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
Blood Bank Act
Repealed by Republic Act No. 7719
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 a reasonable allowance for spoilage.
Section 3. 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.
• 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.
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.

• Approved: June 16, 1956.
REPUBLIC ACT NO.7719
SECTION 1. Title. – This Act shall be known as the “National
Blood Services Act of 1994”.

SEC. 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;
• 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;
• 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.
SEC. 3. 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) Hospital-based blood bank – a blood bank which is located
within the premises of a hospital and which can perform
compatibility testing of blood;
• e) Blood collection unit – an institution or facility duly authorized
by the Department of Health to recruit and screen donors and
collect blood;
• f) Voluntary blood donor – one who donates blood on one’s
own volition or initiative and without monetary compensation;
• g) Department – the Department of Health;
• h) Blood transfusion transmissible diseases – diseases which
may be transmitted as a result of blood transfusion, including
AIDS, Hepatitis-B, Malaria and Syphilis;
• i) 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
• j) 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.
SEC. 4. Promotion of Voluntary Blood Donation. – In
order to ensure adequate supply of human blood, voluntary blood
donation shall be promoted through the following:

• a) Public Education. – Through an organized and sustained

nationwide public education campaign by the Department, the
Philippine National Red Cross (PNRC) and the Philippine Blood
Coordinating Council (PBCC), as the lead agencies, other
government agencies, local government units (particularly the
barangays), non-governmental organizations, all medical
organizations, all public and private hospitals, all health and health-
related institutions, print and broadcast media as well as other
sectors. The Department is hereby authorized to set aside funds and
generate financial support for all sectors involved in the collection
and processing of blood from voluntary blood donors through a
system of reimbursement for costs for patients who can afford to
pay or from donations from government and private institutions.
Voluntary donors shall likewise be provided non monetary
incentives as may be determined by the Department.
• b) Promotion in Schools. – The benefits and rationale of
voluntary blood donation shall be included and given emphasis
in health subjects of schools, both public and private, at the
elementary, high school and college levels. The Department of
Education, Culture and Sports shall also require such inclusion in
its non-formal education curricula.
• c) Professional Education. – The Department, the PBCC, the
Philippine Society of Hematology and Blood Transfusion
(PSHBT), the Philippine Society of Pathologists (PSP), the
Philippine Medical Association (PMA), the Philippine
Association of Medical Technologists (PAMET) and the
Philippine Nursing Association (PNA) are encouraged to conduct
for their respective members and as part of the continuing
medical education, trainings on the rational use of blood and
blood products including the merits of voluntary blood donation.
• d) Establishment of Blood Services Network. – Blood centers
shall be strategically established in every province and city
nationwide within the framework of a National Blood
Transfusion Service Network spearheaded by the Department,
in coordination with the PNRC. The collection of blood in
various areas in the community, such as schools, business
enterprises, barangays, and military camps shall be promoted.
• The Secretary shall set the standards for the scientific and
professional establishment and operation of blood
banks/centers and collection units. The Department shall
provide training programs and technical assistance to enable
communities, schools, industrial and business sites, barangays,
military camps and local government units to implement their
own voluntary blood donation programs.
• e) Walking Blood Donors. – In areas where there may be
inadequate blood banking facilities, the walking blood donor
concept shall be encouraged and all government hospitals,
rural-health units, health centers and barangays in these areas
shall be required to keep at all times a list of qualified
voluntary blood donors with their specified blood typing.
SEC. 5. 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.
SEC. 6. Upgrading of Services and Facilities.
All blood banks/ centers shall provide preventive health
services such as education and counseling 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.

SEC. 7. Phase-out of Commercial Blood Banks. – AH

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.
SEC. 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.

SEC. 9. Regulation of Blood Sciences. – It shall be unlawful for any

person to establish and operate a blood bank/center unless it is
registered and issued a license to operate 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 and operation 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
SEC. 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 implemented by the rules and regulations to be
promulgated by the Department in consultation and coordination with
the Department of Finance.
SEC. 11. 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 unless amended 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.
SEC. 12. 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.
• 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.
• 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.
• The Secretary, after due notice and hearing, may impose administrative
sanctions such 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.
• 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.
SEC. 13. Separability Clause. – If any provision of this Act is
declared invalid, the other provisions hereof not affected thereby
shall remain in force and effect.

SEC. 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.

SEC. 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.
Approved:
• Sgd.) JOSE C. DE VENECIA, JR.
Speaker of the House
of Representatives
• (Sgd.) EDGARDO J. ANGARA
President of the Senate
• This Act which is a consolidation of Senate Bill No. 1011 and
House Bill No. 879 was finally passed by the Senate and the
House of Representatives on April 28, 1994.
• Sgd.) CAMILO L. SABIO
Secretary General
House of Representatives
• (Sgd.) EDGARDO E. TUMANGAN
Secretary of the Senate
• Approved: MAY 5, 1994
• (Sgd.) FIDEL V. RAMOS
President of the Philippines
ADMINISTRATIVE ORDER
No. 36 series 1994
(August 12, 1994)
RULES AND REGULATIONS IMPLEMENTING REPUBLIC
ACT NO. 7719 OTHERWISE KNOWN AS THE “NATIONAL
BLOOD SERVICES ACT OF 1994”

• Chapter I
• TITLE AND APPLICATION

Section 1 (TITLE)

• These rules shall be known as the “Rules and Regulations

Implementing Republic Act No. 7719 otherwise known as the
NATIONAL BLOOD SERVICES ACT OF 1994.”
 
Section 2 (PURPOSE)
• These Rules and regulations are adopted prescribing the
principles, guidelines, procedures and standards for the
implementation of R.A. 7719 to facilitate compliance therewith
and achieve the objective thereof.

Section 3 (SCOPE)
• These rules shall apply to all hospitals, entities, establishments
or institutions, government owned and operated or private,
engaged in blood transfusion services in the Philippines,
whether full time or part time, local or foreign.
Section 4 (DEFINITION OF TERMS)
• As used in these Rules and Regulations, the terms below shall be
defined as follows:
1.  ACT – Republic Act 7719 otherwise known as the “National Blood
Services Act of 1994”, unless herein specified;
2. DEPARTMENT – the Department of Health;  
3. SECRETARY OF HEALTH – the Secretary of Health or any other
person to whom the Secretary delegates the responsibility of carrying out
the provision of this Act;
4. BLOOD/ BLOOD PRODUCT – refers to human blood, processed or
unprocessed and includes blood components, its products and derivatives;
5. BLOOD TRANSFUSION SERVICES – a set of activities and
functions related to blood transfusion such as, but not limited to,
motivation and recruitment of donors, blood collection, testing and
screening of donor blood, preparation of blood components, storage and
distribution of blood and components, inventory control and quality
assurance;
6. 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 transmissible diseases;
7. NATIONAL BLOOD CENTER  – refers to the central institution of the
National Voluntary Blood Services Program and serves as a base for
development of a network of regional blood centers, also sets as the regional
blood center for the region in which it is situated;
8. REGIONAL BLOOD CENTER – refers to the laboratory or an
institution with the responsibility of ensuring a safe, stable and cost –
effective supply of blood and blood products to fulfill the needs of patients
in the region; it serves as a base for the development of a network of blood
banks in the region;
9. HOSPITAL–BASED BLOOD BANK/CENTER – a blood bank/center
which is located and performing blood bank services within the premises of
a hospital and which can perform compatibility testing of blood; 
10.  NON–HOSPITAL BASED BLOOD BANK/CENTER – a blood
bank/center which is not located and not performing blood bank services
within the premises of a hospital and is not part of a hospital;
11.  COMMERCIAL BLOOD BANK – a blood bank that exists for
profit, money or any material gain earned out of sale of, or exchange for,
blood or blood products which profit, money or any material gain are not
used solely for the operation and maintenance of the blood bank service;
12.  BLOOD COLLECTION UNIT – an institution or facility duly
authorized by the Department of Health to recruit and screen donors and
collect blood;
13.  BLOOD STATION – a government or private hospital or a
Philippine National Red Cross chapter which has not been licensed as a
blood center but has been authorized by the Department to store and
issue blood and blood products, and perform compatibility testing, when
necessary, according to specific regulations in Section 40 hereby;
14.  BLOOD SERVICE FACILITY – any unit, office, institution
providing any of the blood transfusion services, which can be a Blood
Bank/Center, a Blood Collection Unit or a Blood Station;
15.  VOLUNTARY BLOOD DONOR – an individual who donates
blood on one’s own volition or initiative and not induced, directly or
indirectly, in any manner whatsoever, by any monetary compensation;
16. 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 referred to in Section 4, paragraph (e) of R.A. No. 7719,
who is ready to donate blood when needed in his or her
community;
17.  BLOOD TRANSFUSION TRANSMISSIBLE DISEASES
– diseases which may be transmitted through blood transfusion,
including, but not limited to, Acquired Immune Deficiency
Syndrome (AIDS), Hepatitis B, Hepatitis C, malaria and syphilis;
• Chapter II
• NATIONAL VOLUNTARY BLOOD SERVICES
PROGRAM

Section 5 (NATIONAL PROGRAM COMMITTEE)

1. Composition
A National Voluntary Blood Services Program Committee is
hereby created and shall be chaired by the Secretary of Health. It
shall be composed of, but not limited to, the Heads of the
following Offices and associations.
The Secretary of Health may designate such other members from
other societies and cooperating or donor agencies as may be
necessary to the operations of the Committee.
Heads of the following Offices and associations:
• Department of Education, Culture and Sports
• Department of Interior and Local Government
• Department of Finance
• Department of Social Welfare and Development
• Professional Regulation Commission
• Philippine National Red Cross
• Philippine Blood Coordinating Council
• Philippine Society of Hematology and Blood Transfusion
• Philippine Society of Pathologists
• Philippine Medical Association
• Philippine Hospital Association
• Philippine Association of Medical Technologists, and
2. The National Voluntary Blood Services Program Committee shall
be responsible for the following:

• a. Formulation of a five–year Directional /Strategic Plan of the National

Voluntary Blood Services Program taking into consideration the 1992
National Blood Services Program Directional Plan of the Department;
• b. Operationalization and institutionalization of the National Voluntary
Blood Services Program including budgetary allocation for program
activities;
• c. Monitoring and evaluation of the National Voluntary Blood Services
Program including budgetary allocation for program activities;
• d. Creation of multi–sectoral sub–committees such as, but not limited to,
advocacy and promotion, programming, monitoring and evaluation and
curriculum development
• e. Generation of multi–sectoral and inter–disciplinary support for
national activities focused on blood services including the organization
of the National Blood Congress.
3.      Meetings
The National Voluntary Blood Services Program Committee shall
meet at least quarterly. Unscheduled or emergency meetings shall
be called upon the discretion of the chairperson.

