Law Summary
Objective of the Revised Rules
- Prescribes minimum standards for clinical laboratories.
- Ensures accuracy and precision in laboratory examinations.
- Safeguards public health and safety through improved lab service quality.
Scope and Coverage
- Applies to all individuals, partnerships, corporations operating clinical labs analyzing human specimens.
- Includes tests used in prevention, diagnosis, treatment, and health management.
- Exempts specific government labs performing microscopy work for DOH programs (e.g., malaria, STIs).
Definitions of Key Terms
- Applicant: person/entity applying to operate a lab.
- Clinical Laboratory: facility performing health-related human specimen tests including multiple disciplines.
- Critical Values: life-threatening test results requiring prompt corrective action.
- EQAP: External Quality Assessment Program for evaluating lab performance through unknown sample testing.
- License/Licensee/LTO: official authorization for operation issued by DOH.
- Other definitions include Mobile Lab, NRL (National Reference Laboratory), POL (Physician’s Office Lab), POCT (Point of Care Testing), STAT and Routine Tests, Satellite Testing Site.
Classification of Clinical Laboratories
- By Ownership: Government or Private.
- By Function: Clinical Pathology or Anatomic Pathology.
- By Institutional Character: Institution-based or Freestanding.
- By Service Capability:
- General Clinical Labs (Primary, Secondary, Tertiary categories based on tests offered).
- Special Clinical Labs offering highly specialized services not commonly provided.
General Guidelines
- LTO issued only after meeting DOH standards checked by BHFS.
- Research and teaching labs exempted from licensing but must register.
- Special clinical labs must register and be led by appropriately trained pathologists or physicians.
- NRLs are licensed under their hospital labs or registered if independent with international/local accreditation.
- POLs need license if issuing official results, performing more than monitoring exams, or serving beyond own patients.
- POCT in hospitals supervised by hospital’s licensed clinical lab.
Specific Guidelines: Standards
- Human Resources: headed by certified pathologist; adequate trained staff; continuing education.
- Equipment: must be operational with maintenance and contingency plans.
- Reagents and Supplies: adequate inventory and proper storage.
- Policies and Procedures: documented operational and technical protocols.
- Quality Assurance: internal quality control and participation in EQAP.
- Communication and Records: proper procedures for receiving requests, reporting results, including critical values; signatures required; records retention standards.
- Physical Facilities: compliance with regulations; adequate space; safety; proper waste disposal; biosafety and biosecurity.
- Referral of Examinations: must have agreements ensuring quality with outside labs.
License to Operate (LTO)
- Issued to licensee and non-transferable.
- Valid for one year; specific details stipulated on the license.
- Must be displayed prominently.
- Hospital labs licensed via One-Stop-Shop system; non-hospital labs must obtain separate licenses.
- Satellite labs inside compound covered under main LTO; outside premises require separate license.
- Mobile labs licensed with main lab, only specimen collection, operating within 100 km radius.
- Material changes reported in writing within two weeks.
- Penalties include suspension/revocation for non-compliance or false information.
Procedural Guidelines
- Registration procedures for special labs, NRLs, research/teaching labs including application, fees, evaluation.
- Application and renewal procedures for LTO with submission of documents and fees.
- CHD conducts inspections using standardized tools.
- Renewal periods with discounts for timely filings; automatic cancellation for failure to renew.
Inspection and Monitoring
- CHD conducts announced inspections; licensee ensures accessibility and documents availability.
- Monitoring visits assess ongoing compliance.
- Non-compliant labs receive Notice of Violation.
- Violations reported quarterly to BHFS.
- Health officers encouraged to report unlicensed lab operations.
Schedule of Fees
- Non-refundable fees for initial and renewal applications.
- Payment to DOH via prescribed methods.
- Fees follow DOH’s current schedule.
Violations and Penalized Acts
- Refusal to participate in EQAP.
- Issuance of inaccurate or unauthorized test reports.
- Allowing unauthorized personnel to perform tests.
- Use of expired reagents or deviation from standard procedures.
- False reporting, improper result transfer, unauthorized licensing use.
- Engaging in commissions or kickbacks relating to patient referrals.
Complaint Investigations
- BHFS or CHD investigate complaints and may suspend or revoke licenses.
- Assistance from law enforcement may be requested for enforcement.
Penalties
- Operating without license: imprisonment for at least one month or fine of Php1,000 to Php5,000, or both.
- Corporations liable through managing heads or owners.
Appeal Process
- Decisions of BHFS/CHD appealable to Office of the Health Secretary within 10 days.
- Appeals reviewed with full documentation.
- Final decision by Health Secretary is executory.
Repealing Clause
- Previous inconsistent rules rescinded or modified.
Separability Clause
- Invalid provisions do not affect validity of remainder of the Order.
Effectivity
- Order effective 15 days after approval and publication.