1

Foreword

This Guide was created as a model quality manual and process manual for
Blood Centers and serves as the exemplar of the best practices in Blood
Centering and Transfusion Medicine.

This Guide, with its complementary volume, describes Blood Center

processes in detail. It has two sections: Quality Manual and Process Manual.
The Process Manual is further divided into Administrative Procedures and
Technical Procedures. The general policies in this Guide are in accordance
with the Republic Act 7719 (National Blood Services Act), Manual of
Standards for Blood Service Facilities (DOH NVBSP), and relevant circulars
from the Department of Health. The policies are supported by quality
procedures along with respective work instructions, forms, and worksheets.
Blood Centers may adopt or customize the templates for their use.

This Guide adopts the total quality management framework by the World
Health Organization (WHO), which emphasizes five elements, namely,
organizational management, standards, training, documentation, and
assessment. It follows the Good Manufacturing Practices for blood
establishments instituted by the WHO, which details that the Blood Center
first and foremost should adopt “a systematic approach to quality and the
implementation and maintenance of a quality management system.” Hence,
the requirements of GMP for blood establishments are embodied in this
Guide, such as clearly defined policies and procedures, provision of all
necessary requirements, qualification of equipment and reagents and
validation of processes and methods, a system that allows traceability of all
released products, and a system that supports quality improvement functions
and activities. (WHO 156)

This Guide was also constructed with reference to the Department of Health
Manual of Standards for Blood Service Facilities and the Technical Manual
of American Association of Blood Centers 18th edition and embodies the
principles of ISO 9001 quality management system.

The Department of Health – National Voluntary Blood Services Program does

not warrant that the information in this Guide is complete and correct and
shall not be liable for any damages incurred as a result of its use. Blood
Centers are encouraged to seek the latest publication of the references used
in this Guide.

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 Table of Contents

Foreword 2
Part I: Quality Manual for Blood Centers (BC) 6
Part II: Process Manual – Administrative Procedures 22
Planning for Preparedness and Response to Emergencies 22
Preparedness and Response to Internal Emergencies 26
Managing Blood Supply During Disasters 29
Budget Preparations 30
Recruitment, Selection, Hiring of Human Resources 33
Promotion of Human Resources 33
Competency Assessment of Blood Center Technical Personnel 35
Control of Documents 36
Equipment Management 39
Equipment Management Process 43
Performance Qualification/Equipment Validation 48
Material Management 56
Work Instruction: Material Reception, Inspection, Verification/Validation,
Storage, and Use 59
Maintaining and Managing an Optimum Blood Inventory 65
Blood Donor Recruitment and Retention 67
Provision of Information to Prospective Donors 70
Customer Satisfaction Measurement and Complaint Management 74
Internal Audit 76
Work Instruction: Conducting an Internal Audit 79
Corrective Action 81
Part III: Process Manual – Technical Procedures 84
Quality Procedure Blood Collection 84
Blood Collection Donor Procedural Guidelines
Positive Identification and Assessment Blood Donors 86
Blood Collection Donor Procedural Guidelines
Identification of Vein for Phlebotomy 88
Blood Collection: Work Instruction, Aseptic Technique for Blood donation 89
Blood Collection: Work Instruction, Phlebotomy Procedure for Blood Donation 90

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Blood Collection: Work Instruction, Performance of Platelet Apheresis 92
Blood Collection: Procedural Guidelines, Post Donation Care 96
Storage and Transport 97
Screening for Transfusion Transmissible Infection 102
Testing for Transfusion Transmissible Infection 108
Screening for Transfusion Transmissible Infection 109
Component Processing 110
Preparation of Packed Red Cells 114
Preparation of Platelet Concentrate 117
Preparation of Fresh Frozen Plasma 119
Preparation of Cryoprecipitate 121
Pretransfusion Testing (Routine) 122
Daily QC of Immunohematology Reagents 126
Preparing Laboratory Red Cells Solution 129
Resolving ABO Discrepancies 139
Reverse Typing of Blood Components 143
Issuance of Blood for Transfusion 146
Validation of Blood Units Prior to Issuance Units 148
Quality Procedure Issuance of Blood to/from
Blood Center to End User Facility 152
Suspected TTI 157
Disposal of Blood Units and Samples 161
TTI Serology NEQAS Participation 169
Appendices 185
Form 1. Risk Assessment Chart 186
Form 2. Critical Contact Information 187
Form 3. Event Assessment 189
Form 4. Budget Proposal 191
Form 5. Procurement Management Plan 193
Form 6. Application Summary Sheet 194
Form 7. Proficiency Assessment for BC Staff 195
Form 8. Evaluation Matrix for Promotion 197
Form 9. Quality Policy Issuance Monitoring 199
Form 10. Document Change Request Monitoring 201

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Form 11. List of Records 202
Form 12. Equipment Management Program Form 204
Form 13. Master Validation Plan 216
Form 13. Equipment Maintenance and Calibration 218
Form 14. Supplier Evaluation 220
Form 15. List of Approved Suppliers 221
Form 16. Verification and Traceability of Critical Material 222
Form 17. Lot Validation 223
Form 18. Data Collection Analysis 223
Form 19. Daily Blood Inventory 225
Form 20. Registry of Prospective Blood Donors 226
Form 21. Registry of Regular Blood Donors 227
Form 22. Blood Donor’s Record of Donations 227
Form 23. Donor Satisfaction Survey 228
Form 24. Complaint Report 230
Form 25. Internal Quality Audit Program 231
Form 26. QMS Audit Checklist for Blood Center 235
Form 27. Non-conformance Report 237
Form 28. Summary of Blood Center Audit 238
Form 29. Occurrence Report 245
Form 30. Occurrence Analysis 246
Form 31. Corrective Action Implementation 248
Form 32. Quarterly Corrective Action Monitoring 249
Form 33. Blood Transport Monitoring Form 250
Acronyms 251
Definitions 255
References 260

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Blood Centers (BC)

Part I: Quality Manual

1. ORGANIZATION
1.1 INTRODUCTION

a. The Blood Center upholds the provisions of the Republic Act

7719 (National Services Act of 1994) in the performance of all its
functions. The Blood Center, duly licensed by the Department of
Health (DOH), shall perform its functions under the provisions in
the DOH Administrative Order No. 2008-0008 on Rules and
Regulations Governing the Regulation of Blood Service Facilities
and DOH Administrative Order No. 2012-0012 on Rules and
Regulations Governing the New Classification of Hospitals and
Other Health Facilities in the Philippines, DOH AO No. 2021-
0066 on Guidelines of COI in BSN.

b. Blood Centers (BCs) duly licensed by the DOH shall perform the
following functions:

● Advocacy and promotion of voluntary blood donation

and a healthy lifestyle;

● Recruitment, retention, and care of voluntary blood

donors;

● Collection of blood (mobile or facility-based) from

qualified voluntary blood donors;

● Conduct health education and counseling;

● Testing of units for TTIs;

● Processing and provision of WB and blood components;

● Storage, issuance, transport, and distribution of units of

whole blood and/or blood products to hospitals and other
health facilities;

● WB component processing and labeling;

● Apheresis donation and in-house whole blood donation;

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 ● Leukoreduction and leukodepletion;

● Aliquoting of red cells for pediatric bags;

● Immunohematology and antibody screening;

● Rh-negative and other rare blood type registry;

● Quality control of blood and blood components using

statistical process control (SPC);

● Pathogen reduction technology (PRT);

● Blood irradiation;

● Cryopreservation of Rh-negative and rare blood;

● Antibody identification;

● Cord Blood Banking;

● Plasma fractionation technology;

1.2 LEADERSHIP AND COMMITMENT

The Blood Center management has the overall responsibility for the
implementation of the Quality Management System (QMS) and
communicates the direction of the organization through its Quality Policy.
The management defines Blood Center's organizational quality objectives
pertaining to good manufacturing practices, quality services, and blood
products and legal requirements. The management ensures that all
quality-related activities are coordinated at all levels of the Blood Center.
The management conducts regular monitoring and periodic reviews to
ensure effective implementation of the QMS and continuous quality
improvement.
The management recognizes that Blood Center stakeholders include the
blood donors, patients and clinicians, and suppliers.
All activities in the Blood Center are aimed at improved client satisfaction,
health outcomes, and benefits to the staff and society.
The management ensures that sufficient and appropriate resources are
available for the effective, efficient, and safe execution of the Blood
Center’s functions.

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 1.3 QUALITY POLICY

Our quality policy is defined and strongly driven by the following

management principles and behaviors, mandating that the Blood Center
shall:

● Prioritize the health and safety of the volunteer non-

remunerated blood donors, patients, personnel, and
community.

● Campaign and advocate for a 100% voluntary blood donation.

● Conform to the inspection and licensing requirements.

● Regularly and systematically review and continually enhance

processes via continuous quality improvement across all
functions of the Blood Center.

This quality policy shall be at the core of the Blood Center's strategic and
operational plans.

2. PLANNING
2.1 STRATEGIC DIRECTION

● The Blood Center shall create or formulate its vision, mission,

values, and objectives. These shall be popularized, shared, and
advocated for among its internal and external stakeholders.

● Further, the Blood Center shall write its results-oriented,

evidence-based long-term strategic plan and the key
performance indicators as the measurement of its success.

2.2 OPERATIONAL PLAN

The Blood Center shall write its annual operational plan and set its
targets for the key performance indicators as the measurement of its
success.

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2.3 QUALITY OBJECTIVES

The Blood Center shall formulate its quality objectives and set a
mechanism to monitor its progress. Examples of these quality
objectives are as follows:

To ensure the appropriate use of blood by issuing the right blood

product to the right patient at the right time and the right place at all
times.

To investigate 100% of all reported blood transfusion reactions.

To promote a 100% voluntary blood donation

To collect non-reactive blood units in 99% of donor populations.

To increase customer satisfaction rating from ___ in 2020 to ___ in

2022.

To strengthen advocacy, donor recruitment, retention, and care of

volunteer blood donors.

To maintain an updated blood donor registry.

To maintain an updated rare blood group donor registry.

To promote further research and training

2.4 EMERGENCY PREPAREDNESS AND RESPONSE

2.4.1 POLICY

The Blood Services Network shall prepare for and respond to natural
and human-induced disasters affecting the blood supply.

The Blood Services Network shall have a disaster preparedness plan

for all possible disaster scenarios affecting blood supply.

The members of the Blood Services Network shall follow the chain of
command to facilitate efficient coordination with relevant agencies.

2.4.2 QUALITY PROCEDURES

Preparedness and Response to External Disasters

Preparedness and Response to Internal Disasters

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 2.4.3 RELATED DOCUMENTS

Planning for Emergency Preparedness and Response in cases of

Disasters Affecting the Blood Supply

Managing the Blood Supply During Disasters

3. MANAGEMENT
3.1 FINANCE MANAGEMENT

3.1.1 POLICY

Due diligence shall be exercised in financial planning.

The budget shall reflect desired results, priority programs and

activities of the Blood Center, and the plan for acquiring and using its
resources. Budgetary projections shall be based on reasonable,
achievable targets for the incoming fiscal year.

All departments shall submit accomplishment reports at the end of

each fiscal year.

Fund utilization is evaluated against accomplishment reports from

the previous year.

3.1.2 QUALITY PROCEDURE

Budget Preparation

3.1.3 RELATED DOCUMENTS

Budget Proposal

3.2 HUMAN RESOURCE MANAGEMENT

3.2.1 POLICY

The Blood Center management shall ensure that all personnel has
the appropriate education, skills, training, and experience to execute
their jobs. Necessary competence and appropriate training

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 requirements have been pre-determined for each position and shall
be the basis for the selection, hiring, and promotion of personnel.

All personnel shall be given an orientation on the scope of work,

duties and responsibilities, authorities, and appropriate training to be
able to maintain competence and allow professional development.

The Blood Center management shall conduct competency

assessments for all personnel and shall maintain records of
performance.

The Blood Center management shall record employee qualifications

and update records during the entire tenure of the personnel for
reference purposes, such as promotion of personnel.

The Blood Center management shall ensure that all personnel are
made aware of the relevance and importance of their activities to the
vision and mission of the organization, desired health outcomes, and
how they can contribute to the achievement of the quality objectives.

3.2.2 QUALITY PROCEDURES

Recruitment, Selection, Hiring, Training, and Promotion of Personnel

Succession and retirement plan

Information system for Human Resources

3.2.3 RELATED DOCUMENT

Competency Assessment of Personnel

Human Resource Management and Development Plan

4 SAFETY AND WASTE MANAGEMENT

4.1 POLICY

The Blood Center shall comply with the latest Manual on Health Care
Waste Management

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 The Blood Center management shall always provide its employees
with a workplace free of hazards to ensure the safety and health of
its workforce

The Blood Center management shall effectively manage incidents

that adversely affect the safety and health of all its personnel

All personnel shall be oriented on their responsibilities on safety and

waste management and on the latest Manual on Health Care Waste
Management

4.2 QUALITY PROCEDURE

Infectious control procedure of the Blood Center

Proper disposal of expired blood products, samples, paraphernalia,

and used logistical supplies.

Proper use and disposal of single-use supplies.

Handling and Disinfection of Spills

Blood Cold Chain

Blood Donor Safety and Security – near-missed events, biosafety,

and security

Proper Disposal of PPEs

4.3 RELATED DOCUMENT

Healthcare waste management and infectious control plan and

implementation

5. EQUIPMENT MANAGEMENT
5.1 POLICY

The Blood Center shall have all the functional equipment,

instruments required for the safe, effective provision of blood
services and blood products, based on its qualification as a Blood
Center

The Blood Center shall follow procedures in equipment selection,

acquisition, qualification, operation, maintenance, calibration,

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 decommissioning, and the necessary documentation of all related
activities.

The Blood Center shall check the quality of equipment and

instruments (performance qualification/ validation) used in the
laboratory, initially prior to use in patient testing and at specified
intervals.

The Blood Center shall ensure that all equipment used in the
laboratory complies with the standard specifications and has an SOP
that details the operation, maintenance, and calibration procedures.

The Blood Center shall maintain an inventory of all equipment used

in the laboratory.

The Blood Center shall document the incidence of equipment-related

injuries and report to proper authorities for action such as, but not
necessarily limited to, maintenance, corrective actions, or recalls.

The Blood Center keeps a record of the proper maintenance and

monitoring of its equipment and instruments.

5.2 QUALITY PROCEDURE

Equipment management process

5.3 RELATED DOCUMENTS

Equipment Management Plan

Conduct of Performance Qualification/Equipment Validation

6 MATERIAL MANAGEMENT
6.1 POLICY

The Blood Center shall maintain a stock inventory and has a

documented procedure for supplies management to ensure
uninterrupted supplies of quality reagents and materials stored in a
manner that preserves integrity and reliability.

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 The Blood Center shall use reagents with a Certificate of Product
Registration (CPR) and equipment and devices that have met
international standards.

The Blood Center shall follow the procedure in the selection and
evaluation of suppliers and adheres to the procurement procedure of
the institution.

The Blood Center shall identify and track critical materials and
services and inspect and verify/validate critical supplies to ensure
that necessary quality requirements have been fulfilled.

The Blood Center shall have a procedure for the investigation and
reporting of adverse incidents or accidents directly attributed to
specific reagents and other consumables.

6.2 QUALITY PROCEDURE

Material Management

6.3 RELATED DOCUMENT

Material Reception, Inspection, Validation-Verification, Storage,

Handling, and Use

7 DOCUMENTED INFORMATION
7.1 POLICY

All documents shall be properly and systematically filed electronically

and in hard copies (if so warranted)

The Blood Center shall have a designated area for storage and
maintenance of records

All documents shall be approved prior to use. Documents that have

undergone review and revision shall be subjected to the approval
process prior to circulation and implementation.

All relevant versions of applicable documents shall be available at

points of use.

The Blood Center shall have a policy and procedure for retention of
records following DOH standards and/or competent professional

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 organizations, as stipulated in the DOH Assessment Tool for
Licensing Blood Service Facilities.

The Blood Center shall determine obsolete and prevent their

unintended use.

7.2 QUALITY PROCEDURE

Control of Documents

8 OPERATION
● BLOOD SUPPLY

8.1.1 POLICY

The Blood Center shall identify the actual demand within its area of
responsibility and ensure that balance is maintained between supply
and demand. It ensures that blood supply within the network is
appropriately managed to avoid shortage and wastage.

The Blood Center shall ensure that the blood supply comes from
voluntary blood donors from low-risk populations.

The Blood Center shall provide proper education to prospective

donors through pep talks and other educational materials and ensure
that healthy donors are encouraged to become regular donors.

The Blood Center shall maintain and monitor records of productivity

indicators to identify training needs and use this for planning and
budgeting.

The Blood Center shall maintain a record of all donors, including

adverse reactions during phlebotomy and outcome of testing for
transfusion-transmissible infections.

The Blood Center shall ensure donor safety and security

8.1.2 QUALITY PROCEDURES

Blood Donor Recruitment, Retention, and Care

Pre and post-donation counseling

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Maintaining an Optimal Blood Inventory

Blood Collection

Blood unit testing/ Transfusion transmissible infection (TTI) testing

Component Processing

Advocacy and Public Education on NVBSP

Maintaining an Optimal Blood Inventory

Quality assurance of immunohematology reagents

Antibody Screening and Antibody Identification

Blood Grouping (ABO/Rh) – Forward and Reverse

Pathogen reduction

Blood irradiation

Leukoreduction

Rare blood group phenotyping

Apheresis products

Convalescent plasma collection

Nucleic acid amplification test (negative validation)

Cryopreservation

Blood derived products (plasma fractionation)

8.1.3 RELATED DOCUMENTS

Blood Stock Inventory Management

Provision of Information to Prospective Donors (Pre-Donation)

Registration, Positive Identification, and Assessment of Blood

Donors

Donor Assessment and Preparation for Platelet Apheresis

Identification of Vein for Phlebotomy

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 Aseptic Technique for Blood Donation

Phlebotomy Procedure for Whole Blood Donation

Donor Assessment and Preparation for Platelet Apheresis

Post Donation Care

Suitability Criteria for Blood Units for Processing

Preparation of Packed Red Blood Cells

Preparation of Platelet Concentrate

Preparation of Fresh Frozen Plasma

Preparation of Cryoprecipitate

Daily QC of all equipment, analyzer (See Appendix _)

Preparation of Laboratory Red Cells Suspension (See Appendix _)

Forward and Reverse Blood Grouping (See Appendix _)

8.2 STORAGE AND TRANSPORT

8.2.1 POLICY

The Blood Center shall implement a proper cold chain procedure

during the transport and distribution of blood and blood products to
maintain the integrity of the blood components.

The Blood Center shall ensure that it has adequate equipment,

materials, and space to maintain the integrity and safety of blood and
blood products during storage and transport.

The Blood Center management shall ensure that all technical

personnel handling the blood units are trained on proper blood cold
chain procedures.

The BC shall adhere to and comply with the WHO Blood Cold Chain
Management Manual.

8.2.2 QUALITY PROCEDURES

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 Storage and Transport

Issuance and Transport of Blood from Blood Center to End User

Hospital

8.2.3 RELATED DOCUMENTS

Packing and Transport of Blood Units

8.3 SCREENING FOR TRANSFUSION TRANSMITTED INFECTIONS

8.3.1 POLICY

8.3.1.1 Only whole blood and apheresis donations that are

non-reactive in all screening tests for all markers of
the following transfusion transmissible infections
(TTI’s) shall be released for clinical use:

o Human Immune Deficiency (HIV)

o Hepatitis B

o Hepatitis C

o Syphilis

o Malaria

8.3.1.2 The Blood Center shall only use testing

methodologies prescribed by the Department of
Health – National Voluntary Blood Services Program
(DOH Circular 2013 – 0132).

8.3.1.3 Only qualified and trained staff shall perform

screening for TTIs.

8.3.2 QUALITY PROCEDURE

Screening for Transfusion Transmissible Infections

8.3.3 RELATED DOCUMENTS

Preparation of Equipment and other Instruments

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9 PERFORMANCE EVALUATION
9.1 MEASUREMENT, ANALYSIS, AND EVALUATION

9.1.1 CLIENT SATISFACTION

9.1.1.1 POLICY

The Blood Center shall implement a mechanism to monitor

consumer satisfaction. It will measure, analyze and interpret
satisfaction ratings given by its clients (blood donors, Blood
Center, partner agencies, stakeholders). Recommendations
shall be considered where and when appropriate in improving
quality blood products and blood services.

All complaints shall be managed and resolved accordingly.

Monthly reports with appropriate corrective action shall be

submitted to the healthcare facility’s Quality Assurance Office.

9.1.2 QUALITY PROCEDURE

Customer Satisfaction Measurement

9.2 EXTERNAL QUALITY ASSURANCE

9.2.1 POLICY
The Blood Center shall participate actively in an external quality
assurance program conducted by the appropriate national reference
laboratory designated by DOH or other External Quality Assessment
Program approved by the DOH

9.2.2 POLICY PROCEDURE

The Blood Center shall participate actively in external quality

assurance programs conducted by the national reference laboratory
or other External Quality Assessment programs approved by the
DOH

The Blood Center shall keep records of the certificate of its

participation in such Quality Assessment Program (including
competency assessment of personnel)

9.3 INTERNAL QUALITY ASSURANCE

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 9.3.1 POLICY
The Blood Center shall implement its own Quality Assurance
Program in conformity with the DOH policies and guidelines as well
as updated, universally accepted standards depending on its
capacity and resources.

The Blood Center shall keep records of internal quality audits and its
results

The Blood Center shall analyze the results of the internal quality
audit, recommend improving blood services and blood products

The Blood Center shall conduct quality improvement studies to

improve the delivery of blood services and blood products.

9.3.2 POLICY PROCEDURE

The Blood Center shall have procedures on internal quality control of

its reagents and internal quality audit.

9.4 INTERNAL AUDIT

9.4.1 POLICY

The Blood Center head shall ensure that all processes in the blood
service facility conform to the different standards set by the DOH and
of the different regulating bodies.

The Blood Center management shall ensure that the audit team is
provided with appropriate training in the administration of internal
audits.

The Blood Center shall conduct an internal audit regularly as

planned.

The Blood Center shall keep records of the results of its internal audit.

9.4.2 QUALITY PROCEDURE

How to Conduct an Internal Audit

9.4.3 RELATED DOCUMENTS

Internal Audit Records

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9.5 MANAGEMENT REVIEW

9.5.1 POLICY

The Blood Center management shall review the organization’s

quality management system bi-annually to ensure adequate and
effective implementation and alignment with the strategic direction of
the organization.

9.6 CONTINUOUS QUALITY IMPROVEMENT (CQI)

9.6.1 POLICY

The Blood Center shall maintain a system of identification and

documentation of all non-conformities, deviations from planned
arrangements, or other problems.

All identified non-conformities, deviations from planned

arrangements, or other problems shall be properly investigated,
analyzed, and corrected.

All implemented corrective actions shall be monitored and evaluated

for effectiveness, safety, and relevance.

Progress to the attainment of quality objectives shall be monitored.

Opportunities for improvements shall be identified and translated into

strategic and operational action

The Blood Center shall integrate the Continuous Quality

Improvement Plan into its strategic and operational plans.

9.6.2 QUALITY PROCEDURE

Corrective action

9.6.3 RELATED DOCUMENTS

Root Cause Analysis using analytical tools

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Part II: Process Manual – Administrative Procedures
Planning for Preparedness and Response to
Emergencies

1. PURPOSE
This document guides the institutional members of the Blood Center
network in ensuring the adequacy and timely distribution of blood, personnel
and donor mobilization, and safety during disasters.

This is also to guide members of the Blood Center network on the effective
implementation of the emergency response plan (ERP) of the DOH NVBSP.

2. PRINCIPLE

Careful planning and sourcing are essential in emergency preparedness,

disaster response, and risk reduction.

3. SCOPE AND LIMITATIONS

This document starts with planning for emergency preparedness, disaster

response, and risk reduction. (to include recovery and rehabilitation) to post-
disaster evaluation.

4. RESPONSIBILITIES

Department of Health National Voluntary Blood Services Program (DOH-

NVBSP) – issues directives to the Blood Center network for a coordinated
response during disasters

Emergency Preparedness and Crisis Management Team (EPCMT) –

formulates guidelines /and operationalizes the emergency response plan
(ERP) of the Blood Center network

BC Coordination with Central Command like/for example, One Hospital

Command/Emergency Operation Center (EOC)

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5. GUIDELINES

Formulate an emergency management plan that contains preparedness,

contingency measures, risk mitigation, communications, transport, and
logistics, among others.

Create procedures for staff to deploy the emergency response plan (i.e.,
whom to contact, when and how to contact, and what information to
exchange). Maintain and update regularly the Critical Contact Information.
Disseminate in all areas.

Define the roles of the essential employees during a disaster. Employees

who have been selected for special roles (e.g., those who live near the Blood
Center) should be identified.

Prepare a list of critical products, services, and supplies.

Determine critical supplies that may be needed during disaster-related

events.

Reassess minimum inventory requirements.

Determine product reserves of suppliers, and lead time.

Prepare for alternative means of communication since it is possible that

telecommunication lines will be cut off during disasters.

Identify transportation options such as Blood Center motor pool, local police,
or commercial carriers where necessary.

Identify an area within the perimeter grounds of the Blood Center where
emergency supplies may be stored (flashlights, batteries, water, etc.)

Identify alternative facilities.

Access alternative power sources for storage refrigerators, freezers,

machines used for screening transfusion-transmitted infections, and
workstations.

Conduct drills semi-annually to test the ERP.

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6. RISK MANAGEMENT / SAFETY PRECAUTIONS

Natural and human-induced disasters may significantly increase the

demand for blood supply. Heightened community connections also increase
over-response. Potentially infectious donations from first-time donors are
also likely to increase.

Anticipate the need for essential resources, including:

People

Facilities

Materials and supplies

Communications

Money

Logistics and transport

Other special support

6.1 Identify the triggers that will activate the ERP.

6.2 Establish the chain of command and order of succession.

6.3 Conduct risk assessment annually.

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7. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
1. Blood Center Service Network
Start ● The Blood Center may be chosen
as an alternative facility for a
Command Center if it is
strategically located outside the
impact areas.
1. Plan
● Refer to Risk Assessment Chart
and WI Planning for Disasters
2. Blood Center Service Network with
EPCMT

2. Respond ● The Blood Center nearest the

disaster area activates the response
team within the network. Refer to
Table of Critical Contact
Information.
● Review the extent of physical
damage among Blood Centers in
areas affected (if any) and the need
for blood supply.
● If possible, check the NBBNets for
available stocks of blood in the
network for immediate mobilization
to the area of impact.
3. Evaluate effectiveness of ● Refer to Template – Event
response Assessment
3. Blood Center Service Network with
RRCMT
● Review the effectiveness of the
response and identify areas for
4. Formulate and implement improvement
agreed improvements
● Monitor and evaluate the
performance and effectiveness of
the mitigations
End 4. Blood Center SERVICE network
with RRCMT
● Disseminate policy/procedure
updates

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 8. DOCUMENTATION (Forms, Worksheets)

● Risk Assessment Chart (Please see Appendix A)

● Critical Contact Information (Please see Appendix B)
● Event Assessment (Please see Appendix C)

Preparedness and Response to Internal Emergencies

1. PURPOSE

This document guides the Blood Center management and personnel in

ensuring adequate and effective response during internal disasters to
minimize casualties and injuries.

2. SCOPE AND LIMITATIONS

This document starts from the detection of an internal disaster to post-

disaster evaluation.

3. RESPONSIBILITIES

3.1 Blood Center Personnel who first detected the emergency or disaster
shall notify the designated incident commander

3.2 Incident Commander – activates the emergency response teams

3.3 Disaster Response Team – spearheads the operations and logistics

during disasters affecting the Blood Center

3.4 Evacuation Team – responsible for organized evacuation to minimize

casualties and injuries during disasters

3.5 Medical Emergency Team – provide immediate on-site stabilization

and management during disasters

3.6 Designated Triage Personnel – classifies injured individuals according

to the severity of physical injuries and level of medical care needed.

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4. RISK MANAGEMENT/SAFETY PRECAUTIONS:

4.1 All Blood Center personnel should follow the disaster response
protocol to minimize casualties and injuries.

4.2 All Blood Center personnel who have been identified to have critical
roles in the implementation of the disaster response protocol should
be properly trained.

4.3 Drills should be conducted quarterly.

4.4 Appropriate personal protective equipment (PPE) should be made

available in case of emergencies/disasters.

4.5 All forms of mitigation implemented should be monitored and

reviewed for effectiveness.

