t

Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY
November 20, 2019

DEPARTMENT CIRCULAR
No. 20T5F 201g¢- 0034-A

FOR : ALL REGIONAL DIRECTORS CENTERS FOR HEALTH

DEVELOPMENT, CHIEFS OF THE HEALTH FACILITIES AND
SERVICES REGULATORY BUREAU AND THE CENTERS FOR
HEALTH DEVELOPMENT REGULATION, LICENSING AND
—-

ENFORCEMENT DIVISION, MINISTRY OF HEALTH OF THE

BANGSAMORO AUTONOMOUS REGION IN MUSLIM
MINDANAO (MOH-BARMM), REGULATORY OFFICERS, AND
ALL OTHERS CONCERNED

SUBJECT : Amendment to Department Circular No. 2018-0039 dated, February 15,

2018, titled “Revised Assessment Tool for Licensing Blood Service
Facilities.”

Pursuant to Administrative Order No. 2008-0008 dated May 2, 2008, which sets the rules and
regulations governing the licensure of Blood Service Facilities (BSFs), the following items in the
attachment of Department Circular No. 2018-0039 dated February 15, 2019, titled “Revised
Assessment Tool for Licensing Blood Service Facilities” are hereby amended:

-XXX-
Under Item 1.5.1:
1.5.1 There is an adequate number of functional equipment to provide the procedures the
Blood Service Facility is authorized for.

1.5.1.1 Equipment listed in Standards available in the Blood Service Facility

1.5.1.2 Records of monitoring of temperature of Refrigerator and other cold storage

equipment, if any.

1.5.1.3 Personal protective equipment available.

The following requirement shall be inserted as item no. 1.5.1.4

1.5.1.4 Certificate of Product Registration (CPR) from Food and Drug
Administration (FDA) as one of the licensing requirements.

-XXX-
Under Item 1.6.1
1.6.1 There is an adequate supply of properly stored and inventoried reagents and supplies.
1.6.1.1 Records of inventory, usage/ consumption and disposal of reagents/ supplies.

1.6.1.2 Materials Safety Data Sheet (MSDS) for all reagents/supplies accessible when
needed

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 local 1113, 1108, 1135
Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh.gov.ph; e-mail: ftduque@doh.gov.ph
 The following requirement shall be inserted as item no. 1.6.1.3
1.6.1.3 Certificate of Product Registration (CPR) from Food and Drug
Administration (FDA) one of the licensing requirements. as
-XXX-
Under 1.8Item
1.8 QUALITY ASSURANCE PROGRAM
The Blood Center shall put into practice a Quality Assurance Program.

The aforementioned is hereby amended

1.8 QUALITY ASSURANCE PROGRAM
read as follows: to
The Blood Service Facility shall put into practice a Quality Assurance Program.

-XXX-
of

i
Under Annex A. Number Personnel
Hospital based Blood Station — non-requirement of Donor Recruitment/Counselling
ANNEX A. NUMBER OF PERSONNEL
Dot Transfus!
BSF Category Renna Pre-collection / Collection Teating
for
Poe corn Releasing rantory Networking
pannel
ee 4
designated RMTShit 3 designeled RMT

To amend as
Hospital based Blood Station
Recruitment/Counselling
— Requirement of designated Donor

ANNEX A, NUMBER OF PERSONNEL

Transfusi

poate
Bor

BSF Category
Reet Pre-colleotion / Collection Testing
for
Prete corey Releasing iwscton Managurat Networking

peenialbased Designated RMT 4

designated RMTistift 3 designated RMTs

-XXX-
Under Annex B. Equipment, Item 30.1 Requirement of Clinical Thermometer on Blood
Station (BS)
EQUIPMENT Bs acu accu) Hes HBBH BC REMARKS
30, Thermometer
30.1 Clinical Thermometer (non-mercurial}
30.2 Laboratory Thermometer
30.3 Room Th i

