effective haemovigilance
programme within the hospital, where these events are collected, analysed and its
findings used in formulating corrective and preventive measures.
I wish to congratulate members of the working committee for their perseverance
in spending many laborious hours revising this guideline. I also wish to thank all
external reviewers and editors for contributing to the completion of this guideline.
Datuk Dr. Noor Hisham Abdullah

Director General
Ministry of Health Malaysia
iii
Transfusion Practice Guidelines for Clinical and Laboratory Personnel
Preface
Transfusion Medicine field is a rapidly evolving medical specialty. This 4th edition of
Transfusion Practice Guidelines for Clinical and Laboratory Personnel is produced
after thorough revision and update of all the chapters in the previous edition. The
guideline is aimed to ensure safe practice in every step of the blood transfusion chain.
As far as possible, the recommendations made in this edition are evidence based,
information are obtained from published journals and established international
standards and guidelines. Where local practical adaptations are necessary, findings
from local scientific studies and expert opinion from consultants are considered.
Providing safe and adequate blood is a vital component of healthcare delivery system.
In addition to that, all processes involved in the blood transfusion chain must be of
quality which will result in the best patient care. Understanding and implementing
the requirements of this guideline will result in adherence to quality management
system that includes Good Manufacturing and Good Transfusion Practices which are
the basis of safe and quality BTS.
Special acknowledgement is conveyed to all contributors for their efforts in revising
this edition, to the external reviewers for their valuable comments and suggestions
and to the co-editors for their excellent cooperation and input.
Dr. Noryati Abu Amin Dato’ Dr. Roshida Hassan

Director (2014 - present) Director (2009 - 2014)
National Blood Centre National Blood Centre
Kuala Lumpur Kuala Lumpur
iv
Editorial
WORKING GROUP
CHAIRPERSON
Dr. Noryati Abu Amin
Senior Consultant Haematopathologist
Dato’ Dr. Roshida Hassan

Senior Consultant Haematopathologist
CONTRIBUTORS
Dato Dr. Faraizah Abd. Karim Dr. Norasrina Ishak Pn. Ainisah Md. Ariffin
Senior Consultant Haematopathologist, Transfusion Medicine Specialist Senior Medical Laboratory Technologist
Deputy Director I
Dr. Nor Hafizah Ahmad Pn. Rosalind Choo Poh Yoke
Dr. Afifah Haji Hassan Transfusion Medicine Specialist Senior Medical Laboratory Technologist
Senior Consultant Haematopathologist,
Deputy Director II En. Abd. Hamid Bon Dr. Thayani Sivasambu
Senior Microbiologist Senior Medical Oficer
Dr. Norris Naim
Consultant Haematopathologist, En. Chong Tar Wei Dr. Chitra Cumarasamy
Quality Manager (2014-2015) Biochemist Senior Medical Oficer
Dr. Tun Maizura Mohd. Fathullah Pn. Ilya Raihana Semsudin Dr. Sabeha Sahabudin
Consultant Haematopathologist Biochemist Medical Oficer
Dr. Wooi Seng Pn. Nurul Munira Yahya
Transfusion Medicine Specialist Biochemist
Quality Manager (2016-present)
Pn. Vimala Raffael
Dr. Zalina Mahmood Senior Medical Laboratory Technologist
Transfusion Medicine Specialist
v
EXTERNAL REVIEWERS
Assc. Prof. Dr. N. Veera Sekaran Assc. Prof. Dr. Leong Choo Fun
V. Nadarajan Universiti Kebangsaan Malaysia Medical Centre
Universiti Malaya Medical Centre
Dr. Azizon Othman
Assc. Prof. Dr. Rosline Hassan Hospital Tuanku Jaafar
Universiti Sains Malaysia Hospital
Prof. Dr. M. A. Kadar Marikar
Dr. Ng Soo Chin Malaysian Society for Quality in Health (MSQH)
Subang Jaya Medical Centre
Dr. Zanariah Kassim

Hospital Sultanah Aminah
EDITORS COORDINATOR &

Dr. Noryati Abu Amin
PUBLICATION
Dato’ Dr. Roshida Hassan
Dr. Afifah Haji Hassan
Dato’ Dr. Yasmin Ayob
Dr. Zalina Mahmood
Dr. Afifah Haji Hassan
Dr. Ailin Mazuita Mazlan
Dr. Zalina Mahmood
En. Sin Ka Soon 4th Edition June 2016
Dr. Ailin Mazuita Mazlan
vi
Code of Ethics for Blood Donation and Transfusion

I. THE DONOR
1. Blood donation shall, in all circumstances, be voluntary; no pressure of any kind shall be
brought upon the donor.
2. The donor shall be advised of the risks connected with the procedure; the health and safety
of the donor shall be a constant concern.
3. Financial profit shall never be a motive either for the donor or for those responsible for
collecting the donation. Voluntary non-remunerated donor should always be encouraged.
4. Anonymity between donor and recipient shall be respected except in special cases.
5. Blood donation shall not entail discrimination of any kind, either of race, nationality or
religion.
6. Blood shall be collected under the responsibility of a registered medical practitioner.
7. The frequency of donations and total volume of blood collected according to the sex and
weight of the individual, as well as the minimum and maximum age limits for blood
donation, shall be as specified by the Director General.
8. Suitable testing of each donor and blood donation shall be performed in an attempt to
detect any abnormalities –
a) that would make the donation dangerous for the donor; and
b) that would likely be harmful to the recipient.
9. Donation by plasmapheresis should be the subject of special regulations that would specify –
a) the nature of additional tests to be carried out on the donor;
b) the maximum volume of plasma to be taken during one session;
c) the maximum time interval between two consecutive sessions; and
d) the maximum volume of plasma to be taken in one year.
10. Donations of leukocytes or platelets by cytapheresis should be the subject of special

regulations that would specify –
a) the information to be given to the donor about any drugs injected and about the risks
connected with the procedure;
b) the nature of any additional tests to be carried out on the donor; and
c) the number of sessions within a given time frame.
vii
11. Deliberate immunization of donors by any foreign antigen with the aim of obtaining
products with specific diagnostic or therapeutic activity should be the subject of special
regulations that would specify –
a) the information to be given to the donor about the substance injected and the risks
involved; and
b) the nature of any additional tests which have to be carried out on the donor.
12. Pursuant to paragraphs 9, 10 and 11 of this Code, after being told about the nature of the
operation and the risks involved, a statement of consent must be signed by the donor.
13. For donor immunized against red cell antigens, a special card should indicate the
antibodies and specific details as to the appropriate blood to be used in case donors need
to be transfused.
II. THE RECIPIENT

1. The object of transfusion is to ensure for the recipient the most efficient therapy compatible
with maximum safety.
2. Before any transfusion of blood or blood products, a written request signed by a registered
medical practitioner or issued under his responsibility shall be made, which specifies the
identity of the recipient and the nature and quantity of the substances to be administered.
3. Except for the emergency use of type “O” blood or red blood cells, every red blood cell
transfusion necessitates preliminary blood grouping tests on the recipient and compatibility
tests between the donor and the recipient.
4. Before the administration, one shall verify the blood and blood products are correctly
identified and that the expiry date has not been passed. The identity of the recipient shall
be verified.
5. The actual transfusion shall be given under the responsibility of a registered medical
practitioner.
6. In the case of a reaction during or after the injection of blood or blood products, appropriate
investigations may be required to ascertain the origin of the reaction and to prevent its
recurrence. A reaction may require the interruption of the transfusion.
7. Blood and blood products shall not be given unless there is genuine therapeutic need. There
shall be no financial motivation on the part of either the prescriber or the establishment
where the patient is treated.
8. Whatever their financial resources, all patients must be able to benefit from the
administration of blood or blood products, subject only to their availability.
9. As far as possible the patient should receive only the particular component (cells, plasma
or plasma derivatives) that is needed. To transfuse whole blood into a patient who requires
viii
only part of it may deprive other patients of necessary components, and may carry some
additional risks to the recipients.
10. Owing to the human origin of blood and to the limited quantities available, it is important
to safeguard the interest of both recipient and donor by avoiding abuse or waste.
11. The optimal use of blood and blood products requires regular contact between the
physician who prescribe and those who work in blood transfusion centres.
RELATED PROCEDURES/DOCUMENTS
Eleventh Schedule; Code of ethic for blood donation and transfusion, Law of Malaysia, Jil.50,
No.7, version 2006, (Regulation 299); Page;1312 – 1314.
ix
Table of Contents
1.0 INTRODUCTION 1
2.0 PROCUREMENT OF BLOOD 2
2.1 Blood Procurement Team 2
2.2 Promotion & Recruitment 2
2.3 Identification of Blood Donor 3
2.4 Criteria for Acceptance of Blood Donor 4
2.5 Frequency of Donation 5
2.6 Records of Donors 6
2.7 Pre-Donation Questionnaire 7
2.8 Pre-Donation Interview 7
2.9 Collection of Blood 8
2.10 Blood Donor Confidentiality 10
2.11 Training 10
2.12 Competency of Personnel for Bleeding of Blood Donors 10
2.13 Confidential Unit Exclusion 10
2.14 Adverse Reactions in Donors 11
2.15 Management of Adverse Reactions in Donors 12
2.16 Documentation of Adverse Reactions in Donors 13
2.17 Registry 13
2.18 Record Keeping 13
3.0 PRODUCTION OF BLOOD COMPONENTS 15
3.1 Procedures for Preparation of Blood Components 15
3.2 Types of Blood and Blood Components 15
3.3 Labelling 22
3.4 Quarantine 22
3.5 Storage 23
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Table of Contents
3.6 Release of Screened Blood Components from Quarantine 23

3.7 Discard of Unsuitable Unit of Blood 23
3.8 Quality Control 24
4.0 BLOOD SUPPLY MANAGEMENT 28
4.1 Stock Forecasting 28
4.2 Optimal Inventory 28
4.3 Minimum and Maximum Stock of Red Blood Cells 28
4.4 Stock Counts 29
4.5 Storage 29
4.6 Blood Supply Systems 29
4.7 Safe O 29
4.8 RhD Negative Blood Stock 29
4.9 Maximum Surgical Blood Ordering Schedules (MSBOS) 30
4.10 Storage of Blood 30
4.11 Cold Chain 30
4.12 Containers for Transporting Blood 31
4.13 Crossmatch to Transfusion (CT) Ratio and Expiry Rate 32
5.0 TRANSFUSION MICROBIOLOGY 32
5.1 Setting Up TML 32
5.2 Scope of Screening 32
5.3 Assays and Methods 32
5.4 Samples 33
5.5 Screening Procedure 33
5.6 Release Algorithm 33
5.7 Verification and Release of Results 34
5.8 Quality 34
5.9 New Methods and Assays 34
5.10 Handling of Reactive Samples 34
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5.11 Disposal of Reactive Blood 35

5.12 Documentation 35
5.13 Chain of Custody 36
5.14 Confidentiality 36
6.0 BLOOD GROUPING 37
6.1 Blood Grouping of Donors at the Donation Site 37
6.2 Blood Grouping of Donors in the Laboratory 37
6.3 Further Comformation of Donation Typed as RhD Negative 37
6.4 Blood Grouping for Patients Scheduled for Transfusion 38
6.5 Blood Grouping for Medical or Antenatal Check Up 38
6.6 Methods for Blood Grouping 38
7.0 ORDERING BLOOD FOR TRANSFUSION 40
7.1 Processes, Procedures, Methods and Records 40
7.2 Consent for Transfusion 40
7.3 Positive Patient Identification 41
7.4 Taking and Labelling Patient’s Blood Sample 41
7.5 Blood Samples for Red Cells Transfusion 42
7.6 Blood Samples for Blood Components (other than Red Cells) 43
Transfusion
7.7 Request Forms 43
7.8 Type of Requests 43
7.9 Receiving Request 44
7.10 Rejection of Requests 44
8.0 PRE-TRANSFUSION TESTING 45
8.1 Registration of Request for Transfusion 45
8.2 Determination of ABO and RhD Group 45
8.3 Antibody Screening 46
8.4 Records of Previous Transfusions 46
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Table of Contents
8.5 Antibody Identification 46

8.6 Crossmatching 47
8.7 Selection of Non Red Cell Components 48
8.8 Transfusion Records 48
9.0 ISSUE AND TRANSPORT OF BLOOD TO THE WARD 49
9.1 Issue and Collection of Blood 49
9.2 Storage and Transport 49
10.0 TRANSFUSION PROCESS 51
10.1 Identification Check Prior to Transfusion 51
10.2 Monitoring of Patient 53
10.3 Record Keeping 54
10.4 Duration for Transfusion of Blood 54
10.5 Blood Administration Sets 55
10.6 Microaggregate Filters 55
10.7 Leukocyte Filters 56
10.8 Blood Warmers 56
10.9 Sodium Chloride (0.9% NaCl)/Normal Saline 57
10.10 Discontinued Transfusion 57
10.11 Return of Used Blood Bags 58
10.12 Return of Untransfused Blood 58
11.0 PAEDIATRIC TRANSFUSION 59
11.1 Intrauterine Transfusion 59
11.2 Neonatal Transfusion 59
12.0 TRANSFUSION IN SPECIAL CIRCUMSTANCES 62
12.1 Transfusion in Cases of Life Threatening Bleeding 62
12.2 Transfusion in Thalasseamia and other Multiply Transfused 63
Patients
12.3 Transfusion in Stem Cell and Organ Transplant Patients 64
xiii
12.4 Transfusion in RhD Negative Patients 65

12.5 Transfusion in Antibody Cases 66
12.6 Rare Red Cell Phenotype 67
13.0 ADVERSE TRANSFUSION REACTION 69
13.1 General Management 69
13.2 Training and Competency 69
13.3 Investigation and Immediate Management 69
14.0 MANAGEMENT OF DONORS WITH REACTIVE TTI MARKERS 71
14.1 Post Donation Counselling 71
14.2 Managing Blood Donor 71
15.0 MANAGEMENT OF SEROCONVERT DONORS AND PATIENTS 72
15.1 Seroconvert Donors 72
15.2 Seroconvert Recipient 74
15.3 Investigation and Reporting 75
16.0 QUALITY MANAGEMENT IN BLOOD TRANSFUSION 76
SERVICES
16.1 Quality Management System 76
16.2 Essential Elements of Quality 76
17.0 HOSPITAL TRANSFUSION COMMITTEE 81
17.1 Members of the Committee 81
17.2 Terms of Reference 81
18.0 HAEMOVIGILANCE IN BLOOD TRANSFUSION 83
18.1 Haemovigilance Repoting 83
18.2 Patient Haemovigilance 84
18.3 Donor Haemovigilance 84
18.4 National Haemovigilance Coordinting Centre 85
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Appendix
Appendix
APPENDIX CONTENT PAGE
Appendix 1 Guidelines for the Acceptance and Deferral of Donors 86
Appendix 2 Blood Donor Registration Form 103
Appendix 3 Management of Adverse Reactions in Blood Donors 111
Appendix 4 Reporting Form for Adverse Donor Reaction 115
Appendix 5 Description of Adverse Donor Events 118
Appendix 6 Grading of Complication Severity and Imputability 125
Appendix 7 Criteria for Setting Up Transfusion Microbiology 127
Laboratories in the Ministry of Health, Malaysia
Appendix 8 Blood Screening and Blood Release Flowchart 128
Appendix 9 Consent Form for Blood or Blood Component Transfusion 130
Appendix 10 Blood Transfusion Request Form 132
Appendix 11 Examples of Rejection Criteria 133
Appendix 12 Instructions on Proper Handling of Blood and Blood 134
Components in the Ward
Appendix 13 Example of Transfusion Checklist 135
Appendix 14 Flowchart for Transfusionof RhD Negative Patients 136
Appendix 15 Flowchart for Transfusion in Patients with Rare 137
Phenotype Blood
Appendix 16 Flowchart on Management of Seroconverted Donor 138
Appendix 17 Flowchart on Management of Seroconverted Receipient 139
Appendix 18 Request Form for Transfusion Reaction Investigation 140
(Blood and Blood Components)
Appendix 19 Worksheet for Investigation of Transfusion Reaction 142
Appendix 20 Reporting Form for Transfusion-Related Adverse Event 143
Transfusion Medicine Service, Ministry of Health,
Malaysia
xv
APPENDIX CONTENT PAGE

Appendix 21 Flowchart for Reporting Transfusion-Related Adverse 147
Events
Appendix 22 Seroconvert Donor Notification Form 148
Appendix 23 Flowchart for Reporting of Adverse Donor Reaction 150
GLOSSARY 151
xvi
1.0 Introduction
This 4th edition of Transfusion Practice Guidelines For Clinical and
Laboratory Personnel has been revised extensively to include the development
that has occurred in transfusion medicine and the body of knowledge that
has accumulated in the last few years. Relevant requirements of established
standards, guidelines and principles such as MS ISO 15189, current good
manufacturing practice (GMP) and good clinical practice (GCP) in the BTS
have been incorporated.
This document shall be used as a guide for all healthcare personnel in
Malaysia. It provides the minimum requirements expected to ensure that the
products and services are safe, reliable and of good quality. Both clinicians
and laboratory personnel in transfusion practice, are therefore expected to
comply with the requirements. Where practices differ, they shall be based on
sound scientific and medical evidence.
The role of healthcare personnel is crucial in meeting the needs of patients.
Adherence to standard operating procedures, regular training and constant
supervision are important. Healthcare personnel involved in the transfusion
chain need to comply with National Blood Service Policies and relevant codes
of ethics that has been adopted by MOH.
It is the responsibility of BTS to provide “Adequate and Safe” blood at any time.
In order to achieve that, every activity in the BTS from blood procurement
from voluntary donors, processing, screening till supply of blood to patients
will emphasize on quality, safety, accountability, responsibility and traceability
of every personnel involved. This can only be achieved by implementing
effective Quality Management System (QMS) for the whole transfusion chain.
Each hospital shall establish a Hospital Transfusion Committee (HTC)
which serves as an effective forum for all stakeholders. The HTC shall
monitor transfusion practices, identify challenges and implement corrective
and preventive measures. Its activities shall also include Patient Blood
Management and Haemovigilance Programme.
Complementary to this guideline, “Handbook of rational use of blood and
blood products” shall be used as reference. These two documents will provide
a more comprehensive guidance for blood transfusion in Malaysia.
Right blood are given to the right patient, in the right place at the right time
2.0 Procurement of Blood

Blood shall be procured only from voluntary non-remunerated blood donors. The
blood collection centre shall ensure that there is a blood procurement team to
manage the blood collection activities.
2.1 Blood Procurement Team

2.1.1 Composition
The blood procurement team should comprise of the following personnel:
• Medical Officer(s).
• Health Education Officer or Public Relation Officer(s) (Penolong
Pegawai Penerangan).
• Nurse(s).
• Medical Laboratory Technologist(s).
• Clerical Staff.
• Health Attendant(s) (Pembantu Perawatan Kesihatan).
• Driver(s).
2.1.2 Responsibilities
The blood procurement team is responsible for:
• Promotion of blood donation.
• Recruitment and retentions of healthy, voluntary non-remunerated donors.
• Assessment of suitable and safe donors.
• Collection of quality blood from donors.
• Providing effective counselling services to donors screened reactive to
markers of transfusion transmitted infections (TTIs).
• Maintenance of records, data and information pertaining to its
activities for traceability, reference and quality improvement.
2.2 Promotion and Recruitment

2.2.1 Promotion
• Creating public awareness on blood donation.
2
• Giving talks to targeted group such as students and communities.

• Organizing and promote blood donation campaign for new organiser.
• Promoting health education through exhibitions, social media, mass
media and others and disseminating health education materials such
as pamphlets and posters.
• Managing, monitoring and coordinating all complaints/feedback from
customers/the public received via suggestion boxes, emails, integrated
system for monitoring of complains from the public to the government
agencies (iSPAAA) and others.
• Handling visits at blood collection centre.
• Managing and coordinating World Blood Donor Day.
2.2.2 Recruitment
• Recruitment of donor organisers.
• Recruitment of blood donor through donation campaigns.
• Target collection setting by weekly, monthly and yearly.
• Overcome the seasonal blood shortage by having blood stock
forecasting system.
2.3 Identification of Blood Donor

2.3.1 Acceptable identification documents
The following documents are acceptable for blood donor registration:
• MyKad ID.
• Army ID card.
• Police ID card.
• Driving license with photo.
• Worker pass with photo and MyKad or passport number.
• Student pass with photo and MyKad or passport number.
• Passport (Photostated copy must be verified by relevant authority e.g.
employer).
2.3.2 Documents not acceptable for identification
The following documents MUST NOT be accepted for registration of
blood donors:
3
• PATI form (Pendatang Asing Tanpa Izin).

