MTLBE

Handouts (MT)-B

RA 7719: National Voluntary Blood Services Act

(Voluntary Blood Donation)

Before World War II, blood was collected and directly administered to patients.
With the advent of anticoagulants, blood could be preserved and stored in Blood Banks.
Voluntary Blood Donation began to be promoted after WWII.

PNRC (Philippine National red Cross) National Blood Program

July 17, 1948 - The Philippine National Red Cross launched the National Blood Program with President Elpidio. Quirino as the
first
Blood Donor.

The original objective of the NBP was:

"To maintain a constant and ready supply of whole blood or plasma at least for emergency cases".

RA 1517: Blood Bank Law

(Blood Bank Law in 1956)

Subsequently, some government and private hospitals set up blood banks Through the
years, the demand for blood for transfusion grew and because of the inability of the
PNRC NBP and hospital blood banks to cope with this growing demand, commercial
blood banks were established.
In order to assure the safety of the supply of blood from the hospital and commercial blood banks, the government passed the
Blood Bank Law in 1956 . Blood Donors Week is held annually on the second week of July.

June 16, 1956 - An Act regulating the collection, processing and sale of human blood, and the establishment and operation of blood
banks and blood processing laboratories was approved.
Purpose:
Safeguarding and promoting public health and welfare by preventing improper collection, processing and sale of human blood
or its product to the public.

May 5, 1994 - RA 1517 was repealed by RA 7719

Implementing guidelines:
Administrative Order No. 9, Series of 1995
Administrative Order No. 17-A, Series of 1998
Administrative Order No. 2005-0002
Administrative Order No. 2008-0008

RA 7719 - National Blood Services Act of 1994

(Approved on May 5, 1994)

Purpose:
1. To promote voluntary blood donation
2. To provide safe, adequate, affordable and equitable blood products
3. To inform the public
 4. To require all blood banks/ centers to operate on a non profit basis

The bill was initiated by the Committee on NBSP - filed in 1989 by Sen. R. Saguisag.
Promotes Voluntary Blood Donation and mandates a N V Blood Services Program. Phases out commercial blood banks in
two to four years.
Provides Duty-free importation of blood bank equipment, reagents, blood bags, and supplies.
Regulates Blood Service Facilities

Blood/blood product
Refers to human blood, processed or unprocessed and
includes blood components, its products and derivatives.

Blood Service Facility (BSF)

Any unit, office, institution providing any of the blood transfusion services,
which can be a Blood Bank, Blood Center, a Blood Collection Unit or a Blood Station.

Blood Station (BS)

A government or private hospital or PNRC chapter which has not been licensed as a blood
center but has been authorize by the DOH to store and issue blood and blood product, and perform compatibility testing, when
necessary.

Blood Collection Unit (BCU)

An institution or facility duly authorized by the Department of Health to recruit and screen donors and collect blood.

Blood Bank (BB)

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.

Hospital-based blood bank

A blood bank which is located within the premises of a hospital and which can perform compatibility testing of blood.

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

Apheresis Facility
A blood service facility where blood collection procedure is done in which whole blood is removed, a selected component
separated and the remainder returned to the donor.

End-User Hospital (EU)

A hospital with a licensed clinical laboratory capable of red cell typing and cross-matching and
which does not have any blood service facility but which only receives blood and blood
components for blood transfusion as needed.

Pheresis machine

End-User Non-Hospital
Health Facility
A licensed/accredited non-hospital health facility without a licensed clinical laboratory but which administers blood transfusion.

Blood Donors
Voluntary blood donors - one who donates blood on one's own volition or initiative and without monetary compensation.
 Paid donors
Replacement donors
Walking Blood Donor is an individual included in the list of qualified voluntary blood donors referred to in Section 4 ,
paragraph (e), who is ready to donate blood when needed in his community.

