You are on page 1of 89

, , ,

((J)}F i •



CCC[))ILILIECC1fTIC[))N llJN]j11['§
I I'


i '


, [,
, '
h.... ' ,
.. I:



I '

Department of Health , I:
Manila, Phlllppines

First Edition
December, 997

. I ." ",if:

Department of Health


_ M31c 1997 I Manual of standards for blood collection unit

Bureau of Research and Laboratories

Department of Health
Manila, Philippines

December, 1997
Printed in the Philippines

ISBN 971-91605-2-7

First Printing, December 1997

Published by:
Bureau of Research and Laboratories
Department ofHeaith
Bldg. 19, San Lazaro Compound
Sta. Cruz, Manila, Philippines

Second Printing, December 1999

Introduction v

Section 1 General Principles 3

Seelion 2 Quality System Requirements 5

2.1 Quality Objectives, Policies and Guidelines 7
2.2 Organization and Personnel 7
2.3 Standard Operating Procedures and Work
Instructions 9
2.4 Quality Control, Quality Assessment and
Quality Assurance Audit 10
2.5 Personnel Safety 11
2.6 Buildings, Facilities, Equipment and Materials 12
2.7 Quality Records 12

Section 3 The Physical Plant, Equipment and Materials 15

BUildings and Facilities 16

3.1 Building Design and Maintenance 16
3.2 Restriction of Entry of Unauthorized Persons
and Personnel 16
3.3 Construction Materials and Work Surfaces 16
3.4 Clear Demarcation and Smooth Flow of Work
and Activities 16
3.5 Adequacy of Space 16
3.6 Storage 17
3.7 Lighting and Ventilation 18
3.8 Safety and Cleanliness 18

3.9 Appropriate and Adequate Equipment 19
3.10 Quality of Equipment and Instruments 19
3.11 Proper Use of Equipment 19
3.12 Maintenance and Service 19
3.13 Calibration 21
3.14 Storage Equipment 21
3.15 Sterilization of Equipment 23
3.16 Breakdown of Equipment 23

Supplies and Materials 24

3.17 Appropriate and Adequate Glassware, Reagents
and Supplies 24
3.18 Quality of Reagents and Materials 24
3.19 Proper Use of Glassware, Reagents and Supplies 27
3.20 Defective Blood Bags and Poor Quality Reagents 27
3.21 Supplies Other Than Blood Bags or Reagents 27
3.22 Tax-Free Importation 27
Section 4 The Donor 31

Advocacy 32
4.1 Donor Recruitment and Retention 32
4.2 Donor Incentive Schemes 32
4.3 Avoiding Competition among BCUs for the Same
Population 33

Donor Selection 33
4.4 Target Groups for Blood Donation 33
4.5 Donor Temporary Deferment 33
4.6 Donors Needing Additional Medical Assessment
at the Time of Donation 35
4.7 Persons Who Cannot be Allowed to Donate Blood 36

ThE: Pre-Donation Process 37

4.8 Pre-Donation Interview, Education and Counselling 37
4.9 Donor Screening 37
4.10 Donor and Medical Declaration Forms 38
4.11 Issuance of Blood Donation Number 38

The Post-Donation Process 39

4.12 Donor Reactions and Donor Care 39
4.13 Reporting Procedures and Post-Donation Counselling 39
4.14 Repeat Donation 40

Section 5 Blood Collection, Compatibility Testing, Labelling, Storage

and Transport 43

Blood Collection 44
5.1 Prevention of Contamination 44
5.2 Training of Phlebotomists 44
5.3 Inspection of Biood Packs Priorto Venipuncture 44
5.4 Venipuncture 44
5.5 Individual Blood Handling Materials and Supplies 45
5.6 Mixing of Anticoagulant 45
5.7 Proper Recording and Labelling 45
5.8 Prolonged Duration of Blood Collection 45
5.9 Blood Samples for Testing 45
5.10 Volume of Whole Biood Collection 45
5.11 Labelling 46
5.12 Counterchecking of Labels Before Termination of
Collection and Discarding Unused Numbers 46
5.13 Terminating Blood Collection 46
5.14 Submission and Processing of Blood Units to BB/BC 47

Compatibility Testing 47
5.15 Compatibility of Donor Blood with Recipient Blood 47

Handling and Storage of Blood 48

5.16 Storage Requirements of Whole Blood 48
Release and Dispatch to Central BB/BC 50
5.17 Reinspection and Packing 50
5.18 Release/Transport Process 50
5.19 Records of Collection, Packino and Transport 50
5.20 Transport of Blood Units 51
5.21 Defective Blood Units 51
5.22 Complaints and Recall 51
5.23 Controlling Supply 51

Section 6 Waste Management 53

6.1 Responsibility for Safe Waste Handling 54
6.2 Education and Training 54
6.3 Contingency Plan for Employee's Injuries
and Disruption of Disposal 54
6.4 Classification of Generated Waste from Blood
Collection Unit 54
6.5 Guidelines on Waste Disposal 55

Section 7 Quality Records 58

General Requirements 60
7.1 Record Design 60
7.2 Record Changes 60
7.3 Confidentiality 60
7.4 Document Control 60
7.5 Security and Retrieval 61
7.6 Storage of Records 61
7.7 Retention of Record 61

Classification of Manuals and Records 61

7.8 Quality System Manual 61
7.9 BCUTechnical Procedure Manual 61
7.10 Biosafety and Waste Management Manual 62
7.11 Equipment Maintenance and Repair Record 62
7.12 Quality Management Record 63
7.13 Blood Donation Records 63
7.14 Records of Compatibility Testing 64
7.15 Records of Storage, Transport and Submission
of Collected Blood to Central BB/BC 64
7.16 Records of Errors and Accidents 65
7.17 Summary Records 65

Section 8 Research 69
8.1 BCU Operation Research Program 70
8.2 Personnel Training on Research Methodologies 70
8.3 Ethical Review 70
8.4 Funding 70
8.5 Data Submission and Utilization 70
Annexes 1,2,3,4 71-75

Abbreviations 76

Glossary 77-82

Acknowledgements 83-84

References 85-87
Republic of the Philippines
Department of Health


The protection of the blood supply begins with the enunciation of principles and standards
which are indispensable for the safe and efficient practice of blood banking and blood transfusion in
the Philippines.

At a time when blood transmissible diseases and transfusion reactions are a growing problem, it
Is imperative that everyone concerned with these vital issues come together to define the standards of
professional practice. This Manual is a product of such cooperation.

The Standards for Blood Collection Units were prepared by the staff of the Bureau of
Research and Laboratories of the Department of Health (DOH), in collaboration with a technical panel
of experts, the DOH pathologists, representatives from the different specialty societies and various
resource persons.

We enjoin all concerned to strive towards the attainment of these Standards. Let us strive
towards the noble goal of ensuring the safety of the blood supply and achieving and maintaning its
adequacy through a fully voluntary system.

Dugong Pinoy, Sapat at Ligtas!

/ ' ( ;-rQ..U &' L A? I J,

r-; t4-.
Secretary of Health


In an effort to move our country's blood banking system and blood transfusion services to a
totally voluntary system, the National Voluntary Blood Services Program (NVBSP) has classified Blood
Service Facilities (BSF) into: Blood Bank/Center (BB/BC), Blood Collection Unit (BCU) and Blood
Station (BS).

This Manual was prepared specifically for Blood Collection Units in the Philippines. The Manual
specifying the Standards for BB/BC was published in February,1996. The Manual of Standards for Blood
Stations is issued separately.

The relationships of the different Blood Service Facilities are briefly described' in Table 1 and
Figure 1. When the term BSF is used, it covers the central BB/BC to which the BCU or BS is linked within
the blood services network.

The Blood Collection Units will function under the license of their parent BB/BC. This means
that the parent BB/BC must closely supervise the BCU and guarantee its compliance with all standards.
Any violation or non-compliance with existing Standards by BCU will jeopardize the license of the parent

In addition to compliance with the standards, the BCU shall also comply with the guidelines in
the establishment of blood services network set by the DOH Blood Program Management Unit.

As in the Standards for Blood Banks and Blood Centers, these Standards have been formulated
with careful consideration of major factors:

1. the present status and conditions of blood banking technologies and

practices in the country; and,
2. the envisioned blood service network under the National Voluntary
Blood Services Program.

These Standards represent accepted performance guidelines and are classified into:

1. Mandatory: These are requirements necessary for a BCU to be given authorization to operate
by the concerned Regional Health Director. Each describes the single acceptable activity
or method. Failure to meet the specified requirement will constitute a deficiency and will
cause revocation of authorization to operate the BCU. Words like "shall" or "musf" are used
to signal these mandatory requirements. These are in bold print for emphasis.

2. Recommendatory: These are standards which have several acceptable alternatives or range
of acceptable values. These are indicated by the words "should" or "may".

These Standards are pursuant to Section 9 of R.A. 7719 and its Implementing Rules and Regu-
lations·(A.O. No.9, s. 1995). We welcome comments and suggestions that may find useful in subse-
quent editions. A page at the back has been provided for this purpose.

( edical Officer VII)
Bureau of Research and Laboratories


Blood Urn'
Blood Station / B I O O d Station

Blood Collection Unit r Blood Collection Unit

Regional Blood Center/Zonal Blood Center in Region or Jurisdiction Area

II 8Collection Unit

Blood Station Blood Bank Blood Station


Table 1 Blood Service Facilities' Service Capabilities



Recruitment of Recruitment of Recruitment of voluntary Recruitment of voluntary Recruitment of voluntary Recruitment of voluntary
voluntary voluntary blood donors blood donors blood donors blood donors
blood donors blood donors

Health education and Health education Health education and Health education and Health education and Health education and
counselling and counselling counselling counselling counselling counselling

Donor screening and Donor screening and Donor screening and Donor screening and Donor screening and Donor screening and
selection selection selection selection selection selection

Blood collection Blood collection Blood collection Blood collection Blood collection Blood collection

Blood screening & testing of Blood screening & testing Blood screening & testing Blood screening & testing
transmissible diseases of transmissible diseases of transmissible diseases of transmissible diseases

Provision of whole blood & Provision of whole blood, Provision of whole blood, Provision of ....mole blood,
red blood celts (RBC) red blood cells (RBC) red blood cells (RBC) & red blood cells (RBC) &
blood products blood products

Storage of blood & blood Storage of blood & blood Storage of blood & blood Storage of blood & blood
products products products products
Storage and Storage and Transport of blood to Transport of blood to
issuance of issuance of Blood Banks/Blood Blood Banks/Blood Issuance, transport and Issuance, transport & Issuance, transport & Issuance, transport &
whole blood and whole blood and Centers Centers distribution of whole blood distribution of whole blood distribution of whole blood distribution of whole blood
red blood cells red blood cells and blood products & blood products & blood products & blood products

Compatibility lesting Compatibilily testing

Compatibilily testing Compatibility testing

Investigation of
transfusion reactions

Resolution of incompatible
, I

Section 1
Section 1


Ensuring blood safety through quality blood bank services and blood
products, achieving and maintaining blood supply adequacy through a fully
voluntary system begin with enunciating the following principles:

1.1 All Blood Collection Units (BCUs) should place highest priority on the
health and safety of their donors, patients, personnel and the community.

1.2 All BCUs shall achieve.and maintain 100% voluntary blood donation. The key
function of the BCU is effective donor recruitment and safe blood collection.

1.3 These Standards should be regarded as performance goals to be

attained and maintained by each BCU.

1.4 Inspection and authorization should take into account the capability
and commitment of the BCU to continuously improve the safety and
quality of its services and products.

1.5 Every person involved in any aspect of the blood transfusion service from
collection to transfusion, auditinq to licensing or authorization must be
responsible for the quality of his! her work.

1.6 All BSF, hospitals and all other health facilities should mutually support and
assist each other to attain and maintain these Standards.

1.7 All BSF should endeavor to gain and sustain the public confidence
support and commitment through consistent high quality of its blood
services and products.
Section 2
Section 2


Quality System Requirements refer to the critical components that should be in

place for smooth operations in the BCU for quality service and quality blood for
processing and transfusion.

2.1 Quality Objectives, Policies and Guidelines

2.1.1 Defining Organizational Objectives

The management of each BCU should define organizational

objectives pertaining to good manufacturing practices, quality
services and blood products and legal requirements. These should
indicate how the Standards herein can be complied with.

2.1.2 Policies and Guidelines

There should be a series of related or tiered documents, consistent

with each other, describing the systems in each BCU, each tier
becoming progressively more detailed. These documents should
cover essential policies, gUidelines, procedures and specific work
instructions, forms and records.

2.1.3 Administrative Procedures

A Quality System Manual which puts together the policies, job

delineation, task delegation and coordination including the flow of
authority and responsibility shall be required of each BCU.

2.2 Organization and Personnel

2.2.1 Qualification and Minimum Number Requirements

The establishment, implementation and maintenance of a satisfac-

tory system of quality assurance in the BCU starting with proper
donor selection and blood collection for product preparation rely
upon competent people. For this reason, personnel should have the
education, training, experience and skills to ensure that they can
perform assigned duties. In addition, there must be a sufficient
number of qualified and experienced personnel to carry out the
required services and provide the necessary blood.

Table 2 presents the interim qualification and minimum requirements

for headship and staffing of BCUs. These interim requirements can
serve as the guide for authorizing BCUs during the transition period
(1997) and the first year of f;,,11 implementation (199B) and until


MANPOWER 2.1. . Pursuantto Section 36, DOH A.O. No. 9,s. 1995 2.2. Interim Requirements (Manual of Standards
(IRR ofRA 7719) for BBIBC, A.O. No.4 s. 1996)

HEAD Physician Physician

PRC Registered with valid professional license PRC Registered with valid professional license
with at least (I) month training on: with at least four (4) months training in basic blood
- voluntary donor recruitment and screening banking services including compatibility testing and
- voluntary donor holding and motivation attendance at continuing education seminar/work-
- health education and counselling shop in Blood Transfusion Medicine suflicient to
- blood collection, handling & transport maintain competency
- management of blood collection activities
and problems. or with at least one (I) year on-the-job experience as
head or associate of a currently licensed blood bank
and attendance at continuing education seminar/
workshop in Blood Transfusion Medicine suflicient
to maintain competency

PERSONNEL (I) Trained Medical Technologist (I) Trained Medical Technologist

PRC Registered with valid professional license PRC Registered with valid professional license
with at least (I) month training on: with at least one (I) year on-the-job experience in a
. voluntary donorrecruitment and screening currently licensed blood bank, and attendance at
- voluntary donor holding and motivation continuing education seminar/workshop in Blood
- health education and counselling Transfusion Medicine suflicient to maintain compe-
- blood collection, handling & transport tency and with at least one month training in
- management of blood collection activities compatibility testing.
and problems.

(I) Medical Technologist

PRC Registered with valid professional license
shall be under the responsibility of a Trained
Medical Technologist

(I) Donor Recruitment Officer (MDIRMTIRN)

PRe Registered with valid professional license
with at least 6 months training on:
- voluntary blood donor recruitment and
- voluntary donor holding and motivation
- health education and counselling
- blood collection
- prevention and management of adverse reaction
2.2.2 Job Description and Functions

Each position in a BCU should have a written job description which

should include the following: duties, functions and responsibilities,
measurable standards of performance for each task, hours of work,
qualifications, and name of immediate supervisor. Each BCU staff
shall be required to sign their specific job description forms that should
be filed in their individual personnel records.

Each staff should likewise be required to document the fact that they
have read the required manuals that apply to their tasks.