• United Nation High Commissioner for Refugees (UNHCR) card.
2.4 Criteria for Acceptance of Blood Donors (Donor Eligibility Criteria)

2.4.1 To be eligible to donate, each prospective donor must meet the following
criteria:
a. Age
• Between 17 to 70 years old.
• Prospective donor aged 17 years old must provide written consent
from his or her parent or guardian. This consent must be duly
signed, and must contain the name and identity card number of
the parent or guardian.
• First time donor can be accepted up to the age of 60 years old.
• Regular donors can be allowed to donate up to the age of
70 years. However, donors aged more than 60 years old, are
required to undergo and pass yearly medical examinations
which, among others, should include chest X-Ray, ECG,
liver function tests, renal profile tests, fasting serum lipid
test, fasting blood sugartest and full blood count, or produce
an official letter from a qualified physician stating his or her
fitness to donate.
b. Weight and Haemoglobin Level
• The minimum weight for a whole blood donor shall be 45kg.
• The minimum weight for an apheresis donor shall be 55kg.
• The haemoglobin level of a male donor shall be between 13.5g/
dl and 18.0g/dl while for female donor between 12.5g/dl and
18.0g/dl.
c. Blood Pressure
The acceptable limits of blood pressure of the donor are:
• 100 to 150mm Hg for systolic pressure, and
• 70 to 100mm Hg for diastolic pressure.
d. Medical History
The blood collection centre must not accept as a donor any person
who is found to have any medical history that could cause harm to the
donor during donation, or to the recipient of the donated blood. Please
4
refer to the Guidelines for the Acceptance and Deferral of Donors

(Appendix 1).
ȤȤ Each prospective donor must be screened against the data base in
the central registry (e.g. SUKUSA- Sistem Pengumpulan Maklumat
untuk Pusat Kutipan & Pusat Saringan) or records of any previous
deferrals. Any person found to have been permanently deferred
should not be accepted as a donor. A person who has been
temporarily deferred must be assessed by the doctor in-charge to
ascertain if the person is eligible to donate again.
e. High Risk Behaviour
• Persons involved in any activities that put oneself at high risk of
being infected with TTIs shall not be allowed to donate and shall
be permanently deferred from future donation.
• Sexual partners of the above mentioned person shall also not be
accepted as blood donors.
ȤȤ The last sexual partner must be maintained more than twelve
(12) months before donation is allowable.
f. Replacement or Directed Blood Donation
• The blood collection centre must not allow blood donation for the
purpose of replacement or directed to specified recipient.
• Exceptions however are applicable subject to the approval by the
medical officer or specialist in-charge.
g. Specific Criterion for Foreigners (Non-Malaysian Citizen)
A prospective donor who is a foreigner (non-Malaysian citizen) can be
considered for donation only if he or she:
• Has resided in Malaysia for at least 12 months.
• Able to provide a residential or postal where the donor is
contactable.
• Must be able to read and understand Bahasa Malaysia or English.
2.5 Frequency of Donation

2.5.1 Whole blood donation
• A donor is allowed a maximum of 4 whole blood donations in a
period of 12 months subject to a minimum interval of 8 weeks
between successive donations.
5
• If a donor donates whole blood regularly every 8 weeks, (subject to

2.4.1 a.), iron store of the donor should be estimated at least once per
annum.
• Whole blood donor must be deferred from donating for at least 8 weeks
if more than 100m of red blood cells was lost during blood donation.
• The maximum quantity of whole blood allowed to be collected from
a donor per donation is 15% of the estimated body blood volume, or
10.5ml/kg of body weight, whichever is lower.
2.5.2 Apheresis donation
• A donor donating platelet and/or plasma via apheresis is allowed
a maximum donation of a total volume of 15 liters, or 24 times in a
period of 12 months, whichever comes first, subject to a minimum
interval of 2 weeks between successive donations.
• An apheresis donor must revert to whole blood donation if there is a
lapse of more than 6 months from the last apheresis donation.
• An apheresis donor may choose to donate whole blood at anytime
subject to a minimum interval of 2 weeks from the last apheresis
donation.
• An apheresis donor must be deferred from donating for at least 8
weeks if more than 100ml of red blood cells was lost or unreturnable
during the last apheresis donation.
• The minimum pre-donation platelet count for a prospective platelet
apheresis donor must be 150 x 109/L.
2.6 Record of Donors

2.6.1 Record of each donation must be maintained and updated. The eligibility
status of a prospective donor to donate shall also be clearly stated in the
records.
2.6.2 A prospective donor must complete the Blood Donor Registration Form
(Appendix 2) before donation.
2.6.3 All donor registration forms and records shall be kept secure and
confidential.
6
2.7 Pre-Donation Questionnaire

2.7.1 A prospective donor is required to read, understood, and answer all
the questions in the pre-donation questionnaire in the Blood Donor
Registration Form before being allowed for donation.
2.7.2 Appropriate assistance may be provided to those who are unable to read or
understand the questionnaire (applicable only to Malaysian citizen).
2.7.3 Consent for the donation must be clearly indicated on the Blood Donor
Registration Form.
2.8 Pre-Donation Interview

2.8.1 Pre-donation interview must be conducted in privacy by a doctor or nurse
who has been trained and qualified in blood donation process.
2.8.2 The interviewer must explain to the prospective donor about the blood
donation process.
2.8.3 There must be adequate assessment made of the health status of the
prospective donor.
2.8.4 If the prospective donor is on any medication, it must be ascertained that

it does not have any potential negative impact on the safety of the donor
during the blood donation process, and safety of the recipient of blood
and blood product.
2.8.5 The interviewer should enquire from the prospective donor for presence
of relevant symptoms such as skin rashes, swollen glands, needle marks,
pallor or jaundice that may indicate that the prospective donor may not be
fit to donate. Where feasible or necessary a physical examination should
be carried out.
2.8.6 The interviewer must explain to the prospective donor about high risk
behaviours that expose oneself to TTIs, and assess if the prospective donor
has or is suspected to have any of these high risk behaviours.
7
2.8.7 The prospective donor must be made aware of the possible legal action
that can be made on donors who make false declaration about their high
risk behaviour:
“Any blood donor who is found to make false declaration pertaining to his
or her high risk lifestyle behaviour will be prosecuted in Court under the
existing laws” (ref: KKM87/A6/1/23(16) Jld.2 dated 9/4/2012 – Bahagian
Amalan Perubatan, Ministry of Health Malaysia).
2.7.8 If a prospective donor is deferred, the reasons for deferral must be clearly
recorded in the donor’s Blood Donor Registration Form and in the donor’s
record.
2.9 Collection of Blood

2.9.1 Identification of donor
• The identity of the donor must be asked and checked against the record
in the Blood Donor Registration Form.
• Check (expiry date and any physical defect) and identify the type of
blood bag and the volume to be collected.
• Label the blood bag with blood group sticker and barcode at the
bedside before performing the venepuncture.
2.9.2 Venepuncture
• Venepuncture must be done by aseptic technique.
• The sterilised area must not be touched by unsterilised finger.
• The standard operating procedure must be strictly adhered to during
the venepuncture process.
• In the event of an unsuccessful venepuncture at the first attempt, use a
new set at a different venepuncture site/arm subject to consent of the
donor.
2.9.3 Mixing of donated whole blood
• Validated automated blood mixer is recommended for the purpose
of mixing the donated whole blood. The personnel attending to a
donation must ensure that blood flows uninterrupted into the bag at
an acceptable rate.
8
• In the absence of an automated blood mixer, the contents of the

collection bag should be manually mixed immediately at the start of
the collection, and then at regular intervals every 30 to 45 seconds
throughout the whole collection period.
2.9.4 Duration of bleeding for whole blood donation
• Ideal bleeding time should not take more than 10 minutes.
• Where the duration of bleeding exceeds 12 minutes, the blood must
not be used to prepare platelets.
• Where the duration of bleeding exceeds 15 minutes, the plasma must
not be used for direct transfusion or the preparation of coagulation
factors.
2.9.5 Handling of blood containers and collection of blood samples
• Tubes or containers should be checked before and after donation for
any defect.
• Samples of blood for laboratory testing must be collected from
the pouch of the blood collection set or directly from the donor
venepuncture tubing at the end of the donation.
• The blood samples must not be obtained by squeezing the blood out
from the blood bag.
• The collection of the blood samples and the labelling of the samples
must be carried out at the bedside.
• The blood bag and the corresponding blood samples must not be
removed from the donor bedside until all of the sample tubes or
containers have been correctly labelled and duly checked and verified
against the donor’s identification.
2.9.6 Blood donation identification
• Each blood donation shall be uniquely identified. The identification
shall contain a code identifying the blood collection centre and a serial
number identifying each individual donation.
• The above identification for each donation must be secured onto:
ȤȤ the Blood Donor Registration Form,
ȤȤ the primary blood bag,
ȤȤ the satellite blood bag(s), and,
ȤȤ sample tubes for laboratory tests.
• Records of donors and donations shall be traceable to the blood
donation identification.
9
2.10 Blood Donor Confidentiality

All information relating to the blood donor shall be kept confidential, and this
includes:
• During donor screening and blood collection.
• Donor record.
• Donor consent.
• Published information.
2.11 Training
All personnel involved in blood procurement must be adequately and properly
trained and made to understand the principles of the following:
• Blood donor eligibility criteria.
• Donor health assessment.
• Blood collection, sampling and handling of blood and blood containers.
• Storage and transport of blood.
2.12 Competency of Personnel for Bleeding of Blood Donors.

2.12.1 All personnel involved in collection of blood from blood donor must
undergo appropriate training and pass a practical competency tests before
they are allowed to perform unsupervised venepuncture.
2.12.2 A competency certificate should be issued to the competent personnel.
2.12.3 Only competent personnel should be allowed to perform venepuncture

on blood donors.
2.12.4 Competency of the personnel should be re-evaluated every 2 years.
2.13 Confidential Unit Exclusion

2.13.1 The prospective donor must be made to understand fully about confidential
unit exclusion.
10
2.13.2 Confidential unit exclusion is the act of the donor notifying the blood
centre/blood collection centre as soon as the donor has any doubts that
the donated blood is safe for use. This may be due to risk factors or any
medical reasons.
2.13.3 Upon such notification, the blood and any blood component(s) prepared
from this donor shall be immediately removed and disposed of. Records
of this event shall be maintained.
2.14 Adverse Reactions in Donors

2.14.1 Donors should be managed with high standards of care to assure them
safe during blood donation process.
2.14.2 Despite this, adverse donor reactions (ADR) do occur.
Table 2A: Some Common Adverse Donor Reactions
A. Local Symptoms
A1. Blood outside the vessel ȤȤ Haematomas
ȤȤ Arterial puncture
ȤȤ Delayed bleeding
A2. Arm pain ȤȤ Nerve injury/ irritation

ȤȤ Other arm pain
ocalised infection/ inflammation

A3. L ȤȤ Superficial thrombophlebitis
of vein or soft tissue ȤȤ Cellulitis
A4. Other major blood vessel injury ȤȤ Deep Venous Thrombosis (DVT)
ȤȤ Arteriovenous Fistula
ȤȤ Compartment Syndrome
ȤȤ Brachial Artery Pseudoaneurysm
B. General Reactions
Vasovagal reaction ȤȤ With injury/ without injury
ȤȤ Immediate/ delayed type
C. Related to Apheresis
• Citrate toxicity
• Haemolysis
• Air embolism
11
D. Allergic Reactions
• Local allergic reaction
• Generalized (anaphylactic) reaction
E. Other Serious Complications Related to Blood Donation
• Acute Cardiac symptoms (other than Myocardial Infarct or cardiac arrest)
• Myocardial Infarct
• Cardiac Arrest
• Transient Ischemic Attack (TIA)
• Cerebrovascular Accident
F. Others
2.15 Management of Adverse Reaction in Donors

2.15.1 Special attention shall be given to donors in whom an adverse reaction
associated with blood donation is identified.
2.15.2 Any ADR should be attended immediately. The donor shall be referred as
soon as possible to the doctor in-charge for further management.
2.15.3 The necessary treatment measures shall be instituted as soon as possible

and investigations shall be carried out to identify the cause of the reaction.
2.15.4 Donors shall be explained about the adverse reaction and reassurance
shall be given.
2.15.5 Appropriate preventive and corrective measures shall be implemented.
2.15.6 All staff shall be trained to recognize early signs and symptoms of an
adverse reaction and to be able to respond immediately and appropriately
manage such events in donor.
2.15.7 A guide to the management of specific adverse donor reactions is provided

in Appendix 3.
12
2.16 Documentation of Adverse Reactions in Donors

2.16.1 The doctor in charge and/ or health personnel shall fully document the
incident, treatment and outcome of all adverse donor reactions.
2.16.2 All adverse reactions shall be documented in a dedicated incident reporting

form for donor reaction. An example of such a form – see Appendix 4
(BTS/DV/2/2016) and the reports shall be kept at the respective collection
centres. A copy of the completed form shall be sent to the National
Haemovigilance Coordinating Centre every month. Appendices 5 and 6
provide description and grading of severity of adverse reactions.
2.17 Registry
2.17.1 The blood collection centre shall maintain registries of the following:
• Whole blood and apheresis donors.
• Donors with positive makers to Transfusion Transmitted Infection
(TTI).
• RhD negative donors and donors with rare blood groups.
2.17.2 The blood collection centre should establish registries for
• Permanently deferred donors (due to reasons other than positivity to
TTI).
• Temporarily deferred donors.
2.18 Record Keeping

2.18.1 Retention
2.18.1.1 Manual keeping

• All the donor records shall be kept for at least 20 years. (Surat Pekeliling
Ketua Pengarah Kesihatan Malaysia Bil 13/2001 - Garis Panduan
Penyimpanan Rekod Penderma dan Penerima Darah).
13
2.18.1.2 Database/systems
i. Donor Database - Online for 3 years for active record
- Archive database for 12 years
- Microfiche storage permanently
ii. Recipient Database - Online for 3 years for active record
- Archive database for 10 years
- Microfiche storage permanently
2.18.2 Policy
• “Public officials are prohibited from destroying records without written
permission of the Ketua Pengarah Arkib Negara Malaysia (Section 25-
ANM Act 2003)”.
2.18.3 Penalties
• Section 25(5) of the National Archive Act: “a fine of not more than
RM5,000 or 1 year imprisonment or both”.
2.18.4 Destruction of records
• Records should always be disposed of with the same level of security
that was maintained during the life of the records.
• Wherever possible, destruction of records should be supervised by an
officer.
• Before records destruction can occur, the following must take place:
i. National Archives should be consulted first before any
destruction of any records including electronic data.
ii. There is no active or pending litigation and audit for the records.
iii. The records are no longer required under any other legislation,
and all statutory and regulatory requirements are fulfilled.
iv. All records have been authorized for destruction in accordance
with the requirements of an approved Records Retention
Schedule and also permission from Ketua Pengarah Arkib
Negara Malaysia.
v. The destruction of all records must be documented, so that it is
able to determine whether a record has been destroyed.
14
3.0 Production of Blood Components

Blood components shall be prepared in adherence to the principles of Good
Manufacturing Practice (GMP), and any other applicable regulatory requirements.
The blood processing centre shall establish documented procedures and instructions
for the preparation and storage of blood and blood components.
3.1 Procedures for Preparation of Blood Components

3.1.1 Procedures for the preparation of blood components shall clearly state
the acceptable specifications of the starting materials, anticoagulant and/
or additive solutions, packaging materials (e.g. blood bags), equipment
as well as intermediate and final components. The specifications shall
include all factors that influence the quality of the component(s) prepared.
3.1.2 Blood cold chain shall be monitored and maintained from the time of
collection to processing, including during transportation.
3.1.3 Components should be prepared according to the time frames specified

below (para 3.2) where applicable.
3.1.4 Preparation of components beyond the time limits mentioned in para 3.2
below shall be fully validated before implementation. The validation shall
be documented and records made easily available.
3.1.5 Underweight whole blood units shall not be used for the preparation of
components.
3.2 Types of Blood and Blood Components

Below are the definition, criteria, preparation method, storage and shelf life of blood
and blood components.
3.2.1 Component : Whole Blood

Definition : Blood taken from a suitable donor and collected
into a pyrogen-free anticoagulant bag without
further processing.
15
Criteria for : No further preparation required.

preparation
Preparation : Not applicable.
Storage : 4º 6 2ºC.
temperature
Shelf life : 28 to 35 days depending on the anticoagulant/
preservative used.
3.2.2 Component : Whole Blood, Leukocyte-depleted
Definition :
Derived from whole blood by removing the
leukocytes to a residual leukocyte content of less
than 1 3 106 per unit.
Criteria for : Volume of whole blood within 10% of the range as
preparation specified for the type of bag used.
Preparation :
Filtration technique is used to produce whole
blood, leukocyte-depleted. Leukocyte depletion
should be done within 48 hours after donation.
temperature
preservative used.
3.2.3 Component : Red Cell Concentrate

Definition : A component obtained by removing most of the
plasma from whole blood.
Criteria for : Whole blood volume within 10% of the range as
Preparation : Plasma is removed from whole blood after
centrifugation.
temperature
preservative used.
3.2.4 Component : Red Cells in Additive Solution

Definition : A component derived from whole blood by
removing plasma with subsequent addition of an
additive solution.
Criteria for : Whole blood volume within 10% of the range as
16
Preparation : Plasma is removed from whole blood after

centrifugation with immediate addition of additive
solution.
temperature
additive used.
3.2.5 Component : Red Cells, Leukocyte-depleted

Definition : A component obtained from red cells by removing
the leukocytes to a residual leukocyte content of
less than 1 3 106 per unit.
Criteria for : Red cell concentrate and red cell in additive
preparation solution within the volume range as specified for
the type of bag used.
Preparation : Filtration technique is used to produce whole

blood, leukocyte-depleted. Leukocyte depletion
should be done within 48 hours after donation.
temperature
additive solution used.
3.2.6 Component : Red Cells, Buffy Coat Removed, in
Additive Solution
Definition : A component prepared by the removal of most
of the plasma and the buffy coat layer from whole
blood with subsequent addition of an additive
solution.
Criteria for : Whole blood volume shall be within 10% of the
preparation range as specified for the type of bag used.
Preparation : Prepared from whole blood by centrifugation, with
20-60ml of the buffy coat layer removed followed
by suspension of the red cells in additive solution.
Leukocyte count in red cell, buffy coat removed,
should be less than 1.2 3 109 cells per unit.
temperature
17
3.2.7 Component : Red Cells, Leukocyte-depleted for

Paediatric Transfusion (Paedipack)
Definition : A unit of leukocyte-depleted red cells aliquotted
into smaller volumes of 25-100ml per pack.
Criteria for : Prepared from blood of regular donors.
preparation
Preparation : Refer to 3.2.3 and 3.2.4 for the preparation of red
cell concentrate and red cells in additive solution.
The prepared component is then transferred
into several small volume packs which contain a
residual content of leukocyte count of less than
1 3 106 per unit. A closed system preferably an
aliquot blood bag system shall be used to ensure
sterility during transfer of the red cells.
temperature
3.2.8 Component : Red Cells, Washed

Definition : A component derived from red cells or whole
blood through sequential washing in an isotonic
solution, followed by re-suspension of the red
cells in an additive or saline solution.
Criteria for : Whole blood, red cell concentrate and red cells
preparation in additive solution within the volume range as
specified for the type of bag used.
Preparation :
According to in-house validated protocol
(manual or automated). Redcells or whole blood
is suspended in the isotonic solution and the
supernatant containing protein is removed. The
total protein of the final supernatant shall be less
than 0.5g per unit.

temperature
Shelf life : Shelf life is 24 hours using open system. The shelf
life for closed system is subject to local validation.
18
3.2.9 Component : Red Cells, Cryo-preserved/deglycerolized

Definition :
A component derived from thawing frozen red
cells, where most of the cryoprotectant (glycerol)
is removed.
Criteria for :
3.2.1, 3.2.3, 3.2.4 can be used as starting material.
preparation

Freezing (glycerolization) of red cells is preferably
carried out within 7 days of donation.
Preparation :
Red cells are frozen in cyroprotectant using either
low or high glycerol technique. Regardless of the
techniques, washing/deglycerolization procedure
is required.
Storage :
Red cells, cryopreserved:
temperature a. Below minus 65ºC (≤-65ºC).
b. Deglycerolized red cells : 4º 6 2ºC.
Shelf life : Red cells, cryopreserved:10 years.

Deglycerolized red cells: Maximum of 14 days.
3.2.10 Component : Red cells, Irradiated

Definition :
Red cells that have been irradiated to inactivate
lymphocytes to prevent TA-GVHD.
Criteria for :
Can be irradiated anytime up to 14 days after
preparation collection. All irradiated units shall be labelled as
such using appropriate barcode labels.
Preparation :
Unit shall be labelled with irradiation indicator tag
to indicate successful irradiation process.
Storage : Red Cells: 4º 6 2º C.

temperature
Shelf life : Maximum of 14 days after irradiation or up to the
expiry date of the blood, whichever is earlier.
3.2.11 Component : Platelet Concentrate, Random

Definition :
Derived from whole blood containing majority of
the original platelet content, suspended in plasma.
19
Criteria for : The whole blood (Refer to 3.2.1) used for

preparation preparation of platelet concentrates shall meet the
following criteria:
- Duration of bleeding is less than 12 minutes.
- Storage temperature prior to preparation: 20º to
24ºC .
Preparation : Preparation within 24 hours of collection.
Storage :
22º 6 2ºC under constant agitation throughout
temperature storage and shall be placed and arranged such as
to allow maximum respiration.
Shelf life : 5 days.
3.2.12 Component : Plateletpheresis

Definition : A component which contains platelet in a
therapeutically effective dose suspended in
plasma obtained from a single donor by apheresis
technique using automated cell separation
equipment.
Criteria for : None.

preparation
Preparation : Whole blood is removed from the donor by the
apheresis machine and platelets are harvested
from it.
Storage : 22º 6 2ºC under constant agitation agitation

temperature throughout storage and shall be placed and
arranged such as to allow maximum respiration.
Shelf life : 5 days.
3.2.13 Component : Fresh Frozen Plasma (FFP)

Definition : A component which contains labile clotting
factors and other constituents, for transfusion or
fractionation.
Criteria for :
Duration of whole blood donation shall not exceed
preparation 15 minutes. Plasma should be prepared within 24
hours of whole blood collection, preferably within
12 hours.
Preparation : Plasma is obtained from whole blood after
centrifugation, or by plasmapheresis and
immediately frozen to achieve complete freezing
within 1 hour to a core temperature of below
minus 30ºC (-30ºC).
20
Storage a. 36 months at or below -25ºC (≤-25ºC).

temperature b. 3 months at -18ºC to -25ºC.
and shelf life
3.2.14 Component : Cryoprecipitate
Definition : A component containing the cryoglobulin fraction
obtained by thawing and further processing of
FFP.
Acceptance : Refer to 3.2.13.
criteria
Preparation : Prepared by slow thawing of plasma at 2ºC to
6ºC overnight. After thawing, the component
is re-centrifuged using a hard spin at the same
temperature. The supernatant, cryo-poor plasma
is then partially removed while the remaining
cryo-poor plasma is used for resuspension. The
resulting cryoprecipitate is then rapidly frozen.

and shelf life
3.2.15 Component : Cryosupernatant
Definition : A by-product from the preparation of cryoprecipitate.
Acceptance : Refer to 3.2.13 and 3.2.14.

criteria
Preparation : Refer to 3.2.14.
and shelf life
3.2.16 Component : Pathogen inactivated plasma
Definition :
Plasma subjected to pathogen inactivating
procedure to reduce the risk of pathogen
transmission.
Acceptance : Plasma obtained from a single donor by apheresis
criteria technique.
Preparation :
Prepared by pathogen inactivation procedures
using one of the following methods: methylene
blue, amotosalen and riboflavin methods.
and shelf life
21
3.3 Labelling
3.3.1 Each blood component shall be uniquely identified by a unique barcode
number to allow for full traceability to the donor and the collection,
testing, processing, storage, release, distribution and the final fate of the
component (e.g. transfusion or discard of the blood component).
3.3.2 The labelling of blood components must be able to distinguish non-

released from released blood and blood components.
3.3.3 Each unit of component shall be labelled, at the minimum, with the
following information:
a. Unique barcode number as described in 3.3.1.
b. Date of collection.
c. Date of expiry.
d. ABO and RhD group.
e. Name of the blood component.
f. Volume of the blood component.
g. The name of the blood processing centre.
h. The word SCREENED.
i. Additional component information e.g. Irradiated, Phenotype.
3.4 Quarantine
3.4.1 The blood centre shall establish and implement a system of administrative
and physical quarantine for blood and blood components to ensure that
only blood and blood components that meet all mandatory requirements
are allowed to be released.
3.4.2 All unscreened blood and blood components shall be quarantined in

storage compartments distinctly separate from storage compartments
used for screened blood.
22
3.5 Storage
3.5.1 Complete segregation of screened and unscreened blood shall be
maintained at all times. The system of storage shall not give rise to
unintended release of unscreened blood.
3.5.2 Storage temperatures shall be controlled and appropriate for the blood or
blood components stored and temperature monitoring shall be carried
out and documented.
3.5.3 Storage equipment and facilities shall be equipped with appropriate alarm
systems which have both audible and visual signals. Alarm systems shall
be regularly checked and tested to ensure they are in working condition.
Records of tests and checks shall be maintained.
3.5.4 Documented procedures on actions to be taken in response to alarms
shall be established. Records of actions taken in response to occasions in
which alarms are activated shall be maintained.
3.6 Release of Screened Blood Components from Quarantine

