Law Summary
Objective
- To protect and promote public health by ensuring authorized Blood Collection Units and Blood Stations have adequate staff, equipment, and resources.
- Aims for safe, efficient, and effective performance of all required blood-related functions.
Scope
- Applies to all government and private Blood Collection Units and Blood Stations operating within the Philippines.
Definition of Terms
- Defines key terms such as Act (RA 7719), Authority to Operate, BHFS, Blood, Blood Component, Blood Derivative, Blood Product, Blood Transfusion Services, BSF, CHD, DOH, NVBSP, PNRC, Secretary, and Voluntary Non-remunerated Blood Donor.
Classification of Blood Collection Units and Blood Stations
- Ownership: Government-operated or Private-operated.
- Institutional Character: Hospital-based or Non-hospital-based.
- Service Capability:
- Blood Station: Authorized to provide, store, issue, transport whole blood and packed red cells, and conduct compatibility testing if hospital-based.
- Blood Collection Unit: Authorized for donor recruitment, screening, education, blood collection, transport to Referral Blood Center, compatibility testing if hospital-based.
Technical Requirements
- All BCUs and Blood Stations must comply with technical requirements specified in the annex, including staffing, equipment, facilities, and quality assurance.
Procedural Guidelines
- Application process involves:
- Requesting and submitting forms to CHD.
- Documentary requirements include certificate of inclusion, application form, registrations, personnel certificates, maps, diagrams, equipment lists, and reports.
- Payments follow DOH prescribed schedule.
- CHD and lead BSF conduct surveys to ensure compliance.
- Approval leads to registration and authority issuance; disapproval requires corrective actions within 15 days.
- Ongoing monitoring by BHFS and lead BSF through site visits.
Terms and Conditions
- Authority is conditional on continuous compliance.
- Cannot be assigned or transferred.
- CHD must be notified of management or location changes; new application required for location transfer.
- Separate authority required for each facility or branch.
- Blood Banks oversee affiliated BCUs and Blood Stations with regular site visits.
- Authority and fee schedules must be publicly displayed.
- Authority to operate is renewed annually, application filed 90 days before expiration.
Validity of Authority to Operate
- Authority is valid for one year from issuance.
Maximum Allowable Service Fees
- Facilities operate on a non-profit basis.
- May charge reasonable service fees not exceeding DOH-prescribed maximums.
- Fees cover direct and indirect costs of blood collection and processing, excluding cross-matching and special testing costs.
- Fees are determined by BHFS and NVBSP based on cost studies and expert consultations.
Violations
- Includes false statements, misrepresentations, unnotified changes, refusal of surveys, overcharging, paid blood donations, dispensing unscreened blood, improper disposal of contaminated blood, and other unacceptable blood banking practices.
Investigation and Hearing of Charges or Complaints
- DOH Legal Division/BHFS investigates sworn complaints.
- CHD Director may suspend or revoke authority to operate upon finding violations.
- Criminal action may follow administrative sanctions.
Appeal
- Aggrieved parties may appeal within 30 days to the DOH Secretary.
- Appeals involve certification and filing of hearing transcripts.
- The Secretary's decision is final and executory.
Administrative Liabilities
- Penalty of P3,000 for operating without authority.
- Possible recommendation for Professional Regulation Commission to revoke certificates.
- Suspension or revocation of authority upon violations.
Operating Without an Authority to Operate
- CHD must close unauthorized Blood Collection Units/Stations immediately, with assistance from other government agencies if needed.
Publication
- CHDs will periodically publish a list of authorized facilities in local newspapers.
Separability Clause
- Invalidity of any provision does not affect the remaining provisions.
Repealing Clause
- Supersedes inconsistent administrative orders and issuances.
Effectivity
- Takes effect upon approval and publication in a newspaper of general circulation.
Annex: Technical Requirements for Authorization
- Promotion of Voluntary Blood Donation
- Only healthy voluntary non-remunerated donors allowed.
- Documented recruitment, retention, screening system required.
- Staffing
- Head of Blood Service Facility: Authorized physicians with specific clinical pathology or blood banking certifications or experience.
- Medical Technologists: Registered, experienced with shifts covering 24-hour service.
- Donor Recruitment Officer: Qualified and trained per NVBSP standards.
- Quality Assurance Officer: Designated from medical technologists, trained and recognized by affiliated Blood Bank/Center.
- Staff Development Plan
- A documented plan for personnel development must be in place.
- Physical Facilities
- Adequate lighting, ventilation, water supply.
- Sufficient space for activities with clear fire exits.
- Technical areas are exclusive and well-maintained.
- Equipment
- Specific equipment mandated for Blood Stations and Collection Units based on hospital or non-hospital setting.
- Regular maintenance and contingency plans required.
- Adequate quality supplies maintained.
- Quality Assurance/Control
- Continuous QA program including internal quality control.
- Monitoring by affiliated Blood Bank/Center.
- Biosafety
- Safety precautions must be observed constantly.
- Recording, Reporting, and Documentation
- Follow NVBSP standardized formats and procedures.
- Blood Collection Units must submit schedules and donor recruitment plans to attached Blood Bank/Center.
- Agreement to regularly submit blood collected and donor lists to Blood Bank/Center.