1

Foreword

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

This Guide and its complementary volume describe processes in Blood Stations,
from maintaining the blood inventory to blood administration. This Guide is
comprised of 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 Stations 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: 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 Stations 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 Technical Manual of American
Association of Blood Banks 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 Stations are encouraged
to seek the latest publication of the references used in this Guide.

2
 Table of Contents

Foreword 2
Part I. Quality Manual for Blood Stations (BS) 6
Part II: Process Manual – Administrative Procedures 22
Planning for Preparedness and Response to Emergencies 22
Preparedness and Response to Internal Emergencies 25
Managing Blood Supply During Disasters 28
Budget Preparations 29
Recruitment, Selection, Hiring of Human Resources 32
Promotion of Human Resources 34
Competency Assessment of Blood Stations’ Technical Personnel 36
Control of Documents 37
Equipment Management 39
Equipment Management Process 43
Performance Qualification/Equipment Validation 48
Material Management 55
Material Reception, Inspection, Verification/Validation,
Storage, and Use 58
Maintaining and Managing an Optimum Blood Inventory 64
Blood Donor Recruitment and Retention 66
Provision of Information to Prospective Donors 69
Blood Utilization Review 72
Customer Satisfaction Measurement and Complaint Management 74
Internal Audit 76
Conducting an Internal Audit 78
Corrective Action 79
Part III: Process Manual – Technical Procedures 82
Storage and Transport 82
Pretransfusion Testing (Routine) 87
Daily QC of Immunohematology Reagents 91
Preparing Laboratory Red Cells Solution 94

3
Positive Patient Identification and Sample Collection 105
Blood Grouping in Infants 0-6 Months Old 108
Resolving ABO Discrepancies 110
Reverse Typing of Blood Components 114
Crossmatch 116
Crossmatch (Neonates) 119
Issuance of Blood Products from Blood Stations to the Patient Area 125
Issuance of Blood for Transfusion 128
Validation of Blood Units Prior to Issuance 129
Blood Administration Procedural Guideline 133
Investigating BT Reactions 139
Suspected Hemolytic Transfusion Reaction 142
Work Up for Blood Transfusion Reaction 143
Disposal of Blood Units and Samples 154
TTI Serology NEQAS Participation 161
Appendices 177
Form 1. Risk Assessment Chart 178
Form 2. Critical Contact Information 179
Form 3. Event Assessment 180
Form 4. Budget Proposal 182
Form 5. Application Summary Sheet 185
Form 6: Proficiency Assessment for Blood Station Staff 186
Form 7. Evaluation Matrix for Promotion 188
Form 8. Quality Policy Issuance Monitoring 190
Form 9. Document Change Request Monitoring 191
Form 10. List of Records 192
Form 11: Equipment Management Program Form 193
Form 12: Master Validation Plan 200
Form 13. Supplier Evaluation 203
Form 14. List of Approved Suppliers 204
Form 15. Verification and Traceability of Critical Material 205
Form 16. Lot Validation 206
Form 17. Data Collection/Analysis 207

4
Form 18. Lot Validation (2) 208
Form 19: Daily Blood Inventory 209
Form 20. Registry of Prospective Blood Donors 210
Form 21. Registry of Regular Blood Donors 211
Form 22. Blood Donor’s Record of Donations 212
Form 23. Donor Satisfaction Survey 213
Form 24: Complaint Report 215
Form 25. Internal Quality Audit Program 216
Form 26: QMS Audit Checklist for Blood Stations 219
Form 27. Non-conformance Report 220
Form 28: Summary of Blood Station’s Audit 221
Form 29: Occurrence Report 226
Form 30. Occurrence Analysis 227
Form 31: Corrective Action Implementation 229
Form 32. Quarterly Corrective Action Monitoring 230
Form 33: Blood Transport Monitoring Form 231
Acronyms 232
Definitions 236
References 242

5
Blood Stations (BS)

Part I: Quality Manual

1. ORGANIZATION

1.1 INTRODUCTION

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

7719 (National Services Act of 1994) in the performance of all its
functions. The Blood Stations, 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, DOH Administrative Order No. 2012-0012 on Rules
and Regulations Governing the New Classification of Hospitals
and Other Health Facilities in the Philippines, and DOH
Administrative Order No. 2021-0066, guidelines for issuing the
Certificate of Inclusion (COI) in Blood Service Facilities (BSF).

b. Blood Stations, duly licensed by the DOH, shall perform the

following functions:

● Advocacy and promotion of voluntary blood donation and

a healthy lifestyle;

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

blood products; and

● Compatibility testing of red cell units, if hospital-based.

1.2 LEADERSHIP AND COMMITMENT

The Blood Stations management has the overall responsibility for

implementing the Quality Management System (QMS) and
communicates the organization's direction through its Quality Policy.
The management defines the Blood Stations’ 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 Stations.

6
 The management conducts regular monitoring and periodic reviews
to ensure effective implementation of the QMS and continuous
quality improvement.
The management recognizes that Blood Stations’ stakeholders
include the blood donors, patients and clinicians, and suppliers.
All Blood Stations activities aim to improve client satisfaction, health
outcomes, and benefits to the staff and society.
The management ensures that sufficient and appropriate resources
are available for effective, efficient, safe execution of the Blood
Stations’ functions.

1.3 QUALITY POLICY

The Blood Stations’ quality policy is defined and strongly driven by

the following management principles and behaviors, mandating that
the Blood Stations 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 Stations.

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

2. PLANNING
2.1 STRATEGIC DIRECTION

● The Blood Stations 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, Blood Stations shall write its results-oriented,

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

7
2.2 OPERATIONAL PLAN

The Blood Stations shall write its annual operational plan and set its targets
for the key performance indicators to measure its success.

2.3 QUALITY OBJECTIVES

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

● To issue 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 within the healthcare facility.

● To achieve 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.

2.4 EMERGENCY PREPAREDNESS

2.4.1 POLICY

● The Blood Stations shall prepare for and respond to

domestic, natural, and human-induced disasters affecting
the blood supply.

● The Blood Service Network shall have a disaster

preparedness plan for all possible disaster scenarios
affecting blood supply.

● The members of the Blood Stations network shall follow

the chain of command to facilitate efficient coordination
with relevant agencies.

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 2.4.2 QUALITY PROCEDURES

● Preparedness and Response to External Disasters

● Preparedness and Response to Internal Disasters

2.4.3 RELATED DOCUMENTS

Planning for 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 Stations, 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

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3.2 HUMAN RESOURCE MANAGEMENT

3.2.1 POLICY

● The Blood Stations management shall ensure that all

personnel have the appropriate education, skills, training,
and experience to execute their jobs. Necessary
competence and appropriate training 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 Stations management shall conduct

competency assessments for all personnel and shall
maintain records of performance.

● The Blood Stations 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 Stations 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

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3.3 SAFETY AND WASTE MANAGEMENT

3.3.1 POLICY

● The Blood Stations shall comply with the latest edition of

the Manual on Health Care Waste Management

● The Blood Stations management shall always provide its

employees with a workplace free of hazards to ensure
the safety and health of its workforce

● The Blood Stations 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 edition
of the Manual on Health Care Waste Management

3.3.2 QUALITY PROCEDURE

● Infectious control procedure of Blood Stations

● Proper disposal of expired blood products, samples,

paraphernalia, used logistical supplies`

● Proper use and disposal of single-use supplies.

● Cleaning of blood spills

3.3.3 RELATED DOCUMENT

Healthcare waste management and infectious control plan

and implementation

3.4 EQUIPMENT MANAGEMENT

3.4.1 POLICY

● The Blood Stations shall have all the functional equipment

and instruments required for the safe, effective provision
of blood services and blood products, based on its
qualification as BCU.

11
 ● The Blood Stations shall follow procedures in equipment
selection, acquisition, qualification, operation,
maintenance, calibration, decommissioning, and the
necessary documentation of all related activities.

● The Blood Stations shall check the quality of equipment

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

● The Blood Stations shall ensure that all equipment used

in the laboratory complies with the standard specifications
and has the Standard Operating Procedure (SOP) that
details the operation, maintenance, and calibration
procedures.

● The Blood Stations shall maintain an inventory of all

equipment used in the laboratory.

● The Blood Stations 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 Stations keep a record of the proper

maintenance and monitoring of its equipment and
instruments.

3.4.2 QUALITY PROCEDURE

Equipment management process

3.4.3 RELATED DOCUMENTS

Equipment Management Plan

Conduct of Performance Qualification/Equipment Validation

3.5 MATERIAL MANAGEMENT

3.5.1 POLICY

● The Blood Stations shall maintain a stock inventory and

have a documented procedure for supplies management
to assure uninterrupted supplies of quality reagents and

12
 materials stored in a manner that preserves integrity and
reliability.

● The Blood Stations shall use reagents with Certificate of

Product Registration (CPR) and equipment and devices
that have met international standards.

● The Blood Stations shall follow the procedure in the

selection and evaluation of suppliers and adheres to the
procurement procedure of the institution.

● The Blood Stations 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 Stations shall have a procedure for

investigation and reporting of adverse incidents or
accidents directly attributed to specific reagents and other
consumables.

3.5.2 QUALITY PROCEDURE

Material Management

3.5.3 RELATED DOCUMENT

Material Reception, Inspection, Validation-Verification,

Storage, Handling, and Use

3.6 DOCUMENTED INFORMATION

3.6.1 POLICY

● All documents shall be properly and systematically filed

electronically and in hard copies (if so warranted)

● The Blood Stations 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.

13
 ● All relevant versions of applicable documents shall be
available at points of use.

● The Blood Stations shall determine what documented

information needs to be retained. Obsolete documents
shall be identified, and unintended use shall be prevented.

● The Blood Stations shall have a policy for disposal of

documents and records based on the updated policies
issuances

3.6.2. QUALITY PROCEDURE

Control of Documents

4. OPERATION
FOR NON-HOSPITAL-BASED BLOOD STATIONS

4.1 BLOOD SUPPLY

4.1.1 POLICY

● The Blood Stations shall identify the actual demand within

its area of responsibility and ensures 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 Stations shall ensure that the blood supply

comes from voluntary blood donors from low-risk
populations.

● The Blood Stations shall provide proper education to

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

● The Blood Stations shall maintain and monitor records of

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

● The Blood Stations shall maintain a record of all donors,

including adverse reactions during phlebotomy and

14
 outcome of testing for transfusion-transmissible
infections.

4.1.2 QUALITY PROCEDURES

● Blood Donor Recruitment and Retention

● Maintaining an Optimal Blood Inventory

4.1.3 RELATED DOCUMENTS

● Provision of Information to Prospective Donors (Pre-

Donation)

● Registration, Positive Identification, and Assessment of

Blood Donors

● Blood Stock Inventory Management

4.2. STORAGE AND TRANSPORT

4.2.1. POLICY

● The Blood Stations shall implement proper cold chain

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

● The Blood Stations 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 Stations management shall ensure that all

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

4.2.2. QUALITY PROCEDURES

● Storage and Transport

● Issuance and Transport of Blood from Blood Center to

End User Hospital

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 4.2.3. RELATED DOCUMENTS

Packing and Transport of Blood Units

FOR HOSPITAL-BASED BLOOD STATIONS

4.3. COMPATIBILITY TESTING

4.3.1. POLICY

4.3.1.1. Compatibility testing procedures shall include the

following:

● Positive identification of recipient and recipient's blood

sample
● Review of the recipient transfusion records
● ABO and D typing of recipient's blood
● Antibody screening and identification
● Selection of blood components of the appropriate ABO
and D types
● Crossmatch
● Labeling of the components with the recipient information.

4.3.1.2. Only qualified and trained staff shall perform positive

patient identification, sample collection, and
compatibility testing.

4.3.2. QUALITY PROCEDURES

● Pretransfusion Testing (Routine)

● Pretransfusion Testing for Neonates

● Issuance of Blood from Blood Stations to Patient Area

4.3.3. RELATED DOCUMENTS – harmonize with DOH’s issuance

on service capabilities

● Daily QC of Immunohematology

● Preparation of Laboratory Red Cells Solution

16
 ● Positive Identification and Sample Collection for
Compatibility Testing

● Blood Typing (Forward and Reverse)

● Blood Typing in Infants Less than 6 Months Old

● Reverse Typing of Blood Components

● Resolving ABO Discrepancies

● Antibody Screen

● Crossmatch (Routine)

● Crossmatch in Neonates

● Proper Issuance of Blood for Transfusion

5. PERFORMANCE EVALUATION
5.1. MEASUREMENT, ANALYSIS, AND EVALUATION

5.1.1. CLIENT SATISFACTION

5.1.1.1. POLICY

● The Blood Stations shall implement a mechanism

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

● All feedback shall be addressed and acted upon

accordingly.

● Monthly reports with appropriate corrective action

shall be submitted to the healthcare facility’s
Quality Assurance Office.

5.1.1.2. QUALITY PROCEDURE

● Customer Satisfaction Measurement

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 5.1.2 HOSPITAL BLOOD TRANSFUSION COMMITTEE

5.1.2.1 POLICY

● A Hospital Blood Transfusion Committee shall be

established with appropriate policy and procedure
for its operation

● The Committee shall be mandated to perform

based on a Letter, Memorandum, or Order for its
establishment, composition, duties, and
responsibilities

● The Committee shall meet regularly, and minutes

of its meetings shall be documented, kept, and
available.

● The Committee shall implement a system to

monitor, evaluate and audit its blood transfusion
activities.

● There should be records of blood utilization

reviewed and performed, including but not limited
to corrective actions taken

● The Committee shall record, report activities

conducted, including but not limited to review of
policies, procedures, and blood utilization

5.1.2.2 RELATED DOCUMENT

● Conducting a Blood Utilization Review

5.2. EXTERNAL QUALITY ASSURANCE

5.2.1. POLICY

● The hospital-based Blood Stations shall participate

actively in the External Quality Assurance Program

18
 conducted by the national reference laboratory or other
External Quality Assessment Program approved by the
DOH.