2.2.3 Levels of Responsibility and Delegation

The levels of responsibility, delegation and limitations should be

formally defined for each group or individual members of the staff.
The degree of authority, especially to evaluate problems, and to
recommend, initiate or provide corrective actions should be
determined by the BCU Head. Functional organizational charts may
be used to define the flow of work and responsibilities.

2.2.4 Evaluation of Staff Competency

The competency level of each staff should be continuously and

periodically evaluated by the BCU Head. Validation can be done
through external certification, formal evaluation or periodic informal
sessions at various levels. This should be defined in the SOP.

2.2.5 BCU Staff Development Plan

There should be a program for continuing education of staff, and a

system of consultation and communication with the personnel. The
program should be prepared in consultation with the concerned
staff. A yearly staff development plan shall be prepared at the
beginning of each year by the BCU Head. This shall be submitted
to the parent BB/BC and NVBSP Subcommittee for Professional
Education. All possible opportunities for staff training and develop-
ment should be accessed.

2.3 Standard Operating Procedures and Work Instructions

Each BCU shall develop and maintain clear, well-documented, updated and
detailed SOPs to cover all activities performed on-site and in the community
(E.g. mobile collection).

2.3.1 Format of SOPs for Test Methods

When describing test methods, the followinq format should be

• Name of Test Method
• Principle of the Test and Its Clinical Application

• Specimen Collection and Storage
• Quality Control
• Reagents, Equipment and Supplies
• Procedural Protocol
• Expected or Reference Values
• Interpretation of Results
• Sources of Error and Troubleshooting
• Laboratory Safety and Waste Disposal

These detailed test methods should be compiled into a BCU Tech-

nical Procedure Manual.

2.3.2 Accessibility and Use of SOPs

The SOPs should be made readily available to all staff. The BCU head
should institute measures to assure that all concerned BCU staff have
read and understood all the procedures in their BCU.

2.3.3 Control of Copies and Revisions

The SOPs should be legibly printed, securely bound and signed and
dated by the BCU Head. It should be regularly reviewed and
updated at least yearly and initialed by the reviewer. Such review,
updates and changes should be well-documented and signed by
the BCU Head. Effectivity dates of these changes should be clearly

Master copies of obsolete SOPs must be archived in a secure area,

and made readily available for reference or verification.

2.4 Quality Control, Quality Assessment and Quality Assurance Audit

2.4.1 Quality Control of Equipment and Materials

All equipment must be carefully examined for quality and perfor-

mance and must be standardized. Equipment must be regularly
checked, calibrated and maintained. All materials must be
examined for physical defects and evidence of contamination
or deterioration. Reagents must be tested for quality before
acceptance or use. Use of control tests must be routinely
performed. Records of internal quality control must be maintained.

2.4.2 Process Control

Reliability of a testing method is assured only by using dependable

and verified materials required for the method, by following exactly
the specific and previously defined procedures as recommended
by the manufacturers for reagents and test kits, and by following the
accepted standard technical procedures.
A system should be established to detect and document any devia-
tion from normal processes and procedures. This should include the
action and corrective action instituted.

2.4.3 Changes Control

Any proposed changes on the systems and procedures must be

clearly identified, documented, justified, reviewed and approved
by the Head before these are executed. The changes and revisions
should also be systematically instituted and disseminated to
concerned staff.

2.4.4 Quality Assurance Audits

Internal and external auditing systems should be established and

consistently implemented. Audits should be performed by trained
personnel who do not have direct responsibilities for the procedures
being audited. Internal audltinq should be done by designated
Regional Quality Assurance Officers. External auditing should be done
by BRL auditors or authorized regional BRL representatives.

The training of auditors, the findings from reviews and audits, and the
actions required and executed should be properly documented.

2.4.5 Quality Performance in BCU

The Blood Collection Unit (BCU) and mobile collecting sites as

subsidiary blood service facilities within the blood services network
must be adequately supervised by the parent blood bank/center
for quality service and product handling during blood collection and
transport to parent BB/BC.

2.5 Personnel Safety

Blood should be regarded as potentially infectious. The most dangerous occu-

pational hazard is infection, especially with HIV, HBV, or HCV. Measures must
be taken to avoid direct and indirect transmission of diseases to personnel,
volunteers, patients, donors or visitors.

2.5.1 Routine Infection Control Measures

Routine infection control measures such as frequent handwashing,

use of protective devices such as laboratory gowns, masks, gloves
and eye protectors, and daily disinfection of work surfaces shall
be emphasized in the BCU's policies, guidelines, SOPs and work
instructions. All work surfaces should be cleaned and sanitized at
the beginning and at the end of the work day with an acceptable

The guidelines for biological, chemical safety and precautionary

reminders should be clearly stated, what should be used, by whom,
where and when to be used.
There must be .an established system for proper waste disposal. These
quidelines on Routine Infection Control Measure and Proper Waste
Disposal should be compiled in a BCU Biosafety and Proper Waste
Disposal Manual. This BCU Biosafety and Waste Management Manual
shall be prepared by the BCU Head arid personnel based on
accepted Guidelines on Waste Management (Section 6) and other
internationally accepted procedures.

2.5.2 Spills and Accidents

Guidelines and procedures for cleaning up spills and for manage-
ment of accidents such as needlepricks shall be clearly described
and adequately disseminated to all staff.

2.5.3 Adequate and Appropriate Protective and Cleaning Devices

Staff should wear appropriate clean work garments for work.
Adequate supplies of protective devices and disinfectants and proper
training on how to use andmalntain these shall be provided.

2.5.4 Strict Implementation of Universal Precautions

Procedures that have been found to increase the risk of disease trans-
mission and accidents such as pipetting by mouth, recapping of
needles shall be prohibited.

2.5.5 Training on Safety Procedures and Monitoring of Compliance

A system for training on safety procedures and monitoring of
compliance to these and universal precautions shall be instituted
and maintained.

2.5.6 Immunization of Staff

A program of identification and immunization of BCU staff exposed

to blood transmissible diseases such as HBV is mandatory.

2.6 Buildings, Facilities, Equipment and Materials

Each BCU must be appropriately situated in a well-designed, constructed, and

adequately equipped building. Necessary reagents, supplies and materials must be
continuously available. Details of the requirements for the physical facilities, equip-
ment, instruments, reagents, supplies and materials are in Section 3 (The Physical
Plant, Equipment and Materials).

2.7 Quality Records

Each Blood Collection Unit shall have procedures to maintain all records
related to all the activities within the BCU and the BB/BC to which it is affiliated within
the blood services network. These records are stated and elaborated in Section 7
(Quality Records). All personnel should not be permitted to sign or initial BCU records,
forms and documents unless they have been trained in the task and informed of the
significance of the signature. A registry of signatures and initials must be main-

Section 3
The Physical Plant,
Equipment and Materials
Section 3



Buildings and facilities shall be located, designed, constructed and utilized so as to

ensure both safety of donor, personnel, quality of blood products and services.

3.1 Building Design and Maintenance

Buildings should be designed, constructed and maintained so as to protect against

the effects of weather, ground seepage, flooding, and the entry of vermin,
insects, pests, stray animals and termites.

3.2 Restriction of Entry of Unauthorized Persons and Personnel

Selected rooms shall be secured against entry of unauthorized persons and


3.3 Construction Materials and Work Surfaces

Construction materials should be sturdy and resistant to cleaning. Wood should be

avoided for construction and support. Building materials in the Processing Areas
shall be free from cracks or open joints and shall be non-porous. Floors should be
non-slip and easy to clean. Work areas should have coated surfaces resistant to

3.4 Ciear Demarcation and Smooth Flow of Work and Activities

The physical arrangement should allow for the smooth and orderly flow of
activities and movement of people and supplies.

Work areas for blood collection, validation, packaging, release for transport
and special activities like apheresis should be separated and well-demarcated.

3.5 Adequacy of Space

The BCU shall provide adequate space for the different activities applicable
to the services provided.

3.5.1 Donor Reception and Refreshment Areas

This must be equipped with comfortable waiting facilities, clean and

convenient handwashing and toilet facilities with adequate water

Educational and promotional materials on blood donation and

other related health issues should be available. Audio-visual facilities
are encouraged.

3.5.2 Donor Assessment Area

Donor assessment area must provide auditory. and visual privacy to

assure confidentiality of donor-related information and to promote
accuracy of medical and social history.

3.5.3 Education and Counselling Area

The education and counselling area must be well lighted and well
ventilated. It must provide adequate privacy to allay apprehensions of
donors and allow more time for necessary discussion and explanation.

3.5.4 Hemoglobin Determination Area

The area for hemoglobin determination must be clean and organized

to avoid errors and mislabelling.

3.5.5 Blood Collection Area

This area should be suitable, adequate and approxirnatery equipped

and organized to ensure minimal risk of contamination and' errors.

3.5.6 Area for Compatibility Testing (For Hospital-Based)

This area should be suitable, adequate and approximately equipped

and organized to ensure minimal risk of contamination and error.

3.5.7 Area for Packaging, Validation, Labelling and Other Finishing and
Documentation Operations

There should be a space for counterchecking and validation,

packaging, computer work, and other finishing and documentation

3.6 Storage

Storage areas should provide adequate space, suitable lighting, easy access,
arranged and equipped to allow dry, clean and orderly placement of stored
material under controlled temperature conditions."

3.6.1 Blood Units

There should be clear demarcation of stored blood units under con-

trolled temperatures.

3.6.2 Reagents, Other Supplies and Materials

There should be temperature-controlled storage areas for reagents and

adequate dry areas for other materials and supplies.

3.6.3 Records, SOP Manuals and References

Records, manuals and references should be orderly arranged in a

readily accessible area.

3.7 Lighting and Ventilation

There shall be adequate lighting and ventilation in all work areas.

3.8 Safety and Cleanliness

3.8.1 Eating, Drinking and Smoking

Eating, drinking and smoking are not permitted in any area where
activities might adversely influence product quality or where staff may
be exposed to potentially harmful agents. There should be areas
designated for eating, drinking and rest of personnel.

3.8.2 Toilet and Washing Facilities and Lockers for Personnel

Adequate, clean and convenient handwashing, toilet facilities and

secure lockers shall be provided for personnel.

3.8.3 Doors and Fire Exits

Access to temperatura-controlled rooms and areas should be from

corridors and other collection and labelling areas. Where internal
doors are a barrier to avoid contamination, they should be kept closed
when not in use. There shall be accessible and clearly demarcated
Fire Exits.

Doors that lead from blood collection and packaging areas directly
to the outside, e.g. fire exits, should be secured in such a way that
they may be used only as emergency exits.

3.8.4 Housekeeping

Floors should be cleaned daily with appropriate cleaning agents. Walls

should be cleaned when grossly contaminated and regularly, at least
weekly. Work areas should be neat and tidy at all times.

3.8.5 Drains

Drains shall be of adequate size and, where it is connected directly

to a sewer, shall be equipped with traps to prevent back-siphonage.

3.8.6 Pest Control

Where pest control is needed, as in the case of storage of papers

and records, it should be carried out in such a way as to ensure that
the chemicals used do not contaminate BSF materials.


Equipment that is technically suitable, properly located, easy to clean, and well-
maintained is essential for accurate testing; prevention of contamination and
ensurance of quality blood products.

3.9 Appropriate and Adequate Equipment

3.9.1 Recommended Equipment, Furniture and Instruments

Each BCU shall have appropriate and adequate equipment, furni-

ture and instruments for the required blood banking. The quality and
quantity of equipment needed depends on the number of blood
units collected and processed, the methods used, and the existing
infrastructure. Recommended equipment, furniture and instruments
for each type of service are listed in Table 3.1.

3.9.2 Procurement Plan and Specifications 01 Basic Equipment

A comprehensive equipment procurement plan should be

prepared by each BCU with consideration for the local conditions
(e.g. weather, room temperatures) and physical plant (e.g. source of
electricity and water, space available, and others).

Specifications for equipment should be precise. Whenever possible,

arrangement for training of staff on new equipment and maintenance
agreements should be considered when procuring equipment.

3.10 Quality 01 Equipment and Instruments

Equipment should pass the standards set by the Bureau of Research and
Laboratories, Department of Health or the Bureau of Product Standards,
Department of Trade and Industry (DTI).

All surfaces that come in contact with plastic, such as blood bags, should be
smooth to avoid damage to the plastic. All equipment should prevent spills,
such as the use of sealed dome centrifuges.

3.11 Proper Use of Equipment

Equipment Instructions Manual must be available to all concerned staff at all

times. New equipment should be demonstrated to meet specified performance
requirements when installed and before being introduced.

3.12 Maintenance and Service

3.12.1 Regular Performance Tests

Performance tests should be carried out regularly to ensure that each

instrument is in working condition. The recommended schedule of




Automatic Emergency Light

Blood Collection Set
Blood Collection Couch/Bed All those stated for BCU-Non Hospital Based plus:
Spring scale for blood unit
Surgical instruments :Forceps Serologic Centrifuge
: Scissors Agglutination viewer for Compatibility Testing
Tube Sealer Waterbath at 37 0 C
Tray- carrier for blood units Tachometer for centrifuge calibration
Fire Extinguisher
Generator Power Unit
Refrigerator, Blood Bank
controlled at 1-6 0 C
with temperature recorder
with alarm system
Blood Hemoglobin Photometer
Sphygmomanometer N
Clinical Thermometer
Laboratory Thermometer
Weighing Scale
- for Adults
'Airconditioning Unit
'Computer with printer, UPS, AVR
, Balance
Rough Balance top loading
, Bar coding machine
, Laboratory Oven
, Spectrophotometer
, Mechanical device for agitation of blood units
during blood collection
, TV monitor with video casselle player

, Ootional
performance check for various types of equipment is in Table 3.2.
These tasks should be carried out before use if an instrument is

3.12.2 Documentation of Performance Tests Done

The service and maintenance of all equipment shall be documented

and in general follow the instructions .ot the manufacturer. Any
deviation from these instructions should be documented. Protocols
should be available for any validation carried out on equipment.

3.12.3 Cleaning of Equipment

Equipment should be kept clean and protected

, when not in use.
Any part of equipment that comes into contact with plastic bags
should be cleaned daily and after every blood spill with appropriate

3.13 Calibration

Each equipment that measures physical parameter should have a record

indicating that it has been calibrated and/or checked on a regular schedule
based on established procedures. Specifically trained personnel should be
assigned to calibrate equipment regularly.

The SOPs shall have procedures to describe the calibration of equipment. It

should include the method to be used, the frequency of calibration and
action taken when results deviate from defined acceptable limits. Each item
should bear a label or ta'g indicating the calibration date.

