[ REPUBLIC ACT NO.

4688, June 18, 1966] o failure to submit duly accomplished form, non-payment of
fees on expiration date,
AN ACT REGULATING THE OPERATION AND MAINTENANCE o non-participation in EQAS/EQAP
OF CLINICAL LABORATORIES AND REQUIRING THE o Usage of test report of the referral lab
REGISTRATION OF THE SAME WITH THE DEPARTMENT OF  Appeal of decisions made thru the office of the DOH Sec within 10
HEALTH, PROVIDING PENALTY FOR THE VIOLATION days upon receipt of decision
THEREOF, AND FOR OTHER PURPOSES.  Record keeping within 1 year, reports need to have name of lab, bear
name and signature of RMT and pathologist
Be it enacted by the Senate and House of Representatives of the Philippines
in Congress assembled:  exemption of National Tuberculosis Reference Laboratory and
Regional TB Ref Labs from licensing (Aug. 28, 2008)
SECTION 1. Any person, firm or corporation, operating and maintaining a
 AO 393-E s. 2000 – Designation of National Reference Laboratories
clinical laboratory in which body fluids, tissues, secretions, excretions and
(NRL) (2000) Approved: Nov. 14, 2000
radioactivity from beings or animals are analyzed for the determination of NRL
the presence of pathologic organisms, processes and/or conditions in the  RITM – mycobacterial diseases, parasitic diseases, bacterial enteric
persons or animals from which they were obtained, shall register and secure diseases, viral exanthems, mycology, enteroviruses, antimicrobial
a license annually at the office of the Secretary of Health: Provided, That resistance and emerging diseases; NRL for confirmatory testing of
government hospital laboratories doing routine or minimum laboratory blood units.
examinations shall be exempt from the provisions of this section if their  SACCL – HIV/AIDS, Hepatitis, SY and other STIs
services are extensions of government regional or central laboratories.  EAMC – Environmental & Occupational Health, Toxicology &
Micronutrient Assay
SEC. 2. It shall be unlawful for any person to be professionally in-charge  NKTI – Hematology including Immunohematology,
of a registered clinical laboratory unless he is a licensed physician duly Immunopathology and Anatomic Pathology
qualified in laboratory medicine and authorized by the Secretary of Health,  LCP – Chemistry
such authorization to be renewed annually.
DM 2009-0086
No license shall be granted or renewed by the Secretary of Health for the  Implementation of external quality assessment program as
operation and maintenance of a clinical laboratory unless such laboratory is regulatory requirement for licensing of clinical laboratories (Feb.
under the administration, direction and supervision of an authorized 3, 2009)
physician as provided for in the preceding paragraph.
Proficiency Testing Areas
SEC. 3. The Secretary of Health, through the Bureau of Research and  Hematology – primary, secondary & tertiary clinical labs
Laboratories shall be charged with the responsibility of strictly enforcing  Clinical chemistry – tertiary clinical labs
the provisions of this Act and shall be authorized to issue such rules and  HIV/AIDS, Hepa B & C – all labs with such tests
regulations as may be necessary to carry out its provisions.  Water proficiency testing – all screening & confirmatory water testing
labs
SEC. 4. Any person, firm or corporation who violates any provisions of
 Drug proficiency testing – screening & confirmatory DTLs
this Act or the rules and regulations issued thereunder by the Secretary of
 Microbiology
Health shall be punished with imprisonment for not less than one month but
not more than one year, or by a fine of not less than one thousand pesos nor
more than five thousand pesos, or both such fine and imprisonment, at the AO No. 2007-0027
discretion of the court.
