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• Clinical Laboratory Act of 1966


  An act regulating the operation and maintenance of Clinical Laboratories and requiring the registration of the same with the Department of Health, providing penalty for the violation thereof and for other purposes
• Clinical Laboratory Act of 1966 approved

  June 18, 1966
• Implementing rules and regulations for the Clinical Laboratory Act of 1966

  • AO 201 s. 1973
  • AO 290 s. 1976
  • AO 52 s. 1983
  • AO 49-B s. 1988
  • EO 102 s. 1999
• EO 102 s. 1999 - Redirecting the Functions & Operations of the DOH
• AO No. 2012 S 0021 - National framework of National Health Laboratory Network
• Department Memo 2009-0086 - Implementation of external quality assessment program as is regulatory requirement in licensing of clinical laboratory
• Department Memo 2009-0086 approved

  February 3, 2009
• AO No 2007-0027-A - Exemption of National Tuberculosis Reference Laboratory and Regional TB Ref Labs from licensing
• AO No 2007-0027-A approved

  August 28, 2008
• AO 393-E s. 2000 - Designation of National Reference Laboratories (NRL)
• AO 393-E s. 2000 approved

  November 14, 2000
• National Reference Laboratories (NRL)

  For surveillance, trainings, EQAS (required to participate)
• National Reference Laboratories (NRL)

  • RITM (Research Institute for Tropical Medicine)
  • SACCL (San Lazaro Hospital- STD AIDS Central Cooperative Laboratory)
  • EAMC (East Avenue Medical Center)
  • NKTI (National Kidney And Transplant Institute)
  • LCP (Lung Center of the Philippines)
  • PHC (Philippine Heart Center)
• AO No. 2007-0027 - Revised rules and regulation governing the registration, operation, and maintenance of clinical laboratories in the Philippines
• AO No. 2007-0027 approved

  August 22, 2007
• AO No. 2007-0027

  • Classification of laboratories
  • LTO is applied thru BHFS, renewed every year
  • Exempted from licensing but need to be registered
  • Non-hospital based labs can apply for renewal starting Oct. 1 until Nov. 30 filed under CHD/BHFS; hospitals under the one-stop shop
  • Automatic cancellation of LTO for failure to submit duly accomplished form, non-payment of fees on expiration date, non-participation in EQAS/EQAP
  • Usage of test report of the referral lab
  • Appeal of decisions made thru the office of the DOH Sec within 10 days upon receipt of decision
  • Record keeping within 1 year, reports need to have name of lab, bear name and signature of RMT and pathologist
• AO No. 2005-0027 - Rules and regulations governing the regulation of HIV laboratories
• AO No. 2005-0027 approved

  August 15, 2005
• Authority


  DOH through the BRL - Agency that authorizes the regulation and maintenance of the clinical lab
• Purpose

  To protect and promote the health of the people by ensuring availability of the clinical laboratory that are properly managed with adequate resources with effective and efficient performance through the compliance of the quality standards
• Rationale - The registration, operation and maintenance of Clin. Lab. In the Phils. Preventing substandard, Improperly managed and poorly equipped clinical laboratories
• Objective - Promulgated to prescribe a revised minimum standard for clinical Laboratories
• Definition of Terms

  • Applicant
  • BHFS Bureau of Health Facilities & Services
  • CHD-Center for Health Development
  • Clinical Laboratory
  • Critical values
  • DOH - Department of Health
  • EQAP - External Quality Assurance Program
  • Inspection Tool
  • Institution
  • License
  • Licensee
  • LTO - license to operate
  • Mobile Clinical Laboratory
  • Monitoring Examinations
  • NRL - National Reference Laboratory
  • POL- Physician Office Laboratory
  • POCT - Point of Care Testing
  • Routine Test
  • Satellite Testing Site
  • STAT Tests
• Classification of Laboratories by Ownership

  • Government
  • Private
• Classification of Laboratories by Function

  • Clinical Pathology
  • Anatomic Pathology
  • Forensic Pathology
• Classification of Laboratories by Institutional Character

  • Institution-based
  • Freestanding
• Classification of Laboratories by Service Capability

  • General Clinical Laboratory - Primary, Secondary, Tertiary
  • Limited Service Capability (for institution based only)
• Types of clinical laboratories

