AT

DOH-AO-37-S.-2021 2

Administrative Order No. 2021-0037: New Rules and Regulations Governing Clinical Laboratories

I. Rationale

  • Issued under the authority of Republic Act No. 4688 (1966) which regulates clinical laboratories in the Philippines.

  • Department of Health (DOH) and Health Facilities and Services Regulatory Bureau (HFSRB) ensures public health through enforcement of licenses and regulations for clinical laboratories.

  • The importance of accurate and reliable laboratory test results for effective patient care.

  • Previous standards have not kept pace with technological advancements; revision aligns with current healthcare needs and Universal Health Care Act (RA 11223).

II. Objectives

  • Establish guidelines for licensing diagnostic clinical laboratories in the Philippines.

  • Ensure accountability and compliance for generation of laboratory results.

III. Scope of Application

  • Applicable to all entities seeking DOH licenses for clinical laboratory operations, including government and private sectors.

  • Extends to the Bangsamoro Autonomous Region in Muslim Mindanao (BARMM).

IV. Definition of Terms

  • Applicant: Every person or entity seeking a license to operate a clinical laboratory.

  • Clinical Laboratory (CL): Facilities conducting pre-analytical, analytical, or post-analytical tests on human specimens.

  • Department of Health License to Operate (DOH-LTO): Authorization to perform laboratory tests.

  • External Quality Assessment Program (EQAP): Program for performance quality evaluation through unknown samples.

  • Mobile Clinical Laboratory (MCL): Portable laboratory unit for limited diagnostic procedures.

V. General Guidelines

  1. All clinical laboratories must obtain DOH-LTO before commencing operations.

  2. DOH-LTO's must meet minimum regulatory and technical requirements.

  3. Only DOH-licensed institutions can establish a Satellite Clinical Laboratory (SCL), located within health facility premises.

  4. DOH-licensed laboratories may offer services beyond licensed capabilities with prior approval.

  5. Personnel responsible for laboratory tests must be competent and properly certified.

VI. Specific Guidelines

A. Classification of Clinical Laboratories

  1. By Ownership:

    • Government: Operated by public entities.

    • Private: Owned by individuals or corporations.

  2. By Institutional Character:

    • Institution-based: Located within DOH-licensed facilities.

    • Non-institution based: Operates independently.

  3. By Function:

    • Clinical Pathology, Anatomic Pathology, Molecular Pathology.

  4. By Service Capability:

    • Various minimum service capabilities defined for primary, secondary, and tertiary categories.

B. Procedural Guidelines

  1. Permit to Construct (PTC):

    • Applicants must complete and submit a DOH-PTC application.

  2. License to Operate (LTO):

    • All applications for DOH-LTO need thorough documentation and compliance assessment.

    • Applications must be processed following DOH’s guidelines within specified timelines.

  3. Certificate of Registration (COR):

    • Required for laboratories focused on research and teaching.

    • Must follow specified application procedures.

VII. Monitoring and Compliance

  • Regular monitoring by HFSRB/CHD for compliance with DOH standards.

  • Laboratories failing to comply may face penalties including suspension or revocation of licenses.

VIII. Roles and Responsibilities

Health Facilities and Services Regulatory Bureau (HFSRB)

  • Sets standards and enforces this order.

  • Provides technical assistance and responds to complaints.

DOH-Licensed Clinical Laboratories

  • Ensure continuous compliance with imposed regulations and actively participate in quality assessment programs.

IX. Violations, Sanctions, and Appeal

  • Specific prohibited acts outlined, such as refusal of inspection or erroneous laboratory reporting, carry defined penalties.

  • A system established for complaints and investigation of violations.

X. Transitory Provisions

  • Existing laboratories given specific timeframes to meet new requirements and standards.

  • New laboratories must comply immediately with all regulations.

XI. Repealing Clause

  • Rescinds previous relevant orders and guidelines not aligned with this order.

Appendix

Annex A-E: Licensing Standards and Guidelines

  • Including detailed templates for equipment, floor plans, and operational procedures for clinical laboratories.