5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART DESCRIPTION OF ACTIVITY

Start
1. Personnel present at the area
where the emergency is first
detected
● The following are the different
types of internal emergencies
1. Detect and disasters
disaster/emergency
- Fire
- Bomb explosions
within the Blood
Center and
surrounding areas
2. Notify - Biohazard spills
- Earthquake
2. Personnel who first detected the
emergency situation

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 ● Internal communication is
A very important during any
emergency situation.
● In case of fire, activate the
nearest fire alarm where
required and call the
appropriate emergency
3. Activate emergency
response and resource
response teams
personnel immediately.
3. Incident Commander
● Activate Disaster Response
Team, Evacuation Team,
4. Evacuate and Medical Emergency
Team.
4. Evacuation Team
● Follow evacuation protocol.
Lead evacuees to identified
5. Triage, assess and manage safe areas.
the injured appropriately. 5. Designated Triage Personnel
and Medical Emergency Team
● Set up a mobile emergency
treatment room.
● Triage injured patients
according to the severity of
End the injury.
● Attend first to seriously injured
individuals.
● Coordinate transfer of the
injured to other health
facilities if necessary.

28
 Managing Blood Supply During Disasters

1. INTENDED USE

To guide the Blood Center management and personnel in managing blood

donors and blood supply during disasters

2. PRINCIPLE

2.1 An optimum balance between the supply and demand for blood during
disasters may be achieved by having a sound logistic plan and making
informed decisions.

3. PROCEDURE

3.1 Identify a clean and spacious area for blood collection. Consider other
contingency locations if the estimated need for blood supply is high.

3.2 Implement infectious control measures

3.3 Determine traffic control measures to maintain order and security of

donors and staff.

3.4 Determine the maximum number of donors that the Blood Center can
handle. Consider the following:

● Need
● Staff
● Supplies (materials, reagents for blood grouping and
screening for TTIs)
● Time
● Capacity for storage
3.5 Document the event, its effects, mitigation, and the need of end-users.

3.6 Refer to the NBBNets for available stocks within the network. If stocks
are low, consider the need to draw blood only from group O positive
donors for the first 24 hours. Reassess after 24 hours. Avoid
unnecessary donations that may only flood the supply.

3.7 Maintain close coordination with members of the Blood Center network
to determine medical needs.

29
 3.8 Open communication lines for all stakeholders

3.9 Inform stakeholders of the current setup and available blood services
and blood products

Budget Preparations

1. PURPOSE

This document guides the Blood Center middle managers on the steps in
preparing a budget proposal that will effectively support the programs and
operations of the Blood Center

2. PRINCIPLE

A carefully planned budget proposal should be able to support the core

functions, strategic direction, and obligations of the Blood Center.

3. SCOPE AND LIMITATIONS

This document covers the orientation regarding the budget policies process
for budget allocation to the approval of the budget.

4. RESPONSIBILITIES

4.1 Finance Head – conducts orientation to the department heads and

supervisors on budget preparation and policies

4.2 Section Head –prepares the initial budget proposal for each functional
unit

4.3 Unit Supervisor – reviews the initial budget proposal prepared by the
Section Head and elevates the proposed budget to the Finance/Budget
Committee; responsible for teaching section heads on how to prepare a
budget proposal.

4.4 Budget Committee – responsible for final deliberation of the budget and
recommends approval to the Blood Center Director

4.5 Blood Center Head – approves final budget for implementation

30
5. PROCEDURE

5.1 Check for new directives from the Department of Health, related
regulatory offices (local government office, Philhealth), and Blood
Center management that would affect the requisition/procurement
process.

5.2 Take the following factors into consideration when doing the budget
planning:

● Historical data (previous two to three years)

● Staff needs related to capacity requirements, education and

training, occupational health, and safety

● New standards and technology upgrade

● Replacement of defective equipment (beyond repair)

● Repair, preventive maintenance, and calibration requirements of

machines

● Regulatory expenses (licenses, external quality assessments,

etc.)

● Special facilities such as irradiation facilities

● Waste management and disposal

● Risk management, including biosafety concerns and estimated

allowance for disaster

5.3 Make reasonable projections based on history, desired results, and

identified emerging needs.

31
6. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
1. Finance Head
Start
● Orient new heads/supervisors;
discuss new policies and formats as
needed.
2. Section in charge
1. Orient department heads ● Refer to the following:
and supervisors on budget
preparation ● WI - Preparing an Initial Budget
Proposal
● Template - Budget Proposal
● Template - Procurement
Management Plan
2. Prepare initial budget
proposal ● Ensure that all templates are
the updated version
3. Unit Supervisor
● Validate the programs/projects;
make necessary revisions.
3. Review initial budget
proposal ● Recommend the budget proposal
to the Finance/Budget
Committee.

4. Budget Committee
4. Validate budget proposal ● Check alignment of programs and
projects with the mandate/purpose
of the Blood Center.

5. Blood Center Head

5. Approve final budget ● Ensure that all recommended
budget proposals undergo
deliberation by the Budget
Committee.
● Approve and sign the final budget
End for implementation

32
7. DOCUMENTATION

● Budget Proposal
● Procurement Management Plan

Recruitment, Selection, Hiring of Human Resources

Promotion of Human Resources

1. PURPOSE

This document guides the Blood Center human resource staff and
personnel board on procedures regarding the promotion of personnel.

2. SCOPE AND LIMITATIONS

This document starts from the determination of vacancies of higher

positions for filling up to the final approval for promotion. It describes the
minimum standard requirements in Education, Experience, and
Performance.

3. RESPONSIBILITIES

● HR Manager - initiates the promotion procedure by determining the

vacancies, calling for applications, and initial screening of documents.
● Personnel Board – reviews applications and recommends to the Blood
Center Head for final approval
● Blood Center Head/Medical Director - gives final approval for personnel
promotion

4. RISK MANAGEMENT / SAFETY PRECAUTIONS

● Ensure integrity of personnel records.

● Use personnel promotion matrix to ensure objectivity in assessment.

33
5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start
1. HR Manager
● Ensure that all personnel who
deserve promotion are considered
for career advancement.
1. Determine vacancy of
positions
1. HR Manager

● Publish vacant positions and

minimum requirements for
promotion.
2. Call for applications for ● Establish the application period.
promotion

2. HR Personnel

● Ensure completeness of the

following documents.

- Letter of Intent / Updated

3. Receive applications curriculum vitae

- A minimum of three letters of

support from professional
colleagues

3. HR Manager
4. Determine eligibility of ● Determine completeness of
personnel for promotion documents required for
promotion.
● Prepare Application Summary
A Sheet.
● Analyze performance

34
 A 4. Personnel Board

● Check if the applicant meets the

minimum standards for
5. Review applications and Education, Experience, and
recommend personnel for Performance. Use the Evaluation
promotion Matrix for Promotion (EMP)
template in ranking applicants.

5. Blood Center Head/Medical

Director
6. Approval
● Makes final promotion decision.

● Writes formal notification to the

End successful applicant.

6. DOCUMENTATION (Forms, Worksheets)

● Application Summary Sheet

● Evaluation Matrix for Promotion

Competency Assessment of Blood Center Technical

Personnel

1. INTENDED USE

This document guides the human resource personnel, supervisors, and

department heads in conducting competency assessments among
personnel. Contents of the competency assessment should be appropriate
for the position of the personnel being assessed.

2. PRINCIPLE

Objective assessment of the performance of personnel is essential to

human resource planning. It aids in the preparation of the training plan and
the basis for the promotion of personnel.
3. GUIDELINES

3.1 Competency assessment shall be conducted semi-annually.

35
 3.2 The competency assessment must include the following:

3.2.1 Direct observation of:

● routine test/procedure performance;

● recording and reporting test results or worksheets;
● review of intermediate test results or worksheets, quality
control records, and preventive maintenance records; and
● performance of instrument maintenance and function
checks.
● Assessment of test performance through testing
previously analyzed specimens, internal blind testing
samples; and
● Evaluation of problem-solving skills.
● Evaluation of leadership skills

3.3 Competency must be evaluated and documented for each test system.

Control of Documents
1. PURPOSE

This document guides all Blood Center personnel on the document control
procedure

2. SCOPE AND LIMITATIONS

This document starts from the identification of need document control to the
final updating of controlled documents.

3. RESPONSIBILITIES

● Supervisor/Section Head - initiates creation of a new document or

amend an existing controlled document; prepares document control
request upon discusses of changes in the document with the Unit
Head

● Unit Head – checks appropriateness of the content of new or revised

documents

36
 ● Document Controller – controls the numbering, filing, sorting, and
retrieval of documents. These documents may be in hard copy or
electronically stored.

● Quality Manager – ensures that the document control procedure is

strictly followed and implemented; maintains the Master Copy of all
documented information master list of documents and records

4. RISK MANAGEMENT/SAFETY PRECAUTIONS

● All documents disseminated in the Blood Center must be of the

latest revision.
● Ensure availability and security of backup of controlled documents.

5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start
1. Supervisor/Section Head

● The need may arise from a new

regulatory standard, organizational
1. Determine needed
resolution, or corrective/preventive
document
action for an identified
problem/issue.

2. Supervisor/Section Head/Unit Head

2. Creation/Revision of
document ● Use Document Control Form.

● Check content.

3. Control document. 3. Document Controller

● Mark new document

A ‘CONTROLLED.’

A
4. Document Controller

37
 ● Pull out the obsolete document
from files in work areas.
Replace with a new/revised
4. Distribute controlled document.
document to concerned units.

5. Document Controller
5. Archive obsolete ● Remove the obsolete document
document. from current files.

6. Document Controller
6. Update and maintain
● Update all records.
records.

END

6. DOCUMENTATION (Forms, Worksheets)

● Quality Policy Issuance Monitoring

● Document Register
● Document Change Request Monitoring
● List of Records

38
 Equipment Management

1. PURPOSE

This document guides the Blood Center technical staff on the

implementation of the equipment management program and documentation
of all related activities.

2. SCOPE AND LIMITATIONS

This document contains the procedures from selection, acquisition,

qualification, operation, maintenance, calibration, decommissioning, and
the necessary documentation of all related activities. Equivalent forms for
recording all activities are provided in this document.

3. RESPONSIBILITIES

● Section Head – performs the initial equipment selection process,

performance qualification, calibration, and maintenance as
scheduled, and documents all processes
● Blood Center Biomedical Engineer – together with the Section Head,
supervises the installation and operation qualification processes
conducted by the vendor/supplier engineer.
● Unit Supervisor – together with the Biomedical Engineer, supervises
the installation and operation qualification processes conducted by
the vendor/supplier engineer; supervises performance qualification;
ensures that all activities are documented properly.
● Procurement Committee – evaluates a selection of equipment
according to preset standards and recommends to the Blood Center
Head for final approval
● Blood Center Head– gives final approval for the equipment selection
and acquisition processes.

4. RISK MANAGEMENT / SAFETY PRECAUTIONS

● Identify the hazards inherent to the equipment (e.g., UV, radiation),

operational hazards (e.g., moving parts, sharps), chemical hazards
(e.g., reagents, calibrators, and controls), and biological hazards
(specimen used).
● Implement mitigation strategies such as elimination/substitution,
engineering control, administrative (training, availability of standard

39
 operating procedures [SOP], precautionary labels and signages), and
use of personal protective equipment (PPE).
● Equipment operating manual must be available. Read and understand
the safety precautions necessary in the operation of the equipment.
● Safety Data Sheets (SDS) of all chemicals/substances used in the
operation of the equipment should be available.
● Safety signages and precautionary labels should be posted in visible
areas.
● Universal precautions must be observed.
● Only trained and authorized staff should operate the equipment.
● Appropriate PPE should be used at all times.
● Monitor periodically and review the performance and effectiveness of
the mitigation implemented.

5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start 1. Section Head/Unit Supervisor

Discuss the need for new
equipment with the Unit Head

1. Determine what equipment List the standard technical

to procure (Selection specifications of equipment
Qualification)
Request for quotations and
brochures from vendors.

2. Procure equipment 2. Blood Center Management

(Equipment Acquisition)
Equipment acquisition follows the
facility procurement policies and
procedures.

A
3. Section Head

40
 Initiate and maintain an
equipment master file.

4. Section Head and Blood Center

Biomedical Engineer
3. Create the equipment file
and records Perform the Installation
Qualification (IQ), Operation
Qualification (OQ), and
Performance Qualification (PQ)

Section Head

4. Perform the equipment Record the results of the IQ, OQ,

qualification process and PQ.

Prepare the Validation Report.

5. Section Head

● Refer to the WI Equipment

5. Write the equipment
Management Process.
SOP
6. Section Head and Unit Supervisor

● Review and approve the Validation

Report, and put it in use for patient
testing.
6. Approve equipment for
use in patient testing
7. Section Head and Product Engineer

● Identify the calibration materials, and

establish calibration procedure and
7. Perform the calibration acceptance/ rejection criteria following
procedure. the manufacturer’s specification.

● Perform the calibration at a specified

frequency using the recommended
calibration materials

● Evaluate the results based on the

A established acceptance/ rejection
criteria.

8. Section Head
A

41
 ● Perform and record the maintenance
activities (routine, corrective and
preventive), function checks, service,
and repairs performed.

● Report equipment-related
8. Perform and record injuries/incidents, if any
maintenance activities

Unit Supervisor
● Maintain an inventory of all equipment

9. De-commissioning

9. Section Head

● Perform the various steps in the

decommissioning process
End ● For the detailed procedure of the above
activities, refer to the following WI –

- Equipment Management Process

Conducting Performance
Qualification/ Equipment Validation

6. DOCUMENTATION (Reports, Worksheets)

● Equipment Management Form

● Master Validation Plan
● Validation Plan
● Validation Report
● Equipment Calibration and Maintenance Form

42
 Equipment Management Process

1. INTENDED USE

This document guides the technical staff, section supervisor, biomedical

engineering staff, QA officer, and unit head in performing the various steps
in equipment management

2. PRINCIPLE

A functional equipment management program ensures that equipment

used in the facility meets the standard specifications and is calibrated and
maintained to produce optimum quality results.

3. PROCEDURE

3.1 Selection Qualification

3.1.1 Discuss the need for new equipment to the Unit Head based on
the evidence-based assessment of need.

3.1.2 Prepare the standard technical specifications of the equipment.

3.1.3 Request for quotations and brochures from vendors.

3.1.4 Coordinate and follow the procurement policies and procedures

of the institution.

3.1.5 Keep a copy of all communications, minutes of meetings, and

other relevant documents for future reference.

3.1.6 Evaluate the equipment based on the technical performance

and service capability of the vendor.

3.1.7 Document the above activities in the “selection qualification”

section of the Equipment Management Form

3.2 Equipment Acquisition

● Follow the institution procurement procedure for approvals and

signatories.
● Procure equipment that met the approved requirement set by the
FDA or equipment that met the required technical specifications
for the Blood Center.

43
 ● Upon delivery, call the responsible person and double-check the
received equipment with the delivery receipt and the agreed
specifications.
● Record the above activity in the “Inspection Upon Delivery”
section of the Equipment Management Form.

3.3 Creating equipment and record

● Maintenance Record (Routine, Corrective and Preventive)

● Calibration Record
● Qualification (IQ, OQ, PQ) Record
● Other files, e.g., operation manuals
3.4 Equipment Qualification

● Equipment Identification
a. Biomedical Engineering or an equivalent unit issues
the unique identifier of the equipment. Laboratory may
opt to add additional ID such as centrifuge 1, 2, etc.
● Enter all relevant data into the “Equipment Identification”
section of the Equipment Management Form.
● Performing installation qualification (IQ)
a. Check the installation of equipment.
b. Confirm/verify that the instrument's installation
meets environmental requirements established by
the manufacturer. Refer to the criteria listed in the
“Installation Qualification” section of the Equipment
Management Form.
c. Record the above activities in the “Installation
Qualification” section of the Equipment
Management Form.
● Performing operational qualification (OQ)
a. Confirm/verify that the instrument’s basic
operational specifications established by the
manufacturer are met. Refer to the criteria listed in
the “Operation Qualification” section of the
Equipment Management Form.

44
 b. Record the above activities in the “Operation
Qualification” section of the Equipment
Management Form.
● Conduct performance qualification (PQ)
a. Prepare the validation plan and perform the
validation process.
b. Perform the validation experiment as deemed
appropriate. Refer to WI Conducting the
Performance Qualification/Equipment Validation
for detailed instruction on the validation process.
c. Confirm/verify that the equipment produces
acceptable results under normal operating
conditions by testing both the device and the
process's ability to manage the work in the
anticipated time frame and meets the acceptance
criteria as set forth. Refer to the criteria listed in the
“Performance Qualification” section of the
Equipment Management Form.
d. Record the above activities in the “Performance
Qualification” section of the Equipment
Management Form.
● Writing the equipment standard operating procedure (SOP)
a. Write the SOP following the institution document
template/format and control procedure and
informed by the equipment’s operating manual
b. Ensure that procedures on equipment routine use/
operation, including the start-up and emergency
shutdown procedure, maintenance and function
checks, and calibration (material, frequency, and
procedure for internal calibration and external
calibration with a reference device traceable to the
National Institute of Science and Technology
[NIST] or equivalent, as applicable) are described
in the equipment SOP.
c. Prepare the maintenance and calibration form by
listing the recommended daily, weekly, monthly,
and as-needed activities in the “description of
activity” section of the Equipment Calibration and
Maintenance Form.

45
● Approval for use in patient testing
a. Train all staff in operation, calibration, and
maintenance of the equipment.
b. Ask the technical staff to read the SOPs.
c. Document the staff training and competency
assessment.
d. Review the Validation Report
e. Approve the validation Report and its use for
patient testing.
f. Authorize the trained staff to use the equipment
for patient testing.
● Performing calibration
a. Refer to equipment SOP on how to calibrate the
equipment
b. Perform the calibration as scheduled
c. Upon installation, ask the supplier to calibrate the
new equipment.
d. Ask for a copy of the certificate of calibration.
e. Maintain the calibration by performing the
recommended internal and external calibration
procedures as per the manufacturer’s
instructions.
f. When the initial calibration is due, perform the
recommended external calibration with a
Reference Device (traceable to a national
standard of measurements such as NIST or
equivalent) or maybe sub-contracted to an
external party. Note the identity of the reference
standards’ traceability to a national standard of
measurement.
g. Keep a record of calibration supported by the
calibration certificate.
h. Label all calibrated equipment with the date of the
last calibration, the signature of who performed
the calibration, and the date of the next calibration
due.
i. Record all activities performed in the maintenance
and calibration form (attach the PM and

46
 Calibration reports in the appropriate section of
the equipment folder).

● Performing Performance Checks and Maintenance

a. Refer to equipment SOP on how to maintain the
equipment
b. Use the prepared Maintenance and Calibration
form to guide which function check or
maintenance procedure is due.
c. Perform the recommended function checks and
maintenance (routine, preventive and corrective)
activities as scheduled.
d. Routine maintenance: perform the recommended
daily, weekly, and monthly function checks and
maintenance procedures.
e. Corrective Maintenance: Equipment minor
troubleshooting and equipment service and repair
are recorded in the maintenance and calibration
form.
f. Preventive Maintenance: keep a schedule of the
Periodic Preventive Maintenance (PPM) and
arrange with the supplier or external party in
performing the PPM.
g. Record maintenance activities in the Equipment
Calibration and Maintenance Form.
h. Section Supervisor reviews and signs the monthly
Equipment Calibration and Maintenance Form.
i. File/Archive the signed Equipment Calibration
and Maintenance Form in the appropriate section
of the equipment folder.
● De-commissioning procedure
a. Decide to de-commission/retire or dispose of the
equipment.
b. Remove all containers of hazardous and/or
infectious substances from equipment. Follow the
Blood Center waste management protocol.
c. Decontaminate the equipment according to the
manufacturer’s recommendations.

47
 d. Transfer patient information, for equipment
capable of retaining patient health information or
other confidential information, to an alternative
location (e.g., external hard drive, etc.). Once the
confidential data is transferred, delete all
information from the equipment.
e. Arrange the disposal/ transfer of the equipment.
f. Record the above activities in the “de-
commissioning” section of the Equipment
Management Form.
● Reporting equipment-related injuries/incidents
a. Follow the Blood Center procedure on incident
reporting.

Performance Qualification/Equipment Validation

1. INTENDED USE

This document guides the Technical Staff, Unit Supervisor, and Biomedical
engineer in performing the various steps in the equipment performance
qualification/validation process. It describes the minimum requirements in
equipment performance qualification. Reference to the manufacturer’s
specification inherent to the equipment, procedure, or assay, is
recommended.

2. PRINCIPLE

Equipment validation confirms that the level of measurement is sufficient,

the measurement procedures are correct, and the calibration was properly
done. Likewise, verification confirms that the measurement method/
measuring system is fully functional in a specific laboratory.

3. DEFINITIONS

● Validation - Establishing recorded evidence that proves a high

degree of assurance that a specific process will consistently
produce an outcome meeting its predetermined specification
and quality attributes.

48
● VMP - Validation Master Plan

● Verification - Evaluating the performance of a system with

regard to its effectiveness based on the intended use.

● Accuracy Protocol - intended to estimate inaccuracy or

systematic error. Usually done by running the same set of
specimens in the new method and the comparative method

● Precision Protocol - intended to estimate the imprecision or

random error of the analytical method expected in a test result
under the normal operating conditions of the laboratory

● Linearity / Analytical Measurement Range Protocol - intended

to determine the range of analyte values that a method can
directly measure on the specimen without any dilution,
concentration, or any pre-treatment used to extend the direct
analytical measurement range

● Analytical Sensitivity Protocol - intended to estimate the lowest

concentration of an analyte that can be measured

● Analytical Specificity Protocol - intended to estimate the

systematic error caused by other materials that may be present
in the specimen being analyzed

● Diagnostic Sensitivity/Diagnostic Specificity Protocol -

Diagnostic Sensitivity is the probability that a test result is
positive given the subject has the disease. Diagnostic
Specificity is the probability that a test result is negative given
the subject does not have the disease

● Predictive Value Protocol - Positive Predictive Value is the

probability that a subject has the disease, given that the result
of the test is positive. Negative Predictive Value is the
probability that a subject does not have a disease given that the
result of the test is negative

49
 ● Carry-Over Check Protocol- used to check if the analyte has a
carry-over into the subsequent sample, which may lead to
inaccurate qualitative or quantitative results when using
instrumental methods

● Dilution Check Protocol – the effect of sample dilution must be

determined for samples that are above the established
calibration curve to evaluate its effect on the method’s accuracy
and precision.

● Stability Check Protocol- it is carried out to address situations

normally encountered in laboratory operations since an
analyte’s stability may be affected by a number of variables,
including storage conditions and sample processing

4. SPECIMEN

● Biological samples
● Reference samples

5. MATERIALS / EQUIPMENT

● Reagents
a. Standards
b. Calibrators
c. Control

6. QUALITY CONTROL

● Perform validation and verification activities.

● Complete and maintain documents.

7. PROCEDURE

● Making a Validation Master Plan (VMP)

a. Make a master list of all equipment in the facility.
b. List down first all the analytical equipment/test systems,
followed by the non-analytical equipment/device.

50
 c. For the analytical equipment, identify if the equipment/ test
system is a qualitative test, semi-quantitative test
(instrument response is quantitative, results are reported
qualitatively), or quantitative test. Identify if the method is
non-modified, FDA approved, or modified-FDA-approved.
d. For the non-analytical equipment (e.g., centrifuge, timers,
etc.), enter the calibration schedule instead of the
validation schedule. Put n/a for items that are not
applicable.
e. Enter all relevant data in the Validation Master Plan Form.
f. Preparing the validation protocol and experiments for
analytical equipment
g. Identify the validation protocols that will be performed as
follows:
● For qualitative tests (non-modified, FDA approved),
follow the manufacturer’s instructions on operation
strictly and ensure an internal quality control
program is in place. No further validation is
required.

● For quantitative tests (non-modified, FDA

approved), verify the manufacturer’s claim of
accuracy, precision, and linearity/analytical
measurement range.

● For quantitative tests (modified, FDA approved) or

laboratory-developed tests, perform validation
experiments to establish the performance in terms
of accuracy, precision, linearity/analytical
measurement range, analytical sensitivity, and
analytical specificity.

h. Make the validation plan and protocol for the equipment

scheduled for validation.
i. Set the acceptance criteria for the validation protocols that
will be performed. Refer to the manufacturer’s inserts on
the method kit, reagent, calibrators, and control for the
claimed performance characteristics.
j. Enter all relevant data in the Validation Plan.
● Performing the required validation protocol/experiment, as
required

51
 a. Select the suitable material/specimen to be used in the
validation experiment.
b. Prepare all the samples that will be needed, and ensure
that enough samples are available to finish the validation
experiment.
c. Calibrate and maintain the equipment as per routine.
d. Ensure that the same lot of reagents, calibrators, and
controls are available to finish the validation experiment.
e. Prepare all the validation worksheets that will be needed.
f. Enter all relevant information in the validation worksheets.
g. Perform the validation experiment.
h. Enter all data at the time the tests are performed.
i. Assess any failure encountered in the validation.
j. Validation Protocols – perform the following as required
k. Accuracy
l. Precision
m. Linearity/Analytical Measurement Range
n. Analytical Sensitivity
o. Analytical Specificity
p. Diagnostic Sensitivity/Diagnostic Specificity
q. Predictive Value
r. Other Protocols/ as needed:
● Carry Over Check

● Dilution Check

● Stability Check

● Preparing the Validation Report

a. Select the appropriate data analysis and the acceptance
criteria.
b. Calculate the appropriate statistics for data analysis.
c. Evaluate and compare the observed error with the
acceptable error or the manufacturer’s claim.
d. Accept or reject the validation protocol.
e. Approve or disapprove of patient testing.
f. Attach the validation report to the Equipment Management
Form
g. Maintaining the Validated State
h. Verify the following parameters every six (6) months.

52
 ● Linearity/analytical measurement range

● Carryover the check (if applicable)

● Method comparison every 6 months if two or more

equipment/test systems are used for patient testing.

8. PROCEDURAL NOTES

Table 1: Suggested Validation Protocols (experiments)

No. of Levels/
Validation No. of Replicates/ Duration/ Data Analysis Acceptance Criteria
Protocol Run Order
(as appropriate)
1. Linearity/ ● 3-5 levels Plot the data ● Visual checking

9. AMR ● replicates per level ● Each level must be

Calculate r, slope, within the +20% of the
● Run in 1 day and intercept nominal value

● Acceptable r, slope, and

intercept

2. Precision ● 2-3 levels Calculate mean, ● Calculated SD less than

SD and CV manufacturer’s claim
● 20 replicates/ level for precision

● Run 4 samples/5 days or

2 samples/10 days

3. Accuracy ● 40 samples at varying Difference Plot ● Qualitative tests:

levels covering the AMR
No discrepant result
● 2 replicates/ level Comparison Plot
● Quantitative Tests :
● 8 samples/day for 5 days
Each level must be
Calculate r, slope,
within the +20% of the
● Run within 2 hours and intercept
nominal value
intervals between 2
methods ● Acceptable r, slope, and
intercept

53
 Table 2: Other Validation Protocols (perform as needed)

No. of Levels/
Validation No. of Replicates/ Duration/ Data Analysis Acceptance Criteria
Protocol Run Order
(as appropriate)
1. Analytical ● 2 levels (Blank and sample Check the data ● For L0B, the claim is
Sensitivity near LoD) verified if <3 of the
20 results on the
LoB- ● 20 replicates/sample blank sample exceed
the claimed LoB.
limit of blank
● Run 4 samples/ day for 5
LoD – days ● For LoD, the claim is
verified if <3 of the
20 results on a
limit spiked sample is
of below the LoB.
detection

2. Analytical ● 3 sets of paired samples Calculate the Observed systematic

Specificity average of error<Tea
● 2 replicates per sample duplicates, the
difference between
● Run in 1 day the results on the
paired samples, and
the average of the
difference for all the
specimens.
3. Diagnostic Known negative and positive Diagnostic Obtained result should be
Sensitivity/ samples Sensitivity = TP/ < the manufacturer’s
Diagnostic (TP+FN) claim.
Refer to guidelines in
Specificity
calculating the sample size Diagnostic
Specificity = TN/
(TN+FP)
4. Predictive Positive Predictive Obtained result should be
Value Value: < the manufacturer’s
claim.
TP/(TP+FP)
Negative Predictive
Value:
TN/(TN+FN)
5. Carry Over ● 2 levels (High (H) and Low Low % Carry Over : % carry over <TEa
Check (L)
(H1-H3/H3-L3)*100
● Run in the following order High % Carry Over:
L1-L2-L3-H1-H2-H3-L4-L5-
(L4-L6/H3-L6)*100
L6

● Run in 1 day

54
 No. of Levels/
Validation No. of Replicates/ Duration/ Data Analysis Acceptance Criteria
Protocol Run Order
(as appropriate)
6. Dilution ● Serial dilutions of the ● Difference Plot ● Each level must be
Check patient sample with a high of the nominal within the +20% of
concentration value and the the nominal value
obtained values
● 1 replicate/dilution at varying time ● Acceptable r, slope,
dilutions and intercept
● Run in 1 day
● Calculate r,
slope, and
intercept

7. Stability ● 2 levels (Patient samples ● Difference Plot ● Stable up to time or

Check with high and low levels) of the nominal situation where the
value and the result is within the
● 2 replicates/level obtained values +20% of the nominal
at varying time value
● Run at different time intervals or
intervals or in different situations
situations

55
 Material Management

1. PURPOSE

This document guides the Blood Center technical staff in the

implementation of the material management program and documentation
of all related activities.