Section 6 (FIELD REPRESENTATIVE OF THE NATIONAL

COMMITTEE)

The Regional Health Director shall be the field representative of

the National Voluntary Blood Services Program Committee, and
such shall coordinate the Voluntary Blood Services Program
activities in the region.
Section 7 (NATIONAL VOLUNTARY BLOOD SERVICES UNIT)

1. The Secretary of Health shall institutionalize a National Voluntary Blood

Services Unit within the organizational structure of the Office of Health Facilities
Standards and Regulation of the Department.
2. The unit, as the program management arm of the Department, shall be
responsible for the following:
• a. Integration and coordination of all voluntary blood service program efforts
such as, but not limited to, integration of blood service facilities operations and
upgrading;
• b. Development of training, information, education and communication (IEC)
materials, program guidelines and standards especially on preventive services,
and pre– and post–donation counseling for blood transfusion transmissible
diseases in coordination with other health programs and units in the Department;
• c. Provision of technical assistance and training in designing and implementing a
voluntary blood donation program in private hospitals;
• d. Preparation of the blood services operational pan incorporation the activities
and needs of the other Department units and services involved in the blood
services programs such as, but not limited to, the Bureau of Licensure and
Regulation, and Hospital Operation and Management Service;
• e. Provision of secretariat services to the National Voluntary
Blood Service Program Committee and as such shall:

(1) Collate and review all annual operational plans, proposed

budgets of the different sub–committees at the national and sub–
national levels;
(2) Propose priorities for budgetary allocation;
(3) Prepare the consolidated annual National Voluntary Blood
Services Program Plan which shall be submitted during the first
quarter meeting of the National Program Committee for
approval;
(4) Coordinate and document all National Voluntary Blood
Service Program Committee and sub–committee meetings and
activities.
Section 8 (PROGRAM FUNDING)

1. The funds for the National Voluntary Blood Services Program

shall be provided by:

• a. The budgetary allocation of the Department;

• b. The Philippine Charity Sweepstakes Office with the initial
amount of at least twenty–five million pesos (P 25,000,000.00)
• c. The Philippine Amusement and Gaming Corporation with the
initial amount of at least twenty–five million pesos (P
25,000,000.00)
• d. The trust liability account of the Duty Free Shop with the
initial amount of at least twenty million pesos (P 20,000,000.00)
• e. The contributions of other agencies such as civic and
charitable organizations
2. The National Voluntary Blood Services Program Committee
shall work out a plan with the Philippine Charity Sweepstakes
Office, Philippine Amusement and Gaming Corporation and Duty
Free Shop and similar civic and charitable organizations for
continued funding and material support.
3. The utilization of the fund shall be based on the consolidated
and approved National Voluntary Blood Services Program
Committee Plan.  
4. The Department shall allocate an annual budget for personnel,
capital outlay, infrastructure, maintenance, operating and other
expenses to be used by the program.  
5. A trust fund shall be established for the National Voluntary
Blood Services Program at the national level and at the level of the
different blood service facilities of the Department out of the
donations generated by the office and/or the facility. Use of funds
shall be based on the operational plan of the different sub–
committees and blood service facilities concerned.
• Chapter III
• PROMOTION OF VOLUNTARY BLOOD DONATION

Section 9 (PUBLIC INFORMATION AND EDUCATION)

1. Composition
The National Advocacy and Promotion sub–committee shall be composed of representatives
of the
   Department of Health, the
   Department of Education, Culture and Sports
   Department of Social Welfare and Development
   Philippine National Red Cross
   Philippine Blood Coordinating Council
   Philippine Information Agency,
   Kapisanan ng mga Brodkaster sa Pilipinas
   National Press Club

The National Voluntary Blood Services Committee may designate such other members from
similar organizations whose activities are related to advocacy and promotion of voluntary
blood donation as may be deemed necessary to the functions of the sub–committee.
2. Functions  
The National Advocacy and Promotion sub–committee shall be
responsible for the following:

• a. Preparation of a five–year advocacy and promotion plan

based on the National Voluntary Blood Services Program five–
year directional/ strategic plan which shall be submitted to the
Secretary of Health for approval;
• b. Formulation of designs for non–monetary or non–profit
oriented incentives for voluntary blood donors such as, but not
limited to, Blood Assurance Plans;
• c. Planning, coordination, monitoring and evaluation of the
national advocacy and promotion activities;
3. Regional Counterpart

The Regional Advocacy and Promotion sub–committees shall be

created in each region of the country with similar corresponding
composition as that of the National Advocacy and Promotion sub–
committee but may be expanded to include other organizations. In turn,
the Regional Advocacy and Promotion sub–committee shall encourage
the creation of similar committees at the provincial and city levels.
The Regional Advocacy and Promotion sub–committee shall be
chaired by the representative of the Department of Health and shall
have the following responsibilities:
• a. Formulation of the regional advocacy and promotion operational
plan which shall be submitted to the Regional Health Director for
approval and endorsement to the National Voluntary Blood Services
Program Committee;
• b. Implementation, monitoring and evaluation of the regional
advocacy and promotion activities;
Section 10 (PROMOTION IN SCHOOLS AND
COMMUNITIES)

1.  Composition
The National Voluntary Blood Services Program sub–committee
on Curriculum Development shall be chaired by the Secretary of
Education and shall be composed of members including, but not
limited to, the representatives.
The National Voluntary Blood Service Committee may designate
such other members from similar organizations whose activities
are related to curriculum development of voluntary blood
donation as may be deemed necessary to the operations of the
sub–committee.
• Representatives:
 
Department of Health
Philippine Society of Hematology and Blood Transfusion
Philippine Society of Pathologists
Philippine Association of Medical Technologists
Philippine Association of Schools of Medical Technology
and Public Health
Philippine Nursing Association
Association of Philippine Medical Colleges
Philippine Medical Association
Philippine National Red Cross
2.  Functions
 
• A. Preparation of the syllabus, course content and training module on the
subject of voluntary blood donation which shall be incorporated in the health
subjects of all schools, public or private, and in all levels of education, formal
and informal.
• B. Operationalization of the policy “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” in all school curricula.
• C. Continuous and sustained upgrading of the curriculum training module.
• D. Provision of training programs and technical assistance to enable
communities, schools, industrial and business sites, barangays and military
camps and local government units to implement their own voluntary blood
donation programs.  
• E. Orientation and/or training of teachers on the utilization of such materials
and methods;
• F. Monitoring of the use and effectiveness of such material and methods in
terms of process and product and continuing revision of such as necessary.
• G. Preparing and submission of the National Voluntary Blood Services Unit of
the annual budgetary requirements for the promotion of voluntary blood
services in the schools.
3. Training Programs and Technical Assistance

• The Department shall likewise provide training programs and

technical assistance to enable communities, schools, industrial
and business sectors, barangays, military groups and local
government units to implement their own voluntary blood
donation programs.
Section 11 (PROFESSIONAL EDUCATION AND RATIONAL USE OF BLOOD AND
BLOOD PRODUCTS)

1.  Composition
The National Voluntary Blood Services Program Sub–committee on Professional Education
shall be composed of representatives of the:

         Department of Health

         Professional Regulation Commission
         Philippine Medical Association
         Philippine Hospital Association
         Philippine Society of Hematology and Blood Transfusion
         Philippine Society of Pathologists
         Philippine Blood Coordinating Council
         Philippine Nursing Association
         Philippine Association of Medical Technologist

• The National Voluntary Blood Services Committee may designate such other members
from similar organizations whose activities are related to professional education and
rational use of blood and blood products as may be deemed necessary to the operations of
the sub–committee.
2.  Functions
 
• A. Encouragement of all medical and other health professional
association and societies to conduct training and seminars on
the rational use of blood and blood products including the
benefits of voluntary blood donation for their respective
members as part of the continuing professional education.
• B. Making compulsory the conduct of continuing professional
education on the rational use of blood and merits of voluntary
blood donation for the hospital medical and paramedical staff.
• C. Inclusion of the rational use of blood and the merits of the
voluntary blood donation in the residency training program of
the different medical subspecialties.
3. Hospital Blood Transfusion Committee
 
To assist the National Voluntary Services Program sub–committee in ensuring the
rational use of blood and blood products and the promotion of the merits of
voluntary blood donation, the Department shall require the establishment of a
Hospital Blood Transfusion Committee as a prerequisite for licensure of
teaching/training hospitals.  
The Hospital Blood Transfusion Committee shall be composed of, but not limited
to:  
·  Physicians from the Department of Pediatrics, Medicine, Surgery,
Obstetrics and Gynecology and Pathology
·  Hematology Consultant
·  Representative from the Nursing service
·  Hospital Medical Training Officer
·  Blood Service Quality Assurance Officer  

The Hospital Blood Transfusion Committee shall be primarily responsible for the
establishment of hospital policies and guidelines for blood transfusion therapy and
monitoring and audit of the use of blood and blood products within the facility
according to the Standard Operating Manual on Blood Services of the BRL.
• Chapter IV
• BLOOD SERVICES NETWORK AND BLOOD DONOR
RECRUITMENT

