Prepared by:

Dayle Daniel G. Sorveto, RMT

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RA 1517 &
RA7719
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REPUBLIC ACT NO. 1517 - AN ACT

REGULATING THE COLLECTION,
PROCESSING AND SALE OF HUMAN
BLOOD, AND THE ESTABLISHMENT
AND OPERATION OF BLOOD BANKS
AND BLOOD PROCESSING
LABORATORIES
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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.
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SECTION 2

"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 a reasonable allowance for spoilage.
 SECTION 3
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 It shall be the 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 and 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.
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 No license shall be granted or renewed by the Department of Health for the

establishment or operation of a blood bank or blood processing laboratory
unless such bank or laboratory be established or operated in
accordance with accepted scientific standards, is under the
administration, direction and supervision of a licensed and qualified
physician, and blood is collected and/or processed therein by licensed
physicians or under their direct supervision and responsibility.
 No license shall be granted or renewed by said Department for the
collection and/or processing of blood unless the licensee complies with
the requirements hereinabove established for blood banks and blood
processing laboratories.cralaw
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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.
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 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.
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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.
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 This Act shall take effect upon its approval.

 APPROVED: JUNE 16,1956

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RA 7719

 AN ACT PROMOTING VOLUNTARY BLOOD DONATION,PROVIDING FOR

AN ADEQUATE SUPPLY OF SAFEBLOOD, REGULATING BLOOD
BANKS, AND PROVIDINGPENALTIES FOR VIOLATION THEREO
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SECTION 1

 Title
This Act shall be known as the "National Blood Services Act of 1994."
 SECTION 2
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 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 in still 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;
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 (c) to provide for adequate, safe, affordable and equitable distribution of

supply of blood and blood products;
 (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;
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 (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;
 (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;
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(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
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 Definitions
-For purposes of this Act, the following terms shall mean:(a)
 Blood/blood product
- refers to human blood, processed or unprocessed and includes blood
components, its products and derivatives;(b)
 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;(c)
 Commercial blood bank
- a blood bank that exists for profit;(d)
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 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 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 orinitiative and without monetary
compensation.
 Department
- the Department of Health;
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 Blood transfusion transmissible diseases
– diseases which may be transmitted as a result of blood transfusion, including AIDS, Hepatitis-B,C,
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;and
 Walking Blood Donor
- an individual included in the list of qualified voluntary blood donors referred to in Section 4,
paragraph (e), who is ready to donate blood when needed in his/her community.
- Blood Service Facility:
- Any unit, office, institution providing any of the blood transfusion services, which can be a blood
bank/center, blood collection unit, or blood station
- Blood Collection unit:
- An institution or facility duly authorized by the department of health to recruit and screen donors and
collect blood for the blood bank to which it is attached.
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SECTION 4

 Promotion of Voluntary Blood Donation

. – In order to ensure adequate supply of human blood, voluntary blood
donation shall be promoted through thefollowing:

(a) Public Education. –

(b) Promotion in Schools. –

(c) Professional Education. –

(d) Establishment of Blood Services Network.

(e) Walking Blood Donors. -

 SECTION 5
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 National Voluntary Blood Services Program

 . – The Department, in cooperation with the PNRC and PBCC and other
government agencies and non-governmental organizations shall plan and
implement a National Voluntary Blood Services Program (NVBSP) to meet in an
evolutionary manner, the needs for blood transfusion in all regions of the country.
Funds for this purpose shall be provided by the Government through the budgetary
allocation of the Department, by the Philippine Charity Sweepstakes Office
(PCSO) with an initial amount of at least Twenty-five million pesos
(P25,000,000), by the Philippine Amusement and Gaming
Corporation(PAGCOR) with an initial amount of at least Twenty-five million
pesos (P25,000,000),by the trust liability account of the Duty Free Shop (Duty
Free Philippines) with an initial amount of at least Twenty million pesos
(P20,000,000) and through contributions of other agencies such as civic
organizations.
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 Upgrading of Services and Facilities

 . – All blood banks/centers shall provide preventive health services such as
education and counselling on blood transfusion transmissible diseases.
All government hospitals, including those that have been devolved, shall be
required to establish voluntary blood donation programs and all private hospitals
shall be encouraged to establish voluntary blood donation programs. The
Department, in consultation with the PSHBT and the PSP, shall also establish
guidelines for the rational use of blood and blood products
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SECTION 7

 Phase-out of Commercial Blood Banks

– All commercial blood banks shall be phased-out

over a period of two (2) years after the effectivity
of this Act, extendable to a maximum period of two
(2) years by the Secretary.
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SECTION 8

 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.
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SECTION 9

