Clinical Laboratory LawClinical Laboratory Law

RA 4688RA 4688& its implementing guidelines & its implementing guidelines

(AO # 2007-0027)(AO # 2007-0027)

RA 4688RA 4688 Approved June 18, 1966Approved June 18, 1966

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

Redirecting the Functions & Operations of the DOHRedirecting the Functions & Operations of the DOH AO #59 s. 2001AO #59 s. 2001

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

AO #27 s. 2007AO #27 s. 2007 Revised Rules & Regulations Governing the Licensure and Revised Rules & Regulations Governing the Licensure and

Regulation of Clinical Laboratories in the PhilippinesRegulation of Clinical Laboratories in the Philippines

AO No. 2007 - 0027AO No. 2007 - 0027 I. RationaleI. Rationale II. ObjectiveII. Objective

Promulgated to prescribe a revised minimum Promulgated to prescribe a revised minimum standard for clinical laboratoriesstandard for clinical laboratories

III. Scope & CoverageIII. Scope & Coverage 4.1 Applies to all entities performing the 4.1 Applies to all entities performing the

activities and functions of clinical labsactivities and functions of clinical labs 4.2 excludes government laboratories doing 4.2 excludes government laboratories doing

laboratory examinations limited to AFB laboratory examinations limited to AFB microscopy, malaria screening and cervical microscopy, malaria screening and cervical cancer screening; declared as extension of a cancer screening; declared as extension of a licensed government clinical lablicensed government clinical lab

IV. Definition of Terms IV. Definition of Terms Applicant – who intends to operate a clinical labApplicant – who intends to operate a clinical lab BHFS – Bureau of Health Facilities & ServicesBHFS – Bureau of Health Facilities & Services CHD – Center for Health DevelopmentCHD – Center for Health Development Clinical Laboratory Clinical Laboratory Critical values – panic values that needs for some corrective Critical values – panic values that needs for some corrective

actionaction DOH – Department of HealthDOH – Department of Health EQAP – External Quality Assurance Program EQAP – External Quality Assurance Program Inspection Tool – checklist used by regulatory officerInspection Tool – checklist used by regulatory officer Institution – any corporate body organized for educational, Institution – any corporate body organized for educational,

medical, charitable or similar purposemedical, charitable or similar purpose License – document issued by DOH to applicant upon License – document issued by DOH to applicant upon

compliancecompliance Licensee –whom the license is issuedLicensee –whom the license is issued

LTO – license to operateLTO – license to operate Mobile Clinical Laboratory – moves from testing site but affiliated Mobile Clinical Laboratory – moves from testing site but affiliated

with base labwith base lab Monitoring Examinations – series of tests on patients Monitoring Examinations – series of tests on patients NRL – National Reference Laboratory; gov’t hospital lab designated NRL – National Reference Laboratory; gov’t hospital lab designated

by DOH and may or may not be a part of general clinical labby DOH and may or may not be a part of general clinical lab Confirmatory testing; surveillance; resolution of conflicting results; Confirmatory testing; surveillance; resolution of conflicting results;

training; research; implementation of EQAS; evaluation of diagnostic training; research; implementation of EQAS; evaluation of diagnostic kits and reagentskits and reagents

POL – Physician Office LaboratoryPOL – Physician Office Laboratory POCT – Point of Care Testing (at or near the site of the patient)POCT – Point of Care Testing (at or near the site of the patient) Routine Test – basic, commonly requested testsRoutine Test – basic, commonly requested tests Satellite Testing Site – any testing site that performs lab exams Satellite Testing Site – any testing site that performs lab exams

outside the physical confines of the base laboutside the physical confines of the base lab STAT Tests – urgent tests and to be realsed wihtin one hour after STAT Tests – urgent tests and to be realsed wihtin one hour after

procedureprocedure

V. Classification of LaboratoriesV. Classification of Laboratories A. Classification by OwnershipA. Classification by Ownership

Government Government PrivatePrivate

B. Classification by FunctionB. Classification by Function Clinical PathologyClinical Pathology Anatomic Pathology Anatomic Pathology

C. Classification by Institutional CharacterC. Classification by Institutional Character Institution-basedInstitution-based FreestandingFreestanding

D. Classification by Service D. Classification by Service CapabilityCapability 1. General Clinical Laboratory1. General Clinical Laboratory

Primary Primary Routine hematology (CBC) – Hb, Hct, Routine hematology (CBC) – Hb, Hct,

WBC & Differential countWBC & Differential count Qualitative platelet determination Qualitative platelet determination Routine urinalysis Routine urinalysis Routine fecalysisRoutine fecalysis Blood typing (Hospital-based)Blood typing (Hospital-based)

Secondary – primary lab services + Secondary – primary lab services + Routine clinical chemistry – Routine clinical chemistry –

includes blood glucose, BUN, BUA, includes blood glucose, BUN, BUA, Crea & total cholesterolCrea & total cholesterol

Quantitative platelet determinationQuantitative platelet determination Cross matching (Hospital-based)Cross matching (Hospital-based) Gram staining (hospital based)Gram staining (hospital based) KOH (hospital based)KOH (hospital based)