Section 12 (ESTABLISHMENT OF BLOOD SERVICES

NETWORK)
There shall be established, in coordination with the Regional hospitals
and medical centers, representatives of the private hospitals, local PNRC,
official of the local government units, various civic, religious and other
organizations, a Regional Blood Services Network which shall be chaired
by the Regional Health Director. The Regional Blood Services Network
shall be the venue for:
•  1. Review of the existing blood services network and blood
requirements in the area;
• 2. Formulation of a design of an effective blood donor recruitment
campaign, sustained blood collection and equitable distribution scheme
to include the concept of a clearing house for the region and sharing of
blood bank facilities.
• 3. Designation and authorization of different blood service
facilities according to geographic location, to complementary
tasks and other related undertakings;
• 4. Review of the annual consolidated Regional Blood Services
Operational Plan which will be recommended for funding to
the National Program Committee
• 5. Formulation of uniform guidelines in the implementation of
the networking scheme, including recommendation to the
Bureau of Research and Laboratories as to the maximum rates
to be charged for the cost of providing blood.
Section 13 (BLOOD DONOR RECRUITMENT)

The Department shall adopt a system of procedures or programs to

promote blood donor recruitment and ensure the increase in the number
of retention of voluntary blood donors as follows:

• 1. The Department shall coordinate with heads of agencies,

institutions, offices, organizations, business establishments and
communities, be they government or non–government, and encourage
them to actively participate in donor recruitment in order to secure
commitments to regular blood donations in their particularly
designated blood services facility;
• 2. The Department in collaboration with the Philippine National Red
Cross shall be the lead agency in the celebration of the Blood Donor’s
Week which shall he held annually from July 11 to 17. During the
Blood Donor’s Week, the Department, in coordination with other
agencies shall adopt a program or system of awards, rites, ceremonies
or activities in special recognition of the voluntary blood donors;  
• 3. The Department shall coordinate the professionalization of
voluntary blood donors, health educators and donor recruiters
through organized training activities;
• 4. The Department shall encourage and convince local
government units to pass ordinances or resolutions that will
promote the walking blood donor concept such as, but not
limited to, the mandatory keeping of a list of qualified
voluntary blood donors  in the government hospitals, rural
health units, health centers and barangays, and the conduct of
mass blood typing activities in areas where there are no
adequate blood service facilities
• Chapter V
• UPGRADING OF SERVICES AND FACILITIES

Section 14 (MONITORING AND EVALUATION SUB–

COMMITTEE)

1.  Composition

• The Monitoring and Evaluation sub–committee shall be composed

of, but not limited to, representatives of the Hospital Operations
and Management Service, the Bureau of Licensure and Regulation
and Bureau of Research and Laboratories or other members as
designated by the Secretary of Health.
2. Functions  

It shall be tasked to:

• a. Design a development plan for upgrading the different blood
banks and collection units, including the provision for cold chain
facilities in support of the Blood Services Network;  
• b. Establish a criteria indicators to monitor the progress or success in
meeting the targets of the program as envisioned in the strategic
plan;
• c. Monitor and evaluate all activities of the Program and recommend
ways by which targets could be met;
• d. Study the feasibility of establishing a Plasma Fractionation Plant
at some opportune time and recommend to the NVBSP Committee
of such plan in order to meet the national requirements for special
plasma derivatives.
• e. The National Monitoring and Evaluation sub–committee shall be
responsible for reviewing and recommending changes on the non–
monetary incentives for voluntary blood donors.
Section 15 (DEPARTMENT OF HEALTH REGIONAL
HOSPITALS AND MEDICAL CENTERS)

All DOH regional hospitals and medical centers shall be

upgraded in accordance with the development plan designed by
the Monitoring and Evaluation sub–committee as provided for in
the previous section.
 
Section 16 (PROVINCIAL AND DISTRICT HOSPITALS)

The Department shall assist in the upgrading of provincial and

district hospitals to meet the blood transfusion services
requirement in the area by providing technical assistance,
training and mobilizing resources and other similar forms of
assistance.  
Section 17 (BLOOD CENTERS)

Strategically located blood centers shall be established in support of

the networking scheme. They shall be identified as follows:

1. A National Blood Center shall be established under the Office of

the Secretary of Health to serve as a base for the development of a
network of regional blood centers to meet the national requirements
for blood and blood products. It should be accommodated in a
separate building, preferably near a large general or teaching
hospital. In addition to the usually blood bank activities, the National
Blood Center will have the following special responsibilities:
• a. Planning and organizing the different blood centers of the
National Voluntary Blood Services Program;
• b. Evolving standard procedures and quality control tests for the
regional blood centers and all categories of blood banks, including
the blood collection units;
• c. Training the director/heads, the medical technologists,
and the blood donor recruiters/organizers of the newly
developed/existing blood centers and blood banks;
• d. Establishing an active research program for the
development or adaptation of new technologies and for
the assessment of the real needs of the country;
• e. Maintaining a national reference laboratory for blood
group serology;
• f.  Providing the country with those blood products that
are not produced at large scale at the regional level.
2. The blood bank facilities of the regional hospitals and medical centers
shall be upgraded to enable them to function as the lead blood banks and
referral center for component preparation and other laboratory tests in the
region following the networking scheme. They shall be referred to as
Regional Blood Centers with similar range of activities as that of the
National Blood Center but on a smaller scale. These activities include:
 
• a.  Planning and coordination between the blood center and the different
hospital blood banks it serves to meet not only the ordinary requirements
for blood and blood products but also to service the unexpected demands
of emergencies;  
• b. Providing consultation services to the different hospitals it serves on
transfusion and transfusion–related problems;
• c. Training and education of the staff of the different blood banks it serves,
including the teaching of clinicians in the field of transfusion medicine;
• d. Supervising the different blood banks in its region and assist in
introducing new standardized techniques and procedures;
• e. Acting as a referral center for the entire region it serves.
Section 18 (LICENSING OF PRIVATE HOSPITALS)
The Department, through the Bureau of Licensure and Regulation, shall
require private hospitals to submit their Voluntary Blood Donation
Program Plan.
 
Section 19 (LICENSING OF GOVERNMENT HOSPITALS)

Together with other requirements as contained in this IRR for licensure,

all government hospitals shall submit to the Department, through the
Licensure and Regulation, a Voluntary Blood Donation Program Plan.
The application for renewal of their licenses shall be accompanied by
the following:
 
• 1. Preceding year’s voluntary blood donation program report
according to the format designed by the Monitoring and Evaluation
sub–committee.
• 2. Bureau of Licensure and Regulation monitoring visit report for the
preceding year.  
Section 20 (PHILIPPINE NATIONAL RED CROSS)

The Department shall assist the PNRC in mobilizing resources and in the
upgrading their facilities or chapter by facilitating linkages with private
or government hospitals with laboratory facilities and trained personnel.
 
Section 21 (PREVENTIVE SERVICES)

All blood service facilities shall provide preventive health services such
as education and pre– and post–donation counseling on blood
transfusion transmissible diseases in line with the guidelines and
standards of the National Voluntary Blood Services Unit.
 
Section 22 (HOSPITAL BUDGET FOR BLOOD)

• It is the responsibility of the transfusing hospitals to provide the

necessary blood and blood products to patients. All hospitals are
therefore required to set aside a budget for this purpose.
Section 23 (RECOGNITION AWARDS)

The Department, in coordination with the PNRC, shall grant seals of

excellence in recognition of outstanding service of blood service
facilities to be awarded in a formal ceremony as part of the Blood
Donor’s week.
 
• Chapter VI
• PHASE–OUT OF COMMERCIAL BLOOD BANKS
 
Section 24 (PROCESS OF PHASING OUT)

The Department shall affect the phasing–out of all commercial blood

banks over a period of two (2) years, extendable for a maximum
period of (2) year after the effectivity of R.A. 7719. The decision to
extend shall be based on the result of a careful study and review of
the blood supply and demand and public safety.
Section 25 (OPTIONS FOR COMMERCIAL BLOOD
BANKS)

The Department hereby encourages the commercial blood

banks to:
 
• 1. Convert to solely clinical laboratories in order to ensure
job security of their personnel and allow a reasonable
return on their investment on training and equipment; or,

• 2. Shift to other forms of business/investment schemes.

 
• Chapter VII
• NON–PROFIT OPERATION

Section 26 (OPERATION AND MAINTENANCE OF

BLOOD SERVICE FACILITIES)

The operation and maintenance of all blood service facilities and

any other entities, agencies, establishments engaged in blood
services and covered by these Rules shall be non–profit, provided
that, service fees may be collected, but not greater than the
amount prescribed by the Department, which shall be limited to
the necessary expenses entailed in the collection and processing
of blood and reasonable fees for maintaining and upgrading
facilities and services. Blood shall be collected from healthy
voluntary donors only.
• Chapter VIII
• REGULATION OF BLOOD SERVICES
 
Section 27 (REGULATORY AUTHORITY)

The licensing and regulatory functions of the Department of

Health regulating blood services shall be exercised through the
Bureau of Research and Laboratories (BRL) in the Office of
Health Facilities Standards and Regulations, and as such, it is
hereby authorized to issue orders and circulars providing for
implementation details and specific technical requirements
related to licensing and regulation.
Section 28 (CATEGORIES OF BLOOD SERVICE CAPABILITIES)
Blood service capabilities shall be classified into categories as follows:
 
• A.     BLOOD BANK/CENTER:
A Blood Bank/Center may either be hospital–based or non–
hospital–based in the case of the Red Cross and shall be classified as
Category A, B or C when it meets the following minimum required
capabilities as follows:

