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
 TITLE
RA 1517 RA 7719 AO NO.9 S.1995
AN ACT AN ACT PROMOTING RULES AND
REGULATING THE VOLUNTARY BLOOD REGULATIONS
COLLECTION, DONATION, IMPLEMENTING
PROCESSING AND PROVIDING FOR AN REPUBLIC ACT NO.
SALE OF HUMAN
BLOOD, AND THE ADEQUATE SUPPLY OF 7719 OTHERWISE
ESTABLISHMENT SAFE BLOOD, KNOWN AS THE
AND OPERATION OF REGULATING BLOOD "NATIONAL BLOOD
BLOOD BANKS AND BANKS, AND SERVICES ACT OF
BLOOD PROVIDING PENALTIES 1994"
PROCESSING FOR VIOLATION
LABORATORIES THEREOF
 EFFECTIVITY DATE
RA 1517 RA 7719 AO NO.9 S.1995

JUNE 16, 1956  MAY 5, 1994 APRIL 28, 1995

 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
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
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
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 BCU/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 BRL about changes in BB,
BCU, 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 Bank/Center
Blood Collection Unit, and
Blood Station
 Blood Service Facility

• Any unit, office, institution, providing any of

the blood transfusion services which can be
Blood Bank/Center, Blood Collection Unit, or
Blood Station
 Blood bank/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
 Blood collection unit

• an institution or facility duly authorized by the

Department of Health to
– recruit and screen donors
– collect blood
 Blood station
• A government or private hospital or a 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
– AIDS
– Hepatitis B
– Hepatitis C
– Malaria
– Syphilis
Hospital-based blood bank and
non-hospital based blood bank
• 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

• 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
 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
 Categories of Blood Bank/Center
• Non hospital based Category A
• Non hospital based Category B
• Hospital based Category A
• Hospital based Category B
 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 2ᴼC
• 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
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 store 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