Chapter 3: Blood Banking Laws

1. RA1517
3. RA 7719
4. Implementing Rules
a. AO 9, s. 1995
b. AO 2005-002 (separate PDF file)
c. AO 2008-008
5. GR 133640, Beltran v. Secretary of Health, November 25, 2005

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

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.

Sec. 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.

Sec. 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.cr

Sec. 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.cr

Sec. 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.

Sec. 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.

Sec. 7. This Act shall take effect upon its approval.

Approved: June 16, 1956

REPUBLIC ACT NO. 7719
REPUBLIC ACT NO. 7719 - AN ACT PROMOTING VOLUNTARY BLOOD DONATION,
PROVIDING FOR AN ADEQUATE SUPPLY OF SAFE BLOOD, REGULATING BLOOD BANKS,
AND PROVIDING PENALTIES FOR VIOLATION THEREOF

Section 1. 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 Sec. 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 rationale 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 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 a revolutionary
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 counselling on blood transfusion transmissible diseases.
All government hospitals, including those that have been devolved, shall be required to establish
voluntary blood donation programs and all private hospitals shall be encouraged to establish
voluntary blood donation programs.

The Department, in consultation with the PSHBT and the PSP, shall also establish guidelines for
the rational use of blood and blood products.

Sec. 7. Phase-out of Commercial Blood Banks. - All commercial blood banks shall be phased-out
over a period of two (2) years after the effectivity of this Act, extendable to a maximum period
of two (2) years by the Secretary.

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 Services. - 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 the Department.

SECTION 10. Importation of Blood Bank Equipment, Blood Bags and Reagents. - Upon the
effectivity of this Act, equipment, blood bags and reagents used for the screening and testing of
donors, collection and processing and storage of blood shall be imported tax- and duty-free by
the PNRC, blood banks and hospitals participating actively in the National Voluntary Blood
Services Program. This provision shall be implemented by the rules and regulations to be
promulgated by the Department in consultation and coordination with the Department of
Finance.

SECTION 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.

SECTION 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 Sec. 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 (500,000), 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 may 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.

SECTION 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.

SECTION 14. Repealing Clause. - This Act shall supersede Republic Act No. 1517 entitled "Blood
Bank Act." The provisions of any law, executive order, presidential decree or other issuances
 inconsistent with this Act are hereby repealed or modified accordingly.

SECTION 15. Effectivity Clause. - This Act shall take effect after fifteen (15) days following its
publication in the Official Gazette or in two (2) national newspapers of general circulation.

Approved: May 5, 1994

Administrative Order No. 9 s. 1995

28 April 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

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. 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;

8. 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;

9. 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;

10. BLOOD COLLECTION UNIT – an institution or facility duly authorized by the Department of Health to recruit and
screen donors and collect blood;

11. 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;

12. 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;

13. 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

14. 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;

15. 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;

16. 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.

17. 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.

18. 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.
 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:

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
representative from other societies and cooperating or donor agencies

2. Functions

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
DOH PROGRAM MANAGEMENT
1. National Voluntary Blood Services Unit

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. Functions

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, but not limited to, representatives of the
Department of Health, the Philippine National Red Cross (PNRC), the Philippine Blood Coordinating Council (PBCC),
the Philippine Information Agency, and other similar organizations whose activities are related to advocacy and
promotion of voluntary blood donation.

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 from the:

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

This sub–committee shall be responsible for the following:

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;

d. Preparation and submission to 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. 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

There shall be established, in coordination with the local PNRC, a Regional Blood Service Network which shall be
chaired by the Regional Health Director. The Regional Blood Services Network shall be the venue for the following:

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;

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

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 on the second week of July. 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 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

The Department shall assist in the upgrading of provincial and district hospitals to meet the blood transfusion services
requirement in the area especially by providing technical assistance, training and mobilizing resources.

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
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

The Department, through the Bureau of Licensure and Regulation, shall require all government hospitals to submit 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
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 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

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.
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

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 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.

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

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 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.

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 38).

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 unavailable.

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 38).

All entries in the application forms, logbooks, reports and other written documents should be true and correct.

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.

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 cold storage chain.
No untrained person shall be allowed to handle, transport or issue blood and blood products.

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.

Section 29
 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. The Blood Bank/Center shall have achieved at least 70% of the staff development plan targets.

3. The Blood Bank/Center shall have bled only voluntary blood donors the previous year, including those bled in its
authorized Blood Collection Units.

4. 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)

5. 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.

6. The Blood Bank/Center has been shown to collet only the allowable service fee for each blood unit dispensed.

Section 30
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. The license fee shall cover the cost of
inspection and printing of special license certificates and other required forms and documents.
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.

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 31
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. Biosafety and Quality Control arrangements and procedures.

f. List of Blood Collection Units (Names of head, qualifications and complete addresses);

g. 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. Certified true copy of hospital license for preceding year (hospital–based only);

f. Names and addresses of regular blood donors who donate at least twice a year;

g. Any changes in the list of authorized Blood Collection Units and Blood Stations (deletions or additions only);

h. 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 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.
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 authorized BRL inspectors upon
presentation of a valid inspection mission order signed by the Secretary or his authorized representative.

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.

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 32
TRANSITION PERIOD FOR CONFIRMATION OF LICENSES

The year nineteen ninety–five to nineteen ninety–six (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 33
PHASE OUT OF COMMERCIAL BLOOD BANKS

No new license shall be issued for a commercial blood bank

Renewal of license of existing commercial blood banks beginning 01 January 1995 shall upon compliance with the new
requirements under these Rules and Regulations subject to the 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
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 28 (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 38
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 39
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 40
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 42
CERTIFICATION OF IMPORTAION 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 43
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 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

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.

Section 50

Approved on this twenty–eight days of April nineteen hundred and ninety–five

JAIME GALVEZ–TAN, MD, MPH

Acting Secretary of Health

Administrative Order No. 2008-0008

May 2, 2008

ADMINISTRATIVE ORDER
No. 2008 – 0008

RULES AND REGULATIONS GOVERNING THE REGULATION OF BLOOD SERVICE FACILITIES

I. BACKGROUND/RATIONALE

Republic Act 7719 otherwise known as the “National Blood Services Act of 1994” was passed to ensure safe and efficient
Blood Banking and transfusion practices in the Philippines. To carry out the provision of Republic Act 7719,
Administrative Order No. 9 s. 1995 “Rules and Regulation Implementing Republic Act 7719” was formulated. Chapter
VIII of the said Administrative Order addresses the regulation of blood services by the Bureau of Research and
Laboratories. This was amended by Administrative Order No. 17–A series 1998 otherwise known as the “Requirements
and Procedures for a License to Operate a BB/BC in the Philippines.” The “Rules and Regulations Governing
Authorization of BCU and BS” was formulated and approved in 2003.

In January 2005, Administrative Order No. 2005–0002 “Rules and Regulations for the Establishment of the Philippine
National Blood Services Amending pertinent provisions of Administrative Order No. 9 s. 1995” was formulated pursuant
to Section 5 and 6 of R.A. 7719. This Administrative Order established the National Council for Blood Services and the
Philippine National Blood Services. It also defined the new functions and/or service capabilities of the different blood
service facilities, including hospital BBs and BCs, as well as those of the end–user hospitals and other health facilities.
With these newly delineated functions and service capabilities of blood service facilities, it is imperative that relevant
provisions of A.O. No. 9 s. 1995 and A.O. No. 17–A s. 1998 be revised.

Regulation is one of the main thrusts of current health sector reforms under FOURmula One (F1) for health. The main
objective of regulatory reforms is to ensure access to quality and affordable health products, devices, facilities and
services especially those commonly used by the poor. It is the responsibility of the state to provide the public with safe
and adequate blood through an efficient blood services network. With the separation of the regulator functions from the
programming functions, it is envisioned that the goals of the national voluntary blood services program shall be better
achieved.