3.14 Storage Equipment

3.14.1 Clear Demarcation of Stored Blood and Materials

Ideally, Blood Bank refrigerators should be used mainly for storage of

blood unit". This is to maintain the required temperature storage for
quality blood. However for practical purposes and without detriment
to quality of blood, refrigerators where blood units are stored may
also be used for storage of donor samples or blood bank reagents
only, provided that demarcations are clear for the following:

Area 1: Whole blood ready for transport to parent BB/BC

Area 2: Blood units under quarantine awaiting repetition of tests

that initially gave questionable results

Area 3: Blood units under quarantine for disposal or submission

to the Bureau of Research and Laboratories or designated
regional unit

Area 4: Donors' blood samples for testing at SS/SC

Area 5: Reagents Department of Health

H46.45 M31c1997
1. Thermometer Mercury
a. Room thermometer Compare with other thermometer daily upon initial receipt or as needed
b. Laboratory thermometer Electronic
c. Clinical thermometer Compare with mercury thermometer
, .;

2. Adult Weighing Scale Zero check daily upon initial receipt or as needed
(for blood donors) Compare with known standard weight

3. Spring Scale Zero Check

( for blood units) Compare with known standard volume daily upon initial receipt or as needed

4. Sphyqrnomanometer Zero check daily upon initial receipt or when parts

a. Aneroid Compare with other sphygmomano- are replaced
b. Mercury meter
c. Digital

5. Stethoscope Compare with other stethoscope day of use upon initial receipt or as needed

6. Spectrophotometer Check wavelength day of use upon initial receipt of as needed

Check bulb
7. Autoclave Check atmospheric pressure, tempe- each use upon initial receipt or when parts
rature recorder and timer are replaced
Observe acceptable temperature
and range

8. Computer Check validation, programming each use upon initial receipt or as needed
a. Hardware and updates or when parts are replaced

b. Software

9. Centrifuge
a. Serologic Centrifuge Determine (RPM) using day of use upon initial receipt or as needed
Check timer-zero check
Check carbon brush
10. Blood Bank Refrigerator Monitor internal temperature daily upon initial receipt and when
Compare temperature recorder parts are replaced
against internal temperature
Check alarm systems
3.14.2 Temperature Monitoring and Alarm Systems

There shall be temperature monitoring of refrigerators every four (4)

hours. These temperature readings should be properly recorded.
Alarm systems with signals audible to an adequate number of
personnel should also be required. The alarm should be set at a
temperature that will allow proper action to be taken before the blood
reaches undesirable temperatures. Only authorized personnel should
reset the alarms.

3.15 Sterilization Equipment

Sterilization equipment for materials used in blood collection or for disposition of

contaminated blood shall be designed, maintained and utilized to ensure
eradication of contaminating microorganisms.

The following are the desirable temperature and duration of sterilization for each
general type of sterilization equipment:

Type of Temperature of Duration of

Equipment Sterilization Sterilization

Saturated Steam 121 °C 20 Mins.

(Autoclave) at 15 Ibs pressure

Dry Heat 170°C 2 Hours


Records should show that these requirements are met for every sterilization.

3.16 Breakdown of Equipment

Equipment found to be defective should be tagged and, if portable, be

removed from the processing areas. There shall be a written and readily
available contingency plan in case of instrument or equipment breakdown.

Each BCU should ensure the provision of adequate and suitable materials and
supplies for donor screening, blood collection, compatibility testing,storage and trans-
port of blood units.

3.17 Appropriate and Adequate Glassware, Reagents and Supplies

3.17.1 Recommended Supplies

The BCU shall have appropriate and adequate glassware,

reagents and supplies.Tables 3.3 to 3.4 contain the recommended
glassware, reagents and supplies- according to the service to be

3.17.2 Use of Disposables and Plastics

Items that are required to be sterile and have come in contact

with blood should be disposable. As much as possible, replace
glassware with plastic counterparts to minimize possible sources
of breakage which can affect the safety of donors and

3.17.3 Use of Capped or Sealable Containers

Whenever possible, capped or sealable containers for specimen

and reagents should be used to avoid spillage.

3.17.4 Blood Bags

Blood bags shall be sterile and shall contain the allowable anti-
coagulants. Solutions with citrate, phosphate, and dextrose with
or without adenine, or solutions with sodium, adenine, glucose
and mannitol are allowable. The general rule is to have 7 parts
blood to 1 part anticoagulant for every bag.

Blood bags should be stored according to the instructions

prescribed by the manufacturer.

3.18 Quality of Reagents and Materials

3.18.1 BFAD Registration and BRL Approval

Only reagents, blood bags and other materials registered with

the BFAD and approved by the BRL for bloodobankinq purposes
shall be procured by the BSF. ....;. ,.: '.'

3.18.2 Maintenance of Potency

The SOPs should contain quality control procedures and mea-

sures on the proper transport and storage of; .. and
supplies to ensure integrity and potency. The recommended
quality control of reagents are stated in Table 3.5.




1.1.1 Beakers 1.1 by CuS04 method
1.1.2 Reagent bottle for CuS04 1.1.1 CuS04 solution sp. gr. 1.053
soln. Pycnometer 1.1.2 Distilled water
1.2 by Cyanmethemoglobin Method 1.2 by Cyanmethemoglobin
1.2.1 Test tubes, plain 1.2.1 Drabkin's Reagent
1.2.2 Amber bottles for Drabkin's 1.2.2 Hemoglobin Standard
reagent 2. ABO Grouping
1.2.3 Volumetric pipettes 2.1 Forward Typing (Slide/Tube method)
1.2.4 Volumetric flasks 2.1.1 Anti-sera A
1.2.5 Cuvette 2.1 .2 Anti-sera B
1.3 oy Blood Hemoglobin Photometer 2.2 Reverse Typing (Tube method)
1.3.1 Hgb microcuvette 2.2.1 Known Al Cells
2.2.2 Known B Cells NaCI or NSS

2. ABO Grouping, Slide MethodfTube Method 3. Rh typing (Tube method)

2.1 Glass slides 3.1 Anti-D with appropriate Control
2.2 Test tubes


3.1 Testtubes
Crossmatching Reagents
1. 0.9 % NaCI or NSS
2. 22% Bovine Serum Albumin
1. Test tubes, plain, with rubber stopper
3. Anti-Human Globulin Reagent (polyspecifc)
2. Capillets for malarial parasite detection
wtth IgG-sensttized RBC as control
3. Glass slides for malarial smear


1. Test tubes
2. Pasteur pipette


ire materials lEe materials Donor Declaration Form Biosafery: for personnel protection Biosafety: for personnel protection Transport containers and supplies:
Posters Posters Donor Medical History and Physical Laboratory gown Laboratory gown Cold box with cold packs or ice
Leaflets Examination record in plastic folder Gloves, disposable, latex Gloves, disposable, latex bags
Brochures Mask, disposable Cryovials in cryoboxes or screw-
Brochures Biosafety: for personnel protection Eye protector
Video tapes Eyewash capped test tubes in test tube
>II "video tapes Laboratory gown Mask, disposable
Gloves, disposable. latex For skin preparation & disinfection Eyewash racks
Mask. disposable Cotton/gauze Laboratory plastic bag; suitable
Isopropyl alcohol, 70% For Test procedures rOT packing
Polyvidone iodine Pipette, disposable, Pasteur or plastic
For Hemoglobin determination Test Tube racks Stick on labels:
For phlebotomy "NOT FOR TRANSFUSION-
Cotton/gauze Test Tubes.plain
Blood bags with anticoagulant
Isopropyl alcohol, 70% Wash bottles For other Scientific Purposes"
Lancet Micropore tape/plaster , NSS
• Computer diskettes
Torniquet Metal dips
Evacuatcd tubes with EDTA Rubber sqeeze ball For proper waste disposal • Computer fonn feeds
Multi-sample needles with adaptor Biohazard plastic bags • Printer ribbon or toner
Test tube racks Labdling • Diskette filer
Sodium hypochlorite solution
Stick-on labels for: "Computer instruction sheet
Pipettes, disposable, Pasteur or plastic Disinfectant
ABO group/Rh Type
Scaling film Expiration date Transfusion forms
Unit identification Request forms for compatibility test
For ABOlRh Grouping Result forms for compatibility lest
Applicator stick Permanent or water proof ink pens Worksheets
NSS Tracer form or logbook
Emergency medical kit
Spirit of ammonia
For proper waste disposal
Biohazard plastic bags Sphygmomanometer
Biohazard needles or "Sharps" Surgical tape/bandage
container Penlight
Sodium hypochlorite solution Intravenous fluid (lVF)
Disinfectant Intravenous set
Post-donation care
Receptacle with cover
IEC materials
Worksheets Refreshments (juice, biscuits, ctc.)
.. For mobile collection unit
Transport containers.Cold box/bag
with cold packs/ice bags

Special stick-on labels:

"Not for Preparation of Platelet
" Not for AHF Preparation"
" Defective Material"

* Optional
.. For mobile collection sites
3.19 Proper Use of Glassware, Reagents and Supplies

3.19.1 Inspection Before Use

Glasswares should be inspected for breakages or scratches prior

to their use or reuse. These should also be inspected for remnants
of cleaning solution or detergent particularly which could alter
serologic tests. The SOPs should contain glassware washing

3,19.2 First In, First Out

Supplies and reagents should be stored in such a manner that the

oldest is used first.

3.19.3 Manufacturer's Instructions

Supplies and reagents shall be used and stored according to the

instructions of the manufacturer.

3.20 Defective Blood Bags and Poor Quality Reagents

Defects in the blood bags and the quality of reagents should be properly documented
and reported to the BRL section of Licensing and Regulation or Quality
Assurance. BRL shall report appropriately to the BFAD of the DOH or the Bureau
of Product Standards of the DTI.

3.21 Supplies Other Than Blood Bags or Reagents

Other supplies such as coolants arnor.q others, should be of good quality and should
also be registered and approved by the appropriate government agencies.
These should also be inspected, stored and used properly according to the
manufacturers' instructions.

3.22 Tax-Free Importation

Only BCUs actively participating in the NVBSP may be recommended for tax-
free importation.




1. Hemoglobin Determination

a. CuS04 method solution Known borderline hemoglobin day of use

b. Cyanmethemoglobin Drabkin's reagent or Hemoglobin standard
Method Cyanmethemoglobin kit

2. Blood Typing

2.1. ABO grouping (Forward Anti-A Known Al cells each batchj run of test
and Reverse) Anti-B Known Bcells
a. Slide method Anti-A1 Lectin
b. Tube method 0.9% NaG or NSS
2.2. Rh typing (Tube Method) Anti-D Known D positive cells each batchj run of test
Known D negative cells
.j Control system appro
priate to the anti-D
sera in use

3. Crossmatching Saline Phase (Coombs Control Cells) each batchj run of test
0.9% NaG or NSS IgG-coated Red Blood Cells
'" .-
Protein Phase
22% Bovine Serum
Albumin Solution
Antiglobulin Phase
Anti-Human Globulin
Section 4
Section 4


Donated blood provides the material from which all blood products are derived.
Safe and correct blood collection shall be the responsibility of the BCU that collects
blood. It is therefore, imperative to obtain blood only from healthy voluntary blood



Healthy individuals should be encouraged to voluntarily donate blood at
least twice a year. Blood donor recruitment should be centered on
humanitarian values rather than political or material considerations. Every
voluntary blood donor should be given the highest regard and respect for
performing such a noble act.
Principles and strategies for advocacy and effective donor recruitment and
retention targetting specific donor age population shall be in accordance
with the NVBSP Strategic Plan issued by the DOH National Voluntary Blood
Services Unit and in accordance with internationally accepted guidelines.


As a means to sustain and honor voluntary blood donors, the following are
the acceptable donor incentives in accordance to the Policies stated in the
NVBSP Strategic Plan: certificates and plaques of appreciation, medals and
pins, commemorative items, donor awarding and recognition ceremonies.
Low cost giveaway items for the general public may be allowed during
awareness raising campaigns.

The following are not acceptable donor incentives since these are either
unsafe or not sustainable: free or discounted screening tests; dlscounted or
free other serologic or clinical laboratory tests; consumer's goods or its equiva-
lent which are locally regarded to have intrinsic value.

Blood testing and screening, especially for HIV/AIDS and other bloodborne
diseases, shall not be used as incentive for blood donation because this will
attract individuals who suspect themselves to have the disease, which in
turn increases the likelihood of collecting infected blood from donors within
the window period. Persons who come to the blood collecting unit because
they want to get free testing for HIV/AIDS or other diseases shall not be
accepted as donors, but shall be appropriately counselled and referred to
HIV/STD testing or surveillance centers or other laboratories accredited for
HIV testing. Similarly, donors who want free serologic or other clinical labora-
tory tests shall be referred to appropriate testing facilities.


Blood Collection Units should be located within practical geographical distances from
each other to effectively serve the Blood Services Network and to avoid competition
for the same donor population. Clear. policies to prevent such competition should be
stated in the memoranda of agreement among the different BSFs within the Blood
Services Network. Schedules of community-based donations and mass blcodlettlnq
should be coordinated with other BCUs within the Network. Copies of such schedules
should be regularly submitted to the authorized leader or coordinator of the Blood
Services Network.


4.4 Target Groups for Blood Donation

Healthy men and women with the following characteristics should be considered
"potential blood donor". They should be encouraged to regularly donate blood in
authorized blood collection facilities.

Table 4.1 Target Groups for Blood Donation

Age Between 16 - 65 years old

(parental consent for ages under 18)

Weight For 500 ml blood unit, at least 50 kg

For 250 ml blood unit, at least 45 kg

. Pulse Rate Regular rhythm, 50 - 100 beats/min.

Blood Pressure 90 -160 mmHg systolic and

60 -100 mmHg diastolic

Hemoglobin at least 125 gIL (12.5 g/dL)

4.5 Donor Temporary Deferment

4.5.1 For the protection of the donor and recipient, donors with the following condi
tions should be deferred accordingly. Table 4.2 provide examples or conditions
with their stated duration and deferment. Details and updates on conditions for
donor deferment shall be issued through Bureau Circulars and Memoranda.

4.5.2 The period of deferment shall also vary according to the type of vaccine
and date when this was received. are listed In ,Table 4.3.
. ..

Table 4.2 *Donor Temporary Deferment


Pregnant women Defer until 9 months after childbirth or 3

months after weaning, whichever is longer

Acute febrile illness Defer until fully recovered, or about 2-3

.)1 weeks after febrile episode

Previous donation Defer until Interval from previous donailon

of 200 ml and 450 ml Is from 6-8 weeks
and 12 weeks or longer respectively.

Major operation (including dental Defer until 12 months after operation or

surgery) or Blood Transfusion transfusion
(InclUding transfusion of

Defer donation until after skin lesions have

Skin lesions at venipuncture site
completely healed
Past exposure to unhygienic skin Defer donation for 1 year after the
piercing, tattooing, ear holing, Incident
needle puncture, etc.
Past exposure to a close household Defer donation for 1 year after exposure
contact with hepatitis
All, persons who have been diagnosed Defer donation for 3 years after the
or treated for Malaria cessation of signs and symptoms
or treatment for Malaria
Recent alcohol intake (positive for Defer donation for 12 hours after the
alcoholic breath) last alcohol intake
* Australian Red Cross-Guidelines for the Selection of Blood Donors, April, 1994

Table 4.3 Deferment Period of Blood Donation FollOWing Vaccination

Vaccine Received Duration of Deferment after.


Live, attenuated vaccines:

Category 1: measles (rubeola), Defer donation for 2 weeks after
oral polio, mumps & yellow vaccination
fever vaccines; BCG
Category 2: german measles Defer donation for 1 month after vaccination
(rubella) vaccine
Category 3: rabies vaccine Defer donation for 1 year after vaccination

Killed vaccines & toxoids:

(OPT & DT; polio vaccine, injectable; May donate anytime if without vaccine-
hepatitis B; cholera; typhoid; para- associated symptoms like fever
typhoid; typhus & influenza vaccines)

4.6 Donors Needing Additional Medical Assessment at the Time of Donation

The following donors may donate blood depending on the evaluation of the
authorized BSF personnel at the time of donation. Details and updates on
conditions for donof·'deferment shall be issued through Bureau Circulars-and
memoranda. _

4.6.1 Special Donors

Donors older then 65 years or younger than 16 years and

athletes with pulse rates slower than 50 beats per minute may
donate depending on the assessment of the BCU physician.