 Regulation of Blood Services

– It shall be unlawful for any person toestablish and operate a blood bank/center
unless it is registered and issued a license tooperate by the Department:
Provided , That in case of emergencies, blood collection and transfusion under the
responsibility of the attending physician shall be allowed in hospitals without such
license under certain conditions prescribed by the Department.
 No license shall be granted or renewed by the Department for the establishment
andoperation of a blood bank/center unless it complies with the standards
prescribed by the Department.
 Such blood bank/center shall be under the management of a licensed and qualified
physician duly authorized by the Department.
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SECTION 10
 Importation of Blood Bank Equipment, Blood Bags and
Reagents
–Upon the effectivity of this Act, equipment, blood bags and
reagents used for the screening and testing of donors,
collection and processing and storage of blood shall be
imported tax-and duty-free by the PNRC, blood banks and
hospitals participating actively in the National Voluntary
Blood Services Program. This provision shall be
implementedby the rules and regulations to be promulgated by
the Department in consultation and coordination with the
Department of Finance.
 SECTION 11
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 Rules and Regulations

 – The implementation of the provisions of this Act shall be in
accordance with the rules and regulations to be promulgated by the
Secretary, within sixty (60) days from the approval hereof. The
existing Revised Rules and Regulations Governing the
Collection, Processing and Provision of Human Blood and the
Establishment and Operation of Blood Banks shall remain in
force or revised by the Secretary. The rules and regulations shall
prescribe from time to time the maximum ceiling for fees for the
provision of blood, including its collection, processing and
storage, professional services and a reasonable allowance for
spoilage.
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 Penalties
 Collect charges and fees greater than themaximum prescribed by the Department
shall have its license suspended or revoked bythe Secretary. Any person or persons
penalty of
who shall be responsible for the above violation shallsuffer the
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 Fiftythousand pesos (P50,000), or
both at the discretion of the competent court.
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 Any person who shall establish and operate a blood bank without securing
anylicense 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. The Secretary,
after due notice and hearing, may impose administrative sanctionssuch as,
but not limited to fines, suspension, or revocation of license to operate a
blood bank/center and to recommend the suspension or revocation of
the license to practice the profession when applicable.
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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.
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SECTION 13

 Separability Clause

 . – If any provision of this Act is declared invalid,

theother provisions hereof not affected thereby shall
remain in force and effect.
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SECTION 14

 Repealing Clause

 . – This Act shall supersede Republic Act No. 1517

entitled "Blood Bank Act." The provisions of any law,
executive order, presidential decree or other
issuances inconsistent with this Act are hereby
repealed or modified accordingly
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SECTION 15

 Effectivity Clause

 . – This Act shall take effect after fifteen (15) days

following its publication in the Official Gazette or in
two (2) national newspapers of general circulation.
 MAY 15, 1994
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ADMINISTRATIVE
ORDER NO36 Series of
1994
 Rules and Regulation of RA 7719
CHAPTER 2z
NATIONAL VOLUNTARY BLOOD SERVICE PROGRAM
1. COMPOSITIONS: national voluntary blood service committee is created and shall be chaired by
secretary of health. And shall be composed by the heads of the following offices:
1. Department of education, culture and sports
2. DILG
3. Department of finance
4. DSWD
5. PRC
6. PNRC
7. PBCC
8. PSHBT
9. PSP
10. PMA
11. PHA
12. PNA
13. PAMET
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RESPONSIBILITIES OF COMMITEES
 Formulation of 5-year directional/strategic plan of NVBSP
 Operationalization and institutionalization of the NVBSP
 Monitoring evaluation of NVBSP
 Creation of multi-sectoral technical sub-committees
 Advocacy and promotion
 Programming agency
 Monitoring and evaluation
 Curriculum development
 Professional education

 Generation of multi-sectoral and inter-disciplinary support for national activities on

blood services
 Meetings- shall meet at least quarterly
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Section 7: DOH Program management
1. National Voluntary Blood services Unit. The secretary of health shall
institutionalize a NVBSU within the organizational structure of office.
2. Functions.
 Integration and coordination of all voluntary blood service program efforts
 Development of training, information, education and communication (IEC)
materials, program guidelines and standards on preventive maintenance, pre-
and post-donation counselling
 Provision of technical assistance and training in designing and implementing a
voluntary blood donation
 Preparation of blood services operational plan
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Section 9: Public information and education
1. composition: the national advocacy and promotion sub-committee.
1. Representative of DOH.
2. PNRC
3. PBCC
4. PIA

2. Functions:
 Preparation of 5-year advocacy and promotion plan based on the BVBSP
 Formulation of designs for non-monetary or non-profit oriented incentives for voluntary blood
 Planning, coordination, monitoring and evaluation of national advocacy and promotion activities
3. Regional advocacy
 Formulation of regional advocacy and promotion operational plan
 Implementation, monitoring and evaluation of regional advocacy.
Administrative order
no-17 series of 1998
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Requirements and Procedures for LTO a
blood bank/blood center in the philippines

 Section 1: Title: shall be known as “ Requirements and Procedures for a

License to Operate a blood bank/ Blood Center in the Philippines
 section 2: REGULATORY AUTHORITY
 The Licensing and regulatory functions of the department of health for blood
service facilities shall be exercised through the BUREAU OF RESEARH AND
LABORATORIES (BRL) and OFFICE FOR HEALTH FACILITIES, STANDARDS
AND REGULATION (OHFSR)
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SECTION 3: PURPOSE

 To Protect and Promote the health of the people by preventing the operation
and maintenance of sub-standard blood bank/blood center in the country
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Section: 4 Scope

