Chapter III – RA 7719: The National Blood
Service Act of 1994
THE PHILIPPINE BLOOD BANK LAW
TWO MAJOR LAWS:
1. REPUBLIC ACT NO. 7719 (NATIONAL BLOOD SERVICES ACT OF 1994)
2. REPUBLIC ACT NO. 1517 (Regulating the Collection, Processing and Sale of
Human Blood, and the Establishment and Operation of Blood Banks and Blood
Processing Laboratories)
TWO MAJOR AGENCIES THAT FACILITATE BLOOD DONATION AND
EDUCATION:
1. Philippine National Red Cross (PNRC)
2. Philippine Blood Coordinating Council (PBCC)
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”
- Approved on June 16, 1956
§
Blood - human blood, processed or unprocessed, and includes its products and
derivatives
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.
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
Ø such bank or laboratory be established or operated in accordance with accepted
scientific standards,
Ø is under the administration, direction and supervision of a licensed and qualified
physician,
Ø 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.
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.
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.
REPUBLIC ACT NO. 7719 (NATIONAL BLOOD SERVICES ACT OF 1994)
- approved on May 5, 1994
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.
Definition
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.
Promotion of Voluntary Blood Donation
a) Public Education
b) Promotion in Schools
c) Professional Education
d) Establishment of Blood Services Network
e) Walking Blood Donors
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
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.
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.
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.
ADMINISTRATIVE ORDER NO. 9 s. 1995
RULES AND REGULATIONS IMPLEMENTING REPUBLIC ACT No. 7719 OTHERWISE
KNOWN AS THE “NATIONAL BLOOD SERVICES ACT OF 1994”
NATIONAL VOLUNTARY BLOOD SERVICES PROGRAM
NATIONAL PROGRAM COMMITTEE
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.
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.
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.
PROMOTION OF VOLUNTARY BLOOD DONATION
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.
UPGRADING OF SERVICES AND FACILITIES
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.
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
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.
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.
PHILIPPINE NATIONAL RED CROSS (PNRC)
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.
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.
PHASE–OUT OF COMMERCIAL BLOOD BANKS
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.
NON–PROFIT OPERATION
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.
REGULATION OF BLOOD SERVICES
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.
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.
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
2. STAFF DEVELOPMENT PLAN
3. PHYSICAL FACILITIES, EQUIPMENT AND SUPPLIES
4. BIOSAFETY
5. QUALITY CONTROL
6. RECORDING, REPORTING AND DOCUMENTATION REQUIREMENTS
7. BLOOD DISTRIBUTION AND TRANSPORT REQUIREMENTS:
8. BLOOD TRANSFUSION COMMITTEE
9. PREVENTIVE SERVICES
10. NETWORKING
THE LICENSING PROCESS
The following shall be the process of licensing:
1. INITIAL APPLICATION
2. APPLICATION FOR RENEWAL OF LICENSE
3. INSPECTION
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.
PHASE OUT OF COMMERCIAL BLOOD BANKS
No new license shall be issued for a commercial blood bank.
APPEALS AND REPORTS ON VIOLATION
Reports on violations of 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.
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).
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.
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.
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.
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.
AO 57 S. 1989
REVISED RULES AND REGULATION GOVERNING THE COLLECTION,
PROCESSING AND PROVISION OF HUMAN BLOOD AND THE ESTABLISHMENT
AND OPERATION OF BLOOD BANKS
These rules and regulations are issued to implement the Blood Bank Law (R.A. 1517)
consistent with Executive Order No. 119 (Reorganization Act of the Ministry of Health)
Purpose
These rules and regulation are promulgated to protect and promote the health of the
people by preventing the operation and maintenance of sub–standard, improperly
managed and poorly–equipped blood banks and by elevating the quality of blood
banking services and blood products.
Scope
1. These regulations shall apply to all entities performing the activities and functions of
blood banks in the Philippines including those in all government or private hospitals.
2. A blood bank or blood processing center is an institution or laboratory in which any
three (3) or more of the following are done (referred to as blood bank):
(a) Recruitment and screening of blood donors
(b) Collection of blood for transfusion
(c) Processing and/or storage of blood
(d) Transport and/or issuance to hospitals
(e) Compatibility testing of blood
Classification of Blood Banks
1. For purposes of service extent and level, the blood banks are both (1) primary
(2) secondary (3) tertiary depending on the range of blood bank services provided and
the presence of certain manpower, equipment and facilities required. The minimum
services required for each respective category of blood bank shall be:
(a)
(1)
(2)
(3)
(4)
(5)
(6)
Primary Category
Donor screening and selection
Collection and processing of blood
Storage of blood
Transport and issuance of blood
Compatibility testing (for hospital)
Transfusion of whole blood (for hospital)
(b)
(1)
(2)
(3)
Secondary Category
Services required for Primary Category
Provision of packed red cells, plasma and platelet rich plasma
Investigations for transfusion reaction (for hospitals)
(c) Tertiary Category
(1) Services required for Primary category
(2) Services required for Secondary category
(3) Provision of blood components, products or derivatives not included in secondary
category
(4) Investigations of incompatible crossmatches (for hospitals)
2. For purposes of institutional character, Blood Banks may be classified into
hospital blood banks or free standing (non–hospital) blood banks depending on whether
or not they operate within a licensed hospital.