Tertiary – secondary lab services +Tertiary – secondary lab services + special chemistry special chemistry special hematology special hematology immunology/serology immunology/serology Microbiology (C/S)Microbiology (C/S)

Limited Service Capability (for institution based Limited Service Capability (for institution based only) – i.e. dialysis centers & social hygiene clinicsonly) – i.e. dialysis centers & social hygiene clinics

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

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

Assisted Reproduction Technology LabsAssisted Reproduction Technology Labs Molecular and Cellular TechnologyMolecular and Cellular Technology Molecular BiologyMolecular Biology Molecular PathologyMolecular Pathology Forensic PathologyForensic Pathology Anatomic PathologyAnatomic Pathology

VI. GuidelinesVI. Guidelines A. General GuidelinesA. General Guidelines

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

2. Clinical labs operated and maintained for research and 2. Clinical labs operated and maintained for research and teaching purposes – exempted but needs to be teaching purposes – exempted but needs to be registered w/ BHFSregistered w/ BHFS

3. Special clinical labs are required to register w/ BHFS 3. Special clinical labs are required to register w/ BHFS w/o being licensed (if not subject to other AO)w/o being licensed (if not subject to other AO)

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

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

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

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

6. POCT6. POCT

B. Specific GuidelinesB. Specific Guidelines 1. Standards1. Standards

Human ResourcesHuman Resources EquipmentEquipment Glassware, Reagents & SuppliesGlassware, Reagents & Supplies Administrative Policies & ProceduresAdministrative Policies & Procedures Technical ProceduresTechnical Procedures Quality Assurance ProgramQuality Assurance Program Communication & RecordsCommunication & Records Physical facilities/ Work EnvtPhysical facilities/ Work Envt Referral of Examinations Outside of the Linical LabReferral of Examinations Outside of the Linical Lab

2. LTO2. LTO Issued in the name of licensee and is non-Issued in the name of licensee and is non-

transferrabletransferrable Valid for one year and expires on the date set Valid for one year and expires on the date set

forth by CHDforth by CHD Capability to perform HIV testing and /or drinking Capability to perform HIV testing and /or drinking

water analysis shall be specifically indicated in the water analysis shall be specifically indicated in the LTO LTO

Mobile labs permitted to collect specimens only & Mobile labs permitted to collect specimens only & operate w/n 100 kms radius from base laboperate w/n 100 kms radius from base lab

Any substantial changes shall be reported to CHD Any substantial changes shall be reported to CHD w/n 2 wks in writing w/n 2 wks in writing

VII. Procedural Guidelines VII. Procedural Guidelines A. Registration for Special Clinical Labs, NRL, A. Registration for Special Clinical Labs, NRL,

Research & teaching LabsResearch & teaching Labs B. Procedures for Application for Initial/Renewal B. Procedures for Application for Initial/Renewal

of LTO of LTO C. Renewal of LTOC. Renewal of LTO

Hospital-based – processed under the One-Stop-Shop Hospital-based – processed under the One-Stop-Shop Licensure System for HospitalsLicensure System for Hospitals

Non-hospital based – beginning first day of October Non-hospital based – beginning first day of October until end of November of current year (discount on until end of November of current year (discount on renewal fee)renewal fee)

Automatic cancellation of LTO Automatic cancellation of LTO Failure to submit duly accomplished formFailure to submit duly accomplished form Payment of proper fee on or before expiration datePayment of proper fee on or before expiration date

D. InspectionD. Inspection CHD shall conduct announced inspections at CHD shall conduct announced inspections at

reasonable time using inspection toolreasonable time using inspection tool E. MonitoringE. Monitoring

BHFS/CHD Director or rep shall monitor clinical labsBHFS/CHD Director or rep shall monitor clinical labs Notice of violation for non-compliant labs shall be Notice of violation for non-compliant labs shall be

issued immediatelyissued immediately CHD concerned shall submit quarterly summary of CHD concerned shall submit quarterly summary of

violations to BHFSviolations to BHFS Provincial, City & Municipal Health Officers can Provincial, City & Municipal Health Officers can

report existence of unlicensed labsreport existence of unlicensed labs

VIII. Schedule of FeesVIII. Schedule of Fees IX. ViolationsIX. Violations

Refusal on any clinical lab to participate in EQAPRefusal on any clinical lab to participate in EQAP Issuance of a report, orally or in writing (in whole or Issuance of a report, orally or in writing (in whole or

part thereof) which is not in accordance w/ part thereof) which is not in accordance w/ documented proceduresdocumented procedures

Permitting unauthorized persons to perform technical Permitting unauthorized persons to perform technical proceduresprocedures

IncompetenceIncompetence Deviations from standard test proceduresDeviations from standard test procedures Lending or using the name of licensed lab or head or Lending or using the name of licensed lab or head or

RMT to an unlicensed labRMT to an unlicensed lab

Unauthorized use of the name and signature of Unauthorized use of the name and signature of Pathologist and RMT to secure LTOPathologist and RMT to secure LTO