5.2.2. POLICY PROCEDURE

● The Blood Stations 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 Stations shall keep records of the certificate of

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

5.3. INTERNAL QUALITY ASSURANCE

5.3.1. POLICY

● The Blood Stations 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 Stations shall keep records of internal quality

audits and its results.

● The Blood Stations shall analyze the results of the internal

quality audit and make recommendations to improve blood
services and blood products.

● The Blood Stations shall conduct quality improvement

studies to improve the delivery of blood services and blood
products.

5.3.2. POLICY PROCEDURE

● The Blood Stations shall have procedures on internal

quality control of its reagents and internal quality audit.

5.4. INTERNAL AUDIT

5.4.1. POLICY

19
 ● The Blood Stations’ 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 Stations’ management shall ensure that the

audit team is provided with appropriate training in the
administration of internal audits.

● The Blood Stations shall conduct an internal audit regularly

as planned.

● The Blood Stations shall keep records of the results of its

internal audit.

5.4.2 QUALITY PROCEDURE

How to conduct Internal Audit

5.4.3 RELATED DOCUMENTS

Internal Audit Records

5.5 MANAGEMENT REVIEW

5.5.1 POLICY

● The Blood Stations’ 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.

5.6 CONTINUOUS QUALITY IMPROVEMENT (CQI)

5.6.1 POLICY

● The Blood Stations 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.

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 ● 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 Stations shall integrate the Continuous Quality

Improvement Plan into its strategic and operational plans.

5.6.2 QUALITY PROCEDURE

● Corrective action

5.6.3 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 Service 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 Service Network on the effective
implementation of the Emergency Response Plan (ERP) of the Department of
Health National Voluntary Blood Services Program (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 post-disaster evaluation.

4. RESPONSIBILITIES

4.1. Department of Health National Voluntary Blood Services Program (DOH-

NVBSP) – issues directives to the Blood Service Network for a coordinated
response during disasters

4.2. Emergency Preparedness and Crisis Management Team (EPCMT) –

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

22
5. GUIDELINES:

5.1. Formulate an emergency management plan that contains preparedness,

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

5.2. 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 regularly update the Critical Contact
Information. Disseminate in all areas.

5.3. 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 Stations) should be identified.

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

5.5. Determine critical supplies that may be needed during disaster-related

events.

5.6. Reassess minimum inventory requirements.

5.7. Determine product reserves of suppliers, and lead time.

5.8. Prepare for alternative means of communication since it is possible that

telecommunication lines will be cut off during disasters.

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

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

5.11. Identify alternative facilities.

5.12. Access alternative power sources for storage refrigerators, freezers,

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

5.13. Conduct drills semi-annually to test the ERP.

6. RISK MANAGEMENT / SAFETY PRECAUTIONS

6.1. 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.

23
 6.2. Anticipate the need for essential resources, including:

● People

● Facilities

● Materials and supplies

● Communications

● Money

● Logistics and transport

● Other special support

6.3. Identify the triggers that will activate the ERP.

6.4. Establish the chain of command and order of succession.

6.5. Conduct risk assessment annually.

7. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start
1. Blood Service Network

1. Plan ● The Blood Stations may be chosen as

an alternative facility for a Command
Center if it is strategically located
outside the impact areas.
2. Respond
● Refer to Risk Assessment Chart and
WI Planning for Disasters

2. Blood Service Network with EPCMT

● The Blood Stations nearest the disaster

area activate the response team within
the network. Refer to Table of Critical
A Contact Information.

24
 A ● Review the extent of physical damage
among Blood Stations in areas affected
(if any) and the need for blood supply.

3. Evaluate effectiveness of ● If possible, check the NBBNets for

response available stocks of blood in the network
for immediate mobilization to the area of
impact.

● Refer to Template – Event

Assessment
4. Formulate and implement
agreed improvements
3. Blood Stations network with
RRCMT

● Review the effectiveness of the

response and identify areas for
End improvement

● Monitor and evaluate the performance

and effectiveness of the mitigations

4. Blood Stations network with

RRCMT

● Disseminate policy/procedure updates

8. DOCUMENTATION (Forms, Worksheets)

8.1. Risk Assessment Chart (Please see Appendix A)

8.2. Critical Contact Information (Please see Appendix B)

8.3. Event Assessment (Please see Appendix C)

Preparedness and Response to Internal Emergencies

1. PURPOSE

This document guides the Blood Stations’ management and personnel in

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

25
2. SCOPE AND LIMITATIONS

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

disaster evaluation.

3. RESPONSIBILITIES

a. Blood Stations’ personnel who first detected the emergency or

disaster shall notify the designated incident commander

b. Incident Commander – activates the emergency response teams

c. Disaster Response Team – spearheads the operations and logistics

during disasters affecting the Blood Stations

d. Evacuation Team – responsible for organized evacuation to

minimize casualties and injuries during disasters

e. Medical Emergency Team – provide immediate on-site stabilization

and management during disasters

f. Designated Triage Personnel – classifies injured individuals

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

4. RISK MANAGEMENT/SAFETY PRECAUTIONS

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

4.2 All Blood Stations’ 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.

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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
1. Detect disaster/emergency
of internal emergencies and
disasters
- Fire
- Bomb explosion within the
BLOOD STATIONS and
surrounding areas
- Biohazard spills
- Earthquake
2. Personnel who first detected the
2. Notify emergency
● Internal communication is very
important during any emergency
situation.
● In case of fire, activate the nearest
fire alarm where required and call
the appropriate emergency
response and resource personnel
immediately.
3. Activate emergency response
teams 3. Incident Commander
● Activate Disaster Response Team,
Evacuation Team, and Medical
Emergency Team

4. Evacuate 4. Evacuation Team

● Follow evacuation protocol. Lead
evacuees to identified safe areas
5. Triage, assess and manage the
5. Designated Triage Personnel and
injured appropriately.
Medical Emergency Team
● Set up a mobile emergency
treatment room.
● Triage injured patients according to
the severity of the injury.
● Attend first to seriously injured
End
individuals.
● Coordinate transfer of the injured to
other health facilities if necessary

27
 Managing Blood Supply During Disasters

1. INTENDED USE

To guide the Blood Stations management and personnel in managing blood

donors and blood supply during disasters.

2. PRINCIPLE

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 Stations 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

28
 positive donors for the first 24 hours. Re-assess after 24 hours. Avoid
unnecessary donations that may only flood the supply.

3.7 Maintain close coordination with members of the Blood Service

Network to determine medical needs.

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 Stations' middle managers on the steps in
preparing a budget proposal that will effectively support the programs and
operations of the Blood Stations.

2. PRINCIPLE

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

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

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:

a. Finance Head – conducts orientation to the department heads

and supervisors on budget preparation and policies

b. Section Head –prepares the initial budget proposal for each

functional unit

c. 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.

d. Budget Committee – responsible for final deliberation of the

budget and recommends approval to the Blood Stations’ Director

29
 e. Blood Stations’ Head – approves final budget for implementation

5. PROCEDURE

5.1 Check for new directives from the Department of Health, related
regulatory offices (local government office, Philhealth), and Blood
Stations’ 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.

30
6. WORKFLOW DIAGRAM

FLOWCHART RESPONSIBLE PERSON/

DESCRIPTION OF ACTIVITY

Start 1. Finance Head

● Orient new heads/supervisors;
1. Orient department heads and discuss new policies and
supervisors on budget formats as needed.
preparation
2. Section in charge
2. Prepare initial budget Refer to the following:
proposal ● WI - Preparing an Initial Budget
Proposal
● Template - Budget Proposal
● Template - Procurement
Management Plan
● Ensure that all templates are
the updated version

3. Unit Supervisor
3. Review initial budget ● Validate the programs/projects;
proposal
make necessary revisions.
● Recommend the budget
proposal to the Finance/Budget
Committee.
4. Validate budget proposal
4. Budget Committee
● Check alignment of programs
and projects with the
5. Approve final budget mandate/purpose of the Blood
Stations

5. Blood Stations’ Head

● Ensure that all recommended
budget proposal undergoes
deliberation by the Budget
End Committee.
● Approve and sign the final
budget for implementation

31
7. DOCUMENTATION

● Budget Proposal

● Procurement Management Plan

Recruitment, Selection, Hiring of Human Resources

1. PURPOSE

This document guides the Blood Station's human resource personnel in

the recruitment, selection, hiring, and of personnel

2. SCOPE AND LIMITATIONS

This document starts with the identification of the need for human
resources, selection, and hiring.

3. RESPONSIBILITIES

a. Unit Supervisor – responsible for determining the need for

personnel, either for replacement of resigned or retired personnel,
regulatory requirement, or to match the capacity requirements of
the Blood Stations

b. HR Personnel – assists the HR Manager in ensuring

completeness and authenticity of required documents

c. HR Manager – validates the personnel request by the Section

Supervisor; publishes positions for filling up, processes
applications, and recommends to the Blood Stations’
Head/Medical Director; ensures that all newly hired personnel are
given appropriate orientation, and hands-on training before
specific tasks are assigned

d. Blood Stations’ Head/Medical Director - gives the final decision

4. RISK MANAGEMENT / SAFETY PRECAUTIONS

a. Verify correctness of documents submitted by applicants.

b. Conduct background investigation.

c. Referencing and credentialing

32
5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
1. Unit Supervisor
Start ● Request for replacement of
resigned or retired personnel
one (1) month before the
1. Determine need for personnel effectivity of resignation/
retirement to allow for the
smooth transition of operation.
● May request for additional
personnel to match the
increasing capacity
2. Recruit applicants for requirements of the Blood
positions that need filling up Stations; should be based on
historical data.

2. HR Manager
3. Process applicationst
● Publish positions that need
filling up and the minimum
requirements for each
position.
● Establish the application
period.

3. HR Personnel
Ensure completeness of the
following documents.
4. Conduct aptitude and ● Letter of Intent
psychological tests ● Updated curriculum vitae
● Copy of college diploma or
equivalent
● Copy of professional license, if
applicable
● Letter of support from two (2)
Passed? NO
professional colleagues or
previous employer or school
dean/registrar
B 4. HR Manager
YES
● Prepare an application
summary and forward it to the
A Personnel Board.
● Refer to Template –
Application Summary Sheet

33
 A B

5. Personnel Board
5. Inspect documents submitted by ● Determine eligibility of applicant
applicant and results of tests and according to set standards
make recommendation to BS Head ● A medical certificate issued by a
recognized health facility is
required before forwarding a
‘favorable recommendation’ to the
6. Approve the recommendation
Blood Stations Head/Director.

6. Blood Stations Head/Director

● Approve the recommendation of
the HR Manager
End ● Send notice to successful
applicants

6. DOCUMENTATION (Forms, Worksheets)

Application Summary Sheet

Promotion of Human Resources

1. PURPOSE

This document guides the Blood Stations’ human resource 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

a. HR Manager - initiates the promotion procedure by determining the

vacancies, calling for applications, and initial screening of documents.

34
 b. Personnel Board – reviews applications and recommends to the Blood
Stations Head for final approval

c. Blood Stations Head/Medical Director - gives final approval for

personnel promotion

4. RISK MANAGEMENT / SAFETY PRECAUTIONS

a. Ensure integrity of personnel records.

b. Use personnel promotion matrix to ensure objectivity in assessment.

5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

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

2. HR Manager
2. Call for applications for ● Publish vacant positions and
promotion minimum requirements for
promotion.
● Establish the application period.

3. Receive applications 3. HR Personnel

Ensure completeness of the following

documents.
● Letter of Intent
4. Determine eligibility of ● Updated curriculum vitae
personnel for promotion ● A minimum of three letters of
support from professional
colleagues

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

35
 A 5. Personnel Board
● Check if the applicant meets the
minimum standards for Education,
Experience, and Performance. Use
5. Review applications and the Evaluation Matrix for Promotion
recommend personnel for
(EMP) template in ranking
promotion
applicants.

6. Approval 6. Blood Stations’ Head/Medical Director

● Makes final promotion decision.

● Writes formal notification to the
successful applicant.
End

6. DOCUMENTATION (Forms, Worksheets)

● Application Summary Sheet

● Evaluation Matrix for Promotion

Competency Assessment of Blood Stations’ 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.

3.2 The competency assessment must include the following:

36
 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.

3.2.2 Assessment of test performance through testing previously

analyzed specimens, internal blind testing samples; and

3.2.3 Evaluation of problem-solving skills.

3.2.4 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 Stations 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

a. 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

b. Unit Head – checks appropriateness of the content of new or revised

documents

37
 c. Document Controller – controls the numbering, filing, sorting, and
retrieval of documents. These documents may be in hard copy or
electronically stored.

d. 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 Stations must be of the latest

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

5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
1. Supervisor/Section Head
Start
● The need may arise from a new
regulatory standard, organizational
resolution, or corrective/preventive
1. Determine needed document
action for an identified problem/issue.

2. Supervisor/Section Head/Unit Head

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

3. Control document.
3. Document Controller
● Mark new document
‘CONTROLLED.’
4. Distribute controlled
document to concerned units. 4. Document Controller
● Pull out the obsolete document from
files in work areas. Replace with a
5. Archive obsolete document. new/revised document.

5. Document Controller
● Remove obsolete documents from
6. Update and maintain records.
current files.

6. Document Controller
End ● Update all records.

38
6. DOCUMENTATION (Forms, Worksheets)

● Quality Policy Issuance Monitoring

● Document Register

● Document Change Request Monitoring

● List of Records

Equipment Management

1. PURPOSE

This document guides the Blood Stations’ 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

a. Section Head – performs the initial equipment selection process,

performance qualification, calibration, and maintenance as scheduled,
and documents all processes

b. Blood Stations’ Biomedical Engineer – together with the Section Head,

supervises the installation and operation qualification processes
conducted by the vendor/supplier engineer.

c. 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.

39
 d. Procurement Committee – evaluates a selection of equipment according
to preset standards and recommends to the Blood Stations’ Head for
final approval

e. Blood Stations Head– gives final approval for the equipment selection
and acquisition processes.

4. RISK MANAGEMENT / SAFETY PRECAUTIONS

4.1 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).

4.2 Implement mitigation strategies such as elimination/substitution,

engineering control, administrative (training, availability of standard
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.