3.6.1 Each unit of blood component shall be individually checked before it is
released into inventory/ for use by an authorized person.
3.6.2 Computer systems (if available) used to release blood or blood components
must be validated to prevent the inadvertent release of blood components
that do not meet all mandatory requirements. In the absence of a computer
system for release or in the event of computer system failure, the labelling
of blood component must be able to distinguish between a quarantined
and a released component.
3.7 Discard of Unsuitable Units of Blood

3.7.1 Units of blood that are found unsuitable to be released owing to reactivity
to markers of TTI shall follow the requirements in Section 5.11.
3.7.2 Units of blood that are found unsuitable due to reasons other than reactivity
to markers of TTI shall be systematically separated and discarded.
3.7.3 The discard of blood shall be fully recorded to ensure full traceability and
the chain of custody.
23
3.8 Quality Control

3.8.1 Acceptance parameters for blood shall be defined. Appropriate tests and
assessments shall be performed to monitor these parameters at regular
intervals. Table 3A below lists the recommended parameters to be
monitored and the frequencies of monitoring.
Table 3A: Quality Parameters and

The Frequencies of Monitoring for Blood
Type Parameter Quality Requirement Frequency of

(Specification) Control
a. Volume in:
Whole Blood i. 450ml bag 450ml ± 10%

ii. 350ml bag 350ml ± 10%
1% of all units
iii. 250ml bag 250ml ± 10%
with a minimum
b. Haemoglobin for: of 4 units per
month
i. 450ml bag >45g/unit
ii. 350ml bag >35g/unit
iii. 250ml bag >25g/unit
c. Haemolysis at the end < 0.8% of red cell mass

of storage
d. Sterility at the end of No Growth
the shelf-life
a. Volume in: To be defined for the system
used
i. 450ml bag
ii. 350ml bag
b. Haematocrit 0.65–0.75 1% of all units
with a minimum
Red Cell c. Haemoglobin >45g/unit of 4 units per
month
d. Haemolysis at the end <0.8% of red cell mass
of storage
e. Sterility at the end of No Growth
the shelf-life
24

a. Volume To be defined for the

particular system used
b. Haematocrit 0.50 - 0.70

1% of all units
Red Cells, c. Haemoglobin >45g/unit with a minimum
in Additive
of 4 units
Solution d. Haemolysis at the end <0.8% of red cell mass
per month
of storage
e. Sterility at the end of No Growth

the shelf-life
a. Volume To be defined for the system

used
1% of all units
b. Haematocrit 0.50 – 0.70
with a minimum
c. Haemoglobin >40g/unit of 4 units per
Red Cells, month
Leukocyte- d. Haemolysis at the end <0.8% of red cell mass
Depleted of storage
e. Residual Leukocytes <1.0 3 106 cell per unit 1% of all units

content1 with a minimum
of 10 units per
month
a. Volume 450ml 6 10%

1% of all units
b. Haemoglobin >43g per unit with a minimum
of 4 units per
c. Haemolysis at the end <0.8% of red cell mass
Whole Blood, month
of storage
Leukocyte-
Depleted d. Residual Leukocyte <1.0 x 106 cell per unit 1% of all units
content1 with a minimum
of 10 units per
month
25

a. Volume To be defined for the system

used
Red Cells, b. Haematocrit 0.50-0.7

1% of all units
Buffy Coat c. Haemoglobin >43g/unit with a minimum
Removed,
of 4 units per
in Additive d. Residual Leukocytes <1.2 3 109 cell per unit
month
Solution content1
e. Haemolysis at the end <0.8% of red cell mass

of storage
a. Volume 25ml – 100ml

Red Cell, 1% of all units
Leukocyte- b. Other related Refer to specifications for
with a minimum
parameters primary component from
Depleted for of 4 units per
which the red cells were
Paediatric month
derived
a. Volume To be defined
b. Haematocrit 0.65 – 0.75
c. Haemoglobin >40g/unit
Red Cell,
d. Haemolysis at the end <0.8% of red cell mass All units
Washed
of storage
e. Protein content of final <0.5g/unit

supernatant
Platelet a. Volume 50 - 70ml

Concentrates,
Random b. Platelet content per final
>60 3 109 cell per unit
unit
c. Residual Leukocytes
content1
<0.2 3 109 cell per unit 1% of all units
ȤȤ prepared from PRP
<0.05 3 109 cell per unit with a minimum
ȤȤ prepared from Buffy-
of 10 units per
coat
month
d. pH measured (22°C)
at the end of the >6.4
recommended shelf life
e. Sterility at the end of
No Growth
the shelflife
26

a. Volume >40ml per 60 3 109 platelets

Plateletpheresis
b. Platelet content >200 3 109/unit 1% of all units

with a minimum
c. Residual Leukocytes of 10 units per
<0.3 3 109/unit
content1 month
d. pH measured (22°C)
>6.4
upon issue
Stated volume ±10%

a. Volume (based on the blood bag
used)
b. Factor VIII level >0.7IU/ml

Every 3 months
c. Leakage No leakage at any part 10 units in the
Fresh Frozen
of container e.g. visual first month of
Plasma
inspection after pressure in storage.
a plasma extractor, before
freezing and after thawing
d. Visual changes No abnormal colour or

visible clots
a. Volume 35ml 6 5ml

Cryoprecipitate
b. Factor VIII level

ȤȤ Group A,B,AB >70IU/unit Pool of 6 units
of same blood
ȤȤ Group O To be define by user
group
c. Fibrinogen
>140mg/unit
Concentration
Standards of Compliance:
At least 75% of the units sampled should have the relevant parameters fall within the
specifications indicated in the table. However for parameters marked with superscript
1, 90% of the units sampled should have the relevant parameters fall within the values
indicated.
27
4.0 Blood Supply Management

There shall be procedure in place to ensure that only blood SCREENED NEGATIVE
for TTI are kept in the inventory.
4.1 Stock Forecasting

4.1.1 Data on blood collected, blood supplied, and usable blood stock-in-
hand shall be systematically recorded and analysed. Information derived
from the data can be used, among others, to forecast blood stock, predict
impending shortages and plan blood procurement.
4.2 Optimal Inventory

4.2.1 The blood centre/hospital blood bank shall estimate the optimal, the
minimum and the maximum stock levels of blood component of each
ABO and RhD group.
4.2.2 The minimum and maximum stock levels shall also be established, from
the average baseline usage and one of the methods to establish this is as
follows.
a. Record the weekly usage over a 6 month period.
b. Arrange them according to the ABO and RhD groups.
c. Total the weekly usage for each group. Divide this total by 26. This will
give the average of weekly usage for that group.
d. The final inventory levels may be based on number of beds and are also
influenced by the logistics and distances from the collection centres.
4.3 Minimum and Maximum Stock of Red Blood Cells

4.3.1 Each blood centre/hospital blood bank should hold 7 days of stock of red
blood cells. The minimum level of red blood cells should be between 2 to3
days of stock.
28
4.4 Stock Counts

4.4.1 Daily stock count shall be performed to manage the stock to optimal
levels. Appropriate records shall be maintained.
4.5 Storage
4.5.1 Blood shall be systematically arranged according to groups, component
types and expiry dates, so as to facilitate the issuance on a ‘First In First
Out’ (FIFO) basis.
4.5.2 However, in cases which require fresh blood, the blood centre/hospital
blood bank may choose not to follow FIFO.
4.6 Blood Supply Systems

4.6.1 Reliable blood supply systems for emergency and routine shall be
established and implemented.
4.7 Safe O
4.7.1 If and when necessary, the hospital blood bank shall make available Safe O
(that is Group O RhD positive packed cells) at suitable sites for managing
emergencies.
4.7.2 Procedures for managing Safe O shall be established and implemented.
4.7.3 Appropriate records of the use and movement of Safe O shall be
maintained.
4.8 RhD Negative Blood Stock

4.8.1 Blood collection centre shall maintained ABO and RhD negative blood
stock.
29
4.9 Maximum Surgical Blood Ordering Schedules (MSBOS)

4.9.1 Hospitals shall develop own MSBOS to meet local requirements. Refer
Guidelines for the Rational Use of Blood and Blood Products, Ministry of
Health 3rd edition for details.
4.10 Storage of Blood

4.10.1 Blood shall be stored at appropriate temperatures at all times. Storage
temperatures shall be monitored. Records of temperature monitoring
shall be maintained and made readily available. Refer Table 4A.
4.11 Cold Chain

4.11.1 The blood centre/hospital blood bank shall ensure blood cold chains are
maintained during storage and transportation as shown in the table below:
Table 4A: Storage and Transportation Temperatures for Blood
Temperature
Component Transport Boxes
Storage Transportation
Red Cell 2ºC to 6ºC 2ºC to 10ºC –
Insulated box with
(all types of coolant pack
red cell) –
Direct contact with
coolant shall be
AVOIDED
Platelet 20ºC to 24ºC 20ºC to 24ºC Insulated box with NO
ICE
Frozen products More than More than Insulated box. If

(Fresh Frozen minus -25ºC minus -25ºC temperature rises less
Plasma/ than –25ºC, the shelf life
Cryoprecipitate/ will be shortened to 3
Cryosupernatant) months
Thawed FFP, To be 2ºC to 10ºC –

Insulated box with
Cryoprecipitate/ issued out coolant pack
Cryosupernatant immediately –
Direct contact with
coolant shall be
AVOIDED
30
4.12 Containers for Transporting Blood

4.12.1 Containers (re-useable or disposable) for transporting blood shall be
adequately insulated, robust, tamper proof and clearly labelled for easy
identification.
4.12.2 The containers and the ratios of coolant to blood and component shall be
validated.
4.12.3 Records of validation shall be maintained.
4.13 Crossmatch to Transfusion (CT) Ratio and Expiry Rate

4.13.1 The hospital blood bank shall closely monitor
a. CT ratio.
b. Expiry rates of blood and platelet.
31
5.0 Transfusion Microbiology

The primary function of the Transfusion Microbiology Laboratory (TML) is to
screen blood for Transfusion Transmitted Infections (TTIs). The TML shall be placed
directly under the purview of the blood centre. This is to ensure that donated blood,
donors and screening algorithms are effectively managed.
5.1 Setting up TML

5.1.1 The setting up of any TML shall comply strictly to the criteria shown in
Appendix 7.
5.2 Scope of Screening

5.2.1 All donated blood shall be screened for the following TTIs:
a. Human Immunodeficiency Virus (HIV).
b. Hepatitis C virus.
c. Hepatitis B virus.
d. Syphilis.
5.2.2 Blood collected in areas with high risk of malaria infection should be
screened for malaria parasites.
5.2.3 Screening for other infectious diseases may be carried out if deemed
necessary.
5.3 Assays and Methods

5.3.1 TML within the Ministry of Health shall use only assays and standard
methods approved by the Ministry of Health. Test methods shall be
strictly adhered to at all times. Modifications to the standards methods
are not allowed.
5.3.2 Rapid test SHALL NOT BE USED for screening of donated blood.
32
5.4 Samples
5.4.1 All donations, any subsequent components and their laboratory samples
shall be correctly identified by barcoded and eye-readable numbers which
can be linked to their donor.
5.5 Screening Procedure

5.5.1 All unscreened donations and their blood components should be placed
in a secured physical segregation/ quarantine until all the required tests
have been completed.
5.5.2 Use single assay and test each blood donation singly.
5.5.3 All initially reactive pilot tubes shall be retested in duplicates.
5.5.4 Component preparation unit shall retrieve the corresponding blood bag
of all initially reactive donations.
5.5.5 Samples, for serology testing, from the corresponding blood bags should
also be tested to verify the source of the reactive pilot tubes.
5.5.6 A collection batch shall be quarantined if there is any discrepancy

between the results of the pilot tubes and those of the corresponding
blood bags in that batch. The quarantine shall be lifted only after thorough
investigations, and resolution of the discrepancies. Appropriate corrective
and preventive actions shall be taken. Records of the events, the findings
of the investigations, and the corrective and preventive actions taken shall
be maintained.
5.6 Release Algorithm

5.6.1 A complete result must be obtained from each batch before the final
results can be released. Only blood and blood components that are non-
reactive for all markers can be released for use. TMLs within the Ministry
of Health shall follow the algorithm in Appendix 8A for screening and
release of screening results.
33
The alternative protocol (Appendix 8B) is for the blood bank which
has an established and effective quality system for all its processes. Risk
assessment shall be made and approval from the Head of Department is
required before implementing such protocol.
5.7 Verification and Release of Results

5.7.1 All screening results shall be verified and released by a trained and
competent Scientific Officer (Microbiologist).
5.8 Quality
5.8.1 To ensure quality in screening of donated blood, the TML shall, at the
minimum:
a. Perform daily internal quality control monitoring for both reagents
and techniques.
b. Participate in external quality assessment/proficiency programs.
5.8.2 Additional quality assurance efforts should be established and implemented
for continual improvement.
5.9 New Methods and Assays

5.9.1 The National Blood Centre (NBC) TML is the national reference laboratory
for Transfusion Microbiology and shall be responsible for evaluation of
new assays and methods for use in blood screening.
5.9.2 Each TML shall perform verification or validation (whichever is

applicable) before implementing any new methods or assays.
5.10 Handling of Reactive Samples

5.10.1 Each TML shall establish and implement procedures to handle all reactive
donation and reactive results. These shall encompass, at the minimum
procedures to:
34
a. Ensure repeat testing on segments of the blood bag for all initial
reactive pilot tube samples as per 5.6.
b. Ensure donation reactive to HBsAg are confirmed.
c. Ensure all donations that are repeatedly reactive to anti-HIV and anti-
HCV are sent to NBC TML for further testing.
5.11 Disposal of Reactive Blood

5.11.1 The component preparation unit or its equivalent shall be responsible to
immediately retrieve all blood and its component that have been found
reactive. These shall be immediately removed from its storage and sent to
the TML for discard.
5.11.2 All reactive blood and blood components shall be autoclaved before it is
sent for final disposal.
5.11.3 The disposal of the reactive blood shall be fully documented to ensure
audit trail.
5.12 Documentation
5.12.1 Proper documentation of test procedures and records of results such
as worksheets and printed results shall be made available and properly
maintained. Worksheets shall contain, among others, the following:
a. Personnel performing the test.
b. Date and time of testing.
c. Reagent name, lot number and expiry date.
d. Personnel verifying the test results.
5.12.3 Record of the tests on donation samples shall be reviewed and compiled
on monthly basis.
5.12.3 All the screening results and monthly statistics shall be updated in
Sistem Pengumpulan Maklumat untuk Pusat Kutipan & Pusat Saringan
(SUKUSA).
5.12.4 All screening records shall be kept for at least 20 years.
35
5.13 Chain of Custody

5.13.1 The whole process starting from the time specimens are delivered to TML
for testing till blood is released and tainted blood is identified and disposed
of, involves various personnel and several departments/unit. Documented
procedure(s) shall be established and implement to ensure appropriate chains
of custody are maintained.
5.13.2 In establishing such procedures, proper checks shall be put in place especially
during critical steps to prevent errors. It is strongly recommended that
checklists are used for all critical steps.
5.14 Confidentiality
5.14.1 All test results and donor particulars shall be kept confidential. The TML
shall establish and implement a system for delineating access to controlled
data and information to appropriately authorized personnel.
36
6.0 Blood Grouping
6.0 Blood Grouping

6.1 Blood Grouping of Donors at the Donation Site
Blood grouping of donors at the donation site should be done using anti-A and
anti-B antisera on blood samples obtained by finger prick. The blood grouping result
obtained should only be considered a preliminary result of the blood group and
should not be used for any other purpose whatsoever.
6.2 Blood Grouping of Donors in the Laboratory

Blood grouping of donors in the laboratory shall employ full ABO and RhD blood
grouping procedure, as follows:
6.2.1 Forward grouping shall be performed using anti-A, anti-B, anti-AB and
anti-D antisera. Tests for RhD shall be carried out with two different IgM/
IgG blends of monoclonal anti-D. One of the two monoclonal anti-D used
shall not detect DVI for RhD negative blood.
6.2.2 Reverse grouping shall be performed using A1-cells, B-cells and O-cells.
The O-cell test is incorporated to detect Bombay blood group and other
unexpected IgM antibodies.
6.2.3 The results of the forward grouping have to match the results of the reverse
grouping. In the event these results do not match, an investigation of this
discrepancy shall be carried out.
6.2.4 Any blood donor found to be RhD negative shall be confirmed as
described in 6.3 below. The blood grouping result obtained from this full
blood grouping procedure is the final result.
6.3 Further Confirmation of Donation Typed as RhD Negative

6.3.1 All donated blood that is typed as RhD negative shall be subjected to a
weak-D test (also known as Du test).
6.3.2 If the weak-D test is negative, the donated blood is confirmed as RhD
negative.
37
6.3.3 If the weak-D test is positive, a direct antihuman globulin (DAT) test shall
be carried out and the results shall be interpreted as below:
a. If the weak-D positive blood is DAT negative, the blood is a D variant.
b. If the weak-D positive blood is DAT positive, the blood is probably a
false positive D.
c. The true RhD status of the above can only be determined through
further tests.
6.3.4 Donations confirmed to be RhD negative by the above tests shall be
phenotyped for C, c, E and e antigen. In the event the blood transfusion
centre is unable to perform this, the tests concerned shall be outsourced.
a. Blood that is phenotyped as cde/cde (rr) shall be labelled as “RhD
negative” blood.
b. RhD phenotype other than cde/cde (rr) shall be labelled with its actual
Rh phenotype, e.g. Cde/Cde (r’r’) or cdE/cdE (r’’r’’). This type of blood
can be given to patient with same phenotype or RhD positive patients.
c. All cases of cde/cde (rr) phenotype shall be informed to the respective
collection centres. This is to enable the centres to develop, maintain
and regularly update their ‘Registry of rare blood donors’.
6.4 Blood Grouping for Patients Scheduled for Transfusion - Refer 8.2
6.5 Blood Grouping for Medical or Antenatal Check Up

6.5.1 The blood grouping shall be performed using a full grouping procedure.
6.5.2 All RhD negative cases shall be subjected to further tests for confirmation
(see 6.3 above).
6.6 Methods for Blood Grouping

6.6.1 The methods recommended to be used in blood grouping are as follows:
a. Tile method:
This is considered a rapid grouping test. It shall be allowed ONLY for
38
6.0 Blood Grouping
blood grouping on donors at blood donation sites. Results obtained

from the tile method shall be considered as preliminary results only
and SHALL NOT BE TREATED as the final grouping result.
b. Microtitre plate method:
This is recommended for testing large numbers of samples such as
grouping of donor samples in the laboratory, or testing patient samples.
The results obtained are acceptable as final results.
c. Tube method:
This is considered the ‘gold standard method’ for blood grouping.
This is recommended for samples from patients or donors. The results
obtained are acceptable as final results.
d. Column agglutination method:
This is recommended for patient blood grouping. The results obtained
are acceptable as final results.
39
7.0 Ordering Blood for Transfusion

The decision to transfuse shall be made based on clinical judgment. The benefits
and risks shall be assessed, and alternative therapy considered. Among the risks of
blood transfusion are the transmission of infectious disease agents and transfusion
reactions.
The clinician managing the patient shall be responsible for prescribing blood for that
patient. When necessary the clinician should discuss with the doctor in-charge of the
hospital blood bank.
7.1 Processes, Procedures, Methods and Records

7.1.1 Each hospital shall establish adequate documented processes, procedures
and methods pertaining to the ordering of blood for transfusion. Records
shall be kept.
7.2 Consent for Transfusion

7.2.1 The patient must give written informed consent prior to transfusion.
7.2.2 The clinician in charge of the patient shall explain to the patient the
indication, benefits, risks and alternatives to transfusion therapy, and
ensure that the patient understands the issues discussed. The patient
should be given an opportunity to ask questions. The decision of the
patient regarding which therapy to take shall be clearly documented.
7.2.3 If for any reason, the patient is unable to personally give consent, a
responsible family member of the patient shall be asked to do so. If no
such family member is available, or in emergencies when the need for
transfusion leaves no time for consent, the decision shall be made by
two fully registered medical practitioners. This decision shall be clearly
documented. Refer to Appendix 9 for a sample of consent form.
7.2.4 Each hospital shall develop its own policy for obtaining consent for
patients receiving long term transfusion support, example annual consent
for Thalassaemia cases.
40
7.3 Positive Patient Identification

7.3.1 Positive patient identification is a process to correctly identify patients
thus avoiding medical error.
7.3.2 The phlebotomist shall ensure that the patient is correctly identified by:
a. Asking the patient to state their full name and IC number (use of at
least 2 identifier) in open ended questions such as “Can you tell me
your full name and IC number?”.
b. Check the answers given against the information stated on the patient’s
identification wristband and/or case notes.
7.3.3 If it is not possible to identify the patient in the above manner (e.g. in
the case of an unconscious patient, paediatric patients or in cases of
emergencies), the phlebotomist shall identify the patient by asking the
relative or carer to name the patient and then check the answer given
against the information stated on the patient’s identification wristband,
and case notes.
7.4 Taking and Labelling Patient’s Blood Sample

7.4.1 The process of taking and labelling of blood samples is critical to ensure
that the right blood sample is collected from the right patient.
7.4.2 The above procedure shall be carried out as one process by one person at
the bedside.
7.4.3 Only one patient shall be attended to at any one time till completion.
7.4.4 The phlebotomist shall clearly and accurately label the blood sample at the
patient’s bedside immediately after blood taking.
7.4.5 Use of pre-printed label is not encouraged. If this cannot be avoided the
hospital shall be responsible to establish and implement a procedure to
ensure that patients are correctly identified using the printed labels.
7.4.6 Information on the label shall include, at the minimum, the patient’s full
name, hospital registration number (or Identity Card (IC) number), the
date and time of collection and the initial of the phlebotomist.
41
7.5 Blood Samples for Red Cells Transfusion

7.5.1 Collect the required amount of blood into the appropriate sample tube as
follows:
a. Infant up to 4 months old
i. The sample to be taken from the infant shall be 1.5 to 2.0ml
blood sample in EDTA tube.
ii. 3-5ml blood sample in EDTA tube shall be also taken from the
mother.
The sample from the infant and the sample from the mother
shall be sent to the hospital blood bank together under a single
request.
b. Older than 4 months old
The sample to be taken shall be 3-5ml of blood sample in EDTA tube.
7.5.2 Repeated red cell transfusion
7.5.2.1 For infant up to 4 months old

No further sample is required for repeat transfusion of the same set of the
paedipack. However infant’s sample is required for subsequent transfusion
if another set of paedipack is going to be issued. For this, crossmatching
will be performed using the infant’s sample.
7.5.2.2 For patient older than 4 months
If a patient requires repeated red cell transfusion, each request for red cells
shall be accompanied by a new request form and blood sample of 3-5ml
of blood in EDTA tube.
7.5.2.3 Elective cases
For elective cases, samples should be sent to the hospital blood bank
during office hours at least 24 hours before the blood is required except
for rare blood groups and/or RhD negative where the hospital blood bank
should be informed at least 5 working days in advance.
42
7.6 Blood Samples for Blood Components (other than Red Cells) Transfusion
7.6.1 A new request for blood component other than red cells shall be
accompanied by a blood sample taken in EDTA tube.
7.6.2 For a patient who has at least two previous blood grouping records at
the hospital blood bank, a new blood sample need NOT accompany the
request for blood component. However, a copy of the previous request
form clearly stating the blood grouping results shall be attached to the new
request form.
7.6.3 If previous request form is not available, a fresh blood sample shall be sent
to the hospital blood bank to determine the patient’s blood group.
7.6.4 For ABO mismatched haemopoietic stem cell transplantation, this is not
applicable. A new sample must accompany all requests in the immediate
post transplant period until the patient’s blood group has change to that of
the donor.
7.7 Request Forms