1. Category A when it can and is performing the following:  

• a. Promotion of voluntary blood donation and donor recruitment
• b. Storage of blood already screened by the blood bank or blood center
• c. Provision of whole blood and packed RBC only to the hospital it
serves
• d. Compatibility testing (hospital based only)
2.      Category B when it can and is performing the following:
• a. Recruitment of voluntary blood donors
• b. Donor screening and selection
• c. Blood collection
• d. Basic blood screening and testing
• e. Provision of whole blood and packed RBC to the hospital it
serves and to the network of blood banks with which it is
affiliated.
• f.  Issuance, transport and distribution of blood
• g. Storage of blood and blood products
• h. Compatibility testing (hospital – based)
• i.  Health education and counseling
3.  Category C when it can and is performing the following:  
• a.  Recruitment of voluntary blood donors
• b.  Donor screening and selection
• c.  Blood collection
• d.  Basic blood screening and testing
• e.  Preparation of blood components
• f.  Issuance, transport and distribution of blood and blood
products
• g.  Storage of blood/blood products
• h.  Compatibility testing (hospital–based)
• i.   Health education and counseling
• B.  BLOOD COLLECTION UNITS
In coordination with other related or appropriate agencies, the Blood
Banks/Centers shall organize and establish Blood Collection Units (BCU)
which is authorized to perform the following:

• 1. Recruitment of voluntary blood donors

• 2. Screening of blood donors
• 3. Provision of health education and counselling
• 4. Collection and transport of blood to Blood Banks/Centers to which it
is attached
 
• C. BLOOD STATION
 
All other hospitals and PNRC chapters rendering blood services not
classified as a Blood Bank/Center or Blood Collection Unit may be
allowed by these rules to store blood and blood products, subject to
regulation by the BRL. Further, duly–authorized Blood Stations (BS) shall
be properly identified and specified for each Blood Bank/Center.
Section 29 (REQUIREMENTS FOR NEW LICENSE)

1. The Blood Bank/Center may be granted a license to

operate only if it shall have complied with the following
minimum requirements:
 
• a. It shall be under the supervision of a physician certified by
the Philippine Board of Pathology in Clinical Pathology or the
Philippine Board of Hematology and Blood Transfusion for all
blood centers and Category B and C blood banks. In the case of
the Philippine National Red Cross Category A and B blood
banks and Category A hospital–based blood banks, the
supervision and management shall be under a competent
physician duly registered by the Professional Regulation
Commission with a valid professional license and who has at
least six (6) months of training in transfusion medicine in an
institution recognized by BRL.
• b. All Blood Centers and Blood Banks shall be manned by
Medical Technologists duly registered by the Professional
Regulation Commission with a valid certificate and valid
professional license except for the already existing blood banks
of the Philippine National Red Cross where medical technicians
will be allowed. They are either rotating or permanently
assigned depending on the categories of blood bank:

(1) For Category A, medical technologists are rotating and can

handle other sections of the laboratory during the tour of duty.  
(2) For Category B, medical technologists are rotating but
handle only the Blood Bank during the tour of duty.
(3) For Category C, at least one senior medical technologist
who has undergone 3 months of training in blood banking shall be
permanently assigned to the Blood Bank. The other medical
technologists are rotating from other sections of the laboratory but
handle only the blood bank during the tour of duty.
2. STAFF DEVELOPMENT PLAN  
The Blood Bank/Center shall prepare a one (1) year staff development
plan for all categories of personnel.
 
3. PHYSICAL FACILITIES, EQUIPMENT AND SUPPLIES 
 
• a. All Blood Banks/Center shall operate and maintain blood bank
services under good physical conditions and with adequate physical
facilities, equipment and supplies. Specifications for these shall be
defined in appropriate BRL Bureau Orders and shall be included in
the Manual on Standard Operating Procedures on Blood Services of
the BRL (Section 39).  
• b. All Blood Banks/Centers, Blood Collection Units and Blood
Stations shall have a regular schedule, and a written record, of
maintenance and service of all equipment and instruments used in
blood bank services.
• c.  There shall also be a written and readily available contingency
program in case an instrument or equipment becomes incapacitated or
4. BIOSAFETY  
Safety precautions shall be followed in all Blood Banks/Centers at all times.
This shall include, but shall not be limited to, prominent display of easily
understandable posters on safety procedures; wearing of protective clothing and
gadgets such as laboratory gowns, gloves, masks, and eye protectors; and
adherence to clear and acceptable procedures and physical arrangements for
decontamination and disposal of contaminated materials such as blood,
equipment, clothing and other supplies.
 
5.  QUALITY CONTROL  
All the technical staff of the Blood Bank/Center shall have satisfactorily passed
the minimum proficiency test given by the BRL or any of its certified
proficiency testing agencies.  
Adequacy of quality control procedures of each Blood Bank/Center shall be
assess based on their compliance with quality control standards set by the BRL,
including but not limited to, the use of quality reagents, techniques and
equipment; the presence of an adequately trained and competent Quality
Assurance Officer; the acceptability of procedures and arrangements for
internal and externa calibration and maintenance procedures; the adequacy of
documentation of accountability in key steps and procedures; and the
acceptability of procedures for reporting errors and instituting remedial action.
6. RECORDING, REPORTING AND DOCUMENTATION
REQUIREMENTS
 
All Blood Banks/Centers shall follow standard recording,
reporting and documentation formats and procedures and other
documentation requirements of the BRL which shall be described
in appropriate BRL Bureau Orders and included in the SOP
Manual on Blood Services of the BRL (Section 39).
 
All entries in the application forms, logbooks, reports and other
written documents should be certified true and correct, according
to the applicant’s personal knowledge.  
7. BLOOD DISTRIBUTION AND TRANSPORT
REQUIREMENTS:

Blood shall be distributed to the hospitals, not to individuals or patients.

The blood distribution scheme of each Blood Bank/Center shall be
clearly described and shall include the complete list of authorized Blood
Stations strategically located to provide maximum equitable distribution
of blood to its catchment area and the names and qualifications of the
person authorized to handle transport or issue blood.
Blood shall be issued only to authorize Blood Stations except during
emergency conditions such as disasters and major accidents, breakdown
of equipment or facilities in other Blood Banks/Centers, and other
similar circumstances subject to the conditions specified in Section 42
of this IRR.  
The Blood Bank/Center shall have adequate facilities and arrangements
for keeping blood and blood products under appropriate refrigeration
during transport and storage following the principles of an unbroken
8. BLOOD TRANSFUSION COMMITTEE
Blood Banks/Centers shall have organized Blood Transfusion
Committees. The names of committee members, their corresponding
qualifications and tasks and functions shall be submitted upon
application for license.
 
9.  PREVENTIVE SERVICES
All Blood Banks/Centers shall have adequate and effective health
education and counseling services and materials. Health education
should cover the benefits of blood donation; the social behaviors that
increase the risk of acquiring blood – borne diseases; and the effective
measures of preventing disease transmission.
 Counselling of donors found to have infectious blood–borne diseases
should include advice on the nature of the disease, the basic treatment
and management options and referral to clinics, hospitals or
physicians for continuing treatment and clinical management. The
principle of confidentiality, especially for AIDS patients, shall be
upheld.
10.  NETWORKING  
Blood Banks/Centers shall have clear arrangements for continuing
staff training on blood banking and rational blood use, sharing of
manpower and other resources, geographical coordination of donor
recruitment, complete list of authorized strategically –located
Blood Collection Units and laboratory referral arrangements.
 
11.  All blood banks shall be required to join the Blood Services
Network of their respective locality to ensure an adequate and safe
blood supply.
 
12.  Only duly licensed hospitals, the Philippine National Red
Cross, and agencies/corporations which are registered with the
Securities and Exchange Commission as non–profit agencies and
corporations maybe licensed to operate a blood bank.
 
Section 30 (REQUIREMENTS FOR RENEWAL OF LICENSE)
The license of Blood Bank/Center to operate may be renewed only if it shall have
complied with all the requirements for a new license with the following additions or
modifications:
 
• 1. All the technical staff of the Blood Bank/Center shall have passed the basic
proficiency tests the previous year.  
• 2. All medical technologists, including new staff, shall have acquired at least 30 CPE
units each year.
• 3. The Blood Bank/Center shall have achieved at least 70% of the staff development
plan targets.
• 4. The Blood Bank/Center shall have bled only voluntary blood donors the previous
year, including those bled in its authorized Blood Collection Units.
• 5. The complete annual report of the preceding year’s operations shall have been
submitted on or before January 31 of the succeeding year, following the required
format (BRL Blood Services Form No. 3)
• 6. The inspection visit shall have confirmed that the Blood Bank/Center has continued
to operate under good physical conditions and according to prescribed technical and
operating standards.
• 7. The Blood Bank/Center has been shown to collet only the allowable service fee for
each blood unit dispensed.
Section 31 (TERMS AND CONDITIONS OF LICENSING)
The following are the terms and conditions of licensing:
 
• 1. In regions outside the National Capital Region, the Regional Health
Director shall be the designated representative of the Director of the BRL
in the licensing and regulation of Blood Banks/Centers.  
• 2. Applications for new license shall be addressed and submitted to the
Director of the BRL. Applications for renewal of license shall be officially
addressed to the Director of the BRL and submitted, for Blood
Banks/Centers in Metro Manila, directly to the BRL; or, for Blood
Banks/Centers in other regions, to the Regional Health Directors.
• 3. A license to operate a Blood Bank/Center shall be valid for one year
from the date of issue and shall be signed by the Undersecretary of Health
for Health Facilities Standards and Regulations and issued to persons,
agencies or corporations who have successfully complied with all of the
standards and requirements listed in Section 28 or 29, as appropriate.
• 4. The exact date of expiration of the license shall be printed on the
license.
• 5. Assessment of a Blood Bank/Center for initial licensing and renewal of
license shall involve evaluation of documents and at least once a year actual
inspection of the facility by authorized BRL inspectors.
• 6. The license, as well as the rights under the license, is non–transferrable,
directly or indirectly.
• 7. The license of the Blood Bank/Center shall be displayed in a conspicuous
place within the Blood Bank/Center. A notice shall be posted informing the
public that complaints about the services may be addressed to the Director of
the Bureau of Research and Laboratories.  
• 8. A non–refundable license fee of six hundred pesos (P600) shall be charged
on application for a license to open and operate a Blood Bank/Center and four
hundred pesos (P400) for renewal of license.
 