2. SCOPE AND LIMITATIONS

2.1 This document describes the various procedures from supplier evaluation,
purchase of materials, inspection and verification of received materials,
storage and handling, identification and tracking of critical materials, and
inventory management. Existing forms and records or an electronic
inventory system may be used, provided all the required documentation is
met.

2.2 It describes the minimum quality requirements in the management of

supplies and logistics necessary for the effective, efficient, safe operations
of the Blood Center. For more detailed requirements, refer to the
manufacturer’s instructions.

3. RESPONSIBILITIES

3.1 Section Head, Unit Supervisor – responsible for selection, qualification,

receiving and inspection of materials, monitors storage and handling,
identifies critical materials, verification/validation.

3.2 Procurement/Purchasing Officer – reviews purchasing agreements and

maintains a list of accredited suppliers.

3.3 Technical Staff – checks storage conditions of materials and reports

deviations from prescribed storage conditions.

4. RISK MANAGEMENT / SAFETY PRECAUTIONS

4.1 Identify the hazards that may be incurred while handling the supply.

4.2 Implement mitigation such as elimination/substitution, engineering

control, administrative, and use of personal protective equipment
(PPE).

4.2.1 Package inserts must be available; read the precautions

necessary in handling and using the material/supplies.

56
 4.2.2 Safety Data Sheets (SDS) of all chemicals/substances must
be available.

4.2.3 Proper labeling of all prepared solution/s must be observed.

4.2.4 Safety signage and precautionary labels, in a manner that is

easily understood, shall be posted in visible areas.

4.2.5 Storage and handling must follow the manufacturer’s

instructions.

4.2.6 Availability of SOPs.

4.2.7 Only trained and authorized staff shall work in the

laboratory.

4.2.8 Wear appropriate PPEs where necessary.

4.3 Monitor and review the performance and effectiveness of the mitigation
implemented.

5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
1. Section Head and Procurement
Start Officer

● Evaluate the suppliers based on

their capability to meet the facility's
1. Selection qualification expectations for supplies.

● Make a list of approved suppliers

2. Purchase materials 2. Procurement/Purchasing Officer

● Review purchasing agreements

3. Section Head
3. Receiving and inspection
● Ensure that the quantity and
packaging are consistent with the

57
 description of the item in the
purchase request.
4. Verification of received
materials 4. Technical Staff

● Perform the lot validation of critical

materials

5. Storage and handling/ 5. Technical staff

● Store and handle all supplies

according to the manufacturer’s
instruction
6. Inventory management 6. Section Head

● Maintain the inventory of supplies

7. Section Head/Technical Staff

● Identify the critical materials.

7. Identification and
tracking ● Record the identity of critical
materials used or put in use for
traceability

End

6. DOCUMENTATION (Forms, Worksheets)

● Supplier Evaluation Form

● List of Approved Suppliers Form
● Verification and Traceability of Critical Material Form
● Lot Validation Worksheet

58
 Work Instruction: Material Reception, Inspection,
Verification/Validation, Storage, and Use

1. INTENDED USE

This document guides the Technical Staff, Section Supervisor, Unit Head and
Procurement Officer in performing the various steps in material management.

2. PRINCIPLE

A functional material management program ensures the uninterrupted supply

of materials and the specified quality requirements for critical supplies and
services are consistently met.

3. PROCEDURE

3.1 Selection Qualification of Suppliers

● Identify the specifications of the supplies needed.

● Evaluate the capability of suppliers based on the minimum requirements set
by the procurement committee. Document supplier qualification using the
Supplier Evaluation Form.
● List all approved suppliers using the List of Approved Suppliers Form.
Update the list annually.

3.2 Purchase of Materials

● Follow the procurement policies and procedures of the Blood Center.

● Procure supplies that are registered with the FDA and evaluated by the
National Reference Laboratory.

3.3 Receipt and Inspection

● Inspect the received materials.

● Record the general condition, lot number, date of expiration, storage
requirement, and check against the accompanying delivery document.
● Document the inspection performed in the delivery receipt.

59
3.4 Verification or Validation of Critical Materials/New Lot Confirmation of
Acceptability of Incoming Critical Materials (such as reagents)

● List down the critical materials received in the facility in Verification and
Traceability of Critical Material Form.
● Verify the performance of all incoming critical materials (reagents and
consumables that can affect the quality of examinations) prior to its usage
for patient testing.
● If applicable, check the maintenance and calibration of the instrument/test
system to be used, and ensure that these procedures are performed as
scheduled before doing the reagent lot validation. If a new lot of calibrator
is available, calibrate the machine with the new lot of calibrator and a new
lot of reagent.
● Examples of suitable reference materials for reagent lot validation include:
a. Positive and negative patient samples were tested on the
previous lot.

b. Previously tested proficiency testing materials.

c. External quality control (QC) materials were previously

tested in the previous lot.
● Follow the validation protocol described below.
a. Run the selected samples using the old and new reagent
lot for at least a 2-hour interval. Record the validation data
in the Lot Validation Worksheet.

b. For qualitative tests (e.g., typing sera)

c. Minimum cross-checking includes re-testing at least one

(1) positive and one (1) negative patient sample tested on
the previous lot.

d. A weakly positive sample must be included if patient

results are reported in that fashion.

e. Acceptance Criteria: Results should match between the

current lot and the new lot. Any discrepancies must be

60
 investigated, and the parallel testing should be repeated
until the results are the same.

f. For semi-quantitative tests - tests with quantitative

instrument response, but reported qualitatively. (e.g., EIA,
CLIA)

g. Minimum cross-checking includes re-testing at least one

(1) reactive, one (1) intermediate, and one (1) non-reactive
sample. Make serial dilution for the reactive samples (1:2;
1:8; 1:16). Total of seven (7) samples.

h. Acceptance Criteria: Results should match between the

current lot and the new lot. Any discrepancies must be
investigated, and the parallel testing repeated until the
results are the same.

i. For quantitative tests (e.g., CBC analyzer)

j. Minimum cross-checking includes re-testing at least three

(3) samples (low, normal, and high). Refer to the
manufacturer’s instruction for the number of specimens to
be tested if a more stringent requirement is needed in a
special assay/procedure. Samples are run in duplicate.

k. Compute the mean for each sample, the reagent mean

(average of all sample means for each current and new
reagent), and the grand mean (average of all sample
means for both reagents).

l. Calculate the difference (Xc) between the current lot mean

and the new reagent means.

m. Calculate Xn by multiplying the grand mean by the

cumulative coefficient of variation (CV) of the quality

61
 control with the value closest to the grand mean. Convert
this value into a decimal by dividing it by 100.

n. Calculate the acceptability ratio by dividing the value of the

Xc with the value of Xn.

o. Acceptance criteria: the acceptability ratio should be less

than or equal to 1 (<1). Multiplying the historical CV by the
grand mean provides a standard deviation. Dividing this
value into the difference between the two reagent means
provides a standard deviation index. Differences between
successive lots of reagents should not be more than 1 SD.

3.5 New Quality Control (QC) Lot /Range Verification of Quantitative QC materials

● Verify new lot/new shipment of quality control materials prior to its use.
● Run each level of the new QC materials in parallel with the old QC lot,
preferably 4 times per day for 5 consecutive days or twice a day for 10
consecutive days.
● Verify that there are no trends/outliers and that the precision is
acceptable.
● Record the validation data in the Lot Validation Worksheet.
● Calculate the mean, CV, and SD, and calculate the new QC range
(mean+2SD).
● Acceptance Criteria: the calculated range should fall within the pre-
determined range of acceptability of the QC (manufacturer’s
specification or previously established QC range).

3.6 Documentation of the Validation/Verification Study

● Document the validation/verification performed using the Lot

Validation Worksheet.
● Write the specimen/ sample description (Reagent, QC, or calibrator)
and other details such as lot number, date of expiry). Put a ( ✔ ) tick
mark on the appropriate detail/s. Put N/A on cells that are not
applicable for the validation being performed. Write “nothing follows”
on the cell after the last entry.

62
 ● Write the appropriate acceptance criteria and the obtained/ calculated
result.
● Evaluate the results and write the conclusion such as:
a. Reagent lot is acceptable/Reagent Lot is not acceptable.

b. New QC Range is verified/acceptable/New QC Range is

not verified/not acceptable.
c. Attach the package insert with the Lot Validation
Worksheet and file it in the Critical Materials Validation
Folder.

d. After performing the validation/verification, record the date

of validation in the Verification and Traceability of Critical
Material Form to indicate that the critical material is ready
to use for patient testing.

e. Likewise, once the lot number of the critical material is put

in use, record the date in the Verification and Traceability
of Critical Material Form.

3.7 Storage, Handling, and Use of Critical Materials and Supplies

● Inspect the storage areas to ensure adequate space and handling

capabilities that prevent damage and deterioration of the purchased
materials. Records of each inspection visit should be documented.
● Monitor the temperature in the storage areas every shift.
● The store received materials according to the manufacturer’s
instructions on handling and storage to prevent alterations that could
affect stability and performance.
● Label with precautionary labels as needed. Place all reagents and
chemicals in the cupboard, at eye level or below. Proper segregation
shall be implemented.
● Label individual containers with the date opened, and the new expiration
date must be recorded if opening the container changes the expiration
date and storage requirement.
● All reagents, calibrators, controls, and prepared solutions are labeled
with the following information such as:
a. Content

63
 b. Concentration

c. Storage requirement

d. Date opened/preparation/reconstituted by the laboratory

e. Date of expiry/ date of expiry upon opening (if opening the

container changes the expiration date and storage
requirements)

f. Initials of the personnel who prepared the materials

● Assign an expiration date to any reagents that do not have a
manufacturer-provided expiration date based on known stability,
frequency of use, storage conditions, and risk of deterioration.
● Use of expired reagents and consumables is strictly prohibited unless
performance verification of expired reagents is conducted. This may
apply with reagents that are difficult to obtain, or the delivery of a new
shipment is delayed through causes not under the control of the
laboratory. The approval of the Blood Center/Immunology Head is
required in such cases.
● Reagent kits are used only within the kit lot unless otherwise specified
by the manufacturer or approved by the Unit Head after verification of
performance.
● Uninspected and unacceptable reagents and consumables shall be
segregated from those that have been accepted for use and labeled
accordingly.

3.8 Inventory Management

● List down all materials used in the laboratory in the Inventory of

Supplies Form.
● Specify the frequency of doing the inventory. Ensure that a system for
the continuous supply of critical materials is implemented and efficient.
● Track and record expiration dates and communicate inventory levels
and when re-order is necessary.

3.9 Reagents and Consumables Package Inserts

64
 ● Records are maintained for each reagent/consumable that contributes
to the performance of examinations. This may include but is not limited
to the package insert (indicating the date of expiration, lot number, and
other relevant information) and the validation report, as appropriate.
● Keep the Safety Data Sheets (SDS) of chemicals on file for reference.

3.10 Reporting of Adverse Incident Directly Related to a Reagent/Supply

● Record, investigate, resolve, and mitigate any incident or accident

directly related to a specific reagent or supply.

Maintaining and Managing an Optimum Blood Inventory

1. PURPOSE

This document guides the concerned personnel within the Blood Center network
in maintaining an optimum inventory of blood for the service area.
To ensure an optimum balance between blood supply and demand by utilizing
a tool that automatically computes the average weekly usage of each ABO and
R type.

2. PRINCIPLE

The ideal weekly bloodstock inventory may be computed based on the Blood
Center’s usage of each blood type and component over a period of several
months. Keeping such a bloodstock inventory ensures optimum blood utilization
and minimizes wastage and shortages.

3. SCOPE AND LIMITATIONS

This procedure starts from the determination of blood needs within the Blood
Center network to the implementation of corrective action if targets are not met.
This process is affected by inappropriate requests for blood, the reluctance of
hospitals to participate in the direct blood distribution scheme, and unanticipated
increases in demands due to emergency situations and disasters.

4. RESPONSIBILITIES

65
 a. Lead Blood Center – convenes Blood Center network to determine
blood needs

b. End-User Hospital and other health facilities – submit accomplished

Blood Stock Inventory Management (BSI Man) to the regional Blood
Center network monthly

5. PROCEDURE

● Collect weekly blood and component data over a six-month period

of utilization.
● Record usage by ABO and Rh type for each week segregated into
specific blood components.
a. Enter data into BSIMan.
b. In the BSIMan, click on the box located on the right side
for the specific blood component inventory.
c. BSIMan will automatically:
● Disregard the single highest usage for each type to correct for
unusual week-to-week variation (e.g., large volumes for
emergencies).
● Total the number of units of each ABO and Rh type, omitting the
highest week in each column,
● Divide each total by 25, and
● Give an estimate of the average weekly blood usage of each
ABO and Rh type.

6. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start
1. Lead Blood Center

● Convene the Blood Center network

to determine the blood needs of the
1. Determine blood needs
hospitals within the service area,
weekly target, and other issues

66
 such as factors affecting the
2. Schedule MBD’s reliability of data.

2. Blood Center
3. Assess attainment of
● Prepare the schedule of MBDs to
target
meet the demands

3. Blood Center
A
● Determine if the target is attained.
A ● Use BSI Man and Productivity
Measures Excel Worksheet.

● Submit to the Lead Blood Center.

4. Repeat the process on an 4. Blood Center Network

annual basis
● Implement corrective action as
needed.

End

7. DOCUMENTATION (Forms, Reports, Worksheets)

● Daily Blood Inventory

Blood Donor Recruitment and Retention

1. PURPOSE

This document guides the Blood Center donor recruitment team on blood
donor recruitment and retention in order to attain the national average
donation target rate of at least 10/1,000 and a 100% fully voluntary blood
donation as per the DOH Executive Order 2020.

2. SCOPE AND LIMITATIONS

The procedure starts from the identification of low-risk populations to the

provision of quality care to blood donors.
While this process describes the steps to be taken in community-
based/mass-approach blood donor recruitment, this can also be used for

67
 individualized blood donor recruitment with the omission of some of the
steps.
This assumes the parallel implementation of major activities of advocacy
and promotion of voluntary blood donation to major stakeholders. This
procedure also assumes that there is concomitant capacity building of blood
donor recruiters and mobile blood donation organizers.

3. RESPONSIBILITIES

a. Blood Service Facility – ensures that mobile donation organizers and

that blood donor recruiters are well oriented on the principles of
voluntary blood donor recruitment, that blood donor recruiters are well
aware of and observe privacy and confidentiality in handling personal
information and understand and sign the Non-Disclosure Agreement
(NDA) provided by the MBD Organizer.
b. MBD Organizer – ensures that all blood donor recruiters receive basic
training on voluntary blood donation, identification of low-risk
populations, the procedure of pre-donation information, pre-donation
counseling, and post-donation care and follow-up; and that they sign
the Non-Disclosure Agreement.
c. Blood Program Coordinator – maintains the blood donor registry,
coordinates blood donor recruitment, as well as recall and retention
activities with MBD Organizers and Blood Donor Recruiters and the
Blood Service Facility.
d. Blood Donor Recruiters – follow this procedure and observe the
confidentiality agreement.
e. Phlebotomist – provides a positive experience to blood donors in order
to motivate them to become regular donors.

4. RISK MANAGEMENT

Blood donor recruiters shall keep private and confidential all personal
information gathered from the blood donors in the process of blood donor
recruitment.

5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

68
 Start
1. MBD Organizer

1. Identify low risk ● Identify communities/organizations

communities. where members are healthy and
where the prevalence of high-risk
behavior is low. Coordinate with the
local health unit if possible.

1. Blood Donor Recruiter

2. Provide pre-donation ● Refer to WI –Provision of

information. Information for Prospective Blood
Donors (Pre-donation)

2. Blood Donor Recruiters and MBD

3. Prepare list of prospective Organizer
donors.
● Use Form – List of Prospective
Blood Donors. Update fields after
the donors have donated blood.

A
3. Blood Donor Recruiters

● Conduct pre-donation risk

assessment and counseling.
4. Conduct pre-donation risk
assessment and counselling.

4. Phlebotomist

● Accomplish Form – Blood Donor’s

5. Provide the donor a positive Record of Donation.
experience during blood
● Refer to the following:
donation.

69
 o QP – Blood Collection
o WI – Post Donation Care

6. Update blood donor 5. Blood Program Coordinator

registry.
● Use Form - Blood Donor Registry.
● Compute the Blood Donor
Recruitment Rate. See Glossary for
End the formula.

6. DOCUMENTATION (Forms, Worksheets)

● List of Prospective Blood Donors

● Blood Donor Registry (Regular)
● Blood Donor’s Record of Donation

Provision of Information to Prospective Donors

1. INTENDED USE

Voluntary non-remunerated blood donors are the foundation of blood safety

and adequacy. For potential blood donors to start and continue donating
blood, it is crucial that blood donors are well educated on voluntary blood
donation (VBD) to enable them to correct myths and misconceptions about
the blood donation process and thus, overcome their fear and
apprehension.

The objective of this SOP is to educate the potential donors about voluntary
blood donation and provide pre-donation counseling.
This is for the use of the MBD Organizer and/or Blood Donor Recruiters,
who will conduct the pep talk.

70
2. PRINCIPLE

● Blood and blood products shall be sourced from regular repeat voluntary
non-remunerated blood donors.
● All potential blood donors shall receive education on voluntary blood
donation (VBD) before blood donor screening to enable prospective blood
donors to give informed consent.

3. MATERIALS / EQUIPMENT

● When the venue is closed and has access to the source of electricity
allowing the use of the digital light projector, the materials needed are:
a. Digital light projector
b. Extension cord
c. Copy of PowerPoint presentation and/or video
d. Leaflets and other information materials

● When the venue is open and the use of a digital light projector is not
feasible, the materials needed are:
a. Flip chart
b. Copy of PowerPoint presentation and/or video
c. Leaflets and other information materials
4. PROCEDURE

4.1 Coordinate the pre-donation activity (pep talk) or with the Mobile
Blood Donation (MBD) Organizer as to:

● Venue of activity: Check if the venue is suitable for a PowerPoint

presentation or showing of the video. If not, bring a flip chart instead.
● Time of the activity: Ask the MBD Organizer how much time is allotted
for the presentation. Adjust the duration of the presentation
accordingly.
● Expected number of participants to ensure the adequate number of
leaflets for distribution.

4.2 Prepare materials to be used during the conduct of the pep talk or pre-
donation information activity as enumerated in #3.

● Review and update PowerPoint presentation.

71
● Review and update the flipchart.
● Prepare an adequate number of leaflets/information materials to be
brought to the venue of the activity for the participants, with extra
copies to be left with the MBD Organizer for those who are unable to
attend the pep talk.

4.3 Conduct the pep talk.

● Ensure that the prospective donors are comfortable and feel safe

● The duration of the pep talk depends on the time allocated for it by the
community (workplace, place of worship, school, non-government
organization [NGO], or barangay).

● Introduce yourself and the office/agency that you represent, including

the Blood Center that will come to collect the blood donation.

● Using the communication script for blood donor education, inform

potential blood donor/s on the following subject matters:

o Blood needs of the geographic area where MBD organizer

belongs, and shelf life of red cell unit, platelet concentrate,
fresh frozen plasma, and cryoprecipitate

o Basic blood physiology – functions of red blood cells,

platelets, and plasma; the volume of blood that can be
collected at one time

o Who can donate blood and who cannot donate blood

o Window period of transfusion-transmitted infections (TTIs),

and why it is crucial to source blood from healthy low, risk
regular repeat voluntary non-remunerated blood donors

o Blood donation process

o Confidential Unit Exclusion

o Pre-donation instructions and self-care (how to prepare

oneself for blood donation):

● Donors should know and list their history of

travel outside the place of residence within the
country and outside the country, and the
duration of stay (less than 6 months or more
than 6 months),

72
 ● He/she should know illnesses and history of
medical consultation within the past 6 months
and medications taken,

● He/she should refrain from eating fatty foods

one (1) day prior to MBD and on the day prior to
MBD,

● He/she should get adequate rest, typically 6 – 8

hours of sleep, the night before donation,

● He/she should drink 8 to 10 glasses (250 ml –

glass) of water starting 1 day prior to MBD.
Avoid alcohol and minimize coffee and other
caffeinated beverages to keep the body well
hydrated,

● He/she should eat a full non-fat breakfast at

least 2 hours before blood donation and full
meals during the day,

● He/she should bring a valid photo ID which shall

include his/her full name (including full middle
name) and the date of birth. In the absence of a
valid photo ID, any two known blood donor
recruiters in the barangay/NGO shall identify the
donor. Names of these donor identifiers shall be
documented, and,

● Post-donation instructions and self-care

4.4 After the pep talk, ask the participants if they have any questions. Use
a standard response to frequently asked questions to avoid
misinformation or inconsistent responses.

4.5 List down the complete name, home address, and contact number of
those who have decided to donate blood.

4.6 Determine the Bloor Donor Recruitment Rate and proxy indicator for
the number of blood donors recruited.

73
Customer Satisfaction Measurement and Complaint
Management

1. PURPOSE

This document guides the Blood Center customer service officer in

measuring the satisfaction of blood donors and other customers, including
measurement and analysis of performance.

2. SCOPE AND LIMITATIONS

This procedure covers from distribution of customer survey forms to

collation, analysis, and interpretation of reports and updating and
maintenance of records.

3. RESPONSIBILITIES

a. Customer Service Officer – responsible for conducting customer

satisfaction survey, collating and interpreting the data from the survey;
provides the result of the survey to Unit Head/Supervisor

b. Unit Head/Supervisor – ensures that all unit personnel are aware of the
service excellence goal of the Blood Center and have the necessary
knowledge and skills needed to execute their jobs properly

c. Quality Manager – monitors satisfaction ratings of Blood Center units;

implements corrective action if necessary

74
4. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART DESCRIPTION OF ACTIVITY

Start 1. Customer service officer

● Donors are asked to answer the

Donor Feedback Form after a
donation.
1.Distribute donor
satisfaction forms ● Feedback box is opened every
15th and 30th of each month.

● CSO may receive a complaint

from donors or other customers
such as end-user hospital
2. Analyze results

2. Customer service officer

● Determine if the target rating is

attained.

● Check for trends and random

NO
Needs deviations.
corrective
Section Supervisor/Quality Manager
action?
● Conduct root cause analysis.

YES

3. Section Supervisor/Quality
Manager
3. Do corrective action ● Implement corrective action, and
update and disseminate new
policies/information as needed.

A B

75
 A B

4. Quality Manager
4. Monitor implementation ● Monitor performance.
and effectiveness of
corrective action

End

5. DOCUMENTATION (Forms, Worksheets)

● Donor Satisfaction Survey

Internal Audit

1. PURPOSE

This document guides the Blood Center's internal auditors on the conduct
of an internal audit

2. SCOPE AND LIMITATIONS

This procedure begins with the preparation of the audit program up to the
implementation of corrective action from reported non-conformances.

3. RESPONSIBILITIES

a. Blood Center Management - ensures that the audit team is provided

with appropriate training in the administration of internal audits.

b. Audit Program Leader - ensures that audits are conducted as

planned.

c. Team Leader – spearheads the conduct of an internal audit. Ensures

that lessons learned and recommendations are applied

76
4. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

1. Audit Program Leader

Start
● Prepare audit program. This
should include scheduling,
audit type, audit objectives,
1. Prepare audit program audit scope, audit criteria, and
responsible persons and must
be approved by the Blood
Center head.

2. Team Leader
2. Prepare audit plan
● Prepare assignment of internal
auditors.
● Ensure that the audit scope is
adequately covered.

3. Team Leader/Auditors
3. Prepare audit checklist ● Refer to the standards being
used in the development of
the audit checklist.

4. Team Leader/Auditors

4. Conduct audit ● Inspect department/sections and

their processes on the
predetermined date and according
to the audit checklist.

5. Team Leader/Auditors
5. Submit audit report ● Present audit findings to units
concerned and determine the
date for follow-up on non-
conformances.
6. Team Leader/Auditors
6. Conduct follow-up

77
 ● Request for development on
A the determined non-
conformances.

7. Blood Center Management

A
● Resolve non-conformances by
executing corrective
7. Close NCAR action/preventive action
processes.

8. BSH Management

● Analyze changes or
8. Review effectiveness of improvements of processes
the audit and services from the date of
internal audit.

Effective? YES

9. Blood Center Management

NO ● Executes corrective actions to

further improve processes and
services.
9. Implement corrective
actions

End

5. DOCUMENTATION (Forms, Worksheets)

● Audit Program
● Nonconformance Report
● Audit Report

78
 Work Instruction: Conducting an Internal Audit

1. INTENDED USE

This procedure guides the Blood Center personnel on the proper conduct
of an internal audit of the Blood Center to ensure conformance to the
different regulatory, statutory, and accreditation requirements.

2. PRINCIPLE

Internal audit ensures the compliance of the Blood Center to regulatory and
statutory requirements. It also ensures that the policies and procedures of
the Blood Center are optimal, efficient, and effective.

3. MATERIALS

• Audit Checklist

• Audit Report

4. PROCEDURE

4.1 Preparing an audit program

• Determine the objective of the supposed audit.

• Prepare the necessary documents for audit.

• Determine the target date of the action.

• Prepare the audit checklist.

• Determine the date of audit.

• Determine the date of reporting.

• Determine the date of performance/implementation of corrective

action.

• Present to the Blood Center management and secure approval.

79
4.2 Preparing an internal audit checklist.

• Review the standards and QMS documents.

• Review previous audit results and audit checklist.

• Ensure that auditors do not audit their own process.

• Secure comments from the audit team if necessary.

4.3 Conducting audit.

• The lead auditor presides over the opening meeting

• Execute the audit plan.

• Prepare the NCAR before the closing meeting.

• Lead auditor presides over the closing meeting.

• Request for auditee acknowledgment.

• Provide NCAR copies to auditees and auditors.

• Prepare the audit report.

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 Corrective Action

1. PURPOSE

To ensure that all non‐conformances and other deviations from planned

arrangements are identified and recorded and that the appropriate
corrective action/s is/are taken to prevent their recurrence in the future.

2. SCOPE AND LIMITATIONS

This procedure begins with the identification of non-conformances,

occurrences, or deviations from planned arrangements to monitor the
effectiveness of corrective actions.

3. RESPONSIBILITIES

● Responsible Personnel – detects problems from daily activities

● Auditor – performs compliance check with standards according to
audit plan; prepares non-conformance report
● Supervisor – receives reports of non-conformities; initiates
investigation; formulates implements corrective; monitors
implementation of corrective action;
● Quality Manager – oversees the implementation of the corrective
action process; monitors the effectiveness of corrective actions

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4. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
1. Responsible Personnel/
Supervisor/Auditor
Start
Occurrences may be any of the
following:
- customer complaint
- accident
- error
1. Detect problem/ - adverse reaction
occurrences/NCAR - near-miss

NCAR may be identified from the

following:
internal/external audit
- findings of regulatory/accreditation
2. Identify root cause
bodies

Non-attainment of process goals

needs appropriate corrective action
Refer to Form - Occurrence Report
3. Formulate corrective 2. Responsible Personnel/
action Supervisor/ Quality Manager
● Refer to the following:
- WI – Conducting Root Cause
Analysis
- Form - Occurrence Analysis
A - Appendix - Ishikawa Diagram

A 3. Supervisor/Quality Manager

● The corrective action/s must be

able to address the identified root
cause/s.
● Activities supporting the
corrective action must be
specific, realistic, and time-
4. Implement corrective bound.
action ● Responsible person and
resources needed for each
activity must be identified.

82
 4. Supervisor/Quality Manager
● Corrective action must be
documented, together with the
timeframe for implementation.
● Use CA/PA Implementation
Form
5. Monitor implementation ● Disseminate new policies,
procedures, and other
associated documents

5. Supervisor/Quality Manager
● Monitor performance within the
6. Assess effectiveness of defined monitoring period.
corrective action ● Use Monitoring of Corrective
Action Form

6. Quality Manager
● For persistent or recurring
problems in Blood Center units,
the quality manager intervenes,
and an intensive root cause
End
analysis is conducted with the
concerned unit

5. DOCUMENTATION (Forms, Reports, Worksheets)

● Occurrence Report
● Non-conformance Report
● Occurrence Analysis
● Corrective Action Report
● CA/PA Implementation Form Monitoring of Corrective Action

83
 Part III: Process Manual – Technical Procedures
Quality Procedure Blood Collection

1. PURPOSE

This document guides the phlebotomist in the preparation of donor prior to

phlebotomy and the actual blood collection

2. SCOPE AND LIMITATIONS

This procedure starts from the time the donor is accepted to donate to post-
donation care.