7.7.1 The clinician shall ensure that each request form is completed. Refer
Appendix 10 for the request form.
7.7.2 For elective surgery, the clinician shall ensure that the quantity of red cells
requested for patients follow the local Maximum Surgical Blood Ordering
Schedules (MSBOS).
7.7.3 The clinician shall sign, and clearly state his name in block letters on the
request form.
7.8 Type of Request

7.8.1 Group and Crossmatching (GXM)
a. GXM consists of checking ABO & RhD grouping and antibody
screening for the patient’s sample and crossmatching patient and
donor unit for compatibility.
b. GXM shall be requested for cases with high certainty for transfusion
at that time.
43
c. The full procedure takes about 2 hours to be completed. However in

emergency situation blood can be issued out as described in section
12.1.
7.8.2 Group, Screen and Hold (GSH)
a. GSH is a procedure that consists of ABO and RhD grouping, and
antibody screening for the patient’s sample. The patient’s serum or
plasma is subsequently retained for a minimum of 48 hours.
b. It is recommended only for cases where there is a higher chance of
requiring blood transfusion during admission.
c. For elective clinical procedures, GSH shall be requested in accordance
to the locally established Maximum Surgical Blood Ordering Schedule
(MSBOS).
d. Should the patient require transfusion following GSH, blood should
be made available on time.
7.9 Receiving Requests

7.9.1 All requests for transfusion shall be registered.
7.9.2 The hospital blood bank personnel receiving a request shall ensure that
the request form is complete and the corresponding samples are correctly
labelled. Information on the request form and the label of the sample shall
tally.
7.10 Rejection of Requests

7.10.1 Rejection of requests shall comply with local policies and procedures.
Refer Appendix 11 for an example of rejection criteria.
7.10.2 However in LIFE THREATENING SITUATIONS, the hospital blood

bank shall immediately facilitate the resolution of any discrepancies that
cause the rejection of the request, by discussing with the clinician. Any
resolution including that made through telephone conversation shall be
fully documented.
44
8.0 Pre-transfusion Testing

Pre-transfusion testing in the laboratory should include ABO and RhD grouping,
antibody screening and crossmatching. Other relevant tests such as antibody
identification or sub group identification are carried out when necessary. The
rationale is to ensure that the appropriate blood type is given to the patient.
8.1 Registration of Request for Transfusion

8.1.1 All requests for transfusion shall be registered.
8.2 Determination of ABO and RhD Group

8.2.1 Blood grouping shall be carried out twice, as follows:
a. The first and second blood grouping tests shall be performed using
samples from the SAME SOURCE of pre-transfusion specimen
(EDTA specimen) but from DIFFERENT CELL SUSPENSION
preparations. The first and second grouping tests shall be performed
by two persons, independently.
b. In situations where it is absolutely not feasible to have two persons
available, the grouping may be carried out by one person. However,
the first and the second grouping shall be carried out at different times
and using different cell suspensions. The two grouping tests shall NOT
be carried out simultaneously.
c. Blood can be released only if the results of both the two groupings are
identical.
8.2.2 Refer 6.3 for procedure of ABO and RhD grouping.
8.2.3 All unanticipated findings noted when determining the ABO and RhD
shall be fully investigated and documented.
45
8.3 Antibody Screening

Antibody screening is mandatory for all requests for transfusion.
8.3.1 In laboratories that carry out antibody screening by tube method, the
following phases shall be performed at,
a. Room temperature,
b. 37°C and
c. Anti Human Globulin (AHG).
8.3.2 In laboratories that use other standard methods (e.g. column agglutination
technology) manufacturer’s recommendations shall be followed.
8.3.3 The red cell reagents used shall consist of at least two group O red cells,
(not pooled), and shall express all of the following antigens: C, c, D, E,
e, M, N, S, s, K, k, Fya, Fyb, Jka, Jkb. Where possible, one of the red cell
reagents should be of the R1R1 phenotype (CDe phenotype) and another
of R2R2 phenotype (cDE phenotype). Additional red cell antigens may be
considered to reflect the antigenic profile of the local population.
8.4 Records of Previous Transfusions

8.4.1 Records of previous transfusions shall be traced.
8.4.2 Any discrepancy between current and previous blood group shall be fully
investigated and documented.
8.5 Antibody Identification

8.5.1 Antibody identification shall be carried out whenever the antibody
screening test is positive, and/ or incompatible crossmatch is detected.
8.5.2 If the antibody identification result is inconclusive, or difficult case,

reference laboratory shall be consulted.
8.5.3 If the discussion cannot provide the solution, the case should be referred
to the reference laboratory for further investigation with the followings:
10ml of blood in EDTA tube and 10ml blood in plain tube accompanied
by a duly completed request form.
46
a. Provide the reference laboratory with initial laboratory findings.

b. Notify the reference laboratory before sending the sample.
8.6 Crossmatching
8.6.1 Red cell unit selected for crossmatching shall be of the same ABO and
RhD type as that of the patient. In special circumstances, refer chapter 11
and chapter 12.
8.6.2 In laboratory that carry out crossmatching using tube method, the
following phases shall be performed at:
a. Room temperature,
b. 37° C, and
c. AHG .
8.6.3 In laboratory that use other standard methods (e.g. column agglutination
technology), manufacturer’s recommendations shall be followed.
8.6.4 When a clinically significant red cell antibody is identified, every effort
shall be made to provide blood that is antigen negative (with respect to the
identified antibody). Refer 12.5 for selection of blood in antibody cases.
8.6.5 Where fully compatible blood is not available, and the patient needs
urgent transfusion, the hospital blood bank shall discuss with the clinician
in charge of the patient for the issue of the most compatible blood. The
decision to use the most compatible blood shall be arrived at after taking
into consideration.
a. The potential risks of adverse reactions, and
b. the potential risks of harm to the patient owing to delay in transfusion
arising from searching for fully compatible blood.
8.6.6 Crossmatched samples shall be retained securely under appropriate
storage conditions for a minimum of 7 days.
8.6.7 Crossmatched blood that has not been issued shall be released into general
stock after 48 hours.
47
8.7 Selection of Non Red Cell Components

8.7.1 Plasma and platelet concentrates selected for transfusion shall be
compatible and preferably of the same ABO group.
8.7.2 Recommendations for selection of plasma and platelets.
Table 8B: Guide for The Selection of Plasma and Platelets
ABO blood group ABO group of plasma ABO group of platelet to be

of patient to be issued in order of issued *
preference
Unknown Issue AB if urgent Issue O if urgent
(request sample for
baseline grouping)
O O, A, B, AB O
A A , AB A, O
B B, AB B, O
AB AB AB , O
8.8 Transfusion Records

8.8.1 All transfusion records, in the form of hard or soft copies or both, shall be
archived for not less than 20 years.
8.8.2 The following requirements shall be fulfilled when an IT system is used,

a. Active records shall be maintained online for not less than three years.
b. The database shall be archived for the legally designated period of
retention.
c. A mechanism for maintaining and protecting records from loss or
unintentional removal or destruction shall be put in place.
48
9.0 Issue and Transport of Blood to the Ward

Blood shall be kept at appropriate temperature and condition at all times before
transfusion. There shall be an appropriate procedure to ensure that the correct blood
is issued out to the correct patient.
9.1 Issue and Collection of Blood

9.1.1 Only authorized hospital blood bank personnel shall be allowed to issue
blood.
9.1.2 The ward personnel collecting the blood shall bring documentary proof of
the patient’s identity.
9.1.3 The blood compatibility label shall be duly completed by the hospital
blood bank and shall carry at least the following information:
a. Full name of patient.
b. Identity card or passport number of patient.
c. Hospital registration number of patient.
d. ABO and RhD blood group of patient.
e. Unique pack number (donation barcode number) of the blood
product.
f. Date of issue.
g. Type of component.
9.1.4 The authorized hospital blood bank and ward personnel shall verify that
the particulars of patient match those of the blood to be issued.
9.1.5 The authorized hospital blood bank personnel shall record the dates and
times of issue and collection, the name of person issuing and the name of
the person collecting the blood.
9.2 Storage and Transport

9.2.1 The ward personnel shall transport the issued blood to the ward or
returned blood to the hospital blood bank without delay. Transportation
shall be carried out in an appropriate temperature.
49
9.2.2 Issued blood shall be transfused without undue delay. However, in the
event where delay is inevitable, the ward shall maintain the blood at the
appropriate temperatures and condition until they are used or returned to
the blood bank immediately. (Please see Appendix 12.)
50
9.0 Issue and Transport of Blood to the Ward
10.0 Transfusion Process

Patient identification before commencing administration of blood or blood
components is critical to ensure that the right blood is transfused to the right patient.
10.1 Identification Check Prior to Transfusion - FINAL BEDSIDE CHECK

10.1.1 Each hospital shall establish procedure for carrying out identification
checks, to prevent any error occurring at this final stage before transfusion
commenced. The check shall include the blood bag label, blood
compatibility label, request form, and the patient’s identification.
10.1.2 Each unit of blood supplied by the hospital blood bank shall be appropriately
labelled (Figure 10A) and accompanied by a blood compatibility label
(Figure 10B).
Figure 10A: Example of a blood bag label Figure 10B: Example of a blood compatibility
label (PPDK 1)
10.1. Prior to transfusion, personnel in charge shall perform a positive patient

identification as elaborated in 7.3.
51
10.1.4 A check shall be conducted to ensure that the patient’s information (listed
in 10.1.3 above) on the blood compatibility label match those on the:
a. Blood bag label.
b. Patient’s wristband.
c. Patient’s blood request form.
d. Case notes.
Figure 10C: Example of a cross checking of patient’s wristband, request form, PPDK card and
blood bag label
10.1.5 The blood shall also be checked to ensure that it has not expired and that
it conforms to the following in appearance:
a. No change in colour.
b. Absence of clots.
c. No foamy appearance.
d. No leakage.
10.1.6 A competent personnel (doctor or paramedic) shall perform all the steps
in 10.1.2 to 10.1.5 above, and a second person (doctor or paramedic) shall
countercheck that the steps mentioned have been carried out correctly.
These shall be carried out BEFORE the transfusion. The checking and the
counterchecking shall be documented in a transfusion checklist form.
Refer for example of transfusion checklist.
52
10.1.7 In the event of any discrepancy in the identification check of intended

recipient, blood compatibility label, request form and blood component,
the blood bank shall be immediately informed. The implicated blood shall
be immediately returned to the blood bank for appropriate measures to be
taken. The chain of custody shall be documented.
10.1.8 DO NOT transfuse if there is any non-compliance to any of the

requirements stated in 10.1.2 to 10.1.6 above.
All the steps performed above are intended to minimize the risk of a
patient receiving wrong blood. Failure to adhere to these steps may
lead to wrong blood transfusion resulting in harm or even death of
the patient.
10.2 Monitoring of Patient

10.2.1 The patient shall be closely observed and monitored during blood
transfusion.
10.2.2 Parameters to be monitored shall include:

a. Blood pressure.
b. Pulse rate.
c. Temperature.
d. Clinical features of acute transfusion reactions.
10.2.3 The vital signs shall be monitored and recorded:
a. Before starting transfusion.
b. During the transfusion (close observation and monitoring for the
first 5 to 10 minutes, and subsequently half hourly and then hourly.
Perform vital sign monitoring every 15 minutes for unconscious
patients receiving transfusion).
c. After completion of transfusion.
The first 50ml of red cells should be transfused slowly as it serves

as an in vitro compatibility testing.
53
10.3 Record Keeping

10.3.1 The following information for each transfusion shall be recorded into the
patient’s case note:
a. Type of product transfused.
b. Identification of product transfused (donation barcode number).
c. Times transfusion starts and ends.
d. Date of transfusion.
e. Adverse transfusion reaction, if any.
10.3.2 A copy of the blood request form (with clear compatibility test results
from the blood bank) shall be kept with the patient’s case notes.
10.4 Duration for Transfusion of Blood

10.4.1 Red cells:
Packed red cells and whole blood should be transfused within 30 minutes
of removal from the blood refrigerator. The transfusion of each unit shall
not exceed 4 hours.
Note: There is significant risk of bacterial contamination if a unit of red cells
is kept at room temperature for too long.
10.4.2 Platelets:
Platelets should be transfused as soon as it is received from the hospital
blood bank. The transfusion of each pack should not exceed 30 minutes.
Do not refrigerate platelets. Keep platelets at room temperature

(20-24°c).
10.4.3 Plasma
Plasma should be transfused as soon as the thawed unit is received from
the hospital blood bank. The transfusion should be carried out at a rate
that the patient can tolerate.
54
10.5 Blood Administration Sets

10.5.1 ALL blood and blood components shall be transfused through a blood
administration set containing special IV tubing with an integrated filter
(170 - 260 micron) to remove blood clots and particles.
10.5.2 A mechanism should exist in the IV setup to allow the administration of

0.9% NaCl in the event of transfusion reaction e.g. a “Y” port.
10.5.3 The tubing of the administration set shall be primed with 0.9% NaCl or
with the component itself.
10.5.4 If an administration set has previously been used for the transfusion of red
cells, it shall NOT be used for transfusing platelets. A fresh transfusion set
shall be used.
10.6 Microaggregate Filters

10.6.1 Microaggregate filters retain degenerating platelets, fibrin strands and
clumps of red cells of 20-40 micron. These are formed in all blood stored
beyond 5-10 days.
10.6.2 Microaggregate filters are not used for routine blood administration.
10.6.3 These filters are recommended to be used in:

a. Cardio-pulmonary bypass.
b. Patients with pre-existing lung disease receiving large volume
transfusion.
Microaggregate filters shall not be used for granulocyte and

platelet transfusions.
55
10.7 Leukocyte Filters

The reduction of the numbers of leukocytes in red cells can be achieved by using
leukocyte filters designated for this purpose.
10.7.1 Leukocyte filters may be used for the following purposes:-

a. To decrease the incidence of febrile non-haemolytic transfusion
reactions.
b. To reduce the rate of HLA alloimmunization.
c. To reduce the rate of platelet alloimmunization.
d. To decrease the incidence of CMV transmission.
Leukocyte filters shall not be used for granulocyte transfusions.
10.8 Blood Warmers

Blood warmers are rarely needed during routine transfusion situations as there is no
evidence that warming blood is beneficial to patients when the transfusion is slow (1
unit over 2 hours). Warmed blood minimizes the incidence of hypothermia, cardiac
arrest and arrhythmia associated with massive transfusion of cold blood components.
10.8.1 The ward shall ensure that only validated blood warmers are used.
10.8.2 Indications for use:

a. Massive or rapid transfusion
i. >15ml/kg/hr in children
ii. >5 ml/kg/hr in adult
b. Transfusion in neonates e.g. exchange transfusion.
c. Cold agglutinin syndrome.
When using blood warmers ensure that:
a. Blood warmers shall be validated before use and maintained regularly.
b. Each blood warmer shall have a visible thermometer and an audible
warning device to detect malfunctions and to prevent haemolysis.
c. NEVER warm blood by placing it in hot water, in microwave, on radiator,
under running water or near any uncontrolled heat source.
56
d. NEVER refrigerate blood, which has been warmed.

e. Recheck the blood unit against the intended recipient before commencing
the transfusion if blood is placed in a common blood warmer.
10.9 Sodium Chloride(0.9%NaCl)/ Normal Saline

10.9.1 0.9% NaCl is iso-osmotic with red blood cells. Red cell concentrates may
be diluted with 0.9% NaCl to improve the flow rate.
10.9.2 Medications or solutions, other than 0.9% NaCl, SHALL NOT be

administered through the same tubing used for blood transfusion.
The reasons for this are:

a. Other solutions may affect the properties of the blood components
e.g. Ringer’s lactate solution which contains calcium additive can
cause citrated blood to clot, and 5% Dextrose solution can cause
haemolysis.
b. It may be difficult to determine the cause of an adverse transfusion
reaction. (Whether it is due to the blood or blood component, or the
medication, or to an interaction of these.)
10.9.3 If administration of medication is required and there is no other venous

access available to allow separate administration of medication:
a. Stop the transfusion and flush the IV tubing with 0.9% NaCl before
administrating medication.
b. Flush the medication with 0.9% NaCl before resuming transfusion.
10.10 Discontinued Transfusion

10.10.1 Any blood remaining from a discontinued transfusion SHALL NOT be used.
10.10.2 Remnants of blood shall be clearly labelled as USED BLOOD and returned to
the hospital blood bank immediately.
10.10.3 Details and reasons for discontinuing the transfusion shall be clearly
documented in the patient’s case notes.
57
10.11 Return of Used Blood Bags

10.11.1 The ward shall be responsible to return used blood bags and compatibility
card/ label which has been completely filled up to the hospital blood bank
within 24 hours.
10.11.2 The ward shall correctly and completely fill up a compatibility card/ label.
10.11.3 The compatibility card/ label shall contain at least the following information:
a. Name of hospital.
b. Ward.
c. Full name of recipient.
d. Identity card/passport number of recipient/hospital registration
number of recipient.
e. Recipient’s blood group (ABO and RhD), age and gender.
f. Date of transfusion.
g. Time transfusion starts and ends.
h. Volume transfused.
i. Adverse transfusion reaction, if any.
j. Name and signature of staff.
10.11.4 The hospital blood bank shall keep the used blood bags in a refrigerator
duly marked and designated for this purpose, for 7 days after transfusion.
10.12 Return of Untransfused Blood

10.12.1 The ward shall return all untransfused blood immediately to the hospital
blood bank. (Refer Appendix 12 for instructions on proper handling of
blood and blood component in the ward.)
10.12.2 Untransfused blood that is returned to the blood bank shall be discarded
unless it is kept in an appropriate condition and temperature.
10.12.2 The ward shall inform the hospital blood bank if any of the untransfused
blood returned to the blood bank has not complied with the storage or
transportation temperature.
58
11.0 Paediatric Transfusion

The requirement for paediatric transfusion takes into account the ability of the patient
to form alloantibodies which is generally from 4 months old and above. Patients less
than 4 months may have passive transfer of antibodies from the mother.
11.1 Intrauterine Transfusion

Intrauterine transfusion of red cells is indicated to prevent fetal death due to severe
anaemia or haemorrhage. This is generally limited to hospitals which have established
facilities for this procedure.
For intrauterine transfusion, the blood shall be:
a. Fresh (preferably not more than 5 days old),
b. group O RhD positive or negative red cells, depending on maternal
ABO and Rh blood group,
c. leukodepleted blood by filtration,
d. irradiated to prevent Transfusion-Associated Graft-Vs-Host Disease
(TA- GVHD), and
e. Cytomegalovirus (CMV) negative if indicated.
11.2 Neonatal Transfusion

Volume of blood to be transfused is calculated based on the neonate’s body weight.
Volume required (mls) = body weight (kg) 3 Hb rise required (g/dL) 3

transfusion factor (0.4)
11.2.1 Blood used for neonatal transfusions shall be compatible with the mother’s
blood.
The choice of red cells:
a. Group O packed cells are generally suitable for top-up transfusion.
b. Use infant’s own ABO group if crossmatching is done using infant’s
blood.
c. Blood for exchange transfusions in neonatal jaundice cases are as
provided in Table 11A below.
59
11.2.2 Pre-transfusion testing

a. Samples from mother and neonate should be obtained for the following
tests:
i. Sample from the mother:
• Determine the ABO group using both forward and reverse
methods.
• Determine the Rh group.
• Screen for the presence of unexpected red cell antibodies.
ii. Sample from the neonate:
• Determine the ABO group using forward method only.
• Determine the Rh group.
• Perform direct antiglobulin test (DAT).
b. If the maternal blood is not available, the neonatal serum/plasma shall
be screened to exclude unexpected red cell antibodies.
c. If unexpected red cell antibodies are detected during screening, and/or
DAT is positive, investigations shall be performed to further identify
the unexpected antibodies.
d. Crossmatching with the maternal serum/plasma shall be performed.
Where maternal serum is not available, infant serum/plasma can be
used. However, this is not encouraged.
11.2.3 For neonatal transfusion, the blood shall be:
a. Fresh (preferably not more than 5 days old).
b. Leukodepleted by filtration.
c. Irradiated.
11.2.4 Blood for neonatal transfusion
a. Red cells
i. Red cells in exchange transfusion (ET)
Indications for ET include the management of severe anaemia at
birth, particularly in the presence of heart failure and the treatment
of severe hyperbilirubinaemia, usually caused by haemolytic disease
of newborn (HDN).
In the treatment of HDN, the primary aim is to remove both the
antibody-coated red cells and excess bilirubin.
60
Recommended groups of blood to be used for ETs in cases of neonatal

jaundice are as provided below:
Table 11A: Recommended Blood To Be Used Based on

Blood Groups of Recipient Neonate and Corrresponding Mother
Blood Group Of Mother

O A B AB
O O O O O
A EO A EO A
Blood Group of
Neonate B EO EO B B
AB EO A B AB
Note: In Malaysia, emergency O blood (EO) is group O RhD

positive whole blood with low titres of Anti-A and Anti-B, and
negative for haemolysin.
In hospital blood banks which do not have facilities to identify EO by

performing haemolysin test, blood group O RhD positive fresh packed
cells suspended in fresh AB plasma can be used.
ii
Red cell transfusion for correction of anaemia (“top-up”
transfusion)
naemia in neonatal period may require blood transfusion. The
A
common causes of anaemia include congenital or acquired disease, and
or blood loss from trauma or surgery. Red cells for top up transfusion
may not be less than 5 days old.
b. Platelets and plasma:
Requirements are as per transfusion in adults. It is preferable that all
FFP used are pathogen inactivated.
61
12.0 Transfusion in Special Circumstances

In emergency situation whereby patient is bleeding and in dire need of blood, the
choice of blood to be transfused to the patient might be different with regards to
its compatibility testing. Whereas for multiply transfuse and transplant patient,
the requirement of the blood might be different in view of its preparation such as
phenotype blood, filtration and irradiation.
12.1 Transfusion in Cases of Life Threatening Bleeding

Life-threatening bleeding is defined as bleeding that could result in severe morbidity
and mortality unless there is prompt intervention. Every hospital shall establish its
own protocol and procedures on managing life threatening bleeding cases. Health
care personnel who are likely to be involved in such cases must be well versed with
the local protocols.
12.1.1 Choice of blood

The choice of blood for transfusion in cases of life threatening bleeding
is dependent on the urgency for transfusion and the time available. The
options available are:
a. Uncrossmatched Group O RhD positive packed red cells (Safe O)
In Malaysia where RhD negative phenotype is not common, Group
O RhD positive packed cells is used as Safe O. Safe O can be used
for resuscitation in dire emergency while waiting for group specific or
crossmatched blood to be available.
Any decision to use Safe O shall only be made after the clinician has
carefully assessed the urgency of the patient’s need for blood. The
requesting doctor shall clearly state the reasons for the transfusion in
the patient’s records and in the request form. A sample of the patient’s
blood shall be taken before the transfusion of Safe O for the purpose
of determining the patient’s actual blood group, and for subsequent
management.
It is recommended that Safe O be made available in the