A non–refundable proficiency testing fee shall also be charged to cover the cost
of materials and supplies especially reagents used during the proficiency testing.
The proficiency test fess shall be three hundred pesos (P300) per bank/center.  
The fees shall be uniform for both government and private Blood Banks/Centers
and shall be adjusted by the BRL through appropriate Bureau Orders as
necessary. All fees shall be payable to the Bureau of Research and Laboratories.
Section 32 (THE LICENSING PROCESS)
The following shall be the process of licensing:

• 1. INITIAL APPLICATION
Any person, agency, or corporation desiring to operate a Blood
Bank/Center shall submit to the BRL a duly–accomplished and
notarized BRL Blood Services Form No. 1 (Application for New
Blood Center License) together with the following supporting
documents:
 
• a. Certified true copy of Securities and Exchange Commission
registration (if a corporation or a foundation);  
• b. Names and qualifications of proposed staff, including certified
true copies of PRC certificate of registration and professional
license; PSP or PSHBT certification; results of proficiency tests,
and other certificates of training, as appropriate and applicable;
• c. Floor diagram of proposed premises;
• d. List of equipment for blood services;
• e. Certified true copy of hospital license for preceding
year (hospital–based only);
• f.  Biosafety and Quality Control arrangements and
procedures.
• g. List of Blood Stations (Names of medical technologists
in–charge and complete addresses);
• h. List of Blood Collection Units (Names of head,
qualifications and complete addresses);
• i.  Names and tasks of the members of the BTC (hospital–
based only);
2. APPLICATION FOR RENEWAL OF LICENSE
Any person, agency, or corporation desiring to renew its license to operate a Blood
Bank/Center shall submit to the BRL or the Regional Health Director, as
appropriate, a duly–accomplished and notarized BRL Blood Services Form No. 2
(Application for Renewal of Blood Center License) together with the following
supporting documents:
 
• a. Names, qualification and proofs of qualifications of new staff and any staff
changes (e.g. resignations, additional trainings or qualifications for existing
staff);  
• b. Changes (improvements or deterioration) in existing physical facilities and
functioning of facilities and equipment;
• c. Newly acquired equipment and facilities;
• d. Annual Report on Blood Services for the previous year (BRL Blood Services
Form No. 3);
• e. Names and addresses of regular blood donors who donate at least twice a year;
• f.  Any changes in the list of authorized Blood Collection Units and Blood
Stations (deletions or additions only);
• g. Any other changes in blood banking operations and services;
3.  INSPECTION
 
• a. Each Blood Bank/Center shall be visited by an authorized BRL
inspector at least once before initial licensing and once a year for the
renewal of license. Those who failed to apply for renewal of license
within the prescribed period shall also be visited within the year to
confirm that blood operations have been ceased.  
• b. Only inspector who have satisfactorily completed the BRL Course
for Blood Bank/Center Inspectors are qualified to inspect Blood
Banks/Center and other blood service facilities. A blood bank inspector
shall be entitled to basic per diem expenses and two hundred pesos
(P200) honorarium for Blood Service Facility inspected.
• c. For applicants desiring to open a Blood Bank/Center (i.e. new
license), inspection shall be done only if applicants have fulfilled all the
basic written requirements.
• d. Inspection of licensed blood bank/center shall be done while its
activities are going on and shall be unannounced. Each licensee shall
make available all records and documents as may be required by the
inspectors.
4. TIMETABLE FOR APPLICATION AND INSPECTION
 
• a. Applications for new license may be submitted any time.  
• b. Applications for renewal of license should be submitted
within the two (2) months prior to the expiration date of the
current license. Blood Banks/Centers which fail to submit an
application for renewal within the prescribed two–month
period shall be considered as “Blood Banks/Centers operating
without a license” when their current license expires and shall
be subject to the penalties for such violation.
• c. Blood Banks/Centers which have submitted their application
for renewal of license within the prescribed two (2) months
period but have not yet been inspected shall be given six (6)
weeks extension grace period after expiration of their current
license. During the six (6) weeks extension period, their license
shall be considered valid.
5. RELEASE
 
• a. Licenses shall be released only to the heads of the Blood
Bank/Center or their officially designated representatives not
later than two (2) weeks after the completion of the inspection
visit.  
• b. Applicants for new license who, upon inspection, did not meet
all of the prescribed standards shall receive a letter from the
Director of the BRL or the Regional Health Director stating the
requirements which the Blood Bank/Center failed to meet.
• c. Applicants for renewal of license who, upon inspection, did
not meet all of the prescribed standards shall receive, aside from
the letter stating their deficiencies, an order signed by the BRL
Director or respective Regional Health Director, to cease blood
banking operations immediately. These blood centers shall also
be revisited within one month after release of the order to stop
operations for confirmation of compliance with the order.
Section 33 (TRANSITION PERIOD FOR CONFIRMATION
OF LICENSES)

• 1995 –1996 shall be the transition years for confirmation of

compliance to the new licensure requirements of existing
Blood Banks/Centers. During this transition period, the
documents, forms and process for renewal of licenses shall
follow the procedures for new licenses.  
• Existing Blood Banks/Centers which will fail to meet all of the
new or additional requirements may still be allowed to operate
within this two–year period provided such banks/centers
submit a plant to upgrade their services and facilities according
to the prescribed standards.
• Starting January 1, 1997, all licensure requirements will be
imposed without exemption.
Section 34 (PHASE OUT OF COMMERCIAL BLOOD
BANKS)
 
• No new license shall be issued for a commercial blood
bank  
• Beginning January 1, 1996, no renewal of license of
commercial blood banks will be allowed. The commercial
blood banks will continue to operate during the transition
period upon the authority of the Secretary of Health
subject to continuous monitoring by the BRL.
Section 35 (APPEALS AND REPORTS ON VIOLATION)
Reports and appeals on violations or R.A. 7719 and these Rules and
Regulations shall be addressed to the Secretary of Health.
 
Section 36 (ALLOWABLE SERVICE FEES)

• 1. The blood service facility can charge a minimal service fee for every
blood or blood product issued only to provide operational funds for the
Blood Banks/Centers, Blood Collection Units and Blood Stations. The
service fee shall cover all the expenses incurred in collecting and
processing the blood (donor recruitment, blood collection, blood screening
and component preparation, storing and transportation and allowance for
spoilage) including professional services rendered but shall not include the
costs of cross –matching and other special screening and compatibility
tests.  
• 2. The BRL Director, in consultation with professional societies, shall issue
Bureau Orders on the maximum allowable service fees for blood services,
and shall be adjusted from time to time, whenever deemed reasonable,
specifying the basic requirements and special tests not covered by the
service fee.
Section 36 (AUTHORIZATION OF BLOOD COLLECTION
UNITS)
The Regional Health Directors, including the Regional Health
Director of the National Capital Region, shall authorize Blood
Collection Units (BCU) according to the following standards and
procedures:
 
• 1. A Blood Collection Unit upon recommendation of the
appropriate Blood Service Network should have at least three
(3) professional staff: two PRC–registered nurses, and one
PRC registered medical technologist. They should have had at
least 8 weeks training under an agency duly–recognized by the
BRL on voluntary donor recruitment and screening; voluntary
donor holding and motivation; health education and
counseling; blood collection, handling and transport; and
management of blood collection activities and problems.
• 2. A Blood Collection Unit shall have adequate and proper equipment and
supplies of good quality to be able to perform donor recruitment and
screening; health education and counseling; blood collection, handling and
transport; and management of any reactions according to the BRL
standards described in the SOP Manual on Blood Services (Section 38) as
well as accepted medical practice.
There shall be written and readily available contingency plan for all Blood
Collection Units in case of problems such as instrument or equipment
breakdown.
All Blood Collection Units shall have a regular schedule, and a written
record, of maintenance and service of all equipment and instruments used in
blood bank services.

• 3. A Blood Collection Unit may be statistic or mobile. Physical

arrangements for both kinds during collection shall be comfortable, clean
and adequate. There is no need to get any authority for mobile BCU. The
request for authority to open a static blood collection unit should be
initiated by the Head of the Blood Bank/Center with which it is affiliated.
Such request shall be endorsed by the appropriate Blood Services
Network.
• 4. The Blood Collection Unit shall be clearly attached to a
network of one Blood Bank/center which has confirmed its
recognition of the coordination and cooperation arrangements
with the BCU. Such confirmation may be contained in an
appropriate certificate.
• 5. The BCU shall submit its schedule of bleeding and target
area of donor recruitment that clearly follows geographical
area agreements with other BCUs within the catchment of the
relevant Blood Bank/Center.
• 6. The BCU shall express agreement to submit the blood bags
collected and the list of donors to its attached Blood
Bank/Center at the end of the collection day. Authorization can
be withdrawn if the BCU fails to execute this agreement.
• 7. Each BCU shall be visited at least once a year by the
head of the Blood Bank/Center it coordinates with or by a
duly designated Blood Bank/Center health staff.
• 8. Authorization as a BCU shall be renewed yearly, signed
by the Regional Health Director, and issue to the Head of
the BCU.
• 9. The authority to operate the BCU shall be revoked by
the Regional Health Director should the procedures and
services be found to be below the standards set by the
BRL in its Standard Operating Procedures Manual on
Blood Services (Section 39).
Section 38 (AUTHORIZATION OF BLOOD STATIONS)

The Regional Health Directors, including the Regional Health Director of the
National Capital Region, shall authorize Blood Stations according to the
following standards and procedures:
 
