Salient Points of the Philippine

Blood Banking Laws

Prepared by:
Shella Mae Gustilo, RMT, MSMT-CAR
Updated and presented by:
JC John T. Jamili, RMT, MSMT-CAR
 PHILIPPINE BLOOD BANKING LAW
A. RA 1517 s. 1956
B. RA 7719 s. 1994
C. AO 9 s. 1995
D. TECHNICAL STANDARDS FOR BLOOD BANKS
IN THE PHILIPPINES
E. AO 2010-0001
F. AO 2010-0002
 RA 1517 RA 7719 AO AO AO
No. 9 S.1995 No. 2010-001 No. 2010-002
An Act Regulating An Act Promoting Rules and Policies and Policies and
the Collection, Voluntary Blood Regulations Guidelines for the Guidelines
Processing, and Donation, Providing Implementing RA Philippine Pertinent to the
Sale of Human for an Adequate 7719, otherwise National Blood Establishment
Blood, and the
Establishment Supply of Safe Blood, known as the: Services (PNBS) and Operation of
and Operation of Regulating Blood "NATIONAL and the Blood Local Blood
Blood Banks and Banks, and Providing BLOOD SERVICES Services Council to
Blood Processing Penalties for ACT OF 1994" Networks (BSN) Support the
Laboratories Violation Thereof Implementation
of the National
Voluntary Blood
Services Program
for Blood Safety
and Adequacy,
Quality Care, and
Patient Safety
 EFFECTIVITY DATE
RA 1517 RA 7719 AO AO AO
No. 9 S.1995 No. 2010-001 No. 2010-002
June 16, May 5, April 28, January 6, January 7,
1956 1994 1995 2010 2010
 PENALTIES
RA 1517
• Any person who violates any provision of this
Act shall be punished by
– imprisonment for not less than one month and
not more than one year or
– fine of not less than one hundred pesos and not
more than one thousand pesos or by both
 PENALTIES
RA 7719
•Penalty of imprisonment of not less than one
(1) month nor more than six (6) months, or a
fine of not less than Five thousand pesos
(P5,000) nor more than Fifty thousand pesos
(P50,000), or both
 PENALTIES
RA 7719
Operating without LTO
– imprisonment of not less than twelve (12)
years and one (1) day nor more than twenty
(20) years or;

– a fine of not less than Fifty thousand pesos

(P50.000) nor more than Five hundred
thousand pesos (P500,000), or both
 PENALTIES
RA 7719
ten (10) years imprisonment
– dispensing, transfusing and failing to
dispose, within forty-eight (48) hours, blood
which have been proven contaminated with
blood transfusion transmissible diseases
Suspension/revocation of LTO of Blood
bank/center, suspension/revocation of license
to practice the profession of personnel
 PENALTIES
RA 7719
Suspension/revocation of LTO of Blood
bank/center,
suspension/revocation of license to practice
the profession of personnel
 PENALTIES
AO NO.9 S.1995
(same with RA 7719)
P5000.00 –head/owner of Blood Bank who
fails to renew LTO within 2 months prior to the
expiration of existing license
P3000.00 – head of Blood Collection Unit
(BCU) or Blood Station (BS) operating without
authorization from the DOH
 AO NO.9 S.1995 Penalties cont.
Revocation/suspension of blood bank/center license
or BCU or BS authorization for:
– Misinterpretation of facts or falsification of documents or
records
– Refusal of entry for inspection
– Refusal to make available its books, accounts, and records
of operations
– Failure to inform the Bureau of Research and Laboratories
(BRL) about changes in Blood Bank (BB), Blood Collecting
Unit (BCU), Blood Station (BS) location, services, facilities,
or operation
 AO NO.9 S.1995 Penalties cont.
Recommendation to revoke the COR or to
suspend said certificate to practice the
profession and to invalidate the professional
license of any health professional involved in
– Misinterpretation of facts or falsification of
documents or records especially medical,
laboratory or inspection results and certificates, or
in violation of RA 7719
 Blood Service Facility

Any unit, office, institution, providing any of the

blood transfusion services which can be:
A. Blood Bank,
B. Blood Center,
C. Blood Collection Unit
D. Blood Station
 B. Blood Bank/Blood Center
• a laboratory or institution with the capability to
– recruit and screen blood donors
– Collect

– Process
– Store
– transport and issue blood for transfusion
– provide information and/ or education on blood
transfusion transmissible diseases
Categories of Blood Bank/Blood Center