II. OBJECTIVE

These rules and regulations are promulgated to protect and promote the health of the people by ensuring available
licensed blood service facilities with adequate staff, equipment and resources to perform all the required functions safely,
efficiently and effectively.
III. SCOPE

The rules and regulations embodied herein shall apply to all government and private blood service facilities engaged in
blood banking and transfusion services.

IV. DEFINITION OF TERMS

A. Act – Republic Act (R.A.) 7719, also known as the National Blood Services Act of 1994, unless herein specified.

B. ATO – refers to the Authority to Operate. It is a formal permit issued by the DOH–CHD to an individual, partnership,
corporation or association to a BCU/BS.

C. BB – refers to the Blood Bank

D. BC – refers to the Blood Center

E. BHFS – refers to the Bureau of Health Facilities and Services

F. Blood – refers to the human blood for transfusion

G. Blood Component – refers, but not limited to whole blood, red cells, granulocytes, plasma, platelets, cryoprecipitate
and cryosupernate prepared in a BC.

H. BCU – refers to the Blood Collection Unit

I. Blood product – a therapeutic substance derived from whole blood or plasma.

J. BS – refers to the Blood Station

K. BSF – refers to the blood service facility. It is a unit, agency or institution providing blood products. The types of BSF
are BS, BCU, Hospital BB and BC (Regional, Sub–national and National).

L. Blood Services Network – an organization composed of the designated BCs, hospital BBs, BCUs, BSs, end–user
hospitals, and other health facilities established to provide for the blood needs of a specific geographical area.

M. CHD – refers to the Center for Health Development, which is the DOH Regional Field Office

N. DOH – refers to the Department of Health

O. End–Use Hospital – a hospital with a licensed clinical laboratory capable of red cell typing and cross–matching and
which does not have any BSF but only receives blood and blood components for blood transfusion as needed.

P. End–User Non–hospital Health facility – a license/accredited non–hospital health facility without a licensed clinical
laboratory but administers blood transfusion such as a dialysis clinic and birthing home under the supervision of a
licensed physician/s.

Q. EQAS – refers to External Quality Assessment Scheme

R. HBTC – refers to the Hospital Blood Transfusion Committee

S. LTO – refers to the License to Operate. It is a formal authority issued by the DOH to an individual, partnership,
corporation, or association to operate a BB/BC.

T. NCBS – refers to the National Council for Blood Services

U. NVBSP – refers to the National Voluntary Blood Services Program

 V. PNRC – refers to the Philippine National Red Cross

W. TTI – refers to the Transfusion–Transmitted Infections

X. Voluntary, Non–remunerated Blood Donor – a donor who gives blood freely and voluntarily without receiving
money or any form of payment.

V. POLICIES AND GUIDELINES

A. General Guidelines

1. Every BSF shall be an integral part of a blood services network and guided by administrative issuances governing the
establishment and operation of blood services networks.

a. Each BC shall have responsibility for and authority over the conduct and close supervision of the BCU/BS affiliated with its
Blood Service Network.

b. The head of the BC or his designated staff shall conduct on site periodic evaluation of each affiliated BB, BCU and BS.

2. All BSF are required to comply with the standards and technical requirements embodied in the inspection tools. It shall be
posted at the DOH website: www.doh.gov.ph

3. Blood shall be collected from qualified healthy voluntary non–remunerated blood donors only.

4. Testing for TTIs shall be based on the DOH prescribed methodology. The number of infections to be screened as well as
the method for their detection shall be determined and reviewed periodically by the NCBS.

5. Testing for TTIs shall be done at the National, Sub–national and designated Regional BCs including PNRC BCs. Such
designation shall be determined by the NCBS pursuant to A.O. 2005–0002.

6. All units of blood issued by the Philippine BC, Sub–national BCs, Regional BCs, and PNRC under the Philippine National
Blood Services Network shall not be retested for TTIs by the end–user hospitals and other health facilities. It is the
responsibility of the issuing BCs to ensure that all units of blood issued have been tested and found to be negative to
TTIs.

7. Blood and blood products for transfusion shall be obtained from licensed and authorized BSF only.

B. Specific Guidelines

1. Classification of BSF

a. Ownership

(1) Government – operated and maintained partially or wholly by a national, provincial, city or municipal government or
other political unit, by any department, division, board or agency thereof or by a government owned or controlled
corporation

(2) Private (for hospital–based BSF only) – privately owned, established and operated with funds through donation, capital
or other means, by an individual, corporation, association, or organization

b. Institutional Character

(1) Hospital–based – a BSF located within the premises of a hospital

(2) Non–hospital based – a government–owned or PNRC–owned BSF located outside the premises of a hospital consistent
with the NVBSP Strategic Plan.

c. Service Capability
 (1) BS

(a) Advocacy and promotion of voluntary blood donation and healthy lifestyle;
(b) Provision of whole blood and packed red cells;
(c) Storage, issuance, transport and distribution of whole blood and packed red cells;
(d) Compatibility testing of red cell units, if hospital based.

(2) BCU

(a) Advocacy and promotion of voluntary blood donation and healthy lifestyle;
(b) Recruitment, retention and care of voluntary blood donors;
(c) Screening and selection of voluntary blood donors;
(d) Conduct of health education and counseling services;
(e) Collection of blood (mobile or facility – based) from qualified voluntary blood donors;
(f) Transport of blood to BC for testing and processing;
(g) Compatibility testing to red cell units, if hospital based.

(3) BCU/BS – all services stipulated under BCU and BS

(4) BB

(a) Advocacy and promotion of voluntary blood donation and healthy life;
(b) Storage and issuance of whole blood and blood components obtained from a BC;
(c) The following services shall also be provided:

i. Compatibility testing of red cell units

ii. Direct Coombs test
iii. Red cell antibody screening
iv. Investigation of transfusion reactions
v. Assist the HBTC in the conduct of post–transfusion surveillance (hemovigilance)

(5) BC

(a) Advocacy and promotion of voluntary blood donation and healthy lifestyle;
(b) Recruitment, retention and care of voluntary blood donors;
(c) Collection of blood (mobile or facility–based) from qualified voluntary blood donors;
(d) Conduct health education and counseling
(e) Testing of units of blood for TTIs
(f) Processing and provision of blood components
(g) Storage, issuance, transport and distribution of units of whole blood and/or blood products to hospitals and other health
facilities

2. Standards and Technical Requirements

a. The BSF appoints and allocates personnel who are suitable qualified, skilled and/or trained to assume the responsibilities,
authority, accountability and function of the position.

b. Services are provided in an environment that promotes safety, has adequate space, meets the needs of clients, service
providers and other stakeholders, and conforms to the current Manual of Standards issued by the DOH.

c. All equipment and instruments necessary for the safe and effective provision of services are available and are properly
maintained.

d. All reagents and glassware to be used by the BSF shall be based on the minimum requirement for sensitivity and specificity
of testing reagents as well as the testing procedures as recommended by the technical committee of the NVBSP.

e. There shall be a system of reporting and recording of results of BSF examinations.

f. The BSF shall put into practice a quality assurance program.

(1) There shall be a policy on quality assurance program and continuous quality improvement
 (2) The BSF shall participate in an External Quality Assessment Program Administered by the designated National
Reference Laboratories (NRL) or other external assessment program approved by the DOH–NVBSP.

g. There shall be a system in outsourcing of examinations and blood components.

h. All hospital–based BB, BCU and/or BS shall establish a HBTC.

i. All BSF shall comply with policies and guidelines of the NVBSP.

3. LTO/ATO

a. Hospital based BBs, BCUs, BS shall be licensed or authorized to operate through the One–Stop–Shop Licensure for
Hospitals and are therefore not required to obtain a separate LTO or ATO. The required documents for the licensure of
the BB or the authorization of the BCU or BS shall be submitted to the CHD, along with other documentary requirements
for the hospital LTO.

b. The LTO/ATO shall be granted in accordance with prescribed documentary and technical requirements and on the basis of
specific conditions and limitations established during inspection.

c. The LTO/ATO as well as any right under the license/authorization cannot be assigned or otherwise transferred directly or
indirectly to any party.

d. The LTO/ATO must be displayed at all times at a prominent place within the premises

e. The CHD shall be notified within fifteen (15) calendar days of any change in management, name or ownership. In cases of
transfer of location, a new application for LTO/ATO shall be required.

f. A separate LTO/ATO shall be required for each BSF or branch maintained in separate premises even if operated by the
same management.

