RA 4688

• RA 4688 Section 4: punishment for violators
• RA 4688 Section I: all labs should be licensed and regulated by the DOH (except government labs doing minimum lab exams)
• RA 4688 Section 2: licensed physicians should be in-charge of the labs
• RA 4688 Section 3: DOH-BRL is the one in-charge with theimplementation of this act and to issue rules andregulations
• RA 4688 Section 5: Separability Clause
• RA 4688 Section 6: Php 50,000 from the National Treasury are appropriated to carry out this act
• RA 4688 Section 7: Repealing Clause
• RA 4688 Section 8: Effectivity Date of Approval: June 18, 1966
• ADMINISTRATIVE ORDER 2021-0037 IS THE NEW RULES AND REGULATIONS GOVERNING THE REGULATION OFCLINICAL LABORATORIES IN THE PHILIPPINES
• CLINICAL LABORATORY - a facility that is involved in the (a) pre-analytical, (b) analytical, (c) and post-analytical procedures, wheretests 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
• RA 4688, also known as the Clinical Laboratory Law of 1966
• A0 2007-0027 - Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
• CLs must generate accurate, precise, and reliable results
• Health Facilities and Services Regulatory Bureau (HFSRB) - Set standards for the regulation of clinical laboratories
• Center For Health Development - Regulatory Licensing, and EnForcement Division (CHD-RLED) - Strictly enforce the provisions of this Order, Submit quarterly report on Suspension/Revocation/Cease and Desist Order issued on CL
• National ReFerence Laboratory - Provide laboratory reference/referral services for confirmatory testing
• NRLs in the Philippines: Philippine Heart Center (1)
• NRLs in the Philippines: East Avenue Medical Center (2)
• NRLs in the Philippines: Lung Center of the Philippines (3)
• National External Quality Assessment Scheme (NEQAS) -an external quality assessment program (EQAP) activity conducted by the National Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories
• Department oF Health- License to Operate (DOH-LTO) A formal authorization issued by the DOH toan 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 CHD-RLED to an applicant who will establish and operate a hospital or other health facility, upon compliance with required documents prior to theactual construction of the said facility
• Satellite Clinical Laboratory is an extension of the main CL located within thefacility's compound or premises
• Mobile Clinical Laboratory a laboratory testing unit capable of performing limited CL diagnostic procedures (urinalysis, fecalysis, pregnancy test, basic serologic rapid tests) and collection ofspecimens
• Physician's OFFice Laboratory -doctor's office/clinic wherein CL examinations areperformed for the purpose of monitoring the doctor'spatients only
• Point oF Care Testing -diagnostic testing done at or near the site ofpatient care rather than in the CL
• ReFerral Tests - CL tests that are either sent-out or outsourced to otherDOH-licensed CL with the same or higher servicecapability (needs MOA)
• Clinical Pathology: chemical and cellular analyses of blood andother body fluids, identification and examination of microbes andparasites
• Anatomic Pathology: processing and examination of surgicaspecimens as to the physical appearance and microscopicstructure of tissues
• Molecular Pathology: analysis of certain genes, proteins, and othermolecules in samples from other organs, tissues, or bodilybased on the principles, techniques and tools of molecular biology