4.3 Monitor periodically and review the performance and effectiveness of

the mitigation implemented.

40
5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
1. Section Head/Unit Supervisor
Start ● Discuss the need for new equipment
with the Unit Head
● List the standard technical
1. Determine what equipment to specifications of equipment
procure (Selection Qualification) ● Request for quotations and
brochures from vendors.

2. Procure equipment 2. Blood Stations’ Management

(Equipment Acquisition)
Equipment acquisition follows the
facility procurement policies and
3. Create the equipment file and procedures.
records
3. Section Head

Initiate and maintain an equipment

4. Perform the equipment master file.
qualification process
4. Section Head and Blood Stations’
Biomedical Engineer

Perform the Installation Qualification

(IQ), Operation Qualification (OQ), and
5. Write the equipment SOP Performance Qualification (PQ)

Section Head
● Record the results of the IQ,
OQ, and PQ.
● Prepare the Validation Report.
6. Approve equipment for use in
patient testing 5. Section Head
● Refer to WI Equipment
Management Process.

7. Perform the calibration 6. Section Head and Unit Supervisor

procedure. ● Review and approve the Validation
Report, and put it in use for patient
testing.

A 7. Section Head and Product Engineer

● Identify the calibration materials, and
establish calibration procedure and

41
 acceptance/ rejection criteria
following the manufacturer’s
specification.
● Perform the calibration at a specified
frequency using the recommended
calibration materials
● Evaluate the results based on the
established acceptance/ rejection
A criteria.

8. Perform maintenance 8. Section Head

activities. ● Perform and record the maintenance
activities (routine, corrective and
preventive), function checks, service,
and repairs performed.
● Report equipment-related
injuries/incidents, if any
9. De-commissioning
Unit Supervisor
● Maintain an inventory of all
equipment

9. Section Head
End ● Perform the various steps in the
decommissioning process
● For the detailed procedure of the
above activities, refer to the
following:

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,

bioengineering 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

3.2.1 Follow the institution procurement procedure for approvals

and signatories.

43
 3.2.2 Procure equipment that met the approved requirement set by
the FDA or equipment that met the required technical
specifications for Blood Stations.

3.2.3 Upon delivery, call the responsible person and double-check

the received equipment with the delivery receipt and the
agreed specifications.

3.2.4 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

3.4.1 Equipment Identification

3.4.1.1 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.

3.4.1.2 Enter all relevant data into the “Equipment

Identification” section of the Equipment Management
Form.

3.4.2 Performing installation qualification (IQ)

3.4.2.1 Check the installation of equipment.

3.4.2.2 Confirm/verify that 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.

3.4.2.3 Record the above activities in the “Installation

Qualification” section of the Equipment Management
Form.

44
 3.4.3 Performing operational qualification (OQ)

3.4.3.1 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.

3.4.3.2 Record the above activities in the “Operation

Qualification” section of the Equipment Management
Form.

3.4.4 Conduct performance qualification (PQ)

3.4.4.1 Prepare the validation plan and perform the

validation process.

3.4.4.2 Perform the validation experiment as deemed

appropriate. Refer to WI Conducting the
Performance Qualification/Equipment Validation for
detailed instruction on the validation process.

3.4.4.3 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.

3.4.4.4 Record the above activities in the “Performance

Qualification” section of the Equipment Management
Form.

3.5 Writing the equipment standard operating procedure (SOP)

3.5.1 Write the SOP following the institution document

template/format and control procedure and informed by the
equipment’s operating manual

3.5.2 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

45
 Institute of Science and Technology [NIST] or equivalent, as
applicable) are described in the equipment SOP.

3.5.3 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.

3.6 Approval for use in patient testing

3.6.1 Train all staff in operation, calibration, and maintenance of

the equipment.

3.6.2 Ask the technical staff to read the SOPs.

3.6.3 Document the staff training and competency assessment.

3.6.4 Review the Validation Report

3.6.5 Approve the validation Report and its use for patient testing.

3.6.6 Authorize the trained staff to use the equipment for patient
testing.

3.7 Performing calibration

3.7.1 Refer to equipment SOP on how to calibrate the equipment

3.7.2 Perform the calibration as scheduled

3.7.2.1 Upon installation, ask the supplier to calibrate the

new equipment.

3.7.2.2 Ask for a copy of the certificate of calibration.

3.7.2.3 Maintain the calibration by performing the

recommended internal and external calibration
procedures as per the manufacturer’s instructions.

3.7.2.4 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.

3.7.2.5 Keep a record of calibration supported by the

calibration certificate.

46
 3.7.2.6 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.

3.7.2.7 Record all activities performed in the maintenance

and calibration form (attach the PM and Calibration
reports in the appropriate section of the equipment
folder).

3.8 Performing Performance Checks and Maintenance

3.8.1 Refer to equipment SOP on how to maintain the equipment

3.8.2 Use the prepared Maintenance and Calibration form to guide

which function check or maintenance procedure is due.

3.8.3 Perform the recommended function checks and

maintenance (routine, preventive and corrective) activities as
scheduled.

3.8.3.1 Routine maintenance: perform the recommended

daily, weekly, and monthly function checks and
maintenance procedures.

3.8.3.2 Corrective Maintenance: Equipment minor

troubleshooting and equipment service and repair
are recorded in the maintenance and calibration
form.

3.8.3.3 Preventive Maintenance: keep a schedule of the

Periodic Preventive Maintenance (PPM) and
arrange with the supplier or external party in
performing the PPM.

3.8.4 Record maintenance activities in the Equipment Calibration

and Maintenance Form.

3.8.5 Section Supervisor reviews and signs the monthly

Equipment Calibration and Maintenance Form.

3.8.6 File/Archive the signed Equipment Calibration and

Maintenance Form in the appropriate section of the
equipment folder.

3.9 De-commissioning procedure

3.9.1 Decide to de-commission/retire or dispose of the equipment.

47
 3.9.2 Remove all containers of hazardous and/or infectious
substances from equipment. Follow the Blood Stations’
waste management protocol.

3.9.3 Decontaminate the equipment according to the

manufacturer’s recommendations.

3.9.4 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.

3.9.5 Arrange the disposal/ transfer of the equipment.

3.9.6 Record the above activities in the “de-commissioning”

section of the Equipment Management Form.

3.10 Reporting equipment-related injuries/incidents

3.10.1 Follow the Blood Stations’ procedure on incident reporting.

Performance Qualification/Equipment Validation

1. INTENDED USE

This document guides the Technical Staff, Unit Supervisor, and

Bioengineer 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.

48
3. DEFINITIONS

a. 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.

b. VMP - Validation Master Plan

c. Verification - Evaluating the performance of a system with regard to its

effectiveness based on the intended use.

d. 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

e. 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

f. 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

g. Analytical Sensitivity Protocol - intended to estimate the lowest

concentration of an analyte that can be measured

h. Analytical Specificity Protocol - intended to estimate the systematic

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

i. 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

j. 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

k. 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

49
 l. 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.

m. 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
● Standards
● Calibrators
● Control

6. QUALITY CONTROL

Perform validation and verification activities

Complete and maintain documents

7. PROCEDURE

7.1 Making a Validation Master Plan (VMP)

7.1.1 Make a master list of all equipment in the facility.

7.1.2 List down first all the analytical equipment/test systems,

followed by the non-analytical equipment/device.

7.1.3 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-approve.

50
 7.1.4 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.

7.1.5 Enter all relevant data in the Validation Master Plan Form.

7.2 Preparing the validation protocol and experiments for analytical

equipment

7.2.1 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.

7.2.2 Make the validation plan and protocol for the equipment
scheduled for validation.

7.2.3 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.

7.2.4 Enter all relevant data in the Validation Plan.

7.3 Performing the required validation protocol/experiment, as required

7.3.1 Select the suitable material/specimen to be used in the

validation experiment.

51
 7.3.2 Prepare all the samples that will be needed, and ensure that
enough samples are available to finish the validation
experiment.

7.3.3 Calibrate and maintain the equipment as per routine.

7.3.4 Ensure that the same lot of reagents, calibrators, and

controls are available to finish the validation experiment.

7.3.5 Prepare all the validation worksheets that will be needed.

7.3.6 Enter all relevant information in the validation worksheets.

7.3.7 Perform the validation experiment.

7.3.8 Enter all data at the time the tests are performed.

7.3.9 Assess any failure encountered in the validation.

7.4 Validation Protocols – perform the following as required

7.4.1 Accuracy

7.4.2 Precision

7.4.3 Linearity/Analytical Measurement Range

7.4.4 Analytical Sensitivity

7.4.5 Analytical Specificity

7.4.6 Diagnostic Sensitivity/Diagnostic Specificity

7.4.7 Predictive Value

7.4.8 Other Protocols/ as needed:

● Carry Over Check

● Dilution Check

● Stability Check

7.5 Preparing the Validation Report

7.5.1 Select the appropriate data analysis and the acceptance

criteria.

52
 7.5.2 Calculate the appropriate statistics for data analysis.

7.5.3 Evaluate and compare the observed error with the

acceptable error or the manufacturer’s claim.

7.5.4 Accept or reject the validation protocol.

7.5.5 Approve or disapprove of patient testing.

7.5.6 Attach the validation report to the Equipment Management

Form

7.6 Maintaining the Validated State

7.6.1 Verify the following parameters every six (6) months.

● 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/ Data Analysis Acceptance Criteria
Protocol Duration/ Run Order (as appropriate)
1. Linearity/ ● 3-5 levels Plot the data ● Visual checking
AMR
● replicates per level ● Each level must be
within the +20% of the
● Run in 1 day Calculate r, slope, nominal value
and intercept
● 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

53
 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 Calculate r, slope, Each level must be

5 days and intercept within the +20% of the
nominal value
● Run within 2 hours
intervals between 2 ● Acceptable r, slope,
methods and intercept

Table 2: Other Validation Protocols (perform as needed)

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

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

Specificity samples duplicates, the difference error <TEa
between the results on the
● 2 replicates per paired samples, and the
sample average of the difference
for all the specimens.
● Run in 1 day

3. Diagnostic Known negative and Diagnostic Sensitivity = Obtained result should be

Sensitivity/ positive samples TP/ (TP+FN) < the manufacturer’s
Diagnostic Refer to guidelines in Diagnostic Specificity = claim.
Specificity calculating the sample TN/ (TN+FP)
size
4. Predictive Positive Predictive Value: Obtained result should be
Value TP/(TP+FP) < the manufacturer’s
Negative Predictive Value: claim.
TN/(TN+FN)

54
5. Carry Over ● 2 levels (High (H) Low % Carry Over : % carry over <TEa
Check and Low (L) (H1-H3/H3-L3)*100

● Run in the High % Carry Over:

following order L1- (L4-L6/H3-L6)*100
L2-L3-H1-H2-H3-
L4-L5-L6

● Run in 1 day

6. Dilution ● Serial dilutions of ● Difference Plot of the ● Each level must be

Check the patient sample nominal value and the within the +20% of
with a high obtained values at the nominal value
concentration varying time dilutions
● Acceptable r, slope,
● 1 replicate/dilution ● Calculate r, slope, and and intercept
intercept
● Run in 1 day

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

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

● Run at different
time intervals or in
different situations

Material Management

1. PURPOSE

This document guides the Blood Stations 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.

55
 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 Stations. 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.

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

56
 mitigation implemented.

5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start
1. Section Head and Procurement Officer
● Evaluate the suppliers based on their
1. Selection qualification capability to meet the facility's
expectations for supplies.
● Make a list of approved suppliers
2. Purchase materials
2. Procurement/Purchasing Officer
Review purchasing agreements

3. Receiving and inspection 3. Section Head

Ensure that the quantity and packaging
are consistent with the description of the
4. Verification of received item in the purchase request.
materials
4. Technical Staff
Perform the lot validation of critical
5. Storage and handling/ materials

5. Technical staff
Store and handle all supplies according to
6. Inventory management the manufacturer’s instruction

7. Identification and tracking 6. Section Head

Maintain the inventory of supplies

End 7. Section Head/Technical Staff

● Identify the critical materials.
● Record the identity of critical materials
used or put in use for traceability

57
6. DOCUMENTATION (Forms, Worksheets)

● Supplier Evaluation Form

● List of Approved Suppliers Form

● Verification and Traceability of Critical Material Form

● Lot Validation Worksheet

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

3.1.1 Identify the specifications of the supplies needed.

3.1.2 Evaluate the capability of suppliers based on the minimum

requirements set by the procurement committee. Document
supplier qualification using the Supplier Evaluation Form.

3.1.3 List all approved suppliers using the List of Approved

Suppliers Form. Update the list annually.

3.2 Purchase of Materials

3.2.1 Follow the procurement policies and procedures of the Blood

Stations.

58
 3.2.2 Procure supplies that are registered with the FDA and
evaluated by the National Reference Laboratory.

3.3 Receipt and Inspection

3.3.1 Inspect the received materials.

3.3.2 Record the general condition, lot number, date of expiration,

storage requirement, and check against the accompanying
delivery document.

3.3.3 Document the inspection performed in the delivery receipt.

3.4 Verification or Validation of Critical Materials/New Lot Confirmation

of Acceptability of Incoming Critical Materials (such as reagents)

3.4.1 List down the critical materials received in the facility in

Verification and Traceability of Critical Material Form.

3.4.2 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.

3.4.3 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 calibrators is available,
calibrate the machine with the new lot of calibrators and a
new lot of reagent.

3.4.4 Examples of suitable reference materials for reagent lot

validation include:

● Positive and negative patient samples were tested on the

previous lot.

● Previously tested proficiency testing materials.

● External quality control (QC) materials were previously

tested in the previous lot.

3.4.5 Follow the validation protocol described below.

● Run the selected samples using the old and new reagent
lot in at least 2-hour intervals. Record the validation data
in the Lot Validation Worksheet.

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

59
 ● Minimum cross-checking includes re-testing at
least one (1) positive and one (1) negative patient
sample tested on the previous lot.

● A weakly positive sample must be included if

patient results are reported in that fashion.

● Acceptance Criteria: Results should match

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

● For semi-quantitative tests - tests with quantitative

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

● 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.