1. Non hospital based Category A

2. Non hospital based Category B
3. Hospital based Category A
4. Hospital based Category B

- According to AO 9 s. 1995
 1. A blood bank/center shall be considered
non–hospital based category A when it can and is
performing the following:
• a. Recruitment of voluntary donors
• b. Health education and counseling
• c. Donor screening and selection
• d. Blood collection
• e. Basic blood processing and testing
• f. Provision of whole blood and packed RBC
• g. Issuance, transport and distribution of
blood/blood products
• h. Storage of blood/blood products
 2. Non–hospital Based Category B when,
in addition to those performed under
the Non –hospital Based Category A
• it is capable of providing, in addition to whole
blood, all blood products and components.
 3. Hospital–Based Category A when,
in addition to those performed under the
Non– hospital Based Category A:
• it is capable of performing compatibility–
testing.
 4. Hospital–Based Category B when,
in addition to those performed under the
Hospital –based Category A:
• it is capable of providing, in addition to whole
blood, all blood products and components;
• and of performing investigation of transfusion
reactions and
• resolution of incompatible cross–matching
results.
 C. Blood Collection Unit

• an institution or facility duly authorized by the

Department of Health to
– recruit and screen donors
– collect blood
 D. Blood Station
• A government or private hospital or a
Philippine National Red Cross (PNRC) chapter
which has not been licensed as a blood
center but has been authorized by the DOH
to:
– Store
– Issue blood & blood products,
– Perform compatibility testing (when necessary)
 “Walking Blood Donor”

• An individual who has been screened by

history and physical examination, found to be
fit to donate blood, and included in the list of
qualified voluntary donors who is ready to
donate blood when needed in his or her
community
Blood transfusion transmissible diseases
• diseases which may be transmitted through blood
transfusion, including but not limited to:
– HIV 1 and 2
– Hepatitis B
– Hepatitis C
– Malaria
– Syphilis

• All blood units must test negative for all of the said TTIs
(AO 2010-0001)
 Hospital-based blood bank
and
Non-hospital based blood bank
A. Hospital-based blood bank
– a blood bank which is located and performing blood
bank services within the premises of a hospital and
which can perform compatibility testing of blood

B. Non hospital-based blood bank

– a blood bank which is not located and not
performing blood bank services within the premises
of a hospital and is not part of a hospital
 Commercial blood bank
• a blood bank that exists for profit, money or
any material gain earned out of sale or
exchange for, blood or blood products which
profit money or any material gain are not
solely for the operation and maintenance of
the blood bank service
Service Capabilities of:
Blood Station (BS), Blood Collection Unit (BCU),
Blood Center (BC), and Blood Bank (BB), and
Hospital-based and Non-Hospital Based Blood
Service Facility

- As defined and differentiated by:

AO No. 2008-008
(Rules and Regulations Governing the Regulation
of Blood Service Facilities)
 Service Capability
Functions BS BCU BC BB
Advocacy and Yes Yes Yes Yes
Promotion of
Voluntary
Blood
Donation and
Health
Lifestyle
Recruitment, No Yes Yes No
retention,
and care of
voluntary
blood donors
Screening and No Yes No No
selection of
voluntary
blood donors
Functions BS
Service
BCU
Capability
BC BB
Conduct of No Yes Yes No
Health
Education
and
Counseling
Services
Testing Units No No Yes No
of Blood for
TTIs
Collection of No Yes Yes No
Blood (mobile
or facility-
based) from
Qualified
Voluntary
Donors
Functions BS
Service
BCU
Capability
BC BB
Transport of No Yes No No
Blood to
Blood Center
(BC) for
Testing and
Processing

Provision of Yes No No No
Whole Blood
and Packed
RBCs

Processing No No Yes No
and Provision
of Blood
Components
Functions BS BCU BC BB
Storage, Yes No No No
issuance,
transport,
and
distribution
of Whole
Blood and
Packed RBCs
Storage, No No Yes No
issuance,
transport,
and
distribution
of Whole
Blood and/or
other blood
products to
hospitals and
other heath
facilities
Functions BS BCU BC BB
Storage, No No No Yes
issuance,
transport,
and
distribution
of Whole
Blood and/or
other blood
products
obtained
from a Blood
Center (BC)
 Service Capability
Functions BS BCU BC BB
Compatibility Yes Yes No Yes
Testing of RBC (hospital- (hospital-
Units based only) based only)

Direct No No No Yes
Coombs Test

RBC Antibody No No No Yes

Screening
 Service Capability
Functions BS BCU BC BB
Investigation No No No Yes
of Transfusion
Reactions
Assist the No No No Yes
HBTC in the
Conduct of
Post-
Transfusion
Surveillance
(hemo-
surveillance)
 What is NVBSP?