4. Maximum Allowable Service Fees

a. The BSF may collect a reasonable service fee for every blood/blood products issued, which shall not be greater than the
maximum fees prescribed by the DOH. The NVBSP shall periodically review the maximum allowable service fee
specifying the basic requirements and special tests covered by the service fee.

b. The prescribed maximum allowable fees shall be placed in an area readily seen by the public.

c. The basic donor screening and blood testing procedures shall be determined by the NVBSP through analysis of research
information such as disease prevalence studies and risk estimates, consultation with the technical experts, and careful
evaluation of the optimum benefits from the expected cost of these tests.

VI. PROCEDURAL GUIDELINES

A. Application for LTO for BCs and BBs and ATO for BCU and BS

1. Applicant requests for relevant information and prescribed form from the CHD under whose jurisdiction the proposed BSF
is located, in person or through mail, email or internet

2. Applicant accomplished required documents and submits them to the CHD.

Documentary requirements for the issuance of LTO/ATO:

a. Certificate of Inclusion in the Regional Blood Services Network approved by the identified Lead Blood Center in the
region

b. Duly accomplished and notarized Application Form

 c. DTI/SEC registration (initial)

d. List of personnel with photocopy of valid PRC card

e. Location map (initial)

f. Floor diagram

g. List of equipment – with serial number, brand, date of purchase, number of units and operational status

h. NVBSP Annual Report (renewal)

i. Certificate of participation in EQAS in previous year (renewal)

3. The CHD Director or his authorized representative(s) reviews documents for completeness, authenticity and compliance
with the requirements

4. The applicant pays the appropriate fees, based on the current prescribed DOH schedule of fees, to the CHD Cashier in
person or through postal money order. BSF operating as BCU/BS shall be charged the corresponding fee for BCU

B. Inspection

1. The CHD Director of his authorized representative(s) inspects the BSF within thirty (30) calendar days from the time of
application to determine compliance with standards and technical requirements.

2. The CHD inspection team prepares official summary of findings and recommends approval or disapproval after inspection.

C. Issuance of LTO/ATO

1. The CHD Director approves or disapproves the issuance of LTO/ATO.

a. If approved, the BSF is registered and an LTO/ATO is issued to the applicant within fifteen (15) calendar days.

b. If disapproved, a copy of inspection findings and recommendation is provided to the applicant within fifteen (15) calendar
days from the time of inspection.

c. An application for an LTO/ATO that is not processed within the thirty (30) calendar day period is considered approved

D. Renewal of LTO/ATO

1. The LTO/ATO shall be renewed every three (3) years. All hospital BSF shall renew their LTO/ATO annually as part of the
One–Stop–Shop licensure for hospitals.

2. Application for renewal of LTO/ATO shall be filed on the first day of October until the last day of November on the last
year of the LTO validity period to the CHD under which jurisdiction the BSF is located.

3. The LTO/ATO may be renewed only if it complies with the prescribed standards and technical requirements.

VII. VALIDITY OF LICENSE TO OPERATE

The LTO/ATO to operate a BSF shall be valid for a period of three (3) years, beginning on January 1 of the first year of
the validity period to December 31 of the third year of the validity period.

As part of the hospital license to operate, the license to operate/authority to operate a BB/BCU/BS shall be valid for a
period one (1) year, beginning January 1 to December 31.

VIII. MONITORING
 The BHFS/CHD Director or his authorized representative(s) is authorized to monitor and conduct on–site visits to the
BSF at any given time. The BSF shall make available to the monitoring team all pertinent records to determine the level
of compliance with the National Blood Services Act and these rules and regulations.

IX. VIOLATIONS

Violations of the National Blood Services Act or the rules and regulations issued in pursuance thereto, include the
commission of the following acts by individual, corporation, association, or organization operating the BSF, or persons
under their authority:

A. Any material false statement in the application

B. Misrepresentation of facts or falsification of documents or records

C. Refusal to make available its books, accounts and records of operation to an authorized person from the BHFS/CHD

D. Charging of blood service fees above the maximum fees set by the DOH

E. Collection of blood from paid or remunerated donor whether payment comes from the hospital or from the
patient/relatives

F. Refusal to participate in EQAS conducted by the designated National Reference Laboratories

X. TRANSITORY PROVISIONS

All previously licensed hospital based and PNRC BCs already performing the blood testing and processing shall be
allowed to operate as such until December 31, 2009. By 2010, there shall be a nationally coordinated blood service
network with only the designated BCs performing the centralized testing and processing.

XI. INVESTIGATION AND HEARING OF CHARGES OR COMPLAINTS

Upon filing of charges or complaints duly sworn to by any individual, corporation, association, or organization against
any BSF or any of its personnel who has violated or is violating the provisions of R.A. 7719 or any of these rules and
regulations, the BHFS/CHD Director or his authorized representative(s) shall investigate and verify if the BSF concerned
or any of its personnel is guilty of charges or complaints. If upon investigation and hearing, the BSF concerned or any of
its personnel is found violating the provision of R.A. 7719 or any of these rules and regulations, the CHD Director shall
suspend the LTO/ATO for a definite or indefinite period of time, or revoke the LTO/ATO without prejudice to taking the
case to judicial authorities for criminal action.

XII. SUSPENSION REVOCATION OF LICENSE/AUTHORITY TO OPERATE

A LTO/ATO shall be suspended or revoked by the CHD Director upon violation of the National Blood Services Act or
the rules and regulations issued in pursuance thereto. The CHD Director shall notify the BSF concerned or any of its
personnel by registered mail the particular reasons for the denial or revocation of LTO/ATO.

XIII. APPEAL

Any BSF or any of its personnel aggrieved by the decision of the CHD Director may, within thirty (30) calendar days
after receipt of notice of the decision, file a notice of appeal with the Office of the Secretary through the BHFS, and serve
a copy of the notice of appeal to the CHD. Thereupon, the CHD Director shall promptly certify and file a copy of the
 decision, including the transcript of the hearings on which the decision is based, with the Office of the Secretary for
review. The decision of the Office of the Secretary shall be final and executory.

XIV. CLOSURE

The CHD Director or his authorized representative(s) shall immediately close all BSF without and LTO/ATO, and may
seek assistance of any government agency to effectively enforce the closure.

XV. PENAL PROVISION

A.Upon conviction, any BSF that collects service fees greater than the maximum prescribed by the DOH shall have its
LTO/ATO suspended or revoked by the CHD Director. Any individual, corporation, association, or organization who is
responsible for the above violation shall suffer the penalty of imprisonment of not less than one (1) month but not more
than six (6) months, or a fine of not less than five thousand pesos (P5,000) but not more than fifty thousand pesos
(P50,000), or both at the discretion of the judicial authority.

B.Any individual, corporation, association, or organization who establishes and manages a BSF without securing the
necessary LTO/ATO from the CHD, or violates any provision of these rules and regulation shall suffer the penalty of
imprisonment of not less than (12) years but no more than twenty (20) years, or a fine of not less than fifty thousand
pesos (P50,000) but not more than five hundred thousand pesos (P500,000), or both at the discretion of the judicial
authority.

C.The head of the BSF and the personnel responsible for dispensing or transfusing unscreened, incompletely tested and/or
contaminated blood or failing to dispose within forty–eight hours blood that is contaminated with transfusion
transmissible infections after receipt of confirmatory testing result from the Research Institute for Tropical Medicine
National Reference Laboratory shall be imprisoned for ten (10) years. This shall be without prejudice to the filing of
criminal charges under the Revised Penal Code.