4.6.2 Donors on Medications

Acceptance or deferral of blood donation depends on the

underlying disease. The severity of the medical condition for
which the drugs are being taken must also be considered in the
overall assessment of the donors. Most medications taken by
donors are not harmful to recipients and many donors taking
medications are acceptable blood donors.

Tables 4.4A and 4.4B recommend timing of donation for

donors under certain medications.

Table 4.4 A Timing of Blood Donation When Medications Are Being Taken by

Medications Timing of Donation

Anorectics Anytime
Anticonvulsant If fits controlled for 2 years
Antifungal (Topical) Anytime. In case where fungal infections
involved the phlebotomy site, the donor
should be deferred temporarily.
Antihypertensive If blood pressure is controlled and without
serious side effects. May require assess-
ment bv BCU ohvsician.
Antihistamine Anvtime
Anti-inflammatory Anytime - blood collected 'is not lor platelet
(Non-steroidal) concentrate oreoaration
Aspirin .. Anytime - blood collected is not for platelet
concentrate preparation
Contraceotive Pills Anvtlrne
Colchicine If over the acute eoisode of oout
Corticosteroid (Topical) Anytime'
Insulin Depends upon the discretion of BCU physician
Paracetamol Anvtime
Vitamins Anytime
Other drugs for symptomatic Anytime .

Table 4 4B Deferment of Donation While on Medication

Medication Being Taken Duration of Deferment

Antibiotic for Infection Until 5 days after the last dose and reason
for takina antibiotics must be assessed
Antifunaal (Oral) Until 5 davs after comoletion of treatment
Anti-TB drugs Until tuberculosis is completely cured
AllergiC drugs like penicillin, aspirin, Until medications are stopped lor at least
others one dav
Corticosteriod (Oral) While on treatment
Retinoids (Anti-acne preparation) Until 2 months after treatment
Other drugs for symptomatic Anytime

• Australian Red Cross-Guidelines for the Selection of Blood Donors, April. 1994

4.6.3 Donors with hypertension (BP over 160/100) or hypotension (BP less than 90/
60), epilepsy, or medical conditions other that those stated In Item 4.6.

Acceptance or deferral depends on the medical assessment at the time of

donation and the availability of medical assistance and monitoring during
donation. Donors with hypertension, hypotension or epilepsy may be
allowed to donate provided the medical cbndition is under control and the
donor is asymptomatic. There must be a competent physician to monitor
the donor while donating.

4.6.4 Donors in Hazardous Occupations

Donors in occupations such as pilots, flight stewardesses, drivers, and occu-

pations needing strenuous physical exertion, may donate provided they
refrain from work for at least 24 hours after donation.

4.7 Persons Who Cannot be Allowed to Donate Blood

For the protection of the donor and the recipient, persons with the following condition
shall not be allowed to donate blood at any time. Details and updates on conditions
for donor deferment shall be issued through Bureau Circulars and memoranda.

4.7.1 Cancers

4.7.2 Cardiac diseases like arrythmias, congestive heart failure, etc.

4.7.3 Severe lung diseases like complicated asthma with bronchiectasis or

atelectasis, etc.

4.7.4 Viral hepatitis or jaundice of unknown origin and other severe liver
diseases like cirrhosis

4.7.5 Use of prohibited drugs (past or present)

4.7.6 High risk sexual behavior or continuing exposure to persons with
hepatitis, HIV/AIDS and other sexually transmitted diseases (STD)
including inmates of mental institution and prisons.
4.7.7 High risk occupations (e.g. prostitution)
4.7.8 Sexually transmitted disease(STD) (past or present)
4.7:9 Prolonged bleeding
4.7.10 Unexplained weight loss of more than 5 kg over six months
4.7.11 Chronic alcoholism
4.7.12 Autoimmune diseases like SLE, etc.


4.8 Pre-Donation Interview, Education and Counselling

The donor must be assured that information concerning his medical and social history
shall be treated as highly confidential and shall not be discussed even with his relatives
or friends.

In addition, the following minimum information shall be given to the donor:

• The importance of truthfulness in his medical and social history

• The risks of the blood donation
• The tests that are going to be done and why
• The steps to be followed when test results are known
• The uses of their blood donation
• Health care during and after donation, including care of the venipuncture site
• Post-donation follow-up

The BCU shall provide the necessary leaflets, information sheets, brochures, and other
visual aids to assure that the basic messages for donors are consistently and effectively

4.9 The Donor Screening

On the day of donation and on every subsequent donation, the donor's medical and
. social history and his physical condition shall be assessed by an adequately trained
physician and/or qualified BSF staff under the supervision of a qualified physician to
determine his suitability as a donor. Donor assessment shall include criteria for the
protection of the donor and the recipient.

4.9.1 Donor Interview and Physical Examination

Donor interview and physical examination must be done in an area which

ensures visual and auditory privacy.

The medical and social history and the health status of the donor shall be
evaluated on the day of donation. The SOPs on the selection of donors should
be followed.
Any condition declared during interview which is not covered by the
standard interviewing procedures should be discussed with the Physician or
the person in charge of the donor session.

4.9.2 Hemoglobin Determination, ABO Grouping and Rh Typing

The hemoglobin level of the donor shall be determined before every dona-
tion using the standardtechniques defined in Section 5. Donors with hemo-
globin lower than 125 gil should be referred to his/her physician.

ABO grouping can be done using the slide or tube method. Routine Rh
typing by tube method mayor may not be taken during this time, unless Rh
negative donors are needed.

4.10 Donor and Medical Declaration Forms

The BSF shall provide self-administered donor forms in the local dialect, with or without
English translations, which are legibly printed on sturdy paper. After the donor has filled
in the .torrns, interviewers and counsellors shall countercheck the understanding and
responses to selected crucial questions. The minimum contents of the, donor form shall

• Name, complete address of donor, home and office telephone numbers

• Age, sex, weight, occupation and marital status
• Donor classification (new/repeat donor) and blood donation number
• Date of last donation
• Hemoglobin level, ABO group and Rh type, if applicable
• Basic medical and social history with emphasis on the history of exposure to
blood-borne diseases and high risk social behavior

In addition, each donor must sign a donor medical declaration form which is
witnessed and signed by the interviewer.

Sample forms for guidance are in Annexes 1 and 2 respectively.

4.11 Issuance of Blood Donation Number

To avoid duplication or confusion, blood donation numbers shall be issued carefully

according to the following procedures:

• At initial donor registration, a blood donation number shall be issued in

advance of the donation. This must be linked to the donor's name on the
registry and on the donor forms issued to each donor.

• When, in special circumstances, it is necessary to issue a second donation

number to the same donor at the same session, the first number must be
destroyed and the records updated accordingly. The second donation
number must be issued before blood collection. never after blood flow has

• At each critical stage of the collection procedure, the donor's name and
donation number must be checked to ensure that they correspond to all
respective donor records and blood units.

4.12 Donor Reactions and Donor Care

4.12.1 Donor Reactions

SOPs shall include specific instructions on the proper procedures for pre-
vention and management of common donor reactions during or after do-
nation. Table 4.5 lists the essential information concerning this.

Medical staff with adequate essential supplies (emergency medical kit,

Table 3.4) shall always be available in the blood collection area.

There shall also be provisions for further medical care of donors who
suffer adverse reactions.

4.12.2 Post-Donation Donor Care

After donation, determine if donor can ambulate without assistance.

Donors should be offered a drink (at least one glass of liquid) and simulta-
neously is observed for 10-15 minutes to ascertain that bleeding at the punc-
ture site has completely stopped. Donors are likewise instructed to drink
liberally and to avoid strenuous exercise for several hours.

Premenopausal women who donate 2-3 times a year should be encou-

raged to take iron supplements.

4.13 Reporting Procedures and Post-Donation Counselling

4.13.1 Reporting Procedure from Parent BB/BC to BCU

A procedure for confidential reporting of blood donations found positive

for disease screening tests must be established by the BCU and the parent
testing BB/BC management. This should be detailed in the SOPs of both
BCU and BB/BC and can be supported by a memorandum of agree-
ment or exchange of letters in order to assure the smooth and confidential
reporting of results.

4.13.2 Counselling Donors With Positive Test Results

Establishment of capabilities for counselling in the BCU is required. Upon

receipt of the confidential report on positive results from the BB/BC,
the BCU physician or counsellor shall notify the donor(s) and provide coun-
selling to explain why the donor has to either postpone donation or refrain
from donating blood altogether. If necessary, the donor(s) must be referred
to the appropriate health facility for additional testing and clinical care
with continuous counselling. Using the appropriate reporting forms, posi-
tive confirmed test results for HIV antibody shall be reported confidentially
by the BCU to the national and local AIDS surveillance unit of the Depart-
ment of Health for statistical purposes.

4.13.3 Counselling Donors With Negative Result

Counselling donors with negative results should be done for it is the best
opportunity to thank and motivate them for their regular donation. The
other purpose is to reinforce their knowledge and to motivate them to
keep fit and healthy and to avoid getting them infected with blood-borne
diseases. These measures among other ways of expression of apprecia-
tion and concern, strengthen the rapport between the donor and the
blood bank facility.

Donor education. can be done through the use of written educational

materials or if possible, by face to face counselling.

4.14 Repeat Donation

When a donor comes for a repeat blood donation, the BCU staff shall check his/her
previous laboratory examinations and tests . A donor with previous negative test results
shall follow the SOP for donor screening and his/her blood samples tested for diseases.

Measures to sustain regular blood donation should include timely invitation for repeat
donations and social affairs such as health education activities and seminars, among

If a donor found positive or reactive to a previous screening test returns for repeat
donation, the BCU physician or counsellor shall provide counselling and Institute
referral and reporting measures as outlined in Item 4.13.2. (Counselling donore with
positive test results).

1:a hI e 45 P revention an dM anazement 0 fC ommon Donor R eactions

Lightheadedness Anxiety Reassuring conversation

Weakness Hypoglycemia Try any of the following:
Tingling sensation - Elevate donor's feet to a 45' angle
Palpitations (few minutes) then lower to 20 0
angle to increase venous return
- Apply cold, wet towels to neck and
- Have donor breathe into paper bag
- Provide juice even before donation
Last resort: Discontinue donation

Fainting Anxiety Discontinue donation

Hypoglycemia If necessary, administer glucose solution
Provide juice even donation.
Position donor in a place protected from a
possible fall

Convulsion Anxiety or underlying Discontinue donation

Disease Elevate feet
Restrain gently to prevent injury
Maintain airway
Reassure after recovering consciousness
Inform about possible involuntary loss of
control of urine or stool during the convul-

Cardiopulmonary Underlying Heart Ventilation

emergency Disease Cardiopulmonary resuscitation (if neces-
Transfer. donor to emergency medical
Hematoma Very fragile veins Discontinue if large
Unskilled phlebotomist Apply pressure to site for at least 5 minutes
or uncooperative donor Apply cold packs
Reassure donor

Jet-like pulsating bleeding Inadvertent puncture of Discontinue immediately

with bright red blood artery when deep vein Apply finn pressure over puncture site for at
punctures are least 10 minutes
attempted Apply dressing on site
Follow-up donor for additional care if

Shooting pain. followed by Inadvertent puncture of Reassurance

numbness and tingling in median nerve or Apply support to arm
the forearm cutaneous branches
I (Rare accident)
Section 5

Section 5



The maintenance of quality blood for transfusion should start with the collection of
blood from properly selected and screened healthy voluntary blood donors, use of
dependable and verified starting material for the preparation of blood products,
reliable and quality result of compatibility testing, to the correct and safe procedures
for storage, handling and transport of blood and blood products.

The BCU is ultimately responsible for the correct and safe procedures for collec-
tion. handling, storage, and transport of all collected blood. Blood shall be collected,
stored, and transported to the testing or central blood bank/center using Good
Manufacturing Practices (GMP) guided by comprehensive Standard Operating
Procedures (SOPs) and work instructions.


5.1 Prevention of Contamination

All surfaces coming in contact with blood intended for transfusion shall be sterile,
pyrogen-free, and shall not interact with the blood in such a manner as to have an
adverse effect upon the safety, purity, potency and effectiveness of the blood for

5.2 Training of Phlebotomists

Medical and paramedical personnel and volunteers shall be trained as phleboto-

mists under the supervision of a competent licensed physician or registered medical
technologist or registered nurse.

5.3 Inspection of Blood Packs Prior to Venipuncture

Each blood collecting container and its satellite containers, if any, shall be examined
visually for damage or evidence of contamination prior to its use and lrnrnadtataly
after filling. Such examination shall include inspection for breakage of seals and
abnormal discoloration. Where any defect is observed, the container shall not be
used, or if detected after filling, shall be properly handled as biohazardous and
disposed of.

Defective supplies shall be immediately labelled "DEFECTIVE MATERIAL" and sepa-

rated from the rest of the supplies for proper disposal. These shall be reported to BRL.

5.4 Venipuncture

The venipuncture procedure must be done using aseptic technique under closed system.
The procedure, especially skin disinfection and preparation, should be described in
detail in the SOP. If more than one (1) venipuncture is needed, a new donor set and
container must be used.

5.5 Individual Blood Handling Materials and Supplies

Each blood collection couch should have individual blood handling materials and
supplies during donation and labelling.

5.6 Mixing of Anticoagulant,,:.

The blood bag should be mixed gently during blood collection by manual inversion, or,
if' available, by a mechanical device.

5.7 Proper Recording and Labelling

The organization of the blood collection area should ensure that no error is made with
donor records or labels. The SOP should state specific recording and labelling

After commencement of blood collection, the blood donation number shall also be
placed on the primary and all satellite bags or transfer packs and on all laboratory
sample containers or cryovials. Use of sturdy cleanable plastic folders have been found
useful to organize donor records and labels.

5.8 Prolonged Duration of Blood Collection

The duration of whole blood collection shall be noted. A whole blood collection taking
longer than 15 minutes from the commencement of blood flow should not be used as
source of cryoprecipitate or AHF-ricll plasma and this should be indicated in its
respective donation record "NOT FOR AHF PREPARATION".

5.9 Blood SamplesforTesting

After each blood collection, blood samples for compatibility testing, screening and
serologic testing for blood transmissible diseases must be collected from the donor
tubing. Complete asepsis must be observed all the time.

5.10 Volume of Whole Blood Collection

Whole blood collection may either be a 450 ml or a 200 ml blood volume, depending
on the availability of blood bags and the donor's preference.

The blood volume can be estimated by weighing the blood unit. A 450 ml
collection should weigh at least 570 grams; and a 200 ml collection should weigh
at least 370 grams. A variation of ± 10 % from these prescribed volumes is

Table 5.1 shows the specifications of whole blood and its storage requirement.

5.11 Labelling

5.11.1 BSF and Blood Donation Number

The BRL shall assign a registration number for each Blood Service Facility.
Each blood donor shall also be assigned a Blood Donation Number which
shall be permanently marked or firmly attached during blood, collection to:
• All blood bags (i.e. including satellite bags)
• The donor form
• All blood sample containers or cryovials

5.11.2 Content of Labels

The following information shall be legibly printed in black ink and firmly
attached to each blood bag:
• Name and Authorization Number of BCU as the collecting unit
• Blood donation number
• ABO group and Rh type (when applicable)
• Date of collection
• Expiry date
• Date and Time released from the BCU
• Name and Signature of BCU Head

5.11.3 Special or Additional Label

Special or additional label shall be added to blood units, when appropriate.
Blood units with torn or not legibly printed labels or those with missing labels

5.12 Counterchecking Labels Before Termination of Collection and Discarding Unused


The donation number on the pack, sample tubes and donor records must be checked
at the end of each collection before donor leaves th" bleeding couch to ensure that
all numbers arc identical.

