AO-2021-0037

• This Administrative Order provides new rules and regulations governing the regulation of clinical laboratories in the Philippines

  
• The Department of Health (DOH) through the Health Facilities and Services Regulatory Bureau (HFSRB) is mandated to ensure public health, safety and welfare through enforcement of the Act and was authorized to issue such rules and regulations as may be necessary to carry out the law
• Clinical laboratory services play an important role in the diagnosis, treatment, prevention and control of disease
• It is imperative that the laboratories generate accurate, precise and reliable laboratory test results in a timely manner to aid the physicians in assuring the quality of patient care
• This policy is being issued to align the laboratory procedures with the requirements of AO 2020-0047 titled "Rules and Regulations Governing the Licensure of Primary Care Facilities in the Philippines"

  
• The necessity to review the current AO and to revise and update the minimum standards and technical requirements for licensing clinical laboratories in the Philippines is aligned with the main objective of Republic Act No. 11223 or the Universal Health Care Act which is to guarantee access to quality and affordable health products, devices, facilities and services

  
• Applicant


  Any natural or juridical person, government instrumentalities/agencies, partnership, corporation or agency seeking a license to operate and maintain a clinical laboratory
• Assessment Tool


  The checklist which prescribes the minimum standards and requirements for licensure of a clinical laboratory

  
• Clinical Laboratory (CL)


  A facility that is involved in the (a) pre-analytical, (b) analytical, (c) and post-analytical procedures, where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis and treatment of diseases
• Department of Health - License to Operate (DOH-LTO)

  A formal authorization issued by the DOH to an individual, partnership, corporation, association or any government agency/unit seeking to perform laboratory tests in compliance with the requirements prescribed in this Order

  
• Department of Health - Permit to Construct (DOH-PTC)


  A permit issued by DOH through HFSRB or Center for Health Development-Regulation, Licensing and Enforcement Division (CHD-RLED) to an applicant who will establish and operate a hospital or other health facility, upon compliance with required documents prior to the actual construction of the said facility
• External Quality Assessment Program (EQAP)

  A program where participating CL are given unknown samples for analysis. These samples should be treated as ordinary human specimens for the usual processing and examination. The quality of performance of the CL shall be assessed through the closeness of its results to the pre-determined value or reference value generated by the participating CL through peer group analysis
• Initial Application


  Refer to applications by newly constructed health facilities, or those with changes in the circumstances of the facility, such as, but not limited to, change of ownership, transfer of site, increase in beds or for additional services beyond their service capability and major alterations or renovations
• Mobile Clinical Laboratory (MCL)


  A laboratory testing unit capable of performing limited CL diagnostic procedures. It moves from one testing site to another, and it has a DOH-licensed CL as its main laboratory
• National External Quality Assessment Scheme (NEQAS)

  An EQAP activity conducted by the National Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories
• National Reference Laboratory (NRL)

  The highest level of laboratory in the country performing highly complex procedures, including confirmatory testing, that is not commonly performed by the lower level of laboratory. It is the responsible entity for facilitating NEQAS to ensure compliance to quality standards for regulation and licensing of all laboratories in the Philippines

  
• Physician's Office Laboratory (POL)


  Refers to a doctor's office/clinic wherein CL examinations are performed for the purpose of monitoring the doctor's patients only, wherein NO official results shall be issued
• Point of Care Testing (POCT)


  Refers to diagnostic testing done at or near the site of patient care rather than in the CL. It may be in the emergency room, operating suites, wards, and ambulances
• Satellite Clinical Laboratory (SCL)


  Refers to an extension of the main CL located within the facility's compound or premises. It shall have the same service capability as the main laboratory
• Referral Tests


  Refers to CL tests that are either sent-out or outsourced to other DOH-licensed CL with the same or higher service capability
• Classification of Clinical Laboratories by Ownership

  • Government
  • Private
• Classification of Clinical Laboratories by Institutional Character


  • Institution-based
  • Non-institution based

  
• Classification of Clinical Laboratories by Function

  • Clinical Pathology
  • Anatomic Pathology
  • Molecular Pathology

  
• Classification of Clinical Laboratories by Service Capability for Clinical and Anatomic Pathology

  • Primary Category
  • Secondary Category
  • Specialized Tests

  
• Secondarycategory


  • Urinalysis
  • Fecalysis
  • Molecular
  • Microscopy
  • Pathology
  • Hormones
  • Trace Metals
  • Tumor markers
  • Allergy Panel
  • Serum
  • Other Clinical Chemistry
  • Hematology
  • Serology/Immunology
  • Microbiology
  • Anatomic Pathology
• Classified under


  • Anatomic or Clinical
  • Molecular
  • Microscopy
  • Pathology, as exemplified below:
• Fecalysis


  • Fecal Occult Blood Test
  • Pregnancy Test (Rapid Test Kits — Lateral Flow)
  • Wet Smear for Trichomonas
• Serum


  • Fasting and Random Blood Sugar
  • Electrolytes (Sodium, Potassium, Chloride)
  • Lipid Profile (Total Cholesterol, HDL, LDL, Triglycerides)
  • ALT
  • AST
  • Creatinine
  • Blood Urea Nitrogen
  • Blood Uric Acid
• Hematology


  • Complete Blood Count (Hemoglobin, Hematocrit, Red Blood Cell Count, White Blood Cell Count with Differential Count, Quantitative Platelet Count)
  • Forward and reverse ABO grouping and Rh (D) typing (tube method)
• Microbiology


  • Gram Stain
  • KOH
  • Culture and sensitivity (aerobic and anaerobic)
  • TB (DSSM) or Nucleic Acid Amplification Test — for government facilities
• Anatomic Pathology


  • Pap smear
  • Cytology and Histopathology
• Clinical Laboratory for Anatomic Pathology only — provides services for any of the following, but not limited to: cytology and histopathology.
• Clinical Laboratory for Molecular Pathology only — provides services for genetics, immuno/hematopathology and infectious disease. COVID-19 testing laboratories shall be covered by another Order.
• ed CL shall be given three (3) years to comply with the physical plant requirements from the date of effectivity of this Order
• All existing licensed CL shall be given two (2) years to fully offer the additional services for each category with corresponding personnel and equipment from the date of effectivity of this Order
• For new CL, this Order shall be immediately applicable
• For CL currently headed by Anatomic Pathologists with an associate Clinical Pathologist or Clinical Pathologists heading tertiary CL with Anatomic Pathology services, such headships shall be retained until his/her eventual retirement, resignation or replacement. Thereafter,all CL shall be headed by a pathologist certified in Clinical Pathology by the Board of Pathology of the Philippine Society of Pathologists, except for tertiary CL with anatomic pathology service which shall be headed by a pathologist certified in both Anatomic and Clinical Pathology

  
• These rules and regulations shall rescind Administrative Order No. 2007-0027 titled "Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines," all administrative orders and previous issuances inconsistent thereof

  
• In the event that any provision or part of this Order be declared unauthorized or rendered invalid by any court of law or competent authority, those provisions not affected by such declaration shall remain valid and effective
• This Order shall take effect fifteen (15) days following its publication in a newspaper of general circulation and upon filing three (3) copies to the University of the Philippines Law Center