BLOOD BANKING LAWS

COLLEGE OF MEDICAL LABORATORY SCIENCE

MEDTECH LAWS AND BIOETHICS
 BLOOD BANKING LAWS
• Republic Act 1517
■ – Blood banking Law of 1956
■ 7 Section
■ – June 16, 1956

■ AN ACT REGULATING THE COLLECTION, PROCESSING

AND SALE OF HUMAN BLOOD, AND THE
ESTABLISHMENT AND OPERATION OF BLOOD BANKS
AND BLOOD PROCESSING LABORATORIES.
Section 1
■ In order to promote public health, it is declared a national
policy to prevent trafficking in human blood and its
products and derivatives.

Section 2
■ As used in this Act:

"Blood" means human blood, processed or unprocessed, and

includes its products and derivatives.

"Person" includes corporations, partnerships, associations

and organizations.

"Cost" means the actual purchase price of unprocessed blood

and its handling charges, such as those for its collection,
processing, storage, transportation, and sale, and reasonable
allowance for spoilage.
Section 3
■ It shall be unlawful for any person to establish or
operate a blood bank or blood processing
laboratory, or to collect or process blood if he is not
a licensed physician, or to sell blood collected from
another person, even if authorized by the latter,
without first securing a license from the
Department of Health: Provided, That in cases of
emergency, blood transfusion shall be allowed
under the responsibility of the attending
physician without such license: And provided,
further, That persons operating blood banks and
blood processing laboratories on the date of the
approval of this Act may continue to operate the
same if they secure such license within sixty days
from the date of the issuance of the rules and
regulations provided for in section five hereof.
Section 4
■ Blood banks and processing laboratories shall be
operated on a non-profit basis. Blood collecting or
processing by other blood collectors or processors or by
individual physicians shall also be on a non-profit basis.
Blood shall be sold by such banks and laboratories, other
blood collectors or processors, and individual physicians at
cost.

Section 5
■ The Secretary of Health is charged with the responsibility
of strictly enforcing this Act, and shall issue such, rules and
regulations as may be necessary to carry out its
provisions, including rules and regulations prescribing,
from time to time, the maximum ceilings for handling
charges of blood, such as charges for its collection,
processing, storage, transportation, and sale, and a
reasonable allowance for spoilage, which shall be
considered as part of the cost of blood.
Section 6
■ Any person who violates any provision of this Act or of the
rules and regulations issued thereunder shall be punished
by imprisonment for not less than one month and not more
than one year or by a fine of not less than one hundred
pesos and not more than one thousand pesos or by both
such fine and imprisonment in the discretion of the court.

Section 7
■ This Act shall take effect upon its approval.
 BLOOD BANKING LAWS

• RepublicAct 7719
– “National Blood Services Act of 1994”
– 15 Section
– May 5, 1994
– AN ACT PROMOTING VOLUNTARY BLOOD
DONATION, PROVIDING FOR AN ADEQUATE
SUPPLY OF SAFE BLOOD, REGULATING
BLOOD BANKS, AND PROVIDING
PENALTIES FOR VIOLATION THEREOF
SECTION 1
■ This Act shall be known as the “National Blood
Services Act of 1994”.
SECTION 2
■ Declaration of Policy. – In order to promote public health, it
is hereby declared the policy of the State:
a) to promote and encourage voluntary blood donation by the
citizenry and to instill public consciousness of the principle
that blood donation is a humanitarian act;
b) to lay down the legal principle that the provision of blood
for transfusion is a professional medical service and not a
sale of a commodity;
c) to provide for adequate, safe, affordable and equitable
distribution of supply of blood and blood products;
SECTION 2
■ Declaration of Policy. – In order to promote public health, it
is hereby declared the policy of the State:
d) to inform the public of the need for voluntary blood
donation to curb the hazards caused by the commercial sale
of blood;
e) to teach the benefits and rationale of voluntary blood
donation in the existing health subjects of the formal
education system in all public and private schools, in the
elementary, high school and college levels as well as the non-
formal education system;
f) to mobilize all sectors of the community to participate in
mechanisms for voluntary and non-profit collection of blood;
g) to mandate the Department of Health to establish and
organize a National Blood Transfusion Service Network in
order to rationalize and improve the provision of adequate and
safe supply of blood;
SECTION 2
■ Declaration of Policy. – In order to promote public health, it
is hereby declared the policy of the State:
h) to provide for adequate assistance to institutions
promoting voluntary blood donation and providing non-profit
blood services, either through a system of reimbursement for
costs from patients who can afford to pay, or donations from
governmental and non-governmental entities:
i) to require all blood collection units and blood banks/centers
to operate on a non-profit basis;
j) to establish scientific and professional standards for the
operation of blood collection units and blood banks/centers in
the Philippines;
k) to regulate and ensure the safety of all activities related to
the collection, storage and banking of blood; and
l) to require upgrading of blood banks/centers to include
preventive services and education to control spread of blood
transfusion transmissible diseases.
 SECTION 3
BLOOD BANKING LAWS