● Acceptance Criteria: Results should match between the

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

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

● 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.

● 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).

● Calculate the difference (Xc) between the current

lot mean and the new reagent means.

● Calculate Xn by multiplying the grand mean by the

cumulative coefficient of variation (CV) of the
quality control with the value closest to the grand

60
 mean. Convert this value into a decimal by dividing
it by 100.

● Calculate the acceptability ratio by dividing the

value of the Xc with the value of Xn.

● 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

3.5.1 Verify new lot/new shipment of quality control materials prior

to its use.
3.5.2 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.
3.5.3 Verify that there are no trends/outliers and that the precision
is acceptable.
3.5.4 Record the validation data in the Lot Validation Worksheet.
3.5.5 Calculate the mean, CV, and SD, and calculate the new QC
range (mean+2SD).
3.5.6 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

3.6.1 Document the validation/verification performed using the Lot

Validation Worksheet.
3.6.2 Write the specimen/ sample description (Reagent, QC, or
calibrator) and other details such as lot number, date of

61
 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.
3.6.3 Write the appropriate acceptance criteria and the obtained/
calculated result.
3.6.4 Evaluate the results and write the conclusion such as:
● Reagent lot is acceptable/Reagent Lot is not
acceptable.

● New QC Range is verified/acceptable/New QC Range

is not verified/not acceptable.

3.6.5 Attach the package insert with the Lot Validation Worksheet
and file both in the Critical Materials Validation Folder.
3.6.6 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.
3.6.7 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

3.7.1 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.

3.7.2 Monitor the temperature in the storage areas every shift.

3.7.3 Store received materials according to the manufacturer’s

instructions on handling and storage to prevent alterations
that could affect stability and performance.

3.7.4 Label with precautionary labels as needed. Place all reagents

and chemicals in the cupboard, at eye level or below. Proper
segregation shall be implemented.

62
 3.7.5 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.

3.7.6 All reagents, calibrators, controls, and prepared solutions are

labeled with the following information such as:

● Content

● Concentration

● Storage requirement

● Date opened/preparation/reconstituted by the laboratory

● Date of expiry/ date of expiry upon opening (if opening

the container changes the expiration date and storage
requirements)

● Initials of the personnel who prepared the materials

3.7.7 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.

3.7.8 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 Bank/Immunology Head is required in such
cases.

3.7.9 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.

3.7.10 Uninspected and unacceptable reagents and consumables

shall be segregated from those that have been accepted for
use and labeled accordingly.

3.8 Inventory Management

3.8.1 List down all materials used in the laboratory in the Inventory
of Supplies Form.

63
 3.8.2 Specify the frequency of doing the inventory. Ensure that a
system for a continuous supply of critical materials is
implemented and efficient.

3.8.3 Track and record expiration dates and communicate inventory

levels and when re-order is necessary.

3.9 Reagents and Consumables Package Inserts

3.9.1 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.
3.9.2 Keep the Safety Data Sheets (SDS) of chemicals on file for
reference.

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

3.10.1 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 Service
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 Stations’ usage of each blood type and component over a period of
several months. Keeping such a bloodstock inventory ensures optimum
blood utilization, minimizes wastage and shortages.

64
3. SCOPE AND LIMITATIONS

This procedure starts from the determination of blood needs within the
Blood Service 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

a. Lead Blood Stations – convenes Blood Service 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
Service Network monthly

5. PROCEDURE

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

utilization.

b. Record usage by ABO and Rh type for each week segregated into
specific blood components.

i. Enter data into BSIMan.

ii. In the BSIMan, click on the box located on the right side for the
specific blood component inventory.

iii. BSIMan will automatically

c. Disregard the single highest usage for each type to correct for unusual
week-to-week variation (e.g., large volumes for emergency).

d. Total the number of units of each ABO and Rh type, omitting the
highest week in each column,

e. Divide each total by 25, and

f. Give an estimate of the average weekly blood usage of each ABO

and Rh type.

65
6. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start
1. Lead Blood Stations
● Convene the Blood Service Network to
1. Determine blood needs determine blood needs of the hospitals
within the service area, weekly target,
and other issues such as factors
affecting the reliability of data,
2. Schedule MBD’s
2. Blood Stations
● Prepare the schedule of MBD to meet
3. Assess attainment of target the demands

3. Blood Stations
● Determine if the target is attained.
4. Repeat the process on an
annual basis
● Use BSI Man and Productivity
Measures Excel Worksheet.
● Submit to the Lead Blood Stations

4. Blood Service Network

● 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 Stations 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

66
 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
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.

67
5. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start 1. MBD Organizer

Identify communities/organizations
where members are healthy and where
1. Identify low risk communities. the prevalence of high-risk behavior is
low. Coordinate with the local health unit
if possible.
2. Provide pre-donation
information. 2. Blood Donor Recruiter
Refer to WI –Provision of Information for
Prospective Blood Donors (Pre-
3. Prepare list of prospective donation)
donors.
3. Blood Donor Recruiters and MBD
Organizer
4. Conduct pre-donation risk Use Form – List of Prospective Blood
assessment and counselling. Donors. Update fields after the donors
have donated blood.

5. Provide the donor a positive 4. Blood Donor Recruiters

experience during blood donation. Conduct pre-donation risk assessment
and counseling.

5. Phlebotomist
6. Update blood donor registry. ● Accomplish Form – Blood Donor’s
Record of Donation.
● Refer to the following:
● QP – Blood Collection
● WI – Post Donation Care
End
6. Blood Program Coordinator
● Use Form - Blood Donor Registry.
● Compute the Blood Donor Recruitment
Rate. See Glossary for the formula.

6. DOCUMENTATION (Forms, Worksheets)

● List of Prospective Blood Donors

● Blood Donor Registry (Regular)

68
 ● 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.

2. PRINCIPLE

a. Blood and blood products shall be sourced from regular repeat

voluntary non-remunerated blood donors.

b. 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

a. 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:

● Digital light projector

● Extension cord

● Copy of PowerPoint presentation and/or video

● Leaflets and other information materials

69
 b. When the venue is open and the use of a digital light projector is not
feasible, the materials needed are:

● Flip chart

● Copy of PowerPoint presentation and/or video

● 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.

● 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

70
● 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 Stations 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:

● Blood needs of the geographic area where MBD

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

● Basic blood physiology – functions of red blood cells,

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

● Who can donate blood and who cannot donate blood

● 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

● Blood donation process

● Confidential Unit Exclusion

● 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),

● 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,

71
 ● 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 Blood Donor Recruitment Rate and proxy indicator for
the number of blood donors recruited.

Blood Utilization Review

1. INTENDED USE

To determine if the transfusions are in accordance with established clinical

practice guidelines

2. PRINCIPLE

An effective blood utilization program helps lower transfusion risks and

improve outcomes for patients. Adequate documentation and regular
discussion with the members of the Hospital Blood Transfusion Committee
are essential to the success of a blood utilization review.

72
3. MATERIALS

● Blood request

● Blood transfusion record

● Blood transfusion reaction registry form

● Clinical Practice Guidelines issued by the DOH

4. PROCEDURE

4.1 Prepare a monthly report on blood transfusion according to the

following:

a. Number of blood requests received

b. Number of cross-matched blood unit

c. Number of canceled blood requests

d. Number of blood units transfused according to:

● blood type

● blood component

e. According to the type of request if regular or STAT

f. According to requesting department/section/center/ward

g. Number of requested blood within the accepted criteria of

indications for rational transfusion

h. Number of requested blood outside the accepted criteria of

indications for rational transfusion, if any

i. Number of blood units transfused from other Blood Stations

j. Number of apheresis platelet units

k. Number and type of adverse reactions

4.2 Analyze and present the data at the HBTC quarterly meetings.

73
 Customer Satisfaction Measurement and Complaint
Management

1. PURPOSE

This document guides the Blood Stations 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 Stations and have the necessary
knowledge and skills needed to execute their jobs properly

c. Quality Manager – monitors satisfaction ratings of Blood Stations 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
1. Distribute donor satisfaction forms
donation.
● Feedback box is opened every 15th
and 30th of each month.
● CSO may receive a complaint from
donors or other customers such as
2. Analyze results
end-user hospital

2. Customer service officer

● Determine if the target rating is
attained.
Needs ● Check for trends and random
corrective NO deviations.
action?

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

4. Quality Manager

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

End

5. DOCUMENTATION (Forms, Worksheets)

Donor Satisfaction Survey

75
 Internal Audit

1. PURPOSE

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

2. SCOPE AND LIMITATIONS

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

3. RESPONSIBILITIES

a. Blood Stations’ 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.

4. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start 1. Audit Program Leader

Prepare an audit program. This
should include scheduling, audit
1. Prepare audit program type, audit objectives, audit scope,
audit criteria, and responsible
persons and must be approved by
the Blood Stations head.
2. Prepare audit plan
2. Team Leader
● Prepare assignment of internal
3. Prepare audit checklist auditors.
● Ensure that the audit scope is
adequately covered.
A
3. Team Leader/Auditors
Refer to the standards being used in
the development of the audit
checklist.

76
 A
4. Team Leader/Auditors
Inspect department/sections and their
4. Conduct audit processes on the predetermined date
and according to the audit checklist.

5. Submit audit report 5. Team Leader/Auditors

Present audit findings to units
concerned and determine the date for
follow-up on non-conformances.
6. Conduct follow-up
6. Team Leader/Auditors
Request for development on the
determined non-conformances.
7. Close NCAR
7. Blood Stations’ Management
Resolve non-conformances by
8. Review effectiveness of the executing corrective action/preventive
audit action processes.

8. Blood Stations’ Management

Analyze changes or improvements of
processes and services from the date of
internal audit.
Effective?
YES

NO

9. Blood Stations’ Management

Executes corrective actions to further
9. Implement corrective actions improve processes and services.

End

77
5. DOCUMENTATION (Forms, Worksheets)

● Audit Program

● Nonconformance Report

● Audit Report

Conducting an Internal Audit

1. INTENDED USE

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

2. PRINCIPLE

Internal audit ensures the compliance of the Blood Stations to regulatory

and statutory requirements. It also ensures that the policies and procedures
of the Blood Stations are optimal, efficient, and effective.

3. MATERIALS

Audit Checklist
Audit Report

4. PROCEDURE

4.1 Preparing an audit program

4.1.1 Determine the objective of the supposed audit.

4.1.2 Prepare the necessary documents for the audit.

4.1.3 Determine the target date of the action.

4.1.4 Prepare the audit checklist.

4.1.5 Determine the date of audit.

4.1.6 Determine the date of reporting.

78
 4.1.7 Determine the date of performance/implementation of
corrective action.

4.1.8 Present to the Blood Stations’ management and secure

approval.

4.2 Preparing an internal audit checklist.

4.2.1 Review the standards and QMS documents.

4.2.2 Review previous audit results and audit checklist.

4.2.3 Ensure that auditors do not audit their own process.

4.2.4 Secure comments from the audit team if necessary.

4.3 Conducting audit.

4.3.1 The lead auditor presides over the opening meeting

4.3.2 Execute the audit plan.

4.3.3 Prepare the NCAR before the closing meeting.

4.3.4 Lead auditor presides over the closing meeting.

4.3.5 Request for auditee acknowledgment.

4.3.6 Provide NCAR copies to auditees and auditors.

4.3.7 Prepare the audit report.

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.

79
3. RESPONSIBILITIES

a. Responsible Personnel – detects problems from daily activities

b. Auditor – performs compliance check with standards according to

audit plan; prepares non-conformance report

c. Supervisor – receives reports of non-conformities; initiates

investigation; formulates implements corrective; monitors
implementation of corrective action;

d. Quality Manager – oversees the implementation of the corrective

action process; monitors the effectiveness of corrective actions

4. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
1. Responsible Personnel/ Supervisor/
Start Auditor
Occurrences may be any of the
following:
1. Detect problem/ ● customer complaint / error
occurrences/NCAR ● accident
● adverse reaction
● near-miss
NCAR may be identified from the
following:
● internal/external audit
● findings of regulatory/accreditation
bodies
● Non-attainment of process goals
2. Identify root cause needs appropriate corrective action
● Refer to Form - Occurrence Report

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

A 3. Supervisor/Quality Manager
● The corrective action/s must be able
to address the identified root
cause/s.

80
 ● Activities supporting the corrective
action must be specific, realistic, and
time-bound.
● Responsible person and resources
needed for each activity must be
identified.

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

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

6. Quality Manager
End ● For persistent or recurring problems in
Blood Stations, the quality manager
intervenes, and an intensive root
cause 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

81
Part III: Process Manual – Technical Procedures

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 Stations to end-
user hospitals/health facilities.

This does not include transport procedures when relatives of patients are
tasked to procure blood from the Blood Stations and transport it to the
hospital’s blood bank.

3. MATERIALS / EQUIPMENT

● Blood transport boxes

● Coolants

● Temperature monitoring device

● Standard electric blood bank refrigerator

4. RESPONSIBILITIES

4.1 MBD Staff – ensure that donated blood is stored properly during MBD
sessions and transported to Blood Stations 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.

82
 4.3 Medical Technologist – receives blood and blood components from
the MBD collection sites or Blood Stations and monitors the
temperature of stored blood components at the Blood Stations.

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

a. Place the temperature monitoring device in the transport

container.

b. 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.

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

d. Close the transport container.

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

f. Transport the blood units to the blood center or end-user hospital

as soon as possible.

g. Record temperature at intervals until the blood units arrive at the

blood center.

83
 6.2 When receiving blood and blood components from MBD sites or from
other Blood Stations, check the following:

a. Correctness of storage and transport procedure upon receiving

of blood units.

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

c. Blood transport manifest.

d. Registry of transported units if it matches the received number of

units.

