R.A 7719: National Blood Services Act of 1994- An act promoting voluntary blood donation, providing an adequate supply of safe blood, regulating blood banks & providing penalties for violation thereof

- Natl Blood Services Act of 1994

- May 5, 1994

RA 1517 an act regulating the collection, processing & sale of the human blood & the establishment & operation of blood banks & blood processing laboratories

June 16, 1956

Repealed by RA 7719

Several innovations & changes are introduced like:

Promotion of voluntary blood donation to discourage commercialization of human blood.

Phase out of commercial blood banks to operate in a non-profit basis.

To lay down the principle that blood transfusion is a humanitarian act.

Providing the heavier penalties in case of violations that will give more teeth to the new law.

AO no.9 s.1995 April 28, 1995

Implementing guidelines: Rules & regulations implementing RA 7719.

AO no.2008-0008

Rules & regulations governing the regulation of blood service facilities

May 2, 2008

Classification Blood Services capabalities

Purpose: Declaration of Policy

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

To lay down the legal principle that the provision of blood for transfusion is a professional medical service & not a sale of a commodity;

To provide for adequate, safe, affordable & equitable distribution of supply of blood & blood products;

To inform the public of the need for voluntary blood donation the hazards caused by the commercial sale of blood; To teach the benefits & rationale of voluntary blood donation existing health subjects of the formal education system in all public/private schools, in the elementary, high school & college levels as the non-formal education system;

To mobilize all sectors of the community to participate in mechanisms for voluntary & non-profit collection of blood;

To mandate the DOH to establish & organize a National Blood Transfusion Service Network (NBTSN) in order to rationalize & improve the provision of adequate & safe supply of blood;

To provide for adequate assistance to institutions promoting non-profit blood services, either through system of reimbursement for costs from patients who can afford to pay, or donations from governmental & nongovernmental entities;

To require all blood collection units & blood banks/centers to operate on a non-profit basis;

To establish scientific & professional standards for the operation of blood collection unit & blood banks/centers in the Phils.;

To regulate & ensure the safety of all activities related to the collection, storage & banking of blood; and

To require upgrading of blood banks/centers to include preventive services & education to control spread of blood transfusion transmissible diseases.

SCOPE

These rules shall apply to all hospitals, entities & establishments/institutions, government owned & operated or private engaged in blood transfusion services in the Phils. Whether full time / part time, local / foreign.

Definition of Terms:

Secretary of health any other person to whom the Secretary delegates the responsibility of carrying out the provisions of this Act.

Blood/blood product refers to human blood, processed or unprocessed & included blood components, its products & derivatives.

Blood transfusion services a set of activities & functions related to blood transfusion such as, but not limited to:

Motivation & recruitment of donors

Blood collection

Testing & screening of blood donor

Preparation of blood components storage & distribution of blood & components

Components inventory control & quality assurance

Blood bank/center a laboratory or institution w/ the capability to recruit & screen blood donors, collect, process, store, transport & issue blood for transfusion & provide information and/or education on blood transmission disease. Voluntary blood donor one who donates blood on ones own volition / initiative & not induced, directly / indirectly w/o money compensation. Walking blood donor an individual who has been screened by history & physical exam, found to be fit to donate blood; ready to donate blood when needed.

Hospital-based blood bank/center located & performing blood bank services w/in the premises of a hospital end w/c can perform compatibility testing of blood

Non-hospital-based blood bank/center not located & not performing blood bank services, w/in the premises of a hospital & not as part of a hospital.

Commercial blood bank a blood bank that exist for profit, money or any material gain earned out of sale of, or exchange for, blood/blood products w/c profit, money / any material gain are not used solely for the operation & maintenance of blood bank service

Blood collection unit an institution/facility duty authorized by the DOH to recruit & screen donors & collect blood.

Blood station a gov. or private hospital / a Phil. Natl Red Cross chapter w/c has not been licensed as a blood center but has been authorized by the Dept to store & issue blood & blood product, & perform compatibility testing, when necessary. Blood service facility any unit, office, institution providing any of the blood transfusion services, w/c can be a Blood bank/center, BCU or BS.

Blood transfusion transmissible disease dse w/c may be transmitted through blood transfusion, including but not limited to, AIDS, hepaB&C, malaria & syphilis.