3. RESPONSIBILITIES

Phlebotomist – performs phlebotomy and ensures donor safety before,

during, and after blood collection; phlebotomy may be performed by a
medical technologist or a nurse trained in phlebotomy.

4. RISK MANAGEMENT/SAFETY PRECAUTIONS

a. The Blood Center shall implement infection control measures.

b. The phlebotomist should never leave the donor unattended as

serious adverse reactions may occur before, during, and after
donation.

c. Phlebotomy should be performed in accordance with the policies and

protocols observing the Good Manufacturing Practice (GMP).

d. The phlebotomy site area should be free from skin lesions or

evidence of infection, and no more than one venipuncture should be
performed on each arm. The vein selected should have a sufficient
diameter adequate to support a 16-gauge needle. It should be turgid
to support the blood flow after entry and have adequate tissue
support to prevent movement when the needle is inserted

84
5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART DESCRIPTION OF ACTIVITY

1. Phlebotomist
Start
● Ensure that the donor was
assessed completely and eligible
for blood donation.
Ask the donor for a valid personal
1. Positive identification of identification with a photo. Refer to
the blood donor PG –Positive Identification and
Assessment of Blood Donors
2. Phlebotomist
2. Preparation of donor and ● Ensure that the donor is
materials appropriately and comfortably
positioned in the blood donation
couch or bed.
● Use a triple or quadruple bag if
3. Identification of the most planning to process blood into
suitable vein components.
● Check the blood collection system
for defects, damage, and
contamination.

4. Performance of aseptic 3. Phlebotomist

procedure
● Identify the most suitable vein
for phlebotomy.
● Refer to WI –
- Identification of Vein for
A Phlebotomy
A - Platelet Apheresis

4. Phlebotomist
● Refer to WI – Aseptic
Technique for Blood Donation
5. Performance of the
phlebotomy procedure
5. Phlebotomist
● Refer to WI –

85
 - Phlebotomy Procedure for
Blood Donation
- Platelet Apheresis
● Give immediate care to the donor
if there is any adverse reaction.
6. Provide post donation
care

6. Phlebotomist
● Provide post-donation instructions
and care.
End
Refer to WI Post Donation
Instructions and Care.

6. DOCUMENTATION (Forms, Worksheet)

● Donor History Questionnaire

Blood Collection Donor Procedural Guidelines

Positive Identification and Assessment Blood Donors

1. GUIDELINES

1.1 Prospective donors who are 16-17 years old may be accepted only if
the written consent of a parent or guardian is presented/obtained.

1.2 Donor consent must be obtained before the donation. The elements of
the donation procedure shall be explained to the prospective donor.
The explanation shall include information about the risks of the
procedure and tests to be performed.

1.3 Ensure that the donor reads the pre-donation information material prior
to blood donation.

86
1.4 Discuss the elements of the donation procedure, including the
confidential unit exclusion (CUE), possible adverse reactions, and the
tests that will be performed on his/her blood. This will help the donor
in determining his/her readiness for the procedure, in signing the
consent form, or in deferring himself/herself from donating blood.

1.5 Emphasize the need to be truthful in answering the DHQ to prevent

high-risk individuals from donating blood.

1.6 Positive identification of blood donors is an essential requirement to

safeguard the blood supply. Ask the donor for a valid personal
identification with a photo. Forms of acceptable identification are the
following:

● Government-issued ID
● Student ID
● Passport
● Company ID

1.7 If the donor doesn’t have a valid personal identification at the time of
donation, ask for the donor’s name and other personal information in
a passive manner to ensure that he/she is not feigning identity.

1.8 Ask the donor to fill out the Donor History Questionnaire (DHQ). Assist
the donor if he/she needs help in understanding the items.

87
 Blood Collection Donor Procedural Guidelines
Identification of Vein for Phlebotomy

1. GUIDELINES

1.1 A successful phlebotomy is largely determined by finding the most

suitable vein. Knowledge of the anatomy of the antecubital fossa and
the technique of making it palpable is critical to the success of the
procedure.

1.2 Greet the donor and introduce yourself before starting the procedure.

1.3 You may ask the following questions to identify any potential problems:

● Have you donated blood before? If yes, which arm?

● Have you had any problems when donating blood in the past?

1.4 Explain the procedure to the donor, especially if it is the donor’s first
time donating.

1.5 Inspect both arms of the donor and look for evidence of illicit intravenous
drug use. Drug use is a cause for permanent deferral and should be
referred to the Medical Officer for proper investigation and deferral.

1.6 Apply a tourniquet at least two (2) inches above the antecubital fossa.
Ask the donor to squeeze the hand-gripper or clench and open the hand
several times to distend the vein. Assess the veins.

1.7 Once the most suitable veins are identified, release the tourniquet and
proceed with the aseptic procedure.

88
 Blood Collection: Work Instruction, Aseptic Technique
for Blood donation

1. INTENDED USE

To guide the phlebotomist on the proper aseptic technique procedure for

blood donation.

2. PRINCIPLE

A properly performed aseptic technique minimizes the risk of microbial

contamination to donated blood.

3. PROCEDURE

3.1 Disinfect hands before each donation.

3.2 Use a clean pair of forceps in applying the disinfectant to the

phlebotomy site.

3.3 Apply the disinfectants in the proper order (alcohol–iodine–alcohol),

with the circular pass over the site, moving outward from the prospective
area of penetration.

3.4 Allow an interval of thirty (30) seconds for each to dry.

3.5 Avoid touching the prepared skin area after it has been disinfected and
before inserting the needle.

4. PROCEDURAL NOTES

Check the date of manufacture and the date of opening of disinfectants

prior to use.

89
 Blood Collection: Work Instruction, Phlebotomy
Procedure for Blood Donation

1. INTENDED USE

To guide the phlebotomist on the proper venipuncture for whole blood

donation.

2. PRINCIPLE

The venipuncture for whole blood donation requires a smooth, clean entry
with the needle.

3. MATERIALS / EQUIPMENT

● Blood donation couch

● Blood weighing scale
● Donation sticker labels

4. PROCEDURE

4.1 After disinfection of the phlebotomy site, re-apply a tourniquet or

blood pressure cuff at 40-60 mmHg at least 2 inches above the
antecubital fossa to make the vein prominent again.

4.2 Clamp the donor tubing with an artery forceps or green clip just by
the needle guard to prevent air contamination.

4.3 Remove the needle guard and inspect for any defect.

4.4 Pull the skin taut below the selected venipuncture using the
forefinger of the freehand.

4.5 Hold the needle at a 30-45° angle, aim it carefully, and puncture the
skin with a quick thrust at the selected point of entry.

4.6 Lower the angle of the needle at 10-15°, and with a steady thrust,
advance the needle to pierce the vessel wall to approximately 1/2
inch inside the lumen of the vein.

4.7 Remove the forceps/clip to initiate blood flow.

90
 4.8 Secure the needle with a piece of hypoallergenic plaster. Secure the
hub first.

4.9 Cover the venipuncture site with a sterile gauze pad.

4.10 Lift the dressing occasionally to check signs of hematoma.

4.11 Ask the donor to open and close his/her hand slowly, relaxing after
every squeeze at an interval of ten (10) seconds for a better flow.

4.12 Label the unit and. On the DHQ, record the pilot tube number, time
started and ended, and the initials of the phlebotomist.

4.13 Advise the donor that the needle will be removed once the collection
is complete.

4.14 Clamp the tubing at the distal end.

4.15 Remove the tourniquet. Stabilize the needle at its hub with one hand
and remove the tape with the other.

4.16 Withdraw the needle with one fluid motion. Apply pressure to the
phlebotomy site just as soon as the needle has been withdrawn. This
will minimize the pain and avoid hematoma formation.

4.17 Ask the donor to apply pressure on the gauze or cotton on the
venipuncture site and to raise his/her arm for two (2) minutes, after
which the donor may lower the arm, but pressure should be
maintained on the venipuncture site. Repeated flexion and extension
of the arm should be avoided to prevent hematoma formation.

4.18 Inspect the arm for signs of bleeding.

4.19 Collect a sample for testing.

4.20 Seal pilot tubes less than an inch distal to the needle hub and strip
the tubing.

5. PROCEDURAL NOTES

5.1 Prepare the blood mixer prior to use. Adjust the setting to the desired
amount of blood to be collected and the time limit. The clamp closes
a second before the time limit.

91
 5.2 A weighing scale may be used if a blood mixer is not available. Mix
blood gently with hand every 45 seconds and monitor the collection
closely.

5.3 Record the duration of the phlebotomy.

Blood Collection: Work Instruction, Performance of

Platelet Apheresis

1. INTENDED USE
To guide the Blood Center technical staff in the proper performance of
platelet apheresis

2. PRINCIPLE:
● Single donor platelets are often required for patients who are
refractory to random donor platelets.
● Platelets are collected using an intermittent or continuous flow
apheresis machine.

3. MATERIALS / EQUIPMENT

Supplies and Reagents

● Platelet apheresis kit

● Collect flow path overlay

● 0.9% normal saline (1 liter)

● ACD-A Solution (600 to 700 ml)

● Adapter or holder

● Sterile cotton balls

● Tourniquet

● 70 % alcohol

● Povidone Iodine

92
 ● Medical Plasters

● Dry sterile gauze

● Plastic clips

● Forceps

Equipment
● Apheresis machine (continuous flow or intermittent)

4. QUALITY ASSURANCE/CONTROL

4.1 Only trained personnel must be allowed to operate the apheresis machine.

4.2 Regular maintenance and periodic calibration of the apheresis unit.

4.3 Proper venipuncture site selection and disinfection. The extended storage
of platelets at +20 to +24oC requires awareness of any possible source of
contamination.

4.4 Post donation platelet count must not be lower than 3 x 10 11/L.

5. PROCEDURE

5.1 Prepare an apheresis machine to perform a single needle platelet

collection procedure.

5.1.1 Refer to the machine’s Operator’s Manual for the set-up, loading of
disposables, and priming of the machine, or follow the step-by-step
instructions from the machine.

5.1.2 The system performs three checks to ensure proper function:

● A self-test is performed when the power is turned on. The

power-up diagnostics ensure that the internal electronics,
microprocessor communications, and voltage are working
properly. Any detected problem triggers an alarm.
● A check of all valves, sensors, and pumps is performed during
the priming process. Again, an alarm would be generated if
the system were not functioning properly.
● The alarm test verifies the functionality of the return valve, the
leak sensor, door latches, and access and returns pressure
sensor alarms.

93
 5.1.3 Always perform the alarm test and document any setup
complications or errors.

5.1.4 Enter donor information into the fields as requested – SEX,

HEIGHT, WEIGHT, HEMATOCRIT (%) as a whole number.

It is important to enter the correct hematocrit to avoid red blood cell

spillover and ensure that the maximum plasma volume is available
for platelet and plasma collection; if red cell contamination is more
than 2 ml, collect the sample for compatibility testing.

5.2 Peripheral Access

5.2.1 Prepare venous access. Refer to WI Aseptic Technique for Blood

Donation.

5.2.2 Before connecting the donor to the machine, check the access and
return line for air. Start venipuncture using a gauge 18 needle
attached to the apheresis set.

5.2.3 Apply light pressure with a tourniquet in order to promote adequate

blood flow. You can release the tourniquet if the “ACCESS” pressure
is adequate.

5.2.4 Close saline line when “cued.”

5.2.5 Set the machine to print parameters and vital signs every 15-20
minutes.

5.2.6 Observe the patient for any intolerance to the procedure, especially
signs of citrate toxicity and hypotension

5.3 End of procedure

5.3.1 The machine will prompt the operator that the machine has reached
the end of the procedure.
5.3.2 Refer to the Operator’s Manual or the step-by-step instructions from
the apheresis machine for the rinse back and unloading of
disposables instructions.
5.3.3 Collect one blood in an EDTA tube from the donor for post-donation
platelet count (optional).
5.3.4 Disconnect and remove the needle assembly.

94
 5.3.5 Check vital signs and record along with final machine values.
5.3.6 Unload the apheresis machine. Follow proper waste disposal when
disposing of the apheresis set.
5.3.7 Document procedure and results, including platelet yield.
5.3.8 Counter-check yield by doing platelet count on the actual yield
sampler. Platelet apheresed must have a minimum count of 3 x
1011/L.

5.4 Label the apheresis unit.

5.5 Waste disposal

5.5.1 Dispose of all needles in the sharp containers.

5.5.2 Dispose of the apheresis set in the yellow waste bag.

6. PROCEDURAL NOTES

After the apheresis set has been primed, it should be used within the same
working day. Once the donor connection has been primed, the set should be
used as soon as possible.

95
Blood Collection: Procedural Guidelines, Post Donation
Care

1. GUIDELINES

1.1 A positive experience of a donor during blood donation increases the

likelihood of future donation.

1.2 Ensure that the donor is in a comfortable position and place.

1.3 After the blood donation and before allowing the donor to leave the area,
the donor shall be instructed on post phlebotomy care. Instructions may
include the following:

● Rest and remain in the area for another fifteen (15) minutes for
observation and to prevent injury in case of an adverse reaction.

● Leave the adhesive bandage over the venipuncture site for four (4)
hours to prevent contamination.

● Increase fluid intake for twenty-four (24) hours to replace the lost
volume.

● Have something to eat or drink, or both, before leaving the donor

area.

● Do not put strong pressure on or try to lift or carry heavy objects with
the donating arm for the next few fours to avoid bleeding and
hematoma formation.

● If bleeding occurs from the phlebotomy site, reapply direct pressure

until it stops.

● If you feel dizzy or faint, sit down with your head lowered between
your knees or lie down with your feet elevated. If the symptoms
continue, return to the Blood Center or see your doctor.

● Refrain from very strenuous activity or hazardous work for a few

hours.

● Provide information on whom to contact for a referral or for

management of any untoward event.

1.4 Thank the donor for donating his/her blood and remind him/her to come
back after three (3) months for his next donation.

96
 Storage and Transport

1. PURPOSE

This document guides the MBD staff on the proper packing of blood units
for transport and storage conditions of blood units throughout the shelf life

2. SCOPE AND LIMITATIONS

This procedure starts from the preparation of blood units prior to transport
to the MBD collection site to the distribution from the Blood Center to end-
user hospitals/health facilities.

This does not include transport procedures when relatives of patients are
tasked to procure blood from Blood Centers and transport it to the hospital
Blood Center.

3. MATERIALS / EQUIPMENT

● Blood transport boxes

● Coolants

● Temperature monitoring device

● Standard electric Blood Center refrigerator

4. RESPONSIBILITIES

4.1 MBD Staff – ensure that donated blood is stored properly during
MBD sessions and transported to Blood Center according to
appropriate conditions

4.2 Attendant/Support Staff – follows the cold chain procedures in

packing donated blood, monitoring temperature during transport (on
long distances), and delivering blood to end-user hospitals at the
required temperatures and within the specified time.

4.3 Medical Technologist – receives blood and blood components from

the MBD collection sites or Blood Center; monitors the temperature
of stored blood components at the Blood Center

97
5. RISK MANAGEMENT/SAFETY PRECAUTIONS

5.1 Train all users of blood cold chain equipment on correct

maintenance and use.

5.2 Ensure that all transport devices and vehicles are working properly.

5.3 Ensure that there is no sharp or pointed object that can rupture the
packaging of the blood and blood products.

5.4 Universal precaution must always be practiced. Wear appropriate

PPE when handling blood and blood components.

6. GUIDELINES

6.1 When preparing for blood/blood components for transport –

6.1.1 Place the temperature monitoring device in the transport

container.

6.1.2 Pack the blood and blood components according to the length
and time of travel.

● Blood units should be maintained between +1°C to +10°C.

● Platelets and blood units from MBD sites that will be used for
the preparation of platelet concentrate should be maintained
between +20°C to +24°C.

6.1.3 The coolants should not be in direct contact with the blood
units. Place insulator pads between the coolants and the blood
units.

6.1.4 Close the transport container.

6.1.5 Label the container “KEEP UPRIGHT” with an arrow.

6.1.6 Transport the blood units to the Blood Center or end-user

hospital as soon as possible.

6.1.7 Record temperature at intervals until the blood units arrive at

the Blood Center.

98
 6.2 When receiving blood and blood components from MBD sites or
from another Blood Center, check the following:

6.2.1 Correctness of storage and transport procedure upon receiving

blood units.

6.2.2 Check and log the temperature upon receipt of transport boxes.

6.2.3 Blood transport manifest.

6.2.4 Registry of transported units if it matches the received number

of units.

6.3 The Blood Center must ensure the quality of the blood products during
storage and transport. The following tables provide information on
storage and transport temperature for specific blood products.

Table 1. Temperature requirement for freshly-collected blood during

transport from MBD site to Blood Center

Product Transport Temperature

To be maintained as Whole Blood +20C to +10 0C

Intended for PRBC +2 0C to +10 0C

Intended for Platelet Concentrate +20 0C to +24 0C
Intended for FFP +20C to +10 0C

Table 2. Temperature requirement for blood units during transport from

Blood Center/Blood Center to end-user hospital

Product Transport Temperature

Whole Blood +2 0C to +10 0C
Conventional Packed Red Cells +2 0C to +10 0C
Leukoreduced Packed Red Cells +2 0C to +10 0C
Irradiated Packed Red Blood Cells +2 0C to +10 0C
Washed Packed Red Cells +2 0C to +10 0C

99
 Table 3. Storage temperature requirement and maximum shelf life of
whole blood and packed red cells.

Blood Bag/Maximum
Product Storage Temperature Storage Time
Whole Blood +2 0C to +6 0C CPDA-1;. 35 days
Conventional Packed Red
CPDA-1; 35 days
Cells +2 0C to +6 0C
Leukoreduced Packed Red
CPDA-1; 35 days
Cells +2 0C to +6 0C
Irradiated Packed Red Blood +2 0C to +6 0C 14 days post-irradiation or 28
Cells days post-collection
Washed Packed Red Cells +2 0C to +6 0C 24 hours

Table 4. Length of time permitted for the storage and transportation of

platelet concentrates with the temperature range of +20 0C to +24 0C

Process Maximum Storage Time

Storage 5 days
Transport 24 hours
After issue, before transfusion 30 minutes

Table 5. Storage temperature requirement and maximum shelf life of

plasma products.

Product Storage Temperature Maximum Storage Time

°
FFP -65 C or below 7 years
FFP or Cryoprecipitate -40 °C to -64 0C 24 months
° 0
FFP or Cryoprecipitate -30 C to -39 C 12 months
FFP or Cryoprecipitate -25 °C to -29 0C 6 months
° 0
FFP or Cryoprecipitate -20 C to -24 C 3 months

100
7. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start
1. Medical Technologist
● Pack the blood units for transport
from the collection area to the
Blood Center processing area.
1. Prepare the blood units ● Ensure that proper cold chain
for transport. procedure is followed.
● Refer to WI – Transport of Blood
Units

2. Transport the blood

units to the Blood Center 2. Attendant
processing unit. ● Monitor and record temperature
during transport.
● Use Temperature Log

3. Receive blood units 3. Medical Technologist

from collection
● Check and validate received blood
units from the collection area

4. Medical Technologist
4. Place blood units in
quarantine until tested ● Store processed blood units in a
negative for TTI’s designated quarantine area until
testing
● Use an appropriate setting of
refrigerated centrifuge when
processing blood
5. Update inventory of
blood pool
5. Medical Technologist
● Store blood units in proper storage
equipment until the release
A

101
 A

6. Medical Technologist

● Refer to PG Packing and

6. Distribute/Issue blood
Transport of Blood Units.
units

End

8. DOCUMENTATION (Reports, Worksheets)

● Blood Transport
● Blood Quarantine Records
● Daily Blood Inventory
● Equipment Temperature Monitoring Chart

Screening for Transfusion Transmissible Infection

1. PURPOSE

This document guides the Blood Center technical staff in the performance
of blood screening for TTI’s to achieve uniformity of standards and ensure
patient safety.

2. SCOPE AND LIMITATIONS

This procedure starts from the receipt of samples to the referral of reactive
blood units to RITM TTI-NRL.

102
3. RESPONSIBILITIES

● Medical Technologist 1- collects and labels samples for TTI

screening
● Medical Technologist 2 – prepares all equipment, supplies, and
blood samples; runs controls; performs screening for TTI’s
● Medical technologist 3 – counterchecks all test results
● Laboratory Supervisor - responsible for reviewing worksheets,
validating test results identifying possible errors, and taking
corrective actions.

4. RISK MANAGEMENT/SAFETY PRECAUTIONS

4.1 Possible Risks:

a. Needle prick/ broken tubes injury

b. Splashes to the mucous membrane

c. Sample spillage

4.2 Safety Precautions:

a. Proper laboratory protective clothing and gloves (PPE) should

always be worn when handling biohazard wastes to avoid viral
and other infectious disease transmissions.

b. Adequate and conveniently located biohazard containers

should be available for the disposal of contaminated materials.

c. All wastes shall be disposed of in accordance with existing

policies of the Department of Health and Department of
Environmental and Natural Resources.

d. Biological safety cabinets or other physical containment

devices should be used for all manipulations that may cause
splashes, droplets, or aerosols of infectious materials (e.g.,
centrifugation, vigorous shaking, or mixing).

e. Work surfaces must be decontaminated immediately after any

spill of potentially infectious material and at the end of the
working day. Generally, freshly prepared bleach solutions are

103
 appropriate for dealing with a bio-hazardous spillage.
Personnel must wash their hands often, especially after
handling infectious materials before leaving the laboratory
working areas.

f. Personal protective equipment (PPE) must be removed before

leaving the laboratory.

g. Refer to the Handling Precautions inserts in the reagent kit

being used.

104
5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start 1. Medical Technologist 1

● Ensure proper collection and
labeling of blood samples for TTI
testing.
● Placing blood units that are
1. Collect specimen samples undergoing testing in quarantine.
from the blood bags

2. Medical Technologist 2
2. Receive and inspect ● Inspect all specimens coming
specimen samples from MBD or bleeding room walk-
in donors upon receipt.
● Check and ensure that all tubes
of blood received in the
Request a new laboratory are properly labeled;
specimen
note and record any
inappropriate samples.
● If sample quality is unacceptable,
Specimen request a new specimen.
acceptable? ● Allow frozen samples to thaw and
NO mix well.

3. Medical Technologist 2
YES
● Prepare the working bench for
testing
- Clean and disinfect the working
3. Prepare the working table with 5% Sodium
table Hypochlorite/70% alcohol
before starting the laboratory
work.
- Place a laboratory mat on the
4. Prepare the equipment working table to protect it from
and organize other sample spillage during testing.
instruments
4. Medical Technologist 2
● Refer to the Automated Machine
Operating Manual for each of the
A equipment to be used.

105
 RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
● Perform daily maintenance of the
A machine as indicated in the
operational manual. Use
Template Testing Equipment
User’s Logbook
5. Prepare samples, testing
protocol and test kit 5. Medical Technologist 2
reagents ● Determine the adequacy of the
number of reagents to be used for
testing the samples
● Allow reagents to reach room
temperature (18- 30 o C) before
6. Run controls starting the test procedures.
● Refer to Template TTI Worksheet
for testing protocol.

6. Medical Technologist 2
Results NO ● Refer to reagent kit inserts for
valid? controls calculation, acceptance,
and validations.
● Repeat the test run in case of
YES Investigate; contamination or invalid controls.
check for
contamination 7. Medical Technologist 2
● Prepare testing protocols as a
guide for testing.
● Identify and make a list of
Repeat the samples to be tested according to
test run
its arrangement during testing.
● Follow the manufacturer’s
procedures for reagent kits.
● Refer to WI TTI Screening
7. Test samples for TTIs Process

8. Medical Technologist 2
● Refer also to the Department
Circular 2013-0132 regarding
8. Re-validate test results “NCBS-TWG
Recommendations, Strategies,
Methodologies and Algorithms
A for Testing Blood Units for

106
 RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
Transfusion Transmissible
A Infections.”
● If revalidation of tests is
warranted, re-run reactive
samples and check consistency
with initial test results.
- Identify discrepant results and
9. Encode results decide on repeat testing.
- Decide on the final status of
the sample

9. Medical Technologist 2
● Encode the results in the TTI
10. Counter check all Worksheet.
encoded and recorded test
results

10. Medical Technologist 2 and 3

Sign report after counterchecking
encoded and recorded test
11. Sort the units and results
assign non-reactive units
to blood pool
11. Medical Technologist 2
● Sort the quarantined blood units
using the test report.
● Place the non-reactive units in
the designated and appropriate
End storage equipment and update
the blood inventory records.
● Keep the reactive units in
quarantine. Dispose or send
reactive units to RITM-NRL, if
applicable.

6. DOCUMENTATION (Forms, Worksheets)

● Testing Equipment User’s Logbook

● Testing Protocol Worksheet
● Reactive Blood Units

107
 Testing for Transfusion Transmissible Infection

1. GUIDELINES

1.1 Only qualified, proficient, and trained staff shall perform this procedure.
The technical staff must be trained by the supplier in the operation and
troubleshooting of the machine analyzers.

1.2 Only reagent kits evaluated by SACCL and approved by the FDA which
are intended for TTI serology shall be used in screening. Refer also to
the Department Circular 2013-0132 regarding “NCBS-TWG
Recommendations, Strategies, Methodologies and Algorithms for
Testing Blood Units for Transfusion Transmissible Infections.”

1.3 Quality Control

i. Run quality control and monitor the Levey-Jennings chart

daily.

a. Watch out for random and systematic errors. Identify root

cause and implement appropriate corrective action.

1.4 Each run must include the recommended set of quality controls for the
specific test kit that is being used.

1.5 The controls for each test run must yield results within the limits of the
manufacturer's criteria for acceptability and validity of the run.

1.6 Any run below the minimum number of controls falling within the
acceptable range is invalid and must be repeated. Refer to the kit
inserts of the respective equipment used.

1.7 External controls (third party control) can be included on the run to
monitor consistent performance, a lot-to-lot variation between kits, and
to serve as an indicator of assay performance on samples that are
borderline reactors.
1.8 Values for the internal controls, external controls (third party control),
and cut-off should be monitored by quality control charts using
statistical methods.

1.9 All test kits must be used before the expiration date to ensure valid
results.

108
 1.10 Physical parameters of the test, such as incubation time and
temperature, must be followed to ensure proper performance.

Screening for Transfusion Transmissible Infection

1. INTENDED USE

To guide the Blood Center technical staff in the proper performance of

the TTI testing process

2. PRINCIPLE

Enzyme immunoassay and chemiluminescent immunoassay are the

platforms that may be used for screening for Hepatitis B, C, HIV, and
Syphilis.

3. MATERIALS / EQUIPMENT

EIA/ChLIA machine

4. PROCEDURE

4.1 Prepare the samples and test kit reagents to be used.

4.1.1 Check for proper labeling of samples.

4.1.2 Prepare testing protocols:

a. Count the number and adequacy of samples to be tested.

b. List samples to be tested according to its arrangement
during testing
c. Check/determine the adequacy of the number of reagents
to be used for testing the samples; allow reagents to reach
room temperature (18- 30 °C) before starting the test
procedures.
d. Perform reconstitution, dilution, and mixture if necessary
using the procedure recommended in the reagent kit’s
insert.

109
 4.2 Test samples for the five (5) TTIs. Refer to the Automated
Machine Operating Manual for each of the equipment to be
used. Follow the manufacturer’s procedures for reagent kits.

4.2.1 Check if the machine dispenses all the samples

appropriately into the microwell plates.

4.2.2 Do not leave the automated machine until it dispenses

all the samples.

4.2.3 Identify the sample/s that were/were not appropriately

dispensed during machine sample distribution.

4.2.4 Dispense manually the sample/s that were/were not

appropriately dispensed in accordance with the
operational procedure manual of the machine in use.

4.3 Check and validate controls to ensure accurate test results.

(Refer to reagent kit inserts for controls calculation,
acceptance, and validations.)
4.3.1 Repeat the test run in case of contamination or invalid
controls.

4.3.2 Re-validate test results and check for the correctness

of the final status of the samples.

4.3.3 Identify discrepant results and decide on repeat

testing. Decide on the final status of the sample.

4.3.4 Encode results.

4.3.5 Another medical technologist shall conduct a second

verification check on all encoded and recorded test
results.

