SECTION 4

PENALTY
Clinical Laboratory Law
1. Imprisonment – 1 month to 1 year
2. Fine – 1,000 to 5,000 pesos
It is an act regulating the operation and
maintenance of clinical laboratories and
requiring the registration of the same with the SECTION 5
Department of Health, providing penalty for the
violation thereof, and for other purposes. SEPARABILITY CLAUSE

These are the rules and regulations governing - If any section or part is found
the establishment, operation, and inconsistent or invalid, the judgment by
maintenance of clinical laboratories in the the court will not affect, impair, or
Philippines. invalidate the other sections or parts.

SECTION 1 SECTION 6

License to Operate (LTO) & Authorization FUNDING – 50,000 pesos

- Required before a clinical laboratory
can operate - Authorized amount by the NATIONAL
TREASURY to fund and carry into
Government Hospitals are exempted from effect the following provisions under RA
securing an LTO prior operation. 4688

Laboratories within the hospital premises are SECTION 7

included in the LTO of the entire hospital.
REPEALING CLAUSE – all acts or parts that
are inconsistent within the Act shall be
SECTION 2 repealed.

LICENSED PHYSICIAN is duly qualified in SECTION 8

laboratory medicine
JUNE 18, 1966 – DATE OF APPROVAL
- HEAD OF THE LABORATORY

SECRETARY OF HEALTH authorizes the

physician
- The authorization must be renewed
annually
- Will not grant or renew operation unless
the laboratory is under the supervision
of an authorized physician.

SECTION 3

Secretary of Health strictly enforces the

provisions
- Authorized to issue rules and
regulations necessary for RA 4688
 SECTION 3: Scope & Coverage

SCOPE:
Revised Rules and Regulations Governing the 1. All individuals
Licensure and Regulation of Clinical 2. Agencies
Laboratories 3. Partnerships
4. Corporations operating clinical
laboratories
SECTION 1: Rationale
ACTIVITIES:
HEALTH SECTOR REFORMS:
Examinations & Analyses of:
- Major focus of FOURmula One (F1) to
ensure access to quality and affordable 1. Human Tissues
health services 2. Fluids
3. Secretions
IMPORTANCE OF LABORATORY 4. Excretions
ACCURACY:
PURPOSE:
- Physicians rely on laboratory tests for
diagnosis and patient management. 1. Ensure reliable results for disease
prevention, diagnosis, treatment, and
NEEDED FOR UPDATED STANDARDS: public health management.

- Technological advancements EXEMPTIONS:

necessitate revisions in minimum
standards and technical requirements 1. Government clinical laboratories
for clinical laboratories performing specific DOH program-
related microscopy work
RA 4688 (1966) – mandates the regulation
and registration of clinical laboratories under
the Depart to ensure public welfare and SECTION 4: Definition of Terms
improve laboratory performance.
Applicant – a natural or juridical person who
AO 59 (2001) – previously set regulations for intends to operate a clinical laboratory.
clinical laboratories. It aims to update and
enhance quality standards nationwide. BHFS – Bureau of Health Facilities and
Services

SECTION 2: Objective CHD – Center for Health Development

1. To prescribe a revised minimum Clinical Laboratory – a facility where tests

standard for clinical laboratories. are done on specimens from the human body
2. To ensure accuracy and precision of to obtain information about the health status of
laboratory examinations in order to a patient for the prevention, diagnosis, and
safeguard public health and safety. treatment of diseases.

Critical Values – panic values originally

described by Lundberg as “life-threatening”
unless something is done promptly and for
which some corrective action could be
undertaken.

DOH – Department of Health

EQAP – External Quality Assessment STD-AIDS - HIV/AIDS
Program; It is a program where participating Cooperative - Hepatitis
laboratories are given unknown samples for Central - Syphilis
analysis. These samples are TO BE Laboratory, - STIs
TREATED AS ORDINARY. San Lazaro
Hospital
Inspection Tool – the checklist used by the (SACCL)
regulatory officers during inspection visit(s) to East Avenue - Environmental and
evaluate compliance of a clinical laboratory to Medical Occupational Health
the minimum standards and technical Center - Toxicology and
requirements. (EAMC) Micronutrient Assay
- Drugs of Abuse
Institution – a corporate body or
establishment organized for an educational, National - Hematology and
medical, charitable, or similar purpose. Kidney & Coagulation
Transplant - Immunohematology
License – the document issued by the DOH to Institute - Immunopathology
an individual, agency, partnership, or - Anatomic Pathology
corporation that operates a clinical laboratory
upon compliance with the requirements set Lung Center - Biochemistry and
forth in this Order. of the Clinical Chemistry
Philippines
Licensee – the individual, agency,
partnership, or corporation to whom the POL – Physician’s Office Laboratory; It is an
license is issued and upon whom rests individual doctor’s office/clinic wherein
compliance with this Order. laboratory examinations are performed.

