Law Summary
Purpose
- To protect and promote public health.
- Ensures availability of properly managed clinical laboratories with adequate resources.
- Promotes effective and efficient performance through compliance with quality standards.
Scope
- Applies to all entities performing clinical laboratory activities and functions.
- Includes examination and analysis of human and related samples for pathologic or diagnostic purposes.
- Excludes government laboratories performing limited screenings unless they operate as extensions of licensed government clinical laboratories.
Classification of Laboratories
- By Function:
- Clinical Pathology: includes Hematology, Chemistry, Microbiology, Immunology, Blood Banking, Toxicology, etc.
- Anatomic Pathology: includes Surgical Pathology, Cytology, Autopsy, Forensic Pathology.
- By Institutional Character:
- Hospital-based laboratories.
- Non-hospital-based laboratories.
- By Service Capability:
- Primary: basic services such as routine hematology, urinalysis, fecalysis, blood typing.
- Secondary: includes primary services plus clinical chemistry and cross-matching.
- Tertiary: includes secondary services plus special chemistry, hematology, immunology and microbiology.
Policies
- Permit to construct and design layouts must be approved by BHFS before operation.
- Construction requires approved plans and permits issued by BHFS.
- Must operate with valid license based on compliance with minimum licensing requirements.
- Laboratories must be effectively organized and managed.
- Safety measures must be provided for personnel and clients.
Requirements and Procedures for Permits and License
- Application to BHFS including site plans, DTI/SEC registration for private labs.
- Petition to operate and renewal forms must be duly notarized and filed with BHFS/CHD.
- Renewal applications filed within 90 days before license expiry; specific regional schedules apply.
- Non-refundable fees applied for construction permit, license, and renewal; fees follow DOH schedule.
Penalties for Late Renewal
- P1,000 fine if renewal is filed within two months post-expiry.
- Additional P100 per month after two months delay.
Inspection and Monitoring
- Licensees must allow inspection of premises and records by BHFS/CHD representatives.
- Inspections occur every two years or as necessary.
- Continuous monitoring with mandatory availability of records.
Issuance and Conditions of License
- Licenses issued by CHD Director or authorized representative upon meeting requirements.
- License is non-transferable but relocation requires prior written notice and reinspection.
- Extension laboratories require separate licenses.
- Any material change affecting license conditions must be reported within 15 days.
- License must be displayed conspicuously.
Violations and Sanctions
- Operation without certified pathologist or registered medical technologist is prohibited.
- Changes in ownership, location or personnel must be reported; failure results in sanctions.
- Refusal of inspection and gross negligence are grounds for penalties.
- Provincial, City, and Municipal Health Officers authorized to report unlicensed labs.
Investigation and Penalties
- BHFS/CHD authorized to investigate complaints.
- Violations may result in suspension, cancellation, or revocation of license.
- Operating without license may lead to imprisonment (1 month to 1 year), fines (P1,000 to P5,000), or both.
- Closure orders by BHFS/CHD are enforceable even against court injunctions.
Modification and Revocation of License
- Licenses may be modified, suspended, or revoked for false statements or non-compliance.
- Prior notice and investigation required unless willful or repeated violations pose public health risk.
Repealing Clause
- This regulation supersedes all prior issuances regarding clinical laboratories.
Publication of Licensed Laboratories
- Annual publication of licensed clinical laboratories in a newspaper of general circulation.
Effectivity
- Effective 15 days after publication in the Official Gazette or major newspaper.
Technical Standards and Minimum Requirements
Staffing
- Managed by licensed physicians certified by the Philippine Board of Pathology.
- In absence of pathologists, a physician with 3 months clinical lab training may manage primary/secondary labs.
- Employ sufficient registered medical technologists proportional to workload.
- Minimum one registered medical technologist per shift for hospital labs.
- Mandatory staff development and continuing education.
Physical Facilities
- Well-ventilated, adequately lit, clean and safe.
- Sufficient working space allowing smooth workflow: Primary (10 sq.m), Secondary (20 sq.m), Tertiary (60 sq.m including separate microbiology room).
- Adequate water supply.
Equipment/Instruments
- Sufficient and appropriate instruments for laboratory activities.
- Safety compliance mandatory.
- Minimum equipment listed by category:
- Primary includes clinical centrifuge, hemacytometer, refrigerator, microscope, etc.
- Secondary adds photometer, balance, incubator, autoclave, etc.
- Tertiary adds advanced instruments like biosafety cabinet, differential blood cell counter.
Glasswares/Reagents/Supplies
- Adequate and appropriate supplies for services.
Waste Management
- Efficient disposal of laboratory waste according to DOH and local government guidelines.
Quality Control Program
- Internal QC: documented competency assessments, standard methods, equipment maintenance, use of control materials.
- External QC: participation in designated National Reference Laboratories quality assurance programs.
- Refusal to participate in external QC may cause license suspension/revocation.
Reporting
- Laboratory reports must bear signatures of registered medical technologist and pathologist.
- Laboratory results released only under pathologist directive, except emergencies.
Recording
- Effective system to record and file requests and reports.
- Records kept for at least one year; anatomic and forensic pathology records kept permanently.
Laboratory Fees
- Fees to conform to prevailing rates considering cost and quality control.
- Professional services charged separately.
Registration Requirements for Private Laboratories
- Business name registration from DTI and SEC certificate if corporation.
- Certificates from Philippine Board of Pathology and PRC registration for medical technologists.
- Notarized statement of compliance with local business requirements.
- Location map and floor diagram required.