D.The CHD Director, after due notice and hearing, and upon approval of the Secretary, may impose the following
administrative sanctions:

1. Penalty of five thousand pesos (P5,000) for any BSF that fails to submit the application for renewal of LTO/ATO to the
CHD within three (3) months prior to the expiration of the existing license;

2. Recommendation to the PRC to revoke the certificate of registration or to invalidate the license of any health professional
found violating the provision of R.A. 7719 or of these rules and regulations.

XVI. PUBLICATION

A list of licensed/authorized BSF according to their classification shall be published or posted at the DOH website
annually.

XVII. SEPARABILITY CLAUSE

In the event that any provision or part of this Order be declared unauthorized or rendered invalid by any court of law or
competent authority, those provision not affected by such declaration shall remain valid and effective.

XVIII. REPEALING CLAUSE

These rules and regulation shall repeal and supersede all administrative orders and previous issuances inconsistent
thereof.
XIX. EFFECTIVITY

These rules and regulations shall take effect within fifteen (15) days after publication in a newspaper of general
circulation.

FRANCISCO T. DUQUE III, M.D., MSc.

Secretary of Health

EN BANC

G.R. No. 133640 November 25, 2005

RODOLFO S. BELTRAN, doing business under the name and style, OUR LADY OF FATIMA BLOOD
BANK, FELY G. MOSALE, doing business under the name and style, MOTHER SEATON BLOOD BANK;
PEOPLE’S BLOOD BANK, INC.; MARIA VICTORIA T. VITO, M.D., doing business under the name and
style, AVENUE BLOOD BANK; JESUS M. GARCIA, M.D., doing business under the name and style,
HOLY REDEEMER BLOOD BANK, ALBERT L. LAPITAN, doing business under the name and style,
BLUE CROSS BLOOD TRANSFUSION SERVICES; EDGARDO R. RODAS, M.D., doing business under
the name and style, RECORD BLOOD BANK, in their individual capacities and for and in behalf of
PHILIPPINE ASSOCIATION OF BLOOD BANKS, Petitioners,
vs.
THE SECRETARY OF HEALTH, Respondent.

x ------------------------------------------------ x

G.R. No. 133661

DOCTORS’ BLOOD CENTER, Petitioner,

vs.
DEPARTMENT OF HEALTH, Respondent.

x --------------------------------------------- x

G.R. No. 139147

RODOLFO S. BELTRAN, doing business under the name and style, OUR LADY OF FATIMA BLOOD
BANK, FELY G. MOSALE, doing business under the name and style, MOTHER SEATON BLOOD BANK;
PEOPLE’S BLOOD BANK, INC.; MARIA VICTORIA T. VITO, M.D., doing business under the name and
style, AVENUE BLOOD BANK; JESUS M. GARCIA, M.D., doing business under the name and style,
HOLY REDEEMER BLOOD BANK, ALBERT L. LAPITAN, doing business under the name and style,
BLUE CROSS BLOOD TRANSFUSION SERVICES; EDGARDO R. RODAS, M.D., doing business under
the name and style, RECORD BLOOD BANK, in their Individual capacities and for and in behalf of
PHILIPPINE ASSOCIATION OF BLOOD BANKS, Petitioners,
vs.
THE SECRETARY OF HEALTH, Respondent.

DECISION

AZCUNA, J.:

Before this Court are petitions assailing primarily the constitutionality of Section 7 of Republic Act No. 7719,
otherwise known as the "National Blood Services Act of 1994," and the validity of Administrative Order (A.O.)
No. 9, series of 1995 or the Rules and Regulations Implementing Republic Act No. 7719.
G.R. No. 133640,1 entitled "Rodolfo S. Beltran, doing business under the name and style, Our Lady of Fatima
Blood Bank, et al., vs. The Secretary of Health" and G.R. No. 133661,2 entitled "Doctors Blood Bank Center
vs. Department of Health" are petitions for certiorari and mandamus, respectively, seeking the annulment of
the following: (1) Section 7 of Republic Act No. 7719; and, (2) Administrative Order (A.O.) No. 9, series of
1995. Both petitions likewise pray for the issuance of a writ of prohibitory injunction enjoining the Secretary of
Health from implementing and enforcing the aforementioned law and its Implementing Rules and Regulations;
and, for a mandatory injunction ordering and commanding the Secretary of Health to grant, issue or renew
petitioners’ license to operate free standing blood banks (FSBB).

The above cases were consolidated in a resolution of the Court En Banc dated June 2, 1998.3

G.R. No. 139147,4 entitled "Rodolfo S. Beltran, doing business under the name and style, Our Lady of Fatima
Blood Bank, et al., vs. The Secretary of Health," on the other hand, is a petition to show cause why respondent
Secretary of Health should not be held in contempt of court.

This case was originally assigned to the Third Division of this Court and later consolidated with G.R. Nos.
133640 and 133661 in a resolution dated August 4, 1999.5

Petitioners comprise the majority of the Board of Directors of the Philippine Association of Blood Banks, a duly
registered non-stock and non-profit association composed of free standing blood banks.

Public respondent Secretary of Health is being sued in his capacity as the public official directly involved and
charged with the enforcement and implementation of the law in question.

The facts of the case are as follows:

Republic Act No. 7719 or the National Blood Services Act of 1994 was enacted into law on April 2, 1994. The
Act seeks to provide

an adequate supply of safe blood by promoting voluntary blood donation and by regulating blood banks in the
country. It was approved by then President Fidel V. Ramos on May 15, 1994 and was subsequently published
in the Official Gazette on August 18, 1994. The law took effect on August 23, 1994.

On April 28, 1995, Administrative Order No. 9, Series of 1995, constituting the Implementing Rules and
Regulations of said law was promulgated by respondent Secretary of the Department of Health (DOH).6

Section 7 of R.A. 7719 7 provides:

"Section 7. Phase-out of Commercial Blood Banks - All commercial blood banks shall be phased-out over
a period of two (2) years after the effectivity of this Act, extendable to a maximum period of two (2) years by
the Secretary."

Section 23 of Administrative Order No. 9 provides:

"Section 23. Process of Phasing Out. -- The Department shall effect the phasing-out of all commercial blood
banks over a period of two (2) years, extendible for a maximum period of two (2) years 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."8

Blood banking and blood transfusion services in the country have been arranged in four (4) categories: blood
centers run by the Philippine National Red Cross (PNRC), government-run blood services, private hospital
blood banks, and commercial blood services.

Years prior to the passage of the National Blood Services Act of 1994, petitioners have already been operating
commercial blood banks under Republic Act No. 1517, entitled "An Act Regulating the Collection, Processing
and Sale of Human Blood, and the Establishment and Operation of Blood Banks and Blood Processing
Laboratories." The law, which was enacted on June 16, 1956, allowed the establishment and operation by
licensed physicians of blood banks and blood processing laboratories. The Bureau of Research and
Laboratories (BRL) was created in 1958 and was given the power to regulate clinical laboratories in 1966
under Republic Act No. 4688. In 1971, the Licensure Section was created within the BRL. It was given the
duty to enforce the licensure requirements for blood banks as well as clinical laboratories. Due to this
development, Administrative Order No. 156, Series of 1971, was issued. The new rules and regulations
triggered a stricter enforcement of the Blood Banking Law, which was characterized by frequent spot checks,
immediate suspension and communication of such suspensions to hospitals, a more systematic record-
keeping and frequent communication with blood banks through monthly information bulletins. Unfortunately, by
the 1980’s, financial difficulties constrained the BRL to reduce the frequency of its supervisory visits to the
blood banks.9

Meanwhile, in the international scene, concern for the safety of blood and blood products intensified when the
dreaded disease Acute Immune Deficiency Syndrome (AIDS) was first described in 1979. In 1980, the
International Society of Blood Transfusion (ISBT) formulated the Code of Ethics for Blood Donation and
Transfusion. In 1982, the first case of transfusion-associated AIDS was described in an infant. Hence, the
ISBT drafted in 1984, a model for a national blood policy outlining certain principles that should be taken into
consideration. By 1985, the ISBT had disseminated guidelines requiring AIDS testing of blood and blood
products for transfusion.10

In 1989, another revision of the Blood Banking Guidelines was made. The DOH issued Administrative Order
No. 57, Series of 1989, which classified banks into primary, secondary and tertiary depending on the services
they provided. The standards were adjusted according to this classification. For instance, floor area
requirements varied according to classification level. The new guidelines likewise required Hepatitis B and HIV
testing, and that the blood bank be headed by a pathologist or a hematologist. 11

In 1992, the DOH issued Administrative Order No. 118-A institutionalizing the National Blood Services
Program (NBSP). The BRL was designated as the central office primarily responsible for the NBSP. The
program paved the way for the creation of a committee that will implement the policies of the program and the
formation of the Regional Blood Councils.

