Clinical Laboratory Law

Clinical Laboratory Law RA 4688 & its implementing guidelines (AO # 2007-0027)

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RA 4688 

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AO 201 s. 1973 AO 290 s. 1976 AO 52 s. 1983 AO 49-B s. 1988 EO 102 s. 1999 

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Redirecting the Functions & Operations of the DOH

AO #59 s. 2001 

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Approved June 18, 1966

Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the Philippines

AO #27 s. 2007 

Revised Rules & Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines

AO No. 2007 - 0027

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I. Rationale II. Objective 

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Promulgated to prescribe a revised minimum standard for clinical laboratories

III. Scope & Coverage  

4.1 Applies to all entities performing the activities and functions of clinical labs 4.2 excludes government laboratories doing laboratory examinations limited to AFB microscopy, malaria screening and cervical cancer screening; declared as extension of a licensed government clinical lab

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IV. Definition of Terms  Applicant – who intends to operate a clinical lab  BHFS – Bureau of Health Facilities & Services  CHD – Center for Health Development  Clinical Laboratory  Critical values – panic values that needs for some corrective action  DOH – Department of Health  EQAP – External Quality Assurance Program  Inspection Tool – checklist used by regulatory officer  Institution – any corporate body organized for educational, medical, charitable or similar purpose  License – document issued by DOH to applicant upon compliance  Licensee –whom the license is issued

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LTO – license to operate Mobile Clinical Laboratory – moves from testing site but affiliated with base lab Monitoring Examinations – series of tests on patients NRL – National Reference Laboratory; gov’t hospital lab designated by DOH and may or may not be a part of general clinical lab 

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Confirmatory testing; surveillance; resolution of conflicting results; training; research; implementation of EQAS; evaluation of diagnostic kits and reagents

POL – Physician Office Laboratory POCT – Point of Care Testing (at or near the site of the patient) Routine Test – basic, commonly requested tests Satellite Testing Site – any testing site that performs lab exams outside the physical confines of the base lab STAT Tests – urgent tests and to be realsed wihtin one hour after procedure

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V. Classification of Laboratories 

A. Classification by Ownership Government  Private 

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B. Classification by Function Clinical Pathology  Anatomic Pathology 

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C. Classification by Institutional Character Institution-based  Freestanding 

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D. Classification by Service Capability  1. 

General Clinical Laboratory Primary  Routine hematology (CBC) – Hb, Hct, WBC & Differential count  Qualitative platelet determination  Routine urinalysis  Routine fecalysis  Blood typing (Hospital-based)

 Secondary

– primary lab services +  Routine clinical chemistry – includes blood glucose, BUN, BUA, Crea & total cholesterol  Quantitative platelet determination  Cross matching (Hospital-based)  Gram staining (hospital based)  KOH (hospital based)

Tertiary – secondary lab services +  special chemistry  special hematology  immunology/serology  Microbiology (C/S)  Limited Service Capability (for institution based only) – i.e. dialysis centers & social hygiene clinics 

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Note: Labs can be permitted to offer other lab services provided they comply with reqt’s with respect to, staff, equipment, reagents and supplies and listed under its LTO

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2. Special Clinical Laboratory – offers highly specialized laboratory services that are usually not provided by a general clinical laboratory     

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Assisted Reproduction Technology Labs Molecular and Cellular Technology Molecular Biology Molecular Pathology Forensic Pathology Anatomic Pathology

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VI. Guidelines 

A. General Guidelines 

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1. The LTO shall be issued only to clinical labs that comply with standards and technical reqts formulated by the BHFS 2. Clinical labs operated and maintained for research and teaching purposes – exempted but needs to be registered w/ BHFS 3. Special clinical labs are required to register w/ BHFS w/o 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 

Register only w/ BHFS if physically independent & duly accredited by international certifying body i.e. CDC, WHO, or local body recognized by DOH

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5. POL – required of license if doing ay or all of the ff:   

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Issue official lab results Perform more than monitoring exams Cater not only to physician’s own patients

6. POCT

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B. Specific Guidelines 

1. Standards         

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

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2. LTO  

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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 in the LTO Mobile labs permitted to collect specimens only & operate w/n 100 kms radius from base lab Any substantial changes shall be reported to CHD w/n 2 wks in writing

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VII. Procedural Guidelines 

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A. Registration for Special Clinical Labs, NRL, Research & teaching Labs B. Procedures for Application for Initial/Renewal of LTO C. Renewal of LTO 

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Hospital-based – processed under the One-Stop-Shop Licensure System for Hospitals Non-hospital based – beginning first day of October until end of November of current year (discount on renewal fee) Automatic cancellation of LTO  

Failure to submit duly accomplished form Payment of proper fee on or before expiration date

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D. Inspection 

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CHD shall conduct announced inspections at reasonable time using inspection tool

E. Monitoring  

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BHFS/CHD Director or rep shall monitor clinical labs Notice of violation for non-compliant labs shall be issued immediately CHD concerned shall submit quarterly summary of violations to BHFS Provincial, City & Municipal Health Officers can report existence of unlicensed labs

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VIII. Schedule of Fees IX. Violations  

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Refusal on any clinical lab to participate in EQAP Issuance of a report, orally or in writing (in whole or part thereof) which is not in accordance w/ documented procedures Permitting unauthorized persons to perform technical procedures Incompetence Deviations from standard test procedures Lending or using the name of licensed lab or head or RMT to an unlicensed lab

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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-free for referral to clinical labs licensed by DOH

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X. Investigation of Charges or Complaints  

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BHFS/CHD Dir or rep shall investigate the complaint 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

XI. Penalty    

Imprisonment of not less than 1 month; or Fine not less than PhP 1000 but no more than PhP 5000; or Both If a corporation- managing head or owner is liable

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XII. Appeal 

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Office of the Health Sec w/n 10 days after receipt of notice of decision Decision is final & executory

XIII. Repealing Clause XIV. Separability Clause XV. Effectivity

Technical Standards and Minimum Requirements 

Staffing 

Managed by licensed Physician certified by the Philippine Board of Pathology 

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RMTs – available at all times during operation hours 

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If not available – w. 3 mos training on clinical lab medicine, QC & management may manage a primary/secondary lab as certified by BHFS Hospital-based lab – at least 1 RMT/shift

Staff development & CPE program instituted

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Physical Facilities 

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Well-ventilated, adequately lighted, clean & safe Work space reqt’s (at least) 1º - 10 m2  2º - 20 m2  3º - 60 m2 

Equipment/Instruments Primary

Secondary

Tertiary

Clinical centrifuge

All those in 1º plus the ff:

All those in 2º plus the ff:

Hemacytometer

Refrigerator

Incubator

Microhematocrit centrifuge

Photometer or its equivalent

Balance

Microscope with OIL

Waterbath or its equivalent

Rotator

Hemoglobinometer or equivalent

Timer or its equivalent

Serofuge or its equivalent

Differential counter or equivalent

Autoclave Drying oven Biosafety cabinet (BSC) or equivalent

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Glasswares/Reagents/Supplies Waste Management Quality Control Program  

Internal QC External QC  

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All labs shall participate in an EQAS given by designated NRL Satisfactory performance rating – criteria for renewal of license Refusal to participate in EQAS-NRL – basis for suspension/revocation of license

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Reporting  

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Bear the name & signature of Pathologist & RMT No report orally or in writing without directive from pathologist or associate except in emergency cases

Recording  

All requests and reports of all specimens submitted and examined Kept in file for at least 1 year 

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Anatomic and forensic pathology reports are kept permanently

Laboratory Fees