If available, barcoding of blood donations can be done. Any barcoded donation

labels and numbers which have been allocated but not used must be disposed of
appropriately, as stated in the SOPs. A barcode reconciliation should be recorded for
the labels used and destroyed.

5.13 Terminating Blood Collection

At the end of blood collection, the tourniquet is released first and the needle is pulled
gently. The phlebotomy site should be covered with sterile gauze or cotton, and
pressure is applied to the site and the arm is elevated for few minutes.

The cut end of the collection tubing should be permanently sealed as soon as
possible. The blood unit and pilot tubing should be reinspected for defects prior to
release from the blood collection area.

5.14 Submission and Processing of Blood Units ,to BB/BC
Whole bloed collected in BCUs shall stored immediately after collection and vali-
dation in a blood bank refrigerator or cold box at 1-6 0C. As much as possible, blood
should be submitted to the Blood Bank/Center within 24 hours after collection.

Whole blood submitted by BCU to Blood Bank/Center within 6 hours after blood collec-
tion can be used for platelet preparation provided special handling procedures have
been pre-arranged.

( For BCU Hospital- Based Only)

5.15 Compatibility of Donor Blood with-Recipient Blood

5.15.1 Donor and Recipient's Blood Sample Collection

Five to ten milliliters of the intended recipient's biood shall be collected in a

dry and sterile tube which is clearly and accurately labelled in ink at the
bedside with the following information :
• Recipient's full name, age and sex
• Hospital's name, bed number and ward
• Date of collection
• Signature of phlebotomist

A request for compatibility testing shall bear identical information as the

specimen. Information in the request form and the specimen tube shall be
checked and in case of discrepancy, a repeat sample shall be collected.
Unlabelled specimens shall not be accepted for compatibility testing.

Blood samples from patients with infectious diseases shall be labelled

"INFECTIOUS". As a general rule, blood for cross match should be taken no
more than 2 days before the expected transfusion. Once tested, blood
samples of both donor and recipient should be retained for at least 7 days
following transfusion in case there is a need to investigate blood transfusion

If the interval between transfusions for anyone patient is longer than 24 hours,
a fresh specimen must be obtained for crossmatching.

5.15.2 Compatibility Testing of Donor Blood with Recipient's Blood

To decrease complications due to blood transfusion, donor's blood must be

carefully matched with the recipient's blood for the following .- ABO Grouping

The BCU doing the crossmatch must confirm the ABO group of all
units of whole blood and blood products using a sample obtained
from an attached segment of the blood unit. Confirmatory testing
should be done after the original ABO label has been affixed
to the units to permit detection of labelling errors. Discrepancies
shall be reported to the collecting facility and shall be resolved
before issue of the blood for transfusion purposes.

Each blood sample submitted with a request for compatibility

testing (Annex 3) must be tested for ABO group. Blood should not
be released until any discrepancy is resolved. Rh Typing

Rh typing by tube method is mandatory for all recipients of blood


All Rh negative donor unit shall be tested for DU or D variants. A

positive DU shall be read as Rh positive. Crossmatching

The crossmatching procedure shall use methods that

demonstrate ABO incompatibility and clinically significant
unexpected antibodies, and shall include an antiglobulin

A major crossmatch using the donor red cells from the

originally attached whole blood segment and the recipient's
serum or plasma shall be done before transfusion except
for urgent requirements. A full crossmatching procedure may
take up to 2 hours to pertorm but this can be shortened to 30
minutes or less in an emergency.

Results of the compatibility testing shall be legibly printed on

an official result form and duly signed by the BCU staff and
Head. Record ot such will be retained for at least 5 years.


5.16 Storage Requirements of Whole Blood

Table 5.1 summarizes the handling 'and storage requirements of whole blood. Meticu-
lous care must be taken to ensure that these are met to avoid blood product deterio-
ration and bacterial growth.

Written directions on how to properly store each blood must be readily available and
clearly printed on wall posters located in strategic areas where blood is stored. These
directions shall include steps to follow in case of power failure or other emergency
conditions disrupting refrigeration.



WB (+/-10%) BAG

Whole Blood (WB) Unprocessed blood Single or multiple 450 ml (in 63 ml Erythrocyte volume 1-6"C
containing all cellular bag anticoagulant solution) fraction CPD - 21 days
and plasma or 200 ml (in 31.5 ml (EVF) =0.35 to 0:45 CPDA, - 35 days
components of donor anticoagulant solution) CPDA, - 42 days
blood SAG-M- 42 days

7 parts blood to If platelets are to be

1 part anticoagulant harvested, blood units
are stored at 20-24°C
and processed within
6 hours after blood

Red Blood Cells (RBC) Cellular products Double blood bag 350 ml Hematocrit = 55-70% 1-6°C
remaining after
removal of plasma by Same as WB from
sedimentation or which it has been
centrifugation of prepared under
whole blood; contains closed system.
RBC, platelets and
leucocytes which are If under open system
potential immunizing storage is up to 24
agents hours only.

5.17 Reinspection and Packing

5.17.1 Reinspection During Packing and Prior to Transport to BB/BC

All blood units shall be inspected before packing. Those found to have signs of
contamination like significant hemolysis, change in color, presence of blood clots, or
leakage shall not be. packed or released.

5.17.2 Packing in Transport Containers Blood Units

Blood units necessitating cold temperature during transport should

be packed in leak-proof, puncture-resistant and properly-labelled
cold boxes or transport containers made of sturdy insulated
material. Ice should be placed above the blood because cool
air moves downward. In a very hot weather and during trips of
several hours, placing wet ice under as well as above the blood
is necessary. In boxes shipped long distances or at high environ-
mental temperatures, the volume of ice should at least equal that
of the blood. In an insulated container, the temperature will
usually be in the 1-6 °C range as long as an unmelted ice remains
in the box and is in contact with the blood. Blood Samples for Testing

Blood samples corresponding to the blood units collected must

be identically-labelled and contained in tightly-sealed container
such as cryovials or screw-capped test tubes. These tubes or
cryovials must be placed in test tube racks or cryovial boxes to
maintain them in an upright position to prevent leakage. Double-
bagging of laboratory specimen in resealable plastic bags is

5.1B Release/Transport Process

There must be a system to demonstrate release/transport approval with specific

personnel in charge. The SOPs must list in detail what have to be verified by the personnel
approving the release/transport of the product. There should be a system for a
second verification before release/transport.

5.19 Records of Collection, Packing and Transport

The BCU shall retain records which allow the tracing of issued blood from a donor to
BB/BC destination of any issued product.

BCU records on blood donation and distribution must be retained for at least 5 years.

· 5.20 Transport of Blood Units

Cold storage shall be appropriately followed during transport of the blood. the
temperature of whole blood must be kept at 1-6°C during transport. Sturdy, well-
insulated cardboard and/or styrofoam shipping containers maintain this temperature
if they contain adequate cooling material.(Table 5.1).Cold temperature within the
transport containers must be maintained following the proper packing system stated
in item

5.21 Defective Blood Units

All blood units which have been found unsuitable for transfusion such as hemolyzed,
contaminated or punctured units shall be labelled "NOT FOR TRANSFUSiON, FOR
PROPER WASTE DISPOSAL". These shall be disposed of as waste products, see Section
6, Waste Management.

5.22 Complaints and Recall

Each BSF shall have detailed SOPs regarding recall and handling of complaints. Any
blood unit implicated in disease transmission shall be immediately recalled. Mislabelled
blood packs or any blood packs with discrepancies in labelling shall be returned
immediately to the BCU for reconciliation of information and labels. The reasons for
return or recall shall be clearly and properly documented and reported to the
Hospital Blood Transfusion Committee and the issuing BCU.

5.23 Controlling Supply

Blood collection activities by BCUs and BBs/BCs should be adjusted to prevent over-
supply or shortage. A system for controlling and monitoring blood supply stocks shall
be instituted by each BSF particularly the BB/BC. One BCU staff shall be assigned to
record and monitor.

, ,

Section 6
Section 6


Each BCU shall be responsible to the community for the safe and proper disposal of
hazardous waste.

6.1 Responsibilities for Safe Waste Handling

6.1.1 Managerial Responsibilities

BCU Head or supervisors shall design a system for the handling of waste that
provides for proper collection, segregation, storage, transport, disposal,
monitoring, quality control and record keeping. Managers should design a
system that utilizes less hazardous materials wherever and whenever possible.

6.1.2 Employee's Responsibilities

BCU personnel shall comply with established policies and procedures. Bench
technologists shall be assigned the important task of segregating, packing,
and labelling all waste requiring special handling. Employees should bring to
the management's attention the presence of any unsafe working condition
and identify opportunities for hazardous waste reduction.

6.2 Education and Training

Education and training of waste management of all personnel and supervisors shall be
required. Records of such training shall be documented and filed in the individual
personnel chart.

6.3 Contingency Plan for Employee's Injuries and Disruption of Disposal

There shall be written procedures for the management of employee's injuries, spills and
disruption of treatment and disposal due to equipment failure or other problems.

6.4 Classification of Generated Waste from the Blood Collection Unit

6.4.1 Hazardous Waste

Hazardous waste refer to solid or a combination of solid waste which

because of their quantity, concentration, physical, chemical or infectious
characteristics may pose a substantial or potential threat to human health or
to the environment when improperly treated, stored, transported or
disposed of. Infectious Waste

Infectious waste include disposable equipment, utensils and

articles or substances that have been used or have come in con-
tact with blood and/or other body fluids which may harbor or trans-
mit pathogenic organisms.

54 Sharps

Sharps include needles, syringes, scalpels, lancets, blades, broken

glass, any item made of hard plastic or other material that can
cause a cut or puncture. Pathological Waste

Pathological waste consist of blood samples, blood clots, and

serum specimen. This should include any blood unit not fit for
transfusion. Chemical Waste

Any substances or solutions that are flammable, reactive, corro-

sive, toxic, irritating or strongly sensitizing.

6.4.2 Non-hazardous Waste

Any substance which is not known to pose substantial potential hazards to

human health or to environment. Examples are paper and other office
supplies, foods and other kitchen waste .

6.5 Guidelines on Waste Disposal

6.5.1 Use of Personnel Protective Equipment

Water-resistant utility gloves rather than latex or vinyl gloves shall be used for
handling hazardous waste.

6.5.2 Segregation . ., . -'

Segregation at the point of waste generation for classification and bagging

in appropriate waste disposal bags or containers shall be done by the BCU
personnel or authorized house-keeping staff trained in waste management.

6.5.3 Treatment

All infectious waste shall be decontaminated prior to packing by any of the

following methods: Chemical disinfection by soaking for a minimum of eight

(8) hours using any of the following disinfectants:

• Sodium hypochlorite solution with 0.1 -0.5% available chlorine

• Ethyl alcohol/Ethanol 70%
• Isopropyl alcohol/Isopropanol 70%
• Polyvidone iodine 2.5%
• Formaidehyde 4%
• Glutaraldehyde 2%
• Hydrogen peroxide 6%

To maintain effectiveness, the disinfectants must be properly stored
and freshly prepared using proper dilution.
All pathological wastes shall be decontaminated by autoclaving
before disposal. Steam sterilization by autoclaving at 121 0 C for a minimum of 20
minutes. Sterilization by dry heat for two (2) hours at 170°C (340°F). This
method is not suitable for reusable plastic items.

6.5.4 Packaging
Waste containers must be designed to maintain its integrity throughout
handling, storage, transportation and treatment. Color-coding of Disposal Bags/Containers

Separation of hazardous waste by color-coding of disposal bag

/containers will prevent accidents or unnecessary exposure to
infectious waste . This will also facilitate waste disposal. As
prescribed by the DOH Environmental Health Services for
Hospital/Health Facility Waste Management, the color-coding
shall be as follows:

• Red - sharps/needles
• Yellow - infectious waste
• Yellow
(w/ black band) - chemical waste
• Green - non-infectious wet waste
• Black - non-infectious dry waste

All sharps shall be segregated from other waste and must be

contained in a rigid, leak-proof, puncture-resistant and properly
labelled containers. The label should be intact from the site of
origin to final disposal.

6.5.5 Labelling of Waste Disposal Bags

All waste disposal bags/containers shall be labelled with the following:

• Name of BCU
• "BIOHAZARD" sign for all hazardous waste
• Location of waste disposal if outside of the BCU premises
• Name of transporter of wasle, if applicable

6.5.6 Temporary Storage Areas

All BCU wasle should be disposed of within 48 hours. The temporary storage
areas should have appropriate ventilation, fire protection, security and
containment system.
If a temporary storage area is not available, daily disposal should be
Storage areas should be located at a designated place not accessible to
the public, preferably outside the BCU building but within the BCU premises.
The storage area should be regularly treated with disinfectant and kept free
from rodents and insects.

6.5.7 Waste Collection and Transportation

Properly completed manifests and disposal records must be kept on file to
document the transport, route and ultimate destination and disposal of waste.

6.5.8 Disposal Sharps
Sharps contained in properly labelled puncture-resistant
containers shall be disposed of by any of the following:
• Buried within the BCU compound on an adequately secured
and identified lot intended for the purpose
• Pulverization or incineration. Pathological Waste

Pathological waste (blood samples, blood clots and serum
specimens) shall be chemically disinfected or autoclaved prior
to incineration.
Blood units not fit for transfusion nor for other scientific purposes
shall be disposed of by similar methods for sharps as stated in Infectious Waste

Infectious waste shall be disposed of by similar methods for sharps
as stated in Chemical Waste

Toxic chemical waste must undergo pre-treatment process prior
to disposal such as incineration or autoclaving. Non-chemical
hazardous wastes can be disposed of directly into the sink or
treated as ordinary domestic waste. Non-hazardous Waste

Various methods of disposal for non-hazardous waste are
applicable like the following :
• Use of sanitary landfills
• Composting of biodegradable waste materials
• Recycling scheme for factory-returnables, feed fermentable,
fertilizer, fine crafts and filling materials
• Where a municipal or city collection is available, non-
hazardous waste can be disposed of with the domestic/
municipal/city waste
• Use of improvised incinerator or on-site enclosed burning
vault with anti-pollution device.

Section 7
Section 7


Each BCU shall have at least one copy of the most recent edition of the Standards for
Blood Collection Units and the Standards for Blood Banks and Blood Centers. The Standards
should be easily accessible to all staff concerned for reference.

Each BCU shall have a system for record-keeping by manual, computerization or a

combination thereof. Procedures and policies for each part of the system must be estab-
lished, written and followed. The records shall set a clear system of process and control to
prevent any misinterpretation of oral or informally written instructions or communications, and
to prevent unauthorized deviation from standard procedure.

It shall provide a compilation of documents mainly for quality pariormance audit and
for other process review includinq clarification of legal issues.


7.1 Record Design

Record systems must meet the needs of the institution and be used in a manner that
satisfies this need. Each record should have a title that explains its intended use and
includes the name of the BCU and its identifying code or numbers and signature of the
person immediately responsible for each procedure performed.

7.2 Record Changes

If it is necessary to alter or correct any record, the change must be identifiable by date
and name of person responsible, and the reason for change should be noted.