• Definition of terms:
– Blood/blood
product – refers to
human blood,
processed or
unprocessed and
includes blood
components, its
products and
derivatives
 BLOOD BANKING LAWS
• Definition of terms:
– 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 and provide
information and/ or
education on blood
transfusion transmissible
diseases
 BLOOD BANKING LAWS

• Definition of terms:
– Commercial blood bank – a blood
bank that exists for profit
– Hospital-based blood bank – a blood
bank which is located within the premises
of a hospital and which can perform
compatibility testing of blood
 BLOOD BANKING LAWS
• Definition of terms:
– Blood collection unit – an
institution or facility duly
authorized by the
Department of Health to
recruit and screen
donors and collect blood
– Voluntary blood donor – one
who donates blood on one’s
own volition or initiative and
without monetary
compensation
 BLOOD BANKING LAWS

• Definition of terms:
– Blood transfusion transmissible diseases
– diseases which may be transmitted as a
result of blood transfusion, including AIDS,
Hepatitis-B, Malaria and Syphilis
– Secretary of Health – the Secretary of Health
or any other person to whom the Secretary
delegates the responsibility of carrying out the
provisions of this Act
 BLOOD BANKING LAWS

• Definition of terms:
– Walking Blood Donor – an individual
included in the list of qualified voluntary
blood donors who is ready to donate
blood when needed in his/her
community.
 BLOOD BANKING LAWS
• A.O. No. 36 s. 1994
– RULES AND REGULATIONS IMPLEMENTING
REPUBLIC ACT NO. 7719 OTHERWISE KNOWNAS
THE “NATIONAL BLOOD SERVICES ACT OF 1994”
• A.O. No. 01 s.1995
– CREATION OF A NATIONAL VOLUNTARY BLOOD
SERVICES UNIT (NVBSU)
A.O. No. 09 s. 1995
– RULES AND REGULATIONS IMPLEMENTING
REPUBLIC ACT NO. 7719 OTHERWISE KNOWNAS
THE “NATIONAL BLOOD SERVICES ACT OF 1994”
 BLOOD BANKING LAWS
• A.O. No. 17 – A s.1998
– AMENDMENT TO SECTIONS 26 TO 32 OF THE
ADMINISTRATIVE ORDER NO. 9 S. 1995 TO BE
KNOWN AS REQUIREMENTS AND
PROCEDURES FOR A LICENSE TO OPERATE A
BLOOD BLANK/ BLOOD CENTER IN THE
PHILIPPINES
• A.O. No. 2010 – 0001
– POLICIES AND GUIDELINES FOR THE
PHILIPPINE NATIONAL BLOOD SERVICES
(PNBS) AND THE BLOOD SERVICES
NETWORKS (BSN)
 BLOOD BANKING LAWS

• A.O. No. 2008 – 0008 – A

– AMENDEMENT TO THE ADMINISTRATIVE
ORDER 2008 – 0008 THE RULES AND
REGULATIONS GOVERNING THE
REGULTATION OF BLOOD SERVICE
FACILITIES
– MAY 2, 2008
 A.O. No. 2008 – 0008 – A

Classification of Blood Service

Facility:
– Ownership
– Institutional Character
–Service Capability
 A.O. No. 2008 – 0008 – A

Classification of Blood Service

Facility:
– Ownership
• Government
• Private (hospital-based blood service
facility)
 A.O. No. 2008 – 0008 – A