6.3. The Blood Stations must ensure to maintain 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 Stations

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 bank to an 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

84
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
FFP or Cryoprecipitate -30 °C to -39 0C 12 months
FFP or Cryoprecipitate -25 °C to -29 0C 6 months
FFP or Cryoprecipitate -20 °C to -24 0C 3 months

85
7. WORKFLOW DIAGRAM

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY
1. Medical Technologist
Start ● Pack the blood units for transport
from the collection area to the Blood
Stations processing area.
1. Prepare the blood units for ● Ensure that proper cold chain
transport. procedure is followed.
● Refer to WI – Transport of Blood
Units
2. Transport the blood units to
the BSF processing unit. 2. Attendant
● Monitor and record temperature
during transport.
3. Receive blood units from ● Use Temperature Log.
collection
3. Medical Technologist
Check and validate received blood
4. Place blood units in units from the collection area.
quarantine until tested negative
for TTI’s 4. Medical Technologist
● Store processed blood units in a
designated quarantine area until
testing
5. Update inventory of blood
● Use the appropriate setting of
pool
refrigerated centrifuge when
processing blood.

5. Medical Technologist
Store blood units in proper storage
6. Distribute/Issue blood units equipment until release.

6. Medical Technologist
Refer to PG Packing and Transport of
End
Blood Units.

8. DOCUMENTATION (Reports, Worksheets)

a. Blood Transport
b. Blood Quarantine Records
c. Daily Blood Inventory
d. Equipment Temperature Monitoring Chart

86
 Pretransfusion Testing (Routine)

1. INTENDED USE

To guide the Blood Stations 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

a. BT Check – refers to checking the 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

a. Pathologist – supervises the work process of the blood service

facility; ensures that GMP is practiced all the time

b. 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

a. Ensure that appropriate quality control is performed with reagents

and blood products. Refer to Work Instruction on Quality Control of
Immunohematology Reagents.

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

c. Inform the pathologist- or hematologist-on-board of any difficult

problems encountered during pre-transfusion testing. The attending

87
 physician is also informed so that alternative clinical intervention may
be administered, if any.

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

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

e. 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.

6. WORKFLOW DIAGRAM
RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start
1. Medical Technologist
● Check completeness of
1. Receive request for information on the request. Seek
blood/crossmatch clarification if necessary.
● Determine the urgency of the
2. Collect sample for request, STAT/Emergency, or
compatibility testing Routine.
● Take note of special instructions
or preparation, if any (timing of
release, aliquots, irradiated, etc.).

2. Phlebotomist
3. Check the label sample • Check all the data at the blood
against the blood and request, crossmatch and sample
crossmatch requests if all are the same.
• Ensure positive identification of
the patient when collecting blood
samples.
Sample and
requests are NO
acceptable? • Refer to Guidelines on Positive
Identification of Patient and
Sample Collection

YES 3. Medical Technologist

● In case of unacceptable and
A incompletely labeled samples,
repeat the collection of samples.
● Note and record any unacceptable
samples

88
 A 4. Medical Technologist
●Resolve any discrepancy
between the results of the tests
4. Perform blood grouping on with serum or plasma and red
patient’s sample cells before recording an
interpretation of the patient’s
group

ABO
Discrepancy NO

Resolve
discrepancy

YES
5. Medical Technologist
● If antibody screening is
5. Perform antibody screening positive, identify a specific
antibody. Select antigen-
negative unit.
● In case the patient does not
wish to continue further
Positive AB workup, document
screening YES communications in the
patient’s chart
6. Medical Technologist
Identify
method ● Crossmatched-compatible
unit for red blood cell units
NO ● Types-specific for plasma
component
7. Medical Technologist
6. Select appropriate blood ● Perform blood typing of donor
unit prior to crossmatch
● If no compatible unit is
available, refer to a
7. Perform crossmatch pathologist/hematologist on
board and inform the
attending physician
A

89
 A

Compatible? NO

Investigate.
Inform attending
physician

YES
8. Medical Technologist
● Ensure that results of the test
8. Update all records results are accurately recorded in
the following documents:

● Patient transfusion record

● Master logbook
End ● BBIS

7. DOCUMENTATION (Forms, Worksheets)

a. Blood Request for Adult Patients

b. Blood Request for Pediatric Patients

c. Crossmatching Report

d. Patient Transfusion Record

e. Blood Transfusion Reaction Registry Form

90
 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
● Marking pen
● Quality Control Data Sheet
● Quality Control Reagent Sheet

4. QUALITY CONTROL

Calibrated serologic centrifuge

5. PROCEDURE:

91
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.
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.

92
 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

● 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.

93
 Preparing Laboratory Red Cells Solution

1. INTENDED USE

To guide the Blood Stations 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

units
● 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

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.

94
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
● Date and type prepared
● Date and time of expiration
● Storage temperature
● Name of the medical technologist who prepared the red cell
solutions

95
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.

96
 BLOOD STATION 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 mm Hg
systolic
( ) WB-2 : Others. Please specify. (This code will automatically trigger a
review of your indication.) ___________________________

( ) Packed RBC (approx. volume 250 ml)

( ) R - 1: Hgb less than 8 g/dl or Hct less than 24% (if not due to
treatable cause)
( ) R - 2: Patients receiving general anesthesia if:

97
 a) Preoperative Hgb less than 8 g/dl or Hct less than 24%
b) Major blood operation and Hgb 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

( ) 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

98
 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: Document platelet count before (within 8 hours) and after (within 1
hour) Transfusion
Dose: 1 unit/10 kg. BW with a maximum of 8 units

( ) Cryoprecipitate (approx. volume 20 ml)

( ) C - 1: Significant hypofibrinogenemia ( < 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) ___________________

( ) 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

99
( ) 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 FFP
No. of Units needed : _____________________________

Requesting Physician/Consultant : _______________________________

Resident – In – Charge : _______________________________

Reviewed and Endorsed by : _______________________________

Received by: ________________ Date/ Time: ___________________

(Blood Bank Staff)

Revised 10 Sept 2003

NVBSP BB-06
Cc: Source BLOOD STATIONS

100
 BLOOD STATIONS 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: _______________

101
( ) Packed Red Cell

( ) Hypovolemia from acute blood loss with signs of shock or anticipated blood
loss of >10%

( ) 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

102
( ) 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: _______________________________

103
No. of Units needed : ________Volume: __________No. of Aliquot: _________

Requesting Physician/Consultant : _______________________________

Resident – In – Charge : _______________________________

Reviewed and Endorsed by : _______________________________

(Hema fellow –on-duty)

For Blood Bank use only:

Received by: ____________________ Date/ Time:___________________

Revised 10 Sept 2003 #1

NVBSP BB-03

104
Positive Patient Identification and Sample Collection

1. GUIDELINES

1.1 Identify the patient using two patient identifiers. Compare the name
on the blood requisition with the patient's hospital armband. If the
patient does not have an armband, the specimen must not be drawn
until the patient is banded.
1.2 In an emergency situation, when the patient's identity is unknown, an
emergency identification number or a temporary band should be
attached to the patient.
1.3 Blood samples must be drawn into stoppered tubes.
1.4 Label the sample in the presence of the patient. Minimum information
required includes:

● Patient's full name

● Identification number
● Date, time, and identity of the individual drawing the specimen

2. INTENDED USE:

To determine the ABO and Rh group as part of the pre-transfusion testing.

3. PRINCIPLE
Every unit of blood intended for transfusion must be tested for ABO and Rh.
Routine tests on donors and patients must include both red cell and serum
tests. Tests that use anti-A, anti-B, and anti-D to determine the presence or
absence of the antigen/s are often described as direct or forward typing or
red cell tests. The use of reagent A1 and B cells in serum or plasma is called
indirect or reverse typing or serum testing.

For infants less than 4 months of age, forward or red cell testing only is
permissible.

Previous record/s of a donor’s ABO & D results must not be used for labeling
a unit of blood.

4. MATERIALS / EQUIPMENT

● Buffered 0.9% saline

105
 ● Typing sera
o Anti-A

o Anti-B

o Anti-A,B (optional)

o Anti-D

o 6% bovine albumin (optional)

o A1 cells

o B cells

● Test tubes
● Serologic centrifuge
● Pipettes

5. SPECIMEN

Whole blood

6. QUALITY ASSURANCE/CONTROL

a. Daily quality control of reagents

b. Calibrated serologic centrifuge

7. PROCEDURE

7.1 Prepare 2% to 5% red cell suspension of donor cells in buffered

saline.
7.2 Label five (5) to seven (7) clean test tubes as anti-A, anti-B, anti-A, B
(optional), anti-D, Rh control (optional), A1 cell, and B cell.
7.3 Place 1 drop of anti-A in a clean, labeled test tube.
7.4 Place 1 drop of anti-B in a clean, labeled test tube.
7.5 Place 1 drop of anti-A, B in a clean, labeled test tube (if tests are to
be performed with this reagent).
7.6 Place 1 drop of anti-D in a clean, labeled test tube

106
 7.7 Place 1 drop of 6% bovine albumin in a clean, labeled test tube
7.8 Add 1 drop of a 2% to 5% red cell suspension to be tested to tubes
labeled as anti-A, anti-B, anti-A, B, and anti-D & Rh control.
7.9 Add 2 drops of serum/plasma to tubes labeled as A1 cell and B cell.
7.10 Add 1 drop of A1 cells to the tube labeled A1 cell.
7.11 Add 1 drop of B cells to the tube labeled B cell.
7.12 Mix the contents of all tubes gently and centrifuge them for the
calibrated spin time.
7.13 Gently re-suspend the cell buttons and examine them for
agglutination.
7.14 Read, interpret, and record the test results.

8. 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

9. INTERPRETATION

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

10. PROCEDURAL NOTES

a. The ‘tilt and wiggle’ method of resuspension is ideal.

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

results.

c. If using commercially prepared known cells, cells should be placed first

in the test tubes before the serum/plasma to avoid contamination.

d. For other platforms: follow the manufacturer’s instructions.

107
 Blood Grouping in Infants 0-6 Months Old

1. INTENDED USE

To determine the ABO and Rh group of less than 6-month old patients

2. PRINCIPLE

Antigen-antibody reaction.
Tests that use anti-A, anti-B, and anti-D to determine the presence or
absence of the antigen/s as direct or forward typing or red cell tests. To test
the blood of infants less than 6 months of age, forward or red cell testing
only is permissible.

3. SPECIMEN

● Whole blood

● Anti-coagulated sample

4. MATERIALS

● Buffered 0.9% saline

● Typing sera

o Anti-A

o Anti-B

o Anti-A,B (optional)

o Anti-D

o 6% bovine albumin (optional)

● Test tubes

● Pipettes

● Serologic centrifuge

5. QUALITY CONTROL

108
 5.1 Daily quality control of reagents

5.2 Calibrated serologic centrifuge

6. PROCEDURE

6.1 Prepare 2% to 5% red cell suspension of donor cells in buffered saline.

6.2 Label three (3) to five (5) clean test tubes as anti-A, anti-B, anti-A, B
(optional), anti-D, and Rh control (optional).

6.3 Place 1 drop of anti-A in a clean, labeled test tube.

6.4 Place 1 drop of anti-B in a clean, labeled test tube.

6.5 Place 1 drop of anti-A, B in a clean, labeled test tube (if tests are to be
performed with this reagent).

6.6 Place 1 drop of anti-D in a clean, labeled test tube

6.7 Place 1 drop of 6% bovine albumin in a clean, labeled test tube

6.8 Add 1 drop of a 2% to 5% red cell suspension to be tested to tubes

labeled as anti-A, anti-B, anti-A, B, and anti-D & Rh control.

6.9 Mix the contents of all tubes gently and centrifuge them for the
calibrated spin time.

6.10 Gently re-suspend the cell buttons and examine them for
agglutination.

6.11 Read, interpret, and record the test results.

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

109
8. INTERPRETATION

● Trace to 4+ means incompatible

● 0 or negative means compatible

9. PROCEDURAL NOTES

a. Tilt and wiggle method of resuspension is ideal.

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

results.

c. For other platforms: follow the manufacturer’s instructions

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)

110
 ● Refrigerator

● Pipettes

5. QUALITY CONTROL

a. Daily quality control of reagents

b. Calibrated serologic centrifuge

6. PROCEDURE

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

● recent transfusion
● recent transplantation
● patient’s medications

e. For problems with forwarding typing, follow these steps:

i. Wash the patient’s red cells 3 – 4 times with buffered saline.
ii. Prepare 2 - 5% red cell suspension in buffered saline and
repeat the tests with anti-A and anti-B.
iii. If the problem is the 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

111
 iv. 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

f. For problems with reverse typing, follow these steps:

i. If the problem is the 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
● Increase the amount of serum or plasma to 4 drops instead
of 2 drops

ii. If the problem is extra reactions in reverse typing:

● Perform prewarm 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)

112
 ● Newborn or immunocompromised

● Subgroups

● Disease process

b. Problems with forwarding Grouping (extra)

● Acquired B

● Rouleaux

● Mixed-field agglutination

● Polyagglutinable cells

c. Problems with Reverse Grouping (weak or missing)

● Newborn or immunocompromised

● 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.

113
 Reverse Typing of Blood Components

1. INTENDED USE

To guide the Blood Stations 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

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.

114
 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

9. PROCEDURAL NOTES:

When commercial cells are used, drop the cells first before the plasma to
avoid contamination.

115
 Crossmatch

1. INTENDED USE

To select blood component/s that will have acceptable survival when

transfused and will not cause harm to the recipient.

2. PRINCIPLE

Antigen-antibody reaction is performed to prevent transfusion of

incompatible donor cells from preventing immune-mediated transfusion
reactions.

3. MATERIALS / EQUIPMENT

● Buffered 0.9% saline

● Donor red cells
● Enhancement medium
● Antihuman globulin
● Check cells
● Test tubes
● Serologic centrifuge
● Incubator (dry bath or water bath)
● Pipettes

4. SPECIMEN

Serum or plasma

5. QUALITY CONTROL

a. Perform daily quality control of reagents.

b. Ensure regular calibration of the serologic centrifuge.

6. PROCEDURE

6.1. Prepare 2% to 5% red cell suspension of donor cells in buffered

saline.

6.2. Label a tube for each donor red cell unit/s.

116
6.3. Add two (2) drops of patient’s serum or plasma to each tube/s.

6.4. Add one (1) drop of 2% to 5% donor red cell suspension to the
appropriate tube/s.

6.5. Mix the tube contents.

6.6. Centrifuge according to the calibration of the serologic 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 and record results.