• 1. Blood Stations may be located only within hospital premises, government or
private; or within the premises of the Philippine National Red Cross chapters.  
• 2. A Blood Station shall be under the responsibility of a PRC–registered
medical technologist with a valid certificate of registration and a valid
professional license.
• 3. A Blood Station shall have at least one properly functioning blood
refrigerator with twenty–four (24) hours power supply.
• 4. There shall be a written and readily available contingency plan for all Blood
Stations in case of problems such as instrument or equipment breakdown.
• 5. All Blood Stations shall have a regular schedule, and a written record of
maintenance and service of all equipment and instruments used in blood bank
services.
• 6. Blood shall be issued only to patients confined within the hospital
that houses the station or to hospitals within the area, unless called
for by emergency conditions as listed in Section 29 (6).
• 7. The authority to operate a Blood Station shall be renewed yearly,
signed by the Regional Health Director and issued to the agency that
operated the Blood Bank/Center that will distribute the blood bags to
the station, with a copy furnished to the chief of the hospital where
the Blood Station is located and the medical technologist–in–charge.
• 8. Each Blood Station shall be visited at least once a year by the head
of the Blood Bank/Center that distributes blood to the station or by a
duly designated Blood Bank/Center health staff. A record of such
visit shall be open for inspection by the BRL or its duly authorized
representative.
• 9. The authority to operate the Blood Station shall be revoked by the
Regional Health Director should blood storage, handling, issuance,
distribution or disposal to be found to be below the standards set by
the BRL in its Standard Operating Procedure Manual on Blood
Services (Section 38).
Section 39 (STANDARD OPERATING MANUAL)
Standards for donor recruitment and screening; for all laboratory and blood processing
tests and procedures; for handling and disposal of blood and other biosafety
procedures; for inventory and recording procedures; for networking, blood collection
and distribution; and all quality assurance/quality control measures shall follow
international guidelines promoted by the World Health Organization and the
International Society of Blood Transfusion. Such guidelines shall be adapted to the
Philippine situation through a Standard Operating Procedure Manual (SOP Manual) on
Blood Services which shall be developed, pretested and printed by the BRL within six
(6) months after the effectivity of these Implementing Rules and Regulations. The
Manual shall be formally signed and dated by the Director of the BRL. This manual
shall then be incorporated as an integral part of these Rules and Regulations.  
Until the time when the update SOP manual is available, the procedures and standards
incorporated in A.O. 57 s. 1989 (Sections 10, 11, 12 & 13), B.O. No. 5 s. 1990
(Section 6), A.O. 122 s. 1992, Bureau Circulars No. 2 s. 1990, No. 2 s. 1991 and No.
4 s. 1994 of the BRL which are not in conflict with these Rules and Regulations shall
continue to be in effect.  
Such a manual shall be reviewed and revised periodically. In its revisions, the previous
editions shall be collected back by the BRL and precautions taken to ensure that all
relevant key persons are informed of the changes and the effectivity of these changes.
Section 40 (QUALITY ASSURANCE OFFICER)

A Quality Assurance Officer recognized for his/her integrity

and organizational abilities shall be assigned or designated
and trained for each blood service facility by the BRL.
He/she shall organize all documents relating to quality
assurance and, in coordination with the head of the blood
service facility, shall make sure that the required, recognized
standards are instituted and followed according to national
specifications. He/she shall periodically review quality
control procedures and monitor compliance with standard
procedures. He/she shall initiate investigations and remedial
action when error occurs, in cooperation with the head of
the units affected.
Section 41 (CONFIRMATION OF VOLUNTARY
WORKS)

• 1. Paid blood donors who are usually brought in by

relatives of patients should be carefully selected out and
blacklisted from the roster of donors. This can be done
through careful history and physical examination of
donors. Donors which show multiple needle punctures on
the arms and those whose complete names and relations to
the patient are unknown to the patient or his relatives
should be immediately rejected.  
• 2. The Quality Assurance Officer shall countercheck
donors who regularly donate to the Blood Bank/Center as
part of his/her regular monitoring of Blood Bank/Center
operations.
Section 41 (EMERGENCY BLOOD TRANSFUSION)

Blood collection and immediate transfusion in hospitals without a

license as a Blood Bank/Center may be allowed in an emergency
situation subject to the following conditions:
 
• 1. That the medical/surgical condition poses an immediate threat to
the patient’s life;  
• 2. That the collection and transfusion is done under the direct
supervision and with the full responsibility of the attending
physician;
• 3. That the existing standards and specifications for donor screening
including history and physical examination, on asepsis and biosafety,
and on the use of proper and good quality equipment and materials or
supplies, are complied with;
• 4. That the required test for hemoglobin, syphilis, HIV, hepatitis and
for presence of malarial parasites and compatibility testing including
cross–matching are also performed before transfusion.
• Chapter IX
• IMPORTATION OF BLOOD BANK EQUIPMENT AND SUPPLIES
 
Section 43 (CERTIFICATION OF IMPORTATION PRIVILEGES)
An annual list of Blood Banks/Centers and hospitals participating actively
in the National Voluntary Blood Services Program shall be prepared by the
National Voluntary Blood Services Unit. This list duly approved and
certified by the Undersecretary of Health for Health Facilities and Standards
and Regulations and duly noted by the Directors of the Bureau of Research
and Laboratories and the Bureau of Licensing and Regulation of the
Department, shall be submitted to the Department of Finance and the
Bureau of Customs before January 31 of every year.

Section 44 (EQUIPMENT AND MATERIALS COVERED)

The BRL, in consultation with the Department of Finance and Bureau of
Customs, shall enumerate in an appropriate Bureau Circular the detailed list
of equipment, blood bags and reagents, with specifications as necessary,
which may be allowed to be imported tax– and duty –free under the
provisions of R.A. 7719. The list shall be modified by the BRL as necessary.
Section 45 (PROCESS OF IMPORTATION AND
EXEMPTION)

A Blood Bank/Center or hospital, included in the list of

banks/centers and hospitals actively participating in the National
Voluntary Blood Services Program; wishing to import equipment
and materials tax and duty free shall submit to the Secretary of
Health a letter of intent enclosing the list of equipment and
materials with the necessary specifications and justifications for
their use. The BRL Director shall certify that the list of
equipment and materials requested are included in the list of
allowable equipment and supplies and that these are necessary
for the voluntary blood services program of the particular Blood
Bank/Center or hospital. The Undersecretary of Health for
Hospital Facilities, Standards and Regulations shall sign a
recommendation for tax and duty free exemption addressed to the
Commissioner of Customs.
• Chapter X
• PENALTIES FOR VIOLATIONS

Section 46 (PENALTIES)

• 1. 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.  
• 2. The head of the Blood Bank/Center 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 without prejudice to the filing of criminal charges under the Revised Penal Code.
• 3. Fine of five thousand (P5,000) for the head or owner of the Blood Bank/Center
which fails to submit the application for renewal of license to the BRL or its
designated office within two (2) months prior to the expiration the existing license.
• 4. Fine of three thousand pesos (P3,000) for the head of a Blood Collection Unit or
Blood Station which shall operate without securing authorization from the Department
or its designated offices;
• 5. Revocation or suspension of Blood Bank/Center license or Blood
Collection Unit or Blood Station authorization for:
 
• a. Misrepresentation of facts or falsification of documents or records
• b. Refusal of entry for inspection
• c. Refusal to make available its books, accounts and records of operations
• d. Failure to inform the BRL or its authorized representatives about
changes in Blood Bank/Center, Blood Collection Unit or Blood Station
location, facilities, services or operations;
 
• 6. Recommendation to revoke the certificate of registration or to suspend
said certificate to practice the profession and to invalidate the professional
license of any health professional involved in misrepresentation of facts or
falsification of documents or records especially medical, laboratory or
inspection results and certificates, or in violation of R.A. No. 7719 and the
herein Rules, by the Professional Regulation Commission upon
recommendation of the Secretary.
Section 48 (REPEALING CLAUSE)
These Rules and Regulations shall supersede all previous Administrative
and Bureau Orders and Circulars of the Department. The provision of any
Department or BRL order and circular or other issuances inconsistent with
these Rules and Regulations are hereby repealed or modified accordingly.
 
Section 49 (EFFECTIVITY CLAUSE)
These Rules and Regulations shall take effect fifteen (15) days after its
publication in the Official Gazette or in two (2) national newspapers of
general circulation.
 
Approved on this twelfth day of August nineteen hundred and ninety
four (August 12, 1994)
 
JUAN M. FLAVIER, MD, MPH
SECRETARY OF HEALTH
ADMINISTRATIVE ORDER
No. 9 series 1995
(April 28, 1995)
 ADMINISTRATIVE ORDER No. 9 series 1995

RULES AND REGULATIONS IMPLEMENTING REPUBLIC

ACT No. 7719 OTHERWISE KNOWN AS THE “NATIONAL
BLOOD SERVICES ACT OF 1994”
 
• Pursuant to Section 11 of Republic Act No. 7719, otherwise
known as the National Blood Services Act of 1994, passed by the
Senate and the House of Representatives on 28 April 1994 which
took effect on 12 May 1994, the following Rules and Regulations
are hereby opted.
• Chapter I
• TITLE AND APPLICATION

Section 1 (TITLE), Section 2 (PURPOSE), Section 3

(SCOPE )
- same with A.O. no. 36
Section 4 (DEFINITION OF TERMS)
- Subparagraph 7 & 8 of the definition of terms on AO no 36 was repealed, and these
terms were added:

• BLOOD BANKING EQUIPMENTS – essential laboratory machines, instruments

and their accessories used in the different steps in the blood banking process such
as those used to centrifuge blood or separate blood into its various components;
preserve blood or blood products in cold storage or freezer; and perform blood test
such as hemoglobin tests and screening tests for blood transmissible diseases. This
equipment also includes those used in specific supportive processes such as
sterilization and sanitary disposal of blood and blood products.
• BLOOD BAGS – sterile, sturdy plastic bags containing anticoagulants which are
especially designed for blood collection and transfusion. Blood bags can either be
single or multiple types or have an integral sterile needle and collection tubing.
• REAGENTS – substances employed to detect or measure another substance or
convert one substance to another by means of the reaction it causes. In blood
banking, the reagents used are those necessary to measure hemoglobin; screen for
blood transmissible diseases such as HIV, hepatitis, malaria, syphilis, among others;
identify blood groupings; and perform cross–matching and other immunologic
examinations.
Section 5, Section 6, Section 7, Section 8
- same with A.O. no. 36

• Chapter III
• PROMOTION OF VOLUNTARY BLOOD
DONATION

Section 9 (PUBLIC INFORMATION AND

EDUCATION)
- Same with A.O. no. 36 but the Department of
Education, Culture and Sports, and the Department of
Social Welfare and Development was removed from the
list of the National Advocacy and promotion sub-
committee.
Section 10 (PROMOTION IN SCHOOLS AND
COMMUNITIES)

2. Functions
- Subparagraphs a – f of A.O. no 36 was repealed and replaced
with:

• a. Development, printing and distribution of instructional

materials and methods focused on voluntary blood donation for
integration into the health subjects of all schools, public or
private, and at all levels of education, formal or non–formal;  
• b. Orientation and/or training of teachers on the utilization of
such materials and methods;
• c. Monitoring of the use and effectiveness of such materials
and methods in terms of process and product, and continuing
revision of such as necessary;
Section 11 (PROFESSIONAL EDUCATION AND RATIONAL USE OF BLOOD AND
BLOOD PRODUCTS)

1. Role of the PRC

 The Professional Regulation Commission (PRC) shall encourage all medical and other health
professional associations and societies especially those accredited by the PRC to conduct
trainings on rational use of blood and blood products including the benefits of voluntary
blood donation for their respective members as part of the continuing professional education.
 