Blood banking equipment essential lab machines, instruments & their accessories used in the different steps in the blood banking processes such as those used to centrifuge blood/separate blood into various components; preserve blood/blood products in cold storage or freezer.

Blood bags sterile, sturdy plastic bags containing anti-coagulants; it can either be single/multiple types & have a integral sterile needle & collection tubing.

Reagents substances employed to detect/measure another substance/convert 1 substance to another by means of the rxn it causes.Composition A national voluntary blood services program committee is hereby created & shall be chaired by the Sec.of health. It shall be composed of , but not limited to, the heads of the ff offices & assoc.:

DepED

DILG

DOF

DSWD

PRC

PNRC

PBCC

PSHBT

PSP

PMA

PHA

PAMET

Functions:

Formulation of a 5-year Directional/strategic plan

Operationalization & institutionalization of the NVBSP including budgetary allocation for program activities

Monitoring & evaluation of NVBSP activities

Creation of multi-sectoral sub-committees

Generation of multi-sectoral & inter-disciplinary support for natl activities focused on blood services

Meetings shall be at least quarterly

Programming funding

Budgetary allocation of the Dept PCSO

PAGCOR

Trust liability account of Duty free shop

Contributions of other agencies

Promotion of Voluntary Blood Donation

Composition. The natl advocacy & promotion sub-committee shall be composed of, but not limited to, representatives of DOH, PNRC, PBCC, PIA, & other similar organizations. Promotion in school & communities, professional education, establishment of blood services network:

DOH

PSHBT PSP PMA PNRCSec.7. All commercial blood banks shall be phased-out over a period of 2 years after the effectivity of this act, extendable to a maximum period of 2 years of the secretary.Sec.8. All blood banks/centers shall operate on non-profit basis; provided that they may collect service fees bot greater than the maximum prescribed by DOH w/c shall be limited to the necessary expenses entailed on collecting & 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 & operate a blood banl/center unless it is registered & issued a license to operate by the dept provided, that in case of emergencies, blood collection & transfusion under the responsibility of the attending physician should be allowed in the hospitals w/o such license under certain conditons prescribed by the dept.

Licensing

Private shall be required to submit their voluntary blood donation program plan.

Govt hosp VBDPP accompanied by preceding years blood donation program report

AO no.2008-0008

Classification of blood service capabilities;

Ownership govt / private Intitutional character hosp / non-hosp based (PNRC) Service capabilities BS / BCUBlood station

Advocacy & promotion of voluntary blood donation & healthy lifestyle Provision of WB & p-RBC; storage, issuance, transport Distribution of WB & p-RBC; *Compatibility testing of RC unitsBlood collection unit

Advocacy & promotion of voluntary blood donation & healthy lifestyle Recruitment, retention, & care of voluntary blood donors, screening

Selection of voluntary blood donor, conduct health education

Counseling services, collection of blood (mobile/facility based) from

Qualified VBD; transport of blood to BC for testing & processing

*Compatibility testing of RC unitsBlood bankAdvocacy & promotion of voluntary blood donation healthy lifestyle; storage, issuance of WB & blood components obtained from BC; Compatibility testing of RC units; Direct Coombs test; RC antibody screening; assist Hospital Blood Transfusion Committee (HBTC) in the conduct of post-transfusion surveillance (hemovigilance)

Advocacy & promotion of VBD & healthy lifestyle; recruitment, retention, & care of VBD; collection of blood (mobile/facility based) from qualified VBD; conduct health education & counseling; testing of units of blood for transfusion transmitted infections (TTIs); processing & provision of blood components; storage, issuance, transport & distribution of units of WB &/or blood products to hospitals & other health facilities.

The DOH in collaboration w/ the PNRC shall be the lead agency in the celebration of the blood donors week w/c shall be held annually every 2nd week of july.Emergency blood transfusion

Blood collection & immediate transfusion in hospital w/o license as a blood bank may be allowed in emergency situation subject to the ff conditions: That the medical/surgical condition poses & immediate threat to the patients life that the collection & transfusion is done under the direct supervision & w/ full responsibility of the attending physician that the existing standards & specs for donor screening including history & PE on asepsis & biosafety & on use of proper & good quatity equipment & materials & supplies are complied w/ That the required test for hgb, syphilis, HIV, hepatitis & for compatibility testing including cross matching are also performed before transfusion.