3. The permit issued shall state or indicate the institutional type (hospital or free
standing) and category (primary, secondary or tertiary) of the blood bank.
License to Operate a Blood Bank
1. No Blood Bank shall be allowed to operate nor any person allowed to collect, process
and distribute human blood either for sale or for free without having secured a
proper and valid license issued by the Bureau of Research and Laboratories.
2. The following are not required to obtain a license to operate a blood bank:
(a) In cases of emergency, physician in hospitals with a license for a secondary or
tertiary category of laboratory may be allowed to extract and transfuse blood
immediately for their own patients provided:
(1) Donors are screened under medical supervision including history, physical
examination and tests for hemoglobin level, presence of malarial parasites and serologic
test for syphilis.
(2) Collection of blood is done under aseptic condition into proper plastic blood bags.
(3) Compatibility testing including cross matching shall follow acceptable standards.
(4) The blood transfusion shall be medically supervised. A hospital with a laboratory
licensed as secondary or tertiary category may screen donors and collect blood provided
such blood is processed in duly licensed blood bank.
A hospital with a laboratory licensed as secondary or tertiary category may screen
donors and collect blood provided such blood is processed in a duly licensed blood
bank.
Section 9. Management of Blood Bank
The Head (Chief, Director, Physician–In–charge, etc.) is the person who assumes
technical and administrative supervision and control of activities in the blood
bank.
1. For all categories of blood banks, the head shall be licensed physician certified
by the Philippine Board of Pathology in Clinical Pathology or Blood Banking
of Philippine Board of Hematology and Blood Transfusion provided that:
(a) This shall be mandatory for all categories of free standing blood banks and all
secondary and tertiary categories of hospital blood banks.
(b) This shall be voluntary for all primary category hospital blood banks. For those
blood banks unable to comply with the above requirement, they may be headed by a
licensed physician who has completed at least three (3) months of training in blood
banking including quality control and management in an acceptable institution and
passed an examination given or approved by the Bureau of Research and Laboratories.
2.
A certified Pathologist or Hematologist may be authorized to head and manage
not more than two (2) blood banks.
3.
A physician under 9.1 paragraph (2) may be authorized to head only one (1)
hospital blood bank (primary category).
Requirements for the collection, processing and disposition of Blood and
Blood products
1. Donor requirements
(a) Determination of the suitability of the donor shall be the responsibility of the head
of the blood bank and shall be done by him or under his supervision with the assistance
of the necessary trained personnel.
(b) Blood donors shall be in good physical condition and free of diseases transmissible
by blood transfusion as far as can be determined from the donor’s personal history and
from such physical examination and laboratory tests as prescribed by the Bureau of
Research and Laboratories.
2.
Collection of Blood
(a) Drawing blood from donors shall be the responsibility of the Head and shall be
done by him or under his direct supervision with the assistance of the necessary trained
personnel
(b) The drawing shall be performed in a suitable bleeding areas located in the blood
bank.
(c) The expiration date for preserved blood shall be specified in the label in
accordance with the anticoagulant used as specified in the Technical requirements.
3.
Whole Blood and Blood products
(a) The preparation of whole blood and blood products shall be according to standard
procedures acceptable to the Bureau of Research and Laboratories
(b) The characteristics, quality or components, quality of cellular elements, properties
and other specifications of whole blood and blood product s shall be prescribed by the
Bureau of Research and Laboratories and compliance with such specification shall be
determined by periodic Quality Control Test (Section 13).
4.
Dispensing of blood
Blood or its products is to be dispensed only upon the presentation of a proper request
from the attending physician or hospital authority or another blood bank, which shall be
kept on file and subject to inspection.
5.
Records
(a) Blood Banks shall maintain a permanent record to show the donor’s name, card
number, data pertaining to the donor, the result of blood grouping, serologic and other
screening tests, for whom the blood was issued, and the date of issue.
(b) Provisions must be made for recording reactions if any have occurred.
(c) Records must be kept of the quantity of blood in storage, disposed or transferred
daily, and temperature of storage.
6.
Labels
All blood containers shall have labels which shall contain data specified in the technical
requirements
Reporting
Each blood bank shall report annually the volume of blood collected and utilized or
otherwise disposed of and any adverse reactions that have occurred in accordance with
the format prescribed by the Bureau of Research and Laboratories.
Quality Control Tests
The Director of the Bureau of Research and Laboratories or his representative is hereby
authorized to conduct such quality control tests as he does appropriate or necessary for
the administration of these regulations, for the control of operations and as criteria for
the renewal license. These include tests on blood products to determine if they comply
with specifications prescribed by the Bureau of Research and Laboratories.
Donor Registries
1. The Bureau of Research and Laboratories may establish control donor registries of
rare blood types or hazardous donors as the Director may deem necessary.