A&E, Labour Room and where necessary
62
b. Uncrossmatched group specific packed cells

If the blood group of the patient is known, uncrossmatched group
specific blood maybe given.
c. Emergency crossmatch
If the blood is required within 30 minutes, units of blood that are
found to be compatible at immediate spin after 5 minute incubation
at room temperature may be issued. The hospital blood bank shall
proceed to completion of the compatibility testing and antibody
screening of the units of blood issued, at 37ºC and in the AHG phase.
Any incompatibility detected shall be immediately informed to the
clinician concerned for appropriate action.
12.1.2 The indication and personnel responsible for deciding the usage of Safe
O, uncrossmatched group specific and emergency crossmatch shall be
documented in the patient’s records and in the request form.
12.1.3 All requests for emergency crossmatch should be accompanied by a phone

call to the hospital blood bank to facilitate the process. Details of the
communication shall be documented, including the names of the caller
and the receiver.
12.2 Transfusion in Thalasseamia and Other Multiply Transfused Patients

Multiply transfused patients are potentially at risks of acquiring alloimmunization
and TTI through transfusion.
12.2.1 Baseline data for each potential multiply transfused patient shall be
established before starting the transfusion program. This involves:
a. Phenotyping of red cells, which should include Rh, Kell, Kidd, Duffy
and MNSs.
b. Screening for TTIs.
c. Screening for red cell antibodies.
12.2.2 Subsequently, screening for TTIs shall also be carried out every 6
months and screening for red cell antibody shall be carried out each time
transfusion is required by the patient.
12.2.3 Blood units that are issued shall be ABO and Rh compatible. Phenotype
compatible and filtered blood should be considered.
63
12.2.4 Patients who are immunosuppressed or immunocompromised including

bone marrow transplant patients should be given irradiated cellular blood
products.
12.3 Transfusion in Stem Cell and Organ Transplant Patients

12.3.1 Transfusion in stem cell transplant patients
Haemolysis due to ABO incompatibility may occur immediately on
stem cell infusion (usually with bone marrow transplants that are
heavily contaminated with red cells) or be delayed for 7 to 14 days due
to production of antibodies by residual host or transplanted lymphocytes
(more common with peripheral blood-derived haematopoeitic stem cell).
It is occasionally life threatening.
Table 12A: Categories of ABO-Incompatible HSC transplant
Categories of ABO-
incompatible HSC transplant
Major ABO incompatibility The recipient’s plasma contains anti-A, anti-B
or anti-A,B antibodies that are incompatible
with donor red cells
(e.g. group A donor and group O recipient)
Minor ABO incompatibility The donor’s plasma contains anti-A, anti-B
or anti-A,B antibodies that can react with the
recipient’s red cells
(e.g. donor group O and recipient group A)
Bidirectional ABO incompatibility Both the donor and recipient’s plasma contain
anti-A, anti-B or anti-A,B antibodies reactive
with recipient and donor red cells respectively
(e.g. donor group A and recipient group B)
a. Selection of blood for transfusion

Below are table to guide the selection of blood to be crossmatched
for transfusion in patients after ABO incompatibility stem cell
transplantation.
64
Table 12B: Recommended ABO Blood Group of Components

Transfused in The Early Post Transplant Period
Categories of ABO Donor Recipient Red cells Platelets FFP

incompatibility
Major ABO A O O A A
incompatibility B O O B B
AB O O A AB
AB A A A AB
AB B B B AB
Minor ABO O A O A A
incompatibility O B O B B
O AB O A AB
A AB A A AB
B AB B B AB
Bidirectional ABO A B O B AB
incompatibility B A O A AB
12.3.2 Transfusion in organ transplant patients

ABO compatible transplant is generally carried out because ABO antigens
are present on the vascular endothelium of tissues and organs throughout
the body. However, ABO incompatible transplant have been successful
using living donors when the recipient’s incompatible antibodies are
temporarily removed or brought to a low titre by plasma exchange, before
surgery.
Transfusion to these patients shall use blood that is ABO compatible. Any
additional requirements, such as irradiation, are subject to discussions
between the treating clinician and the specialist in hospital blood bank.
12.4 Transfusion in RhD Negative Patients

Blood bank normally stock minimum RhD negative blood for emergency use.
12.4.1 Each hospital shall establish its own procedure on managing RhD negative
cases.
12.4.2 In elective cases involving RhD negative patient, the treating clinician
shall inform the hospital blood bank of the case at least five working days
prior to the procedure that may require transfusion. This notification is
essential to allow the hospital blood bank enough time to source for the
required blood.
65
12.4.3 In emergency situation, where ABO group specific RhD negative blood
is not available in time, the hospital blood bank may issue, in order of
preference:
a. Group O RhD negative blood, or
b. ABO group specific RhD positive blood, only if the patient does not
have pre-formed anti-D.
This shall be done only after discussing with and agreed by the treating
clinician.
12.4.4 Appendix14 summarises the steps to follow in transfusion of RhD negative
patients.
12.5 Transfusion in Antibody Cases

For cases where antibody is present, refer to the table below for the guide of selection
of red cells for transfusion.
Table 8A: Guide For The Selection of Suitable Red Cell Units
For Transfusion In The Presence of Antibodies
Clinical
Specificity Selection of units
significance
Rh antibodies Yes Antigen negative
Kidd antibodies Yes Antigen negative
Duffy antibodies Yes Antigen negative
Kell antibodies Yes Antigen negative
Anti-S, -s Yes Antigen negative
Red cells compatible by AHG

Anti- A1, -P1, -N Rarely
at 37ºC
Anti-M Rarely Red cells compatible by AHG
at 37ºC
Anti-M reactive at 37ºC Yes Antigen negative
Anti-Le a , - Le a+b, Anti-Le b Rarely Red cells compatible by AHG

at 37ºC
Anti-Le a , - Le a+b, Yes Antigen negative
Anti-Le b reactive at 37ºC
66
High titre low-avidity antibodies Unlikely Seek advice from Reference

Laboratory
Antibodies against low/ high Depends on Seek advice from Reference

frequency antigens specificity Laboratory
12.6 Rare Red Cell Phenotype

Rare red cell phenotypes are those that are not commonly found with incidence of
less than 1 in 1000. Examples are:
i. The absence of a high prevalence antigen or the absence of several
antigens within a single blood group system.
ii. Absence of common antigens.
iii. Inheritance of an”Inhibitor” gene e.g. Lu(a-b-).
iv. Null phenotype e.g. Jk(a-b-), Fy (a-b-), Rhnull.
The potential source of rare phenotype blood would be:
i. Family members
ȤȤ Siblings are often the best source of serologically compatible
blood.
ii. Rare donor registry.
iii. Rare donor registry from other blood centres.
iv. Frozen red cells.
12.6.1 All blood centres shall have their own rare donor registry and shall report
to the National Rare Donor Registry .
12.6.2 In elective cases involving rare red cell phenotype patients, the treating
clinician shall inform the hospital blood bank of the case at least five
working days prior to the procedure that may require transfusion. This
notification is essential to allow the hospital blood bank enough time to
source for the required blood.
12.6.3 If the clinical situation allows, autologous RBC transfusions should be

considered for patient with rare phenotypes who are expected to need rare
blood in the future.
12.6.4 Effort should be made to phenotype the siblings.
67
12.6.5 Appendix15 summarises the steps to follow in transfusion of patients with

rare phenotype.
Note: For details on the clinical aspects on transfusion in special

circumstances, please refer to the Guidelines for the Use of Blood
and Blood Products, Ministry of Health. 3rd Edition
68
13.0 Adverse Transfusion Reaction
13.0 Adverse Transfusion Reaction

Adverse transfusion reaction is an undesirable response or effect in a patient
temporarily associated with the administration of blood or blood component.
13.1 General Management

All transfusion reactions shall be investigated and reported as described in Section
18.0.
13.2 Training and Competency

All personnel involved in ordering and administering transfusions shall be trained
and assessed in their competency:
a. Recognizing the signs and symptoms of transfusion reactions, and
b. Management of transfusion reactions.
13.3 Investigation and Immediate Management

All adverse transfusion reactions shall be managed accordingly.
13.3.1 If an adverse transfusion reaction is detected or suspected, the transfusion

shall be stopped immediately. A doctor shall immediately assess and
stabilize the patient. Further management depends on the type and
severity of the reaction.
13.3.2 To facilitate investigation of an adverse transfusion reaction, the following

shall be carried out:
a. Blood samples (at least 8-10mls) in EDTA shall be taken for :-
i. Repeat ABO/Rh grouping.
ii. Repeat crossmatching.
iii. Direct and indirect antihuman globulin test (Coombs).
iv. Urine examination for haemoglobin and red cell.
These specimens shall be accompanied by a request form for investigation
of transfusion reaction. Example as in Appendix 18.
69
b. In addition, for cases suspected of haemolytic transfusion reactions,

further investigation should include full blood picture (FBP), liver
function test (LFT) and lactate dehydrogenase (LDH).
13.3.3 The ward shall keep the transfused blood bag and its transfusion set
under appropriate conditions to ensure integrity and to avoid microbial
contamination. These shall be sent to the hospital blood bank as soon as
possible, together with any unused blood bags and the corresponding
blood compatibility labels.
70
14.0 Management of Donors with Reactive TTI Markers
14.0 Management of Donors with Reactive TTI Markers

All donors whose blood samples are found to be repeatedly reactive to markers of
TTIs during donation shall be counselled and further managed.
14.1 Post-Donation Counselling

14.1.1 During a post-donation counselling, a new blood sample shall be taken
from the donor for confirmation testing. Risk factors related to the TTI
concerned shall be elicited. Details of the counselling sessions shall be
fully documented.
14.1.2 The donors shall NOT be informed of the screening test results from the
donation until the results have been confirmed.
14.2 Managing Blood Donor

Donations that are repeatedly reactive may be confirmed as being of negative,
inconclusive or positive status:
14.2.1 A negative conclusion on confirmatory testing indicates that the donor is not
infected with the specific infection. However, a donor showing repeatedly
reactive results on screening and negative results on confirmatory testing
should be counselled and temporarily deferred until screen non-reactive on
follow-up. The donor can then be accepted for future donations.
14.2.2 An inconclusive outcome is usually due to non-specific reactivity not

related to the presence of the infectious agent. It is also known as a
Biologically False Reactive (BFR) result. The donor should be counselled,
deferred for blood donation and followed-up for further investigations.
14.2.3 A positive conclusion confirms that the donor is infected and should
be deferred from future blood donation, counselled and referred for
appropriate medical care. The case shall be notified to the nearest Public
Health Officer responsible within 1 week from the date of confirmation,
regardless of whether the donor turns up for the post-donation
counselling. Details of all confirmed positive donations and particulars
of the implicated donor shall be registered without delay into a central
registry (Sistem Pengumpulan Maklumat untuk Pusat Kutipan & Pusat
Saringan (SUKUSA)).
71
15.0 Management of Seroconverted Donors and Recipient

The management of sereconvert donors and recipients is an important obligation of
both the blood transfusion service and the clinicians who ordered the transfusion.
15.1 Seroconverted Donor

A seroconverted donor is one who is confirmed positive for a particular TTI in his
current donation but was negative in the previous donation.
15.1.1 All donors found to be seroconverted with HIV, Hepatitis B, Hepatitis C

or Syphilis shall first be informed and counselled by the doctors at the
blood centre, and then referred to the appropriate physician for further
management. Refer Appendix 16 for the flowchart on management of
seroconverted donor.
15.1.2 Upon confirmation of seroconversion of a donor, the blood centre, shall

take the following actions concurrently for donor and blood products
management:
a. Counsel and permanently defer the donor from donating.
b. Register the donor in SUKUSA.
c. Conduct look back procedure for the last negative donation and
donation(s) in the six (6) months period prior to the last negative
donation.
d. Recall blood component that has not been used.
e. Inform the hospital(s) supplied with the previous last negative
donation of the seroconverted donor.
f. Details of look back investigations of seroconverted donor should be
compiled in Seroconvert Donor Notification Form (BTS/SC/1/2016,
refer Appendix 22) and kept in each blood centre. A copy of Part 1 of
the form shall be completed and sent to NHCC within a month after
the donor came for counselling. Upon completion of all investigations,
send a copy of the completed form (both Part 1 and Part 2) to the
NHCC within a month.
72
15.0 Management of Seroconvert Donors and Patients
15.1.3 Each hospital shall develop and implement a system for managing
recipients that received blood or blood product from seroconverted donor.
Upon notification of a seroconverted donor the hospital blood bank shall:-
a. Trace transfusion record of recipient/s of the implicated donation/s and
inform treating clinician to contact recipient/s for further counseling
and testing.
b. Trace any blood component that are still in their inventory and return
to the blood centre immediately.
15.1.4 The team involved in counselling recipients should include at least the
treating specialist/consultant and may include a transfusion medicine
specialist.
15.1.5 First counselling session with recipient should be carried out as follows
(pre-test counselling):
a. Inform recipient the reason for consultation.
b. Inform and explain that the blood or blood component transfused
was from a donor who recently seroconverted. As a precautionary
measure, the recipient needs to be tested to ascertain whether he/
she is infected following the transfusion of a possible window period
donation. Explain that “window period” IS NOT a laboratory error.
c. Assess the risk factors of the recipient with respect to the TTI
concerned. Try to identify risk factors other than blood transfusion.
d. Explain about the TTI concerned, including its mode of transmission
and potential complications.
e. Explain about tests available and the interpretation of the results.
f. Take samples of blood for the implicated infection, and reassure the
recipient that the probability of being infected through transfusion is
low.
g. Inform about the precautions to be taken while waiting for the test
results. This is to prevent potential transmission from the recipient to
others.
h. Discuss with the recipient the probability of the tests outcome.
15.1.6 Second counselling session should be carried out as follows (post-test
counselling):
73
a. If test results is negative

i. Inform recipient and explain.
ii. Reassure the recipient.
iii. If necessary, retest after 6 months or implement any follow-up.
b. If test result is positive to the TTI
i. Inform the recipient and explain.
ii. Further assess the risk factors other than blood transfusion. If
none, explain to blood he or she received was tested negative at
the time of donation.
iii. Reassure and discuss about the treatment options.
v. Refer the recipient to an infectious disease physician. Report
transfusion-related adverse event to NHCC using form BTS/
HV/3/2016.
15.2 Seroconverted Recipient

A seroconverted recipient is one who is confirmed positive for a particular TTI
marker(s) after receiving blood transfusion, but who was negative for that infection
prior to the transfusion.
15.2.1 Recipients of a transfusion may develop HIV, Hepatitis B, Hepatitis C,

Syphilis infection or other possible TTI agent infection resulting from:
a. T
ransfusion of blood that was donated within the window period of
the infection, or
b. other sources not related to the blood transfusion.
15.2.2 However, it is recommended that donors of the blood that has been
transfused to the patient in the 12 months period prior to the detection
of the infection be contacted for testing. The hospital blood bank shall be
informed to identify the blood donors and their status determined (refer
Appendix 17).
15.2.3 If a blood donor is identified as the source of infection, other recipients of

his or her blood should be traced and investigated.
74
15.0 Management of Seroconvert Donors and Patients
15.3 Investigation and Reporting

15.3.1 Blood sample are taken for the suspected infectious disease marker based
on the following table:
TYPE OF INFECTION TEST FOR RECIPIENT

Syphilis RPR
TPPA
Hepatitis B HBsAg
Neutralization
(Other supportive test for e.g. Molecular)
Hepatitis C AntiHCV
Line Immunoassay
HIV AntiHIV
Particle Agglutination
Line Immunoassay
15.3.2 Investigations and reporting of seroconversions of both donors and

recipients shall be carried out as described in Section 18.0 below
(Haemovigilance in Blood Transfusion).
75
16.0 Quality Management in Blood Transfusion Services

16.1 Quality Management System
All blood centres, hospital blood banks and collection centres must establish and
implement a quality management system guided by requirements of established
standards, guidelines and principles such as MS ISO 15189 and current good
manufacturing practice (cGMP). The system must cover all aspects of its activities
carried out in all its facilities.
16.2 Essential Elements of Quality

The quality management system must address the following elements of quality:
16.2.1 Management Responsibility

The management of the hospital blood bank must:
a. Give full commitment and support to the establishment and
implementation of its quality management system.
b. Clearly define its quality policy and quality goals.
c. Provide adequate resources for all activities within the scope to enable
objectives to be met effectively and efficiently.
16.2.2 Organizational Structure and Responsibilities
a. The organizational structure must be well defined. Lines of authority
and responsibility must be clearly spelt out.
b. A suitably qualified person possessing the necessary skills and
expertise should be appointed as a quality manager.
c. Where feasible, a quality assurance unit should be set up, whose
primary function is to coordinate and monitor all quality activities of
the organization.
16.2.3 Documents and Records
a. All relevant processes, procedures and instructions must be
adequately documented. These documents and references must be
made readily available at the places of work. It is the responsibility of
the management to ensure that all staff understand and implement the
76
16.0 Quality Management in Blood Trasnfusion Services
processes, procedures and instructions as documented.

b. All documents must be duly authorized, and regularly reviewed to
ensure they remain current.
c. Records of work carried out must be adequately maintained. These
records should contain details of work done, the personnel who
execute the work and the dates on which the work was carried out.
d. An effective system for the control of documents and records must be
established and implemented.
e. Policies and systems for the archiving of documents and records must
be established and implemented. The policies must be in compliance
with current regulations and laws.
16.2.4 Personnel and Training
It is the responsibility of the management to ensure that:
a. Each personnel have a clear job description which includes lines of
authority and responsibility.
b. Each personnel is adequately trained and assessed to be competent
in the specified task before being allowed to carry out the task
independently.
c. Each personnel is regularly trained and assessed to ensure continuous
competency.
d. Records of training and assessment of competency are established and
systematically maintained.
16.2.5 Premises (Work Environment)
a. The work environment must be designed and maintained accordingly
to facilitate effective and efficient operations.
b. The work environment must not give rise to any detrimental impact
on the quality and safety of products and services
c. Areas for donation, laboratory tests and processing of blood must be
effectively separated from each other.
d. Access to working areas must be effectively delineated and limited to
relevant authorized personnel only.
e. Effective housekeeping of the work environment must be maintained
at all times.
77
16.2.6 Equipment
a. All critical equipment that has impact on the quality of tests or
blood component prepared must be operated within their defined
specifications.
b. Each blood centre, hospital blood banks and collection centres must
have:
i. Documented procedure for the purchase of equipment.
ii. Procedure for validation and qualification to confirm fitness for
purpose which must be performed:-
• When commissioning new equipment, where full validation
data from the manufacturer and approved results of the
installation qualification (IQ), operational qualification (OQ)
and performance qualification (PQ) must be made available.
• According to validation plan (e.g. by using risk assessment)
after being put in use.
• Following repairs and relocation, and after a pre-determined
period after being put in use (e.g. every 5 years).
iii. Effective documented maintenance programs to ensure that all
equipments are functioning optimally at all times.
iv. Procedures and manuals for the operation and maintenance of
all equipment available on site.
16.2.7 Material: Apparatus, Reagents and Chemicals

a. Materials used in laboratory tests and processing must be appropriately
validated by the manufacturer and endorsed by reputable authorities.
b. Notwithstanding the above, all materials must be first verified/
validated by the blood centres and hospital blood banks before being
put into use.
c. All materials must be stored under appropriate storage conditions as
to maintain their integrity.
d. Procedures for the inspection, acceptance and rejection of materials
must be established and implemented.
e. Records of inventory of materials must also be maintained.
78
16.0 Quality Management in Blood Trasnfusion Services
16.2.8 Supplier
Suppliers of materials and services having impacts on the quality of
laboratory tests or blood must be periodically evaluated and monitored.
16.2.9 Validation of Processes and Procedures
a. A policy on validation must be established, and it must clearly define
the scope, process and purpose of validation.
b. The process of validation should commence from the time the decision
is made to implement a particular system, process, procedure or test
method, or to use a particular facility, equipment or material.
c. Validation should be carefully planned and conducted in compliance
with the established standards, guidelines and principles such as MS
ISO 15189 and cGMP.
d. Data and information generated during the validation and the outcome
of the validation must be adequately documented.
16.2.10 Change Control
Change control is a formal process used to ensure that changes to a system,
equipment or processes are introduced in a controlled and coordinated
manner. It reduces the possibility of unnecessary changes being introduced
to the system without forethought, introducing faults into the system or
undoing changes made by other units within the organization. The goals of
a change control procedure would include minimal disruption to services,
reduction in back-out activities, and cost-effective utilization of resources
involved in implementing change.
Changes may result from a planned change in a laboratory process or
input, a systematic review of a procedure, audit findings, incidents or
from complaints. Some laboratory changes e.g. using new equipment of
the same type, or relocating a work process may not require any alteration
to documented procedures but should still be subjected to change control.
However, minor amendments to documented procedures may not need
to be subjected to change control but should still be managed through the
documented control process.
The blood centres, hospital blood banks and collection centres, must
establish a formal procedure for implementing change control:-
a. The unit or person responsible for the change must initiate the process
of change control.
79
b. The relevant change should be planned. As the change may involve

several stages, adequate records of activities leading to the successful
outcome of each stage should be maintained.
c. After successful completion of all the stages involved, it must be duly
reviewed and approved by designated person(s) before the change is
implemented.
16.2.11 Internal Audits
a. Regular internal audits to monitor compliance to the quality
management system, current policies and regulatory requirements
must be planned and carried out.
b. Internal auditors should possess good knowledge of the quality system,
and should have been trained in auditing.
c. Wherever feasible, the auditors should audit an area different from
where he or she is currently working.
d. Findings from the internal audits and any actions taken must be
documented, analyzed and presented to management for quality
improvement.
16.2.12 Continual Quality Improvement
The effectiveness of the quality system and the extent of compliance to the
system by the blood centres and hospital blood banks must be regularly
reviewed. At the very least, one review meeting is to be conducted each
year.
16.2.13 Safety
The blood centres, hospital blood banks and collection centres must
establish policies and procedures on safety and security. Relevant
committees should be set up to maintain and continually improve safety
and security in the organization.
80
17.0 Hospital Transfusion Committee
17.0 Hospital Transfusion Committee

The role of a Hospital Transfusion Committee is to ensure safe and appropriate
transfusion practices within the hospital. The Hospital Transfusion Committee shall
be authorized to take necessary actions to improve transfusion practices within the
hospital.
17.1 Members of the Committee

Members of the committee shall include the following:
Chairman : Hospital Director
Members : Heads of relevant clinical disciplines
Representative of the blood centre
Head of nursing services or designee
Secretariat : Hospital blood bank
17.2 Terms of Reference

17.2.1. Principal Responsibilities:
The Hospital Transfusion Committee shall:
i Promote best practices in the hospital based on current policies,
guidelines and directives.
ii. Proactively and regularly review transfusion practices of various
disciplines in the hospital.
iii. Promote/organize and/or conduct education and training of
all clinical, laboratory and supporting staff involved in blood
transfusion.
iv. Organize regular transfusion audits on the transfusion service to
ensure compliance to policies, guidelines and directives.
v. Ensure all transfusion adverse events such as errors in transfusion
process, donor and recipient seroconversion are investigated,
analysed and reported.
vi. Monitor the hospital haemovigilance unit activities. Refer 18.1.2.
vii. Implement corrective and preventive actions.
81
viii. Monitor the use of blood to ensure adequate supply.