• National Voluntary Blood Services Program

• Mandated to plan and implement by the Department of
Health in cooperation with Philippine National Red Cross
(PNRC) and Philippine Blood Coordinating Council (PBCC)
and other government agencies and non- government
organizations under the virtue of Republic Act 7719
 Functions (page 61-62)
• Promote and encourage voluntary blood
donation by the citizenry and instill public
consciousness of the principle that blood
donation is a humanitarian act
• Provide adequate, safe, affordable and equitable
distribution of supply of blood and all blood
products.
• Mobilize all sectors of the community to
participate in mechanisms for voluntary and non-
profit collection of blood.
 Role of PRC and DOH in the promotion of
voluntary blood donation

• PRC
– Encourage all medical and other health
professional associations and societies esp. those
accredited by the PRC, to conduct training on
rational use of blood and blood products including
the benefits of voluntary blood donation as part of
CPE
Role of PRC and DOH in the promotion of
voluntary blood donation
• DOH
– Ensure the conduct of training on rational blood
use of blood and blood products, on the practice
of blood transfusion medicine and on the merits
of voluntary blood donation for the health
personnel
 BLOOD DONOR QUALIFICATIONS
• Weight of more than 45kg (100lbs) for 250ml of donated
blood, 50kg (110lbs) for 450mlof donated blood.
• Must be in Good Health
• Aged 16- 65 years of age (16 and 17 years needs parental
consent)
• Blood Pressure must be on safe range: Systolic Bp of 90- 160
mmHg and Diastolic Bp of 60- 100 mmHg
• Hemoglobin must be at least 125g/L (12.5g/dl)
 Requirements for New License
1. Minimum number & qualification of trained personnel
2. Staff development plan
– BB shall prepare a 1 yr staff development plan
3. Physical facilities equipment and supplies
4. Biosafety
5. Quality Control
6. Recording, reporting & documentation requirements
7. Blood distribution and transportation requirements
8. Blood transfusion committee
9. Preventive services
10.Networking
 Requirements for Renewal License
1. Technical staff shall have passed the basic proficiency test
the previous year
2. BB shall have achieved at least 70% of the staff
development plan targets
3. BB shall have bled only voluntary blood donors the
previous years
4. Annual report shall have been submitted on or before
January 31 of the succeeding yr
5. Inspection visit shall have confirmed that BB has
continued to operate under good physical conditions
6. BB has been shown to collect only the allowable services
fee for each blood unit dispensed
 LICENSING PROCESS

1. Initial process
2. Application for renewal of license
3. Inspection
4. Time table for application and inspection

5. Release
 TECHNICAL STANDARDS
GOVERNING THE COLLECTION,
PROCESSING & PROVISION OF
HUMAN BLOOD & THE
ESTABLISHMENT & OPERATION OF
BLOOD BANKS IN THE PHILIPPINES
 TITLE

• TECHNICAL STANDARDS GOVERNING THE

COLLECTION, PROCESSING & OPERATION OF
BLOOD BANKS IN THE PHILIPPINES
 SERVICE CAPABILITIES
• PRIMARY CATEGORY
– Donor screening/selection
– Collection & processing of blood
– Transport & issuance of blood
– Compatibility testing (Hosp.based)
• SECONADRY CATEGORY
– Provision of PRBC, plasma, & platelet rich plasma
– Investigation for transfusion reactions (hosp.based)
• TERTIARY CATEGORY
– Provisions of other blood components
– Investigation of incompatible cross matches (hosp.based)
 STANDARDS
• HEAD
• PERSONNEL
• PHYSICAL FACILITIES

Hospital Free standing

PRIMARY 20 sq m 20 sq m

SECONDARY 30 sq m 40 sq m

TERTIARY 40 sq m 50 sq m
• EQUIPMENT/ FURNITURE
• GLASS WARE/ REAGENTS/ SUPPLIES
• DONOR REQUIREMENTS (SCREENING)
• COLLECTION OF BLOOD/LABELLING
– A. COLLECTION OF BLOOD
– B. LABELLING
 A. COLLECTION OF BLOOD

1. Methods
• Aseptic methods using sterile, closed system & a single
venipuncture
2. Protection against contamination
• Sealing, tube segments,
• If more than 1 skin puncture is needed, another set &
container must be used
3. Donor reactions
• instruct donor for prevention & treatment for donor
reactions
• there should be medical care for donors who sustain
adverse reaction
• COLLECTION OF BLOOD/LABELING cont.
4. Anticoagulants & additives
• Anticoagulants & additives should be in the prescribed
amount in relation to the volume of blood to be collected