Classification of Blood Service

Facility:
– Institutional Character
• Hospital-based
• Non-hospital-based (Government owned
or PNRC-owned)
 BLOOD BANKING LAWS

• Service Capability
– BLOOD STATION (BS)
– BLOOD COLLECTION UNIT (BCU)
– BCU/BS
– BLOOD BANK (BB)
– BLOOD CENTER (BC)
 BLOOD BANKING LAWS
A. BLOOD STATION (BS)
1.Advocacy and promotion of voluntary
blood donation and healthy lifestyle.
2.Provision of whole blood and packed
red cells.
3.Storage, issuance, transport and
distribution of whole blood and packed red
cells.
4.Compatibility testing of red cell
units, if hospital based.
 BLOOD BANKING LAWS
B.) BLOOD COLLECTION UNIT (BCU)
1.Advocacy and promotion of voluntary blood donation
and healthy lifestyle.
2.Recruitment, retention, and care of voluntary blood
donors.
3. Screening and selection of voluntary blood donors.
4. Conduct health education and counseling services.
5.Collection of blood (mobile or facility-based) from
qualified voluntary blood donors.
6. Transport of blood to BC for testing and processing.
7. Compatibility testing of red cell units, if hospital based.
 BLOOD BANKING LAWS

C.) BCU/BS
1. All services stipulated under BCU and BS
 BLOOD BANKING LAWS
D.) BLOOD BANK (BB)
1.Advocacy and promotion of voluntary blood donation
and healthy life.
2.Storage and issuance of whole blood and blood
components obtained from a BC.
3. The following services shall also be provided:
a. Compatibility testing of red cell units
b. Direct Coomb’s test
c. Red cell antibody screening
d. Investigation of transfusion reactions
e.Assist the Hospital Blood Transfusion Committee (HBTC)
in the conduct of post-transfusion surveillance
(hemovigilance)
 BLOOD BANKING LAWS
E.) BLOOD CENTER (BC)
1.Advocacy and promotion of voluntary blood donation
and healthy lifestyle.
2. Recruitment, retention, and care of voluntary blood
donors.
3.Collection of blood (mobile or facility-based) from
qualified voluntary blood donors.
4. Conduct health education and counseling.
5.Testing of units of blood for transfusion-
transmitted infections (TTIs).
6. Processing and provision of blood components.
7.Storage, issuance, transport and distribution of units
of whole blood and
 BLOOD BANKING LAWS
• Promotion of Voluntary Blood Donation
A. Public Education – PNRC, PBCC, other government
agencies, LGUs (barangays), non-governmental
organizations, all medical organizations, all public and
private hospitals, all health and health-related
institutions, print and broadcast media
B. Promotion in Schools – DOH
C. Professional Eucation – PBCC, PSHBT, PSP, PMA,
PAMET, PNA
D. Establishment of Blood Services Network
E. Walking Blood Donors
 BLOOD BANKING LAWS

• Non-profit Operation – All blood banks/centers

shall operate on a non-profit basis: Provided,
That they may collect service fees not greater
than the maximum prescribed by the
Department which shall be limited to the
necessary expenses entailed in collecting and
processing of blood. Blood shall be collected
from healthy voluntary donors only.
 BLOOD BANKING LAWS

• Penalties – Upon complaint of any

person and after due notice and
hearing, any blood bank/center which
shall collect charges and fees greater
than the maximum prescribed by the
Department shall have its license
suspended or revoked by the Secretary.
 BLOOD BANKING LAWS

• Any person or persons who shall be

responsible for the above violation shall
suffer the 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 at the discretion of the competent
court.
 BLOOD BANKING LAWS

• Any person who shall establish and operate a blood

bank without securing any license to operate from
the Department or who fails to comply with the
standards prescribed by the Department referred to
in Section 9 hereof shall suffer the penalty of
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 at the discretion of the
competent court.
 BLOOD BANKING LAWS

• The head of the blood bank and the necessary

trained personnel under the head’s direct
supervision found responsible for dispensing,
transfusing and failing to dispose, within forty-
eight (48) hours, blood which have been proven
contaminated with blood transfusion
transmissible diseases shall be imprisoned for ten
(10) years. This is without prejudice to the filing of
criminal charges under the Revised Penal Code.