ix. Establish and ensure implementation of contingency plans to cope
with periods of shortages of blood, and or unexpected increases in
demand for blood such as during disasters.
17.2.2. Meetings:
The committee shall meet at least twice a year. Copies of minutes of the
meetings shall be forwarded to its State Transfusion Committee.
82
18.0 Haemovigilance in Blood Transfusion

Haemovigilance is a surveillance programme covering adverse events occurring
during the entire blood transfusion chain from the donation of blood to the follow-up
of patients receiving transfusion. The ultimate goal of haemovigilance is to improve
patient and donor safety through the detection, reporting, analysis of information on
unexpected or undesirable effects, and implementation of corrective and preventive
actions.
Transfusion safety must be ensured in every stage, starting from the donor at the
time of donation, blood sampling from the patient for pre-transfusion tests as well as
blood administration at patient’s bedside during time of transfusion and their follow
up.
18.1 Hemovigilance Reporting

18.1.1 All adverse events relating to blood collection, processing, testing,
transfusion processes and outcome of the transfusion including near
misses must be reported. Incident related to products and equipment
should be included.
18.1.2 Each hospital should have a mechanism to collect, compile and analyzedata
of all adverse events and deviations relating to collection, processing,
testing and transfusion of blood, including near misses.
18.1.3 Regular reports shall be submitted to respective Hospital Transfusion

Committee (HTC), the State Transfusion Committee (STC) (if applicable)
and National Haemovigilance Coordinating Centre (NHCC).
18.1.4 The HTC and the STC shall take corrective and preventive actions, and
facilitate allocation of adequate resources both at the hospital and at the
state level for improving transfusion safety.
18.1.5 The National Blood Centre shall act as the NHCC for the Ministry of
Health.
18.1.6 Confidentiality of reporting to NHCC will be maintained and the identities

of the donor, patient and the reporter of the incident and the institution
shall not be disclosed to a third party.
83
18.2 Patient Haemovigilance

Transfusion process involves many important steps that are critical for patient
safety. Patient haemovigilance is a surveillance system that monitors the transfusion
processes in the clinical area. The process of reporting adverse events shall be as
follows:
18.2.1 The treating doctor shall send a request for transfusion reaction
investigation using the Request Form for Transfusion Reaction
Investigation (BTS/TR/2/2016) (Appendix 18) to the hospital blood bank.
18.2.2 The hospital blood bank shall then carry out relevant laboratory
investigation using the Worksheet for Investigation of Transfusion
Reaction (BTS/TRW/2/2016) (Appendix 19). The findings shall be
reported to the treating doctor concerned.
18.2.3 The treating doctor shall provide a detailed report using the Reporting
Form for Transfusion-Related Adverse (BTS/HV/3/2016) (Appendix 20).
The report shall include information such as clinical findings, laboratory
investigations, personnel involved and corrective actions taken if any
(refer to page 3 of 4 and 4 of 4 of the form). This report shall be forwarded
to the hospital blood bank within two weeks of the occurrence.
18.2.4 It shall be the responsibility of the hospital blood bank concerned to follow
up with the ward and doctor concerned to ensure that the transfusion-
related adverse event report is delivered within a month to the relevant
authorities. Copies of the report shall be sent to the HTC, the STC, and the
NHCC. Refer Appendix 21 for flowchart for reporting adverse transfusion
event.
18.2.5 For Incorrect Blood Component Transfused (IBCT) and Near Miss a
detailed report should be submitted to NHCC with root cause analysis
together with implemented corrective and preventive action.
18.3 Donor Haemovigilance

Donor haemovigilance is a surveillance system for tracking adverse events associated
with blood donation with a view to improve the safety of the donation process. This
system allows the collection centres to monitor the prevalence of adverse donor
84
events, patterns and trends, and find ways to improve blood donation process, which
will result in quality donor care and safety thus better donor return.
18.3.1 All unintended reactions related to blood donation, and cases of

seroconverted donors shall be reported.
18.3.2 Reporting of adverse donor events shall be as follows:

a. The medical personnel attending to the donor with adverse donor
reaction shall investigate and report the event in the Reporting Form for
Adverse Donor Reaction (BTS/DV/2/2016) (Appendix 4). The doctor
in charge of the collection centre shall retain this report. Appendices
5 and 6 provide guidance for the description of complications and the
grading of severity of donor reactions.
b. A copy of Reporting Form for Adverse Donor Reaction shall be
forwarded to the NHCC, HTC and STC at the end of each month
and the original copy will be retained at the collection centre. (Refer
Appendix 23 for flowchart for reporting adverse donor reaction).
c. All seroconverted donors shall be documented using Seroconvert
Donor Notification Form (BTS/SC/1/2016) (Appendix 22).
d. The Seroconvert Donor Notification Form (BTS/SC/1/2016) has to be
retained at the respective hospital blood banks. A copy of Part 1 of the
form shall be forwarded to NHCC within a month after donor came
for post-donation counselling, while a copy of the completed form
(Part 1 and Part 2) shall be forwarded to NHCC within a month after
the whole investigation is completed. (Refer to 15.1.2.f)
18.4 National Haemovigilance Coordinating Centre

The National Haemovigilance Coordinating Centre shall:
18.4.1 Manage the notification of adverse events reports from all hospitals.
18.4.2 Prepare annual report with recommendation of appropriate interventions
for continual improvement to KKM.
18.4.3 Monitor effectiveness of corrective and preventive action taken.
85
Appendix 1: Guidelines for the Acceptance and Deferral of Donors

Condition Acceptance Or Deferral Criteria
Abortion Defer for 6 months.
Acne Medication Retin A cream

• Accept
Isotretinoin (Roaccutane®)
• Defer for 28 days after last dose
Acitretin (Neotigason®)
• Defer for 3 years after last dose
Etretinate (Tigasone®)
• Defer permanently
Acupuncture Defer for 6 months from date of procedure.
Age limits for 17 to 70 years old.

blood donation Accept up to 60 years old for first time donor.
May accept regular donor up to 70 years old with annual medical check-up
which includes chest X-ray, ECG, LFT, Renal Profile, Fasting Blood Sugar
and Full Blood Profile or letter from physician stating that donor is fit to
donate.
For donors aged 17 years old, written parental/guardian’s consent is
compulsory.
Alcohol intake Defer 24 hours if intoxicated.

Accept if no intoxication.
Allergy Accept if mild or symptom free.

Defer permanently
• History of anaphylaxis
• Severe debilitating autoimmune disorders such as systemic lupus
erythematosus, dermatomyositis or severe rheumatoid disease
• Immunosuppression due to congenital or acquired hypogamma-
globulinaemia or immunosuppressive medication
(Also see “Immunological diseases’)
Anaemia Accept if past history of iron deficiency anaemia, with a known cause
not a contraindication to donation, when treatment completed and fully
recovered.
Accept individuals with Thalassaemia traits, provided they are well and
meet the minimum haemoglobin level for blood donation.
Accept if vitamin B12 or folate deficiency when fully recovered and on
maintenance treatment.
Defer permanently if chronic anaemia of unknown cause or associated with
systemic disease.
86

Anaphylaxis Defer permanently.
Ankylosing Defer permanently.

spondylitis
Arthritis Accept if osteoarthritis and donor able to climb on and off donation couch
without assistance.
Defer permanently if systemic diseases affecting joints such as
• Rheumatoid disease
• Psoriatic arthropathy
• Ankylosing spondylitis
Asthma Accept if asymptomatic, even if on medication other than oral or injected

steroid.
Defer for 14 days after full recovery from acute exacerbation.
Defer for 14 days after completion of a course of oral or injected steroid.
Defer permanently if severe asthma requiring regular medication.
Babesiosis Defer permanently.
Biopsy Defer for 6 months from date of procedure.
Bleeding disorders Accept if only family member is affected and donor has no history of
prolonged bleeding. (Also see “Coagulation disorders”.)
Blood pressure Accept if within the following range:

• Systolic: 100-150 mmHg
• Diastolic: 70-100 mmHg
Blood transfusion Defer for 6 months after transfusion with blood or blood component.
Defer for 6 months after immunoglobulin (IVIg) therapy.
Defer permanently if on regular treatment with plasma-derived coagulation
factors.
Defer permanently if ever received a transfusion or injection of blood or
blood components while in England, Scotland, Wales, Northern Ireland or
the Isle of Man from 1st January 1980 onwards.
Body piercing Defer for 6 months from date of procedure.
Bronchitis Defer for 14 days after full recovery from acute attack and completion of
treatment.
Brucellosis Defer permanently.
Burns Accept if fully healed.
87

Campylobacter Defer for 28 days after full recovery.
Cancer See “Malignant diseases”.
Cardiovascular Accept for surgically corrected simple congenital cardiac malformation with
diseases no residual symptoms.
Accept for asymptomatic disorder: e.g. functional murmurs, mitral valve
prolapsed.
Defer permanently all other conditions (e.g. angina pectoris, arrhythmia,
coronary artery disease, heart failure).
Central nervous Defer permanently:

system diseases • Epilepsy or history of seizure
• Dementia or neurodegenerative disease due to any cause
• Multiple sclerosis or other demyelinating diseases
Cerebrovascular Defer permanently.

diseases
Chagas disease Defer permanently.

(American
trypanosomiasis)
Chancroid Defer permanently.
Chickenpox Defer for 14 days after full recovery from infection.

Defer for 21 days after last day of close contact with individual with the
disease.
Chikugunya virus Defer for 6 months after full recovery.
Childbirth Defer for 6 months post-delivery. (Also see “Pregnancy”)
Cholecystitis Accept after fully recovered.

Coagulation Defer permanently if coagulation factor deficiencies whether inherited or
disorders acquired.
Coeliac disease Accept if fully treated .
Colitis Accept if irritable bowel syndrome without debility.
Defer any active inflammatory bowel disease unless well and in long-term
remission.
Common cold Defer for 7 days after full recovery.
Cosmetic Defer for 6 months from date of procedure. (Also see “Injection”)
treatment
(invasive)
88
Appendix 1

Creutzfeldt-Jakob Defer permanently sporadic and familial CJD and first-degree relatives.
disease (CJD) Defer permanently if history of treatment with pituitary-derived human
growth hormone, human gonadotrophin, dura mater graft, corneal
transplantation, neurosurgery. (Also see “Variant CJD”)
Crohn’s disease Defer if active disease.

Accept if well and in-long term remission.
Cupping (Bekam) Defer for 6 months from date of procedure for wet cupping (bekam darah).
Accept if dry cupping or fire cupping.
Dementia Defer permanently.
Dengue fever Defer for 6 months after full recovery.
Dental treatment Defer for 24 hours after simple procedures.

Defer for 7 days after extraction or endodontic procedures.
Defer for 6 months after dental surgery.
Depression Accept if feeling well. (Also see “Psychiatric disorders”)
Dermatitis See “Skin diseases”.
Dermatomyositis Defer permanently.
Diabetes mellitus Accept diabetes mellitus controlled by diet or oral medication provided no
history of orthostatic hypotension and no evidence of infection, neuropathy
or vascular disease.
Defer permanently if requires insulin treatment or has complications with
multi-organ involvement.
Diagnostic Defer following minor diagnostic procedure including rigid endoscopy until
procedures normal activity resumed.
Defer for 6 months after invasive diagnostic procedure using flexible
endoscopy.
Diarrhoea Accept 14 days after full recovery and completion of therapy, including
antibiotics.
Accept for chronic diarrhoea due to irritable bowel syndrome without
debility; otherwise defer.
Defer for 28 days if symptoms suggestive of Yersinia enterocolitica.
Diverticular Accept if well and asymptomatic.

disease
89

Drug use Injecting drug use:
• Defer permanently individuals with history of drug use by injection
Non-injected drug use:
• Defer for 6 months from last in-take of the substance.
Eczema Accept if lesions not infected and venepuncture site unaffected.
Epilepsy Defer permanently.
Epstein-Barr virus Defer for 28 days after full recovery.
Erythrocytosis See “Polycythemia”.
Essential Defer permanently.

thrombocythaemia
Fever Defer for 14 days after full recovery.
(non-specific)
Foreigner Defer for 12 months after entry into Malaysia and after re-entry following
prolonged (>1 month) travel outside of Malaysia.
Fracture Defer until plaster is removed and mobility returns to normal.
Gastritis Accept if well and asymptomatic.
Gallstones Accept if well and asymptomatic.
Gastroenteritis Defer for 28 days after full recovery.
Gastro- Accept mild cases, if well and asymptomatic.

oesophageal reflux
Gonorrhoea Defer permanently.
Gout Defer for 7 days after acute attack.
G6PD deficiency Accept if no history of haemolysis

• Red cells however are not to be used.
Defer permanently if there is history of haemolysis.
Haemochromatosis Accept if well and asymptomatic.
Haemoglobin level Accept if haemoglobin level is between 13.5 to 18.0 g/dl for male and 12.5
to 18.0 g/dl for female.
Haemoglobinopathies Defer permanently if thalassaemia major, thalassaemia intermedia or sickle
cell disease, including sickle cell trait.
Haemophilia Defer permanently.
90
Appendix 1

Hepatitis A, Defer for 12 months after full recovery.
hepatitis E and
hepatitis of
unknown origin
Hepatitis B Defer permanently individuals who are Chronic Hepatitis B carrier or has
been diagnosed with Occult Hepatitis B Infection (OBI).
Recovered from Hepatitis B infection:
• Accept 12 months after full recovery (i.e. negative for HBsAg) with anti-
HBs of >100mIU/ml and blood is screened by NAT.
• Current sexual partner may also be accepted 12 months after full
recovery.
Living with person with active Hepatitis B infection:
• Defer while still living in the same home.
• Accept if immunised for Hepatitis B with anti-HBs >100mIU/ml and
negative for anti-HBc.
• Former household may be accepted 6 months after last contact.
Family history of Hepatitis B (siblings, father, mother):
• Permanent deferral if new donor.
• Accept repeat donor if negative for both HbsAg and anti-HBc, or if anti-
HBc positive must have anti-HBs >100mIU/ml.
Sexual contact:
• Defer current sexual contact.
• Current sexual partner may be accepted 12 months after full recovery.
• Former sexual partner may be accepted 12 months after last sexual
contact.
Hepatitis C Defer permanently.

Recovered from Hepatitis C infection:
• Permanent deferral.
Living with person with Hepatitis C:
• Accept.
Family history of Hepatitis C (siblings, father, mother):
• Accept.
Sexual contact:
• Defer current sexual partner.
• Defer 12 months since last sexual contact for former sexual partner.
Herpes viruses Defer for 28 days after full recovery (except HHV8 infection).
Defer for 28 days for contacts of symptomatic individuals (except HHV8
infection).
Defer permanently individuals with HHV8 infection, and current or former
sexual contacts of individuals with HHV8 infection.
91

Hiatus hernia Accept mild cases, if well and asymptomatic.
High-risk Defer permanently:

behaviours • Men who have sex with men (MSM).
• Individuals who make or receive payment in exchange for sex, including
sex workers and their clients.
• Drug users by injections (IVDUs), including body building drugs.
• Live the lifestyle of having casual sex or having multiple sexual partners.
HIV/AIDS Defer permanently.

Living with person with HIV:
• Accept
Sexual contact:
• Defer permanently current and former sexual partners
HTLV Defer permanently individuals with evidence of HTLV infection.
Living with person with HTLV infection:
• Accept.
Family history of HTLV (mother or maternal grandmother):
• Defer permanently.
Sexual contact:
• Defer permanently current and former sexual partner.
Hypertension Accept if stable and uncomplicated hypertension controlled by medication.

Defer if recently started on or changed anti-hypertensive medication until
28 days after blood pressure stabilized.
Defer permanently if
• Complicated with heart or renal disease.
• On ACE Inhibitor (ACE inhibitor is potentially teratogenic [teratogenic
drugs-defer 6 months after last dose]).
Hypogammaglo- Defer permanently.

bulinaemia
Immunisation Accept
• Toxoids and non-live vaccines (e.g. Diphtheria, Polio, Pneumococcal,
Rabies, Tetanus and Typhoid) – if well and asymptomatic.
Defer
• 48 hours for recombinant virus vaccines (e.g. HBV, HPV, H1N1
vaccines, influenza).
• 14 days for attenuated virus (live) vaccine such as HBV vaccine.
• 28 days for Rubella vaccine.
• 12 months for Rabies vaccine (post-exposure).
92
Appendix 1

Immunological Accept individuals with mild conditions, such as vitiligo or mild rheumatoid
diseases arthritis without systemic symptoms.
Defer permanently individuals with:
• Severe debilitating autoimmune disorders such as systemic lupus
erythematosus, dermatomyositis or severe rheumatoid disease.
• Immunosuppression due to congenital or acquired hypogamma-
globulinaemia or immunosuppressive medication, with the exception of
individuals with IgA deficiency.
• History of anaphylaxis.
(Also see “Allergy”)
Infections Accept 14 days after full recovery and completion of antibiotic treatment.
(acute bacterial) Defer for 28 days following full recovery and completion of treatment
if symptoms suggestive of infection with salmonella, campylobacter,
streptococcus or staphylococcus.
(Also see “Medical conditions”)
Influenza Accept asymptomatic individuals with no close contact with those having
active infection.
Defer asymptomatic close contacts for 7 days after last day of contact.
Defer for 14 days after full recovery and cessation of any therapy.
Defer for 48 hours after influenza vaccination.
Injection Defer for 6 months after any injection for cosmetic purposes such as
Botox, Vitamin C and Collagen injection.
Defer for 6 months for case of needle stick injury.
Interval between Between whole blood donations

donations • Minimum 8 weeks from last donation date.
• Maximum of 6 WB donation per year for male and 4WB donation per
year for female.
Between apheresis (platelet, plasma) donations
• Minimum 2 weeks after last donation date.
• Not exceeding 15 liters/year.
Between whole blood to apheresis donation
• Minimum 8 weeks from last donation date.
Between apheresis to whole blood donation
• Minimum of 2 weeks from last donation date.
Following apheresis donation with red cell loss
• Defer for 8 weeks if more than 100ml loss.
Apheresis donor who did not donate for more than 6 months
• Accept as whole blood donor first before resuming apheresis donation.
93

Iron deficiency See “Anaemia”.
Irritable bowel Accept, if well and without debility.

syndrome
Lactating women Defer during lactation.
Leishmaniasis Defer permanently individuals who have ever been diagnosed with
leishmaniasis.
Defer for 12 months individuals who have spent extended periods in
endemic areas.
Leukaemia Defer permanently.
Lyme disease Defer for 28 days after full recovery and completion of treatment,
whichever is longer.
Lymphoma Defer permanently.
Malaria Defer for 6 months after completion of treatment and full recovery
whenever is longer.
Defer for 4 weeks after completion of malarial prophylaxis.
Malabsorption Defer permanently except treated coeliac disease.

syndromes
Malignant Defer permanently.
diseases
Medical conditions Abscess/ Boils
• Defer for 28 days after full recovery.
Bronchitis
Chickenpox
• Defer close contacts for 21 days after last day of contact.
Cystitis
Dengue fever
• Defer for 6 months after full recovery.
Diptheria
Dysentery
Emphysema
• Permanent deferral.
Encephalitis
94
Appendix 1

Medical conditions Gastroenteritis
Hay fever
H1N1
Infectious mononucleosis (Glandular fever)
Measles
Meningitis
Migraine
• Defer until fully recovered.
• Defer permanently if severe or frequent.
Mumps
Osteomyelitis
Pancreatitis
Phlebitis
Pneumonia
• Defer for6 months after full recovery.
Pneumothorax
Poliomyelitis
Pyelitis
Raynaud’s disease
Rubella
Scarlet fever
Schistosomiasis
95

Medical conditions Sore throat
Tetanus
Thyphus
Tonsilitis
Toxoplasmosis
Trypanosomiasis (African)
Typhoid
Yersinia enterocolitica
Medications Take account of indication for treatment.

Allopurinol
• Accept.
Antibiotics
• Defer for 2 weeks after last dose.
• Defer permanently if on prophylactic antibiotics following splenectomy.
Anticoagulants (other than warfarin)
• Defer for 1 week after last dose.
Anti-depressants
• Accept.
Anti-histamines
• Accept.
Anti-malarial prophylaxis
Anti-platelets (e.g. aspirin, clopidogrel, ticlopidin)
• May be accepted but not for platelet preparation.
Glucosamine
• Accept.
Hormone replacement therapy
• Accept if taken for menopausal symptoms, osteoporosis prevention or
fertility treatment.
• Defer permenantly if human-derived hormone, for replacement of
adrenal steroid hormones or for treatment of malignancy.
Hypnotics
• Accept.
96
Appendix 1

Medications NSAIDs
• Defer for 24 hours after last dose.
Paracetamol
• Accept (subject to reason for taking medication). Statins
• Accept.
Steroids
• Defer for 1 week after last dose of oral or parenteral medication.
• Accept if inhaled or used topically.
Supplements
• Accept, unless known side-effect.
Teratogenic drugs
• Defer for 6 months after last dose.
Tigasone
• Defer permenantly.
Topical/locally applied medication (e.g. eye drops, ear drops, nasal spray)
• Accept.
Menstruation Defer for first 3 days.

Accept from 4th day onward.
Mucosal splash Defer for 6 months from the time of exposure.
with blood
Multiple sclerosis Defer permanently.
Musculoskeletal Accept acute or chronic mild disorders (e.g. mild rheumatoid arthritis, back
disorders pain, sciatica, frozen shoulder, osteoarthritis) if the individual’s mobility
unaffected.
Defer permanently if systemic disease affecting joints: e.g. severe
rheumatoid arthritis, psoriatic arthropathy, ankylosing spondylitis.
(Also see “Arthritis”)
Myelodysplastic Defer permanently.
syndrome
Nephritis Lower urinary tract infections
• Defer for 14 days after full recovery and completion of treatment.
Acute nephritis
• Defer until fully recovered and renal functions returned back to normal.
(Also see “Renal disease)
Operation See “Surgery”.
Peptic ulcer Accept if asymptomatic with or without maintenance therapy.

Defer if symptomatic or if still under investigation.
Defer permanently if associated with underlying malignancy.
97

Platelet disorders Defer permanently if cause is unknown or associated with long term
haematological or systematic disorders.
Polycythaemia Secondary polycythaemia
• Accept if the secondary cause does not lead to deferral.
Defer permanently if polycythaemia rubra vera.
Pregnancy Defer during pregnancy and 6 months following delivery or termination.

See also “Childbirth”.
Prisons and penal Defer inmates of prison and penal institutions.

institutions Acceptance of individuals with history of imprisonment requires close
assessment of risk of transfusion transmitted infection.
Prostate problems Accept if benign prostate hyperplasia (BPH) not on treatment.