Component Processing
1. PURPOSE

This document guides the Blood Center technical staff on the proper
performance of component processing with emphasis on the critical control
points. To document the steps involved in the processing of whole blood
into different components.

110
2. SCOPE AND LIMITATIONS

This document starts from the time the blood units are received up to the
storage of the components in the appropriate equipment.

3. RESPONSIBILITIES

3.1 Medical Technologist - ensures that blood and blood components

are processed within eight (8) hours after collection and properly
stored in their respective required temperatures.

3.2 Section Supervisor – ensures that Good Manufacturing Practice

(GMP) is being followed

4. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start 1. Medical Technologist

Check and record the following:
● Time of receipt
● Temperature upon receipt
● Number & condition of cold
1. Receive the transport
packs
boxes and check the blood
● Number of blood units
units
● Number of samples
● DHQ forms

2. Medical Technologist
2. Sort and check the blood ● Sort the blood units to determine
units. which units are suitable for blood
component processing. Refer to
Procedural Guidelines on Suitability
Criteria for Component Processing
● Use Template – Pre-processing
NO
Suitable for Checklist
processing? ● Discard the units unsuitable for
component processing. Refer to
Discard the QP Disposal of Blood Units and
YES blood unit Samples.
● Quarantine blood units until
screening TTI is completed.
A B

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 RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

A B 3. Medical Technologist
● Check the refrigerated centrifuge
prior to use. Follow the
manufacturer’s operation manual
for the preparation and safe
3. Prepare the blood units and handling of the refrigerated
equipment. centrifuge.

4. Medical Technologist
● Screening for TTI is done
simultaneously with component
processing. Place blood units that
are undergoing processing and
testing in quarantine at the
prescribed storage temperature.
4. Process blood ● Refer to specific Work Instructions
components. for
o Preparation of Red Blood Cells
o Preparation of Platelet
Concentrate
o Preparation of Fresh Frozen
Plasma
o Preparation of Cryoprecipitate
● In case of breakage and blood
spillage, refer to
o PG Cleaning Blood Spills
o QP Disposal of Blood and
Samples

5. Medical Technologist
5. Label the blood ● Identify blood units that have been
component tested negative for TTIs.
● Arrange units in ascending order
and per component processed.
Verify information using the
following:
o MBD Code
o Segment label
o Barcode label
o TTI test worksheet
A

112
 RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

6. Medical Technologist
6. Store blood components
in appropriate storage ● Refer to Appendix - Proper Storage
equipment. of Blood and Blood Components.

7. Medical Technologist
7. Update record.
● Encode in BBIS or logbook.

End

5. DOCUMENTATION (Forms, Worksheets)

● Pre-processing Checklist

Suitability Criteria of Blood Units for Processing

1. SUITABILITY CRITERIA OF BLOOD UNITS FOR PROCESSING

1.1 Duration of Donation

● A blood unit may be considered for component processing if the

duration of blood collection does not exceed 15 minutes.

● A blood unit that exceeded the 15-minute collection time should be

discarded.

1.2 Transport Temperature Requirement of Blood Units for Component

Processing

Intended for PRBC and FFP processing +2°C to +10°C

Intended for Platelet Concentrate +20°C to +24°C

113
 1.3 Volume
● Whole Blood volume must be 405 – 495mL.

● For volumes of 350 – 404mL, process as PRBC and indicate

‘low volume red cell.’

● A blood unit with a volume below 350mL is an ‘unsuccessful

phlebotomy’ and discarded.

1.4 Time from Collection to Completion of Processing

● Blood units should be processed within 8 hours after

collection. An average of 30 blood units can be processed
completely in an hour.

● Blood units that cannot be processed within 8 hours after

collection should be processed into PRBC.

1.5 Hemolysed or clotted blood units are unfit for processing.

1.6 Chylous

● A blood unit collected using a triple bag may be processed as

PRBC. Discard the plasma.

● A blood unit collected using a single bag may be welded with

a satellite bag and processed as PRBC (closed system) or
allowed to stand as Whole Blood and processed as PRBC
when the need arises (open system). Discard the plasma.

● Blood Bag Integrity. Blood units with leaks are not fit for
processing

Preparation of Packed Red Cells

1. INTENDED USE

To separate the red cells from plasma after whole blood donation.

2. PRINCIPLE

Red Blood Cells are obtained by removal of supernatant plasma from

centrifuged Whole Blood. The volume of plasma removed determines the
hematocrit of the component.

114
3. MATERIALS / EQUIPMENT

3.1 Materials

● Freshly collected whole blood was kept at +1°C to +6°C before

processing ( < 8 hours after collection)

● Scissors

● Gloves

● Hemostat

● Ballpoint pen

3.2 Equipment
● Refrigerated centrifuge

● Plasma extractor

● Dielectric sealer/tube sealer

● Weighing scale

4. QUALITY ASSURANCE/CONTROL

4.1 Volume of final unit: 280 + 50 mL

4.2 Hematocrit: 0.65 – 0.75

4.3 Hemoglobin: minimum of 45 g per unit

4.4 Frequency of control per total number of units processed monthly:

o > 500 to 1,000 – 4 units/month

o > 100 to 500 - minimum of 2 units/month

4.5 Hemolysis at the end of storage: < 0.8 % of red cell mass
4.6 Frequency of control per total number of units processed monthly:

115
5. PROCEDURE

5.1 Weigh the blood units and ensure that the weights in the centrifuge
buckets are balanced.

5.2 Centrifuge whole blood using a “heavy” spin, with a temperature setting
of +4°C. If the blood has been separated by sedimentation,
centrifugation is not necessary.

5.3 Place the primary bag containing centrifuged or sedimented blood on a

plasma express or/extractor and release the spring to allow the plate of
expression/extractor to contact the bag.

5.4 Clamp the tubing between the primary and satellite bags with a
hemostat. If a mechanical sealer is not used, make a loose overhand
knot in the tubing.

5.5 If two or more satellite bags are attached, apply the hemostat to one of
the satellite tubings to allow the supernatant plasma to flow into only one
of the satellite bags. Break the seal between the bags and allow
supernatant plasma to flow in the satellite bag.

5.6 Weigh the primary bag. Refer to the supplier’s notes on the acceptable
weight limit for PRBC after tare.

5.7 Use a hemostat in the primary bag to halt the outflow of blood when the
acceptable volume of PRBC is reached. Seal the tubing at two points
between the primary bag and the satellite bag.

5.8 Check if the satellite bag has the same donation sticker like that on the
primary bag and cut the tubing between the two seals.

5.9 Store the PRBC at +1°C to +6°C.

5.10 Record in the blood component register.

116
 Preparation of Platelet Concentrate

1. INTENDED USE

To describe the method of preparing platelets from whole blood

2. PRINCIPLE

Platelet-rich plasma is separated from whole blood by light spin

centrifugation, and the platelets are concentrated by heavy centrifugation
with subsequent removal of supernatant plasma.

3. MATERIALS / EQUIPMENT

3.1 Materials

● Freshly collected whole blood was kept at 20°C to 24°C before

processing (< 8 hours after collection)

● Scissors

● Gloves

● Hemostat

● Ballpoint pen

3.2 Equipment
● Tube sealer

● Weighing scale

● Refrigerated centrifuge

● Plasma extractor

● Platelet agitator

4. QUALITY CONTROL

Do not chill the blood at any time before or during platelet separation.
Ensure that the temperature setting of the centrifuge is at 20°C.
a. Volume of final unit: > 40 mL

117
 b. Platelet count: 60 x 109 of platelets

c. Frequency of control per total number of units processed monthly:

● 500 to 1,000 - 1% of all units with a minimum of 10

units/month
● > 100 to 500 - minimum of 5 units/month
● 100 and below – minimum of 1 unit/month
d. Residual leukocytes:

● Prepared from
o buffy-coat: <0.05 x 109

o prepared from PRP: <0.2 x 109

● Frequency of control: simultaneous with QC schedule for

platelet count determination

5. PROCEDURE

5.1 Centrifuge the blood using a light spin.

5.2 Express the platelet-rich plasma into the transfer bag intended for platelet
storage. Seal the tubing twice between the primary bag and Y connector of
the two satellite bags and cut between the two seals. Store the red cells in
a blood refrigerator with a temperature range between +1°C to +6°C.

5.3 Centrifuge the platelet-rich plasma using a heavy spin at 20°C.

5.4 Express the platelet-poor plasma into the second transfer bag and seal the
tubing. Some plasma should remain with the platelet button for storage.
About 50-70 ml is preferable.

5.5 Centrifuged platelets aggregate irreversibly if subjected to rough agitation.

5.6 Allow the platelet concentrate to stand for 1 hour.

5.7 Re-suspend the platelets in either of the following ways:

● Manipulate the platelet container gently by hand to achieve uniform

suspension.
● Place the container on a rotator at room temperature. The slow, gentle
agitation should achieve uniform re-suspension within two (2) hours.

118
 5.8 Place the platelet suspension in a mechanical platelet agitator and maintain
the ambient temperature at 20°C to 24°C. Platelets should be inspected
before issue to ensure that no platelet aggregates are visible.

5.9 Shelf life is five (5) days from the date of collection.

Preparation of Fresh Frozen Plasma

1. INTENDED USE

To describe the steps for preparing fresh frozen plasma.

2. PRINCIPLE

Plasma is separated from cellular blood elements and frozen to preserve the
activity of labile coagulation factors. Plasma must be prepared for freezing within
8 hours of phlebotomy.

3. MATERIALS / EQUIPMENT

3.1 Materials

● Freshly collected whole blood in double, triple, or quadruple bags

kept at +1°C to +6°C before processing ( < 8 hours after collection)

● Scissors

● Gloves

● Hemostat

● Ballpoint pen

3.2 Equipment
● Refrigerated centrifuge

● Dielectric sealer/tube sealer

● Weighing scale

4. QUALITY CONTROL

4.1 Volume of final unit: stated volume + 10%

119
 4.2 Factor VIII: average should not be < 70IU/100 mL

4.3 Frequency of control, first month of storage:

o > 500 to 1,000 - 10 units

o > 100 to 500 - 5 units

o 100 and below - 1 unit

4.4 Residual cells:

4.5 Frequency of control: simultaneous with QC schedule for Factor VIII

determination

o Red cells: < 6.0 x 109

o Leukocytes: < 0.1 x 109

o Platelets: < 50 x 109

4.6 Leakage, all units: No leakage

4.7 Visual changes, all units: No abnormal color or visible clots

5. PROCEDURE

5.1 Centrifuge the blood using a heavy spin with the temperature set at
+4°C (unless also preparing platelets.

5.2 Place the primary bag containing the centrifuged blood on a plasma
extractor. Release the spring to allow the plate of the extractor to
touch the bag.

5.3 Gently break the closure of the primary bag to allow the plasma to
flow into the satellite bag.

5.4 Seal the tubing at two (2) points between the primary bag and the
satellite bag

5.5 Cut the tubing between the two seals. The tubing may be coiled and
taped against the container, and leave the segments available for
any testing desired.

120
 5.6 Record the volume of the plasma on the label.

5.7 Place plasma at -30°C or colder to ensure that it is frozen solid within
1 hour.

5.8 Check thereafter if plasma is starting to harden. Discard unfrozen

plasma.

5.9 Store requirement:

● 3 months at -18 to -25oC

● 36 months below -25%

Preparation of Cryoprecipitate

1. INTENDED USE

To describe the steps on preparing cryoprecipitate.

2. PRINCIPLE

Coagulation Factor VIII (anti-hemophilic Factor, AHF) can be concentrated

from plasma by cryoprecipitation. Cryoprecipitation is accomplished by slow
thawing at +1°C to +6°C, plasma that has been prepared from freezing
within 8 hours of phlebotomy.

3. MATERIALS / EQUIPMENT

Fresh frozen plasma

4. PROCEDURE

4.1 Allow the frozen plasma to thaw by placing the bag in a 1°C to 6°C
circulating water bath or refrigerator. If thawed in a water bath, use
a plastic wrap to keep the container dry.

4.2 When the plasma has a slushy consistency, separate liquid

plasma.

4.3 Centrifuge the plasma at 2°C to 6°C using a hard spin.

121
 4.4 Place the thawing plasma in a plasma extractor/express or while
approximately 1/10 of the content is still frozen.

4.5 With the bag in an upright position, allowing the supernatant

plasma to flow into the transfer bag, using the ice crystals on top
as a filter. The cryoprecipitate paste will adhere to the side of the
bag or to the ice.

4.6 Seal the bag when about 90% of the cryo-poor plasma has been
removed and refreeze the cryoprecipitate immediately.

4.7 Store at -18°C or colder (preferably -30°C) for up to 12 months

after the date of collection.

Pretransfusion Testing (Routine)

1. INTENDED USE

To guide the Blood Center technical staff in the performance of pre-

transfusion testing.

2. SCOPE AND LIMITATIONS

This document describes the step-by-step procedures of pre-transfusion
testing, from the receipt of the blood request until the blood unit is issued
for transfusion to the correct patient.

3. DEFINITIONS

BT Check – refers to checking of blood type of patients who will be

transfused for the first time in a particular confinement period. While blood
grouping is performed as an initial procedure in pre-transfusion testing, a
repeat blood grouping is performed after the completion of the pre-
transfusion testing and right before the release of the first blood unit for
transfusion as a final check to ensure that the patient who will be receiving
the blood will have the same blood type as the unit for release.

4. RESPONSIBILITIES

4.1 Pathologist – supervises the work process of the blood service facility;
ensures that GMP is practiced all the time

122
 4.2 Medical Technologist – performs pre-transfusion testing, selects the
right blood group and blood component for transfusion, and updates
all transfusion records.

5. RISK MANAGEMENT / SAFETY PRECAUTIONS:

5.1 Ensure that appropriate quality control is performed with reagents and
blood products. Refer to Work Instruction on Quality Control of
Immunohematology Reagents.

5.2 Ensure that red cell solutions are reagents are not expired to avoid
erroneous reactions during testing.

5.3 Inform the pathologist or hematologist on board of any difficult

problems encountered during pre-transfusion testing. The attending
physician is also informed so that alternative clinical intervention may
be administered, if any.

5.4 Record all results accurately. Work up of difficult cases (ambiguous

test results, atypical characteristics of blood specimens, incompatible
crossmatches) should be adequately documented.

5.5 If the need for transfusion is extremely urgent, where blood products
are required before pre-transfusion testing can be performed or until
an identified compatible unit has been obtained, give group O packed
red cells and group AB plasma product.

123
6. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
1. Medical Technologist
● Check completeness of
Start
information on the request. Seek
clarification if necessary.

● Determine the urgency of the

1. Receive request for request, STAT/Emergency or
blood/crossmatch Routine.

● Take note of special instructions

or preparation, if any (timing of
release, aliquots, irradiated, etc.).
2. Collect sample for
compatibility testing 2. Phlebotomist

● Check all the data at the

blood request, crossmatch
and sample if all are the
same.

3. Check the label sample ● Ensure positive identification

against the blood and of patient when collecting a
crossmatch requests blood sample.

● Refer to Guidelines on
Positive Identification of
Patient and Sample
Collection

Sample and 3. Medical Technologist

requests
are NO ● In case of unacceptable and
acceptable? incompletely labeled
samples, repeat the
collection of samples.
YES
- Note and record
any unacceptable
A samples

124
 RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

4. Medical Technologist
● Resolve any discrepancy
A
between the results of the tests
with serum or plasma and red
cells before recording an
interpretation of the patient’s
group.
NO 5. Medical Technologist
Compatible? ● If antibody screening is positive,
identify a specific antibody.
Select antigen-negative unit.
● In case the patient does not
wish to continue further workup,
YES
document communication in the
patient’s chart.
Investigate.
Inform attending 6. Medical Technologist
physician. ● Crossmatched-compatible unit
for red blood cell units
● Type-specific for plasma
components
7. Medical Technologist
● Perform blood typing of donor
8. Update all records unit prior to crossmatch.
● If no compatible unit is
available, refer to a pathologist/
hematologist on board and
inform the attending physician.
● Inform the attending physician
immediately when there is
difficulty finding compatible
blood.
End 8. Medical Technologist
● Ensure that results of the test
are accurately recorded in the
following documents:
o Patient transfusion
record
o Master logbook
o BBIS

7. DOCUMENTATION (Forms, Worksheets)

125
 ● Blood Request for Adult Patients
● Blood Request for Pediatric Patients
● Crossmatching Report
● Patient Transfusion Record
● Blood Transfusion Reaction Registry Form

Daily QC of Immunohematology Reagents

1. INTENDED USE

To ensure that serologic test reagents are suitably reactive for each day of
use based on antigen-antibody reaction.

2. PRINCIPLE

Antigen-antibody reaction is performed to prevent transfusion of

incompatible donor cells from preventing immune-mediated transfusion
reactions.

3. MATERIALS / EQUIPMENT

● Typing sera, Anti-A

● Typing sera, Anti-B
● Optional: Typing sera, Anti-A, B
● Typing sera, Anti-D
● Reference cells, A1 red blood cell suspension
● Reference cells, B red blood cell suspension
● Antibody Screening Cells
● QC reagent cells
● QC reagent anti-sera
● Enhancement medium (such as LISS)
● AHG (anti-human globulin)
● Check cells
● Calibrated plastic pipette (0.5 – 3mL)
● Buffered Normal Saline Solution (NSS)
● Serologic centrifuge (serofuge)
● Dry bath incubator
● Test tubes and test tube racks

126
 ● Marking pen
● Quality Control Data Sheet
● Quality Control Reagent Sheet

4. QUALITY CONTROL

Calibrated serologic centrifuge

5. PROCEDURE

5.1. Before performing daily QC testing, inspect all reagents for

evidence of contamination or deterioration (i.e., marked turbidity of
blood grouping reagents, hemolysis of reagent red blood cells, etc.).

5.2. Record the lot number and expiration date of each reagent and
observations on the QC Data Sheet.

5.3. Label one test tube for each reagent to be evaluated.

Tube 1 - Anti-A
Tube 2 - Anti-B
Tube 3 - Anti-A, B (if used)
Tube 4 - Anti-D
Tube 5 - A1 cells
Tube 6 - B cells
Tube 7 - Screening cells 1
Tube 8 - Screening cells 2
Tube 9 - Screening cells 3

5.4. Add 1 drop of each reagent to the appropriate tubes.

5.5. Add 1 drop of QC Reagent Cells to tubes 1 to 4.

5.6. Add 1 drop of QC Antiserum to tubes 5 to 9.

5.7. Centrifuge all tubes for 30 seconds (or depending on the calibration
of the serologic centrifuge.

5.8. Gently suspend each red blood cell button and examine for
agglutination.

5.9. Record the results on the QC reagent sheet.

127
 5.10. Add 2 drops of LISS to tubes 7 to 9 and incubate for 10 to 15
minutes (depending on the manufacturer’s insert).

5.11. After incubation, centrifuge tubes 7 to 9 for 30 seconds. Gently

suspend the red cells. Record the result on the QC reagent sheet.

5.12. Wash the contents of tubes 7 to 9 at least 3 times with buffered

saline, being careful to decant completely after each wash. On the
last washing, blot dry.

5.13. Add 2 drops of AHG to tubes 7 to 9.

5.14. Mix the content of the tube thoroughly.

5.15. Centrifuge the tube for 30 seconds.

5.16. Gently suspend each red cell button and examine macroscopically
for agglutination.

5.17. Grade and record the results on the QC Data Sheet.

5.18. Add check cells to all tubes with no agglutination.

5.19. Centrifuge and read, record results.

6. RESULTS

RESULT AGGLUTINATION BACKGROUND

4+ One solid / large agglutinate Clear
3+ Several large agglutinates Clear
2+ Medium-sized agglutinates Clear
1+ Small agglutinates Turbid
+/- or trace Very small agglutinates Turbid
0 No agglutination or negative

7. INTERPRETATION:

128
 ● Trace to 4+ = incompatible
● 0 or negative = compatible

8. PROCEDURAL NOTES:

8.1 Tilt and wiggle method of re-suspension is ideal.

8.2 Excessive shaking or tapping of the tubes may yield false-negative

results.

Preparing Laboratory Red Cells Solution

1. INTENDED USE

To guide the Blood Center technical staff in preparing red cell suspension
to be used in re-checking the ABO group of plasma products.

2. PRINCIPLE

Use a minimum of five (5) segments from different blood units of group A
and five (5) segments from different blood units of group B to have a greater
chance to represent the different subgroups.

3. MATERIALS / EQUIPMENT

● Five (5) segments of equal amounts from different group A blood unit
● Five (5) segments of equal amounts from different group B blood
units
● Buffered 0.9% saline
● Typing sera
o Anti-A

o Anti-B

● Test tubes
● Serologic centrifuge

4. QUALITY CONTROL

Daily QC of typing sera

129
5. PROCEDURE

5.1. Get five (5) segments of the equal amount each of both A and B
PRBC from different blood units with the same blood group.

5.2. Combine the contents of five (5) segments of group A cells in one
test tube.

5.3. Combine the contents of five (5) segments of group B cells in one
test tube.

5.4. Wash the cells 3 times with buffered saline. To ensure complete
washing, re-suspend the cell button thoroughly between washes
before adding more saline.

5.5. After the final wash, shake the tube to completely resuspend the cell
button, then add saline to prepare 2% to 5% red cell suspension for
both A and B cells.

5.6. Blood type of each test tube:

5.6.1. Label 4 test tubes as follows: Aa, Ab, Ba, Bb.

5.6.2. Add 1 drop of anti-A reagent to tubes Aa and Ba.

5.6.3. Add 1 drop of anti-B reagent to tubes Ab and Bb.

5.6.4. Add 1 drop of A cells on tubes Aa and Ab.

5.6.5. Add 1 drop of B cells on tubes Ba and Bb.

5.6.6. Centrifuge all tubes in the serologic centrifuge for 20 seconds

at 3400rpm.

5.6.7. Read and record the result in the daily QC sheet.

5.7. Place the 2% to 5% A and B cells in vials labeled with the following:
● Blood type

130
 ● Date and type prepared

● Date and time of expiration

● Storage temperature

● Name of the medical technologist who prepared the red cell

solutions

6. RESULTS

RESULT AGGLUTINATION BACKGROUND

4+ If one solid / large agglutinate Clear
3+ Several large agglutinates Clear
2+ Medium-sized agglutinates Clear
1+ Small agglutinates Turbid
+/- or trace Very small agglutinates Turbid
0 No agglutination or negative

7. INTERPRETATION:

● Trace to 4+ = positive

● 0 or negative = negative

● Agglutination of tested red cells and either hemolysis or agglutination

in tests with anti-sera is a positive test result.

● A smooth cell suspension after resuspension of the cell button is a

negative test result.

8. PROCEDURAL NOTES

a. Prepare laboratory red cell suspension every shift.

b. Washed cells from 5 different segments can be stored in the reagent

refrigerator and can be used in preparing the red cell suspension.

131
 Blood Request (Adult)

Blood Center Name

BLOOD REQUEST FORM
(Adult)
Date: ___________ Hospital No.: ________________

Name of Patient: __________________________________________________

Surname First Name Middle Name

Age: _________ Sex: __________ Date of Birth: ___________________

Ward: _______ Room #_______ Department: ____________________

Clinical Diagnosis: ________________________________________________

_______________________________________________________________

History of Previous Transfusion: When: ________________

Where: ________________

Type of Request: ( ) ROUTINE ( ) STAT

Check Components Needed and Indication for Transfusion:

( ) Whole Blood (approx. volume 500 ml)
( ) WB-1: Active bleeding with at least one of the following:
a) Loss of over 15% blood volume
b) Hgb less than 9 g/dl
c) Blood pressure decrease over 20 &, or less than 90
mmHg systolic
( ) WB-2 :

Others. Please specify. (This code will automatically trigger a review of your
indication.) ___________________________________________________

132
( ) Packed RBC (approx. volume 250 ml)
( ) R - 1: Hgb less than 8 gm/dl of Hct less than 24% (if not due to
treatable cause)
( ) R - 2: Patients receiving general anesthesia if:
a) Preoperative Hgb less than 8 g/dl of Hct less than 24%
b) Major blood operation and Hbg less than 10 g/dl or Hct
less than 30%
c) Signs of hemodynamic instability or inadequate oxygen
carrying capacity (symptomatic anemia)
( ) R - 3: Symptomatic anemia regardless of Hgb level (dyspnea,
syncope, postural hypotension, tachycardia, chest pains,
TIA)
( ) R - 4: Hgb less than 8 g/dl or Hct less than 24% with
concomitant hemorrhage, COPD, CAD, hemoglobinopathy,
sepsis
( ) R - 5: Others. Please specify. (This code will automatically trigger a
review of your indication) ___________________________

( ) Washed RBC (approx. volume 180 ml)

( ) WP-1 : History of previous severe allergic transfusion reactions or
anaphylactic reactions in immunocompromised patients.
( ) WP-2: Transfusion of group “O” blood during emergencies when
the specific blood is not immediately available.
( ) WP-3 : Paroxysmal nocturnal hemoglobinuria
( ) WP-4 : Others. Please specify. (This code will automatically trigger a
review of your indication) ____________________________

NOTE: Comments on RBC products:

1. Document pre and post-transfusion Hgb & Hct within 24 hours
2. Dose; Adults – give on a unit-to-unit basis
Remember, 1 unit may suffice to alleviate symptoms of anemia.
Infants: 10 ml/kg. BW

133
( ) Platelets (approx. volume 50 ml)

( ) P - 1: Prophylactic administration with count <10,000 and not due

to TTP, ITP, HUS
( ) P - 2: Active bleeding with count 50,000
( ) P - 3: Platelet count 50,000 and patient to undergo invasive
procedure within 8 hours.
( ) P - 4: Platelet count 100,000 if surgery is on critical area (e.g.,
eye, brain, etc.)
( ) P - 5: Massive transfusion with diffuse microvascular bleeding and
no time to obtain platelet count
( ) P - 6: Others. Please specify. (This code will automatically trigger
review of your indication.) ___________________________

NOTE: 1. Document platelet count before (within 8 hours) and

after (within 1 hour) Transfusion
2. Dose: 1 unit/10 kg. BW with a maximum of 8 units

( ) Cryoprecipitate (approx. volume 20 ml)

( ) C - 1: Significant hypofibrinogemia ( < 100 mg/dl)

( ) C - 2: Hemophilia A with bleeding or will undergo surgery or
invasive procedure

( ) C - 3: Von Willebrand’s disease or uremic bleeding with prolonged

bleeding time
( ) C - 4: Others. Please specify. (This code will automatically trigger a
review of your indication) _________________________

134
( ) Fresh Frozen Plasma (approx. volume 200-250 ml)
( ) F - 1 PT or PTT > 1.5 times mid-normal range within 8 hours of
transfusion
(PT > 17 secs., PTT > 47 secs)
( ) F - 2 Specific factor deficiencies not treatable with cryoprecipitate
( ) F - 3 Reversal of coumadin anticoagulation in patients who are
bleeding and not treatable with vitamin K
( ) F - 4 Treatment of TTP
( ) F - 5 Clinical coagulopathy associated with:
a. Massive transfusion ( 20 units of blood in 24 hours.)
b. Late pregnancy termination or abruption placentae
( ) F - 6 Others. Please specify. (This code will automatically trigger a
review of your indication.) __________________________

NOTE: 1. Document PT/PTT pre and post-transfusion within 4

hours.
2. Dose: initial loading dose of 15 ml/kg. BW
Correction of significant coagulopathy requires > 2
units of FFP

No. of Units needed : _______________________________

Requesting Physician/Consultant : _______________________________
Resident – In – Charge : _______________________________
Reviewed and Endorsed by : _______________________________

Received by: __________________________ Date/ Time: ___________

(Blood Center Staff)

Revised 10 Sept 2003

NVBSP BB-06
Cc: Source Blood Center

135
 Blood Request (Pediatrics)
Blood Center Name
BLOOD REQUEST FORM
(For Pediatric)

Date: _________ Hospital No.: ________________

Name of Patient: __________________________________________________

Surname First Name Middle Name
Age: _________ Sex: __________ Date of Birth: _____________________
Ward: _________ Room #_________ Department: _____________________

Clinical Diagnosis:
________________________________________________________________
________________________________________________________________

History of Previous Transfusion: When: ________________

Where: ________________

Type of Request: ( ) ROUTINE ( ) STAT

Check Components Needed and Indication for Transfusion:

( ) Whole Blood

For Exchange Transfusion:

( ) Hyperbilirubinemia in an infant with indirect bilirubin of 20 mg/dl in the first
week of life
( ) Hyperbilirubinemia with prematurity and/or other concomitant illness to
include one or more of the following: Prenatal asphyxia, acidosis, prolonged
hypoxemia, hypothermia, sepsis, and hemolysis
( ) Others – please specify: _______________
( ) Packed Red Cell
( ) Hypovolemia from acute blood loss with signs of shock or anticipated blood
loss of >10%

136
( ) Candidates for Major Surgery and hematocrit < 30 % (Neonatal < 35%)
( ) Hypertransfusion for chronic – hemolytic anemias; (Thalassemia)
( ) Hemoglobin less than 13 gm/dl (Hct. 40 %) in neonates less than 24 hours
old, severe pulmonary disease, with assisted ventilation, cyanotic heart disease
or heart failure
( ) Neonates with phlebotomy loses > 5-10% of total blood volume
( ) Hemoglobin level less than 8 gm/dl or Hct less than 25% in stable newborn
infants with clinical manifestations of anemia
( ) Others – please specify: ______________

( ) Platelet Concentrate
( ) Active bleeding and thrombocytopenia < 50,000/L or at risk for intracranial
hemorrhage
( ) Active bleeding and qualitative defect
( ) Prophylaxis for severe thrombocytopenia < 20,000/L or associated qualitative
defect
( ) Schedule invasive procedure and thromboycytopenia < 70,000/L or
associated qualitative defect
( ) Others – please specify: ________________________________
( ) Uremia with active bleeding or schedule invasive procedure
( ) Others (specify) ______________________________________
( ) Fresh Frozen Plasma
( ) Significant multiple coagulation factor deficiency or acquired factor deficiency
(e.g. dengue, shock syndrome)
( ) Significant congenital factor deficiency
( ) Anti-thrombin III deficiency
( ) Bleeding in exchange transfusion or massive transfusion (> 1 Blood Volume)

( ) Cryoprecipitate
( ) Factor VIII Deficiency (Hemophilia A)
( ) Von Willebrands Disease
( ) Disseminated Intravascular Coagulation
( ) Uremia with active bleeding or schedule invasive procedure
( ) Others – please specify: _______________________________

137
No. of Units needed: _____________ Volume: ________________
No. of Aliquot: ___________

Requesting Physician/Consultant: _______________________________

Resident – In – Charge: _______________________________
Reviewed and Endorsed by: _______________________________
(Hema fellow –on-duty)

For Blood Center use only:

Received by: _____________________ Date/ Time: ___________________

Revised 10 Sept 2003 #1

NVBSP BB-03

138
 Resolving ABO Discrepancies

1. INTENDED USE
● To identify and resolve common ABO grouping discrepancies

2. PRINCIPLE
● Antigen-antibody reaction is performed to resolve ABO discrepancy
since misinterpretation of ABO discrepancies can be life-threatening
to patients.

