Blood Banking Laws & Bioethics (RA 1517, RA 7719; NVBSP & DOH Rules)

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Vocabulary flashcards covering key terms, definitions, and regulatory concepts from the Philippine blood banking laws (RA 1517, RA 7719), NVBSP, and DOH rules.

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22 Terms

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Blood

Human blood, processed or unprocessed, and includes its products and derivatives.

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Blood bank / center

A laboratory or institution capable of recruiting and screening donors, collecting, processing, storing, transporting and issuing blood for transfusion, and providing information/education on transfusion-transmissible diseases.

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Blood collection unit

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

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Voluntary blood donor

A person who donates blood on one's own volition or initiative and without monetary compensation.

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Walking blood donor

An individual listed among qualified voluntary donors who is ready to donate when needed in the community.

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Blood transfusion transmissible diseases (TTIs)

Diseases which may be transmitted as a result of blood transfusion, such as AIDS/HIV, Hepatitis B, Malaria, and Syphilis.

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Blood products

Components derived from blood, including plasma, platelets, and other derivatives.

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Republic Act No. 1517

An act regulating the collection, processing and sale of human blood, and the establishment and operation of blood banks; approved June 16, 1956; repealed by RA 7719.

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Republic Act No. 7719 (National Blood Services Act of 1994)

An act promoting voluntary blood donation, providing for an adequate supply of safe blood, regulating blood banks, and providing penalties for violations; approved May 5, 1994.

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Phase out commercial blood banks

Commercial blood banks shall be phased out over two years after the act’s effectivity.

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Non-profit operation

Blood banks/centers must operate on a non-profit basis; service fees cover only necessary expenses; blood collected from healthy voluntary donors only.

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Regulation of blood services

To establish/operate a blood bank/center, it must be registered and licensed by the DOH; in emergencies, collection/transfusion may be done by the attending physician without a license.

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Importation of equipment, blood bags, and reagents

Imported tax- and duty-free by PNRC to blood banks and hospitals participating in the National Voluntary Blood Services Program.

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Penalty: charging more than the maximum (RA 7719)

License suspended or revoked; imprisonment 1–6 months; fine 5,000–50,000 pesos (or both) for exceeding allowed charges.

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Penalty: operating without a license

Imprisonment 12 years and 1 day to 20 years; fine 50,000–500,000 pesos (or both); possible administrative sanctions.

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Contaminated blood penalty

Head of BSF and responsible personnel may be imprisoned for 10 years; penalties may be in addition to other charges.

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Secretary of Health role

Enforces the act, issues rules/regulations, and provides maximum ceilings for handling charges.

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Administrative Order No. 8 s. 2008 (DOH)

Rules governing regulation of Blood Service Facilities; classifications and guidelines for operation.

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License to Operate (LTO) / Authorization to Operate (ATO)

Licenses/authorizations required to operate a Blood Services Facility; not transferable; must be displayed; changes must be reported; separate LTO/ATO for each BSF.

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One-Stop-Shop Licensure

A unified licensure process for hospital-based BSFs; LTO/ATO issued through a single process; documentation submitted to CHD; separate LTO/ATO for each BSF/branch.

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Renewal of LTO/ATO

LTO/ATO renewed every three years; hospital BSFs renew annually as part of One-Stop-Shop licensure; renewal window Oct 1–Nov 30.

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Validity of LTO/ATO

LTO/ATO valid for 3 years; hospital-based BB/BCU/BS license to operate valid for 1 year (Jan 1 to Dec 31).