The PRC shall provide equivalent continuing professional education units for all training
courses on rational use of blood and blood products.
 
2. Role of Professional Societies and Association
 All medical and other health professional associations and societies whose activities are
related to professional education and blood transfusion shall be encouraged to conduct
trainings and seminars on the rational use of blood and blood products including the dangers
of commercial blood and the benefits of voluntary blood donation for their respective
members as part of their continuing professional education activities and residency programs.
Through sub–committee created by the National Voluntary Blood Services Program
Committee, technical manuals and training modules for health professionals on the “Rational
Use of Blood and Blood Products and Blood Transfusion Medicine” shall be developed
involving various professional societies and associations.
3. Role of the Department of Health
The Secretary of Health shall ensure the conduct of trainings on
rational 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.  
The Department shall require training hospitals to conduct
continuing professional education programs and trainings on the
rational use of blood and blood products and the merits of voluntary
blood donation as one of the prerequisite for licensure of hospitals.
It shall also provide guidelines for the inclusion of the rational blood
and blood products use and the merits of voluntary blood donation
in the examination for residency training admission and the
monitoring of such activities in hospitals.
The Department shall require the establishment of a hospital Blood
Transfusion Committee as a prerequisite for licensure of
teaching/training hospitals and hospitals with blood banks/centers.
4. Composition and functions of the Hospital Blood Transfusion
Committee
 
The Hospital Blood Transfusion Committee shall be composed of, but not
limited to:
 
·  Physicians from the Department of Pediatrics, Medicine, Surgery, Obstetrics
and Gynecology and Pathology
·  Hematology Consultant
·  Representative from the Nursing service
·  Hospital Medical Training Officer
·  Blood Service Quality Assurance Officer

The Hospital Blood Transfusion Committee shall be primarily responsible for

the establishment of hospital policies and guidelines for blood transfusion
therapy and monitoring and audit of the use of blood and blood products
within the facility according to the Standard Operating Manual on Blood
Services of the BRL.
• Chapter IV
• BLOOD SERVICES NETWORK AND BLOOD
DONOR RECRUITMENT

Section 12 (ESTABLISHMENT OF BLOOD SERVICES

NETWORK)
- Subparagraphs 1, 2 & 5 on A.O. no. 36 was repealed and
replaced with:

• 1. Review of the existing linkages among blood service

facilities and requirements for blood within their
respective regions;
• 2. Formulation of a design for a blood collection and
distribution scheme for the region;
Section 13 (BLOOD DONOR RECRUITMENT)
• Blood Donor’s Week which shall be held annually on the second week of July

• Chapter V
• UPGRADING OF SERVICES AND FACILITIES

Section 14 (MONITORING AND EVALUATION SUB–COMMITTEE)

1. Composition  
The Monitoring and Evaluation sub–committee shall be composed of, but not
limited to, representatives from the:  
·       Department of Health
·       Department of Education
·       Philippine National Red Cross
·       Philippine Blood Coordinating Council
·       Other agencies, professional organizations and societies  
This sub–committee may require status reports, when deemed appropriate from
various agency units such as, but not limited to, the Hospital Operation and
Management Service, the Bureau of Licensure and Regulation and the Bureau of
Research and Laboratories of the Department
2. Functions
The Monitoring and Evaluation sub–committee shall
 
• a. Design an upgrading and development plan to ensure, at all
times, better quality blood services. 
• b. Set a criteria of indicators to monitor the progress or success
in meeting the requirements of upgrading of blood services
facilities;
• c. Monitor all continuing professional education activities;
• d. Coordinate all studies and reviews related to the upgrading
of blood service facilities.
• e. Review the non–monetary incentives for voluntary blood
donors and recommend changes when necessary.
Section 15 (DEPARTMENT OF HEALTH REGIONAL
HOSPITALS AND MEDICAL CENTERS)
As much as possible, all regional hospitals and medical
centers of the Department shall upgrade to Hospital–Based
Category B Blood Banks/Centers in accordance with the
requirements of section 28 and 29 of these Implementing
Rules and Regulations.

Section 16 (PROVINCIAL AND DISTRICT

HOSPITALS)
- Same with A.O. no. 36
Section 17 (BLOOD BANKS/CENTERS WITH SPECIAL FUNCTIONS)

1. One Blood Bank/Center shall be designed as the National Blood Center and
shall be developed to be able to perform more specialized function such as, but not
limited to:
 
a. Preparation of special plasma derivatives;
b. Performance of special confirmatory and reference blood tests;
c. Conduct of highly technical specialist on–the–job training courses;
d. Conduct of research and special studies

2.     At least one Blood Bank/Center in every geographical region shall be

designated as the Regional Blood Center and shall be developed to perform special
functions such as, but not limited to:
 
a. Preparation and distribution of blood components for other hospitals within the
region;
b. Training and supervisory function over the other Blood Banks/Centers within
the region;
c. Research
Section 18, Section 19, Section 20, Section 21
- Same with A.O. no. 36

Section 22 (RECOGNITION AWARDS)

The Department, in coordination with the PNRC, shall grant
seals of excellence in recognition of outstanding service of
blood service facilities to be awarded in a formal ceremony
as part of the Blood Donor’s week.
(section 23 of A.O. no. 36)
• Chapter VI
• PHASE–OUT OF COMMERCIAL BLOOD BANKS

Section 23 (PROCESS OF PHASING OUT)

The Department shall affect the phasing–out of all commercial
blood banks over a period of two (2) years, extendable for a
maximum period of (2) year after the effectivity of R.A. 7719. The
decision to extend shall be based on the result of a careful study
and review of the blood supply and demand and public safety.

Section 24 (OPTIONS FOR COMMERCIAL BLOOD

BANKS)
The Department shall encourage and assist existing commercial
blood banks to convert to solely clinical laboratories in order to
ensure job security of their personnel and allow a reasonable return
on their investment on training and equipment.
• Chapter VII
• NON–PROFIT OPERATION

Section 25 (OPERATION AND MAINTENANCE OF

BLOOD SERVICE FACILITIES)
- Same with A.O. no. 36 Section 26
- The BRL Director shall issue Bureau Orders on the schedule of
standard fees as stated in section 35.

• Chapter VIII
• REGULATION OF BLOOD SERVICES
 
Section 26 (REGULATORY AUTHORITY)
- Same with A.O. no. 36 Section 27
Section 27 (CATEGORIES OF BLOOD SERVICE CAPABILITIES)
Blood service capabilities shall be classified into categories as follows:
 
A.     BLOOD BANK/CENTER:
A Blood Bank/Center may either be hospital–based or non–hospital–based and
may be licensed as Category A or B when it meets the minimum required service
capabilities set forth hereunder:
 
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.

- Subparagraph B & C from Section 28 of A.O. no. 36 remains

the same
Section 28 (REQUIREMENTS FOR NEW LICENSE)
A Blood Bank/Center may be granted a license to operate only if it shall have complied with
the following minimum requirements:
 
1. MINIMUM NUMBER AND QUALIFICATION OF PERSONNEL
The minimum number of staff with their corresponding qualifications for each category of
Blood Bank/Center shall be as follows:
 
a. Category A Hospital and Non–hospital Based Blood Bank/Center:  
The overall supervision and management shall be under a competent physician duly
registered by the Professional Regulation Commission (PRC) with a valid certificate of
registration and a valid professional license, who has at least six (6) months training in blood
banking services under an institution or agency recognized by the BRL.
The Blood Bank/Center shall have at least one (1) Trained Medical Technologist duly
registered by the PRC with a valid certificate and a valid professional license, who has at
least one (1) year on–the–job training or experience in blood banking services under an
institution or agency recognized by the BRL.
The Blood Bank/Center shall also have at least one other (1) Medical Technologist or
Medical Laboratory Technician duly registered by the PRC with a valid certificate and a
valid professional license. Pursuant to the Medical Technology Law (R.A. No. 005527), the
Medical Laboratory Technician shall be under the responsibility of the Trained Medical
Technologist.
b. Category B Non–hospital Based Blood Bank/Center
The minimum personnel requirements for Category A Blood
Banks/Centers (Section 28[2a] shall also be required of Category B
Non–hospital Based Blood Banks/Centers.
In addition to the foregoing, the laboratory and blood processing
section of the Category B Non–hospital Based Blood Bank/Center
shall be managed by and under the direct and regular supervision and
of a PRC–registered and licensed physician certified by the
Philippine Board of Pathology in Clinical or Anatomical Pathology
with at least 6 months additional training in blood banking from a
training institution recognized by the BRL, and/or the Philippine
Board of Hematology and Blood Transfusion in Blood Banking.
However, if the overall supervisor of the Blood Bank/Center is
already a pathologist trained in blood banking or a hematologist, this
additional requirement will not be necessary.
c. Category B Hospital Based Blood Bank/Center
The overall supervision and management shall be under a PRC–
registered and licensed physician with a valid certificate in Clinical or
Anatomical Pathology from the Philippine Board of Pathology with at
least 6 months additional training in blood banking from a training
institution recognized by the BRL, and/or a certificate in Blood
Banking from the Philippine Board of Hematology.
The Blood Banks/Centers in this category shall also have one (1)
Trained Medical Technologist and one (1) other Medical Technologist
or Medical Laboratory Technician with the same qualifications as
those required for a Category A Blood Bank/Center.