  • General clinical laboratory
  • Special clinical laboratory
• General clinical laboratory

  • Offers basic and routine tests
  • Primary - minimum service capabilities
  • Secondary - primary lab services plus additional services
  • Tertiary - secondary lab services plus special chemistry, special hematology, immunology/serology, microbiology
  • Limited service capability - for institution based only, e.g. dialysis centers, social hygiene clinics
• Special clinical laboratory


  • Offers advanced and highly specialized laboratory services not usually provided by a general clinical laboratory
  • Examples: Assisted Reproduction Technology Labs, Molecular and Cellular Technology, Molecular Biology, Molecular Pathology, Forensic Pathology, Anatomic Pathology
• National Reference Laboratories (NRL)

  • Dengue, Influenza, TB and Malaria
  • Confirmatory testing of blood units
• Specialty laboratories

  • San Lazaro Hospital - HIV/AIDS, Hepatitis, Syphilis and other Sexually Transmitted Infections (STIs)
  • East Avenue Medical Center - Toxicology and Micronutrient Assay
  • NKTI: National Kidney and Transplant Institute - Hematology / Immunohematology
  • Lung Center of the Philippines - Biochemistry
• NRL


  • Operates independently of the hospital laboratory but accredited by international agency or local accrediting agency recognized by the DOH
  • Local accrediting agencies: CDC, WHO
• Guidelines for clinical laboratories

  1. LTO shall be issued only to clinical labs that comply with standards and technical requests formulated by the BHFS

  2. Clinical labs operated and maintained for research and teaching purposes are exempted but need to be registered with BHFS

  3. Special clinical labs are required to register with BHFS without being licensed (if not subject to other AO)

  4. NRL-designated by DOH shall be covered by license of the clinical lab of the hospital

  5. POL required if doing any of: issuing official lab results, performing more than monitoring exams, catering to non-physician's own patients

  6. POCT
• Standards for clinical laboratories

  • Human Resources
  • Equipment
  • Glassware, Reagents & Supplies
  • Administrative Policies & Procedures
  • Technical Procedures
  • Quality Assurance Program
  • Communication & Records
  • Physical facilities/ Work Environment
  • Referral of Examinations Outside of the clinical Lab
• LTO


  • Issued in the name of licensee and is non-transferrable
  • Valid for one year and expires on the date set forth by CHD
  • Capability to perform HIV testing and /or drinking water analysis shall be specifically indicated
  • Mobile labs permitted to collect specimens only & operate within 100 kms radius from base lab
  • Any substantial changes shall be reported to CHD within 2 weeks in writing
• Procedures for clinical laboratories

  1. Registration for Special Clinical Labs, NRL, Research & teaching Labs

  2. Application for Initial/Renewal of LTO

  3. Renewal of LTO - hospital-based processed under One-Stop-Shop Licensure System, non-hospital based beginning first day of October until end of November (discount on renewal fee)

  4. Automatic cancellation of LTO for failure to submit duly accomplished form or pay proper fee on or before expiration date

  5. Inspection - CHD shall conduct announced inspections at reasonable time

  6. Monitoring - BHFS/CHD Director or rep shall monitor clinical labs, notice of violation for non-compliant labs, provincial/city/municipal health officers can report unlicensed labs
• Violations

  • Refusal to participate in EQAP
  • Issuance of report not in accordance with documented procedures
  • Permitting unauthorized persons to perform technical procedures
  • Incompetence
  • Deviations from standard test procedures (SOP)
  • Lending or using the name of licensed lab or head or RMT to an unlicensed lab
  • Unauthorized use of the name and signature of Pathologist and RMT to secure LTO
  • Reporting a test result for clinical specimens even if the test was not actually done
  • Transferring results of tests done in an outside lab to the result form of the referring lab
  • Performing and reporting tests in a specialty or subspecialty in which the lab is not licensed
  • Giving and receiving any commission, bonus or kickback or rebate or engaging in any split-fee for referral to clinical labs licensed by DOH
• Investigation of Charges or Complaints

  1. BHFS/CHD Dir or rep shall investigate the complaint

  2. BHFS/CHD Dir or rep shall suspend, cancel or revoke & may seek any law enforcement agency to execute the closure of any erring lab when necessary
• Penalty for violations