To amend as Non-requirement of Clinical Thermometer on BS

EQUIPMENT as Bcu Bsiecu HBB HBBt} BC REMARKS

30. Thermometer
30.1 Clinical Thermometer (non-mercurial)
30.2 Laboratory Thermometer
30.3 Room Thermometer

All other provisions of Department Circular No. 2018-0039 dated February 15, 2018, shall
remain in effect. For strict implementation.

rou
lu

|
By Authority of the Secretary of Health

RIQUE D) DOMINGO, MD, DPBO

ndersecretary of Health
Health Regulations Team
 Republic of the Philippines
Department Health of
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

ASSESSMENT TOOL FOR LICENSING A BLOOD SERVICE FACILITY

INSTRUCTIONS:

1. Check to make sure that you have the complete tool with a total of ------- pages with annex A------ that serve as reference for Equipment, Reagents & Supplies per Category.
If the corresponding items are present, available or adequate, place von of the appropriate spaces under the FINDINGS column
If not, put an X instead.
or space provided alongside each corresponding item.

w The REMARKS column shall document relevant observations for Quality Improvement.
Make sure to fill-in the blanks with the needed information. Do not leave any items blank; write (N/A) not applicable or ---if needed.
ak
Mm (Shaded cell) means that specific items are not applicable to the BSF category. With (*) asterisk-policies incorporated in One Stop Shop facility are acceptable.

GENERAL INFORMATION:

Name of Facility: Certificate of Inclusion No. Exp.

Address:
(Number & Street) (Barangay/District) (Municipality/City) (Province & Region)
Telephone/ Fax No. E-mail Address:
Initial:
_
Name of Owner
Renewal:
_—
or Governing
License to Operate No.:
Body
(if corporation):
Authority to Operate No.: Date Issued: _——_—séEExpiiry Date:

Name of Head of Blood Service Facility:

Classification According to: Ownership:
_Government _ Private
Institutional Character: _Institution-based (specify) _Free-Standing
Category: Blood Station _Blood Collection Unit _BCU/BS
_
_Blood Bank _Blood Bank with Additional Functions:
- _Blood Center _
Collection
_ Testing __ Processing

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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

Application D

Documentary requirements complete (refer to

application)

Certificates valid and required forms duly

accomplished (refer to application)
1. REQUIREMENTS
1.1.
RESPONSIBILITY

MANAGEMENT
The Blood Service Facility (BSF) shall be managed
effectively and efficiently and in accordance with its
vision, mission, and objectives.
1.1.1 Management shall formulate a_ vision,
mission, objectives and values for the BSF.
1.1.1.1 Mission, Vision, Objectives, Values

1.1.2 There shall be an Annual Operational Plan

4.1.2.1 Annual Operational Plan

1.1.3 There shall be Management Review

1.1.3.1 Management Review’ with Key

Performance Indicators

1.2 MANAGEMENT OF BLOOD SERVICE FACILITY

The BSF shall be managed by qualified physicians

with proper training.

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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

1.2.1 The BSF is headed by a duly licensed physician who

Is:

For Hospital-based Blood Stations

1.2.1.1 Certified in Clinical Pathology by the Philippine Board of
Pathology of the PSP,
1.2.1.1.1. Specialty Board Certificate
1.2.1.1.2. Resume
1.2.1.1.3. Notarized Contract of Employment
1.2.1.1.4. Job Description

For Non Hospital-based Blood Stations

1.2.2.1 Physician with at least three (3) months formal training
in basic blood banking provided by DOH recognized
training provider.
1.2.2.1.1. PRC Board Certificate
1.2.2.1.2. Resume
1.2.2.1.3. Notarized Contract of Employment or Service
Contract Agreement
1.2.2.1.4. Job Description
1.2.2.1.5. Training Certificate on Laboratory Management
and Transfusion Medicine
For Non hospital-based Blood Collection Unit
1.2.3.1. Physician with formal training in basic blood banking
provided by the DOH recognized training provider.
1.2.3.1.1. PRC Board Certificate
1.2.3.1.2. Resume
1.2.3.1.3. Notarized Contract of Employment or Service
Contract Agreement
1.2.3.1.4. Job Description
1.2.3.1.5. Training Certificate on Laboratory Management
and Transfusion Medicine
For Non hospital-based Blood Station/ Blood Collection Unit
1.2.4.4. Physician with formal training in basic blood banking
provided by the DOH recognized training provider.
1.2.4.1.1. PRC Board Certificate
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OF
Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS
D AND
ND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