Defer if on treatment:
• Dutasteride: defer for 6 months after stopping.
• Finasteride: defer for 28 days after stopping.
Defer permanently if associated with malignancy.
Psoriasis Accept individuals with mild psoriasis provided lesions not infected, no
systemic symptoms, venepuncture site not affected, or not receiving
immunosuppressive or retinoid therapy. Otherwise defer.
(See also “Skin disease”)
Psoriatic Defer permanently.
arthropathy
Psychiatric Accept anxiety disorder and mood (affective) disorder such as depression
disorders provided in generally good health and able to answer questionnaire and
give informed consent.
Defer permanently psychotic disorder (e.g. bipolar, schizophrenia) requiring
treatment.
Red cell Accept if no history of haemolysis.

membrane defects Defer permanently if history of haemolysis.
(Also see “G6PD deficiency”)
Renal diseases Acute self-limiting condition (e.g. acute nephritis)

• Accept when fully recovered and renal function normal.
Chronic renal disease
98
Appendix 1

Respiratory Acute respiratory infection
diseases • Defer for 14 days following full recovery and completion of therapy,
including antibiotics.
Defer permanently
• Breathlessness at rest or minimal exertion or if cyanosed.
• Severe obstructive airways disease (including if on long-term oral
steroid therapy).
• Chronic or recurrent respiratory infection.
Rubella infection Defer for 14 days after full recovery.

Close contacts
• Defer for 21 days after last day of close contact.
Salmonella Defer for 28 days following full recovery.

infection
Sarcoidosis Defer permanently.
Scleroderma Defer permanently.
Seizure Defer permanently.
Severe Acute Defer for 28 days after full recovery.

Respiratory Close contacts
Syndrome • Defer for 14 days after last day of contact with individual diagnosed
(SARS) with SARS or suspected to have SARS.
Shingles Defer permanently.
Sexual activity Defer permanently sexual partner to:

• Men who have sex with men (MSM).
• Individuals who make or receive payment in exchange for sex, including
sex workers and their clients.
• Drug users by injections (IVDUs), including body building drugs.
• Individuals who live the lifestyle of having multiple sexual partners.
• Individuals diagnosed with HIV/ AIDS, HTLV, HHV8.
Defer
• Current sexual partner to individuals with HIV, hepatitis B, hepatitis C or
syphilis.
• For 12 months from date of sexual contact following change of sexual
partner.
• For 12 months from date of sexual contact with the new wife in a
polygamous marriage.
Accept
• Former sexual partner to individuals with hepatitis B, hepatitis C or
syphilis 12 months after last sexual contact.
99

Sickle cell disease Defer permanently, including sickle cell trait.
Skin diseases Accept mild common skin disease (e.g. acne, eczema, psoriasis) if lesions
not infected and venepuncture site is not affected.
Defer if generalized skin disease and on systemic medication.
Defer if contagious skin disease.
Defer permanently if systemic disease affecting skin (e.g. scleroderma,
systemic lupus erythematosus, dermatomyositis, systemic cutaneous
amyloidosis).
Snake bite Accept after fully recovered.

Defer for 6 months if given anti-venom.
Streptococcus Defer for 28 days following full recovery.
infection Defer for 14 days following full healing of superficial but significant wounds.
Stroke Defer permanently.
Surgery Defer for 6 months following minor or major surgery.

Defer permanently following neurosurgical procedure, dura mater graft or
corneal transplant.
Syphilis Defer permanently if ever been diagnosed with syphilis.

Sexual contact
• Defer current sexual partner.
• Defer 12 months since last sexual contact for former sexual partner.
Systemic lupus Defer permanently.

erythematosus
Tattoos Defer for 6 months from date of procedure.
Thalassaemia Accept thalassaemia trait provided well and haemoglobin above required
lower limit.
Defer permanently for thalassaemia major and thalassaemia intermedia.
(Also see “Haemoglobinopathies”.)
Thrombocytopenia Accept past history of acute autoimmune thrombocytopenia (ITP) more
than 5 years previously, if well and not on treatment.
Defer permanently if thrombocytopenia of unknown cause or associated
with long-term haematological or systemic disease.
Thrombophlebitis Accept if had only a single episode in the last 12 months, otherwise well
and off treatment for at least 7 days.
Defer permanently
• Affects the upper limb.
• Two or more episodes in the last 12 months.
100
Appendix 1

Thrombosis Defer permanently.
Thyroid disorders Accept if benign disorder and euthyroid (with or without treatment).
Defer if under investigation for thyroid disease, if hyper- or hypo-thyroid, or
with a history of malignant thyroid tumours.
Defer permanently if history of thyrotoxicosis due to Graves’ disease.
Transient cerebral Defer permanently.

ischaemic
episodes
Transplantation Defer for 12 months after full recovery following transplantation of

allogeneic tissues.
Defer permanently if transplanted with allogeneic cells or tissue sourced
since 1980 from a country at risk of vCJD.
Defer permanently following stem cell or organ transplantation, dura mater
graft, corneal transplant or xenograft.
Tuberculosis Defer for 5 years following confirmation of cure.
Ulcerative colitis Defer if active disease.

Accept if well, in long-term remission and meet the minimum haemoglobin
level of blood donation.
Urinary tract Accept lower urinary tract infections 14 days after full recovery and
diseases completion of treatment.
Variant Defer permanently if ever suspected or diagnosed with variant Creutzfeldt-
Creutzfeldt-Jakob Jakob disease (vCJD).
disease (vCJD) Defer permanently if ever visited or lived in the United Kingdom (England,
Northern Ireland, Ireland, Wales, Scotland, the Isle of Man, the Channel
Island) or the Republic of Ireland for a cumulative period of 6 months or
more between 1st January 1980 to 31st December 1996.
Defer permanently if ever visited or lived in the following European countries*
for a cumulative period of 5 years or more between 1st January 1980 until
now.
(*Austria, Belgium, Denmark, Finland, France, Germany, Greece, Holland,
Italy, Liechtenstein, Luxembourg, Norway, Portugal, Spain, Sweden and
Switzerland.)
Vitiligo Accept.
Weight Accept for whole blood donation if weight is 45kg or more.

Accept for apheresis donation if weight is 55kg or more.
101

West Nile virus Individuals who have known WNV infection or symptoms suggestive of
(WNV) WNV.
• Defer for 6 months from date of full recovery.
Defer for 28 days following return from visit to endemic area and
asymptomatic.
Yersinia Defer for 28 days following full recovery if recent abdominal symptoms,
enterocolitica particularly diarrhoea, suggestive of Y. enterocolitica infection.
infection
102
Appendix 2
Appendix 2
103
104
Appendix 2
105
106
Appendix 2
107
108
Appendix 2
109
110
Appendix 3
Appendix 3 - Management of Adverse Reactions in Blood Donors

(a) Mild Vasovagal Reaction
• Discontinue the donation process.
• Raise the donor’s legs and lower the head to improve the blood
circulation to the brain (Trendelenburg Position).
• Alert the doctor in charge as soon as possible for further management.
• Loosen any tight fitting clothing and keep the donor cool and provide
sufficient ventilation.
• Check donor’s blood pressure, pulse rate and respiratory rate.
• After sufficient period of rest and improvement, encourage oral fluid
intake.
• Observe the donor till full recovery.
• Reassure the donor and explain to the donor what has occurred.
• Advise the donor that if symptoms persist, they should contact the
blood bank for further consultation.
(b) Moderate Vasovagal Reaction without Convulsions

Institute all the steps as in (a) for mild vasovagal reaction, following which additional
management steps should be taken as follows
• Check the blood pressure, pulse rate and respiratory rate every 5
minutes until donor recovers.
• Maintain privacy of the donor.
• Administer intravenous fluids (e.g. normal saline or 5%dextrose saline
infusion) if hypotension is prolonged.
• Health personnel should remain with the donor during this period.
• Advise the donor not to donate blood in future.
(c) Moderate or Severe Vasovagal Reactions with Convulsions

Institute all the steps as in (a) for mild vasovagal reaction, following which additional
management steps should be taken as follows:
• Alert the doctor in-charge immediately for further management.
• Turn the donor to a lateral position andmaintain a clear airway.
111
• Check the blood pressure, pulse rate and respiratory rate every 5
minutes until donor recovers.
• Gently restrain the donor to prevent any injury.
• Maintain privacy of donor.
• When the seizure aborts spontaneously, take blood samples for the
following investigations:
ȤȤ Random Blood Sugar.
ȤȤ Renal Profile.
ȤȤ Serum Calcium, Magnesium, Phosphate.
ȤȤ Full Blood Picture.
• If the convulsion last longer than 5 minutes (status epilepticus), this is
a medical emergency.
ȤȤ At a collection centre, intravenous valium may be given by the
doctor in-charge.
ȤȤ At the mobile unit, the donor shall be sent to the nearest hospital
immediately, accompanied by the doctor.
ȤȤ Referral to a neurologist may be necessary.
• Allow sufficient amount of period for rest and provide refreshments
before allowing the donor to leave the premise.
• The donor shall be referred to the nearest hospital if there is any
evidence of poor or slow recovery.
• Advice the donor not to donate blood again (permanent deferral).
• Advise the donor and/or family member that if convulsion reoccurs
at home, the donor shall be taken to the nearest hospital for further
management.
• Follow up with the donor the next day and arrange for an appointment
to assess the condition of the donor and for review of the blood
investigation results.
(d) Haematoma
• Release the tourniquet pressure immediately and discontinue the
donation process.
• Apply firm pressure on the venepuncture site.
• Apply a cold compression over the haematoma.
• Apply a local analgesic gel over the affected area to reduce the swelling
and bruising, and which is to be continued to be applied at home.
112
Appendix 3
• Prescribe oral analgesic for moderate discomfort.

• Advise the donor to refrain from liftingany heavy objects till
haematoma resolves.
• Advise donor thatif the area becomes unduly painful they should
contact the blood bank doctor immediately.
(e) Local Nerve Injury

donation process.
• Observe for any haematoma as it could be one of the causative factors.
• Prescribe oral analgesic if the pain is severe and/or persistent.
• Advise the donor to refrain from lifting any heavy objects till symptoms
resolve.
• Local nerve injury is almost always transient. However advises the
donor to return to the blood bank if the symptoms persist or worsen
as referral to a neurologist may be indicated.
(f) Arterial Puncture

donation process.
• Apply firm pressure on the venepuncture site after the withdrawal of
the needle and maintain the compression pressure for a minimum of
15 minutes.
• Raise the affected limb above thelevel of the heart.
• When the bleeding has stopped, apply a compression bandage and
instruct the donor to keep it on for 6 hours.
• Prescribe oral analgesic for moderate discomfort.
• Advise the donor to refrain from lifting any heavy objects till symptoms
resolve.
• Advise donor thatif the area becomes unduly painful they should
contact the blood bank doctor.
• If the arterial bleeding is suspected to be continuing, the donor shall be
referred to nearest hospital.
• Follow up with the donor the next day to assess the condition of the
donor.
113
(g) Citrate Toxicity (In Apheresis Donation)

• Evaluate the level of severity by assessing the symptoms.
• Reduce the ACD level by decreasing the ratio of ACD flow into
machine if the symptoms are mild.
• Encourage oral fluid intake.
• Observe the donor for 10 minutes.
• If symptoms persist or worsen, alertthe doctorin-charge for assessment
of the level of severity and further management.
• Give more fluid and prescribe 2 tablets of calcium lactate 500 mg to be
taken immediately.
• Terminate the apheresis procedure if necessary.
• Take blood samples for the following investigations:
ȤȤ Renal profile
ȤȤ Liver function test
ȤȤ Serum calcium, magnesium, phosphate
• The donor shall be sent to the nearest hospital for further management,
accompanied by a doctor if there is no improvement after instituting
the above measures.
• Arrange for an appointment to assess the condition of the donor and
to review the blood investigation results.
(h) Delayed Adverse Reaction

• If the donor develops an adverse donor reaction within the premise of
the blood collection centre or mobile unit, the donor shall be managed
accordingly as above (refer (a) to (g).
• If the adverse donor reaction occurs away from the premise of blood
donation, advise the donor to go to the nearest clinic or hospital for
further management.
114
Appendix 4
Appendix 4 BTS/DV/2/2016
115
116
Appendix 4
117
Appendix 5 - Description of Adverse Events

A. Complications Mainly with Local Symptoms
These complications are directly caused by the insertion of the needle. Some of these
are mainly characterized by occurrence of blood outside vessels, whereas others are
mainly characterized by pain.
A1. Complications Mainly Characterized by the Occurrence of Blood Outside the Vessels
Haematoma (bruise)
Definition: A haematoma is an accumulation of blood in the tissues outside the
vessels.
Mechanism: The symptoms are caused by blood flowing out of damaged vessels and
accumulating in the soft tissues. For apheresis procedures, haematomas may also be
caused by infiltration of the soft tissues by red cells during the return phase of the
procedure. Large haematomas, particularly those in deeper layers of the forearm, put
pressure on surrounding tissues and may contribute to other complications such as
nerve irritation and injury and more rarely compartment syndrome.
Signs and symptoms: Bruising, discolouration, swelling and local pain. Accumulation
of blood in deeper tissues may result in more serious pain and pressure syndromes
listed below.
Arterial puncture
Definition: Arterial puncture is a puncture of the brachial artery or of one of its
branches by the needle used for bleeding the donor.
Mechanism: Because of the rapid blood flow, the risk of a large haematoma is increased
and thereby risks of more serious pain and pressure syndromes listed below.
Signs and symptoms: A lighter red colour than usual of the collected blood can be
seen. The needle and tubing may appear to pulsate; the blood bag fills very quickly.
There may be weak pain localized to the elbow region.
Delayed bleeding (re-bleeding)

Definition: Leakage of blood from the venepuncture site after the initial bleeding has
stopped.
118
Appendix 5
Mechanism: Re-bleeding may be related to pressure not being applied to the correct
location or for an adequate duration, or premature removal of the bandage. After
the donor has left the clinic, re-bleeding may be related to heavy lifting or strain
to the donor’s arm. Donors on certain medications, such as autologous donors on
anticoagulants, may be at higher risk to re-bleed.
Signs and symptoms: Spontaneous recommencement of bleeding from the
venepuncture site, after pressure has been applied and the initial dressing has been
removed, or leaking through the dressing.
A2. Complications Mainly Characterized by Pain

Nerve injury/irritation
Definition: Injury or irritation of a nerve.
Mechanism: A nerve may be hit directly by the needle at insertion or withdrawal, or
there may be pressure on a nerve due to a haematoma or inflammation of the soft
tissues. Include medically diagnosed cases, as well as cases reported on the basis of
documented ‘nerve’ type symptoms.
Signs and symptoms: Radiating, often ‘electrical’ sharp pain moving away from the
venepuncture site, and/or paraesthesias such as tingling, burning sensations in the
hand, wrist or shoulder area but away from the venepuncture site. Symptoms may
arise immediately when the needle is inserted or withdrawn. In cases associated with a
haematoma, pain may not be apparent at the time and may start when the haematoma has
reached a sufficient size, some time after insertion of the needle. Symptoms may be worse
in certain positions or with certain arm motions. Rarely, weakness of the arm may develop.
Other painful arm

Definition: Pain in the arm is the primary symptom, without the characteristics of
nerve irritation outlined above, or the presence of a large hematoma or other defined
complications that may be painful.
Mechanism: Pain may be related to tissue injury, possibly due to hematoma in the
deeper tissues.
Signs and symptoms: Pain in the arm, without characteristics of nerve irritation.
May be described as an ache or heaviness in the arm, similar to that experienced
after vaccination. Include all cases where arm pain is the main symptom, unless
a diagnosis of nerve injury/irritation is suspected in the presence of nerve type
symptoms recognised by trained staff.
119
A 3. Localised Infection/Inflammation
Localised infection/inflammation
Definition: Inflammation along the course of a vein, which may progress to localised
infection several days after phlebotomy. There may be clotting in the vein.
Mechanism: Tissue damage and introduction of surface bacteria into the deeper
tissues with venepuncture. The superficial vein itself (thrombophlebitis) or the
surrounding subcutaneous tissue (cellulitis) may be predominantly affected.
Signs and symptoms: Warmth, tenderness, local pain, redness and swelling at the site
of phlebotomy. The site and the vein may feel tender, firm, and warm to the touch.
Fever may be present.
Thrombophlebitis: The redness, swelling, and tenderness extend along the course
of the vein.
Cellulitis: The redness, swelling and tenderness affect the soft tissues, and are not
localised to the course of the vein.
A4. Other Major Blood Vessel Injury

These rare, serious conditions must always be medically diagnosed.
Deep venous thrombosis (DVT)

Definition: Thrombosis of a deep vein in the donor’s phlebotomy arm.
Mechanism: Superficial venous thrombosis may progress into the deeper veins of
the donor’s arm. DVT may also rarely occur without previous signs and symptoms
of superficial thrombosis. An additional risk factor for thrombosis, in particular, the
use of oral contraceptives, may be present in these donors.
Symptoms and signs: Swelling and pain in the upper arm. May be accompanied by
symptoms of superficial inflammation and thrombosis (see above).
Arteriovenous fistula
Definition: Acquired connection between the vein and artery due to venepuncture
lacerations.
Mechanism: A channel forms between the lacerated vein and artery immediately
post-venepuncture, or in the healing process. May be related to arterial puncture.
120
Appendix 5
Signs and symptoms: Pulsating mass with a palpable thrill and associated bruit. The
affected area may be warm, and the distal part of the arm may be cool if significant
shunting of blood is present. The distal veins may be dilated and may pulsate.
Compartment syndrome
Definition: Increased intracompartment pressure leading to muscle and soft tissue
necrosis.
Mechanism: Blood may accumulate in the frontal deep areas of the forearm, closing
small blood vessels and resulting in muscle and nerve tissue necrosis. May be related
to arterial puncture.
Signs and symptoms: Painful arm, particularly on movement; swelling, paresthesias
and partial paralysis.
Brachial artery pseudoaneurysm

Definition: Collection of blood outside an artery, contained by adventitia or the
surrounding tissues alone.
Mechanism: After a traumatic arterial puncture, blood may leak out of the artery and
accumulate in the surrounding space.
Signs and symptoms: Pulsating mass in the arm. May be accompanied by pain and
paraesthesias. May be preceded by a large hematoma following arterial puncture.
B. Complications mainly with generalized symptoms: vasovagal reactions

Definition: A vasovagal reaction (VVR) is a general feeling of discomfort and weakness
with anxiety, dizziness and nausea, which may progress to loss of consciousness
(faint). It is the most common acute complication related to blood donation.
Mechanisms: Both physiologic and psychological factors may be important. The
reaction is generated by the autonomic nervous system and further stimulated by
psychological factors and the volume of blood removed, relative to the donor’s total
blood volume.
Signs and symptoms: Usually several of the following: discomfort, weakness,
anxiety, light-headedness/dizziness, nausea, chills, sweating, vomiting, pallor,
hyperventilation, rapid or a slow pulse.
Hypotension and loss of consciousness (LOC) may occur and can be accompanied
by loss of bladder or bowel control or convulsive movements. Reactions may occur
before phlebotomy (rare), during phlebotomy or immediately after phlebotomy,
121
when the donor stands up, in the refreshment area, or after the donor has left the
collection site. Most reactions occur within 12 hours of phlebotomy. Reactions
accompanied by LOC carry a risk of injury, particularly if they occur once the donor
has left the collection site (delayed vasovagal reactions).
Vasovagal reactions are divided in two main subgroups:
With injury - Injury caused by falls or accidents in donors with a vasovagal reaction
Without injury
Location of reaction:
Immediate: On collection facility*- Symptoms occurred before donor has left the
donation site
Delayed: Outside collection facility - Symptoms occurred after donor has left the
donation site
*in area within which staff can observe the donor and be responsible for the care of
donors with complications
C. Complications Related to Apheresis

Citrate reaction
Definition: Neuromuscular hyperactivity related to reduced ionized calcium levels.
Mechanism: Infusion of citrate anticoagulant during apheresis causes a fall in ionised
calcium levels, leading to neuromuscular hyperactivity. If untreated, symptoms
may progress to tetany and severe cardiac arrhythmias, including cardiac arrest.
Operator error with mix up of saline and citrate bags may occur with some apheresis
equipment, and lead to rapid citrate infusion.
Symptoms and signs: Numbness or tingling of lips, feelings of vibrations, numbness
or tingling in the fingers, metallic taste, chills, shivering, light-headedness, feeling of
tightness, muscle twitching, rapid or slow pulse, shortness of breath.
Symptoms may progress to carpopedal spasms and vomiting, and in severe reactions,
to generalised muscle contractions (tetany), shock, irregular pulse and cardiac arrest.
Haemolysis
Definition: Donor red cells may be damaged, releasing haemoglobin.
122
Appendix 5
Mechanism: There may be malfunctioning valves, kinks or obstruction of the

tubing, incorrect installation of equipment, or other equipment failures affecting the
extracorporeal circuit. Incompatible replacement fluids, such as dextrose D5W, may
be used in error.
Signs and symptoms: Pink or red plasma, blood in lines or filter may appear dark.
The donor may notice pink or red urine after collection.
Air embolism
Definition: Air bubble introduced into the donor’s circulation.
Mechanism: Air may enter into the lines due to incomplete priming of lines, as a
result of a machine malfunction or defective collection kits or through incorrect
manipulation by staff. Air in the donor’s pulmonary circulation may occlude the
pulmonary arteries in the lung and cause cardiopulmonary symptoms. Air may pass
to the arterial circulation through an atrial septal defect, and reduce blood flow to
the brain.
Signs and symptoms: Bubbling sound or feeling at the venipuncture site. Cough,
dyspnea, apprehension, sweating, chest pain, confusion, tachycardia, hypotension,
nausea and vomiting.
D. Allergic reactions
Allergy (local)
Definition: Red or irritated skin at the venipuncture site.
Mechanism: Reaction caused by allergens or irritants in solutions used for
disinfection of the arm (such as iodine or chlorhexidine) or in manufacture of the
collection set. Irritation may also occur due to application of the adhesive bandage
(bandage adhesive dermatitis). An allergic reaction to latex that may be in supplies
such as gloves may also occur.
Signs and symptoms: Itching and redness at the venepuncture site, the bandage site,
or the entire skin disinfection area. In a true allergic reaction, there may be a raised
rash or hives in these areas that may expand to cover a larger area of the arm. The
reaction may occur soon after donation or in the hours to days post-donation.
123
Generalised allergic reaction (anaphylactic reaction)

Definition: Anaphylactic type reactions usually starting soon after the procedure is
begun and may progress rapidly to cardiac arrest.
Mechanism: Extremely rare reactions, attributed to donor sensitivity to ethylene
oxide gas used to sterilize some collection kits.
Signs and symptoms: Apprehension, anxiousness, flushing, swelling of eyes, lips
or tongue, cyanosis, cough, wheezing, dyspnea, chest tightness, cramps, nausea,
vomiting, diarrhoea, tachycardia, hypotension, and altered mentation.
E. Other Serious Complications Related to Blood Donation

Major cardiovascular event (MCE)
Acute cardiac symptoms (other than myocardial infarction or cardiac arrest).
Myocardial infarction.
Cardiac arrest.
Transient Ischemic Attack.
Cerebrovascular accident.
Death.
Reporting is encouraged of MCE or death from any cause up to 24 hours after

donation, with an assessment of imputability. Only cases with definite, probable
or possible imputability should be included in international reporting. Major
cardiovascular events, including death, may occur in the hours after attending the
collection centre for blood donation. This can occur without any relation to the
donation (for deaths, this is described by the term actuarial deaths).
F. Other Complications
Other systemic reactions or complications that do not fit into the above, such as chest
pain that may have been investigated as angina, but was actually musculoskeletal, or
transmission of infection to a donor through erroneous re-use of equipment.
124
Appendix 6
Appendix 6 - Grading of Complication Severity and Imputability