Sec. 4, Paragraph (e)

In areas where there may be inadequate blood banking facilities, the walking blood donor concept shall be encouraged and all
government hospitals, rural health units, health centers and barangays in these areas shall be required to keep at all times a
list of qualified voluntary blood donors with their specified blood typing.

5 Core Test (WHO)

1. Antibody to HIV, subtypes 1 & 2
2. Hepatitis B Surface Antigen
3. Antibody to Hepatitis C
4. Serologic Test for Syphilis (RPR/VDRL)
5. Malaria

Flow Chart of Blood Donors at the Blood Service Facility

Sec. 4 - Promotion of Voluntary Blood Donation

Public Education
Promotion in Schools
Professional Education
Establishment of Blood Services Network
Walking Blood Donors

Sec. 5 - National Voluntary Blood Services Program (NVBSP)

The DOH, in cooperation with the PNRC and PBCC and other government agencies and nongovernmental organizations shall
plan and implement a National Voluntary Blood Services Program (NVBSP) to meet in an evolutionary manner, the needs for
blood transfusion in all regions of the country.
Funds for this purpose shall be provided by the:
1. Government (budgetary allocation of the DOH)
 2. PCSO - P25,000,000
3. PAGCOR - P25,000,000
4. Duty Free Philippines - P20,000,000
5. Contributions of other agencies (civic organizations)
Blood Services Network
An informal organization composed of the designated blood centers and hospital blood
banks, blood stations and end-user hospitals established to provide for the blood needs of
a specific geographical area.

Structural Organization

Sec 7 - Phase-out of Commercial BB

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 DOH which shall be limited to the necessary expenses entailed in collecting and processing of
blood.

Sec. 10. Importation of Blood Bank Equipment, Blood Bags and Reagents.
Imported tax-and duty-free by:
1. PNRC
2. Blood banks and hospitals participating in the
National Voluntary Blood Services Program (NVBSP).

Sec. 12. PENALTIES

Any person or persons who shall be responsible for the above violation shall suffer the penalty of imprisonment of:
a. NOT < 1 MONTH NOR > 6 MONTHS, or
b. a fine of not < P5,000 nor more than P50,000, or
c. both at the discretion of the competent court.

The head of the blood bank and the necessary trained personnel under the heads direct supervision found responsible for
dispensing, transfusing and failing to dispose, within 48 hrs, blood which have been proven contaminated with blood
transfusion transmissible diseases shall be imprisoned for 10 yrs.
 MTLBE
Handouts (MT)-C

RA 7719: National Blood Services Act of 1994

May 15, 1994 was the approval of 15 Sections of RA 7719

President of the Senate

EDGARDO J. ANGARA

Speaker of the House of Representatives

JOSE DE VENECIA, JR.

Secretary of the Senate

EDGARDO E. TUMANGAN

Secretary General House of Representatives

CAMILO L. SABIO

President of the Philippines

FIDEL V. RAMOS

RA 1517: Blood Bank Law

May 5, 1994 - RA 1517 was repealed by RA 7719

Implementing guidelines:
Administrative Order No. 9, Series of 1995
Rules and Regulations Implementing RA 7719
Administrative Order No. 17-A, Series of 1998
Requirements and Procedures for a License to Operate a BB/ BC in the Philippines
Administrative Order No. 2005-0002
Rules and Regulations for the establishment of the Phil. Natl Blood Services
Administrative Order No. 2008-0008
Rules and Regulations Governing the Regulation of Blood Services Facilities

Administrative Order No. 2008-0008

Rules and Regulations Governing the Regulation of Blood Services Facilities

Classification of Blood Service Facility (BSF)

1. Ownership

a. 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
operation.

b. 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.