1.2.4.1.2. Resume
1.2.4.1.3. Notarized Contract of Employment or Service
Contract Agreement
1.2.4.1.4. Job Description
1.2.4.1.5. Training Certificate on Laboratory Management E

and Transfusion Medicine

For Blood Center, Hospital Blood Bank and Hospital Blood

Bank with Additional Functions
1.2.5.1 Certified in Clinical Pathology by Philippine Board of

RESOURCES
Pathology of the PSP, and with experience in a blood

MANAGEMENT
service facility
1.2.5.1.1. Specialty Board Certificate
1.2.5.1.2. Resume
1.2.5.1.3. Notarized Contract of
Employment
1.2.5.1.4. Job Description

HUMAN
1.3.

The Blood Service Facility appoints and allocates

personnel who aresuitably qualified, skilled and/ or
trained to assume the responsibilities, authority,
accountability, and functions of the position.
1.3.1. There shall be an adequate number of qualified medical
technologists proportional to the workload as
determined by the head of the Blood Service Facility.

4.3.1.1. Adequate number of personne!. As workload

increases, the number of personnel increases.
(refer to Annex A)

1.3.2 There shail be a policy and procedure for hiring,

orientation and promotion for all levels of personnel.
1.3.2.1. Policy and procedure for hiring, orientation and
promotion of personnel at all levels.
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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

1.3.2.2 Records of hiring, orientation and promotion of

personnel.

1.3.3 Duties and responsibilities shail be clearly spelled

out.

1.3.3.1 Documented duties and responsibilities of all

Blood Service Facility personnel.

1.3.4 There shall be a program on staff development and

training.

1.3.4.1. Program for staff development and training

1.3.4.2 Certificates or Records of Training

1.3.5 There shall be a policy and procedure for

discipline, suspension, demotion and termination of
personne! at all levels.
1.3.5.1 Policy and procedure on discipline, suspension,
demotion and termination of personnel at
all levels

1.3.5.2 Records of discipline, suspension, demotion and

termination of personnel

1.3.6 The Blood Service Facility shall designate and train one
(1) Registered Medical Technologist as a Quality
Assurance Officer. Such training shall be recognized
by the DOH.

. 1.3.6.1 Designation of a Quality Assurance Officer

1.3.6.2 Certificate of Training as Quality Assurance

Officer

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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STAN DARDS
DS AND REQUIREME
QUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

Work
1.3.7. The Blood Service Facility shall designate one (1)
qualified and trained full-time Donor Recruitment
Officer (DRO). Such training shall be recognized by the
DOH and shall include training on pre- and post-
donation counseling. As the workload increases, the
number of DROs increases. See Annex A

1.3.7.1. Designation as Donor Recruitment Officer

PHYSICAL
Environment
1.3.7.2 Certificate of training as Donor Recruitment Officer
DRO from Philippine Blood Coordinating Council
(PBCC) or Philippine Red Cross (PRC)

1.3.8 There shall be a structured organizational chart

1.3.8.1 An Organizational chart* indicating the names with
pictures and designation, reflecting lines of authority,
accountability and, communication, inter-
relationship, hierarchy of functions and flow of
referrals

1.3.9 Each Staff member shall read and sign his Duties and
responsibilities
1.3.9.1 Duties and responsibilities of each Staff member
signed by Staff member.
1.4.
FACILITIES/
Services are provided in an environment that promotes
safety, has adequate space, meets the needs of clients,
service providers and other stakeholders, and conforms
- tothe current Manual of Standards issued by the DOH.
1.4.1 The Blood Service Facility has adequate space thefor
conduct of itsactivities.
1.4.1.1 Ocular inspection demonstrates adequate space for
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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

the equipment, furniture, storage of glassware,

reagents and supplies and the activities of the Blood
Service Facility staff

1.4.1.2 Work area accessible to Blood Service Facility

personnel only

Areas for Blood Station — Designated area in the Clinical

Laboratory
Storage blood bank refrigerator
Blood typing and Cross matching
Releasing of blood products

