Law Summary

I. Background and Rationale

This Administrative Order is issued by the Department of Health (DOH) under the authority of the Republic Act 9165, known as the Comprehensive Dangerous Drugs Act of 2002. It mandates the DOH to regulate drug testing laboratories across the Philippines, ensuring quality and integrity in drug testing services.

• Key Definitions:

  • Bureau of Health Facilities and Services (BHFS): The principal regulatory office of the DOH overseeing drug testing laboratory accreditation.
  • National Reference Laboratory (NRL): East Avenue Medical Center designated for environmental and occupational health.

• Requirements:

  • The BHFS will require a DOH Permit to Construct (DOH-PTC) for the establishment of new freestanding Screening Drug Testing Laboratories (SDTL), including changes in site or ownership.

II. Objectives

The main objective of this Order is to standardize drug testing procedures and ensure quality assurance across laboratories.

• Important Goals:
  • Impose the requirement of DOH-PTC prior to accreditation applications for all SDTLs.
  • Develop prototype plans and guidelines for SDTL facilities to assist applicants.

III. Scope and Coverage

This Order applies to all government and privately-owned freestanding SDTLs in the Philippines that seek to establish, operate, or maintain such facilities.

• Applicability:
  • New applications, lapsed accreditations, and changes of ownership for SDTLs.

IV. Definition of Terms

The Order defines several key terms related to the regulation of drug testing laboratories.

• Key Definitions:
  • Accreditation: Formal authorization from the DOH to a facility meeting all regulatory standards.
  • Applicant: Owner or president of an SDTL applying for DOH-PTC and accreditation.
  • DOH-Permit to Construct (DOH-PTC): Required before establishing a freestanding SDTL.
  • SDTL: Refers to facilities conducting drug testing.

V. Guidelines

A. General Guidelines

• A DOH-PTC is mandatory for constructing new SDTLs.

• Accreditation cannot be granted without an approved DOH-PTC.

• SDTLs must adhere to prescribed physical and design standards.

• Requirements:

  • Non-refundable application fee for DOH-PTC.
  • A DOH-PTC lapses if construction does not commence within 90 days.

B. Procedural Guidelines

• Required Documents for DOH-PTC Application:

  • Completed application form.
  • Proof of ownership (DTI/SEC registration, etc.).
  • Architectural plans and location map.

• Application Process:

  • Submit application to BHFS along with fees.
  • Review and evaluation by the Health Facility Establishment Review Committee (HFERC).
  • Applicants can revise submissions once if disapproved.

VI. Schedule of Fees

A non-refundable fee of P1,000.00 is required for the DOH-PTC application.

• Payment Details:
  • Fees may be paid in person, via postal money order, or potentially online.

VII. Appeal

Decisions made by the HFERC can be appealed to the BHFS Director within 10 days of notification.

VIII. Repealing Clause

Previous regulations inconsistent with this Order are rescinded.

IX. Separability Clause

If any part of the Order is invalidated, the remaining provisions remain effective.

X. Effectivity

The Order takes effect 15 days after publication in a widely circulated newspaper.

Key Takeaways

• The DOH mandates a Permit to Construct (DOH-PTC) for all new SDTL establishments.
• All applicants must secure this permit before applying for laboratory accreditation.
• A clear set of procedures and documentation is outlined for obtaining the DOH-PTC.
• The Order aims to ensure standardization and quality assurance in drug testing across the Philippines.