6.9. Add two (2) drops of enhancement medium.

6.10. Mix the tube contents.

6.11. Centrifuge according to the calibration of the serologic centrifuge.

6.12. Examine the tube/s for hemolysis. Gently re-suspend the red cell
button/s and check for agglutination.

6.13. Read macroscopically and record results.

6.14. Wash the red cells three (3) to four (4) times with buffered saline and
completely decant at the final wash.

6.15. Blot the test tube with a clean gauze or paper towel to remove all the
buffered saline. Make sure only the red cells are left in the tube.

6.16. Add two (2) drops of AHG reagent.

6.17. Mix the tube contents.

6.18. Centrifuge according to the calibration of the serologic centrifuge.

6.19. Examine the tube/s for hemolysis. Gently re-suspend the red cell
button/s and check for agglutination.

6.20. Read macroscopically and with the help of the optical lens.

6.21. Grade and record the results.

117
 6.22. If there is no agglutination, confirm the validity of negative AHG
results by adding one (1) drop of O check cells.

6.23. Mix. Centrifuge according to the calibration of the serologic

centrifuge.

6.24. Read macroscopically and record the results.

6.25. Result must be 2+. If results are still negative, repeat the cross-match
procedure.

6.26. Clean the area afterward.

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

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

9. PROCEDURAL NOTES

9.1 Technique:
● Tilt and wiggle method of re-suspension is ideal.

● Excessive shaking or tapping of the tubes may yield false-

negative results.

● For other platforms, follow the manufacturer’s instructions.

9.2 To avoid clerical errors:

● The request form and the sample label should bear the
name of the initials of the phlebotomist.

118
 ● The blood group of the bag being issued should be re-
checked by testing the sample from the donor tubing
attached to the bag.

● Barcoding should be used whenever applicable or

feasible.

10. REFERENCE

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

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

Crossmatch (Neonates)

1. INTENDED USE

To guide the Blood Stations technical staff in selecting blood component/s

that will have acceptable survival when transfused and will not cause harm
to the recipient.

2. PRINCIPLE

Antigen-antibody reaction is performed to prevent transfusion of

incompatible donor cells from preventing immune-mediated transfusion
reactions.

3. SPECIMEN

● Mother’s sample

● Baby’s sample

● Serum or plasma

4. MATERIALS / EQUIPMENT

● Buffered 0.9% saline

● Donor red cells

● Enhancement medium

119
 ● Antihuman globulin

● Check cells

● Test tubes

● Serologic centrifuge

● Dry bath incubator

5. PROCEDURE

5.1 Prepare 2% to 4% red cell suspension of donor cells in buffered

saline.

5.2 Label a tube for each donor red cell unit/s.

5.3 Add 2 drops of patient’s serum or plasma to each tube/s.

5.4 Add 1 drop of 2% to 4% donor red cell suspension to the appropriate

tube/s.

5.5 Mix. Centrifuge according to the calibration of the serologic

centrifuge.

5.6 Examine the tube/s for hemolysis, gently re-suspend the red cell
button/s, and check for agglutination.

5.7 Read macroscopically and record results.

5.8 Add 2 drops of enhancement medium.

5.9 Mix the tube contents. Incubate at 37oC following manufacturer’s

insert.

5.10 Centrifuge according to the calibration of the centrifuge.

5.11 Examine the tube/s for hemolysis, gently re-suspend the red cell
button/s, and check for agglutination.

5.12 Read macroscopically and record results.

5.13 Wash the red cells 3 to 4 times with buffered saline and completely
decant the final wash.

120
 5.14 Blot the test tube in a clean gauze or paper towel to remove all the
buffered saline. Make sure only the red cells are left in the tube.

5.15 Add 2 drops of AHG reagent.

5.16 Mix the tube contents. Centrifuge according to the calibration of the
serologic centrifuge.

5.17 Examine the tube/s for hemolysis, gently re-suspend the red cell
button/s, and check for agglutination.

5.18 Read macroscopically and with the help of the optical lens.

5.19 Grade and record the results.

5.20 If there is no agglutination, confirm the validity of negative AGH

results by adding 1 drop O check cells.

5.21 Mix the tube contents. Centrifuge according to the calibration of the
centrifuge.

5.22 Read macroscopically and record the results.

5.23 Result must be 2+. If the results are still negative, repeat the cross-
match procedure.

5.24 Clean the area after.

6. RESULTS

● 4+ if 1 solid agglutinate

● 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

121
7. INTERPRETATION

Trace to 4+ means incompatible

0 or negative means compatible

8. PROCEDURAL NOTES

a. PRBC for Neonatal Transfusion must be:

● Less than 5 to 10 days old

● Leuko-reduced

● Crossmatch is compatible with both mother and baby

● Red cell antigen-negative for maternal clinically significant

antibody

● Irradiated (if immunocompromised)

b. Plasma products for Neonatal Transfusion:

● Type-specific for the neonates

c. Tilt and wiggle method of resuspension is ideal.

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

results.

122
 BLOOD STATIONS Name

CROSSMATCHING REPORT

Date: _____________ Hospital No.:________________

Name of Patient:__________________________________________________
Surname First Name Middle Name
Age:_________ Sex:__________ Blood Type: ___________
Ward: _________ Room #_________ Department: _________________

Blood Unit Serial Number ________________ Expiry Date:__________

Blood Type ABO/Rh ______________ Issued by:______________________

Type of Component:
( ) Whole Blood ( ) Platelet Concentrate
( ) Red Blood Cells ( ) Cryoprecipitate
( ) Plasma ( ) Others:___________________

Result of Blood Crossmatching: ___________________________________

Comments: ___________________________________________________

Crossmatching done by: ______________________ Date/Time: ___________

(Signature over the printed name and tile)

123
 BLOOD STATION Name
DEPARTMENT OF LABORATORY
BLOOD BANK

HOSPITAL NO.
NAME
OF PATIENT BIRTHDATE

LAST FIRST MIDDLE SEX

FORWARD Rh REVERSE
BLOOD TYPE TYPING TYPING TYPING REMARKS
ANTI- ANTI- ANTI-D Du A1 B
A B

Blood SERIAL CROSS AUTO Done DATE TIME Checked Released

DATE of COMPONENT Type NUMBER MATCH CONTROL by by by
TRANSFUSION

124
 Issuance of Blood Products from Blood Stations to the
Patient Area

1. PURPOSE

This document guides the Blood Stations’ staff on the issuance of blood
and/or blood components from the Blood Stations to the patient area.

2. SCOPE AND LIMITATIONS

This procedure starts from receiving of Blood Request Form up to the

issuance of blood and/or blood components to the requesting unit.

3. MATERIALS / EQUIPMENT
● Pen

● Gloves

● Plasma Freezer

● Masking Tape

● Logbook

● Platelet Agitator

● Blood Bank Refrigerator

● Blood transport bag

4. RESPONSIBILITIES
Medical Technologist – validates and ensures that blood and blood
components are dispensed with maximum accuracy according to
specifications in the blood request form.

5. DEFINITIONS

a. Blood Request Form – form issued by the requesting physician

indicating the blood/blood component needed by the patient

125
 b. Nursing unit – the end-user of blood and blood products.

6. WORKFLOW DIAGRAM

126
7. DOCUMENTATION (Forms, Worksheets)

● Blood Release Order

● Blood Request Form

● Blood Bank Master Logbook

127
 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 bank 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 Stations 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

● Records indicate that the blood has been re-issued and

has been inspected before re-issuance.

2. REFERENCES

American Association of Blood Banks 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

128
 Validation of Blood Units Prior to Issuance

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

2. PRINCIPLE
A 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 Bank 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

● Name and signature of the nurse

129
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 Bank 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 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

o Label products modified by open method

systems with ‘TRANSFUSE WITHIN 24 HOURS’

130
 ● 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 Bank 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)

o Date and time of issue

131
● 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 bank
master logbook. The date and time of
release must also be indicated.

4.10.3 File and maintain records.

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 Blood Administration Procedural Guideline

1. GUIDELINES

1.1 Identify the patient.

1.2 Check the physician’s order for the type of transfusion.

1.3 Check with the patient or chart for any history of:

a. Allergy

b. Previous blood transfusions

c. Reason for current order for blood transfusion

1.4 Check consent for blood transfusion.

1.5 Check if the patient understands the procedure and the reason for it.

1.6 Discuss possible signs and symptoms and the importance of

reporting such (e.g., rash, itchiness, chills, chest pain, lumbar pain,
etc.)

1.7 Check IV site for patency. Inspect for phlebitis.

1.8 Set up the blood administration set. Ensure that the mainline IV is
normal saline.

1.9 #10 or #20 gauge catheter should be used for blood transfusion.

1.10 Confirm the following before hooking the blood unit:

● Patient’s name

● Patient’s armband

● Blood group and type

● Expiration date

● Clots

1.11 Obtain vital signs prior to starting transfusion.

1.12 Start the transfusion slowly (25-50 mL in the first 15 minutes).

133
 1.13 Stay at the bedside for the first 15 minutes to assess for any signs
of transfusion reaction. Recheck vital signs.

1.14 Infuse the remainder of the transfusion as per the doctor’s order.
The length of transfusion should not be more than 4 hours to avoid
the risk of bacterial contamination.

1.15 If a transfusion reaction is suspected:

a. STOP the transfusion immediately.

b. Change IV line to Normal Saline only.

c. Call the physician in charge immediately.

d. Check the patient’s vital signs every 5 minutes and observe for
signs and symptoms.

e. Complete the blood transfusion record and send the incriminated

unit to the blood bank for investigation.

f. Defer future transfusions until the investigation has been

completed.

2. REFERENCES

American Association of Blood Banks 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

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 BLOOD STATION Name
BLOOD TRANSFUSION RECORD
(Adult)

Date: Hospital No.:

Name of Patient:
Surname M.I. First Name Age: Sex: DOB
:

Clinical Diagnosis: Room #:

Blood Unit Serial No.:
Blood Type:
Component:
Expiration (Date/Time):

TRANSFUSION RECORD

VITAL SIGNS
Pre- During Transfusion Post-
Transfusion Transfusion
After 15 min After 1 hour After 2 hours VS
VS Signature VS Signature VS Signature VS Signature VS Signature
Blood Unit T
1
RR

PR
BP
Blood Unit T
2
RR
PR
BP
Blood Unit T
3
RR
PR
BP
Transfusion reaction Yes: No:
noted?
If yes, date/time of blood transfusion
reaction:
IN CASE OF TRANSFUSION REACTION, INFORM BLOOD BANK & ACCOMPLISH BLOOD
TRANSFUSION REACTION FORM
Do the details on the patient’s armband/nametag, blood bag, and the information on this slip
correspond?

Checked by nurse and/or physician (2 persons):

Volume
Released by:
Received by:

135
 Date/Time
Blood Transfused by:
NOD:
ROD:

Date/Time:
No. of hours
consumed:

136
 BLOOD STATION Name
BLOOD TRANSFUSION RECORD
(Pediatric)

Date: Hospital No.:

Name of Patient: Age: Sex: DOB:
Surname First Name M.I.

Clinical Diagnosis: Room #: Ward:

Blood Unit Serial
No.:
Blood Type:
Component:
Expiration
(Date/Time):

TRANSFUSION RECORD
Do the details on the patient’s armband/nametag, blood bag, and the information on this slip
correspond?

Checked by nurse and/or physician (2 persons):

1st Aliquot 2nd Aliquot 3rd Aliquot
Volume
Released by:
Received by:
Date/Time
Blood Transfused by:
NOD:
ROD:
(Signature over printed (Signature over printed (Signature over printed
name) name) name)
Date/Time:
No. of hours
consumed:

VITAL SIGNS
Pre- During Transfusion Post-
Transfusion Transfusion
After 15 min After 1 hour After 2 hours VS
VS Signature VS Signature VS Signature VS Signature VS Signature
Aliq 1 T
RR
PR
BP
Aliq 2 T
RR
PR
BP

137
Aliq 3 T
RR
PR
BP
Transfusion reaction Yes: No: ____
noted? ____
If yes, date/time of blood transfusion ______________________________________
reaction:
IN CASE OF TRANSFUSION REACTION, INFORM BLOOD BANK & ACCOMPLISH BLOOD
TRANSFUSION FORM

138
 Investigating BT Reactions

1. PURPOSE

To improve the efficiency of documentation and reporting of blood

transfusion complications and reactions.

2. SCOPE AND LIMITATIONS

The procedure begins with reporting a blood transfusion complication or
reaction to documentation and reporting steps or measures implemented to
appropriately manage the blood transfusion complication or reaction.
Patients or relatives of patients may refuse the investigation for blood
transfusion complications and reactions.

3. DEFINITIONS

Blood transfusion reaction - Any adverse reaction following the infusion of

blood or blood component.

4. RESPONSIBILITIES
a. Transfusionist – an anesthesiologist, physician, or nurse in charge of
administering blood

b. Attending physician – responsible for managing blood transfusion

reactions

c. Blood bank personnel – performs compatibility testing on pre-

transfusion and post-transfusion samples when a blood transfusion
reaction is reported

d. Pathologist – in charge of the quality of the procedures done in the blood

bank

5. RISK MANAGEMENT

a. Ensure that required clinical and laboratory data are complete,

accurate, and reliable.

b. The transfusing unit should provide the blood bank with a copy of all
blood transfusion records duly signed by the physician in charge.

139
 c. Prioritization of laboratory tests is recommended to allow early
detection and initiate timely clinical intervention if there are difficulties
in obtaining blood samples post-blood transfusion or limited
resources to complete the work-up.

6. WORKFLOW DIAGRAM

140
A

141
 Suspected Hemolytic Transfusion Reaction

1. GUIDELINES

1.1 If there are signs, symptoms, or findings suggestive of a hemolytic

transfusion reaction, blood transfusion MUST BE DISCONTINUED
IMMEDIATELY

1.2 The following measures must be taken immediately.

1.3 Records must be completely filled up and maintained.

1.4 The label on the blood container and all other related records should
be checked to detect if there has been an error in identifying the patient
or the blood unit.