Areas for BCU and BS/BCU

e Reception / waiting area— 1.0 m2 /person
e Donor Counseling — 5.02 m?
e Physical Exam area for donor — 5.02 m2
e Donor extraction — 6 m? per bed or couch
e Provision of sink for hand washing
e Area for Refrigerator and supplies (at least 1.2 m? per
storage unit)
e Preparation Area — 5.02 m2
e Releasing of blood products
Administrative Office

Area for Hospital Blood Bank — Area of at least 19 m?

Areas for blood bank refrigerator, plasma freezer, platelet
agitator, and supplies (at least 1.2 m2 per storage unit)
e Blood typing and Crossmatching Work Counter
e Releasing of blood products
NOTE: Location of HBB must be adjacent or easily accessible to
the main clinical laboratory.
Areas for Hospital Blood Bank with Additional Function

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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

**Reception / waiting area— 1.0 m? /person

Donor Counseling — 5.02 m2
Physical Exam area for donor — 5.02 m?
Donor extraction — 6 m? per bed or couch
Provision of sink for hand washing
***Blood screening for TTIs — 10 m2
Blood typing and Crossmatching Work Counter
Processing of blood into blood components 4.65 m2 per
equipment
o Storage facility4.65 m2 per storage unit
—

Releasing of blood products

Administrative Office

**Reception/Waiting area for HBB++ can be located outside or

can be a common area for clinical laboratory.

***May be carried out within the clinical laboratory

adjacent to the main clinical laboratory.
if the HBB++
is
Areas for Blood Center
Reception / waiting area — 1.0 m? /person
Donor Counseling — 5.02 m?
Physical Exam area for donor — 5.02 m?
Donor extraction — 6 m? per bed or couch
Blood screening for TTIs — 10 m?
Processing of blood into blood components — 4.65 m2 per
equipment
e Storage facility — 4.65 m2 per storage unit
Releasing of blood products
Administrative Office

1.4.2 The Blood Service Facility shall be adequately

ventilated, well-lighted, clean, safe and functional
it
“based on the services provides.
?
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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

1.4.2.1 Ocular inspection demonstrates good ventilation,

lighting, cleanliness with no risk of physical and
chemical hazards.

1.4.3 There shall be a program of proper maintenance and

monitoring of physical plant and facilities.
1.4.3.1. Program for the proper maintenance and monitoring
of physical plant and facilities

1.4.3.2 Records of the proper maintenance and monitoring

of physical plant and facilities

1.4.4 There shall be a policy and procedure on laboratory

biosafety and biosecurity and for the proper disposal of
waste and hazardous/ infectious substances that shall
conform to the standards set by the DOH.

1.4.4.1 Policy and procedure on laboratory biosafety and

biosecurity and for the proper disposal of waste and
hazardous/ infectious substances.

1.4.4.2 Records on laboratory biosafety and biosecurity and

for the proper disposal of waste and hazardous/
infectious substances.

1.5. EQUIPMENT

All equipment and instruments necessary for the safe and

effective provision of services are available and are properly
maintained.

1.5.1 There is an adequate number of functional equipment

to provide the procedures the Blood Service Facility is
authorized for.
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 Blood Biood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

1.5.1.1 Equipment listed in Standards available in the Blood

Service Facility

1.5.1.2 Records of monitoring of temperature of Refrigerator

and other cold storage equipment, any. if
1.5.1.3 Personal protective equipment available.

SUPPLIES
1.5.1.4 Certificate of Product Registration from Food and

REAGENTS
Drug Administration (FDA).