In August 1992, Senate Bill No. 1011, entitled "An Act Promoting Voluntary Blood Donation, Providing for an
Adequate Supply of Safe Blood, Regulating Blood Banks and Providing Penalties for Violations Thereof, and
for other Purposes" was introduced in the Senate.12

Meanwhile, in the House of Representatives, House Bills No. 384, 546, 780 and 1978 were being deliberated
to address the issue of safety of the Philippine blood bank system. Subsequently, the Senate and House Bills
were referred to the appropriate committees and subsequently consolidated. 13

In January of 1994, the New Tropical Medicine Foundation, with the assistance of the U.S. Agency for
International Development (USAID) released its final report of a study on the Philippine blood banking system
entitled "Project to Evaluate the Safety of the Philippine Blood Banking System." It was revealed that of the
blood units collected in 1992, 64.4 % were supplied by commercial blood banks, 14.5% by the PNRC, 13.7%
by government hospital-based blood banks, and 7.4% by private hospital-based blood banks. During the time
the study was made, there were only twenty-four (24) registered or licensed free-standing or commercial blood
banks in the country. Hence, with these numbers in mind, the study deduced that each commercial blood bank
produces five times more blood than the Red Cross and fifteen times more than the government-run blood
banks. The study, therefore, showed that the Philippines heavily relied on commercial sources of blood. The
study likewise revealed that 99.6% of the donors of commercial blood banks and 77.0% of the donors of
private-hospital based blood banks are paid donors. Paid donors are those who receive remuneration for
donating their blood. Blood donors of the PNRC and government-run hospitals, on the other hand, are mostly
voluntary.14

It was further found, among other things, that blood sold by persons to blood commercial banks are three
times more likely to have any of the four (4) tested infections or blood transfusion transmissible diseases,
namely, malaria, syphilis, Hepatitis B and Acquired Immune Deficiency Syndrome (AIDS) than those donated
to PNRC.15

Commercial blood banks give paid donors varying rates around ₱50 to ₱150, and because of this
arrangement, many of these donors are poor, and often they are students, who need cash immediately. Since
they need the money, these donors are not usually honest about their medical or social history. Thus, blood
from healthy, voluntary donors who give their true medical and social history are about three times much safer
than blood from paid donors.16

What the study also found alarming is that many Filipino doctors are not yet fully trained on the specific
indications for blood component transfusion. They are not aware of the lack of blood supply and do not feel the
need to adjust their practices and use of blood and blood products. It also does not matter to them where the
blood comes from.17

On August 23, 1994, the National Blood Services Act providing for the phase out of commercial blood banks
took effect. On April 28, 1995, Administrative Order No. 9, Series of 1995, constituting the Implementing Rules
and Regulations of said law was promulgated by DOH.

The phase-out period was extended for two years by the DOH pursuant to Section 7 of Republic Act No. 7719
and Section 23 of its Implementing Rules and Regulations. Pursuant to said Act, all commercial blood banks
should have been phased out by May 28, 1998. Hence, petitioners were granted by the Secretary of Health
their licenses to open and operate a blood bank only until May 27, 1998.

On May 20, 1998, prior to the expiration of the licenses granted to petitioners, they filed a petition for certiorari
with application for the issuance of a writ of preliminary injunction or temporary restraining order under Rule 65
of the Rules of Court assailing the constitutionality and validity of the aforementioned Act and its Implementing
Rules and Regulations. The case was entitled "Rodolfo S. Beltran, doing business under the name and style,
Our Lady of Fatima Blood Bank," docketed as G.R. No. 133640.

On June 1, 1998, petitioners filed an Amended Petition for Certiorari with Prayer for Issuance of a Temporary
Restraining Order, writ of preliminary mandatory injunction and/or status quo ante order.18

In the aforementioned petition, petitioners assail the constitutionality of the questioned legal provisions,
namely, Section 7 of Republic Act No. 7719 and Section 23 of Administrative Order No. 9, Series of 1995, on
the following grounds: 19

1. The questioned legal provisions of the National Blood Services Act and its Implementing Rules violate the
equal protection clause for irrationally discriminating against free standing blood banks in a manner which is
not germane to the purpose of the law;

2. The questioned provisions of the National Blood Services Act and its Implementing Rules represent undue
delegation if not outright abdication of the police power of the state; and,

3. The questioned provisions of the National Blood Services Act and its Implementing Rules are unwarranted
deprivation of personal liberty.

On May 22, 1998, the Doctors Blood Center filed a similar petition for mandamus with a prayer for the
issuance of a temporary restraining order, preliminary prohibitory and mandatory injunction before this Court
entitled "Doctors Blood Center vs. Department of Health," docketed as G.R. No. 133661. 20 This was
consolidated with G.R. No. 133640.21

Similarly, the petition attacked the constitutionality of Republic Act No. 7719 and its implementing rules and
regulations, thus, praying for the issuance of a license to operate commercial blood banks beyond May 27,
1998. Specifically, with regard to Republic Act No. 7719, the petition submitted the following questions 22 for
resolution:

1. Was it passed in the exercise of police power, and was it a valid exercise of such power?

2. Does it not amount to deprivation of property without due process?

3. Does it not unlawfully impair the obligation of contracts?

4. With the commercial blood banks being abolished and with no ready machinery to deliver the same supply
and services, does R.A. 7719 truly serve the public welfare?
On June 2, 1998, this Court issued a Resolution directing respondent DOH to file a consolidated comment. In
the same Resolution, the Court issued a temporary restraining order (TRO) for respondent to cease and desist
from implementing and enforcing Section 7 of Republic Act No. 7719 and its implementing rules and
regulations until further orders from the Court.23

On August 26, 1998, respondent Secretary of Health filed a Consolidated Comment on the petitions
for certiorari and mandamus in G.R. Nos. 133640 and 133661, with opposition to the issuance of a temporary
restraining order.24

In the Consolidated Comment, respondent Secretary of Health submitted that blood from commercial blood
banks is unsafe and therefore the State, in the exercise of its police power, can close down commercial blood
banks to protect the public. He cited the record of deliberations on Senate Bill No. 1101 which later became
Republic Act No. 7719, and the sponsorship speech of Senator Orlando Mercado.

The rationale for the closure of these commercial blood banks can be found in the deliberations of Senate Bill
No. 1011, excerpts of which are quoted below:

Senator Mercado: I am providing over a period of two years to phase out all commercial blood banks. So that
in the end, the new section would have a provision that states:

"ALL COMMERCIAL BLOOD BANKS SHALL BE PHASED OUT OVER A PERIOD OF TWO YEARS AFTER
THE EFFECTIVITY OF THIS ACT. BLOOD SHALL BE COLLECTED FROM VOLUNTARY DONORS ONLY
AND THE SERVICE FEE TO BE CHARGED FOR EVERY BLOOD PRODUCT ISSUED SHALL BE LIMITED
TO THE NECESSARY EXPENSES ENTAILED IN COLLECTING AND PROCESSING OF BLOOD. THE
SERVICE FEE SHALL BE MADE UNIFORM THROUGH GUIDELINES TO BE SET BY THE
DEPARTMENTOF HEALTH."

I am supporting Mr. President, the finding of a study called "Project to Evaluate the Safety of the Philippine
Blood Banking System." This has been taken note of. This is a study done with the assistance of the USAID
by doctors under the New Tropical Medicine Foundation in Alabang.