5. Temperature
• Blood shall be stored immediately after collection at a
temperature between 2-6ᴼC
• if it is to be used as a source of platelets store at 20-40ᴼC
for not more than 6 hours

6. Reissued blood
• blood that has been returned to BB shall not be reissued
(unless proper handling of blood are met)
 B. LABELING

– Original label shall be attached firmly to the

container & shall be in clear, eye-readable type
– Hand written additions/changes shall be legible &
in permanent moisture-proof ink
– Before the final label is applied, records must be
examined to ensure that the blood & components
from unsuitable donors will not be distributed
B. LABELING cont.
1. Blood unit identification
2. Labeling at collection or preparation

3. Labeling prior to issue

4. Special requirements for component labels

 SCREENING OF BLOOD
DONOR/STORAGE OF BLOOD
 A. SCREENING OF BLOOD DONOR
1. ABO group
– Testing the RBCs with Anti-A and Anti-B sera (forward typing)
– Testing the serum/plasma with a pool ok known group A
cells or a known group B cells (reverse typing)
2. Rh type
– Testing for Rh (D) antigen
– Not mandatory
3. Test for syphilis
4. Test for HBsAg
5. Test for HIV
6. Test for Malarial Parasites
 I. The following shall preclude a donor from blood
donation:

• Pregnancy
• Infection with HIV
• Unexplained rapid weight loss of more than 4.5 kgs or
10 lbs witin 3 months
• Possible donor who received blood or blood
components or derivatives in the preceding 6 months
known to be possible sources of hepatitis
• History of viral hepatitis
• History of close contact with a person with viral
hepatitis during preceding 6 months
 I. The following shall preclude a donor from blood
donation:

• Admission in confidence by prospective donor of

unsuitability of blood to be collected for transfusion
• Temperature above 37C (99.5F) taken orally
• Pulse rate of more than 100 beats/minute or less
than 40 beats/minute (in a non-athlete) taken for
two minutes
• Presence of skin lesion at venipuncture site
• Persons with obvious stigmata of narcotic or alcohol
habituation or intoxication
 I. The following shall preclude a donor from blood
donation:

• Hemoglobin of less than 125 gm/L (finger pricked or

venipuncture)
• Reactive test for HBsAg
• Positive history, clinical symptoms, and/or positive
serologic test for syphilis
 II. The following shall preclude donation until after a
definite time interval:
• Within 12 weeks of donation of a full unit (500 cc) of blood
• Within 1 week after pheresis
• Within 6 months following full term or trimester delivery
• Within 1 year after rabies vaccination
• Within 2 weeks after an immune reaction to smallpox vaccine
• Within 2 weeks after poliomyelitis, measles, mumps, yellow fever
immunization
• Within 8 weeks after inoculation for German measles
• Within 12 months after Hepatitis B immunoglobulin injection
• Within 2 weeks after tetanus, diphtheria, pertussis, and typhoid
immunization
• History of emergency transfusion within 6 months
• Within 6 months of tattooing on skin
II. The following shall preclude donation until after a definite time interval:
(such restrictions are not necessary when donation is to be used for
preparation of plasma component devoid of RBC)

Within 6 months after sojourn in an area considered

endemic for malaria by DOH (refer to Annex B-map),
provided that:
a. Prospective donor was a permanent resident of a
non-endemic area
b. He has been asymptomatic for 6 months
c. He has not taken anti-malarial prophylaxis for 6
months
II. The following shall preclude donation until after a definite time interval:
(such restrictions are not necessary when donation is to be used for
preparation of plasma component devoid of RBC)

• within 3 years after clinical malaria in a prospective

donor who has become asymptomatic
• Is asymptomatic within 3 years after left permanent
residency in an endemic area and having stopped
taking anti-malarial drugs
 III. The following conditions or clinical findings need
further evaluation the Head or qualified physician:

• History and physical examination evidence of

problematic cardiac, pulmonary, malignant disease,
or blood dyscrasia
• Current drug (i.e. digitalis, beta blocks, antibiotic, or
anticoagulant therapy) known to have deleterious
effect in either donor or recipient
• Donor older than 65 years of age or younger than 16
years of age
 III. The following conditions or clinical findings need
further evaluation the Head or qualified physician:

• Donor who has high exercise tolerance with low

pulse rate (athletes)
• Blood pressure reading above 160/100 or below
90/60 mmHg
• Donor weighing less than 50 kgs, but not less than 45
kgs shall be bled 300 mL
• Persons at risk of contracting AIDS
A. SCREENING OF BLOOD DONOR cont.
7. Repeat testing
– BB performing compatibility test must confirm the
ABO group of donor cells
– Discrepancies shall be resolved before the unit is
issued for transfusion
– Unexpected antibodies, HBsAg or syphilis is not
required to repeat testing
8. Previous Records
– A donor’s previous records or ABO/Rh type shall not
serve for identification of units of blood subsequently
given by the same donor
– New determinations shall be made for each collection
A. SCREENING OF BLOOD DONOR cont.