Reporting a test result for clinical specimens Reporting a test result for clinical specimens even if the test was not actually doneeven if the test was not actually done

Transferring results of tests done in an outside Transferring results of tests done in an outside lab to the result form of the referring lablab to the result form of the referring lab

Performing and reporting tests in a specialty or Performing and reporting tests in a specialty or subspecialty in which the lab is not licensedsubspecialty in which the lab is not licensed

Giving and receiving any commission, bonus or Giving and receiving any commission, bonus or kickback or rebate or engaging in any split-free kickback or rebate or engaging in any split-free for referral to clinical labs licensed by DOHfor referral to clinical labs licensed by DOH

X. Investigation of Charges or ComplaintsX. Investigation of Charges or Complaints BHFS/CHD Dir or rep shall investigate the complaintBHFS/CHD Dir or rep shall investigate the complaint BHFS/CHD Dir or rep shall suspend, cancel or BHFS/CHD Dir or rep shall suspend, cancel or

revoke & may seek any law enforcement agency to revoke & may seek any law enforcement agency to execute the closure of any erring lab when execute the closure of any erring lab when necessary necessary

XI. PenaltyXI. Penalty Imprisonment of not less than 1 month; orImprisonment of not less than 1 month; or Fine not less than PhP 1000 but no more than PhP Fine not less than PhP 1000 but no more than PhP

5000; or5000; or BothBoth If a corporation- managing head or owner is liableIf a corporation- managing head or owner is liable

XII. AppealXII. Appeal Office of the Health Sec w/n 10 days Office of the Health Sec w/n 10 days

after receipt of notice of decisionafter receipt of notice of decision Decision is final & executoryDecision is final & executory

XIII. Repealing ClauseXIII. Repealing Clause XIV. Separability ClauseXIV. Separability Clause XV. EffectivityXV. Effectivity

Technical Standards Technical Standards and Minimum Requirementsand Minimum Requirements

StaffingStaffing Managed by licensed Physician certified by the Managed by licensed Physician certified by the

Philippine Board of PathologyPhilippine Board of Pathology If not available – w. 3 mos training on clinical lab If not available – w. 3 mos training on clinical lab

medicine, QC & management may manage a medicine, QC & management may manage a primary/secondary lab as certified by BHFSprimary/secondary lab as certified by BHFS

RMTs – available at all times during operation RMTs – available at all times during operation hourshours

Hospital-based lab – at least 1 RMT/shiftHospital-based lab – at least 1 RMT/shift Staff development & CPE program institutedStaff development & CPE program instituted

Physical FacilitiesPhysical Facilities Well-ventilated, adequately lighted, Well-ventilated, adequately lighted,

clean & safeclean & safe Work space reqt’s (at least)Work space reqt’s (at least)

1º - 10 m1º - 10 m22

2º - 20 m2º - 20 m22

3º - 60 m3º - 60 m22

Equipment/InstrumentsEquipment/InstrumentsPrimaryPrimary SecondarySecondary TertiaryTertiary

Clinical centrifugeClinical centrifuge All those in 1º plus All those in 1º plus the ff:the ff:

All those in 2º plus All those in 2º plus the ff:the ff:

HemacytometerHemacytometer RefrigeratorRefrigerator IncubatorIncubatorMicrohematocrit Microhematocrit centrifugecentrifuge

Photometer or its Photometer or its equivalentequivalent

Balance Balance

Microscope with OILMicroscope with OIL Waterbath or its Waterbath or its equivalentequivalent

RotatorRotator

Hemoglobinometer or Hemoglobinometer or equivalentequivalent

Timer or its Timer or its equivalentequivalent

Serofuge or its Serofuge or its equivalentequivalent

Differential counter Differential counter or equivalentor equivalent

AutoclaveAutoclave

Drying ovenDrying ovenBiosafety cabinet Biosafety cabinet (BSC) or equivalent(BSC) or equivalent

Glasswares/Reagents/SuppliesGlasswares/Reagents/Supplies Waste ManagementWaste Management Quality Control ProgramQuality Control Program

Internal QCInternal QC External QCExternal QC

All labs shall participate in an EQAS given by All labs shall participate in an EQAS given by designated NRLdesignated NRL

Satisfactory performance rating – criteria for renewal Satisfactory performance rating – criteria for renewal of licenseof license

Refusal to participate in EQAS-NRL – basis for Refusal to participate in EQAS-NRL – basis for suspension/revocation of licensesuspension/revocation of license

ReportingReporting Bear the name & signature of Pathologist & RMT Bear the name & signature of Pathologist & RMT No report orally or in writing without directive No report orally or in writing without directive

from pathologist or associate except in from pathologist or associate except in emergency casesemergency cases

RecordingRecording All requests and reports of all specimens All requests and reports of all specimens

submitted and examinedsubmitted and examined Kept in file for at least 1 yearKept in file for at least 1 year

Anatomic and forensic pathology reports are kept Anatomic and forensic pathology reports are kept permanentlypermanently

Laboratory FeesLaboratory Fees