1.5 A properly labeled post-transfusion blood sample should be obtained

from the patient along with the blood container and attached blood
transfusion set.

1.6 The patient’s post-blood transfusion reaction serum or plasma should

be inspected for evidence of hemolysis, preferably comparing it with
the pre-blood transfusion sample.

1.7 A direct antiglobulin test (DAT) should be done on the post-blood

transfusion blood sample, comparing it with the pre-blood transfusion
blood sample.

1.8 Based on the evaluation of clinical findings, review of the accuracy of

records and results of laboratory tests, additional tests should be done,
including:

a. Determination of ABO and Rh (D) types on pre and post-blood

transfusion samples from the patient and from the blood bag.

b. Repeat tests for unexpected antibodies in donor and recipients’

blood and repeat crossmatch using pre and post-blood
transfusion reaction samples of the patient and the donor blood
from the bag.

c. Examination of post-blood transfusion urine should be carried

out for hemoglobin and its metabolites.

142
 d. Determination of bilirubin concentration in serum should be
obtained preferably 5 to 7 hours after the blood transfusion.

e. Supernatant plasma and remaining blood in the blood

container, as well as the post-blood transfusion sample of the
patient, should be tested for smear and culture. Expired blood
units should be tested periodically for bacteriological smear and
culture.

1.9 If investigations are suggestive of a hemolytic reaction or bacterial

contamination, the patient’s physician should be informed
immediately.

1.10 Another medical technologist in the blood bank, aside from the
phlebotomist, performs the clerical check.

Work Up for Blood Transfusion Reaction

1. INTENDED USE

To guide the Blood Stations technical staff in investigating and documenting

unfavorable transfusion-related events that may occur in a patient during or
after transfusion of blood or blood products.

2. PRINCIPLE

To determine if the blood transfusion reaction is either immune-mediated or

non-immune-mediated type and find out the specific type of BTR.

3. SPECIMEN

● Patient’s plasma or serum sample (pre and post-transfusion)

● 1st morning voided urine sample after BTR

● 5th-hour void urine sample after BT

● EDTA sample for DAT, pre, and post-BTR

4. MATERIALS / EQUIPMENT

● Blood transfusion record

143
 ● Blood transfusion reaction registry (filled up)

● Crossmatch result form (for red cells transfusion) or

● Reverse group result (for plasma products transfusion)

● For checking hemolysis:

o Urine hemoglobin

o Bilirubin

● For DAT:

o Test tube

o Antihuman globulin reagent

o Check cells

o Serologic centrifuge

5. QUALITY CONTROL

● Daily QC of blood banking reagents

6. PROCEDURE

6.1 Record calls from the ward notifying the blood bank of a blood
transfusion reaction.

6.2 Issue BTR registry form to the midwife-on-duty or nursing attendant-

on-duty.

6.3 Receive the properly filled BTR Registry form together with the Blood
Transfusion Record, unit, and blood and urine samples. Follow-up
submission of BTR, BT forms, unit/s, and samples in case there is a
delay in submission from the ward.

6.4 Perform the BTR investigation by following these steps:

6.4.1 Clerical check on the BT and BTR Registry forms and the
blood unit/s.

6.4.2 Check for signs of hemolysis by:

144
 ● comparing the samples, pre, and post-transfusion

● determining indirect bilirubin, 1hr & 2hr post-BTR

● determining urine hemoglobin, 1hr & 5hr post-BTR

6.4.3 Perform DAT.

6.5 Repeat form the following tests if anyone among the 6.4.1 to 6.4.3
is positive by following these steps using both the pre and post BTR
samples:

● blood typing

● antibody screen

● crossmatch

6.6 Log all the results in the BTR Registry form.

7. RESULTS

Clerical check - With or without clerical error

Sign of hemolysis - With or without sign of hemolysis
DAT - Negative, mixed field, or positive

8. INTERPRETATION

a. Indirect bilirubin result. Compare the pre and post-sample if there

is an increasing result.

b. Urine hemoglobin result. If positive, compared with the pre-

transfusion sample (if applicable)

c. DAT result:

● Negative – repeat after 6 hours; maybe nonimmune

● Mixed field – transfused cells have been coated with antibodies but not
immediately destroyed

● Positive – perform DAT to the pre-transfusion sample

145
 Blood Station 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 Bank USE

Blood Bank notified: Date & Time : _______________________

BTR form received: Date & Time : _______________________

Amount Volume
Blood Unit No. Source Component
Transfused Returned

146
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.

Visible Hemolysis / Color Bilirubin Urine

of serum or plasma Hgb

Pre-
Transfusion
Post-
Transfusion
1st void

5th hour

1st hour

2nd hour

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:

147
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

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 2 oC temperature

rise)
a. Bacteriology Specimen: Blood segment / Bag for:

● Gram’s Stain ________________________________

● Culture ________________________________
7 . Additional tests: ________________________________

148
 ● If there is evidence of hemolytic reaction, notify Blood Bank
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.

149
 Blood Station 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 Bank USE

Blood Bank notified: Date & Time : _______________________

BTR form received: Date & Time : _______________________

Amount Volume
Blood Unit No. Source Component
Transfused Returned

150
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.
Visible Hemolysis / Color Bilirubin Urine
of serum or plasma Hgb

Pre-
Transfusion
Post-
Transfusion
1st void

5th hour

1st hour

2nd hour

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:

151
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

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 2 oC temperature

rise)
b. Bacteriology Specimen: Blood segment / Bag for:

● Gram’s Stain ________________________________

● Culture ________________________________
7 . Additional tests: ________________________________

152
 ● If there is evidence of hemolytic reaction, notify Blood Bank
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.

153
 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

a. 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.

154
 ● Infectious wastes – human blood and blood products,
isolation waste, pathological waste, contaminated
animal waste, and discarded sharps (broken bottles,
needles, scalpels, etc.).

b. 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

a. Blood units

● Whole blood

● Plasma

● Platelets

● Cryoprecipitate

b. Aliquot

● Plasma

● Serum

5. MATERIALS / EQUIPMENT

● Supplies

o Absorbent Paper
o Biohazard Bags
o Discard Bin
o Gloves
o Goggles
o Laboratory gowns
o Mask
o Twist Tie

155
 o 5% Sodium Hypochlorite/70% alcohol
o Distilled water

● Equipment
o Autoclave Machine

6. RESPONSIBILITIES

a. Director/BLOOD STATIONS Head – ensures the provision of the

necessary resources to fully implement and maintain proper disposal
of infectious and hazardous wastes.

b. Department Head – ensures that laboratory personnel performing

this procedure are qualified and have been trained in Biosafety
procedures and Wastes Disposal Management.
c. Unit Supervisor – ensures that this procedure is strictly done
according to the Biosafety Manual and identifies possible errors for
corrective and preventive actions.

d. 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

7.1.1 Needle prick/broken tubes injury (refer to Infectious Control

Manual)

7.1.2 Splashes to the mucous membrane (refer to Infectious Control

Manual)

7.1.3 Sample spillage (refer to Infectious Control Manual)

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

156
 ● A user’s logbook to record autoclave usage should be maintained
for inspection and monitoring of its operation.

7.3 Safety Precautions

a. No person may receive, possess, and dispose of wastes unless

the person has technical qualifications, including Biosafety and
Wastes Disposal training and experience.

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

always be worn when handling Biohazard Wastes to avoid
transmission of viral and other infectious diseases.

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

d. Biological waste must be rendered non-infectious prior to final

disposal in a landfill.

e. Autoclaving is the preferred method of decontamination of

infectious blood units and other biohazard agents.

f. Any deviation from the procedures outlined shall be recorded and

reported using the non-conformance report form.

157
8. WORKFLOW DIAGRAM

158
9. DOCUMENTATION (Reports, Worksheets)

List of discarded/disposed blood units and aliquots

Autoclave User’s Logbook

Autoclave Quality Control Chart

159
 List of Disposed Blood Units and Samples

Type of Waste (Blood Serial # Date extracted Date of disposal Remarks

Unit /Sample) (if blood unit) (Reactive or Expired)

Prepared by: Checked by:

__________________________ __________________________
(Signature over printed name) (Signature over printed name)

Autoclave User’s Logbook

Date of Type Pressure Temperature* Duration* Amount Operator’s Signatu

Treatment of * * ** of Name re
Waste Waste
Treated

*Minimum pressure: 15psi

**Minimum temperature: 1210C
***Minimum duration of treatment: 30 minute

160
 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 STATIONS 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.

161
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

162
 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.

163
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
STATIONS, 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 solutions 1 are

164
 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.

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.

165
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
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

166
 "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.
● False Positive- confirmed negative specimen incorrectly
identified as positive.

b. Acronyms

● BSF- 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

167
 9. WORKFLOW DIAGRAM

9.1 Registration to RITM TTI-NRL NEQAS

A
1. Supervisor/CMT
• New participants:
- Receive e-mail from TTI-NRL for
YES New Participant NO confirmation of approved
application.
- Receive username and password
from OASYS via e-mail.
Receive e-mail from - Log in to the OASYS account to
TTI-NRL for Renew OASYS
confirmation of Account verify and edit the needed
application information (e.g.,
machines and testing kits,
laboratory user, laboratory
profiles – primary, billing,
Receive username
shipping, reporting contact, etc.)
and password from
OASYS via e-mail
• Old/Existing participants:
- Renew the OASYS account once
Log in to OASYS payment and necessary forms are
account received by TTI-NRL.

End

168
9.2 On-line registration to Oneworld Accuracy System (OASYS)

RESPONSIBLE PERSON/
FLOWCHART
DESCRIPTION OF ACTIVITY

Start
1. Supervisor/Chief Medical
Technologist
1. Receive Test Event
Reminder • 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. Update user’s name 2. Supervisor/Chief Medical
Technologist (CMT) or designated
MT
• Perform the following procedures to
update the user's name 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 Station’s ID or
Search Blood Stations by clicking
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
A necessary data. Click the “Next”
button after completing the data
- Click the “Submit” button.

169
 A 3. Supervisor/CMT or designated MT
• Performs the following procedures to
update instruments (equipment) in
case a new instrument will be used for
3. Update instruments in use
testing.
- On the home page, open the
Profile menu and click the
“Instruments” tab
- Click the “Add” instrument button
- Select the Manufacturer and
Model of the Instrument
- Click Submit
4. Update new reagents and
assay in use
4. Supervisor/CMT or designated MT
• Perform the following procedures to
update reagents and assay in case a
new test kit will be used for testing.
Updating of reagent kits and assays
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
End Processor, click yes and choose
the Instrument Model in the
dropdown box.
- Click the “Submit” Button

170
 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
1. NEQAS panel samples NEQAS panel samples from RITM TTI-
NRL.

2. Inform the TTI-NRL of the 2. Designated MT

EQAS panel date and time of • Inform the TTI-NRL staff of the DATE
receipt AND TIME OF RECEIPT through text,
email, or phone call.

3. Inspect the completeness 3. Designated Proficient MT

and integrity of EQAS panel • Upon receipt, inspect for the
samples completeness and integrity of the EQAS
samples.
4. Store the EQAS samples at
4°C 4. Designated Proficient MT
• Store the EQAS samples at 4°C until the
test event opens.
5. Read and follow EQAS
General Instructions
5. Designated Proficient MT
• Read, follow and understand the written
general instructions accompanying the
EQAS samples. (Refer to General
6. Perform the test procedure Instructions HVHT4320 and MLRA415)
on the pane sample
6. Designated Proficient MT
• Perform the test procedures on the panel
samples in the same manner as the test
procedures routinely used in the Blood
Service Facility. (Refer to Quality
A Procedure (QP) on TTI Serology Testing)

171
 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 the
encode results 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 8. Designated Proficient MT

encoded results to RITM
• Submit a hardcopy of the encoded
TTI-NRL results duly signed by the technologist
who performed the test to RITM TTI-
NRL thru e-mail or courier.

End

172
 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.

2. Review NEQAS results as 2. Supervisor/CMT

compared with Preliminary
• Review NEQAS results by
Reference Results
comparing them with the Preliminary
Reference Results.

3. Supervisor/CMT
With aberrant results? • Wait for the issuance of the
proficiency certificate if an Excellent
or Very Satisfactory rating was
achieved.
3. Wait for the Issuance of the 4. Refer to Guidelines on
Proficiency Certificate NEQAS grading of results
4. Supervisor/CMT
• If with aberrant results, refer to RITM
TTI-NRL Guidelines on grading of
TTI Serology NEQAS results to
discern the status of results.

5. Investigate possible source

5. Supervisor/CMT assisted by
of error
Proficient MT
• Investigate the possible source of
error of unacceptable results to avoid
A the same incident from happening
once more when testing the second
NEQAS panel samples.

173
 A

With aberrant results? YES

NO 6. Supervisor/CMT
• Receive second NEQAS panel
6. Receive second NEQAS from RITM TTI-NRL.
panel
7. Designated Proficient MT
• Perform the test procedures on
7. Perform the test procedures
the second-panel samples in the
on the second panel
same manner as the test
procedures routinely used in the
Blood Service Facility. (Refer to
8. Check e-nail from RITM Manual of Standards on TTI
TTI-NRL of the blank Serology Testing procedures)
worksheets
8. Designated Proficient MT
9. Encode results and final • Check the e-mail from RITM TTI-
status in the black worksheets NRL of the blank worksheets.

10. Countercheck encoded 9. Designated Proficient MT

results and final status in the • Encode results and final status in
worksheets the blank worksheets.

A
10. Designated Proficient MT 2
• Countercheck encoded results
B
and final status in the worksheets

174
 B

11. Supervisor/CMT
11. Validate and do final
review of the results • Validate and do a final review of
the results.

12. Send encoded results thru 12. Designated Proficient MT

email to tti-nrl@gmail.com
• Send encoded results thru e-mail
to tti-nrl@gmail.com.