The original recording must not be obliterated. It may be circled or crossed-out in hand-
written records, but it should remain legible. Computer records should permit tracking
of both original and corrected data to include the date and the user identification of
the person making the change.

Rubber stamps, brackets or ditto marks are not acceptable means of identifying
responsible personnel.

7.3 Confidentiality

Blood bank records like all medical information must not be released or made available
to unauthorized persons. Restricted access to computerized records must be insured
by an appropriately maintained computer access security system.

7.4 Document Control

There should be a system for dissemination and recall of specified documents. The
system also includes cross-referencing with other related documents, references or
regulatory issuances.

The facility must have-an alternative system that ensures continuous operation in the
event that computerized data are not available.

7.5 Security and Retrieval

Records must be complete and retrievable in a reasonable period of time, preserved

and protected from accidental or unauthorized destruction or modification.

7.6 Storage of Records

All records should be stored in a restricted area accessed only by authorized BCU
personnel. The method and location of record storage depend on the volume of records
and available storage space. The degree of accessibility of records of the facility's
operation should be in direct proportion to the frequency of their use.

7.7 Retention of Records

Records are retained to serve as references or basis for clarification of blood product or
blood bank issues including record use as basis for legal proceedings.

Records should be kept for a specified period of time. The required retention period for
specified records are listed in Annex 4.


7.8 Quality System Manual

This Manual shall be prepared by the BCU Head and personnel. It shall include but not
be limited to the following minimum information:

• BCU Organizational Objectives, Policies and Guidelines

• BCU Organization, Personnel Job Delineation, Levels of Responsibility, Task
Delegation and Coordination
• Personnel Development and Competency Evaluation

7.9 BCU Technical Procedure Manual

This Manual shall be prepared by the BCU Head and personnel. It describes the spe-
cific step-by-step procedures and techniques that the laboratory staff need for techni-
cal directions and quality control.

The procedure shall include, but not be limited to the following minimum information:

• Name of Examination/Test
• Principle of Test
• Materials and Reagents
• Methodology
• Reference Value (if applicable)
• Computation (if applicable)
• Interpretation

7.10 Biosafety and Waste Management Manual

Emphasis on biosafety will provide all health workers the necessary information and
tools for maintaining safe work environment. This Manual shall be prepared by the
BCU Head and personnel.

7.10.1 Comprehensive Safety Program Record

Every BCU should develop a comprehensive safety program that includes

special consideration on infection control, physical and chemical injuries.

Elements of the program record should include:

• Objectives of the Program
• List of appropriate facilities and equipment, and proper maintenance
of both
• Safe practices and procedure, and precautionary measures
• Identification of staff at risk
• Development of occupational safety and health programs to educate
and train persons prior to exposure
• Surveillance program
• Recommendations

7.10.2 Waste Management/Waste Disposal Program Record

Waste management program should be designed to protect staff and to

comply with the local regulatory requirements. The ultimate goal of the
program should be to reduce the volume of hazardous materials being
handled to an absolute minimum.

Elements of the record should include:

• Objectives of the program
• Terminologies
• Methodology and principles
• Types of waste for special handling and disposal or transport
• Treatment equipment and alternative systems
• Other equipment and supplies
• Precautionary measures for packaging waste
• Recommendations

7.11 EqUipment Maintenance and Repair Record

Properly functioning equipment is essential for accurate testing. The equipment

maintenance and repair record should document that all instruments are properly
maintained, calibrated, cleaned and monitored. Corrective actions and recommen-
dations must likewise be documented when instruments fail to function as. expected.

Contents of the record include:

• Name of instrument, model, serial number
• Name of accessory parts
• Name and address of local distributor
• Date and amount of purchase
• Date calibrated
• Date of malfunction
• Date of repair/corrective action(s) taken
• Recommendation (s)
• Signature of repair man

7.12 Quality Management Record

Each BCU should have a comprehensive and coordinated management program

that is designed to promote desired quality outcomes. Elements for this activity include
Quality Control (process), Quality Assessment (outcome), prevention of problems and
continuous improvement.

7.12.1 Records of Quality Control and Quality Assessment

Contents of the record include:

• Dated and signed or initialed temperature recording charts for
each equipment
• Record of quality control tests performed on all reagents as specified in
the SOPs
• Results of the evaluation lest on performance of other reagents and
• Results of equipment calibration, validation and maintenance
• Log of personnel signatures and inclusive date of employment
• Record of quality control tests on components prepared
• Record of periodic checks on sterilization technique if components are
prepared in an open system
• Record of sterilization of instruments and reagents prepared within the
• Record of biological indicator tests to determine the effectiveness of
• Record of disposition of rejected supplies and reagents
• Record of proficiency testing
• Record of parallel studies performed

7.13 Blood Donation Records

At each blood donation, there must be a record that provides true identification of
the donor and gives pertinent identification. Either single-use or multiple-donation forms
are acceptable. These records may be filed either by donor name or donation number
with appropriate cross-references. Minimum requirements are:

7.13.1 Donor Session Record

• Donor's identification like first, middle and last names, birth date,
address(es) and phone number(s)
• Date of last donation
• Identification of the person undertaking each impertant activity
associated with the donation
• Date and venue of the session
• Date of donation
• Donation number
• Record of medical history and physical examination results
• Recommendations made for further laboratory work-up and/or clinical
care of donor based on the medical physical and laboratory results;
whether the donor is accepted of deferred temporarily, indefinitely or
permanently with corresponding notations about the deferral
• Donor's signature on the donor's medical declaration form

7.13.2 Blood Collection Record

• Informed consent: Consent to have blood drawn and tested

• Donation number which links to the identity of the donor from which the
blood is collected
• Identification of phlebotomist
• Status of blood collection as completed or withdrawn prior to completion
and its reasons
• Record of any donor reactions, symptoms and treatment, conditions of
the donor upon release, identification of person attending the
donor, time released and notation if the donor refuses treatment
or advice
• Supplementary records: These are additional record requirements for
donors in special categories. These records may be included in the
donor form. maybe attached to it or may be filed separately.
1. Donors under age 18 : Written permission from parent or guardian

7.14 Records of Compatibility Testing

All compatibility tests done on donor and recipient's blood should be recorded with
emphasis on the results observed and final interpretation of results. Data must be
entered as work is done, using symbols that clearly indicate positive or negative results.
The symbols musf be defined and used uniformly by all personnel. These records can
be incorporated in one worksheet to facilitate labelling and review of records before
release of blood units or components to hospitals.

Contents of the record include :

• Patient's identification like first, middle and last names, age and sex, ward and
hospital number
• Name of hospital and attending physician requesting such compatibility testing
• Specimen label should include the date of blood collection and name of
• Blood unit identification such as serial number, blood type, kind of blood
preparation, expiration date, etc.
• Date of testing and type of test procedures done
• Results observed and final interpretation
• Name of reagents used, manufacturer, lot number, expiration date, and if
applicable BFAD registration number

7.15 Records of Storage, Transport and Submission of Collected Blood to Central BB/BC

7.15.1 Records of Storage of Blood Samples

Records for blood samples from patients and donors stored in blood bank
refrigerators should be provided.

Minimum requirements include:
• Recording charts for refrigerator temperatures, with iriclusive dates,
explanation of abnormal temperatures and action taken, and
initials of the certifying personnel
• Records of periodic testing of alarm systems
• Records of temperatures observed daily and their comparison to
automated temperature recordings.
• Notation of quarantine of unsatisfactory units, record of any' tests
performed and final disposition of each unit.

7.15.2 Records of Transport of Blood Units for Submission to BB/Be

• Name and address of receiving BB/BC and personnel
• Date and time of transport or submission
• A list of each donation number, blood group and expiration date
• ABO and Rh type
• Final inspection of Blood Units
• Name of BCU personnel approving the transport
• Periodic tests documenting that transport containers maintain an
acceptable storage temperature range
• Name of BSF personnel who checked the temperature of the transport

7.15.3 Transport Records

Records should demonstrate that a blood unit can be readily located during
transport to another site.

7.16 Records of Errors and Accidents

Each BCU should have a system for detecting, reporting and evaluating reported
errors and accidents. Copy of this record shall be submitted to BRL.The following infor-
mation is recommended in reporting errors and accidents:
• A written detailed description of the error or accident
• Name of the blood unit(s) involved
• Name of collecting or processing facility if not the same as the reporting facility
• Date of discovery or occurrence
• Name of person who discovered the error or accident
• Notation whether the blood component was transfused or not
•. Category of personnel responsible for the error (nurse, technologist, messenger,
others) and identity of the individual
• Corrective action taken
• Action taken to prevent a recurrence of the error or accident
• Name of the manufacturer, lot numbers, and expiration date of product if
defective reagents or supplies were implicated
• A copy of the notification of appropriate authorities/facilities when applicable

7.17 Summary Records

Summary record provides an overview of the BCU operations. It also contains useful
information for audits.

7.17.1 Records that demonstrate all inspection checks, quality controls, methods
and equipment used, results and interpre tation of laboratory tests, and au-
thorized signatures

7.17.2 Records that demonstrate that only blood units fit for further testing and
processing have been submitted to BB/BC

7.17.3 Annual Blood Collection Reports

• Total number of donors screened, accepted or deferred

• Total number of units collected
• Total number of units submitted to BB/BC for processing
• Total number of units returned, if applicable
• Total number of units discarded/not used

Sec.tion 8
Section 8


Research in Transfusion Medicine should be encouraged. Data shall be used for

technology upgrading, revision of Standards and updating of clinical practice.

8.1 BCU Operational Research Program

Each BCU should have a capability building IJrogram for research. Research protocols
can fall in the following areas, but are not limited to:

• Survey of Knowledge, Attitude, Practices (KAP) regarding blood donation in targeted

• Study on blood donor profile
• Survey on causes of deferral of blood donors

8.2 Personnel·Training on Research Methodologies

The designated BCU Head and selected personnel who will be involved in research
activities should undergo a training on research methodologies.

8.3 Ethical review

All research projects shall undergo ethical review by respective Ethical Review
Committee under the Regional Councils on Health Research and Development.

8.4 Funding

Research proposals shall be submitted to their respective Regional Health Research

Units, the National Voluntary Blood Services Unit or to interested non-government
agencies for funding after the required clearing process. Funding should be made
available by the Blood Program Management and other potential research funding

8.5 Data Submission and Utilization

The reports of research studies shall be submitted to their respective Regional Blood
Program Coordinator and the National Committee of the NVBSP for appropriate policy
formulation or revision, decision-making, reference and publication.


Name of Blood Collection Unit

Authorization Number
Name and License Number of Central BB/BC


(Interview and Physical Examination)

BLOOD DONATION NUMBER _--;----::--=-_ Date

[ I New Donor I Repeat Donor Date o"'f'"'L'"'a-s'"'t-:D'""o-n-a'"'ti'"'o-n----
Name: Birthdate: _ Age: __ Sex: __ Status:
Address: TeI.No.:
Occupation: _

Medical History: Please check appropriate answer.

1. Feel you are in good health? [ J [ )
2. Have a flu or cold? [ ) [ 1
3. Take insulin/diabetic medication? [ ) [ I
4. Aware of activities which place you at risk tor AIDS?
5. Aware you must exclude yourself from donating if
you engage in any of these activities?
6. Aware that you can call to prevent your donation
being used as a transfusion?

7. Ever been advised to stop giving blood?
8. Ever been hospitalized?
9. Ever had jaundice, hepatitis or a positive
hepatitis test?
10.Been exposed to jaundice or hepatitis in the [
past 6 months?
11.8. Ever received a blood transfusion in the
past year?
b. If not, have you received before?
12.Ever taken or injected addictive drugs?
13.:':'een tattooed/had ear piercing during the
past 6 months?
14.1 n the past 5 years visited or lived in other countries?
15 a. In the past 3 years had an attack or malaria?
b.Taken any medication to prevent malaria?
16.Ever had a serious illness? Have you seen a
doctor in the past 6 months?
17.Ever experienced unexplained night sweats.
evers, weight loss?
18.Ever had massively enlarged lymph nodes
(swollen glands)?
19.Had persistent diarrhea?
20.Any history of high blood pressure?
21.Any history of heart trouble? chest pain?
shortness of breath? persistent cough?
22.Any disease of the lungs. kidneys, liver or blood?
23.Had cancer?
24.Ever been subjected to fainting, unconsciousness,
convulsion, or epilepsy?
25. Any skin infection?
26. Any allergy that is bothering you today?
27. Been taking medication including in the past
6 months?
28. Received any injections, immunizations, or
vaccinations in the past year?
*29. Been pregnant or had abortion in the past
*30. Given birth to 3 or more children?

Physical Examination:

Temperature: _ _ _'C Blood Pressura : mm/Hg

Weight K Pulsa Rate /min.

Laboratory Examination:

Hemoglobin: giL Blood Type: _


J . Donor is: accepted for blood donation

J Donor is temporarily deferred for blood donation
] Donor is permanently deferred for blood donation

BCU Examining Physician

•••••••••••••••••••••••••••••••••••••••••••• Fa R BLOO 0 DO NOR: ••••••••••••••••••••••••••••••••••••••••••••••••••

I am voluntarily giving blood through --;-_ _-:""""'=,- to be used as decided by the service.
( name of BCU)
I give the BCU the permission for detailed typing of my blood and the parent BB/BC for blood screening tests
for Hepatitis B, Malaria, Syphilis, HIV1& 2 and Hepatitis C virus. The results of these tests may be stored in' corn-
puterized files.

I certify that I have, to the best of my knowledge, truthfully answered the above questions and under-
stand that this information is important in determining whether I am acceptable as a blood donor.

Blood Donor's Signature


Modified from 51. Luke's Medical Center Form


Name of Blood Collection Unit

Authorization Number
Name and License Number of Central BS/Be


There are some people in the community who must not donate blood becayse it may transmit infections to
patients who receive it.

You must complete this form if you want to donate blood. If you do not know how to answer any of the questions,
please check with the interviewing BCU personnel before answering the questions.

It is against the law to knowingly make a false or misleading statement. If you do, you may receive a heavy


Blood Donation Number _
Name _ Age-:-:-- _ Sex
Address _ Tel. No. _

Please answer the following with YES or NO.

"(Note: Partner is defined as any person with whom you have had sexual contact in the la5112 months).

_ _ 1. Have you or your partner any reason to believe that you have been infected with HIV, the virus that
causes AIDS?
2. In the last 6 months, have you had:
persistent night sweats persistent diarrhea
_ _ persistent swollen glands unexplained weight ·loss
_ _ persistent fever
_ _ 3. Have you or your partner had sexual activity within the last 12 months with any person whom you
know to have been exposed to HiV, the virus that causes AIDS?
_ _ 4. Have you had sexual activity with a person with hemophilia within the last 12 months?
5. Have you or your partner been a male or female sex worker {prostitute here or overseas within the
last 12 months?
6. Have you had sexual activity with a male or female sex worker (prostitute) here or overseas within
the last 12 months?
_ _ 7. Have you had male to male sexual activity within the last 12 months?
8. Have you had sexual activity with a male within the last 12 months who has had sexual activity with
another male?
9. Have you or your partner EVER injected yourself, or been injected with any drug not prescribed by a
_ _ 10.Have you or your partner EVER shared needles and/or syringes?
_ _ 11.Have you been injured with a used needle within the last 12 months?
___ 12.Have you been tatooed within the last 12 months?
_ _ 13.Have you received a blood transfusion or treatment with human blood products in the last 12 months?