Part of the long-term measures proposed by this particular study is to improve laws, outlaw buying and selling
of blood and legally define good manufacturing processes for blood. This goes to the very heart of my
amendment which seeks to put into law the principle that blood should not be subject of commerce of man.

The Presiding Officer [Senator Aquino]: What does the sponsor say?

Senator Webb: Mr. President, just for clarity, I would like to find out how the Gentleman defines a commercial
blood bank. I am at a loss at times what a commercial blood bank really is.

Senator Mercado: We have a definition, I believe, in the measure, Mr. President.

The Presiding Officer [Senator Aquino]: It is a business where profit is considered.

Senator Mercado: If the Chairman of the Committee would accept it, we can put a provision on Section 3, a
definition of a commercial blood bank, which, as defined in this law, exists for profit and engages in the buying
and selling of blood or its components.

Senator Webb: That is a good description, Mr. President.

Senator Mercado: I refer, Mr. President, to a letter written by Dr. Jaime Galvez-Tan, the Chief of Staff,
Undersecretary of Health, to the good Chairperson of the Committee on Health.
In recommendation No. 4, he says:

"The need to phase out all commercial blood banks within a two-year period will give the Department of Health
enough time to build up government’s capability to provide an adequate supply of blood for the needs of the
nation...the use of blood for transfusion is a medical service and not a sale of commodity."

Taking into consideration the experience of the National Kidney Institute, which has succeeded in making the
hospital 100 percent dependent on voluntary blood donation, here is a success story of a hospital that does
not buy blood. All those who are operated on and need blood have to convince their relatives or have to get
volunteers who would donate blood…

If we give the responsibility of the testing of blood to those commercial blood banks, they will cut corners
because it will protect their profit.

In the first place, the people who sell their blood are the people who are normally in the high-risk category. So
we should stop the system of selling and buying blood so that we can go into a national voluntary blood
program.

It has been said here in this report, and I quote:

"Why is buying and selling of blood not safe? This is not safe because a donor who expects payment for his
blood will not tell the truth about his illnesses and will deny any risky social behavior such as sexual
promiscuity which increases the risk of having syphilis or AIDS or abuse of intravenous addictive drugs.
Laboratory tests are of limited value and will not detect early infections. Laboratory tests are required only for
four diseases in the Philippines. There are other blood transmissible diseases we do not yet screen for and
there could be others where there are no tests available yet.

A blood bank owner expecting to gain profit from selling blood will also try his best to limit his expenses.
Usually he tries to increase his profit by buying cheaper reagents or test kits, hiring cheaper manpower or
skipping some tests altogether. He may also try to sell blood even though these have infections in them.
Because there is no existing system of counterchecking these, the blood bank owner can usually get away
with many unethical practices.

The experience of Germany, Mr. President is illustrative of this issue. The reason why contaminated blood
was sold was that there were corners cut by commercial blood banks in the testing process. They were
protecting their profits.25

The sponsorship speech of Senator Mercado further elucidated his stand on the issue:

Senator Mercado: Today, across the country, hundreds of poverty-stricken, sickly and weak Filipinos, who,
unemployed, without hope and without money to buy the next meal, will walk into a commercial blood bank,
extend their arms and plead that their blood be bought. They will lie about their age, their medical history.
They will lie about when they last sold their blood. For doing this, they will receive close to a hundred pesos.
This may tide them over for the next few days. Of course, until the next bloodletting.

This same blood will travel to the posh city hospitals and urbane medical centers. This same blood will now be
bought by the rich at a price over 500% of the value for which it was sold. Between this buying and selling,
obviously, someone has made a very fast buck.

Every doctor has handled at least one transfusion-related disease in an otherwise normal patient. Patients
come in for minor surgery of the hand or whatever and they leave with hepatitis B. A patient comes in for an
appendectomy and he leaves with malaria. The worst nightmare: A patient comes in for a Caesarian section
and leaves with AIDS.

We do not expect good blood from donors who sell their blood because of poverty. The humane dimension of
blood transfusion is not in the act of receiving blood, but in the act of giving it…
For years, our people have been at the mercy of commercial blood banks that lobby their interests among
medical technologists, hospital administrators and sometimes even physicians so that a proactive system for
collection of blood from healthy donors becomes difficult, tedious and unrewarding.

The Department of Health has never institutionalized a comprehensive national program for safe blood and for
voluntary blood donation even if this is a serious public health concern and has fallen for the linen of
commercial blood bankers, hook, line and sinker because it is more convenient to tell the patient to buy blood.

Commercial blood banks hold us hostage to their threat that if we are to close them down, there will be no
blood supply. This is true if the Government does not step in to ensure that safe supply of blood. We cannot
allow commercial interest groups to dictate policy on what is and what should be a humanitarian effort. This
cannot and will never work because their interest in blood donation is merely monetary. We cannot expect
commercial blood banks to take the lead in voluntary blood donation. Only the Government can do it, and the
Government must do it."26

On May 5, 1999, petitioners filed a Motion for Issuance of Expanded Temporary Restraining Order for the
Court to order respondent Secretary of Health to cease and desist from announcing the closure of commercial
blood banks, compelling the public to source the needed blood from voluntary donors only, and committing
similar acts "that will ultimately cause the shutdown of petitioners’ blood banks."27

On July 8, 1999, respondent Secretary filed his Comment and/or Opposition to the above motion stating that
he has not ordered the closure of commercial blood banks on account of the Temporary Restraining Order
(TRO) issued on June 2, 1998 by the Court. In compliance with the TRO, DOH had likewise ceased to
distribute the health advisory leaflets, posters and flyers to the public which state that "blood banks are closed
or will be closed." According to respondent Secretary, the same were printed and circulated in anticipation of
the closure of the commercial blood banks in accordance with R.A. No. 7719, and were printed and circulated
prior to the issuance of the TRO.28

On July 15, 1999, petitioners in G.R. No. 133640 filed a Petition to Show Cause Why Public Respondent
Should Not be Held in Contempt of Court, docketed as G.R. No. 139147, citing public respondent’s willful
disobedience of or resistance to the restraining order issued by the Court in the said case. Petitioners alleged
that respondent’s act constitutes circumvention of the temporary restraining order and a mockery of the
authority of the Court and the orderly administration of justice.29 Petitioners added that despite the issuance of
the temporary restraining order in G.R. No. 133640, respondent, in his effort to strike down the existence of
commercial blood banks, disseminated misleading information under the guise of health advisories, press
releases, leaflets, brochures and flyers stating, among others, that "this year [1998] all commercial blood
banks will be closed by 27 May. Those who need blood will have to rely on government blood
banks."30 Petitioners further claimed that respondent Secretary of Health announced in a press conference
during the Blood Donor’s Week that commercial blood banks are "illegal and dangerous" and that they "are at
the moment protected by a restraining order on the basis that their commercial interest is more important than
the lives of the people." These were all posted in bulletin boards and other conspicuous places in all
government hospitals as well as other medical and health centers. 31

In respondent Secretary’s Comment to the Petition to Show Cause Why Public Respondent Should Not Be
Held in Contempt of Court, dated January 3, 2000, it was explained that nothing was issued by the department
ordering the closure of commercial blood banks. The subject health advisory leaflets pertaining to said closure
pursuant to Republic Act No. 7719 were printed and circulated prior to the Court’s issuance of a temporary
restraining order on June 21, 1998.32

Public respondent further claimed that the primary purpose of the information campaign was "to promote the
importance and safety of voluntary blood donation and to educate the public about the hazards of patronizing
blood supplies from commercial blood banks."33 In doing so, he was merely performing his regular functions
and duties as the Secretary of Health to protect the health and welfare of the public. Moreover, the DOH is the
main proponent of the voluntary blood donation program espoused by Republic Act No. 7719, particularly
Section 4 thereof which provides that, in order to ensure the adequate supply of human blood, voluntary blood
donation shall be promoted through public education, promotion in schools, professional education,
establishment of blood services network, and walking blood donors.
Hence, by authority of the law, respondent Secretary contends that he has the duty to promote the program of
voluntary blood donation. Certainly, his act of encouraging the public to donate blood voluntarily and educating
the people on the risks associated with blood coming from a paid donor promotes general health and welfare
and which should be given more importance than the commercial businesses of petitioners.34

On July 29, 1999, interposing personal and substantial interest in the case as taxpayers and citizens, a
Petition-in-Intervention was filed interjecting the same arguments and issues as laid down by petitioners in
G.R. No. 133640 and 133661, namely, the unconstitutionality of the Acts, and, the issuance of a writ of
prohibitory injunction. The intervenors are the immediate relatives of individuals who had died allegedly
because of shortage of blood supply at a critical time.35

The intervenors contended that Republic Act No. 7719 constitutes undue delegation of legislative powers and
unwarranted deprivation of personal liberty.36

In a resolution, dated September 7, 1999, and without giving due course to the aforementioned petition, the
Court granted the Motion for Intervention that was filed by the above intervenors on August 9, 1999.