I. RATIONALE
SEC. 5. If any section or part of this Act shall be adjudged by any court of II. OBJECTIVE
competent jurisdiction to be invalid, the judgment shall not affect, impair,  Promulgated to prescribe a revised minimum standard for clinical
or invalidate the remainder thereof. laboratories
III. SCOPE & COVERAGE
SEC. 6. The sum of fifty thousand pesos, or so much thereof as may be  4.1 Applies to all entities performing the activities and functions
necessary, is hereby authorized to be appropriated, out of any funds in the of clinical labs
National Treasury not otherwise appropriated, to carry into effect the  4.2 excludes government laboratories doing laboratory
provisions of this Act. examinations limited to AFB microscopy, malaria screening and
cervical cancer screening; declared as extension of a licensed
SEC. 7. All Acts or parts of Acts which are inconsistent with the provisions government clinical lab
of this Act are hereby repealed. IV. DEFINITION OF TERMS
SEC. 8. This Act shall take effect upon its approval. For purposes of this Order, the following terms and acronyms shall have
the following definition:
Approved, June 18,
1966. 1. Applicant – a natural or juridical person who intends to operate a
clinical laboratory
ADMINISTRATIVE ORDER NO. 2007–0027 (August 22, 2007)
2. BHFS – acronym for the Bureau of Health Facilities and Services
Revised Rules and Regulations Governing the Licensure and 3. CHD – acronym for the Center for Health Development
Regulation of Clinical Laboratories in the Philippines 4. Clinical Laboratory – a facility where tests are done on specimens
from the human body to obtain information about the health status of a
Features patient for the prevention, diagnosis, and treatment of diseases. These
 Classification of laboratories tests include, but are not limited to, the following disciplines: clinical
 LTO is applied thru BHFS, renewed every year chemistry, hematology, immunohematology, microbiology,
 Exempted from licensing but need to be registered immunology, clinical microscopy, histopathology, cytology,
 Non-hospital based labs can apply for renewal starting Oct. 1 until toxicology, endocrinology, molecular biology, and cytogenetics. Other
Nov. 30 filed under CHD/BHFS; hospitals under the one-stop shop functions of the clinical laboratory are to provide consultative
 Automatic cancellation of LTO advisory services covering all aspects of laboratory investigation
 including the interpretation of results and advice on further 2. Private – owned, established, and operated by any
appropriate investigation including the interpretation of results and individual, corporation, association, or organization -
advice on further appropriate investigation. Facilities that are involved B. Classification by Function
in the pre-analytical processes, such as collection, handling or 1. Clinical Pathology – Includes Clinical Chemistry
preparation of specimens, or act as a mailing or distribution center, Hematology Immunohematology, Microbiology,
such as in a laboratory network or system are also considered to be a Immunology, Clinical Microscopy Endocrinology,
part of a clinical laboratory. The total testing process includes pre- Molecular Biology, Cytogenetics, Toxicology and
analytical, analytical, and post-analytical procedures. Therapeutic Drug Monitoring and other similar disciplines
5. Critical Values – panic values originally described by Lundberg as 2. Anatomic Pathology – Includes Surgical Pathology,
“life-threatening” unless something is done promptly and for which Immunohistopathology, Cytology, Autopsy, Forensic
some corrective action could be undertaken. Pathology and Molecular Pathology
6. DOH – acronym for Department of Health C. Classification by Institutional Character
7. EQAP – acronym for External Quality Assessment Program. It is a 1. Institution Based – a laboratory that operates within the
program where participating laboratories are given unknown samples premises and as part of an institution, such as but not limited
for analysis/ These participating laboratories are given unknown to hospital, medical clinic, school, medical facility for
samples for analysis. These samples are to be treated as ordinary overseas workers and seafarers, birthing home, psychiatric
human specimens for the usual processing and examination. The facility, drug rehabilitation center
quality of performance of the laboratory shall be assessed through the 2. Freestanding – a laboratory that does not form part of any
closeness of its results to the pre-determined value or to the reference other institution
value generated by the participating laboratories through peer group D. Classification by Service Capability
analysis. 1. General Clinical Laboratory
8. Inspection Tool – the checklist used by the regulatory officers during (a) Primary Category-provides the following minimum
inspection visit (s) to evaluate compliance of a clinical laboratory to service capabilities:
the minimum standards and technical requirements. i. Routine Hematology (Complete Blood Count-
9. Institution – a corporate body or establishment organized for an includes Hemoglobin Mass Concentration,
educational, medical, charitable, or similar purpose. Erythrocyte Volume Fraction (Hematocrit).
10. License – the document issued by the DOH to an individual, agency, Leucocyte Number Concentration (White Blood
partnership or corporation that operates a clinical laboratory upon Cell or WBC Count) and Leucocyte Type Number
compliance with the requirements set forth in this Order, Fraction (Differential Count)
11. Licensee – the individual, agency, partnership, or corporation to whom ii. Qualitative Platelet Determination
the license is issued and upon whom rests compliance with this Order. iii. Routine Urinalysis
12. LTO – acronym for License to Operate. It also refers to the license iv. Routine Fecalysis
13. Mobile Clinical Laboratory – a laboratory testing unit that moves from v. Blood Typing-for hospital based
testing site to another testing site or has a temporary testing location. It (b) Secondary Category-provides the minimum service
shall have a base laboratory capabilities of a primary category laboratory plus the
14. Monitoring Examinations – tests done in series on patients as a guide following:
for treatment or follow-up of their condition. i. Routine Clinical Chemistry-includes Blood
15. NRL – acronym for the National Reference Laboratory. It is a Glucose Substance Concentration, Blood Urea
laboratory in a government hospital which had been designated by the Nitrogen Concentration. Blood Uric Acid
DOH to provide special functions and services for specific disease Substance Concentration. Blood Creatinine