- Subparagraphs 2-10 of this section from section 29 of A.O. no. 36

remains the same
- Subparagraphs 11 & 12 of this section from section 29 of A.O. no.
36 was repealed
Section 29 (REQUIREMENTS FOR RENEWAL OF
LICENSE)
- subparagraph 2 of this section from section 30 of A.O. no. 36
was repealed.

Section 30 (TERMS AND CONDITIONS OF LICENSING)

- This section from section 31 of A.O. no. 36 remains the same
except for:

A non–refundable proficiency testing fee shall also be charged to

cover the cost of materials and supplies especially reagents used
during the proficiency testing. The proficiency test fess shall be
two thousand pesos (P2,000) per bank/center.
Section 31 (THE LICENSING PROCESS)
1. INITIAL APPLICATION
- Subparagraphs e & g of this section from Section 32 of A.O. no. 36 was
repealed.

2. APPLICATION FOR RENEWAL OF LICENSE

- Subparagraph e. Certified true copy of hospital license for preceding year
(hospital–based only), has been added.

3.     INSPECTION
• b. A productivity incentive pay of fifty pesos (P50) for every blood
bank/center inspected properly and thoroughly may be allowed subject to
the usual auditing and accounting procedures and to availability of funds of
the agency where the inspector comes from.

4. TIMETABLE FOR APPLICATION AND INSPECTION

- Subparagraph c of this section from Section 32 of A.O. no. 36 was repealed.
Section 32 (TRANSITION PERIOD FOR
CONFIRMATION OF LICENSES)
- This section from section 33 of A.O. no. 36 remains the
same.

Section 33 (PHASE OUT COMMERCIAL BLOOD

BANKS)
-No new license shall be issued for a commercial blood
bank.
-Renewal of license of existing blood bank beginning
January 1, 1995 shall upon compliance with the new
requirements under these Rules and Regulations subject tot
he provisions of Section 32 thereof.
Section 34 (APPEALS AND REPORTS ON VIOLATION)
Reports on violations or R.A. 7719 and these Rules and
Regulations shall be addressed to the Secretary of Health and the
National Director of the Bureau of Research and Laboratories.
The Secretary or the National Director of the BRL may request
for police assistance from the National Bureau of Investigation
and/or the Philippine National Police for the effective
enforcement of R.A. 7719 and these Implementing Rules and
Regulations.
Section 35 (ALLOWABLE SERVICE FEES)

1. The blood service facility may collect a reasonable service fee for every blood or blood
product issued which shall not be greater than the maximum prescribed by the Department
of Health and implemented through an appropriate BRL Bureau Order issued by the
Director of the BRL. The maximum allowable service fee shall be adjusted from time to
time specifying the basic requirements and special tests not covered by the service fee.
2. The BRL shall determine the basic required donor and blood screening tests and
procedures through a thorough analysis and research information such as disease
prevalence studies and risk estimates, consultations with technical experts and careful
evaluation of the optimum benefits from the expected cost of these tests.
3. The maximum allowable service fee shall be calculated by the BRL based on a study of
the direct and indirect costs of running a standard blood bank with basic, minimum
staffing and facilities and corresponding maximum workload.
Direct costs shall include those expenses incurred in collecting and processing blood –
from donor recruitment, blood collection, blood screening, component preparation, storage
and distribution, with allowance for spoilage, and professional services. These shall not
include cost of cross–matching and other special screening and compatibility testing.
Indirect costs shall include reasonable expenses needed to maintain and upgrade services
such as salary of staff and repair of equipment.
4. The direct and indirect costs shall be estimated for every unit of blood collected,
processed and distributed.
Section 36 (AUTHORIZATION OF BLOOD COLLECTION UNITS)
The Regional Health Directors, including the Regional Health Director of the National
Capital Region, shall authorize Blood Collection Units (BCU) according to the following
standards and procedures:
 
• 1. A Blood Collection Unit shall have at least one PRC–registered physician and one PRC–
registered medical technologist, both with valid certificate of registration and valid
professional license. Both should have had at least one (1) month training on voluntary
donor recruitment and screening; voluntary donor holding and motivation; health
education and counseling; blood collection, handling and transport; and management of
blood collection activities and problems. Such training shall be done by an agency duly
recognized by the BRL.  
• 2. A Blood Collection Unit shall have adequate and proper equipment and supplies of good
quality to be able to perform donor recruitment and screening; health education and
counseling; blood collection, handling and transport; and management of any reactions
according to the BRL standards described in the SOP Manual on Blood Services (Section
38).
There shall be written and readily available contingency plan for all Blood Collection Units
in case of problems such as instrument or equipment breakdown.
 
• 3. A Blood Collection Unit may be statistic or mobile. Physical arrangements for both
kinds during collection shall be comfortable, clean and adequate.
• 4. The Blood Collection Unit shall be clearly attached to a network of one
Blood Bank/center which has confirmed its recognition of the coordination and
cooperation arrangements with the BCU. Such confirmation may be contained
in an appropriate certificate.
• 5. The BCU shall submit its schedule of bleeding and target area of donor
recruitment that clearly follows geographical area agreements with other BCUs
within the catchment of the relevant Blood Bank/Center.
• 6. The BCU shall express agreement to submit the blood bags collected and the
list of donors to its attached Blood Bank/Center at the end of the collection day.
Authorization can be withdrawn if the BCU fails to execute this agreement.
• 7. Each BCU shall be visited at least once a year by the head of the Blood
Bank/Center it coordinates with or by a duly designated Blood Bank/Center
health staff.
• 8. Authorization as a BCU shall be renewed yearly, signed by the Regional
Health Director, and issue to the Head of the BCU.
• 9. The authority to operate the BCU shall be revoked by the Regional Health
Director should the procedures and services be found to be below the standards
set by the BRL in its Standard Operating Procedures Manual on Blood Services
(Section 38).
Section 37 – 43 of this act from section 38-44 remains the same.

Section 44 (APPLICATION FOR TAX EXEMPTION)

1. A letter of intent enclosing the list of equipment and materials with the
necessary specifications and justification for their use shall be submitted to the
Secretary of Health. The BRL Director shall certify that the list of equipment
and materials requested are included in the list of allowable equipment and
supplies and that these are necessary for the voluntary blood services program
of the particular Blood Bank/Center or hospital. The Secretary of Health or his
duly–authorized representative shall sign a recommendation for tax– and
duty–free exemption addressed to the Secretary of Finance.
 
2. An application for exemption from custom duties and taxes shall then be
filed with the Revenue Office, Department of Finance, Manila. The PNRC,
blood banks/centers, hospitals and other institutions participating actively in
the National Voluntary Blood Services Program may avail of the tax duty
exemption mentioned herein, upon certification and appropriate endorsement
by the Secretary of Health or his duly – authorized representative
Section 45 (OTHER DOCUMENTATION REQUIREMENTS)

For expeditious processing, the application shall also include a

certification from the Department of Trade and Industry that the
proposed importations are not locally available in sufficient quantity,
comparable quality and reasonable price.

Section 46 (INSPECTION)

The Department of Finance may conduct pre/post–inspection of the

facilities and imported articles release duty and tax–free in accordance
with these Rules and Regulations in line with the monitoring functions
of said office. Said findings/report shall be furnished to the
Department of Health
• Chapter X
• PENALTIES FOR VIOLATIONS

Section 47 (PENALTIES)
1. 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.
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.
 
2. Any person who shall establish and operate a Blood Bank/Center without securing
a license to operate from the Department or who fails to comply with the standards
prescribed by the Department referred to in Section 9 of R.A. No. 7719, shall suffer
the penalty of imprisonment of not less than twelve (12) years and one (1) day nor
more than twenty (20) years of 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.
3. The head of the Blood Bank/Center 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 without prejudice to the filing of criminal
charges under the Revised Penal Code.
 
4. All importation accorded duty– and tax–free release pursuant
to this Order shall not be transferred or disposed of in any
manner whatsoever to any person or entity without prior
approval of the Department of Finance. The penalty provided for
under existing laws or any revenue laws shall be imposed in any
violation of the provision of this Order.
5. The Secretary or his duly–authorized representative, after due
notice and hearing, may also impose the following
administrative sanctions:
 
• a. Penalty of Five thousand pesos (P5,000) for the head or
owner of the Blood Bank/Center which fails to submit the
application for renewal of license to the BRL or its designated
offices within two (2) months prior to the expiration of the
existing license;  
• b. Penalty of Three thousand pesos (P3,000) for the head of a
Blood Collection Unit or Blood Station which shall operate
without securing authorization from the Department or tis
designated offices;
• c. Revocation or suspension of Blood Bank/Center license or Blood
Collection Unit or Blood Station authorization for:

o   Misrepresentation of facts or falsification of documents or records

o   Refusal of entry for inspection
o   Refusal to make available its books, accounts and records of operations
o   Failure to inform the BRL or its authorized representatives about
changes in Blood Bank/Center, Blood Collection Unit or Blood Station
location, facilities, services or operations;

• d. Recommendation to revoke the certificate of registration or to

suspend said certificate to practice the profession and to invalidate the
professional license of any health professional involved in
misrepresentation of facts or falsification of documents or records
especially medical, laboratory or inspection results and certificates, or
in violation of R.A. No. 7719 and the herein Rules, by the Professional
Regulation Commission upon recommendation of the Secretary.
Section 48 (REPEALING CLAUSE)
- This section from A.O. no. 36 remains the same

Section 49 (EFFECTIVITY CLAUSE)

These Rules and Regulations shall take effect fifteen (15) days after its
publication in the Official Gazette or in two (2) national newspapers of
general circulation.
 
Section 50
Approved on this twenty–eight days of April nineteen hundred and
ninety–five (April 28, 1995)

JAIME GALVEZ–TAN, MD, MPH

Acting Secretary of Health