1.5.2 There is a program for calibration, preventive

maintenance and repair for the equipment.
1.5.2.1 Program and schedule of calibration, preventive
maintenance and repair of equipment

1.5.2.2 Records of calibration, preventive maintenance and

repair of equipment.

1.5.3 There shall be a contingency plan in case of

equipment breakdown, especially of Blood Service
Facility cold storage equipment.

1.5.3.1 Contingency plan in case of equipment breakdown

1.5.3.2 Record of actions taken in case of equipment

AND
breakdown

1.6.

All reagents and glassware to be used by the Blood Service

Facility shall be based on the minimum requirement for
sensitivity and specificity of testing reagents as well as the
testing procedures as recommended by the technical
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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

AND
committee of the NVBSP.

1.6.1 There is an adequate supply of properly stored and

inventoried reagents and supplies.

1.6.1.1 Records of inventory, usage/ consumption and

disposal of reagents/ supplies.

1.6.1.3 Certificate of Product Registration from Food and

Drug Administration (FDA).

REPORTING
Materials Safety Data Sheet (MSDS) for all

MANAGEMENT
1.6.1.2
reagents/supplies accessible when needed

1.6.2 There are adequate storage facilities such as

refrigerators for perishable reagents and supplies.

1.6.2.1 Refrigerator for storage of perishable reagents and

supplies
1.6.2.2 Records of monitoring of temperature of refrigerator

1.6.3 There isappropriate storage area/system for flammable,

combustible and hazardous chemicals/ reagents.

1.6.3.1 Appropriate storage area for flammable, combustible,

and hazardous chemicals/reagents.

1.6.3.2 Appropriate system of storage for flammable,

combustible, and hazardous chemicals/ reagents
following safety (MSDS) requirements.

17.
RECORDS
There shall be a system of reporting and recording of stored

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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

and issued blood and blood products.

procedure for reporting of

1.7.1 There shall be a policy and
stored and issued blood and blood products.
1.7.1.1. Policy and procedure for reporting of stored and
issued blood and blood products.

1.7.1.2 Monthly and annual reports on of stored and issued

blood and blood products.

procedure for retention of

1.7.2 There shall be a Policy and
records which shall follow standards promulgated by
the DOH and/or competent professional organizations.
1.7.2.1 Policy and procedure for retention of records.

1.7.2.2 File of retained records.

1.7.2.3 Inventory of disposed records

1.7.3 There shall be a designated area for storage of records.

1.7.3.1 Storage area adequate for records generated

For Blood Center and Blood Bank with Additional Functions

There shall be system of recording and reporting of results of

immunohematology examinations and testing for infectious
diseases and collection, storage and issuance of blood and
blood products.

1.7.4 There shall be a policy and procedure for recording and

reporting of results of immunohematology examinations
and testing for infectious diseases.

1.7.4.1 Policy and procedure for recording and reporting of

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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

results of immunohematology
testing for infectious diseases.
examinations and
Feees
1.7.4.2. Records of results of immunohematology
examinations and testing for infectious diseases.

1.7.4.3 Monthly and annual reports of immunohematology

examinations and tests for infectious diseases.

1.7.5 There shall be a policy and procedure for

the recording
and reporting of collection, storage, issued, and shared
blood and blood products from voluntary donors.

1.7.5.1 Policy and procedure for the recording and reporting

of collection, storage, issued, and shared blood and
blood products.

1.7.5.2 Records of collection, storage, issued, and shared

blood and blood products.

1.7.5.3 Monthly and annual reports of collection, storage,

issued, and shared blood and blood products.

to ensure blood
1.7.6 There shall be a policy and procedure
safety by screening and testing for the five (5) TTls
namely: HIV 1/2, HBsAg, HCV, Malaria, Syphilis and
other TTls mandated for screening by the Technical
Committee of the NCBS.
1.7.6.1 Policy and procedure for testing for the five (5) TTIs,
i.e, HIV 1/2, HBsAg, HCV, Malaria and Syphilis

1.7.6.2 Records of results of Testing for the five (5) TTIs

1.7.6.3 Monthly and Annual Reports of no. of units of
Negative and Reactive Blood.

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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