2. Each blood bank shall establish such registries for the supply of rare blood and
protection recipients
Basic License Requirements
1. Any person, firm or corporation desiring to establish or operate and maintain a blood
bank shall submit to the Bureau of Research and Laboratories a sworn
petition/application on the prescribed form containing among others the following data:
(a) Name, citizenship and domicile of the Head of the Blood Bank
(b) Place, municipality and province where it is to be established
(c) Name of the establishment
(d) Name, citizenship and domicile of the owner
(e) Scope of the nature of work to be undertaken
(f)
Statement of duly notarized that applicant has complied with all business
requirement under existing laws or ordinances that are necessary in pursuance of the
activity for which license is herein applied for.
2. If the applicant is a partnership or corporation, it must be duly registered existing
laws and that the copy of its registration papers be attached to the corresponding
petition.
Section 16. Application for License
1. An application for a license shall be filed by the owner in a form “Petition to
Establish/Operate a Blood Bank” together with the application to Head of Blood Bank
and Information Sheet with the Office of the Bureau of Research and Laboratories for
screening and approval.
2. Each application shall be signed under oath or affirmation by the applicant or a
person duly authorized to act for and on his behalf.
3. The license free should be submitted together with the application.
4. Within 60 days after receipt of said application, an inspector of the Bureau of
Research and Laboratories shall inspect the establishment and verify if the applicant has
complied with the requirements prescribed in these regulations.
5. Any false statement in the application or failure to comply with the requirements may
serve as basis for refusal to issue a license to operate a blood bank.
Publication of list of Blood Banks
1. A list of licensed blood banks according to their type and category shall be published
periodically and made available to any person, agency or organization for legitimate
purposes.
2. The results of quality control testing shall likewise be published
Violations
The license to operate a blood bank may be suspended or revoked by the
Undersecretary of Health for Standards and Regulation upon violation of the Blood Bank
Law (R.A. 1517) or the rules and regulations issued in pursuance thereto or the
commission of the following acts by the persons owning or operating a blood bank and
the persons under their authority.
(a) Operation of a blood bank without a certified Pathologist or Hematologist or a
qualified licensed Physician authorized by the Undersecretary of Health for Standards
and Regulation as Head without employing a duly registered Medical Technologist;
(b) Any false statement in the application;
(c) Change of ownership, location, head of Blood Bank or personnel without informing
the Bureau of Research and Laboratories in writing;
(d) Refusal to allow inspection of the Blood Bank by persons authorized by the
Director of the Bureau of Research and Laboratories during reasonable hours;
(e) Refusal to perform quality control tests or submit samples of blood products for
quality control evaluation as required by the Bureau of Research and Laboratories.
(f)
Imposing charges on blood products higher than those promulgated by the
Bureau of Research and Laboratories.
(g) Failure to correct deficiencies within a reasonable time after due notice from the
Bureau of Research and Laboratories.
Administrative Order No. 2008-0008
May 2, 2008
RULES AND REGULATIONS GOVERNING THE REGULATION OF BLOOD
SERVICE FACILITIES
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.
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 – Blood Station
(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 - Blood Collection Unit
(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)
(a)
(b)
(c)
i.
ii.
iii.
iv.
v.
BB – Blood Bank
Advocacy and promotion of voluntary blood donation and healthy life;
Storage and issuance of whole blood and blood components obtained from a BC;
The following services shall also be provided:
Compatibility testing of red cell units
Direct Coombs test
Red cell antibody screening
Investigation of transfusion reactions
Assist the HBTC in the conduct of post–transfusion surveillance (hemovigilance)
(5) BC - Blood Center
(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.
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.
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.
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
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.
AO 2008-0008-A
AMENDMENT TO AO 2008-0008
Issued to strengthen the existing Blood Services Networks an improve the
delivery of safe adequate accessible and affordable blood supply to health
facilities including those providing Basic and Comprehensive Emergency
Obstetrical and Neonatal Care (B/CEmONC) services. Safe blood supply is one
of the five critical parameters of Functionality of these health facilities
providing B/CEmONC services for the rapid reduction of Maternal Mortality
Ratio (MMR) to attain the Philippine Government’s commitment for
the Millenium Development Goal (MDG) 5.
Starting last January 1, 2010, the regulation of the new categories o Blood
Service Facilities took effect per AO 2008-0008 dated May 2, 2008. The four
new categories of Blood Service Facilities are
1. the Hospital Blood Banks,
2. the Blood Centers,
3. the Blood Collection Units and
4. Blood Stations
However, annually for 2010 and for 2011, the Program Management of the
National Voluntary Blood Services Program (NVBSP) had recommended that
the Blood Banks of Level 3 and Level 4 Government and Private Hospitals
continue blood collection from volunteer blood donors, blood testing for
infectious agents and component processing. This is mainly premised on the
situation where Level 3 and 4 hospitals which have higher service capability
and bed capacity are expected to have high blood need. On the other hand,
for efficiency, the smaller hospitals (Level 1 and 2) and other health facilities
administering blood transfusion were recommended to be part of the Blood
Services Networks where blood products will be supplied by designated Blood
Centers under the Philippine Red Cross, DOH and LGU instead of establishing
and maintaining a high capital intensive and operationally costly blood banks.