Clinical Laboratory

Law
RA 4688

& its implementing guidelines

(AO # 2007-0027)
 RA 4688
 Approved June 18, 1966

 AO 201 s. 1973

 AO 290 s. 1976

 AO 52 s. 1983

 AO 49-B s. 1988

 EO 102 s. 1999
 Redirecting the Functions & Operations of the DOH

 AO #59 s. 2001
 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

 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- A Facility where tests are done on specimens and test in clinical
chem, hematology, cytology, Toxicology, endocrinology
 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 (abbreviation
of Statim means immediately.)
V. Classification of Laboratories

 A. Classification by Ownership
 Government
 Private
 B. Classification by Function
 Clinical Pathology
 Clinical chem, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy,
Endocrinology, Molecular Biology, cytogenetics, toxicology and TDM.

 Anatomic Pathology
 Surgical pathology, immunohistopathology, cytology, autopsy, forensic pathology, molecular
pathology.

 C. Classification by Institutional Character

 Institution-based
 Operates within the premises and as part of institution ( medical clinic, school, medical facility for
overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation.

 Freestanding
 Not form part of any institution
D. Classification by Service Capability

1. General Clinical Laboratory

Primary Category:
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
 A. General 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 i.e. CDC, WHO, or
local body recognized by DOH
 5. POL – required of license if doing ay 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 Linical 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