9. Retention of blood sample

– Processing samples shall be stored at 2ᴼC-6ᴼC for
at least 7 days after transfusion

10.Laboratory records
– Actual results and final interpretation shall be
recorded
 B. STORAGE OF BLOOD & COMPONENTS
1. RBC
– Stored & transported at 2ᴼC-6ᴼC
2. PLATELET CONCENTRATE
– Stored at room temperature 20ᴼC-24ᴼC with
continuous agitation throughout the storage period
3. CRYOPRECIPITATE
– If maintained constantly in the frozen state at
-30ᴼC no longer than 12 months from the date of
phlebotomy
4. PLASMA
– Liquid plasma may be store at 2ᴼC-6ᴼC for no more
than 5 days; (-30ᴼC up to 5 years)
 SPECIFICATION FOR BLOOD
COMPONENTS/PRODUCTS
1. RED BLOOD CELL COMPONENTS
a) RED BLOOD CELLS
• Separated from plasma through centrifugation
b) WASHED RBCs
• remove residual plasma proteins cytokines or
antibodies that may be the cause of the reactions
• Shall be used within 12 hours
c) LEUKOCYTE-POOR RBC
• 70% of the original WBCs are removed
• Removed by filtration, centrifugation, washing
SPECIFICATION FOR BLOOD COMPONENTS/PRODUCTS cont.

2. PLASMA & PLASMA COMPONENTS

a) LIQUID PLASMA
b) FRESH FROZEN PLASMA (FFP)
c) CRYOPRECIPITATED AHF
• Cold-insoluble portion of plasma from FFP
• Thawed between 2ᴼC-6ᴼC
SPECIFICATION FOR BLOOD COMPONENTS/PRODUCTS cont.
3. PLATELETS
 Platelet Pheresis
– Suspension of platelets in plasma by centrifugation of
whole blood
– Platelet preparation shall be stored at 20ᴼC-24ᴼC with
constant gentle agitation
4. GRANULOCYTE PHERESIS
5. WHOLE BLOOD CRYOPRECIPITATED REMOVED:
WB LEUKOCYTES REMOVED
– Blood from which cryoprecipitate/leukocytes have
been removed
 RECORDS
– There shall be accurate recording to assure proper care
of donors & patients
– Records that are discarded must be destroyed
– Medical information should not be released or made
available to unauthorized persons
– Each BB shall establish DONOR REGISTERED of rare
blood types or hazardous donors for supply of rare
blood & protection of recipient
 REPORTING
BB shall report to the BRL in a standard prescribed
format the following:
1. Volume of blood collected
2. Volume of blood issued
3. Volume of out dated blood (expired)
4. Number of units of blood with adverse reactions
5. Number of cross matches done
6. Number of positive screening tests
7. Blood components utilized
 QUALITY CONTROL
1. INTERNAL CONTROL
– Personnel, equipments and supplies, reagents, donor
selection, and blood storage, transport & blood
component processing

2. EXTERNAL CONTROL
– All BB shall participate in EQAP

– Any refusal to participate shall be a basis for

suspension/revocation of license of BB
 DONOR REGISTRIES
• Donor registries with rare blood types shall be
put up
• Any BB with rare blood types shall submit
their names to the file maintained by the BRL
 BLOOD BANKS RATES

• BB shall be operated on a non-profit basis

Safety & Sanitation/Disposal of Infectious or
Toxic Lab Wastes
• Incinerator sewerage disposal system shall be
provided throughout the BB & its premises to
prevent environmental contamination of
infectious & toxic materials

• Serum, plasma, blood & other materials that

have no evidence of having been
contaminated with infectious agent shall be
discarded into the sanitary sewerage w/out
sterilization
• Contaminated specimens or materials must be:
– Incinerated or sterilized by autoclaving
– Glass wares, pipettes, slides must be autoclaved or
chemically disinfected before being discarded or prepared
for re-use
– Single use bottles & other biological specimens containers
shall be in biohazard containers & decontaminated before
disposal
– Rejected blood products positive for serologic test that will
be used for research or for purification of viral antigen shall
be transported in accordance with the BRL
End