1.7.6.4 Quarantine records for blood products that are

reactive to any markers of TTI
[=a sss\/\\\s\\\\Alsl/\ssiiMiMniMine tess 2)
1.7.7 There shall be a policy and procedure for confirmation of
blood/ blood products initially reactive to any of the 5 TTI
markers namely: HIV1/2, HBsAg, HCV, Malaria, and
Syphilis.
1.7.7.1 Policy and procedures for the referral to RITM TTI-
NRL for confirmation of blood/ blood products |

initially reactive to any of the 5 TTI markers

1.7.7.2 Records of referral for confirmation of blood/ blood

products initially reactive to any of the 5 TTI markers.

1.7.7.3 Records of receipt of results of confirmation testing

of blood/ blood products initially reactive to any of
the 5 TTI markers referred.
1.7.7.4 Monthly and Annual Reports of results of confirmation
testing of blood/ blood products initially reactive to
any of the 5 TTI markers referred.
1.7.8 There shall be a policy andprocedure for the storage and
distribution of whole blood/ components.
1.7.8.1 Policy and procedure for
the storage and distribution |
of whole blood/components.

1.7.8.2 Records of storage and distribution of whole blood/

components.
1.7.8.3 Monthly and annual reports of no. of units of whole
blood/components stored and distributed.

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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

1.7.9 There shall be a policy and procedure for the

management of
inventory of blood products.
1.7.9.1 Policy and procedure for the management of
inventory of blood products
1.7.9.2 Logbooks/ records of management of inventory of
blood products.

FOR BLOOD STATION AND HOSPITAL BLOOD BANK

There shall be system of recording and reporting of results of

immunohematology examinations and collection, storage and
issuance of blood and blood products.
1.7.10 There shall be a policy and procedure for recording and
reporting of results of immunohematology examinations.
1.7.10.1 Policy and procedure for recording and reporting of
results of immunohematology examinations.

1.7.10.2 Records of results of immunohematology

examinations.

1.7.10.3 Monthly and annual reports of immunohematology

examinations.

1.7.11 There shall be a policy and procedure for the storage

and distribution of whole blood/ PRBC.
NOTE: For HBB, whole blood, PRBC, and other blood
components.
1.7.11.1. Policy and procedure for the storage and
distribution of whole blood/PRBC.

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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

1.7.11.2 Records of storage and distribution of whole

blood/PRBC.

1.7.11.3 Monthly and annual reports of no. of units of whole

blood/PRBC stored and distributed.
1.8 QUALITY ASSURANCE PROGRAM

The Blood Service Facility shall put into practice a Quality

Assurance Program.
1.8.1 Thereshall be policies and procedures on Quality
Assurance Program and Continuous Quality
Improvement.
1.8.1.1. Policy and Procedure on Quality Assurance
Program including Internal Quality Control
1.8.1.2 Records of
Internal Quality Control and Quality
Control of reagents

1.8.1.3. Policy and Procedure for Internal Quality Audit

1.8.1.4 Records of Internal Quality Audit.
1.8.1.5 Analysis of results of Internal Quality Audit and
recommendations to improve the services.
1.8.1.6 Quality Improvement Studies for improvement of
delivery of services.
1.8.2 The Blood Service Facility shall participate in an External
Quality Assessment Program (EQAP) administered by the
designated National Reference Laboratories (NRL) or
other External Quality Assessment Program approved by
“the DOH.

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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
Blood Bank Bank with

ee
(BS) Unit (BC)
STANDARDS AND REQUIREMENTS
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

1.8.2.1 Policy and Procedures in the participation in

NEQAS administered by the designated NRLs.

4.8.2.2 Certificate of participation of the Blood Center in

the NEQAS administered by the designated NRLs.

For Hospital Based Blood Station, Hospital Based Blood

Bank, Hospital Blood Bank with Additional Functions

1.9 Hospital Blood Transfusion Committee:

1.9.1 There shall be a policy and procedure for

the
establishment and operation of a Hospital Blood
Transfusion Committee.