areas. These functions include provision of referral services such as Concentration, Blood Total Cholesterol
confirmatory testing, surveillance, resolution of conflicting results Concentration
between or among laboratories, training, research, implementation of ii. Quantitative Platelet Determination
EQAS, evaluation of diagnostic kits and reagents. An NRL may or iii. Cross Matching-for hospital based
may not be part of a general clinical laboratory. iv. Gram Staining-for hospital based
16. POL – acronym for Physician's Office Laboratory. It is an individual v. KOH-for hospital based
doctor's office/ clinic wherein laboratory examinations are performed (c) Tertiary Category-provides the minimum service
17. POCT – acronym for Point of Care Testing. It is a diagnostic testing at capabilities of a secondary category laboratory plus the
or near the site of patient care rather than in the clinical laboratory. It following:
includes bedside testing, outpatient, and home care. vi. Special Chemistry
18. Routine Tests – the basic, commonly requested tests in the laboratory, vii. Special Hematology, including coagulation
the results of which are not required to be released immediately upon procedures
completion. It shall follow the usual procedures and system in the viii. Immunology
laboratory. ix. Microbiology-culture and sensitivity (c/s)
19. Satellite Testing Site – any testing site that performs laboratory 1. aerobic and anaerobic (for hospital
examinations under the administrative control of a licensed laboratory based)
but performed outside the physical confines of that laboratory. 2. aerobic or anaerobic (for non-hospital
20. STAT Tests – tests done urgent cases, the results of which shall be based)
released immediately, within one (1) hour after the procedure. STAT (d) Limited Service Capability (for institution-based only)
is an abbreviation for sta'tim which means immediately. provides the laboratory tests required for a particular service
in institutions such as but not limited to dialysis centers and
V. CLASSIFICATION OF CLINICAL LABORATORIES social hygiene clinics.
A. Classification by Ownership A clinical laboratory, licensed under any of the above category, shall be
1. Government – operated and maintained. partially or wholly, permitted to offer laboratory services other than the respective stipulated
by the national government, a local government unit minimum services provided that they comply with the requirements with
(provincial, city or municipal), any other political unit or respect to staff, equipment, reagents and supplies for such additional
any department, division, board, or agency thereof
services, provided further, that such additional services are listed under its
LTO.
2. Special Clinical Laboratory
A laboratory that 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
 GENERAL GUIDELINES
1. The LTO shall be issued only to clinical laboratories
that comply with the standards and technical
requirements formulated by the BHFS.
2. Clinical laboratories that are operated and maintained
exclusively for research and teaching purposes shall be
exempted from the licensing requirement of this Order
but shall be required to register with the 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
i. Register only w/ BHFS if physically
independent & duly accredited by
international certifying body
a. CDC, WHO, or local body
recognized by DOH
5. POL – required of license if doing any or all of the ff:
i. Issue official lab results
ii. Perform more than monitoring exams
VII. PROCEDURAL GUIDELINES
iii. Cater not only to physician’s own patients
6. POCT
 SPECIFIC GUIDELINES
1. STANDARDS
a. Human Resource
i. Every clinical laboratory shall be headed and
managed by a pathologist, certified either as a
Clinical Pathologist, an Anatomic Pathologist, or
both by the Philippine Board of Pathology.
ii. The head of the laboratory shall have
administrative and technical supervision of the
activities in the laboratory
iii. The head of the laboratory shall supervise the staff
in accordance to the standards set by the
Philippine Society of Pathologists.
iv. There shall be an adequate number of medical
technologists and other health professionals with
documented training and experience to conduct
the laboratory procedures. The number of staff
shall depend on the workload and the services
being provided.
v. There shall be staff development and continuing
education program at all levels of organization to
upgrade the knowledge, attitude, and skills of
staff.
b. Equipment
c. Glassware, Reagents & Supplies
d. Administrative Policies & Procedures
e. Technical Procedures
f. Quality Assurance Program
g. Communication and Records
i. There shall be procedures for the receipt and
performance of routine and STAT requests for
laboratory examinations.
ii. There shall be procedures for the reporting of results of
routine and STAT laboratory examinations, including
critical values that would impact on patient care.
iii. All laboratory reports on various examinations of
specimens shall bear the name and facsimile signature
of the pathologist who shall be accountable for the
reliability of the results. The reports shall also bear the
name and signature of the registered medical
technologist (s) who have performed the examinations.
Electronic signatures shall be permitted in accordance
to the provisions of the E-Commerce Law.
iv. There shall be procedures for the reporting of
workload, quality control. inventory control, work
schedule and assignments.
v. There shall be procedures for the reporting and analysis
of incidents, adverse events, and in handling
complaints.
vi. The retention of laboratory records shall be in
accordance to the standards promulgated by the DOH
or by competent authorities for such purposes.
h. Physical facilities/ Work Environment
i. 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
A. Registration for Special Clinical Labs, NRL, Research &
teaching Labs
B. Procedures for Application for Initial/Renewal of LTO
a. Applicants can acquire the prescribed application form
for LTO from the BHFS, CHD that has jurisdiction
over the existing or proposed clinical laboratory, or at
the DOH website (www.doh.gov.ph)
b. The accomplished form together with the necessary
attachments is to be submitted to the CHD that has
jurisdiction over the existing or proposed clinical
laboratory. The applicant shall be required to pay a
non-refundable application fee for LTO upon
submission of the accomplished form.
c. The CHD that has jurisdiction over the existing or
proposed clinical laboratory shall conduct inspections
in accordance with licensing requirements, as provided
for under this Order and the One-Stop-Shop Licensure
System for Hospitals.