Requirements and procedures shall apply to all establishments, owned and

operated by the government and non-government agencies, and private
individuals.
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Section: 5 service Capabilities of Blood bank/
Blood Center
Category A (non-Hospital based)
 Recruitment and retention of voluntary blood
donors
 Health education and counseling
 Donor screening and selection
 Blood collection
 Blood testing for blood transmissible diseases.
 Provision of whole blood and packed RBC
 Storage of whole blood and PRBC
 Issuance, transport and distribution of whole
blood and PRBC
Category B: (non hospital based)
 Recruitment and retention of voluntary blood
donors
 Health education and counseling
 Donor screening and selection
 Blood collection
 Blood testing for blood transmissible
diseases
 Provision of whole blood, PRBC and other
blood components
 Storage of whole blood and blood products
 Issuance, transport and distribution of whole
blood and blood products
 Section: 5 service Capabilities of Blood bank/
z Blood Center
Category A (Hospital Based)
 All of the above in (category A Non-
hospital-based)
 Compatibility testing
Category B (hospital Based)
 All of the above in category B (non-
hospital-based)
 Compatibility testing
 Preliminary investigation of
transfusion reaction
 Resolution of incompatible cross-
matches.
 Section 6: OPERATION AND MAINTENANCE
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OF BLOOD BANK/CENTER
 Operation and maintenance of blood bank/ blood center shall be non-profit basis. Blood
shall be collected only from healthy voluntary donors. Service fees may be collected but
not greater than the amount of prescribed by DOH

 Any individual firm, corporation, entity or institution shall not be allowed to operate a blood
bank/center nor allowed to collect, process and distribute human blood without having
secured a proper and valid license issued by BRL

 In emergency cases wherein the medical/ surgical condition poses an immediate threat to
patient’s life, blood collection and immediate transfusion in hospital without a license to
operate a blood bank/center may allowed to provide the donor selection , blood collection,
blood screening and compatibility testing in existing acceptable standrds.

 blood bank/center whose license has been revoked or suspended shall not be allowed to
reopen without first securing a new license shall be issued upon satisfactory evidence
 SECTION 7: Requirements for license to
operate
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 ALL BB/BC shall granted a license to operate only if it have complied with the following:
 1. pre-licensing requirement:
 Compliance to the guidelines for the establishment of regional blood services network.
2. Licensing Requirements:
Any individual, firm or corporation, entity, establishment and institution desiring to establish or operate and maintain a
BB/BC shall submit to BRL the following
Documents:
A. Duly accomplished and notarized petition/application form (BRL-BSF (BB/BC) Form No.1)
B. Blood Services Network Documents (AO #9 s.95, chapter 8, section 28, item 10)
A. Certificate of inclusion in the official blood services network of the national voluntary blood services program unit (NVBSP)

B. List of blood collection units and blood station within their network to include names of their respective personnel

C. Certificate of registration
A. If corporation/foundation proprietorship/ ownership- sertified true copy of (SEC) securities and exchange commission
registration

B. If single proprietorship/ ownership certified true copy of (DTI)

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 D. photocopies of PRC certificates of personnel of the blood service Facilities,

 Additional requirement for the head of the blood bank/ blood center
 If pathologist, specialty board certificate issued by the Philippine board of
Pathologist
 If Hematologist, Specialty board certificate issued by the Philippine Board of
hematology and blood transfusion.
 E. location map of the BB/BC
 Floor diagram of the BB/BC and its premises
 G. List of equipment- serial number, brand, date of purchase, number of units
 H. list of glasswares
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Human resource requirements:

A. HEAD (For both category A &B hospital based and non-hospital based)
A. Shall be registered physician w/ PRC, certified clinical pathologist by Philippine board
pathology or blood banking by the Philippine board of hematology and blood
transfusion.

B. Medical technologist:
A. Duly registered by the PRC with vaild professional license and with at least 1 year on
the job training or experience in blood banking services.
A. Blood bank Category A – at least 4 RMT based on: 1 RMT in every shift (Morning,
Afternoon and Night) and 1 Off-duty.

B. Blood bank Category B – at least 5 RMT based on: 2 RMT in morning shift, 1 RMT in
afternoon and night shift and 1 Off-duty.
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SECTION 8: License Fees and Charges
 The license fees and charges shall be uniform for both government and non-government
blood banks/centers and shall be adjusted only by the BRL through appropriate official
issuances as the need arises.
 License Fee
 A non-refundable license fee of P600.00 shall be charged for every accepted application for a new
license to operate a blood bank.
 A non-refundable fee of P400.00 shall be charged for every accepted application for renewal of
license.
 The license fee shall cover the cost of inspection and printing of license certificates and other
required forms and documents. Subsequent or separate issuances shall cover other allowable
fees and charges.

 Charges
 A penalty of P5,000.00 for blood banks which fail to submit application for renewal of license to
the BRL within 2 months prior to the expiration of existing license.
 Blood banks which fail to submit an application for renewal within the 2 months period shall be
considered as “Blood banks Operating without a License” when their current license expires and
shall be subject to penalties for such violation.
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