13. Supervisor/CMT
Passed or
failed? • If passed, receive a satisfactory
rating from the RITM TTI-NRL.

13. If passed, receive a

satisfactory rating
from the RITM TTI-
A NRL

14. Receive an investigation 14. Supervisor/CMT

checklist from TTI-NRL • If failed, receives an Investigation
Checklist from RITM TTI-NRL.
(Refer to Investigation Checklist)

15. Conducts CQI and identifies

15. Supervisor/CMT
corrective/preventive actions
• Conducts Continuing Quality
Improvement and identifies
corrective/preventive actions.
End

175
10. Documentation (Reports, Worksheet)

a. Refer to the TTI-NRL website (www.tti-nrl.com)

b. Refer to www.oneworldaccuracy.com.

176
Appendices

177
 Form 1. Risk Assessment Chart
(with sample data)

Probability Human Property Business Recovery

Type of Impact Impact Impact Resources Total
of Occurrence Needed Score
Disaster
High Low High Low High Low High Low High 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

178
 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

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

179
 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
________________________________________________________________
________________________________________________________________

180
 ________________________________________________________________
Transportation
________________________________________________________________
________________________________________________________________
________________________________________________________________

Supplies
________________________________________________________________
________________________________________________________________
________________________________________________________________

Others
________________________________________________________________
________________________________________________________________
________________________________________________________________

III. Network Demand for Blood Supply

Hospital Network # of Current Potential for # of Type O RBC Non-Disaster-

Name Admissions at Expected Units on Shelf Related Need for
Hospital Admissions at Type O RBC
Hospital

181
 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:
________________________________________________________________
________________________________________________________________
________________________________________

Project 1 ________________________________________________________
________________________________________________________________

To be Procured
Activity / Existing
Purpose Quantity /
Requirements Quantity/Amount
Amount

182
Project 2 _________________________________________________________
________________________________________________________________

To be Procured
Activity / Existing
Purpose Quantity /
Requirements Quantity/Amount
Amount

183
BLOOD STATIONS Name
Department/Office:__________________________ Year : _____________________________
Program Title: ________________________________ Project ________________________________________
____________________________________ Title : ____
Delivery / Implementation Schedule
Description / Procurement
Type of Account Account Unit of Unit Estimated (Indicate quantity to be delivered per Method
Item Specification Qty.
Contract Title Code
Scope of Work
Issue Price Budget month)
J F M A M J J A S O N D

TOTAL -

Prepared by: Approvedby:

Department Head BLOOD STATIONS Head

184
 Form 5. 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 (encircle) Fit to Work Conditions:

Professional Competence

Leadership Competence

Technical Competence

Relevant Experience

Recommendation (encircle) Favorable Unfavorable

HR Manager: __________________________________________
Signature:______________________
Date: _________________________________________________

185
 Form 6: Proficiency Assessment for Blood Station Staff
(Oral and Practical Test)

NAME OF EMPLOYEE: __________________________________________

Last, First, Middle Name
DATE: ___________________
Date Hired: ___________ Inclusive Date of Training: _______________

EVALUATION CODES FOR THE TRAINING MODULE

Indicates that the Technologist has done excellent work and has
4 VERY PROFICIENT mastered the course objectives.
Indicates that the Technologist has done above average work,
3 PROFICIENT 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
2 ADVANCING mastered many of the objectives of the course.
PROFICIENCY
Indicates that the Technologist has done below average work
1 NEEDS IMPROVEMENT and has mastered a few of the objectives of the course.
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

1. Daily inventory
2. Procurement of blood from blood
centers/other BLOOD STATIONS
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:

186
Conducted and assessed by:
_____________________________
Blood Bank Section Head
(Signature over printed name)

Noted by: Date:

_______________________ _______________________
Blood Bank Head
(Signature over printed name)

187
 Form 7. 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.

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

● 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, etc.

● Demonstration of relevant professional competencies

● Demonstration of relevant technical competencies

188
 Position Applied For:
________________________________________________________________

Name of Education Experience Performance Interview Recommendation

Applicant

Name of Ratee/Position: _____________________________________

Signature: ____________________

Date: ______________

189
 Form 8. Quality Policy Issuance Monitoring

Quantity Personnel in
Department Date Issued Card Poster charge

Prepared by:

(Name and Signature of Document Controller)

Approved by:

(Name and Signature of Quality Management Representative)

190
 Form 9. Document Change Request Monitoring

DOCUMENT CHANGE REQUEST MONITORING

Date Division/
DCRF# Status
Prepared Department

Prepared by:

(Name and Signature of Document Controller)

191
 Form 10. List of Records

LIST OF RECORDS

Year Retention Manner of

Department Form Title Generated Period Disposal Remarks

Prepared by:

(Name and Signature of Document Controller)

Approved by:

(Name and Signature of Quality Management Representative)

192
 Form 11: 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

Review and Approval Signature Name Signature Date

Section Manager
Section Head
Department Manager
QA Officer
Lab Director

193
 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)

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

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 Signature Name Signature Date

Section Manager
Section Head
Department Manager

194
 Section 5: Operational Qualification (key points/criteria may be customized)

ACCEPTABLE
KEY POINTS / CRITERIA COMMENT
Yes No
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 Signature Name Signature Date

Section Manager
Section Head
Department Manager

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

195
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

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 Signature Name Signature Date

Section Manager
Section Head
Department Manager
QA Officer
Lab Director

196
 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

Review and Approval Signature Name Signature Date

Section Manager
Section Head
Department QA Officer
Department Manager

Section 8: Staff Authorization (List of Authorized Users)*

Review and Approval Signature Name Signature Date

Section Manager
Section Head
Department Manager
QA Officer
Lab Director
*Refer to the training documentation.

197
 Section 9: Validation Summary

PARAMETERS SUMMARY

Passed the environmental requirements established by the

Installation Qualifications (IQ) manufacturer. Yes / No
Passed the basic operational specifications established by
Operational Qualifications (OQ) the manufacturer.
Yes / No
All set criteria for the performance of functional specifications
Performance Qualifications (PQ) are acceptable.
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 :
REPORT FORMAT (UNITS)

REFERENCE RANGES
OTHER PERFORMANCE Result:
CHARACTERISTICS: Acceptance Criteria :
Completion of SOP, Completed and filed accordingly.
Maintenance/calibration Sheets, QC Yes / No
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 Signature Name Signature Date

Section Manager
Section Head
Department Manager
QA Officer
Lab Director

198
 Section 10: Record of Major Repairs/Pulled out by Biomedical Engineering
(Refer to attached service report/s)

Section 11: Equipment De-commissioning

1. Type of hazardous materials used in this

equipment

2. Decontamination plan 4

3. Removal of confidential information 5

4. Final disposition of the equipment 6

5. Other/s 7

Review and Approval Signature Name Signature Date

Section Manager
Section Head
Department Manager
QA Officer
Lab Director

199
 Form 12: 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

200
 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

201
202
 Form 13. 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

203
 Form 14. List of Approved Suppliers

LIST OF APPROVED SUPPLIERS

# PRODUCT NAME OF CONTACT TELEPHONE EMAIL LOCATION

SUPPLIER PERSON NO ADDRESS

204
 Form 15. Verification and Traceability of Critical Material

Verification and Traceability of Critical Material

Critical Type of Description Quantity Lot # Date of Date Date of Date Placed Date
Material Item Expiry Received/ Validation/ In-use/Sign Consumed/
Sign Sign Sign

1.

2.

3.

4.

5.

6.

7.

8.

205
 Form 16. 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

206
 Form 17. 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

207
 Form 18. Lot Validation (2)

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: _____________________________

208
 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

Prepared by: Received by:

____________________________ ____________________________
Name & Signature Name & Signature

209
 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
Name of Date of Blood
Donor Sex Address Birth Type

210
 Form 21. Registry of Regular Blood Donors

Name of
Province:
Name of City/Municipality:
Name of
Barangay/Organization:

Donations Remarks
Name of Date of Blood
Donor Purok Birth 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: _________________

211
 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:

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

212
 Form 23: Donor Satisfaction Survey

BLOOD STATIONS Name

Thank you for donating blood at (Name of BLOOD STATIONS). 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-
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 Station)?

___Nearness to place of residence ___Clean and pleasant environment

___Nearness to place of work ___Adequate facilities and equipment
___Quality of experience

213
Other reasons, please specify _________________

Would you recommend (Name of Blood Station) to your friends/family?

___Yes ___No

REMARKS/SUGGESTIONS FOR IMPROVEMENT

________________________________________________________________
________________________________________________________________
________________________________________________________________
I would like to compliment these persons:
________________________________________________________________
________________________________________________________________
________________________________________________________________

Thank you for your time!

214
 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

215
 Form 25. Internal Quality Audit Program

INTERNAL QUALITY AUDIT PROGRAM

Audit Objectives:

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Month

Planned
1. Assign
Internal Actual
Auditors

Planned
2. Prepared
budget Actual
allocation
and
schedules
for target
Blood
Stations

Planned
3. Prepare
audit Actual
checklist

Planned
4. Send audit
notice to Actual
target Blood
Stations

Planned
5. Conduct
internal audit Actual

Planned
6. Submission
of reports Actual
to
Management

216
 Prepared by:
_____________________________________
(Name and Signature)

Checked by:
_______________________________________
(Name and Signature)

Approved by:
_______________________________________
(Name and Signature)

INTERNAL QUALITY AUDIT PROGRAM

REFERENCE STANDARDS: Manual of Standards

AUDIT SCOPE: BLOOD STATIONS Quality Management System
AUDIT OBJECTIVE: To determine conformance to DOH Manual of Standards for Blood
Service Facilities
AUDIT AREA:
Audit Date:
8 SCHEDULE OF ACTIVITIES
Process Auditees Auditors
9 Time

10 (00:00H) OPENING MEETING

11 (00:00H)

12 (00:00H)

13 (00:00H)

14 (00:00H)

15 (00:00H)

16 (00:00H) Lunch Break

17 (00:00H)

18 (00:00H)

217
19 (00:00H)

20 (00:00H)

21 (00:00H) Exit Meeting

Prepared by:
_______________________________________
(Name and Signature)
Checked by:
_______________________________________
(Name and Signature)
Approved by:
_______________________________________
(Name and Signature)

218
 Form 26: QMS Audit Checklist for Blood Stations
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

8.1
8.2
22

23

24

Prepared by: Checked by

____________________________ ______________________
(Name and Signature) (Name and Signature)

219
 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:

Closing Details
References

Evidences

N.C. Closed by – Auditor: Date: Signature:

220
 Form 28: Summary of Blood Station’s Audit

Name of Facility

Classification

Date of Monitoring Date Reported

1. MANAGEMENT RESPONSIBILITIES

Positive Observations
●

Negative Observations
●

Non-conformance
●

2. MANAGEMENT OF HUMAN RESOURCES

Positive Observations
●

Negative Observations
●

221
Non-conformance
●

3. PHYSICAL FACILITIES

Positive Observations
●

Negative Observations
●

Non-conformance
●

4. EQUIPMENT MANAGEMENT

Positive Observations
●

Negative Observations
●

Non-conformance
●

222
5. REAGENTS AND SUPPLIES

Positive Observations
●

Negative Observations
●

Non-conformance
●

6. REPORTING AND RECORDS MANAGEMENT

Positive Observations
●

Negative Observations
●

Non-conformance
●

223
7. ADMINISTRATIVE AND TECHNICAL PROCEDURES

Positive Observations
●

Negative Observations
●

Non-conformance
●

8. QUALITY ASSURANCE PROGRAMS

Positive Observations
●

Negative Observations
●

Non-conformance
●

224
9. OTHERS

Positive Observations
●

Negative Observations
●

Non-conformance
●

RECOMMENDATIONS:
●

QUALITY AUDITOR/S:
Name Signature Designation

ACCEPTED BY:
Name Signature Designation

DATE FOR FULL COMPLIANCE

DATE OF NEXT VISIT

225
 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

226
 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 Station)

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 _____________________________________________

227
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

228
 Form 31: Corrective Action Implementation

*******(Supervisor’s Checklist for Occurrences)

/
Occurrence Report No.______

PROBLEM:
________________________________________________________________
________________________________________________________________

PERSON TIME DATE OF REMARKS

ACTIVITIES / PLAN RESPONSIBLE FRAME ACCOMPLISHMENT
CORRECTIVE ACTION/S
(to address the ROOT CAUSE)

1.

2.

3.

4.

5.

229
 Form 32. Quarterly Corrective Action Monitoring

DEPARTMENT / SECTION: PERIOD COVERED:

EFFECTIVE PARTIAL /
PROBLEM CORRECTIVE DURATION PROOF OF NOT
ACTION OF IMPLEMENTATION DATE EFFECTIVE
MONITORING (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)

230
 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

Signatur Signatur Signatur

TIME TEMP TIME TEMP TIME TEMP
e e e
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

231
Acronyms

AHG Anti-human Globulin

AMR Antibody-mediated rejection

APH PC Apheresed Platelet Concentration

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 EthylenediamineTetraacetic Acid

EIA Enzyme Immunoassay

232
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

233
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

234
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

235
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 toward 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 BANKING EQUIPMENT. Essential laboratory machines, instruments, and

their accessories are used in the different steps in the blood banking process, such
as those used to centrifuge blood or separate blood into its various components,
preserve blood or blood components in cold storage or freezer; and perform blood
tests such as hemoglobin tests and screening tests for blood transmissible diseases.
This equipment also includes those used in specific supportive processes such as
sterilization and sanitary disposal of blood and blood products.

236
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 STATIONS). Any unit, office, institution

providing any of the blood transfusion services, which can be a blood bank/center
category A and B (non-hospital and hospital-based), a blood collection unit, or a
Blood Station.

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.

237
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.

238
DISPOSAL. The act of eliminating or sequestering indefinitely or permanently either
treated or untreated waste.

DISTRIBUTION. The act of delivery of blood and blood components to other blood
establishments, hospital blood banks, 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 operating
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.

GUIDELINES. Documented recommendations.

LEAD TIME – in procurement and purchasing of goods, it is the amount of time

between placing an order and the receipt of goods ordered

239
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.

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.

240
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 STATIONS and is classified into hazardous
and non-hazardous.

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.

241
References

American Association of Blood Banks (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.p
df

American Association of Blood Banks 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.

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

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

242
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 is 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

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_Blood_Cold_Chain_Equipment.pdf

243
244