In his Comment to the petition-in-intervention, respondent Secretary of Health stated that the sale of blood is
contrary to the spirit and letter of the Act that "blood donation is a humanitarian act" and "blood transfusion is a
professional medical service and not a sale of commodity (Section 2[a] and [b] of Republic Act No. 7719). The
act of selling blood or charging fees other than those allowed by law is even penalized under Section 12." 37

Thus, in view of these, the Court is now tasked to pass upon the constitutionality of Section 7 of Republic Act
No. 7719 or the National Blood Services Act of 1994 and its Implementing Rules and Regulations.

In resolving the controversy, this Court deems it necessary to address the issues and/or questions raised by
petitioners concerning the constitutionality of the aforesaid Act in G.R. No. 133640 and 133661 as
summarized hereunder:

WHETHER OR NOT SECTION 7 OF R.A. 7719 CONSTITUTES UNDUE DELEGATION OF LEGISLATIVE

POWER;

II

WHETHER OR NOT SECTION 7 OF R.A. 7719 AND ITS IMPLEMENTING RULES AND REGULATIONS
VIOLATE THE EQUAL PROTECTION CLAUSE;

III

WHETHER OR NOT SECTION 7 OF R.A. 7719 AND ITS IMPLEMENTING RULES AND REGULATIONS
VIOLATE THE NON-IMPAIRMENT CLAUSE;

IV

WHETHER OR NOT SECTION 7 OF R.A. 7719 AND ITS IMPLEMENTING RULES AND REGULATIONS
CONSTITUTE DEPRIVATION OF PERSONAL LIBERTY AND PROPERTY;

WHETHER OR NOT R.A. 7719 IS A VALID EXERCISE OF POLICE POWER; and,

VI

WHETHER OR NOT SECTION 7 OF R.A. 7719 AND ITS IMPLEMENTING RULES AND REGULATIONS
TRULY SERVE PUBLIC WELFARE.
As to the first ground upon which the constitutionality of the Act is being challenged, it is the contention of
petitioners that the phase out of commercial or free standing blood banks is unconstitutional because it is an
improper and unwarranted delegation of legislative power. According to petitioners, the Act was incomplete
when it was passed by the Legislature, and the latter failed to fix a standard to which the Secretary of Health
must conform in the performance of his functions. Petitioners also contend that the two-year extension period
that may be granted by the Secretary of Health for the phasing out of commercial blood banks pursuant to
Section 7 of the Act constrained the Secretary to legislate, thus constituting undue delegation of legislative
power.

In testing whether a statute constitutes an undue delegation of legislative power or not, it is usual to inquire
whether the statute was complete in all its terms and provisions when it left the hands of the Legislature so
that nothing was left to the judgment of the administrative body or any other appointee or delegate of the
Legislature.38 Except as to matters of detail that may be left to be filled in by rules and regulations to be
adopted or promulgated by executive officers and administrative boards, an act of the Legislature, as a
general rule, is incomplete and hence invalid if it does not lay down any rule or definite standard by which the
administrative board may be guided in the exercise of the discretionary powers delegated to it. 39

Republic Act No. 7719 or the National Blood Services Act of 1994 is complete in itself. It is clear from the
provisions of the Act that the Legislature intended primarily to safeguard the health of the people and has
mandated several measures to attain this objective. One of these is the phase out of commercial blood banks
in the country. The law has sufficiently provided a definite standard for the guidance of the Secretary of Health
in carrying out its provisions, that is, the promotion of public health by providing a safe and adequate supply of
blood through voluntary blood donation. By its provisions, it has conferred the power and authority to the
Secretary of Health as to its execution, to be exercised under and in pursuance of the law.

Congress may validly delegate to administrative agencies the authority to promulgate rules and regulations to
implement a given legislation and effectuate its policies.40 The Secretary of Health has been given, under
Republic Act No. 7719, broad powers to execute the provisions of said Act. Section 11 of the Act states:

"SEC. 11. Rules and Regulations. – The implementation of the provisions of the Act shall be in accordance
with the rules and regulations to be promulgated by the Secretary, within sixty (60) days from the approval
hereof…"

This is what respondent Secretary exactly did when DOH, by virtue of the administrative body’s authority and
expertise in the matter, came out with Administrative Order No.9, series of 1995 or the Rules and Regulations
Implementing Republic Act No. 7719. Administrative Order. No. 9 effectively filled in the details of the law for
its proper implementation.

Specifically, Section 23 of Administrative Order No. 9 provides that the phase-out period for commercial blood
banks shall be extended for another two years until May 28, 1998 "based on the result of a careful study and
review of the blood supply and demand and public safety." This power to ascertain the existence of facts and
conditions upon which the Secretary may effect a period of extension for said phase-out can be delegated by
Congress. The true distinction between the power to make laws and discretion as to its execution is illustrated
by the fact that the delegation of power to make the law, which necessarily involves a discretion as to what it
shall be, and conferring an authority or discretion as to its execution, to be exercised under and in pursuance
of the law. The first cannot be done; to the latter no valid objection can be made. 41

In this regard, the Secretary did not go beyond the powers granted to him by the Act when said phase-out
period was extended in accordance with the Act as laid out in Section 2 thereof:

"SECTION 2. Declaration of Policy – In order to promote public health, it is hereby declared the policy of the
state:

a) to promote and encourage voluntary blood donation by the citizenry and to instill public consciousness of
the principle that blood donation is a humanitarian act;

b) to lay down the legal principle that the provision of blood for transfusion is a medical service and not a sale
of commodity;
c) to provide for adequate, safe, affordable and equitable distribution of blood supply 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 as well as the non-formal 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."

Petitioners also assert that the law and its implementing rules and regulations violate the equal protection
clause enshrined in the Constitution because it unduly discriminates against commercial or free standing blood
banks in a manner that is not germane to the purpose of the law. 42

What may be regarded as a denial of the equal protection of the laws is a question not always easily
determined. No rule that will cover every case can be formulated. Class legislation, discriminating against
some and favoring others is prohibited but classification on a reasonable basis and not made arbitrarily or
capriciously is permitted. The classification, however, to be reasonable: (a) must be based on substantial
distinctions which make real differences; (b) must be germane to the purpose of the law; (c) must not be
limited to existing conditions only; and, (d) must apply equally to each member of the class. 43

Republic Act No. 7719 or The National Blood Services Act of 1994, was enacted for the promotion of public
health and welfare. In the aforementioned study conducted by the New Tropical Medicine Foundation, it was
revealed that the Philippine blood banking system is disturbingly primitive and unsafe, and with its current
condition, the spread of infectious diseases such as malaria, AIDS, Hepatitis B and syphilis chiefly from blood
transfusion is unavoidable. The situation becomes more distressing as the study showed that almost 70% of
the blood supply in the country is sourced from paid blood donors who are three times riskier than voluntary
blood donors because they are unlikely to disclose their medical or social history during the blood screening. 44

The above study led to the passage of Republic Act No. 7719, to instill public consciousness of the importance
and benefits of voluntary blood donation, safe blood supply and proper blood collection from healthy donors.
To do this, the Legislature decided to order the phase out of commercial blood banks to improve the Philippine
blood banking system, to regulate the supply and proper collection of safe blood, and so as not to derail the
implementation of the voluntary blood donation program of the government. In lieu of commercial blood banks,
non-profit blood banks or blood centers, in strict adherence to professional and scientific standards to be
established by the DOH, shall be set in place.45

Based on the foregoing, the Legislature never intended for the law to create a situation in which unjustifiable
discrimination and inequality shall be allowed. To effectuate its policy, a classification was made between
nonprofit blood banks/centers and commercial blood banks.
We deem the classification to be valid and reasonable for the following reasons:

One, it was based on substantial distinctions. The former operates for purely humanitarian reasons and as a
medical service while the latter is motivated by profit. Also, while the former wholly encourages voluntary blood
donation, the latter treats blood as a sale of commodity.

