Clinical

Laboratory Law

RA 4688
& Its Implementing Guidelines
(AO # 2007-0027)
 RA 4688
The 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.

Approved: June 18, 1966

 AO No. 2007-0027
• – Revised rules and regulations governing
the registration, operation, and
maintenance of clinical laboratories in the
Philippines (Aug. 22, 2007)
Features
o Classification of laboratories
o LTO is applied thru BHFS, renewed every
year
o Exempted from licensing but need to be
registered
o Non-hospital based labs can apply for
renewal starting Oct. 1 until Nov. 30 filed
under CHD/BHFS; hospitals under the one-
stop shop
o Automatic cancellation of LTO
o failure to submit duly accomplished form, non-
payment of fees on expiration date,
o non-participation in EQAS/EQAP
o Usage of test report of the referral lab
o Appeal of decisions made thru the office of
the DOH Sec within 10 days upon receipt of
decision
o 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
– (Aug. 15, 2005)
 AO No. 2007-0027(A)
• exemption of National Tuberculosis
Reference Laboratory and Regional TB
Ref Labs from licensing (Aug. 28, 2008)

• AO 393-E s. 2000 – Designation of

National Reference Laboratories (NRL)
(2000) Approved: Nov. 14, 2000
NRL
 RITM – mycobacterial diseases, parasitic
diseases, bacterial enteric diseases, viral
exanthems, mycology, enteroviruses,
antimicrobial resistance and emerging
diseases; NRL for confirmatory testing of
blood units.
 SACCL – HIV/AIDS, Hepatitis, SY and
other STIs
• EAMC – Environmental & Occupational
Health, Toxicology & Micronutrient Assay
• NKTI – Hematology including
Immunohematology, Immunopathology
and Anatomic Pathology
• LCP - Chemistry
• DM 2009-0086 –
• Implementation of external quality
assessment program as regulatory
requirement for licensing of clinical
laboratories (Feb. 3, 2009)
 Proficiency testing areas:
• Hematology – primary, secondary & tertiary
clinical labs
• Clinical chemistry – tertiary clinical labs
• HIV/AIDS, Hepa B & C – all labs with such tests
• Water proficiency testing – all screening &
confirmatory water testing labs
• Drug proficiency testing – screening &
confirmatory DTLs
• Microbiology
 AO No. 2007 - 0027
• I. Rationale
• II. Objective
– 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
 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
– 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
• 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
released within one hour after procedure
V. Classification of Laboratories
– A. Classification by Ownership
• Government
• Private
– B. Classification by Function
• Clinical Pathology
• Anatomic Pathology
– C. Classification by Institutional Character
• Institution-based
• Freestanding
– 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
• 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
• 2. Special Clinical Laboratory – offers highly
specialized laboratory services that are usually not
provided by a general clinical laboratory
– Assisted Reproduction Technology Labs
– Molecular and Cellular Technology
– Molecular Biology
– Molecular Pathology
– Forensic Pathology
– Anatomic Pathology
 VI. Guidelines
• 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
– CDC, WHO, or local body recognized by DOH
• 5. POL – required of license if doing any or
all of the ff:
– Issue official lab results
– Perform more than monitoring exams
– Cater not only to physician’s own
patients
• 6. POCT
 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
cLinical Lab
 2. 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 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
 VII. Procedural Guidelines
– A. Registration for Special Clinical Labs, NRL,
Research & teaching Labs
– B. Procedures for Application for Initial/Renewal of
LTO
– C. Renewal of LTO
• 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
• D. Inspection
– CHD shall conduct announced inspections at reasonable
time using inspection tool

• E. Monitoring
– 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
• VIII. Schedule of Fees

• IX. Violations
– 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
– 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
• X. Investigation of Charges or Complaints
– 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
• XII. Appeal
– 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
• If not available – w. 3 mos training on clinical lab medicine,
QC & management may manage a primary/secondary lab as
certified by BHFS
– RMTs – available at all times during operation hours
• Hospital-based lab – at least 1 RMT/shift
– Staff development & CPE program instituted
• Physical Facilities
– 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 All those in 2º plus the
ff: ff:
Hemacytometer Refrigerator Incubator
Microhematocrit Photometer or its Balance
centrifuge equivalent
Microscope with OIL Waterbath or its Rotator
equivalent
Hemoglobinometer or Timer or its equivalent Serofuge or its
equivalent equivalent
Differential counter or Autoclave
equivalent
Drying oven
Biosafety cabinet (BSC)
or equivalent
• Glasswares/Reagents/Supplies
• Waste Management
• Quality Control Program
– Internal QC
– External QC
• 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
• Reporting
– 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
• Anatomic and forensic pathology reports are kept
permanently
• Laboratory Fees
End of R.A.
4688
 Assignment
• Read and study R. A. 4688
• Quiz next meeting