3. SPECIMEN

● Whole blood

4. MATERIALS/EQUIPMENT

● Buffered 0.9% saline

● Test tubes

● Serologic centrifuge

● Incubator (dry bath or water bath)

● Refrigerator

● Pipettes

5. QUALITY CONTROL

● Daily quality control of reagents

● Calibrated serologic centrifuge

6. PROCEDURE

6.1 Repeat the blood typing and make certain that all areas of testing
were performed correctly.
6.2 Check for clerical errors.
6.3 Check for the patient’s age and diagnosis.
6.4 Check if the patient has a history of:

139
 • recent transfusion

• recent transplantation

• patient’s medications

6.5 For problems with forwarding typing, follow these steps:

6.5.1 Wash the patient’s red cells 3 – 4 times with buffered saline.

6.5.2 Prepare 2 - 5% red cell suspension in buffered saline and

repeat the tests with anti-A and anti-B.

6.5.3 If the problem is a weak or missing reaction in forwarding

typing, test with the following additional reagents (if
available):
● anti-A, B to confirm the results of anti-A and anti-B
● anti-A1 lectin to differentiate subgroup A1 from other A
subgroups
● Anti-H for recognition of H substance
● Perform another test; this time, incubate first at room
temperature for 15 to 30 minutes before centrifugation; if
not yet resolved
● Incubate at 4oC, then centrifuge

6.5.4 If the problem is an extra reaction in forwarding typing, use

another brand of anti-A and anti-B (if available):
● Perform auto control
● Check the diagnosis of the patient and blood culture result
if there is any

6.6 For problems with reverse typing, follow these steps:

6.6.1 If the problem is a weak or missing reaction in reverse typing:

● Incubate at room temperature for 15 to 30 minutes

before centrifugation; if not yet resolved
● Incubate at 4oc, then centrifuge

140
 ● Increase the amount of serum or plasma to 4 drops
instead of 2 drops

6.6.2 If the problem is extra reactions in reverse typing:

● Perform prewar technique

● Perform antibody screen and auto control

7. RESULTS
4+ if 1 solid agglutinate, clear background
3+ several large agglutinates, clear background
2+ medium size agglutinates, clear background
1+ small agglutinates, turbid background
+/- or trace very small agglutinates, turbid background
0 no agglutination or negative

8. INTERPRETATION

● Consider the following in the discrepancies you encountered:

a. Problems with forwarding Grouping (weak or missing)

● Newborn or immunocompromised
● Subgroups
● Disease process

b. Problems with Forward Grouping (extra)

● Acquired B
● Rouleaux
● Mixed-field agglutination
● Polyagglutinable cells

c. Problems with Reverse Grouping (weak or missing)

● Newborn or immunocompromised

141
 ● Elderly

d. Problems with Reverse Grouping (extra)

● Alloantibody
● Autoantibody
● Anti-A1
● Rouleaux

9. PROCEDURAL NOTES

a. A repeat sample collection may be needed.

b. Tilt and wiggle method of resuspension is ideal.

c. Excessive shaking or tapping of the tubes may yield false-negative results.

142
 Reverse Typing of Blood Components

1. INTENDED USE

To guide the Blood Center technical staff in re-check the ABO blood group
of plasma components (fresh frozen plasma, platelet concentrate,
cryoprecipitate & cryosupernatant).

2. PRINCIPLE

Reverse grouping uses known A and B cells reagents to demonstrate the

corresponding presence or absence of anti-A and anti-B in the unit’s
plasma.

3. MATERIALS / EQUIPMENT

● Test tubes
● Known cells (A cells and B cells) either commercially or laboratory
prepared
● Serologic centrifuge
● Calibrated plastic pipettes
● Marking pen

4. SPECIMEN

● Samples from the segment of the blood units

5. QUALITY CONTROL

a. Daily QC of reagents

143
6. PROCEDURE

6.1. Label two (2) tubes as A cells and B cells.

6.2. Add two (2) drops of plasma to each tube.

6.3. Add one (1) drop of known A cells to the appropriate tube.
6.4. Add one (1) drop of known B cells to the appropriate tube.
6.5. Mix the tube contents.
6.6. Centrifuge according to the calibration of the centrifuge.
6.7. Examine the tube/s for hemolysis. Gently re-suspend the red cell
button/s and check for agglutination.
6.8. Read macroscopically. Grade and record the results.
6.9. Record the results of the procedure.

7. RESULTS

RESULT AGGLUTINATION BACKGROUND

4+ If one solid / large agglutinate Clear
3+ Several large agglutinates Clear
2+ Medium-sized agglutinates Clear
1+ Small agglutinates Turbid
+/- or trace Very small agglutinates Turbid
0 No agglutination or negative

8. INTERPRETATION

Group A No agglutination on A cells; with agglutination on B cells

Group B With agglutination on A cells; no agglutination on B cells
Group AB No agglutination on both A cells and B cells
Group O With agglutination on both A cells and B cells

144
 9. PROCEDURAL NOTES
When commercial cells are used, drop the cells first before the plasma to
avoid contamination.

Blood Center Name

DEPARTMENT OF LABORATORY
Blood Center

HOSPITAL NO.
NAME
BIRTHDATE
OF PATIENT
LAST FIRST MIDDLE SEX

FORWARD
BLOOD TYPE Rh TYPING REVERSE TYPING REMARKS
TYPING

ANTI-
ANTI- ANTI-D Du A1 B
B
A

DATE of Blood SERIAL CROSS AUTO Done Checked

DATE TIME Released by
TRANSFUSION COMPONENT Type NUMBER MATCH CONTROL by by

145
 Issuance of Blood for Transfusion

1. GUIDELINES

1.1 Place the blood unit in a transport container that would prevent
damage to the blood bag and contain any spillage in the event of
inadvertent breakage during transport.

1.2 Instruct the Nursing Attendant/Aide to bring the blood unit

immediately to where the patient is.

1.3 Ideally, only one unit is dispensed at a time unless the patient is
actively bleeding and/or there is a need for a massive transfusion.

1.4 If the transfusion cannot be initiated promptly, the blood should be

returned to the Blood Center for storage immediately. Blood units
returned more than thirty (30) minutes after its release will not be
re-issued for transfusion.

1.5 Blood units will only be re-issued if all the following conditions are
fulfilled:

● The blood unit was returned to the Blood Center within 30

minutes.
● The blood bag closure has not been punctured or modified in
any manner
● Blood cold chain was maintained.
● At least one segment of the integral donor tubing remains
attached

146
 ● Records indicate that the blood has been re-issued and has
been inspected before re-issuance.

2. REFERENCES

American Association of Blood Centers 2014, Technical Manual, 18th

Edition. Fung MK, Grossman BJ, Hillyer CD, Westhoff CM (ed), Bethesda
MD, USA

Department of Health – National Voluntary Blood Services Program, 2011,

Manual of Standards for Blood Service Facilities, Manila, Philippines

147
 Validation of Blood Units Prior to Issuance Units

1. INTENDED USE
To guide the Blood Center technical staff on verification procedures when
issuing blood for transfusion

2. PRINCIPLE
Clerical error is the most common cause of serious blood transfusion
reactions. Diligent performance of verification and validation at multiple
points is essential to avoid such errors.

3. MATERIALS/EQUIPMENT

● Blood request

● Blood release order

● Patient transfusion record/ Blood Center Information System (BBIS)

● Compatibility label

● Blood/Blood component releasing logbook

4. PROCEDURE

4.1 Check for the completeness and accuracy of the information on

the Blood Release Order. All the following information must be
provided:

● Complete name of the patient

● Hospital number

● Date of birth

● Physician who authorized the release of blood

● Type of component

● Number of units needed

148
 ● Name and signature of the nurse

4.2 Check the consistency of information in the following documents:

● Blood release order

● Blood request

● Patient transfusion record/BBIS

4.3 Check the Patient Transfusion Record/Blood Center Information

System if the patient had a previous transfusion during that particular
confinement. If none, extract a new blood sample from the patient and
perform blood grouping. Use the tube method or blood typing kit duly
validated and approved by the National Reference Laboratory for
Immunohematology (National Kidney and Transplant Institute).

4.4 Check the reverse typing if plasma components and platelets will be
released.

4.5 Prepare and inspect the blood unit for clots, abnormal discoloration,
and leaks.

4.6 Prepare the compatibility label. The compatibility label must contain
the following data:

● Complete name of the patient

● Ward/room number

● Hospital number or unique identification number

● ABO Group and Rh type of the patient

● Date of birth

● Compatible with the donor ABO group and Rh type

● Serial number of the blood unit

● Type of component, if applicable

● Date of extraction

● Date of expiration

149
 o Label products modified by open method
systems with ‘TRANSFUSE WITHIN 24 HOURS’

● Date of release

● Aliquot number/code, if applicable

● Screening results

4.7 Attach the compatibility label carefully to it, ensuring that the original
blood label and the other side of the bag are not obscured.

4.8 Update the information in the patient’s blood transfusion record and
in the Blood Center Information System (BBIS).

4.9 The nursing attendant/aide/authorized personnel shall write his/her

name and the exact time the blood is released on the Blood/Blood
Component master logbook.

4.10 Check the following:

● Blood typing (BT tubes or gel cards)

● Patient transfusion record to confirm patient’s blood type

● Crossmatching tubes or gel cards and crossmatching report

● Consistency of information on the compatibility label on the

blood unit and the submitted Blood Request:

o Complete name of the patient

o Hospital number

o Date of birth

o ABO/Rh type of the patient and blood unit or

component(s)

o Donor unit serial number

o Compatibility result (if performed). If compatibility

testing is not complete at the time of issue, this must be
conspicuously indicated.

o If the patient has additional needs during transfusion

(e.g., irradiated or if the patient needs phenotype-specific
blood units)

150
 o Date and time of issue

● Blood unit against the all other records

o Serial Number

o Accession Number

o ABO/Rh type

o Screening result

o Pilot tube serial number

o Blood Type sticker

● Data on the submitted Blood Release Order

4.10.1 A second Medical Technologist must also countercheck the

tubes, working cards, blood unit, and all other records prior to
release. If no discrepancy is noted, the two (2) Medical
Technologists must sign the compatibility label.

4.10.2 Release the blood unit.

4.10.2.1 Ask the Nursing Attendant/Aide to state the name of

the patient for transfusion.

4.10.2.2 The Nursing Attendant/Aide must check the blood unit

together with the information on the Blood Release
Order. All discrepancies must be resolved before
releasing the blood unit or component(s).

4.10.2.3 If no discrepancy is noted, the Nursing Attendant/Aide

must sign the blood transfusion record and the Blood
Center master logbook. The date and time of release
must also be indicated.

4.10.3 File and maintain records.

151
 Quality Procedure Issuance of Blood to/from Blood
Center to End User Facility

1. PURPOSE

To guide the nursing staff and other transfusionists (anesthesiologists) on

the critical steps in blood administration

2. SCOPE AND LIMITATIONS

This document starts from receiving the blood unit and compatibility report
up to the end of transfusion.

3. RESPONSIBILITIES

a. Nurse Supervisor – performs initial checking of the blood unit,

information on the labels, and compatibility report.

b. Nurse on Duty/Transfusionist – performs a second, independent

checking of the blood unit, information on the labels, and
compatibility report; monitors the patient during transfusion;
responsible for immediate action following recognition of a
transfusion reaction and reporting of any transfusion reaction or
other incidents related to transfusion.

4. RISK MANAGEMENT/SAFETY PRECAUTIONS

a. Blood transfusion shall be carried out upon the written order of the
attending physician.

b. Consent for blood transfusion should be obtained from the

patient/relative prior to transfusion.

c. Blood units shall be counter-checked against the order in the chart

and compatibility report by the nurse supervisor, nurse on duty, or
transfusionist prior to administration.

152
d. Only licensed and IV therapy-trained nurses and transfusionist
should be allowed to transfuse blood.

e. Red blood cell units should not be left at room temperature or stored
in an unmonitored refrigerator.

153
5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Nurse Supervisor on duty

Start
● Check for any leaks/evidence of
physical damage or abnormal
discoloration, or ambiguity in the
information on the labels. If there’s
1. Receive blood and any, return the unit to the Blood
compatibility report Center immediately.

Nurse Supervisor on duty

● Check for consistency of information

2. Conduct the first check. on the following:

o Doctor’s order

o Compatibility report

3. Conduct second check. o Information on the blood labels

Nurse on duty/Transfusionist

● Conduct the second check

independently. Check the following:
A o Doctor’s order

o Compatibility report
A o Information on the blood labels

Nurse on duty/Transfusionist

Check the identity of the patient. Ask the patient

4. Identify the patient. to state his/her name to confirm identity. If the
patient is mentally incapacitated and in the
absence of next of kin, use the hospital ID
bracelet to positively identify the patient.

Nurse on duty/Transfusionist
5. Check and record initial
vital signs. Check and record baseline temperature and other
vital signs before initiating the blood transfusion.
Refer to the attending physician accordingly.

154
 Inform the patient/companion to watch out for any
sign or symptom during transfusion.

6. Start blood transfusion. Nurse on duty/Transfusionist

Record transfusion details in the patient’s chart:

o Type and volume of product

o Serial number of blood unit/product

BT YES o Blood group

reaction?
o Time at which transfusion started

o Signature of person responsible for

Stop the transfusion
transfusion.
NO ● Observe closely for the first 15
minutes, and monitor vital signs
every 15 minutes thereafter.
Send the blood ● If there is any sign/symptom of blood
unit and blood transfusion reaction, discontinue the
transfusion
record to the transfusion immediately and refer to
blood Center for the attending physician.
investigation.

A B

7. Nurse on duty/Transfusionist
A B
Accomplish blood transfusion
record in duplicate.

Place the empty blood bag in a

clear plastic bag to avoid spillage
of remaining blood in the tubings,
and return it to the Blood Center
7. Complete the transfusion together with the duplicate copy
record and send empty blood of the blood transfusion record.
bag to the blood Center.
8. Nurse on duty/Transfusionist

155
 Record all transfusion details in
the patient’s chart.
8. Update patient’s chart.

End

6. DOCUMENTATION (Forms, Worksheets)

a. Blood Transfusion Checklist

156
 Suspected TTI

1. INTENDED USE

This document provides guidelines for cases of suspected transfusion-

transmitted infection.

2. PRINCIPLE

Accurate and timely identification, management, and proper documentation

are essential to prevent or mitigate complications and reactions.

3. PROCEDURE

3.1 Reported cases of suspected transfusion-transmitted disease should be

evaluated.

3.2 If confirmed, the involved blood unit must be identified in the report.

3.3 Attempts should be made to recall the donor for retesting and
counseling.

3.4 Other recipients who received components from the suspected blood
unit should also be investigated.

3.5 All reported cases of unexplained liver dysfunction occurring between 2

weeks to 6 months after transfusion of blood or its components should
be investigated for possible post-transfusion hepatitis.

3.6 The donor of the impaired blood unit should be informed, counseled, and
permanently deferred.

157
 Blood Center Name
BLOOD TRANSFUSION REACTION RECORD

Name: ________________________________________________________
Surname First Name M.I.

Age: _____ Date of Birth: ____________ Hospital No.: _________________

Sex: ______________ Requesting Physician: ________________________

Transfusion began date: ___________________________ Time: __________

Transfusion ended date: ___________________________ Time: __________

Date of BTR: ____________________________________ Time: __________

Temp Pulse RR BP
Pre-transfusion
Post-transfusion

Symptoms:
□ Hives □ Pain (Location) □ Itchiness □ Nausea
□ Chills □ Rash □ Fever □ Hematuria
□ Others: _________________

Action: Anti-Histamine given : ___________________________

Medicine given : ___________________________
Response to medicine : ___________________________
Volume received by patient : ___________________________
Physician Initiating Investigation : ___________________________
Nurse on-duty : ___________________________
_______________________________________________________________
Blood Center USE

Blood Center notified: Date & Time : _______________________

BTR form received: Date & Time : _______________________

Amount Volume
Blood Unit No. Source Component
Transfused Returned

158
Complete steps 1 – 3 on all reported reactions:

1. Clerical check: Check patient and donor ID on all labels and records
(including all blood components transfused in the last 24 hours.

□ No clerical error detected □ Clerical error detected

Explanation: ______________________________________________

2. Check for visible HEMOLYSIS and run unconjugated BILIRUBIN in the

recipient sample.

3. DIRECT ANTIGLOBULIN TEST: (Recipient)

Post Transfusion: _____________________

If Positive, Pre-Transfusion __________________
MEDICAL TECHNOLOGIST: __________________ Date: ____________

If the above does not indicate a hemolytic reaction, further testing nor required. If
there is evidence of hemolysis, or if the patient’s condition indicates a hemolytic
reaction, continue with the following:

4. Repeat Testing

CELLS SERUM INTERPRETATION

Anti Anti Anti A B Ab
Screen
A B D cells Cells ABO RH
Recipient
Pre-Transfusion
Recipient
Post-Transfusion
Donor
Bag / Segment

159
 5. Repeat Compatibility Testing

IS 37C AHG
Pre-Transfusion
Post-Transfusion

Cross matches should be repeated on all units transfused within 24 hours

prior to reaction. Record in the daily logbook.

All units on hold for further transfusion MUST be crossmatched with the
patient’s post-reaction specimen.

6. Other laboratory tests are performed: (Only if there is a 2oC temperature

rise)

a. Bacteriology Specimen: Blood segment / Bag for:

● Gram’s Stain ________________________________

● Culture ________________________________
7. Additional tests: ________________________________
___________________________________________________
● If there is evidence of hemolytic reaction, notify Blood Center
Head (Pathologist) immediately.

Technologist: ________________________________________________
Date: ________________________________________________

COMMENTS / RECOMMENDATIONS: _________________________________

________________________________________________________________

REVIEWED BY: ___________________________________________________

Head, Blood Transfusion Service

IMPORTANT: To be accomplished in DUPLICATE. Please attach the ORIGINAL

copy to the chart.

160
 Disposal of Blood Units and Samples

1. PURPOSE

This procedure describes the steps in ensuring proper disposal of

unsuitable, reactive, expired, or unused aliquoted blood units and blood
samples for biosafety purposes to avoid human contamination with
infectious waste agents.

2. SCOPE AND LIMITATIONS

This document describes the step-by-step method for proper disposal of

reactive/expired blood units and samples from segregation and autoclaving
until the scheduled collection of decontaminated biohazardous wastes by
the outsourced biohazard waste personnel.

3. DEFINITIONS

3.1 Technical Terms:

● Biohazard – a biological agent or condition that is a hazard to humans

or the environment. Signs of Biohazard should be posted on doors that
can affect humans.

● Biohazard/autoclave bag – is a plastic polypropylene bag capable of

withstanding autoclaving but resistant to heat transfer.

● Autoclave – a device used to destroy microorganisms by subjecting

them to steam at elevated temperatures and pressure 121oC or more,
typically for 15 to 20 minutes, depending on the size of the load and the
contents. Also, autoclaves are used to make the equipment safe for use
and reuse and to eliminate risks associated with materials prior to being
placed into the waste streams.

● Aliquot – a sample or portion of a total amount of a liquid/blood for

analysis.

● Blood unit – a plastic bag containing blood products used in a

transfusion.

● Infectious wastes – human blood and blood products, isolation waste,

pathological waste, contaminated animal waste, and discarded sharps
(broken bottles, needles, scalpels, etc.).

161
 3.2 Acronyms

● BSF– Blood Service Facilities

● PPE – Personal Protective Equipment

● Psi – Pounds per square inch absolute (psia) is used to make it clear
that the pressure is relative to a vacuum rather than the ambient
atmospheric pressure.

4 SPECIMEN

4.1 Blood units

● Whole blood
● Plasma
● Platelets
● Cryoprecipitate

4.2 Aliquot

● Plasma
● Serum

5 MATERIALS / EQUIPMENT

5.1 Supplies

● Absorbent Paper
● Biohazard Bags
● Discard Bin
● Gloves
● Goggles
● Laboratory gowns
● Mask
● Twist Tie
● 5% Sodium Hypochlorite/70% alcohol
● Distilled water

162
 5.2 Equipment

● Autoclave Machine

6 RESPONSIBILITIES

6.1 Director/Blood Center Head – ensures the provision of the necessary

resources to fully implement and maintain proper disposal of infectious and
hazardous wastes.

6.2 Department Head – ensures that laboratory personnel performing this

procedure are qualified and have been trained in Biosafety procedures and
Wastes Disposal Management.

6.3 Unit Supervisor – ensures that this procedure is strictly done according to
the Biosafety Manual and identifies possible errors for corrective and
preventive actions.

6.4 Medical Technologist (with proficiency training in HIV testing) – performs

this procedure with strict compliance with biosafety rules and regulations.

7 RISK MANAGEMENT/SAFETY PRECAUTIONS/QUALITY CONTROL

7.1 Risk Management

● Needle prick/broken tubes injury (refer to Infectious Control Manual)

● Splashes to the mucous membrane (refer to Infectious Control
Manual)
● Sample spillage (refer to Infectious Control Manual)

163
7.2 Quality Control

● To determine the effectiveness of decontamination using the

autoclave, consider the following factors:
o Use of autoclave temperature tape
o Parameter monitoring (pressure and temperature)
o Efficacy monitoring

● A user’s logbook to record autoclave usage should be maintained

for inspection and monitoring of its operation.

7.3 Safety Precautions

● No person may receive, possess, and dispose of wastes unless the

person has technical qualifications, including Biosafety and Wastes
Disposal training and experience.
● Proper laboratory protective clothing and gloves (PPE) should always
be worn when handling Biohazard Wastes to avoid transmission of
viral and other infectious diseases.
● All wastes shall be disposed of in accordance with existing laws.
● Biological waste must be rendered non-infectious prior to final
disposal in a landfill.
● Autoclaving is the preferred method of decontamination of infectious
blood units and other biohazard agents.
● Any deviation from the procedures outlined shall be recorded and
reported using the non-conformance report form.

164
8 WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start 1. Technical Staff assisted by Laboratory

Aide

● Classify according to type as to

1. Classify wastes blood bag or test samples.

2. Technical Staff assisted by Laboratory

Aide
2. Segregate wastes
● Make a list of blood units and
aliquoted samples to be discarded
and documents/files for future use.

3. Laboratory Aide
Blood units Test
samples ● Segregate the blood units from
aliquoted samples.
- Contain the blood units in
biohazard bags and seal
Secure aliquoted properly using a twist tie.
Contain and seal samples in a leak - Secure the aliquoted samples in
blood units in proof and puncture- a puncture-resistant, leak-proof
biohazard bag resistant container plastic container and label them
and label with a biohazard symbol. When
¾ full, seal the top and dispose
of it for autoclaving.
- Ensure tightness of the seal to
avoid leakage during handling
and autoclaving.
4. Laboratory Aide
4. Autoclave
● Autoclave blood units contained in
biohazard bags and properly
labeled plastic containers
containing aliquoted samples at
121C at 15 psi for 30 minutes.
A
● Unload the autoclaved wastes
when the cycle is complete or until

165
 the chamber pressure gauge reads
zero.
A
● Follow the instructions in the
Operating Manual of the specific
autoclaves in use.

5. Laboratory Aide
5. Place autoclave wastes in
designated bins ● Place the autoclaved wastes into
appropriate/ properly labeled waste
bin so as not to generate noxious
odors.

6. Laboratory Aide

6. Disinfect autoclave and ● Clean/Disinfect the autoclave and

work area work areas after every use.

● Perform preventive maintenance of

the autoclave after use. (Refer to
Autoclave Operational Manual)

● Decontaminate the workplace with

5% Sodium Hypochlorite or 70%
7. Place in temporary alcohol solution.
storage area or designated
dumpsite for biohazard 7. Laboratory Aide
wastes
● Place the properly labeled waste
bins in a temporary storage area or,
if available, bring them to the
designated dump site of biohazard
wastes.
End

9. DOCUMENTATION (Reports, Worksheets)

List of discarded/disposed of blood units and aliquots

Autoclave User’s Logbook

Autoclave Quality Control Chart

166
 List of Disposed Blood Units and Samples

Serial # Date extracted Date of disposal Remarks

Type of Waste (Blood
(if blood unit) (Reactive or Expired)
Unit /Sample)

Prepared by: Checked by:

__________________________ __________________________
(Signature over printed name) (Signature over printed name)

167
 Autoclave Quality Control Chart
Name of the Institution

Department/Section: Autoclave Brand: ____________________

Telephone: Autoclave Model: ____________________
Location of Autoclave: ______________________ Autoclave Serial #: ____________________
Last Certification Date: ______________________ Date Acquired: ____________________

Operator's
Date Conditions Sterility/QC check Signature
Time Name
Treated:
Pressure/ (minimum REMARKS
Biological
Temperature Strip of 30
Indicator Result
(minimum 15 Indicator mins)
(Brand/Lot#)
psi/1210C)

Autoclave User’s Logbook

Amount of
Date of Type of Operator’s
Pressure* Temperature** Duration*** Waste Signature
Treatment Waste Name
Treated

*Minimum pressure: 15psi

**Minimum temperature: 1210C
***Minimum duration of treatment: 30 minutes

168
 TTI Serology NEQAS Participation

1. PURPOSE

This document serves as a guide for effective participation in Transfusion

Transmissible Infections Serology National External Quality Assessment
Scheme/Proficiency Test and provides important points to be considered
during the testing of EQAS panel samples.

This document also serves as a reminder to all Blood Service Facilities that
EQA participation helps to evaluate the reliability of methods, materials, and
equipment, to evaluate and monitor training impact, and is a good tool for
enhancing a national laboratory network.

2. SCOPE AND LIMITATIONS

2.1 This document describes the step-by-step procedures in applying for

TTI Serology NEQAS conducted by the RITM TTI-NRL from
registration to receipt of NEQAS panel samples, testing of panel
samples to Blood Center submission of serology results through
OASYS, and receiving NEQAS reference results and certificates of
participation through OASYS. This also covers the procedures and
guidelines in cases of discrepant NEQAS results.

2.2 Only well-trained and proficient Technical Laboratory personnel shall

perform this procedure.

2.3 Treat all NEQAS samples like blood donor samples and MUST be
tested in the same manner as the test procedures are routinely done,
as to the number of times, within the same timeframes, and by using
the same personnel, the same tests, and testing strategy.

2.4 The Laboratory technical personnel MUST perform this procedure

with strict compliance with Biosafety rules and regulations, including
the current pandemic-driven health safety protocols and any health
emergency in the future.