Two, the classification, and the consequent phase out of commercial blood banks is germane to the purpose
of the law, that is, to provide the nation with an adequate supply of safe blood by promoting voluntary blood
donation and treating blood transfusion as a humanitarian or medical service rather than a commodity. This
necessarily involves the phase out of commercial blood banks based on the fact that they operate as a
business enterprise, and they source their blood supply from paid blood donors who are considered unsafe
compared to voluntary blood donors as shown by the USAID-sponsored study on the Philippine blood banking
system.

Three, the Legislature intended for the general application of the law. Its enactment was not solely to address
the peculiar circumstances of the situation nor was it intended to apply only to the existing conditions.

Lastly, the law applies equally to all commercial blood banks without exception.

Having said that, this Court comes to the inquiry as to whether or not Republic Act No. 7719 constitutes a valid
exercise of police power.

The promotion of public health is a fundamental obligation of the State. The health of the people is a primordial
governmental concern. Basically, the National Blood Services Act was enacted in the exercise of the State’s
police power in order to promote and preserve public health and safety.

Police power of the state is validly exercised if (a) the interest of the public generally, as distinguished from
those of a particular class, requires the interference of the State; and, (b) the means employed are reasonably
necessary to the attainment of the objective sought to be accomplished and not unduly oppressive upon
individuals.46

In the earlier discussion, the Court has mentioned of the avowed policy of the law for the protection of public
health by ensuring an adequate supply of safe blood in the country through voluntary blood donation. Attaining
this objective requires the interference of the State given the disturbing condition of the Philippine blood
banking system.

In serving the interest of the public, and to give meaning to the purpose of the law, the Legislature deemed it
necessary to phase out commercial blood banks. This action may seriously affect the owners and operators,
as well as the employees, of commercial blood banks but their interests must give way to serve a higher end
for the interest of the public.

The Court finds that the National Blood Services Act is a valid exercise of the State’s police power. Therefore,
the Legislature, under the circumstances, adopted a course of action that is both necessary and reasonable
for the common good. Police power is the State authority to enact legislation that may interfere with personal
liberty or property in order to promote the general welfare.47

It is in this regard that the Court finds the related grounds and/or issues raised by petitioners, namely,
deprivation of personal liberty and property, and violation of the non-impairment clause, to be unmeritorious.

Petitioners are of the opinion that the Act is unconstitutional and void because it infringes on the freedom of
choice of an individual in connection to what he wants to do with his blood which should be outside the domain
of State intervention. Additionally, and in relation to the issue of classification, petitioners asseverate that,
indeed, under the Civil Code, the human body and its organs like the heart, the kidney and the liver are
outside the commerce of man but this cannot be made to apply to human blood because the latter can be
replenished by the body. To treat human blood equally as the human organs would constitute invalid
classification. 48
Petitioners likewise claim that the phase out of the commercial blood banks will be disadvantageous to them
as it will affect their businesses and existing contracts with hospitals and other health institutions, hence
Section 7 of the Act should be struck down because it violates the non-impairment clause provided by the
Constitution.

As stated above, the State, in order to promote the general welfare, may interfere with personal liberty, with
property, and with business and occupations. Thus, persons may be subjected to certain kinds of restraints
and burdens in order to secure the general welfare of the State and to this fundamental aim of government,
the rights of the individual may be subordinated. 49

Moreover, in the case of Philippine Association of Service Exporters, Inc. v. Drilon, 50 settled is the rule that the
non-impairment clause of the Constitution must yield to the loftier purposes targeted by the government. The
right granted by this provision must submit to the demands and necessities of the State’s power of regulation.
While the Court understands the grave implications of Section 7 of the law in question, the concern of the
Government in this case, however, is not necessarily to maintain profits of business firms. In the ordinary
sequence of events, it is profits that suffer as a result of government regulation.

Furthermore, the freedom to contract is not absolute; all contracts and all rights are subject to the police power
of the State and not only may regulations which affect them be established by the State, but all such
regulations must be subject to change from time to time, as the general well-being of the community may
require, or as the circumstances may change, or as experience may demonstrate the necessity.51 This
doctrine was reiterated in the case of Vda. de Genuino v. Court of Agrarian Relations52 where the Court held
that individual rights to contract and to property have to give way to police power exercised for public welfare.

As for determining whether or not the shutdown of commercial blood banks will truly serve the general public
considering the shortage of blood supply in the country as proffered by petitioners, we maintain that the
wisdom of the Legislature in the lawful exercise of its power to enact laws cannot be inquired into by the Court.
Doing so would be in derogation of the principle of separation of powers.53

That, under the circumstances, proper regulation of all blood banks without distinction in order to achieve the
objective of the law as contended by petitioners is, of course, possible; but, this would be arguing on what the
law may be or should be and not what the law is. Between is and ought there is a far cry. The wisdom and
propriety of legislation is not for this Court to pass upon.54

Finally, with regard to the petition for contempt in G.R. No. 139147, on the other hand, the Court finds
respondent Secretary of Health’s explanation satisfactory. The statements in the flyers and posters were not
aimed at influencing or threatening the Court in deciding in favor of the constitutionality of the law.

Contempt of court presupposes a contumacious attitude, a flouting or arrogant belligerence in defiance of the
court.55 There is nothing contemptuous about the statements and information contained in the health advisory
that were distributed by DOH before the TRO was issued by this Court ordering the former to cease and desist
from distributing the same.

In sum, the Court has been unable to find any constitutional infirmity in the questioned provisions of the
National Blood Services Act of 1994 and its Implementing Rules and Regulations.

The fundamental criterion is that all reasonable doubts should be resolved in favor of the constitutionality of a
statute. Every law has in its favor the presumption of constitutionality. For a law to be nullified, it must be
shown that there is a clear and unequivocal breach of the Constitution. The ground for nullity must be clear
and beyond reasonable doubt.56 Those who petition this Court to declare a law, or parts thereof,
unconstitutional must clearly establish the basis therefor. Otherwise, the petition must fail.

Based on the grounds raised by petitioners to challenge the constitutionality of the National Blood Services Act
of 1994 and its Implementing Rules and Regulations, the Court finds that petitioners have failed to overcome
the presumption of constitutionality of the law. As to whether the Act constitutes a wise legislation, considering
the issues being raised by petitioners, is for Congress to determine.57

WHEREFORE, premises considered, the Court renders judgment as follows:

1. In G.R. Nos. 133640 and 133661, the Court UPHOLDS THE VALIDITY of Section 7 of Republic Act No.
7719, otherwise known as the National Blood Services Act of 1994, and Administrative Order No. 9, Series of
1995 or the Rules and Regulations Implementing Republic Act No. 7719. The petitions are DISMISSED.
Consequently, the Temporary Restraining Order issued by this Court on June 2, 1998, is LIFTED.

2. In G.R. No. 139147, the petition seeking to cite the Secretary of Health in contempt of court is DENIED for
lack of merit.

No costs.

SO ORDERED.