To the best of my knowledge, my answers to the following questions are true. I am signing this
Statement in the presence of a member of the staff of the Blood Collection Unit.

Name & Signature of Donor/Date Name & Signature of Witness/Date

Modified from Victoria Red Cross Biood Bank Form


Name of Blood Collection Unit

Authorization Number
Name and License Number of Central BB/BC


Name of Recipient: --,.. Ward/Room No. Date_ _....,-- _

Recipient's Identification No. Blood Type Age _ _ Sex
Diagnosis/ Procedure _
Indication _

Whole Blood ( ) Plasma ( )

Packed Red Cell ( ) Fresh Frozen Plasma ( )
Washed Red Cell ( ) Cryoprecipitate ( )
Platelet Concentrate ( ) Cryosupemate ( )

Number of Units: Blood Type: _

Routine () Needed on: at: AM / PM
Emergency ( ) Needed within Hours / Minutes

Justification for emergency release of blood: _

Because of extreme need of blood, I hereby direct the blood bank to release the following:
( Please check appropriate box or boxes as needed)

I. ) Crossmatched - (3 phases)
) Crossmatchcd Blood - Saline Phase Only
( ) Crossmatehed Blood - Saline and Albumin Phase Only
( ) ABO Type-Specific Uncrossmatchcd Blood
( ) Group" 0 " Blood Uncrossmatchcd

II. () Fully Screened Blood

() Blood Not Screened for Malaria, Syphilis,HIY-Ab, HBsAg, HCY-Ab
() Blood Not Screened for HBsAg, HIY-Ab, and HCY-Ab
() Blood Not Screened for HIY-Ab and HCY-Ab

Requested by:

-,-:-_ _-:-::c_ _---,--,---_,.,--:-:--',MD

Name and Signature of Attending Physician

Modified from:
I. Forms of Puget sound Blood Center, Seattle Washington. USA
2. United Doctor's Medical Center, Manila



All records either as hard copies or computer files relevant to the operation of the Blood Station
shall be kept accordingly to the recommended time period as specified below.

A. Records That Should Be Retained for at Least 10 years include:

1. Processing Records

1.1. Information to identify facilities that carry out any part of the preparation of blood
components and functions performed
1.2. Information from any intermediate facility if it retains the unit number and identification of
the collecting facility

2. Records of Whole Blood and Packed Red Blood Cells Received From Outside Facilities

2.1. Numeric or alphanumeric identification of blood units and identification of the collecting

3. Records of Disposition of Whole Blood and Packed Red Cells

3.1. Names, signatures and initials or identification code of those authorized to sign or initial or
review reports and records

4. Records of Issuance for Transfusion

4.1. Notification to recipients of potential exposure to disease transmisslbla by blood

4.2. Notffication to transfusing facility of previous receipt of 'units from donors subsequently found
positive for HIV

B. Records that Should Be Retained for Five (5) years Include:

1. Standard Operating Procedures

1.1. Technical manuals, procedures and publications done by the facility

1.2. Biosafety manual includlnq procedures for biological, chemical safety and monitoring
records of training and compliance
1.3. Documentation of staff qualifications and competency

2. Compatibility Testing Results

2.1 Compatibility testing interpretation and clinically significant unexpected antibodies

found in patients

3. Record of Storage and Inspection of Blood Units

3.1 Blood and blood component inspection during storage and prior to issue
3.2 Storage temperature and control testing

4. Records of Quality Control and Quality Assessment"

4.1 Proficiency testing surveys and any corrective actions taken

4.2 Control testing of reagents and calibration of equipment and instruments


AIDS Acquired Immune Deficiency Syndrome

AHF Anti-Hemophilic Factor
AO Administrative Order
AVR Automatic Voltage Regulator
BB/BC Blood Bank/Blood Center
BCU Blood Collection Unit
BFAD Bureau of Food and Drugs
BP Blood Pressure
BRL Bureau of Research and Laboratories
B:F Blood Service Facilities
CPD Citrate Phosphate Dextrose
CPDA-1 Citrate Phosphate Dextrose Adenine-1
CPDA-2 Citrate Phosphate Dextrose Adenine-2
DOH Department of Health
D11 Department of Trade and Industry
EVF Erythrocyte Volume Fraction
GMP Good Manufacturing Practices
HBlg Hepatitis B Immunoglobulin
HBV Hepatitis B Virus
HBsAg Hepatitis B Surface Antigen
HCV Hepatitis C Virus
HCV Ab Hepatitis C Virus Antibody
HIV Ab Human Immunodeficiency Virus Antibody
Hgb Hemoglobin
IEC Information Education Communication
KVA Kilovolt Amperes
PRC Professional Regulation Commission
QA Quality Assurance
QAP Quality Assurance Program
QC Quality Control
RA Republic Act
RBC Red Blood Cells
RMT Registered Medical Technologist
RN Registered Nurse
RPM Revolutions per minute
SAG-M Sodium Adenine Glucose- Mannitol
SOP Standard Operating Procedure
UPS Uninterrupted Power Supply
WB Whole Blood
WHO World Health Organization
ACT. Republic Act 7719 otherwise known as the "National Blood Services Act of 1994."

ADDITIVE SOLUTION. A solution added to whole blood used to extend its shelf life; usually contains
adenine, dextrose and other nutritional components.

AGGLUTINATION. Visible clumping as evidence of the interaction of red blood cells with antibody
directed toward the antigen on the red blood cells.

AIDS. A set of serious clinical ailments resulting from severe immune dysfunction caused by infection
with the human immunodeficiency virus (HIV).

ANTIBODY. Proteins produced by the immune system in response to the presence of a foreign sub-
stance inducing antigen or immunogen.

ANTICOAGULANT. A substance used to prevent coagulation or clotting of blood.

APHERESIS. Blood collection procedure in which whole blood is removed, a selected component
separated and the remainder returned to the donor.

ANTI-HEMOPHILIC FACTOR. Also known as Factor VIII, the coagulation factor deficient in Hemophilia
A, usually prepared from plasma or pools of plasma and package in Iyopholized form.

ATYPICAL ANTIBODY. Antibody to red cell antigens other than the natural or expected group ABO

AUTOLOGOUS DONATION. A blood donation in which the donor and the recipient are the same person.

BAR CODE. A series of marks on preprinted packaging or labelling materials that may be Visually
inspected or read by an optical scanning device.

BIOHAZARD. Substance derived from biological sources such blood or body fluid, capable of trans-
mitting pathogenic organisms ..

BLOOD. Whole blood (WB) collected from a single donor and processed either for transfusion or
further manufacturing.

BLOOD BAGS. Sterile, sturdy plastic bags containing anticoagulants which are especially designed for
blood collection and transfusion. Blood bags can either be single or multiple types with an
integral sterile needle attached to the collection tubinq.

BLOOD BANK/CENTER. A blood service facility with capability to recruit and screen blood donors,
collect, process, store, transport and issue blood for transfusion and provide information and/
or education on blood transmissible diseases.

BLOOD BANKING EQUIPMENT. Essential laboratory machines, instruments and their accessories used in
the different steps in the blood banking process such as those used to centrifuge blood or
separate blood into its various components; preserve blood or blood components in cold
storage or freezer; and perform blood tests such as hemoglobin tests and screening tests for
blood transmissible diseases. These equipment also include those used in specific supportive
processes such as sterilization and sanitary disposal of blood and blood products.

BLOOD COLLECTION UNIT. A blood service facility duly authorized by the Department of Health to
recruit and screen donors and collect blood. .

BLOOD COLLECTION COUCH. Blood collection couch is another term for blood' collection table or
bed. It is a furniture upon which the donor sits or reclines during blood collection.

BLOOD DONATION NUMBER. Number issued to each blood donor on the day of donation.

BLOOD SERVICE FACILITY. Any unit, office, or institution providing any of the blood transfusion services,
which can be a blood bank/center category A and B (non-hospital and hospital based), a
blood collection unit or a blood station.

BLOOD TRANSMISSIBLE DISEASES. Diseases which may be transmitted through blood transfusion,
including, but not limited to HIV infection, Hepatitis B, Hepatitis C, Malaria and Syphilis.

BLOOD STATION. A blood service facility which can be sited in either a government or private hospital
or a Philippine National Red Cross chapter which has not been licensed as a blood bank/
center but has been authorized by the Department to perform compatibility testing and to
store and issue blood and Packed Red Cellls.

CALIBRATION. A comparison of a measurement of a parameter on a piece of equipment with a

standard measurement prescribed to ensure the proper function of the equipment.

CITRATE. Component of anticoagulant composed of citric acid and a base. Citrate binds calcium
and prevents coagulation.

CITRATE PHOSPHATE DEXTROSE. Anticoagulant that is used in routine blood collection; allows a 21-day
storage period.

CITRATE PHOSPHATE DEXTROSE ADENINE. Anticoagulant used in routine blood collection; allows a 35-
day storage period.

COMPETENCE. Capability to do a certain task or job according to set standard operating procedures.

COMPETENCY ASSESSMENT. A method which documents the performance abilities of the personnel
performing the various tasks within the blood service facility. Competency assessment/testing
programs should test technical skills and knowledge.

CONTROL. A device, compound or solution which has one or more accurately known characteristics
and which is used for the purpose of verifying the accuracy and precision of measurements of
these characteristics in unknown similar objects by being treated in the same manner as the

DECONTAMINATION. A procedure that eliminates or reduces microbial contamination to a safe level

with respect to the transmission of infection.

DEPARTMENT. The Department of Health.

DIASTOLIC BLOOD PRESSURE. The blood pressure in a large artery during the period when the cavities
of the heart rlilate and fill with blood. This is the lower number in a blood pressure reading.

DISINFECTANT. An agent that kills microorganisms capable of producing an infection.

DISINFECTION. A procedure that kills pathogenic microorganisms but not necessarily their spores. Chemi-
cal germicides formulated as disinfectants are used on inanimate surfaces (medical devices,
etc.) and should not be used on skin, tissue or any part of the body.

DISPOSAL. The act of eliminating or sequestering indefinitely or permanently either treated or un-
treated waste.

ENDEMIC. A disease that is prevalent in a particular geographic area throughout the year.

ERYTHROPOIESIS. The process of red blood cell production in the bone marrow.

FORWARD GROUPING. Test in which unknown red blood cells are mixed with typing sera of known
specitity to determine the presence or absence of antigens on the red blood cells. Agglutina-
tion with the reagent indicates the presence of the antigen.

FOUR-HUNDRED FIFTY (450 ) ml BLOOD COLLECTION. Amount of blood for collection in a 500 ml blood
bag containing 63 ml of anticoagulant.

GOOD MANUFACTURING PRACTICE. All the elements (ie. blood donor screening and testing, blood
collection, storage, transport and issuance, and others lin established practice that will
collectively lead to final products or services that consistently meet expected specifications.

HEMOLYSIS. The disruption of the red blood cell membrane resulting in a release of hemoglobin in to
the plasma or cell suspension medium.

HEPARIN. An anticoagulant but not a preservative; used when blood is to be filtered for the removal of

HIGH·RISK BEHAVIOR. Refers to a particular behavior and lifestyle predisposing to the occurrence of a
particular condition or illness.

HIV-1. Human Immunodeficiency Virus type 1, the causative agent of AIDS. Initially called HTLV-

HIV-2. Human Immunodeficiency Virus type 2, also associated with AIDS and sharing partial homo-
logy with HIV-1.

HIV POSITIVE. Refers to laboratory evidence of exposure to human immunodeficiency virus. Such
people have had repeatedly reactive screening tests for HiV antibody and confirmed by
supplemental tests for HIV antibody; or persons positive for HIV antigen.

IMMUNE RESPONSE. The reaction of the body following an exposure to an antigen. This can result in
either cellular response or the formation of antibody or both.

IMMUNOCOMPROMISED. Defect in immune system resulting in decreased resistance to infection or

dimi-nished immune response.

INCINERATION. Use of high temperature to convert combustible solid waste material into residual ash
and gases, which are vented to the atmosphere. it is utilized as a treatment technique for
almost all types of infectious waste.

INFORMED CONSENT. Refers to an agreement to testing of blood which is obtained after informing the
blood donors of processes involved in blood donation, including screening and reporting of
posltlve test results as required by ethical rules and legal issuances.
INTERNAL QUALITY ASSESSMENT. Assessment of laboratory performance conducted by a staff within a
laboratory or blood bank/center.

INTERIM. Meanwhile or time intervening.

MALARIA. A parasitic disease caused by Plasmodia which can be transmilled by transfusion.

NON-POROUS. Non-permeable to fluids or non-absorbent such as glazed tiles. acoustic tiles or formica,
or marine plywood ..

MOBILE BLOOD DONATION. A blood donation session conducted in a temporary site away from the
location of the Blood Collection Unit or Blood Bank/Center.

PACKED RED BLOOD CELLS. A blood component consisting mainly of red cell mass. It is prepared when
most of the plasma is removed following sedimentation or centrifugation.

PARALLEL TESTING. A comparison of performance of new lots of kits with the previous lots. Done at the
same time and utilizing common control material. Parallel testing is also performed on serial
samples to obtain results on the same run for comparison.

PHERESIS. See Apheresis.

PHLEBOTOMY. The process of withdrawing blood from the circulatory system through a vein.

PLASMA. The fluid component of uncoagulated blood after cells are removed/settled.

PLATELET CONCENTRATE. A blood component which contains platelets as the major cellular element.
It is prepared from platelet-rich plasma by differential centrifugation or obtained by apheresis.

PROFICIENCY TESTING. External evaluation of performance by the use of unknown test samples.

PYCNOMETER. A device used to measure the specific gravity of Copper Sulfate solution.

PYROGEN-FREE. Free from fever-producing protein substances of antibodies.

QUALITY. The consistent and reliable performance of services or product in conformity with the speci-
fied standards.

QUALITY ASSURANCE. The combination of activities necessary for every blood service facility to ensure
quality blood products and blood services for patients, donors, fellow employees, doctors,
the community, and the regulatory agencies. It is a part of the broader and continuous quality
improvement process which ensures that quality will benefit the organization and its end-users.

QUALITY AUDIT. Formal examination and verification of laboratory performance as a part of the QAP.
It is conducted professionally in a constructive atmosphere without bias to compare some
aspects of quality performance with a standard.

QUALITY CONTROL. Part of the quality assurance system which consists of retrospective tests or other
measures that should provide satisfactory results before proceeding further in a given process
and which demonstrates compliance to certain defined limits and specifications.

QUARANTINE. The sequestration ot materials and blood products, whether physically or by a system,
while awaiting a decision on their suitability for further processing or use.

REAGENTS. Substances employed to detect or measure another substance or to convert one

substance to another by means of the reaction that it causes. In blood banking, the reagents
used are those necessary to measure hemoglobin; screen for blood transmissible diseases such
as HIV, hepatitis, malaria, syphilis; identify blood groups; and perform crossmatching
procedures and other immunohematologic examinations.

RECIPIENT. The person or a patient who receives a transfusion of whole blood or its products.

Rh FACTOR. A blood group antigen, named after the Rhesus monkey, from which it is originally identi-
fied because an antibody agglutinated the erythrocytes of all rhesus monkeys, 85% of Cauca-
sians and over 99% of Asians..

Rh NEGATIVE. An Rh blood type characterized by the absence of D (RHo) antigen and its variant Du
on the surface of a person's red blood cells.

Rh POSITIVE. An Rh blood type characterized by the presence of D (Rho) antigen or its variant Du on
the surface of a person's red blood cells.

RETROVIRUS. Virus that uses an enzyme reverse transcriptase to transcribe an RNA genome into DNA.