169
3. SPECIMEN

Aliquot
● Plasma
● Serum

4. MATERIALS / EQUIPMENT

Materials
Reagents kits (HBV, HCV, HIV, Syphilis, Malaria)
Cryotubes/test tubes
Distilled water
Graduated cylinders
Laboratory Mat
Liquid Soap
Sealing film
Pasteur pipettes
Plate cover
Plate sealer
Pipette tips
Pipettor (Single/multichannel)
Reservoir
Serologic pipettes
Sample racks
Strip holder
Tissue paper
Waste Bin
Wire Bin
Amber Bottles, Washed and Sterilized, 11ml Capacity
Beaker, polypropylene, 500 ml capacity
Absorbent Paper/Paper towel
Biohazard Bags

170
 Gloves
Goggles/face shield
Laboratory gowns
Laboratory mat
Twist Tie
Spill kits
5% Sodium Hypochlorite/70% alcohol
Coupon bonds
Ballpen

Equipment
EIA Modulars
EIA Automated Machine
CLIA Automated Machine
Desktop computers with internet access
Laptop
Printers

5. RESPONSIBILITIES

5.1 The Laboratory Supervisor ensures that this procedure is performed

by well-trained and proficient laboratory technical personnel.

5.2 The Laboratory Supervisor is responsible for reviewing worksheets,

identifying possible errors, and taking corrective actions.

5.3 The Laboratory Supervisor shall also ensure the proper

implementation and monitoring of the serology NEQAS plan and
checklist.

5.4 The Laboratory technical personnel ensures that all procedures are
followed accordingly and is responsible for strictly following the step-
by-step procedures in NEQAS participation.

171
6. RISK MANAGEMENT / SAFETY PRECAUTIONS

6.1 Possible risks

6.1.1 Needle prick/broken tubes injury (refer to Infectious Control

Manual)
6.1.2 Splashes to the mucous membrane (refer to Infectious
Control Manual)
6.1.3 Sample spillage (refer to Infectious Control Manual)

6.2 Safety Precautions

6.2.1 The staff performing this procedure shall subscribe to
appropriate biosafety procedures as described in the Blood
Center Biosafety Manual.
6.2.2 Proper laboratory protective clothing and gloves (PPE) should
always be worn when handling Biohazard Wastes to avoid
viral and other infectious disease transmissions.
6.2.3 Adequate and conveniently located biohazard containers
should be available for the disposal of contaminated
materials.
6.2.4 All wastes shall be disposed of in accordance with the existing
Public Health policies.
6.2.5 Biological safety cabinets or other physical containment
devices should be used for all manipulations that may cause
splashes, droplets, or aerosols of infectious materials (e.g.,
centrifugation, vigorous shaking, or mixing).
6.2.6 Work surfaces must be decontaminated after any spill of
potentially infectious material and at the end of the working
day. Generally, freshly prepared bleach solutions1 are
appropriate for dealing with a bio-hazardous spillage.
Personnel must wash their hands often – especially after
handling infectious materials before leaving the laboratory
working areas.
6.2.7 Personal protective equipment must be removed before
leaving the laboratory.
6.2.8 Refer to reagent kit inserts. Handling Precautions.

172
7. QUALITY CONTROL

Quality Control must be included during each assay in order to verify that
the test is working properly.

7.1 Each run must include the recommended set of quality controls for
the specific test kit that is being used. The controls for each test run
must yield results within the limits of the manufacturer's criteria for
acceptability and validity of the run. Any run not having at least the
minimum number of controls falling within the acceptable range is
invalid and must be repeated (see kit insert).
7.2 External controls (third party control) can be included on the run to
monitor consistent performance, a lot to lot variation between kits,
and to serve as an indicator of assay performance on samples that
are borderline reactors.
7.3 Values for the internal controls, external controls (third party control),
and cut-off should be monitored by quality control charts using
statistical methods.
7.4 All test kits must be used before the expiration date to ensure valid
results.
7.5 Physical parameters of the test, such as incubation time and
temperature, must be followed to ensure proper performance.

8. DEFINITIONS

a. Technical Terms:

● External Quality Assessment Scheme- External quality

assessment (EQA) in blood transfusion laboratory practice is
an important component of a quality system for blood
transfusion services. External quality assessment (EQA) is an
important but very specific and specialized part of the
monitoring process. Formal EQA schemes provide a regular,
independent assessment of performance to identify problems
and weaknesses with the objective of improving performance
and ensuring blood safety.
● Proficiency Test- Inter-laboratory comparison designed and
operated to assure laboratory performance. Sanctions are
linked to inadequate performances. For example, the

173
 laboratory may be required to repeat the testing or even be
discredited from testing.
● EQAS panel samples- A set of blinded samples sent to
participants periodically that is used to assess both the
performance of test kits and processes of a laboratory.
● Biohazard-a biological agent or condition that is a hazard to
humans or the environment. Signs of Biohazard should be
posted on doors that can affect humans.
● Infectious wastes- Human blood and blood products,
isolation waste, pathological waste, contaminated
animal waste, and discarded sharps (broken bottles, needles,
scalpels, etc.).
● Biosafety Cabinet- A biosafety cabinet (BSC)- also called
a biological safety cabinet or microbiological safety cabinet- is
an enclosed, ventilated laboratory workspace for safely
working with materials contaminated with (or potentially
contaminated with) pathogens requiring a
defined biosafety level.
● Continuing Quality Improvement- sometimes referred to as
Performance and Quality Improvement (PQI), is a process of
creating an environment in which management and workers
strive to create constantly improving quality.
● CQI is an approach to quality management that builds upon
traditional quality assurance methods by emphasizing
the organization and systems: it focuses on "process" rather
than the individual; it recognizes both internal and external
"customers"; it promotes the need for objective data to
analyze and improve processes.
● OASYS- is a full web-enabled application and a state-of-the-
art informatics system (OASYS) that will allow the
management of the National EQA program online and provide
quality data analysis. OASYS.
● NEQAS Preliminary Reference Results-EQAS panel samples
final status as tested by the TTI-NRL.
● Aberrant- and assay interpretation that is different from the
reference result.
● Outlier- a statistical observation that is markedly different in
the value from the others in a sample.
● False Negative- confirmed positive specimen incorrectly
identified as negative.

174
 ● False Positive- confirmed negative specimen incorrectly
identified as positive.

b. Acronyms

● Blood Center - Blood Service Facilities

● PPE - Personal Protective Equipment
● BSC - Biosafety Cabinet/Biological safety cabinet
● NEQAS -National External Quality Assessment Scheme
● PT - Proficiency Test
● OASYS – Oneworld Accuracy System

9. WORKFLOW DIAGRAM

9.1 Registration to RITM TTI-NRL NEQAS

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start 1. Supervisor/Chief Medical

Technologist
● Receive an invitation from the TTI-
NRL via courier, email, Facebook

1. Receive TTI EQAS 2. Supervisor/Chief Medical

Invitation Technologist (CMT)
● Visit the TTI-NRL website for more
information regarding NEQAS
● For new participants - Register/fill
out the application form on the TTI-
A NRL website (www.tti-nrl.com/eqas-
registration)

175
 RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
● For old/existing participants -
A Receive the following via
courier/email:
- Renewal Form
- Conforme Form
- TTI-NRL OASYS Account
Update Form
YES NO
New 3. Administrative Staff assisted by the
Participant? Supervisor/CMT
● Processes payable to Research
Institute for Tropical Medicine
(RITM).
4. Supervisor/CMT
Receive EQAS
2. Register and fill
registration forms ● Sends a check to RITM via courier
out application form
via courier or e-mail or personal hand carry.

5. Supervisor/CMT
3. Processes payment
payable to RITM ● New participants:
- Receive e-mail from TTI-NRL for
confirmation of approved
application.
- Receive username and
password from OASYS via e-
4. Sends check payment to mail.
RITM - Log in to the OASYS account to
verify and edit the needed
information (e.g., machines and
testing kits, laboratory user,
laboratory profiles – primary,
billing, shipping, reporting
A
contact, etc.)

176
 RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
● Old/Existing participants:
A
- Renew the OASYS account once
payment and necessary forms
are received by TTI-NRL.

YES New NO
Participant?

Receive e-mail from Renew OASYS

TTI-NRL for
confirmation of account
application

Receive username and

password from
OASYS via e-mail

Log in to OASYS
account

End

177
9.2 On-line registration to Oneworld Accuracy System (OASYS)

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

1. Supervisor/Chief Medical
Technologist
Start ● Receive a Test Event Reminder (via
email) from OASYS two (2) weeks
before the sample sends out and
verifies/edits the OASYS account
before the closing date.

2. Supervisor/Chief Medical
Technologist (CMT) or designated
1. Receive Test Event
MT
Reminder
● Perform the following procedures to
update the user's names in case a
new user will be assigned to test or
report the EQAS samples.
- Click the Profile tab and go to the
Organization User.
- Enter the Blood Center’s ID or
Search Blood Center by clicking
2. Update user’s name the “List All” button.
- In the Participant Users window,
click the “Add” button.
- Fill up the necessary details in the
“User’s Detail” Window and click
the “Next” button.
- In the “Profile Details,” choose
the contact type and fill in the
necessary data. Click the “Next”
A button after completing the data
- Click the “Submit” button.

178
 A 3. Supervisor/CMT or designated MT
● Performs the following procedures to
update instruments (equipment) in
case a new instrument will be used for
testing.
- On the home page, open the
3. Update instruments in use Profile menu and click the
“Instruments” tab
- Click the “Add” instrument button
- Select the Manufacturer and
Model of the Instrument
- Click Submit

4. Supervisor/CMT or designated MT
● Perform the following procedures to
update reagents and assay in case a
new test kit is used for testing.
4. Update new reagents and Updating of reagent kits and assays
assay in use
will be done in the Test Event
Dashboard.
- Click the Registration Button
- In the Assay Registration Assay,
click the “Register Assay” Button.
- Choose the Manufacturer and Kit
Name in the dropdown box under
the “Detection” Test Process. Click
the “Continue” (>>) button
- If the Reagent/ Test kit uses a
Processor, click yes and choose
End the Instrument Model in the
dropdown box.
- Click the “Submit” Button

179
 9.3 Receipt and testing of EQAS samples and submission of test
results

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start
1. Supervisor/CMT or designated MT
● Receive shipment containing the
NEQAS panel samples from RITM
1. NEQAS panel samples TTI-NRL.

2. Designated MT
2. Inform the TTI-NRL of ● Inform the TTI-NRL staff of the
the EQAS panel date and DATE AND TIME OF RECEIPT
time of receipt through text, email, or phone call.

3. Designated Proficient MT

3. Inspect the completeness and ● Upon receipt, inspect for the

integrity of EQAS panel samples completeness and integrity of the
EQAS samples.
4. Designated Proficient MT
● Store the EQAS samples at 4°C until
the test event opens.
4. Store the EQAS samples at 4°C
5. Designated Proficient MT
● Read, follow and understand the
written general instructions
accompanying the EQAS samples.
5. Read and follow EQAS (Refer to General Instructions
General Instructions HVHT4320 and MLRA415)
6. Designated Proficient MT
● Perform the test procedures on the
panel samples in the same manner
6. Perform the test procedure
on the pane sample as the test procedures routinely used
in the Blood Service Facility. (Refer
to Quality Procedure (QP) on TTI
Serology Testing)
A

180
 A
7. Designated Proficient MT
● Access OASYS Account to encode
results through
www.oneworldaccuracy.com. (The
7. Access OASYS account to testing results shall be encoded in
encode results the TEST EVENT DASHBOARD,
along with the assay reagent kits
used, assay reagent kit serial
number, date tested, and the
proficient technical staff who tested
the samples, the date of NEQAS
panel receipt, and the condition of
the specimen.
8. Submit hardcopy of
encoded results to RITM
8. Designated Proficient MT
TTI-NRL
● Submit a hardcopy of the encoded
results duly signed by the
technologist who performed the test
to RITM TTI-NRL through e-mail or
courier.
End

9.4 Receipt of TTI-NRL Reference NEQAS Results and Monitoring

of Discrepant Results

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start

1. Supervisor/CMT
1. Receive NEQAS ● Receive e-mail of NEQAS
Preliminary Results and Preliminary Reference Results of the
Certificate of participation RITM TTI-NRL and Certificate of
Participation from OASYS two (2)
weeks after the closing date.
A

181
 RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

2. Supervisor/CMT
2. Review NEQAS results as ● Review NEQAS results by
compared with Preliminary comparing them with the Preliminary
Reference Results Reference Results.

3. Supervisor/CMT
NO YES ● Wait for the issuance of the
With aberrant proficiency certificate if an Excellent
results? or Very Satisfactory rating was
achieved.
4. Supervisor/CMT
● If with aberrant results, refer to RITM
TTI-NRL Guidelines on grading of
3. Wait for the Issuance of the
4. Refer to Guidelines on TTI Serology NEQAS results to
Proficiency NEQAS grading of discern the status of results.
Certificate results

5. Supervisor/CMT assisted by
5. Investigate possible source of error Proficient MT
● Investigate the possible sources of
error of unacceptable results to
avoid the same incident from
happening once more when testing
Failed? B the second NEQAS panel samples.

NO

6. Supervisor/CMT
6. Receive second NEQAS panel
● Receive second NEQAS panel from
RITM TTI-NRL.

182
 RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

7. Designated Proficient MT
7. Perform the test
procedures on the second ● Perform the test procedures on the
panel second-panel samples in the same
manner as the test procedures
routinely used in the Blood Service
Facility. (Refer to Manual of
Standards on TTI Serology Testing
8. Check e-nail from RITM
procedures)
TTI-NRL of the blank
worksheets
8. Designated Proficient MT
● Check the e-mail from RITM TTI-
NRL of the blank worksheets.
9. Encode results and final
status in the black
worksheets 9. Designated Proficient MT
● Encode results and final status in the
blank worksheets.
10. Countercheck encoded
results and final status in 10. Designated Proficient MT 2
the worksheets
● Countercheck encoded results and
final status in the worksheets

11. Validate and do final

review of the results 11. Supervisor/CMT
● Validate and do a final review of the
results

12. Send encoded results thru

email to tti-nrl@gmail.com
12. Designated Proficient MT
● Send encoded results thru e-mail to
tti-nrl@gmail.com.
A

183
 RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

A 13. Supervisor/CMT
● If passed, receive a satisfactory
rating from the RITM TTI-NRL.

Passed or YES
failed?
14. Supervisor/CMT
● If failed, receives an Investigation
13. If passed, receive a Checklist from RITM TTI-NRL.
NO satisfactory rating from (Refer to Investigation Checklist)
the RITM TTI-NRL
B
15. Supervisor/CMT
● Conducts Continuing Quality
14. Receive an investigation Improvement and identifies
checklist from TTI-NRL corrective/preventive actions.

15. Conducts CQI and identifies

corrective/preventive actions

End

10. Documentation (Reports, Worksheet)

a. Refer to the TTI-NRL website (www.tti-nrl.com)
b. Refer to www.oneworldaccuracy.com.

184
Appendices

185
 Form 1. Risk Assessment Chart
(with sample data)

Probability Human Property Business Recovery

of Impact Impact Impact Resources
Type Occurrence Needed Total
Score
of
Disaster
High High Low High Low High Low High Low
Low
5 … 1 5 … 1 5 … 1 5 … 1
5 … 1

External Hazards

Pandemic 5 5 1 5 5 21
influenza

COVID-19
Earthquake 3 3 4 4 4 18

Typhoon 1 1 1 2 2 7

Terrorist
attack

Flooding

Internal Hazards

Fire or 4 1 4 3 2 24
explosion
Workplace 2 5 2 4 1 14
violence

186
 Form 2. Critical Contact Information

Organization Phone Number Contact Person Last

Updated

Fire

Police

Philippine Blood Center

Hospital customers

Ambulance service

Local Disaster Risk

Reduction and
Management Office

Local media contacts

Critical suppliers/vendors

187
Telecommunications
company

Local water supply

company

Local fuel suppliers

Electrical Power Source

LGU Disaster Risk

Reduction Management
Office
DOH Disaster Risk
Reduction Management
Office
NVBSP Directory

188
 Form 3. Event Assessment

Date___________________________

I. Type of Event

_____Flood ______Earthquake

_____Tsunami or Surge _____Typhoon

_____Act of Terrorism ______ Massive vehicular accident

_____ Public Health Emergency ______Others, please specify

_____ Fire or explosion ______ Volcanic Eruption

II. Potential Effects

Damage to BCU
________________________________________________________________
________________________________________________________________
________________________________________________________________

Effect on Donor Base

________________________________________________________________
________________________________________________________________
________________________________________________________________

Utilities
________________________________________________________________
________________________________________________________________
________________________________________________________________

189
Transportation
________________________________________________________________
________________________________________________________________
________________________________________________________________

Supplies
________________________________________________________________
________________________________________________________________
________________________________________________________________

Others
________________________________________________________________
________________________________________________________________
________________________________________________________________

III. Network Demand for Blood Supply

Hospital # of Current Potential for # of Type O Non-Disaster-

Network Admissions at Expected RBC Units on Related Need
Name Hospital Admissions at Shelf for Type O
Hospital RBC

190
Form 4. Budget Proposal

Department/Office: ___________________________________________
Estimated Budget: ___________________________________________

A. Program Title:

___________________________________________________________
___________________________________________________________
___________________________________________________________

B. Specific Mandated Function to Be Served by the Program:

___________________________________________________________
___________________________________________________________
___________________________________________________________

C. Program Description:

● Objectives:
________________________________________________________
________________________________________________________
________________________________________________________

● Target Beneficiaries:
________________________________________________________
________________________________________________________
________________________________________________________

191
Project 1 ________________________________________________________
________________________________________________________________

To be Procured
Activity / Existing
Purpose Quantity /
Requirements Quantity/Amount
Amount

Project 2 _________________________________________________________
________________________________________________________________

To be Procured
Activity / Existing
Purpose Quantity /
Requirements Quantity/Amount
Amount

192
 FORM 5. Procurement Management Plan

BC Name

Department / Office : _____________________ Year: ________________

Program Title : _______________________________________________

Project Title : ________________________________________________

Type Acco Acco Item Descri Qty. Unit Unit Estim Delivery / Implementation Schedule Procurement Procurement
of unt unt ption / of Price ated Method
Specifi (Indicate quantity to be Method delivered per month)
Contr Title Code c ation
Issue Budg
act Scope et
of
Work

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

193
 Form 6. Application Summary Sheet
Position Applied for: ___________________________________________

Name of Applicant

Education College/ University Diploma Y/N

Experience, if any

Performance Evaluation from

Previous Employer

Interview Desired Rating Actual Rating

Aptitude Test Desired Rating Actual Rating

Psychological Test

Physical Examination Fit to Work Conditions:

(encircle)

Professional Competence

Leadership Competence

Technical Competence

Relevant Experience

Training attended

Recommendation (encircle) Favorable Unfavorable

HR Manager: ______________________
Signature: ______________________
Date: _____________________

194
 Form 7. Proficiency Assessment for BC Staff
(Oral and Practical Test)

Date: __________________
Name of Employee: _________________________________________________
Last Name, First Name, Middle Name
Date Hired: ________ Inclusive Date of Training: ________________________

EVALUATION CODES FOR THE TRAINING MODULE

Indicates that the Technologist has done excellent

work and has mastered the course objectives.
4 VERY PROFICIENT

Indicates that the Technologist has done above

3 PROFICIENT average work, mastered almost all of the course
objectives, and has applied knowledge gained to new
situations.

Indicates that the Technologist has done average

work and has mastered many of the objectives of the
2 ADVANCING
course.
PROFICIENCY

Indicates that the Technologist has done below

average work and has mastered a few of the
1 NEEDS
objectives of the course.
IMPROVEMENT

NOTE: A rating of 3 to 4 is desired in each area of assessment.

Personnel with a rating of 2 or less will be re-trained and re-evaluated until the
desired level of performance and expertise is achieved.

1 2 3 4 COMMENTS

A. Blood Inventory and Procurement

Process

195
 1. Daily inventory
2. Procurement of blood from blood
centers/other BCU
B. Blood Donation Process
1. Donor Screening Procedure
⮚ Basic qualification for donation
⮚ Permanent and temporary
deferral
2. Phlebotomy
⮚ Explain the procedure to the
donor
⮚ Identify materials to be used
⮚ Identify critical control points
⮚ Demonstrate post-donation
care
⮚ Handle adverse donor reaction
C. Documentation

Recommendations:

Conducted and assessed by:

_____________________________
Blood Bank Section Head
(Signature over printed name)

Noted by: Date: ________________

____________________________
Blood Bank Head
(Signature over printed name)

196
 Form 8. Evaluation Matrix for Promotion

Name of Personnel
________________________________________________________________

Standards

A. Educational

Section Head Mastery of routine and special tasks or

procedures in the unit

Unit Supervisor At least 15 units in master's studies in a related

field

Department Head An earned Master’s Degree, or equivalent in the

appropriate field of study, or all degree
requirements completed and the degree is
pending.

Phlebotomist

Registered Medical
Technologist

Nurses

Support Service (driver)

Lab Technician

B. Experience

● For Promotion to Section in charge: An applicant should have at least three (3)
years of experience as a junior staff

● For Promotion to Unit Head/Supervisor: An applicant should have a total of five

(5) years of experience in a related field

197
 ● For Promotion to Division Head: An applicant should have a total of five (5) years
of experience as Department Head

C. Performance

● Demonstration of consistent performance and high achievement in current past

(and previous, if any)

● Management/Administrative/Leadership Capabilities: Demonstrated abilities as

an administrator, department head, nurse, phlebotomist, etc.

● Demonstration of relevant professional competencies

● Demonstration of relevant technical competencies

Position Applied For:

________________________________________________________________

Name of Education Experience Performance Interview Recommendation

Applicant

Name of Ratee/Position: ____________________________________________

Signature: _______________________________________________________
Date: ___________________________________________________________

198
 Form 9. Quality Policy Issuance Monitoring

QUALITY POLICY ISSUANCE MONITORING

Quantity Personnel in
charge
Department Date Issued
Card Poster

Prepared by:

199
 (Name and Signature of Document Controller)

Approved by:

(Name and Signature of Quality Management Representative)

200
 Form 10. Document Change Request Monitoring

DOCUMENT CHANGE REQUEST MONITORING

Division/
DCRF# Date Prepared Status
Department

Prepared by:

(Name and Signature of Document Controller)

201
 Form 11. List of Records

LIST OF RECORDS

Year Retention Manner of

Department Form Title Generated Period Disposal Remarks

202
Prepared by:

(Name and Signature of Document

Controller)

Approved by:

(Name and Signature of Quality Management

Representative)

203
 Form 12. Equipment Management Program Form

Section 1: Selection Qualification/Comparison of Supplier’s Capabilities Based on

Laboratory Expectations (key points/criteria may be customized, related
documents can be attached)

KEY POINTS / CRITERIA Equipment Equipment Equipment

1 2 3

1. Manufacturer/Model

2. Technical Specifications

3. Reagents/standards/calibrators,
controls
4. Performance characteristics

5. Maintenance and training support

6. Contract price

7. Scientific office availability

8. Well trained staff/

engineers/application specialist
9. Able to deliver spare parts

10. Able to deliver the required quantity of

supplies on time
11. Familiarity with the contract and the
terms of the agreement between both
parties

Total Score

Scoring:
1 - Unsatisfactory 2 - Acceptable 3 – Satisfactory
4 – Very good 5 – Outstanding

204
 Review and Approval Signature Name Signature Date

Section Manager

Section Head

Department Manager

QA Officer

Lab Director

Section 2: Inspection upon Delivery

ACTIVITIES NAME/SIGNATURE DATE

Check delivery note

Verify the specifications

Inspect for completeness and general

condition

Check the operating manuals

Schedule installation (if applicable)

Received by:

Noted By:

Endorsed to (end-user)

205
Section 3: Equipment Identification

Equipment Name:

Manufacturer:

Serial Number/ Biomed No./ Property

Number

Lab Identification:

Laboratory Location:

Acquired Date:

Date of Installation

Service Engineer:

Company Name:

Vendor Contact Details

206
Section 4: Installation Qualification (key points/criteria may be customized; related
documents can be attached)

ACCEPTABLE
KEY POINTS / CRITERIA COMMENT

Yes No
1. System components

2. Environmental conditions

3. Utility requirements, e.g., water supply, etc

4. Instructions for operations and backup

mechanism
5. Documents and Records/ Operating Manual

6. LIS communication, if applicable

7. Configuration access, if applicable

Review and Approval Name Signature Date

Signature

Section Manager

Section Head

Department Manager

Section 5: Operational Qualification (key points/criteria may be customized)

ACCEPTABLE
KEY POINTS / CRITERIA COMMENT

Yes No

207
1. Function Checks

2. Calibration

3. Quality Control Testing and QC

management
4. Process control limits including
monitoring and alarms
5. Security limits ( password-protected
access, audit trail, etc.)
6. Data transfer across electronic
interfaces

7. Power

8. Mechanical devices operation

9. Measuring devices

10. Software

Review and Approval Name Signature Date

Signature

Section Manager

Section Head

Department Manager

208
Section 6: Performance Qualification (key points/criteria may be customized)

ACCEPTABLE
KEY POINTS / CRITERIA COMMENT

Yes No
1. Accuracy studies

2. Precision studies

3. Sensitivity/ Limit of Detection/ Limit of

quantitation

4. Specificity/ Interference studies

5. Correlation studies

6. Linearity studies/Analytical Measurement

Range

7. Reference Range verification

8. Dilution / concentration checks

9. Recovery studies

10. Cut off verification/Calibration

11. Work Instruction / Operating Manual

12. Trained and competent staff

13. Supply management

14. QC and patient results management

(review, tracking, retrieval, QC reports,
audit trail, test comment)

15. Computer interface

16. QC Sheets /maintenance sheets/ equipment

file

209
 17. Calculation verification/ Auto verification
confirmation

18. Proficiency testing program

19. Peer review program

20. Other/s

Note: Validation data and calculations must be compiled for reference.

Review and Approval Name Signature Date

Signature

Section Manager

Section Head

Department Manager

QA Officer

Lab Director

Section 7: Hazard Analysis

NO. DESCRIPTION PRESENT NOTATION

Yes No
1 Laser
2 Radioactive
3 Nuclear
4 Ultraviolet light
5 Toxic chemical
6 Infectious agent
7 Other

210
Review and Approval Signature Name Signature Date
Section Manager
Section Head
Department QA Officer
Department Manager

Section 8: Staff Authorization (List of Authorized Users)*

NAME DESIGNATION DATE OF TRAINING

Review and Approval Name Signature Date

Signature

Section Manager

Section Head

Department Manager

211
QA Officer

Lab Director

*Refer to the training documentation.

Section 9: Validation Summary

PARAMETERS SUMMARY

Passed the environmental requirements

established by the manufacturer. Yes / No
Installation Qualifications (IQ)

Passed the basic operational specifications

established by the manufacturer.
Operational Qualifications (OQ)
Yes / No

All set criteria for the performance of functional

specifications are acceptable.
Performance Qualifications (PQ)
Yes / No

Result:
ACCURACY
Acceptance Criteria :

Result:
PRECISION
Acceptance Criteria :

Result:
SENSITIVITY (Detection Limit)
Acceptance Criteria :

Result:
SPECIFICITY (Interferences)
Acceptance Criteria :

Result:
CORRELATION STUDIES
Acceptance Criteria :

Result:
LINEARITY
Acceptance Criteria :

Result:
REPORTABLE RANGE/ AMR
Acceptance Criteria :

212
 REPORT FORMAT (UNITS)

REFERENCE RANGES

OTHER PERFORMANCE Result:

CHARACTERISTICS: Acceptance Criteria :

Completion of SOP, Completed and filed accordingly.

Maintenance/calibration Sheets, Yes / No
QC Log Sheets, Staff training,
and authorization

SPECIMEN STORAGE AND

STABILITY

SPECIMEN REQUIREMENTS
TYPE, CONTAINER

Mitigation:
Hazard Analysis (HA) Local exhaust ventilation and use of PPE
(gloves) are recommended to limit exposure.

CONCLUSION: Acceptable; OK to implement for patient testing.

Acceptable for Patient Testing Reject. Method is not suitable for patient testing.