C. Renewal of LTO
a. Renewal of hospital based clinical laboratories shall be
in accordance with the licensing process under the One
Stop-Shop Licensure System for Hospitals.
b. Non-hospital based clinical laboratories shall file
applications for renewal of LTO beginning on the first
day of October until the last day of November of the
current year. A discount on the renewal fee shall be
granted if a complete application is filed during this
period.
c. Renewal of license for compliant clinical laboratories
shall be processed not later than five (5) working days
after the expiration date of its license.
 d. The LTO of a clinical laboratory shall be automatically  If not available – w. 3 mos training on clinical lab
cancelled without notice when it fails to submit a duly medicine, QC & management may manage a
accomplished application form and to pay the proper primary/secondary lab as certified by BHFS
fee on or before the expiration date stated in its license, o RMTs – available at all times during operation hours
D. Inspection  Hospital-based lab – at least 1 RMT/shift
a. CHD shall conduct announced inspections at o Staff development & CPE program instituted
reasonable time using inspection tool.  Physical Facilities
b. The licensee shall ensure the accessibility of the o Well-ventilated, adequately lighted, clean & safe
premises and facilities where the laboratory o Workspace requirements (at least)
examinations are being performed for the inspection of  1º - 10 m2
the CHD Director or his authorized representative (s).  2º - 20 m2
 3º - 60 m2
E. Monitoring
 Equipment/Instruments
a. Issued in the name of licensee and is non-transferrable
Primary Secondary Tertiary
b. Valid for one year and expires on the date set forth by
Clinical Centrifuge All those in primary All those in
CHD
plus the ff: secondary plus the ff:
c. Capability to perform HIV testing and /or drinking Hemacyotmeter Refrigerator Incubator
water analysis shall be specifically indicated in the Microhematocrit Photometer or its Balance
LTO Centrifuge equivalent
d. Mobile labs permitted to collect specimens only & Microscope with OIL Waterbath or its Rotator
operate w/n 100 kms radius from base lab equivalent
e. Any substantial changes shall be reported to CHD w/n Hemoglobinometer or Timer or its Serofuge or its
2 weeks in writing equivalent equivalent equivalent
Differential counter Autoclave
VIII. SCHEDULE OF FEES or equivalent
Drying Oven
IX. VIOLATIONS
Biosafety Cabinet
 Refusal on any clinical lab to participate in EQAP (BSC) or equivalent
 Issuance of a report, orally or in writing (in whole or part thereof)  Glassware/Reagents/Supplies
which is not in accordance w/ documented procedures  Waste Management
 Permitting unauthorized persons to perform technical procedures  Quality Control Program
 Incompetence o Internal QC
 Deviations from standard test procedures o External QC
 Lending or using the name of licensed lab or head or RMT to an  All labs shall participate in an EQAS given by
unlicensed lab designated NRL
 Unauthorized use of the name and signature of Pathologist and RMT  Satisfactory performance rating – criteria for
to secure LTO renewal of license
 Refusal to participate in EQAS-NRL – basis for
 Reporting a test result for clinical specimens even if the test was not
suspension/revocation of license
actually done
 Reporting
 Transferring results of tests done in an outside lab to the result form of
o Bear the name & signature of Pathologist & RMT
the referring lab
o No report orally or in writing without directive from
 Performing and reporting tests in a specialty or subspecialty in which
the lab is not licensed pathologist or associate except in emergency cases
 Giving and receiving any commission, bonus or kickback or rebate or  Recording
engaging in any split-free for referral to clinical labs licensed by DOH o All requests and reports of all specimens submitted and
X. INVESTIGATION OF CHARGES OR COMPLAINTS examined
 BHFS/CHD Dir or rep shall investigate the complaint o Kept in file for at least 1 year
 BHFS/CHD Dir or rep shall suspend, cancel or revoke & may seek  Anatomic and forensic pathology reports are kept
any law enforcement agency to execute the closure of any erring lab permanently
when necessary  Laboratory Fees
XI. PENALTY
 Imprisonment of not less than 1 month; or AO No. 2005-0027 (Aug. 15, 2005)
Rules and Regulations governing the regulation of HIV laboratories
 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
o Managed by licensed Physician certified by the Philippine
Board of Pathology