1.9.1.1 Policy and procedure for the establishment and

operation of a Hospital Blood Transfusion
Committee.

1.9.1.2 Letter, Memo or Order establishing the Hospital

Blood Transfusion Committee providing forits
composition and duties and responsibilities.

1.9.2 The Hospital Blood Transfusion Committee (HBTC)

shall meet and perform its duties and responsibilities.

1.9.2.1 Minutes of meetings of HBTC, including Monthly

reports of Blood Bank procedures, requests and
issuance of blood and blood products.

1.9.2.2 Memos or letters

issued by HBTC to carry out
recommended policies, procedures, sanctions,
etc.

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 Blood Blood Blood Hospital Hospital Blood Remarks
Station Collection Station / Blood Blood Center
STANDARDS AND REQUIREMENTS (BS) Unit Blood Bank Bank with (BC)
(BCU) Collection (HBB) Additional
Unit Functions
(BS/BCU) (HBB++)

1.9.2.3 Records of blood utilization reviewed and

performed including corrective actions taken.

1.9.2.4 Report on activities conducted in Blood Donors

Month (July), if applicable

1.9.2.5 Annual reports of activities including review of

policies, procedures and blood utilization.

1.9.3 The HBTC shallconduct seminars to promote

voluntary blood donation and the appropriate use of
blood and blood products.

1.9.3.1 Calendar of Seminars and other Training sessions

on voluntary blood donation and the appropriate
use of blood and blood products.

1.9.3.2 Certificates or Records of Training on Seminars and

other Training sessions voluntary blood donation
and the appropriate use of blood and blood products
conducted.

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 BSF Category

poset wased
Non-hospital
based Blood
Station (Not
operating for
more 8 hours

eee
Set
:

(BS/BCU)
.

Blood Collection
Unit

Blood Bank

Blood Bank with

additional
.
Donor

Designated

aM :

raeered
.
Recruitment!
Counselling

RMT

training provider

ina
trained
reco. g

1
by

RNIRMT

4 RN
d
i
DOH

trainin gP rovider
.
1 RMT

{1

1
:
.
Pre-collection

2 phlebotomist which may be

composed of RMTs, RNs or
trained laboratory technician,

RMT
under board
MD per activity

under board MT
MD
per activity

RMT
MT

2 phlebotomist which may be

RE
composed of RMTs, RNs

2 phlebotomist which may be

composed of RMTs, RNs
or
trained laboratory technician,

or
| .
/ Collection

or

or

“4
ANNEX A. NUMBER OF PERSONNEL
.

lL
Testing for Component
Processing

RMT/shift plus 1 reliever

sas
Compatibility
Testing

'

1
Releasing

ee
1
RMT
.

plus
reliever
1
Transfusion

AOD Creal)

1
.
Reaction
Investigation

designated RMT/shift

RMT/shift
Inventory
Management
Networking

Same personnel in Releasing

Same personnel in
:
Releasing

Same
.

personnel in
Donor
Recruitment
. Total Number
personnel /24 hrs

3 designated RMTs

2RMTs

1MD
3 RMTs
2 Phlebotomists
1 RN/RMT

1 RN/RMT

TMD

1
1MD

4RMTs
RMT
2 Phlebotomists

RN/RMT

9RMTs
1MD
of

(oneal)

functions
uncto
trained laboratory technician, or Plus 1 reliever 2 Phlebotomisis
under board MT 1 RN
1 MD
per activity
1 RMT

2 phlebotomist which may be Same RN 1MD

'
.