Review and Approval Name Signature Date

Signature

Section Manager

Section Head

Department Manager

QA Officer

Lab Director

213
Section 10: Record of Major Repairs/Pulled out by Biomedical Engineering (Refer to
attached service report/s)

CHECKED/

DATE ISSUED BY RECEIVED BY RETURNED BY RECEIVED BY

214
Section 11: Equipment De-commissioning

ACTIVITY BRIEF DESCRIPTION OF THE

PERFORMED ACTIVITY

1. Type of hazardous materials used in

this equipment

2. Decontamination plan

3. Removal of confidential information

4. Final disposition of the equipment

5. Other/s

Review and Approval Name Signature Date

Signature

Section Manager

Section Head

Department Manager

QA Officer

Lab Director

215
 Form 13. Master Validation Plan

Validation
Test System/ Responsible Parameters/ Initial Due for next
Instrument/ Methodology Test/s Type of Person Calibration Validation re-validation/
Equipment Tests Parameters recalibration

216
VALIDATION PLAN

Test HBsAg Target Date/s :

Instrument/Test Kit : Reagent
Method Principle Calibration
Reporting Unit QC

No of No of Time Data Acceptance Responsible

Validation Experiments Specimen
levels replicates Period Analysis Criteria Person/s

Linearity/AMR/Reportable
Range

Sensitivity/LOD/LOB/LOQ
Precision
Specificity/ Interference
Accuracy by Recovery
Accuracy by Method
Comparison

Reference Interval

Other Parameters: Carry Over

Check
Dilution Check
Stability Checks
New Rgt Lot Validation
New QC Lot Verification

217
 Form 13. Equipment Maintenance and Calibration

Equipment Name:

Model no.
Serial no.
MONTH: YEAR
:
DAILY
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

WEEKLY
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

MONTHLY
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Month
Maintenanc
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
e

PREVENTIVE
MAINTENANCE

218
CALIBRA-
TION
RECORD

Prepared by: Reviewed by:

219
 Form 14. Supplier Evaluation
Name of
Company

Contact Person/s

Contact Number

Address

A. PRODUCT/S AND SERVICE/S OFFERED:

1. ______________________________________________________
2. ______________________________________________________
3. ______________________________________________________
4. ______________________________________________________
5. ______________________________________________________
B. EVALUATION

EVALUATION CRITERIA YES/NO REMARK/S

Scientific Office Availability

Well trained staff/engineers and application specialist

Ability to provide quality supplies

Ability to deliver the required quantity

Ability to provide service/s promptly

License/permits to operate

Attach Company Profile

220
 Form 15. List of Approved Suppliers

LIST OF APPROVED SUPPLIERS

# PRODUCT NAME OF SUPPLIER CONTACT TELEPHONE EMAIL LOCATION

PERSON NO ADDRESS

221
 Form 16. Verification and Traceability of Critical Material

Verification and Traceability of Critical Material

Type of Date of Date Date of Date Date

Critical Item Description Quantity Lot # Expiry Received/ Validation/ Placed In- Consumed/
Material Sign Sign use/Sign Sign

1.

2.

3.

4.

5.

6.

7.

8.

222
 Form 17. Lot Validation
LOT VALIDATION

Type of Validation Reagent Lot QC Lot Range

Verification

Test Name/Test System:

Type Qualitative Semi-Quantitative Quantitative

Material Date of Material Date of

Description Lot No Description Lot No
In-Use Expiration In-Use Expiration

Reagent;
QC Level 1
Current

Reagent;
QC level 2
New

Calibrator/s QC Level 3

Form 18. Data Collection Analysis

a. Qualitative and Semi-quantitative tests

SAMPLE RESULTS RESULTS SAMPLE RESULTS RESULTS
DESCRIPTION 1 2 DESCRIPTION 1 2
1 4
2 5
3 6
7

b. Quantitative Tests
RESULT RESULT SAMPLE RESULT RESULT Sample
SAMPLE DESCRIPTION
S1 S2 MEAN S1 S2 Mean
1
2
3
Current Lot Reagent Mean New Lot Reagent Mean

Grand Mean Historical Xc Xn

CV

223
 LOT VALIDATION

Acceptability Ratio (Xc/Xn) : ___________ < 1

i. New QC Lot Verification

SAMPLE DESCRIPTION

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
New QC Lot Verification:
Mean
SD
CV
New Range (+2sd)
Manufacturer’s Range

ii. Acceptance Criteria: ____________________________

Conclusion:
________________________________________________________________
________________________________________________________________
________________________________________________________________

Performed by:___________________ Reviewed by: ____________________

Approved by: ___________________

Date: _____________________________

224
 Form 19. Daily Blood Inventory
DATE: __________

Starting Balance
BLOOD BLOOD SHIPPED ADD- ENDING
COMPONENT Rh, Rh
TYPE ISSUED BLOOD ONS BALANCE
neg. pos.
WB 450
PRBC
PC
A
FFP
CRYOPPT
APH PC
WB 450
PRBC
PC
B
FFP
CRYOPPT
APH PC
WB 450
PRBC
PC
O
FFP
CRYOPPT
APH PC
WB 450
PRBC
PC
AB
FFP
CRYOPPT
APH PC

225
Prepared by: Received by:

____________________________ ____________________________
Name & Signature Name & Signature

Form 20. Registry of Prospective Blood Donors

REGISTRY OF PROSPECTIVE BLOOD DONORS
Name of Province/region: __________________________________________________________
Name of City/Municipality: __________________________________________________________
Name of Barangay/Organization: ____________________________________________________

Remarks
Blood
Name of Donor Sex Address Date of Birth Type

226
 Form 21. Registry of Regular Blood Donors
Name of Province:
Name of City/Municipality:
Name of Barangay/Organization:
Donations Remarks
Name of
Donor Purok Date of Birth Blood Type 201_ 201_

Data in this registry is culled from individual blood donor's records of donations (index cards)
No. of Donations:______________
No. of Donors: ________________
Regular: ___________________
Lapsed: ___________________
New: ___________________

Form 22. Blood Donor’s Record of Donations

Donor ID No.
Family Name, First Name/s, Name Extension, Middle Name

Date of Birth: (dd-mmm-yyyy)

Sex:

Blood Type:

227
Marital Status:

Obstetric Score: (G-T-P-A-L)*

History of Transfusion:

Date of Donation Blood Type ID Donation No. Remarks Data Entry by:

G – gravida, T – term, P – preterm, A – abortion, L - live

Form 23. Donor Satisfaction Survey

Blood Center Name

Thank you for donating blood at (Name of Blood Center). Your feedback is
important to us.

2 4
1 3 5
Needs Very
Poor Average Excellent
Improvement Good
FACILITIES
The donor room is clean and organized.
The donor room is adequately lighted.
The donor chair/bed is comfortable.
There is adequate and easy to

228
understand information material on blood
donation.

PERSONNEL
The staff was pleasant and courteous.
He/She is responsive to my concerns.
He/She was able to explain the
procedure well, including possible
reactions that I may have.
He/She was knowledgeable and skillful.

OVERALL EXPERIENCE

OTHERS:

How did you learn about voluntary blood donation? You may tick more than one.
___Relatives /Friends ___Family Physician
___Internet/Social Media ___Newspaper
___School/Company/Employer ___Radio or Television
Others, please specify _____________________________________

What made you choose to donate blood at (Name of Blood Center)?

___Nearness to place of residence ___Clean and pleasant environment

___Nearness to place of work ___Adequate facilities and equipment
___Quality of experience
Other reasons, please specify _________________

Would you recommend (Name of Blood Center) to your friends/family?

___Yes ___No

REMARKS/SUGGESTIONS FOR IMPROVEMENT

________________________________________________________________
________________________________________________________________
________________________________________________________________

229
 I would like to compliment these persons:
________________________________________________________________
________________________________________________________________
________________________________________________________________

Thank you for your time!

Form 24. Complaint Report

COMPLAINT REPORT

Name of Donor
___Donor
Complainant Name
___Others

Date of Incident Date Reported

Complaint

Immediate
Corrective
1. _________________________________________________________
Action
2. _________________________________________________________

3. __________________________________________________________

4. __________________________________________________________

Date

Name and Signature of Responsible Personnel

230
 Form 25. Internal Quality Audit Program

INTERNAL QUALITY AUDIT PROGRAM

Audit Objectives:

Month Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

1. Assign Planned
Internal
Actual
Auditors

2. Prepared Planned
budget
Actual
allocation
and
schedules
for target
Blood
Centers

3. Prepare Planned
audit
Actual
checklist

4. Send audit Planned

notice to
Actual
target Blood
Center

5. Conduct Planned
internal audit
Actual

6. Submission Planned
of reports
Actual
to
Management

231
Prepared by:

_______________________________________
(Name and Signature)

Checked by:

_______________________________________
(Name and Signature)

Approved by:

_______________________________________
(Name and Signature)

232
 INTERNAL QUALITY AUDIT PROGRAM

REFERENCE STANDARDS: Manual of Standards

AUDIT SCOPE: Blood Center Quality Management System
AUDIT OBJECTIVE: To determine conformance to DOH Manual of
Standards for Blood Service Facilities

AUDIT AREA:
Audit Date:
SCHEDULE OF ACTIVITIES
Process Auditees Auditors
● Time

● (00:00H) OPENING MEETING

● (00:00H)

● (00:00H)

● (00:00H)

● (00:00H)

● (00:00H)

● (00:00H) Lunch Break

● (00:00H)

● (00:00H)

● (00:00H)

● (00:00H)

● (00:00H) Exit Meeting

233
Prepared by:

_______________________________________
(Name and Signature)

Checked by:

_______________________________________
(Name and Signature)

Approved by:

_______________________________________
(Name and Signature)

234
 Form 26. QMS Audit Checklist for Blood Center

Audit Scope : Quality Management System

Audit Objective :

REFERENCE STANDARDS REQUIREMENTS REMARKS DETAILS

SECTION CLAUSE SUB
I. Management Responsibilities

1.1
1.2
II. Management of Human Resources

2.1
2.2
III. Physical Facilities

3.1
3.2
IV. Equipment Management

4.1
4.2
V. Reagents and Supplies

5.1
5.2
VI. Reporting and Records Management

6.1
6.2
VII. Administrative and Technical Procedures

7.1
7.2
VIII. Quality Assurance Programs

235
 8.1
8.2
●

Prepared by: Checked by:

_________________________ ____________________________
(Name and Signature) (Name and Signature)

236
 Form 27. Non-conformance Report

Audit No.: ____________________ Audit Date: __________________

Audit Report No.: ______________ Findings No.: ______________________

Process Area / Location / Unit

Process Owner

Procedures / Work Instructions / Standards

Auditee Signature

Auditors Signature

Findings ISO Clause

Corrective Action / Preventive Action (s)

Effective Date of Action:

237
 Closing Details
References

Evidences

N.C. Closed by – Auditor: Date: Signature:

Form 28. Summary of Blood Center Audit

Name of Facility

Classification

Date of Monitoring Date Reported

1. MANAGEMENT RESPONSIBILITIES

Positive Observations
●

238
Negative Observations
●

Non-conformance
●

2. MANAGEMENT OF HUMAN RESOURCES

Positive Observations
●

Negative Observations
●

Non-conformance
●

239
 3. PHYSICAL FACILITIES

Positive Observations
●

Negative Observations
●

Non-conformance
●

4. EQUIPMENT MANAGEMENT

Positive Observations
●

Negative Observations
●

Non-conformance
●

240
 5. REAGENTS AND SUPPLIES

Positive Observations
●

Negative Observations
●

Non-conformance
●

6. REPORTING AND RECORDS MANAGEMENT

Positive Observations
●

Negative Observations
●

Non-conformance
●

241
 7. ADMINISTRATIVE AND TECHNICAL PROCEDURES

Positive Observations
●

Negative Observations
●

Non-conformance
●

8. QUALITY ASSURANCE PROGRAMS

Positive Observations
●

Negative Observations
●

Non-conformance
●

242
 9. OTHERS

Positive Observations
●

Negative Observations
●

Non-conformance
●

RECOMMENDATIONS:

QUALITY AUDITOR/S:

Name Signature Designation

243
 ACCEPTED BY:

Name Signature Designation

DATE FOR FULL COMPLIANCE

DATE OF NEXT VISIT

244
 Form 29. Occurrence Report

Occurrence No: ____________ Date: ___________________

DATE OF OCCURRENCE _____________

WHAT : Check whichever is applicable.

_____Accident
_____Adverse Reaction
_____Other incidents, specify_____________________________

WHO : _____________________________________________________
Name of Patient/Injured (if applicable)
WHEN: _____________________________________________________
(Exact date and time of the occurrence)
WHERE: _____________________________________________________
(Exact place of the occurrence)

Brief description of your involvement in the occurrence

_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
(Use additional sheet if needed)

For accidents, classify severity:

____Accident resulted in an injury or illness requiring first aid only or no treatment
____Accident resulted in injury or illness requiring medical treatment
____Accident resulted in unconsciousness, fatality, or an overnight hospitalization

Reported by: ____________________ Noted by: _________________________

______________________________ ______________________________
Signature over printed name Signature over printed name
Designation Unit Supervisor

245
 Form 30. Occurrence Analysis

Unit Occurrence Report No.: _______ Nature of the Occurrence

_____ Complaint
_____ Incident
_____ Other incidents, please specify__________________________________

Name of Complainant, if any _________________________________________

(patient/blood donor/visitor/end-user Blood Center)

Address _________________________________________________________

Contact information _______________________________________________

Date of Occurrence _______________________________________________
Place of Occurrence_______________________________________________
Involved Personnel________________________________________________
Background Information ____________________________________________

Analysis (Use the back page for Ishikawa Diagram)

Root Cause/s ____________________________________________________

Contributing Factor/s _____________________________________________

246
Documentation

Incident reports by the following: (where applicable)

1. _______________________ 3. _________________________

2. _______________________ 4. _________________________

Supporting Documents, if any______________________________________

Accomplished by:

_______________________________ Date: __________________

Signature over printed name
DEPARTMENT HEAD/SUPERVISOR

247
 Form 31. Corrective Action Implementation

******(Supervisor’s Checklist for Occurrences)

Occurrence Report No.______

PROBLEM:
________________________________________________________________
________________________________________________________________

PERSON TIME DATE OF REMARKS

RESPONSIBLE FRAME ACCOMPLISHMENT
ACTIVITIES / PLAN
CORRECTIVE ACTION/S
(to address the ROOT
CAUSE)

1.

2.

3.

4.

5.

248
 Form 32. Quarterly Corrective Action Monitoring

DEPARTMENT / SECTION: PERIOD COVERED:

EFFECTIVE PARTIAL /
NOT
PROBLEM CORRECTIVE DURATION PROOF OF EFFECTIVE
ACTION OF IMPLEMENTATION
MONITORING DATE (Problems
encountered)

*Examples of proof of implementation may be, but not limited to,

the following:

- new or updated policies; controlled (document # _____)

- orientation / re-orientation done (date)
- replacement / repair of equipment/ physical plant (date)
- other necessary resources made available (enumerate)

249
 Form 33. Blood Transport Monitoring Form

BLOOD TRANSPORT MONITORING FORM

Place of Origin
Destination
Date Transported
Time Transported
Purpose of Transport
Number of Units
Monitored by

o o
First Temperature Read-Out: C Final Temperature Read-Out: C

TIME TEMP Signature TIME TEMP Signature TIME TEMP Signature

1st hr 7th hr 13th hr

2nd hr 8th hr 14th hr
3rd hr 9th hr 15th hr
4th hr 10th hr 16th hr
5th hr 11th hr 17th hr
6th hr 12th hr 18th hr
Time Received
Blood Endorsed to
Reviewed by

250
Acronyms
AHG Anti-human Globulin

AMR Antibody Mediated Rejection

APH PC Apheresed Platelet Concentrate

BBIS Blood Bank Information System

BSC Biosafety Cabinet

BSF Blood Service Facilities

BSI Blood Stock Inventory

BT Blood Typing

BTR Blood Transfusion Reaction

BW Body Weight

CA Corrective Action

CA Coronary Artery Disease

CLIA Chemiluminescence Immunoassay

CPR Certificate of Product Registration

CMT Chief Medical Technologist

COPD Chronic Obstructive Pulmonary Disease

CUE Confidential Unit Exclusion

CV Coefficient of Variation

DAT Direct Antiglobulin Test

DOH Department of Health

DVET Double Volume Exchange Transfusion

EDTA Ethylenediamine Tetraacetic Acid

EIA Enzyme Immunoassay

251
EMP Emergency Response Plan

EQA External Quality Assessment

EQAS External Quality Assessment Scheme

ERP Emergency Response Plan

FDA Food and Drug Administration

FFP Fresh Frozen Plasma

GPAL General Purpose Aspect Language

HA Hazard Analysis

HBTC Hospital Blood Transfusion Committee

Hct Hematocrit

Hb Hemoglobin

HIV Human Immunodeficiency Virus

HR Human Resource

ID Identification

IQC Internal Quality Control

ISO International Organization for Standardization

IQ Installation Qualification

LISS Low Ionic Strength Saline

LoB Limit of Blank

LoD Limit of Detection

LoQ Limit of Quantitation

MBD Mass Blood Donation

NBBNets National Blood Bank Network System

NCAR Non-conformance Report

252
NDA Non-disclosure Agreement

NEQAS National External Quality Assessment Service

NGO Non-government Organization

NIST National Institute of Science and Technology

NKTI National Kidney Transplant Institute

NRL National Reference Laboratory

NSS Normal Saline Solution

NVBSP National Voluntary Blood Services Program

OASYS Oneworld Accuracy System

OQ Operation Qualification

PC Platelet Count

PG Procedural Guidelines

PM Preventive Maintenance

PPM Periodic Preventive Maintenance

PPE Personal Protective Equipment

PQ Performance Qualification

Psi Per square inch

PT Prothrombin Time
PTT Activated Partial Thromboplastin Time

QA Quality Assurance

QC Quality Control

QMS Quality Management System

QP Quality Procedure

PG Procedural Guidelines

253
RBC Red Blood Cell

RITM Research Institute for Tropical Medicine

RMT Registered Medical Technologist

EPCMT Emergency Preparedness and Crisis Management Team

RWB Reconstituted Whole Blood

SD Standard Deviation

SDS Safety Data Sheet

SOP Standard Operating Procedure

STAT Immediately

TACO Transfusion-related Circulatory Overload

TIA Transient Ischemic Attack

TTI Transfusion Transmitted Infection

UV Ultraviolet

VBD Voluntary Blood Donation

VMP Validation Master Plan

WB Whole Blood

WBR Whole Blood, Reconstituted

WHO World Health Organization

WI Work Instruction

254
Definitions
ACCURACY PROTOCOL. Intended to estimate inaccuracy or systematic error and is usually
done by running the same set of specimens in the new method and the comparative method.

AGGLUTINATION. Visible clumping is evidence of the interaction of red blood cells with an
antibody directed towards the antigen on the red blood cells.

AUDIT FINDINGS. Results of the evaluation of the collected audit evidence against the audit
checklist.

AUDIT PLAN. Specific guidelines to be followed when conducting an audit.

AUDIT PROGRAM. Lists of audit procedures to be performed by audit staff in order to obtain
sufficient appropriate evidence.

AUDIT SCOPE. The amount of time and documents which are involved in an audit.

AUDIT. The process of systematic examination of a quality system is carried out by an internal or
external quality auditor or an audit team.

AUTOLOGOUS BLOOD. The blood is drawn from the patient/recipient for re-transfusion into him
/her at a later date.

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

BIOHAZARD. Substances derived from biological sources such as blood or body fluid are capable
of transmitting pathogenic organisms.

BLOOD BAGS. Sterile, sturdy plastic bags containing anticoagulants are specially designed for
blood collection and transfusion. Blood bags can either be single or multiple types and have an
integral sterile needle and collection tubing.

BLOOD CENTER EQUIPMENT. Essential laboratory machines, instruments, and their

accessories are used in the different steps in the Blood Center 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. This equipment also includes those used in
specific supportive processes such as sterilization and sanitary disposal of blood and blood
products.

255
BLOOD COLD CHAIN. A system for storing and transporting blood and blood products, within the
correct temperature range and conditions, from the point of collection from blood donors to the
point of transfusion to the patient.

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

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

BLOOD COLLECTION. The procedure whereby a single donation of blood is collected in an

anticoagulant and/or stabilizing solution under conditions designed to minimize microbial
contamination, cellular damage, and/or coagulation activation of the resulting blood donation.

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

BUDGET PROPOSAL. A budget proposal is an estimate of the future costs, revenues, and
resources over a specific period of time.

BUDGET. A categorical list of anticipated project costs that represent the best estimate of the
funds needed to support the work described in a proposal. A budget consists of all direct costs,
facilities, and administrative costs, and cost-sharing commitments proposed.

CALIBRATE. To set measurement of equipment against a known standard.

CALIBRATION. The set of operations that establish, under specified conditions, the relationship
between values indicated by a measuring instrument or measuring system, or values represented
by a material measure, and the corresponding known values of a reference standard.

CARRY-OVER CHECK PROTOCOL. To check if the analyte has a carry-over into the subsequent
sample, which may lead to inaccurate qualitative or quantitative results when using instrumental
methods.

CITRATE PHOSPHATE DEXTROSE ADENINE. Anticoagulant used in the routine blood

collection; allows a 35-day storage period.

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

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

COMPETENCY ASSESSMENT. A method that 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.

COMPETENCY. Ability for the applicant to perform the task properly and effectively. The
measures of competency are education, skills, training, and experience.

COMPONENT. Capable of doing a certain task or job according to set standards and standard
procedures.

CONFORMANCE. Fulfillment of requirements as determined by standards.

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

CORRECTIVE ACTION. An activity is performed to eliminate the cause of an existing

nonconformance or other undesirable situation in order to prevent a recurrence.

CRITICAL. Capable of affecting quality.

DIAGNOSTIC SENSITIVITY/ DIAGNOSTIC SPECIFICITY PROTOCOL. Diagnostic sensitivity is

the probability that a test result is positive given the subject has the disease. Diagnostic specificity
is the probability that a test result is negative, given the subject does not have the disease.

DILUTION CHECK PROTOCOL. The effect of sample dilution must be determined for samples
that are above the established calibration curve to evaluate its effect on the method’s accuracy
and precision.

DISASTER. A sudden event, such as an accident or a natural catastrophe that causes great
damage or loss of life.

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

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

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

untreated waste.

257
DISTRIBUTION. The act of delivery of blood and blood components to other blood establishments,
hospital Blood Centers, or manufacturers of blood- and plasma-derived medicinal products. It does
not include the issuing of blood or blood components for transfusion.

DOCUMENT (noun). Written or electronically generated information involved in providing a

product or service. Examples are policies, standards, standard opera ng procedures, work
instructions, reports, and records.

DOCUMENT (verb). To capture information for use in documents through writing or electronic
media.

DOCUMENTED INFORMATION. Term that replaced the terms “documents” and “records” in the
revised ISO 14001. It is defined as “information required to be controlled and maintained by an
organization and the medium on which it is contained.” Documented information includes
information to guide how processes are conducted (formerly referred to as “documents”) and
information that is evidence of results achieved (formerly referred to as “records.”).

DONATION NUMBER. The unique identification number that is issued in advance for each blood
donor must be linked to the donor’s name on the register, the donor’s form, all blood bags,
including satellite blood packs, and all blood sample containers.

DONOR. A person in good health who voluntarily donates blood or blood components, including
plasma, for fractionation.

EQUIPMENT. A durable item, instrument, or device used in a process or procedure.

EVALUATION. It is a specific selection process to determine the suitability of a procedure or

material (equipment, blood bags, or reagents).

EXPIRY. The last day on which blood, component, or reagent/supply is considered suitable for
transfusion.

GOOD MANUFACTURING PRACTICE (GMP). All elements in the established practice will
collectively lead to final products or services that consistently meet appropriate specifications and
compliance with defined regulations.

MANUFACTURE. All operational processes or steps — including purchase or selection of

materials and products, production, quality control, release, storage, and distribution of products
and the related controls — are used to produce a blood product. This also includes the donation
process.
MOBILE BLOOD DONATION SITE. A unit or site used for the collection of blood and/or blood
components, operating temporarily or at movable locations off-site from a permanent collection
site, under the responsibility of a blood establishment.

258
NEAR-MISS EVENT. An incident that, if not detected in a timely manner, would have affected the
safety of the recipients or donors.

QUALIFICATION. A set of actions used to provide documented evidence that any piece of
equipment, critical material, or reagent used to produce the final product and that might affect the
quality or safety of a product works reliably as intended or specified and leads to the expected
results.

QUALITY ASSURANCE. A part of quality management focused on providing confidence that

quality requirements will be met.

QUALITY MANAGEMENT SYSTEM. A management system that directs and controls an

organization with respect to quality and that ensures that steps, processes, procedures, and
policies related to quality activities are being followed.

QUALITY MANAGEMENT. The coordinated activities direct and control an organization with
regard to quality.

QUALITY. The total set of characteristics of an entity that affect its ability to satisfy stated and
implied needs and the consistent and reliable performance of services or products in conformity
with specified requirements. Implied needs include safety and quality attributes of products
intended both for therapeutic use and as starting materials for further manufacturing.

REGULAR DONOR. A person who routinely donates blood, blood components, or plasma in the
same blood establishment in accordance with the minimum time intervals.

REPEAT DONOR. A person who has donated before in the same establishment but not within the
period of time is considered a regular donation.

VALIDATION. Actions for proving that any operational procedure, process, activity, or system
leads to the expected results. Validation work is normally performed in advance according to a
defined and approved protocol that describes tests and acceptance criteria.

VERIFICATION. Evaluating the performance of a system with regard to its effectiveness based
on the intended use.

VOLUNTARY NON-REMUNERATED BLOOD DONOR (VNRBD). An individual who donates

blood of one’s own volition or initiative and is not included, 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. This refers to

waste generated by the Blood Center and is classified into hazardous and non-hazardous.

259
 WHOLE BLOOD. A unit of blood not further processed, containing all the cellular and liquid
components, collected into an approved container containing an anticoagulant-preservative
solution.

References

American Association of Blood Centers (AABB), Disaster Operations Handbook.

Coordinating the Nation’s Blood Supply During Disasters and Biological Events, October
2008 https://www.aabb.org/programs/disasterresponse/Documents/disastophndbkv2.pdf

American Association of Blood Centers 2014, Technical Manual, 18th Edition. Fung MK,
Grossman BJ, Hillyer CD, Westhoff CM (ed), Bethesda MD, USA

Clinical & Laboratory Standards Institute (CLSI), 2015 Quality Management System:
Approved Guidelines.

Clinical & Laboratory Standards Institute (CLSI) 2011 GP37-A: Approved Guidelines.

College of American Pathologists (CAP), Accreditation Checklists

www.cap.org/web/home/lab/accreditation/accreditation-checklists

College of American Pathologists (CAP), 2012, ISO 15189:2012(E) Medical Laboratories-

Requirements for Quality and Competence.

Constantine, N. T; Callahan, J.D.; Watts D.M. HIV Testing and Quality Control, Published
by AIDSTECH / Family Health International, Durham, N. C. (1991)

Department of Health – National Voluntary Blood Services Program, 2011, Manual on Blood
Donor Selection and Counseling, Manila, Philippines

Department of Health – National Voluntary Blood Services Program, 2011, Manual of

Standards for Blood Service Facilities, Manila, Philippines

Department of Health – National Voluntary Blood Services Program 2010, Philippine

Clinical Practice Guidelines for the Rational Use of Blood and Blood Products and
Strategies for Implementation, Manila, Philippines

260
European Directorate for the Quality of Medicines & Healthcare (EDQM) Council of
Europe, 2015, Guide to the preparation, use, and quality assurance of blood components,
Recommendation No. R (95) 15, 18th Edition, Strasbourg, France

Glynn SA, et al. Effect of a National Disaster on Blood Supply and Safety, The September
11 Experience, May 2003 http://jamanetwork.com/journals/jama/fullarticle/196489

International Standardization, ISO 9001Quality management system – requirements, 2015

5th Edition, Switzerland

Maggs, PH et al. “Serious hazards of transfusion (SHOT) hemovigilance and progress are
improving transfusion safety.” British Journal of Hematology. 2013; 163, 303-314

National Serology Reference Laboratory. Assuring the Quality of your EQAS, Melbourne
Australia

National Serology Reference Laboratory. EQAS: Their importance to blood screening

laboratories, Wayne Dimech of NRL Melbourne Australia www.oneworldaccuracy.com

RITM Transfusion Transmissible Infections-National Reference Laboratory Standard

Operating Procedures on NEQAS

Simmons HJ, Development, application, and quality control of serologic assays used for
diagnostic monitoring of laboratory. 2008; 49(2):157-69. PMID: 18323578 [PubMed -
indexed for MEDLINE]

World Health Organization. Manual on management, maintenance and use of blood cold
chain equipment 2005, Geneva
http://www.who.int/bloodsafety/Manual_on_Management,Maintenance_and_Use_of_Bloo
d_Cold_Chain_Equipment.pdf

Wright OP, International standards for test methods and reference sera for diagnostic tests
for antibody detection. 1998 Aug; 17(2):527-49. PMID: 9713893 [PubMed - indexed for
MEDLINE]

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