2. Institutional Character

a. Hospital-based a BSF located within the premises of a hospital.

b. Non-hospital-based a government-owned or PNRC-owned BSF located outside the premises of a hospital consistent
with the NVBSP strategic plan.
Service Capability
1. Blood Station (BS)
Advocacy and promotion of voluntary blood donation and healthy lifestyle
Provision of whole blood and packed red cells
Storage, issuance, transport and distribution of whole blood and packed red cells
Compatibility testing of red cell units, if hospital-based

2. Blood Collection Unit (BCU)

Advocacy and promotion of voluntary blood donation and healthy lifestyle
Recruitment, retention and care of voluntary blood donors
Screening and selection of voluntary blood donors
Conduct of health education and counselling services
Collection of blood (mobile or facility-based) from qualified blood donors
Transport of blood to BC for testing and processing
Compatibility testing of red cell units, if hospital-based

3. Blood Bank (BB)

Advocacy and promotion of voluntary blood donation and healthy lifestyle
Storage and issuance of whole blood and blood components obtained from a BC
The following services shall also be provided
a. Compatibility testing for red cell units
b. Direct Coombs test
c. Red cell antibody screening
d. Investigation of transfusion reactions
e. Assist the HBTC in the conduct of post-transfusion surveillance (hemovigilance)

4. Blood Center (BC)

Advocacy and promotion of voluntary blood donation and healthy lifestyle
Recruitment, retention and care of voluntary blood donors
Collection of blood (mobile or facility-based) from qualified blood donors
Conduct health education and counselling services
Testing of units of blood for TTIs
Processing and provision of blood components
Storage, issuance, transport and distribution of units of whole blood and/or blood products to hospitals and other health
facilities

Standards and Technical Requirements

The BSF appoints and allocates personnel who are suitably qualified, skilled and trained to assume the responsibilities,
authority, accountability and functions of the position.
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.
All equipment and instruments necessary for the safe and effective provision of services are available and are properly
maintained.
All reagents and glasswares to be used by the BSF shall be based on the minimum requirement for sensitivity and specificity
of testing reagents as the testing procedures as recommended by the technical committee of the NVBSP.
There shall be a system of reporting and recording of results of BSF examinations.
The BSF shall put into practice a quality assurance program
There shall be a policy on quality assurance program and continuous quality improvement.
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.
There shall be a system in outsourcing of examinations and blood components.
All hospital-based BB, BCU, and/or BS shall establish an Hospital Blood Transfusion Committee (HBTC).
All BSF shall comply with policies and guidelines of the NVBSP.
License to Operate/Authority to Operate
Hospital bases BBs, BCUs and 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 the other documentary requirements for the
hospital LTO.
The LTO/ATO must be displayed at all times at a prominent place within the premises.
The CHD shall be notified within 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.
A separate LTO/ATO shall be required for each BSF or branch maintained in separate premises even if operated by the same
management.

Documentary requirements for the issuance of LTO/ATO

1. Certificate of inclusion in the Regional Blood Services Network approved by the identified Lead Blood Center in the region
2. Duly accomplished and notarized application form
3. DTI/SEC registration (initial)
4. List of personnel with photocopy of valid PRC card
5. Location map (initial)
6. Floor diagram
7. List of equipment with serial number, brand, date of purchase, number of units and operational status
8. NVBSP Annual Blood Report (renewal)
9. Certificate of participation in EQAS in previous year (renewal)

Inspection
The CHD director or his authorized representative/s inspects the BSF within 30 calendar days from the time of application to
determine compliance with standards and technical requirements.
The CHD inspection team prepares official summary of findings and recommends approval or disapproval after inspection.

Validity of License to Operate

The LTO/ATO to operate a Blood Service Facility shall be valid for a period of 3 years. 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 of 1 year.

Violations
1. Any material false statement in the application
2. Misinterpretation of facts or falsification of documents or records
3. Refusal to make available its books, accounts and records of operation to an authorized person from the BHFS/CHD
4. Charging of blood service fees above the maximum fees set by the DOH
5. Collection of blood from paid or remunerated donor whether payment comes from the hospital or from the patient/relatives.
6. Refusal to participate in EQAS (External Quality Assessment Scheme )conducted by the designated National Reference
Laboratories.