REVERSE GROUPING. A blood grouping test in which unknown serum is tested with red blood cells of
known ABO group using A1, B cells, and lor A2 red blood cells

sECRETARY OF HEALTH. The Secretary of Health or any other person to whom the Secretary delegates
the responsibility of carrying out the provisions of this Act.

SERUM. The straw-colored fluid remaining when blood has clotted and cellular components are

SPECTROPHOTOMErER. The instrument used to measure absorbance of light at a specific wavelenght.

SPHYGMOMANOMETER. An instrument used to obtain a person's systolic and diastolic blood pressure.

STANDARD OPERATING PROCEDURE. A document that specifies the way that a paritcular task should
be underlaken within a particular work area.

STARTING MATERIAL. The starling material for component preparation is whole blood or the products
collected by apheresis.

STERILE. Free from viable microorganisms.

STERILIZATION. A procedure that effectively kills microorganisms includinq bacterial spores.

SYMPTOM. A subjective complaint by the patient usually indicating a disturbance of body function or
of a disorder or disease.

SYSTOLIC BLOOD PRESSURE. The blood pressure in a 110Jrge arlery during which the hearl is contracting
to propel blood to the circulatory system. The upper number of a blood pressure reading.

TEST RUN. A group of specimens processed together with the reagent and in-house controls in one

TIERED DOCUMENTS. One of two or more related documents arranged one above the other in
succeeding degree of detailed information.

TRANSFUSION. The administration of blood or blood component to a person through the intravenous

TWO HUNDRED (200)ml BLOOD COLLECTION. Amount of blood for collection in a 250 ml blood bag
containing 31.5 ml of anticoagulant.

UNIT. The volume of blood or one of its components in a suitable volume of anticoagulant obtained
from a single collection of blood from one donor.

VACCINE. Any preparation intended for active immunological prophylaxis.

VALIDATION. A procedure that shows that a piece of equipment or process does what it is supposed
to do. II assures that a process will consistently produce a product according to requirements:

VENIPUNCTURE. See Phlebotomy.

VOLUNTARY BLOOD DONOR. An individual who donates blood on one's own volition or initiative and
not induced, directly or indirectly, in any manner whatsoever, by any monetary compensation
nor blood relations/obligations.

WASTE. A useless or worthless by product, as from a manufacturing process.

WHOLE BLOOD. A unit of blood that contains all the cellular elements and its plasma derivatives. See

WORK INSTRUCTIONS. Steps or procedures that are intended to cater for those activities requiring
detail beyond that included in the authorized procedures.

In behalf of the Department of Health, the Project Management and Editorial

Committee wish to acknowledge the following Technical Advisers, Resource Person, BRL Ad-
ministrative and Support Staff:


Carmen T. Narciso, MD, FPSHBT (SLMC)

Honorata G. Baylon, MD, FPSHBT, FPCP (NKI & PSHBT)
Gilbert S. de Leon, MD, FPSP (Pathologist, llocos Regional Hospital)
Celso S. Ramos, MD, FPSP (Pathologist, Batangas Regional Hospital)
Bu C. Castro, MD,DPSP, LLB (NCR)
Marilyn R. Atienza, RMT (PAMET)
Elvira SN. Dayrit, MD, MSc (NVBSP)
Asuncion A. Paraan, MD, FPSP (NVBSP)
Gordon S. Whyte, MD (Red Cross, Victoria, Australia)


Drafting of Standards

Flerida S. Alunan, BSMT

Alexis A. Aviriante, RMT
Marivic F. Bantog, RMT
Anarissa A. Bumanglag, RMT
Amelia C. Cabatic, BSMT
Nenita S. Cariafranca, RMT, DMM
Melia Ellen Y. Castillo, RMT
Cecilia D. Cuerdo, RMT
Sol C. Dungca, BS Zoo
Buenaventura C. Erese, MD, FPSP, MBA
Angelita O. Jimenez, RMT
Veneracion P. Munar, MD, DTMH, FPSMID, FPSP
Marilyn A. Pacardo, RN
llluminada S. Pama, BSMT
Eleanor P. Pastrana, BS Pharm, RMT
Minda C. Quitoriano, RMT
Gracela Fidela Mina-Ramos, MD, FPSP, FASCP
Leonita G. Resurreccion, RMT
Myrna T. Reyes, RMT
Rizalina S. Riel, BS Pharm, RMT, DMM, MGM
Cornelio L. Roc, Jr., BSMT
Pioquinto G. Resultay, MD, MPH
Edith S. Tria, MD, DPSP

Consultative Meetings

Pathologists of Regional Hospital Clinical Laboratories (DOH)

Eduardo M. Badua, MD, DPSP (Region II) Primo Joel S. Alvez, MD, FPSP (Region VII)
Virginia V. de Joya, MD, FPSP (CAR) Juanita A. Arcay, MD (Region VII)
Carlota B. Manzano, MD, FPSP (Region III) Flora A. de la Pena, MD, FPSP (Region VIII)
Ramon M. Nery, MD, FPSP (Region III) Myrna V. Palahuddin, MD, FPSP (Region IX)
Teresita S. Plaza, MD, FPSP (Region V) Apolinar A. Vacalares, MD, FPSP (Region X)
Ma. Margarita J. Lena, MD, FPSP (Region VI) Oscar P. Grageda, MD, FPSP (Region XI)
Eriberto R. Layda, MD, FPSP (Region VI) Noemi D. Bartolome, MD (Region XII)

Philippine Society of Pathologists (PSP)

Exaltacion A. Caringal, MD, FPSP Juliet L. Lorenzo, MD, FPSP
Ernesto V. Datu, MD, FPSP Manalo N. Onchangco,MD, FPSP
Ma. Lourdes Irao, MD, DPSP Manuel M. Reyes, MD, FPSP
Rafael B. Javier, MD, FPSP Teresita V. Tuazon, MD, FPSP

Philippine Association of Medical Technologists (PAMED

Julieta V. Cobangbang, RMT
Cynthia J. Rabadam, RMT
Shirley F. Cruzada, RMT
Ryan P. Tulia, RMi'

Philippine Nursing Association (PNA)

Nelia C. Avila, RN
Rosalinda G. Cruz, RN
Lourdes R. L. Cruz, RN

Philippine National Red Cross (PNRC)

Eleopoldo P. Magpusai:>, MD
Michael Angelo J. Marquez, Jr., MD

Administration and Document Preparation

Agripina C. Serapio Salina O. Go, BS Chem.
Wilbur E. Marlori Cristina T. Narciso, RMT
Reynaldo R. Velasco Teodoro M. Fajardo, RMT
Pompeyo R. Fontanilla EmilyV. Flores
Luz M. Ramos, BSMT


Criselda G. Abesarnis, MD, FPSP Manuel M. Dayrit, MD, MSc

Marietta C. Baccay, MD, FPSP Cecilia J. Francisco, MD (PNRC)
Marilyn C. Barza, MD, FPSP Raymundo W. La, MD, FPSP (PSP)
Andres S. Bonifacio, MD, FPSP (PSP) Tomas P. Maramba, MD, FPSP,MPH
Norma N. Chang, RMT Agnes Medenilla, RMT
Gloria. L. Tan, MD, DPSP


1. Australia Code of Good Manufacturing Practice for Therapeutic Goods ( Blood and
Blood Product), 2nd Edition 1995

2. Blood Product Issue Policies, Red Cross Blood Bank Victoria, 1994.

3. Guidelines for the Selection of Blood Donors, Australian Red Cross, National Blood Transfu-
sion Center, April 1994.

4. and various Procedural Manuals of the Red Cross Blood Bank Victoria

Grateful acknowledgement is given to Dr. Gordon S. Whyte for providing the Australian

5. Standards for Blood Banks and Transfusion Services, American Association of Blood Banks,
16th Edition 1994

6. Code of Federal Regulations (Food and Drugs ),' USA, Parts 600 to 799, as of April 1, 1993.

7. Guidelines for Blood Transfusion Service, United Kingdom, Amendment 1, 2nd Ed. 1994

8. WHO Documents
8.1 Resolution WHO 28.72 The 28th World Health Assembly, 29 May 1975

8.2 Consensus Statement on How to Achieve a Safe and Adequate Blood Supply by
Recruitment and Retention of Voluntary, Non-Remunerated Blood Donors 1993 WHO/
LBS/93/2, WHO/GPNlNF/93.1 .

8.3 Consensus Statement on Accelerated Strategies to Reduce the Risk of Transmission

of HIV by Blood Transfusion, 1989 WHO/GPNlNF/89.13, WHO/LAB/89.6

8.4 Guidelines for the Appropriate Use of Blood 1989 WHO/GPNINF/89.18,


9. other US AABB Documents:

9.1 American Association of Blood Banks (1976). Seminar on Performance
Evaluation. Presented at the 29th Annual Meeting, San Francisco,California: 121

9.2 Walker, R.H. et al (1993). Technical Manual, 11th Ed. American Association
of Blood Banks, Arlington, Virginia

9.3 Taswell, H.F. & Saed, S.M. (1980). Principles and Practice of Quality Assurance in
Blood Bank, American Association of Blood Banks, Washington, D.C.

9.4 Dixon, M.R. et al (1987). Selection of Method and Instrument for Blood Banks. AABB,
Arlington, Virginia: 1 - 109

9.5 Nance, S.T. (1989).lmmune Destruction of Red Blood Cells. Ariington,VA. American
Association of Blood Bank : 227 • 261

9.6 Nance, S.T. (1991). Clinical and Basic Services Aspect of Immunohematology,
American Association of Blood Bank, Arlington, Virginia: 73 -107 and 179 - 199

10. Bender, J.L., Anhalt, J.P. et al (1992). Quality Assurance Programs. Clinical laboratory
Technical Manuals, NCClS Document GP2-A2 2nd ed. 12 (10): 1

11. Calam, G.B. (1992). Quality Assurance, An Administrative Means to a Managerial End.
Clinical lab. Management Review 6 (5): 426

12. College of American Pathologists (1989). Guidelines for laboratory Safety

13. Constantine, N.T., Callahan, J.D. & Watts, D.M. (1992). Retroviral Testing Essentials for
Quality Control for laboratory Diagnosis, CRC Press, Florida, USA

14. Constantine, N.T., Groen, G.V. et al (1994). Sensitivity of HIV-Antibody Assays Deter-
mined by Seroconversion Panel. AIDS 8: 1715 - 1720

15. Garcia, L.S., Bullock, S.L., Fritsch, T.R., et al (1993). Slide Preparation and Staining of Blood
Films for the laboratory Diagnosis of Parasitic Diseases, NCClS Document 15-T12 (15)

16. Green, R.E., Ford, D.S., Condon, J.A., et al (1987). Basic Blood Grouping Technique
& Procedures, 2nd Ed. Victorian Immunohematology Group

17. Hoeltge, GA, Pollock, P.G., Reinharat, P.A. (1991). Waste Management Systems. Clini-
cal laboratory Waste Management NCClS Document GP5-T 11 (22): 8 - 13

18. Howanitz, P.J. et al (1987). laboratory Quality Assurance. Mc Graw Hill Inc.

19. Issitt, P.O. (1984). Applied Blood Group Serology. Montgomery Scientific Publication 3rd
Ed. : 31 - 37

20. Klein, R.E., Conley, J.E., Mackinney, K. et al (1986), Temperature, Monitoring & Recording
in Blood Banks, NCClS Document 11 O-T 6 (19)

21. Kelton, J.G., Heddle, N.M. & Blajchman, M.A. (1984). Blood Transfusion, A Conceptual
Approach, Churchill Livingstone, N.Y.

22. levine, P. (1967).Blood Group Antigens and Antibodies as Applied to Compatibility

Testing. Ortho Diagnostic Inc.: 1 -12

23. Mollison, P.L., Engelfriet, C.P. & Contreras (1989). Blood Transfusion in Clinical Medicine.
Blackwell Scientific Publication, 9th ed.: 710 - 785

24. National Committee for Clinical laboratory Standards (1989). Reference Procedure for
Qualitative Determination of Hemoglobin in Blood 4 (3): 54 - 62 Second Ed. Document M
29-T2 11 (14)

25. National Committee for Clinical laboratory Standards (1991). Protection of laboratory
Workers from Infectious Diseases Transmitted by Blood, Body Fluids and Tissue.

26. National Committee for Clinical laboratory Standards (1991).Protection of laboratory

Workers from Instrument Biohazards Proposed Guidelines 11 (5)

27. National Archives and Records Administration (1985). Code of Federal Regulations Food
and Drugs 21

28. National Committee for Clinical Laboratory Standards (1992). Internal Quality Control
Testing: Principles and Definitions Document C-24-A 11 (6)

29. Passey, R.B.(1993).CLlA's Quality Assurance: A Study in Total Devotion 25 (5):45-48

30. Programmed Instruction Course for Medical Technologists (1965). Immunohematology:

Principles and Practice. Ortho Diagnostic Inc.

31. Quinley, E.D. (1993). Compatibility Testing. In Immunohematology Principles and Prac-
tice. J.B. Lippincott Company, Philadelphia: 335 - 338; 1191 - 1206

32. Rossi, E.C., Simon, T.L. & Moss, G.S. (1991). Principles of Transfusion Medicine, William and
Wilkins: 709 - 751

33. Schochetman, G., George, J.R. (1992): AIDS Testing: Methodology and Management
Issues. Springer-Verlog 48 - 89 and 189 - 196

34. Tamashiro, H., Maskill, W., Emmanuel, J. et al (1993). Reducing The Cost of HIV Antibody
Testing. The Lancet: Public Health 342: 87 - 89

35. Tiehen, A. (1993). Competency Assessment in the Transfusion Service. Medical Labora-
tory Observer: 35 - 42

36. TIetz, NW. Rodgerson, D.O. & Laessig, R.H. (1992). Are Clinical Laboratory Proficiency
Tests as Good as They Can Be? 38 (4): 473

37. Tsu, V.D. et al (1991). Health Technology Direction: Major Equipment for Peripheral Labo-
ratory Program for Appropriate Technology in Health 11 (1)

38. Turgeon, M.L. (1989). Fundamentals of Immunohematology: Theory and Technique. Lea
& Farbriger:'3 -317

39. DOH Issuances and Manual:

39.1 Administrative Order No. 9 (1995). Rules and Regulations Implementing

Republic Act No. 7719 otherwise known as the "National Blood Services Act of
1994": 1 - 31

39.2 Manual of Standards for Blood Banks and Blood Centers in the Philippines.
Bureau of Research and Laboratories. Department of Health (February 1996)

39.3 Administrative Order NO.4 s. 1996. Standards for Blood Banks and Blood Centers
in the Philippines.

39.4 Environmental Health ServiceslDOH (1994). Manual on Hospital Waste

Management: 1 - 76

39.5 National Voluntary Blood Services Unit/Department of Health (October 1996).

Five Year Strategic Plan for the National Voluntary Blood Services Program of the



The Director
Bureau of Research and Laboratories
Departmenf of Healfh
San Lazaro Compound
Sta. Cruz. Manila

Subject: Comments and/or Reactions to this First Edition of the Standards for consideration/
incorporation in subsequent editions

Please specify page number(s), Section and Item Number(s).


Address and Telephone No.

Dep8rtmen1 of Health

; ...
Ho46.45. _M31c
1.._. _
62:5.\3 •.
1997 I. Manualof alaifdards tor, blood
collectJon unit--' '.

ISBN 971-91605-2-7

. <'