Grading of Severity
Life-threatening complications and long-term disability are thankfully extremely
rare after blood donation. Grading of severity for donor reactions does not easily
fit into grading systems used for adverse reactions in patients. Use of this grading
system is therefore optional. The criteria for classification of a reaction as serious
(severe) as derived from these systems are:
Hospitalization: If it was attributable to the complication. The criterion of hospital
admission is applicable if a donor is kept in hospital overnight. Cases where a donor is
seen, examined, and in some cases given treatment (e.g. suturing, IV fluids, treatment
of a fracture) but discharged home are not automatically classified as serious.
Intervention: To preclude permanent damage or impairment of a body function or to
prevent death (life-threatening).
Symptoms: Causing significant disability or incapacity following a complication of
blood donation and persisted for more than a year after the donation (Long term
morbidity).
Death: If it follows a complication of blood donation and the death was possibly,
probably or definitely related to the donation.
Types and Definitions of Reactions:

Certain complications of donation are by their nature mild or severe.
Local reactions - Most local reactions (hematoma, arm pain syndromes) would not
be considered severe.
Severe consequences are separate reaction types: deep venous thrombosis,
arteriovenous fistula, and compartment syndrome.
Nerve injury may rarely result in long term donor signs and symptoms. This may be
captured by the duration of symptoms (optional split in nerve pain category).
Systemic reactions - Vasovagal reactions are characterised as those with or without
LOC. There are two optional additional characteristics: LOC can be characterised as
having additional symptoms (convulsions, loss of bowel or bladder control and/or
duration of ≥60 seconds). Reactions can be categorised as resulting in injury or not.
125
Complications that are by their nature severe include generalised allergic

(anaphylactic) reactions, and all major cardiovascular events.
Grading of Imputability
The strength of relation between donation and complication is:
Definite or certain: When there is conclusive evidence beyond reasonable doubt for
the relation.
Probable or likely: When the evidence is clearly in favour of a relation.
Possible: When the evidence is indeterminate for attributing the complication to the
donation or an alternative cause.
Unlikely or doubtful: When the evidence is clearly in favour of attributing the
complication to other causes.
Excluded: When there is conclusive evidence beyond reasonable doubt that the
complication can be attributed to causes other than the donation.
Imputability should only be reported for cardiovascular events leading to
hospitalization or death post-donation, and only cases with imputability of possible,
probable or definite should be captured.
Adapted from: Standard for Surveillance of Complications Related to Blood Donation by the
Working Group on Complications Related to Blood Donation, International Society of Blood
Transfusion and Working Party on Haemovigilance, European Haemovigilance Network (2014).
126
Appendix 7
Appendix 7
CRITERIA FOR SETTING UP
TRANSFUSION MICROBIOLOGY LABORATORIES
IN THE MINISTRY OF HEALTH, MALAYSIA
The laboratory shall:
a. Have a comprehensive and effective quality management system

incorporating elements of GMP in place.
b. Have an annual workload of blood collection of at least 40,000 donations.
c. Have infrastructure, resources and equipment that are appropriate for
the function :
ȤȤ proper facility for screening transfusion transmitted infection in
compliance to GMP or other quality systems
ȤȤ partial or full automation system;
ȤȤ adequate budget.
ȤȤ adequate number of personnel of at least 2 Microbiologists and
4 Medical Laboratory Technologist dedicated for the screening
laboratory.
d. Participate in external quality assessment programmes at national or

international level.
e. Obtain a written approval from Kementerian Kesihatan Malaysia.
127
Appendix 8A: Blood Screening and Blood Release Flow Chart
TRANSFUSION MICROBIOLOGY LAB (TML) COMPONENT PREPARATION UNIT
Screening test for HIV 1 & 2, HBV, HCV and Syphilis Quarantine all the blood and blood products
Non-Reactive (NR) Reactive (R)

Identify and retrieve the Blood Bag by comparing
Release Initially Reactive results to Component Preparation Unit the Initially Reactive results released by TML
Repeat testing on sample:

Send Initially Reactive blood bag to TML
(1) Blood bag Segment (SG) (2) Pilot tube (PT) in duplicate
for sample verification testing.
PT: R PT*: NR PT#: R Receipt Final Official Results from TML

SG: NR SG: NR SG: R
Discrepant result between blood bag sample and Result tallied Reactive Non-Reactive
pilot tube, quarantine and carry out the appropriate (PT and corresponding
investigation among others; sample from blood bag) To remove all the Check products ID
128
• echeck the sample ID of the implicated sample
R Reactive blood and against Negative List
Pilot Tube and Blood Bag. blood components from (TML – Official Report).
quarantine blood storage
• Check blood group of the implicated sample
(fridge and freezer). Label blood/
• Repeat the screening test from the sample bag of All Reactive blood and components as
the similar blood group of the implicated batch. blood components should “SCREENED”.
be labelled as
“BIOHAZARD”.
Discrepant Non-Discrepant
Release Non-Reactive
Check the segments to tally blood and blood
• Repeat the screening test on all blood Result of the implicated sample to be with each positive blood bag. components for use
bag samples from the implicated batch. release as Reactive.
• elease final results obtained from
R
repeated screening test on blood bag
samples of the implicated batch
Send the Reactive blood and blood components
to TML for confirmatory testing and disposal.
Release Final Official Results
(containing list of screened blood for a particular collection batch)
Check blood and blood components ID against TML

* Both PT in duplicate are NR;
Final Official Results. All reactive blood and blood components
# Either one of the PT is reactive
shall be autoclaved before it is sent for final disposal.
Appendix 8B: Blood Screening and Blood Release Flowchart
Pilot tube
Screening test ( EIA )

for HIV 1&2, HBV and HCV
Quarantine blood
Initially Reactive Non-Reactive
& components
129
Repeat testing EIA 1 sample Release Non-Reactive blood
Both Non-Reactive
from pilot tube in duplicate and blood components
One or both Reactive Discard all components
Send blood bag sample to This protocol (Appendix 8B) is for blood bank which has established and effective quality
NBC TML for HIV and HCV system for all its processes. Risk assessment shall be made and approval from the
Repeatedly Reactive cases Head of Department is required before implementing the above protocol.
Appendix 8
Appendix 9 BTS/TC/2/2016
CONSENT FORM FOR BLOOD OR
BLOOD COMPONENT TRANSFUSION
Patient’s Name: Age:
Identity Card No.: Sex: c Male c Female
Address:
Attending Medical Practitioner: Dr.
Identity Card No.
I, the above-named/parent/guardian/spouse/next of kin of the above-named*, have been informed

of the need for a blood transfusion of the patient. The attending medical practitioner has explained
to me the risk and benefits involved in the transfusion as well as answering all my inquiries
satisfactorily. I understand that despite testing and screening on the blood/blood components for
HIV, Hepatitis B, Hepatitis C and Syphilis according to established standard, there are still risks of
developing the disease. I also understand that unavoidable complications of transfusion may also
occur.
I fully understood the above and hereby agree to the blood/blood component transfusion.
Signature of the patient/ Signature of Attending

parent/guardian/spouse/next of kin* Medical Practitioner
Name of parent/guardian/spouse/next of kin**:

Identity Card No. of the above :
I was present while the above matter was explained to the patient/parent/guardian/spouse/next
of kin* whose signature appears above. In my opinion, the person referred to has understood the
contents of this form and agreed to the transfusion willingly.
Signature of witness*
Name of witness :
Identity Card No.:
* delete appriopriately
** if necessary
130
Appendix 9
BTS/TC/2/2016
BORANG PERSETUJUAN PEMINDAHAN DARAH
ATAU KOMPONEN DARAH
Nama Pesakit: Umur:
No. Kad Pengenalan: Jantina: c Lelaki c Perempuan
Alamat:
Pengamal Perubatan Yang Merawat: Dr.
No. Kad Pengenalan
Saya, seperti nama tersebut di atas/ibu bapa/penjaga/suami/isteri/saudara kepada pesakit seperti

nama di atas*, telah dimaklumkan bahawa pesakit memerlukan pemindahan darah atau komponen
darah. Pengamal Perubatan yang merawat telah memberi penjelasan kepada saya tentang risiko
dan kebaikan pemindahan darah dan saya berpuas hati dengan semua jawapan yang diberikan
kepada soalan-soalan yang saya kemukakan. Saya faham dan sedar, meskipun darah atau
komponen darah itu telah menjalani ujian saringan untuk HIV, Hepatitis B, Hepatitis C dan Siflis
mengikut standard yang telah ditetapkan, namun risiko jangkitan penyakit menerusi pemindahan
darah masih boleh berlaku. Saya juga faham dan sedar bahawa komplikasi pemindahan darah
yang lain yang tidak dapat dielakkan juga mungkin berlaku.
Saya benar-benar faham kenyataan diatas dan saya bersetuju untuk menerima pemindahan darah
atau komponen darah.
Tandatangan pesakit/ibu bapa/ Tandatangan Pengamal

penjaga/suami/isteri/saudara terdekat Perubatan Yang Merawat
Nama ibu bapa/penjaga/suami/isteri/saudara terdekat**:

No. Kad Pengenalan:
Saya memperakui makluman di atas telah diterangkan kepada pesakit/ibubapa/penjaga/suami/

isteri/saudara terdekat yang tanda tangannya tertera di atas. Pada hemah saya penama yang
dirujuk telah memahami kandungan borang ini dan telah bersetuju untuk menerima pemindahan
darah atau komponen darahsecara sukarela.
Tandatangan Saksi*
Nama saksi:
No. Kad Pengenalan saksi:
* potong yang tidak berkaitan
** jika perlu
131
Appendix 10: Blood Transfusion Request Form
132
Appendix 11
Appendix 11: Examples of Rejection Criteria

No. Reasons for Rejection of GXM/GSH request
1. Sample sent in wrong container.
2. Patient’s name on sample tube does not tally with request form.
3. Patient’s identity card number on sample tube does not tally with request form.
4. Patient’s registration number on sample tube does not tally with request form.
5. No patient’s identity card number written.
6. No patient’s diagnosis written.
7. Date and time of sample collected not written.
8. No doctor’s signature in the request form.
9. Illegible handwriting on request form or tube label.
10. No/ wrong request form used.
11. Form sent has no carbon copy.
12. Double label on sample tube.
13. Sample tube labelled with pre-printed label.
14. Sample tube not labelled.
15. No patient’s blood sample sent.
16. Patient’s blood sample sent in wrong container.
17. Insufficient blood sample sent.
18. Blood sample lysed.
19. Blood sample clotted.
133
Appendix 12: Instructions on Proper Handling of Blood and Blood

Components in the Ward
Whole blood/Red Platelet Plasma
Cell Concentrate components
Supply - After Crossmatch - Group Specific/ - Group Specific

Compatible - No Crossmatching
- No Crossmatching Required
Required - Should be thawed
Collection - Blood Box with Ice - Blood Box without Blood Box with Ice
Ice
Use - As Soon As Possible - Transfuse - Transfuse
(After Reaching The Immediately Immediately
Ward)
Storage +2°C to +6°C Room Temperature Should Not Be Stored
+ 20°C to + 24°C on or
Agitator Kept in The Wards
Do Not Store in Fridge
Return of Unused Return Immediately Return Immediately Return Immediately
Blood to Hospital
Blood Bank
After Fill Up PPDK 1 and Fill Up PPDK 1 and Fill Up PPDK1 and
Use Return Together with Return Together with Return Together with
Empty Bag to Blood Empty Bag to Hospital Empty Bag to Blood
Bank As Soon As Blood Bank As Soon Bank As Soon As
Possible As Possible Possible
134
Appendix 13
Appendix 13: Example of Transfusion Checklist
135
Appendix 14: Flowchart for Transfusion of RhD Negative Patients
Patient requires blood transfusion
Clinician in charge to liase with Blood Bank MO/Specialist
Blood bank MO/Specialist to discuss with clinician

incharge regarding urgency of the transfusion and
availibility of the blood
Blood availability
No Yes
Blood Bank
Transfuse RhD
• Contact nearest/other blood bank for RhD negative blood
negative blood
• Contact donor and relatives/siblings for urgent RhD negative blood
Blood availability
No Yes
Blood Bank to discuss with the physician in charge

Transfuse RhD
regarding transfusion or option available for
negative blood
subsequent management
* For any queries please contact local Hospital blood bank.
136
Appendix 15
Appendix 15: Flowchart for Transfusion in Patients with Rare

Phenotype Blood
Patient requires blood transfusion
Feasibility of autologous blood
Feasibility of
No autologous blood Yes
Blood bank MO/Specialist to discuss

Arrange for
with clinician incharge regarding urgency
autologous donation
and availibility of the blood
Blood availability
No Yes
Blood Bank
• Contact nearest/other blood bank for phenotype blood
• Contact donor and relatives/siblings for urgent phenotype Transfuse relevant
blood phenotype
• Contact National Blood Centre
Blood availability
No Yes
Blood Bank to discuss with the physician

Transfuse relevant
in charge regarding transfusion or option
phenotype
available for subsequent management
* For any queries please contact local hospital blood bank.
137
Appendix 16: Flowchart on Management of Seroconverted Donor

Seroconverted Donor
Call donor for Product(s) recall and trace Notify

post-donation counselling previous negative donation(s) Public Health
Counsel donor List all type of blood and

blood component
Determine risk factor

Trace component(s) Trace where blood products
Take fresh sample from inventory have been issued to
Reconfirm findings Remove for Inform clinician

further management* to call recipient
Refer to phycisian for further

management Pre-test counselling
Determine other risk factors

for the implicated TTI
Take blood sample for

implicated infection
Positive Negative
Post-test counselling Post-test counselling
Inform Blood
If confirmed TTI, Transfusion service
to report transfusion
related adverse event using
form BTS/HV/3/2016 BTS report to NHCC
using BTS/SC/1/2016
138
Appendix 17
Appendix 17: Flow Chart on Management of Seroconverted Recipient

Recipient
Confirmed positive
Counsel & determine risk factors other than transfusion(s)
Trace all transfusion reference no. and date of transfusion(s)
Inform Blood Transfusion Services
Trace all donors to determine status
Send letters and/or call donors
Counsel and retest
Confirmed positive Negative Feedback to clinician
Trace recipient of other Counsel, notify and Feedback

blood product refer to physician to clinician
If regular donor
Report transfusion-related
Negative Positive
adverse event to NHCC
Trace previous donation(s) using form BTS/HV/3/2016
TTI is Possible
unlikely TTI Product recall (refer Flowchart on
Management of Seroconvert Donor)
139
Appendix 18 BTS/TR/2/2016
140
Appendix 18
141
Appendix 19 BTS/TRW/2/2016
142
Appendix 20
Appendix 20 BTS/HV/3/2016
143
144
Appendix 20
145
146
Appendix 21
Appendix 21: Flowchart for Reporting Transfusion-Related Adverse Events

Adverse transfusion events/reactions
Detect nearmiss/ IBCT

Fill up Request form for Transfusion Reaction
Investigation (BTS/TR/2/2016) and send to
Quality Unit
Blood Bank with relevant investigations
Blood Bank performs relevant laboratory

investigations & fill up BTS/TRW/2/2016
Blood Bank to issue results & Reporting

form for Transfusion-related adverse event
(BTS/HV/3/2016) to ward
Complete Reporting form for Transfusion-

related adverse event (BTS/HV/3/2016) and
return to Blood Bank*
Blood Bank to verify and send report to
Hospital Transfusion National Haemovigilance

Committee (HTC) Coordinator at PDN
State Transfusion National Transfusion

Committee (STC) Committee (KKM)
*BTS/HV/3/2016 should be completed within 2 weeks after the event and sent back to Blood
Bank for compilation.
Note:
1. Every case of adverse reaction must be reported.
2. If the case of adverse reaction involves a seropositive recipient, a lookback and recall
procedure must be carried out.
147
Appendix 22 BTS/SC/1/2016
148
Appendix 22
149
Transfusion Practice Guidelines for Clinical and Laboratory Personnel Appendix 23
Appendix 23: Flowchart for Reporting of Adverse Donor Reaction
Blood Collection Personnel to fill up

Incident form for adverse donor reaction
(BTS/DV/2/2016)
Submit form to the Head of Collection

Centre for verification
Blood availability Incomplete
Complete
Head of Collection Centre will analyse and

perform root cause analysis
Implement corrective action if necessary
Compilation of the form:

1.
Completed form shall be retained at the
respective blood collection centre
2.
A copy is to be sent to Haemovigilance
Coordinating Centre, National Blood Centre
monthly
150
Glossary
Glossary
Additive solution Solution specifically formulated to maintain beneficial properties
of cellular components during storage.
Adverse event Any untoward occurrence whether it is incidence, accidence or
deviation from Standard Operating Procedure (SOP) associated
with the collection, testing, processing, storage ,distribution
and administration of blood and blood components that might
lead to an adverse reaction in patient who received blood
transfusion or blood donors.
Adverse reaction Unintended response in donor or in patient associated with the
collection or transfusion of blood or blood components
Anticoagulant Solution that prevents blood from clotting.
Apheresis Procedure of obtaining one or more blood components by
machine processing of whole blood in which the residual
components of the blood are returned to the donor during or at
the end of the process.
Autologous donors Individuals who donate blood for their own use. If the need for
blood can be anticipated and a donation plan developed.
Blood components Blood components are prepared from whole blood through
centrifugation.
Therapeutic components of blood (red cells, white cells, platelets,
plasma) that can be prepared by centrifugation, filtration, and
freezing using conventional blood bank methodology.
Buffy coat (BC) BC is the layer of white cells and platelets that is seen between
the red cells (at the bottom) and the plasma (at the top) of
anticoagulated blood.
Confidential unit exclusion The removal and disposal of a unit of blood after donation
following information obtain from donor.
Crossmatch One of the compatibility procedure involving mixing of patient’s
plasma and donor’s red cells.
Cryopreserve A process employed to prolong the storage life of blood
components by freezing.
Cryoprotectant A solution (eg: glycerol), used in long term storage of materials
in frozen state (e.g. red cell).
Donor A person in normal health with a good medical history who
voluntarily gives blood or components for therapeutic use.
Donor deferral Suspension of the eligibility of an individual to donate blood or
blood components, either on permanent or temporary basis.
Emergency O blood Group O RhD positive whole blood with low titres of Anti-A and
Anti-B (titre ≤1/16), and negative for haemolysin.
151
Fractionation A process of isolating and separating plasma proteins which

include albumin, immunoglobulin (gamma globulin ) and clotting
factors.
Haemovigilance Organized surveillance procedures related to adverse or
unexpected events or reactions in donors and recipients.
Incorrect blood or blood Where a patient is transfused with blood/blood components
component transfused (IBCT) that does not meet the appropriate requirements or which is
intended for another patient.
Lapsed donor A blood donor who has donated before but the last donation
was more than 24 months in the same blood centre.
Near miss event An error which if undetected could result in the determination
of a wrong blood group, or issue, collection or administration
of an incorrect, inappropriate or unsuitable blood or blood
component, but which was recognized before the erroneous
transfusion took place.
Phenotype Observable expression of the gene inherited by a person and
reflects the biologic activity of the gene.
Phlebotomist Health personnel who is trained in drawing blood for testing or
donation.
Phlebotomy The process of inserting a needle into the vein.
Pyrogens Endotoxins produced as a result of the metabolism of gram
negative bacteria which are heat stable.
TTI Infections agents that can be transmitted through transfusion of
blood and blood products.
Reactive donors A blood donors who was found to be reactive during screening
for TTI.
Regular donor A blood donor who has donated minimum of two times within
24 months in the same blood centre.
Safe O Group O RhD positive packed cell that is used in life threatening
condition without crossmatching.
Self-deferral The decision by a potential donor to defer himself/herself from
donating blood.
Validation A process of confirming that a process, equipments, product or
service meets or exceeds a predefined set of criteria.
Voluntary non-remunerated A person who donates blood of his/her own free will and
blood donor receives no payment for it, either in the form of cash, or in kind
which could be considered a substitute for money.
Window period The time interval that elapses between infection and the
appearance of detectable antibodies or antigens by the
laboratory testing methods.
152

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TRANSFUSION

NATIONAL BLOOD CENTRE

Transfusion Practice Guidelines

National Blood Centre

© National Blood Centre 2016

Foreword by the Director General of Health, Malaysia

Datuk Dr. Noor Hisham Abdullah

Dr. Noryati Abu Amin Dato’ Dr. Roshida Hassan

Dato’ Dr. Roshida Hassan

Dr. Zanariah Kassim

EDITORS COORDINATOR &

Code of Ethics for Blood Donation and Transfusion

10. Donations of leukocytes or platelets by cytapheresis should be the subject of special

II. THE RECIPIENT

3.6 Release of Screened Blood Components from Quarantine 23

5.11 Disposal of Reactive Blood 35

8.5 Antibody Identification 46

12.4 Transfusion in RhD Negative Patients 65

APPENDIX CONTENT PAGE

2.0 Procurement of Blood

2.1 Blood Procurement Team

2.2 Promotion and Recruitment

• Giving talks to targeted group such as students and communities.

2.3 Identification of Blood Donor

• PATI form (Pendatang Asing Tanpa Izin).

2.4 Criteria for Acceptance of Blood Donors (Donor Eligibility Criteria)

refer to the Guidelines for the Acceptance and Deferral of Donors

2.5 Frequency of Donation

• If a donor donates whole blood regularly every 8 weeks, (subject to

2.6 Record of Donors

2.7 Pre-Donation Questionnaire

2.8 Pre-Donation Interview

2.8.4 If the prospective donor is on any medication, it must be ascertained that

2.9 Collection of Blood

• In the absence of an automated blood mixer, the contents of the

2.10 Blood Donor Confidentiality

2.12 Competency of Personnel for Bleeding of Blood Donors.

2.12.2 A competency certificate should be issued to the competent personnel.

2.12.3 Only competent personnel should be allowed to perform venepuncture

2.12.4 Competency of the personnel should be re-evaluated every 2 years.

2.13 Confidential Unit Exclusion

2.14 Adverse Reactions in Donors

2.14.2 Despite this, adverse donor reactions (ADR) do occur.

Table 2A: Some Common Adverse Donor Reactions

A2. Arm pain ȤȤ Nerve injury/ irritation

 ocalised infection/ inflammation

2.15 Management of Adverse Reaction in Donors

2.15.3 The necessary treatment measures shall be instituted as soon as possible

2.15.5 Appropriate preventive and corrective measures shall be implemented.

2.15.7 A guide to the management of specific adverse donor reactions is provided

2.16 Documentation of Adverse Reactions in Donors

2.16.2 All adverse reactions shall be documented in a dedicated incident reporting

2.18 Record Keeping

2.18.1.1 Manual keeping

3.0 Production of Blood Components

ocalised infection/ inflammation

3.2.7 Component : Red Cells, Leukocyte-depleted for

Storage : 4º 6 2ºC.

Criteria for : The whole blood (Refer to 3.2.1) used for