Blood Center + RN
composed of RMTs, RNs or wren Same Rv assigned in 9 RMTs
trained laboratory technician, or *1 RMT/shift plus 1 reliever cliever Relvasin
9
donor 2 Phlebotomists
under board MT recruitment 1 RN
1 MD
per activity

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 ANNEX B. EQUIPMENT

EQUIPMENT BS BS/BCU HBB HBB++ BC REMARKS

1. Agglutination viewer

2. Air-conditioning Unit in work area

3. Apheresis Machine with AVR, for BSF with component collection by
Optional Optional
Apheresis
4. Autoclave for sterilization before disposal of used blood bagsif no
outsourced waste disposal provide OR Bio-waste processor or proof of
waste collection (MOA with tertiary clinical laboratory for investigation of
suspected contaminated blood units)
5. Automatic Emergency Light
6. Balance
6.1 Analytical Balance
6.2 Rough balance, top loading
7. Blood Collection
7.1 Blood donor couch or bed
7.2 Spring scale for blood unit
7.3 Surgical forceps, scissors
7.4 Tube sealer
7.5 Blood mixer
7.6 Tube stripper
8. Blood Transport box with non-mercurial thermometer and adequate cold
packs (for mobile blood donation)
9. Centrifuge
9.1 Serological centrifuge (>3400 rpm with minimum timer of 30 seconds)
9.3 Clinical Centrifuge
9.4 Refrigerated centrifuge with AVR - UPS
10. Computer with printer, UPS, AVR
11. Immunology Analyzer for
TTIs:
11.1 Enzyme Immunoassay (EIA) equipment set with AVR
11.1.1 EIA reader
11.1.2 EIA washer microdiluter

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 11.1.3 Incubator or heating block or its equivalent
11.2 Chemiluminiscence (Optional) Optional
11.3 NAT testing
12. Fire Extinguisher

13. Freezer
13.1 Plasma freezer (-30°C) with AVR
13.2 Ultralow freezer (-70°C) with AVR
13.3 Blast freezer (Optional)
14. Generator with capacity of at least 40 KVA

15. Hematology Analyzer for QC of blood products

16. Hemoglobin determination, any one of the

following:
16.1 Copper Sulfate for mobile blood donation
16.2 Hemoglobinometer, or Photometer or Spectrophotometer
17. Microscope, binocular, equipped with Oil Immersion Objective (O10)

18. Needle destroyer

19. Pipettor

20. Plasma Extractor

21. Plasma Thawer or its equivalent, with regulated temperature

22. Platelet Rotator/ Agitator with incubator

23. Red Cell Antibody Screening System and phenotyping Optional Optional Optional
24. Refrigerator
24.1 Blood Bank Refrigerator controlled at 2-6 °C with temperature
recorder and alarm system, and AVR
24.2 Reagent refrigerator with laboratory thermometer and AVR
25. Rotator for RPR or VDRL Optional Optional

26. Sphygmomanometer (Non-mercurial)

27. Stethoscope

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 )
28. Stopwatch or timer
29. Tackle box / Phlebotomy box
30. Thermometer
30.1 Clinical Thermometer (non-mercurial)
30.2 Laboratory Thermometer
30.3 Room Thermometer
31. Water bath/ dry bath set at 37°C for cross-matching and discrepant blood
typing
32. Clinical Weighing Scale
32.1 Calibrated up to 200 kilograms — for blood donors
32.2 Calibrated up to 500 grams — for blood units

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 Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Name of Facility:
Date of Inspection:

RECOMMENDATIONS:
A. For Licensing Process:
[ ] For issuance of License as
Validity from to

[ ] Issuance depends upon compliance to the recommendations given and submission of the
following within days from the date of inspection:

[ ] Non-Ilssuance: Specify reason/s.

Inspected by:
Printed Name Signature Position/Designation

Received by:
Signature
Printed Name
Position/Designation
Date

:
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:
02/26/2018
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Lesenseetteseseccecceednaasenensssanennseaanesccseossssvansesecesaeces
 Republic of the Philippines
Department of
Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

Name of Facility:
Date of Monitoring:

RECOMMENDATIONS:
B. For Monitoring Process:
[ ] Issuance of Notice of Violation

[ ] Non-issuance of Notice of Violation

[ ] Others (Specify)

Monitored by:
Printed Name Signature Position/Designation

Received by:
Signature
Printed Name
Position/Designation
Date

:
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: 02/26/2018
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