LTO – License to Operate; also refers to POCT – Point of Care Testing; it is a diagnostic
license. testing at or near the site of patient care rather
than in the clinical laboratory. It includes
Mobile Clinical Laboratory – a laboratory bedside testing, outpatient, and home care.
testing unit that moves from testing site to
another testing site or has a temporary testing Routine Tests – the basic, commonly
location. It shall have a base laboratory. requested tests in the laboratory, the results of
which are not required to be released
Monitoring Examinations – tests done in immediately upon completion. It shall follow
series of patients as a guide for treatment or the usual procedures and system in the
follow-up of their condition. laboratory.

NRL – National Reference Laboratory; It is a Satellite Testing Site – any testing site that
laboratory in a government hospital which has performs laboratory examinations under the
been designated by the DOH to provide administrative control of a licensed laboratory
special functions and services for specific but performed outside the physical confines of
disease areas. that laboratory.

Research - Dengue, Influenza, STAT – Short Turn-Around Time or Sta’tim;

Institute of Tuberculosis, tests done on urgent cases, the results of
Tropical Mycobacteria, which shall be released IMMEDIATELY, within
Medicine Measles, Mycology one (1) hour after the procedure.
(RITM) - Confirmatory testing:
blood units
- Microbiology &
Parasitology
SECTION 5: Classification of Clinical National Reference Laboratory
Laboratories
- Confirmatory testing
Classification by Ownership - Surveillance
- Government - Resolution of Conflicts
- Private - Training and Research
- Evaluation of kits and reagents
Classification by Function - EQAS
- Clinical Pathology
- Anatomic Pathology Satellite Testing Site

Classification by Institutional Character - Any testing site that performs laboratory

- Institution-based examinations outside the physical
- Freestanding confines of the laboratory.

Classification According to Service Mobile Clinical Laboratory

Capability
- A laboratory testing unit that moves
Primary (10sqm) from testing site to another testing site
- Licensed as part of the main clinical
1. Routine Hematology laboratory
2. Routine Urinalysis - SPECIMEN COLLECTION ONLY
3. Routine Fecalysis - Operate only WITIN 100 KM RADIUS
4. Qualitative Platelet determination
5. Blood Typing – HB
SECTION 6: Guidelines
Secondary (20sqm)
A. General Guidelines
1. 10 laboratory examination
2. Routine Chemistry - LTO is granted only to clinical
3. Quantitative Platelet determination laboratories that meet BHFS standards
4. Crossmatching – HB and technical requirements.
5. Gram staining/KOH – HB - Research and teaching clinical
laboratories are exempted from
Tertiary (60sqm) licensing but MUST register with the
BHFS
1. 20 laboratory examination - Special clinical laboratories not covered
2. Special Chemistry by other administrative orders must
3. Special Hematology register with the BHFS
4. Immunology/Serology - The NRL designated by the DOH shall
5. Microbiology (aerobic/non-aerobic) – be covered by the license of the clinical
HB/NHB laboratory of the hospital where they
are respectively assigned.
Limited Service Capability - POL should secure a clinical laboratory
- Dialysis Center license if it practices:
- Social Hygiene Clinics
B. Specific Guidelines
Special Clinical Laboratory
- Assistant Reproduction Technology Standards:
Laboratory - Human resource
- Molecular and Cellular Technology - Equipment
- Molecular Biology - Glassware, reagents, and supplies
- Molecular, Forensic, Anatomic - Administrative policies and procedures
Pathology - Technical procedures
- Quality assurance program
 - Communication and Records - The BHFS will assess applications
- Physical facilities/Work Environment based on proper form completion and
- Referral of examinations outside of the required attachments.
Clinical Laboratory
B. Procedures for Application for Initial or
LTO: Renewal of LTO

- The LTO is non-transferable and only 1. Applicants can obtain the LTO
valid for the specified location it was application form from the BHFS, CHD,
applied for or the DOH website.
- The LTO for a clinical laboratory is valid 2. The completed form and required
for ONE YEAR unless suspended or documents must be submitted to the
revoked CHD with a non-refundable LTO
- The LTO for a non-hospital clinical application fee.
laboratory must specify the lab’s name, 3. The CHD will inspect clinical
owner, head, service capability, validity laboratories per licensing requirements
period, license number, and location. and the One-Stop-Shop Licensure
- The LTO must always be prominently System for Hospitals.
displayed in the laboratory.
- Hospital-based clinical laboratories are C. Renewal of LTO
licensed through the hospital and do not
need a separate LTO. 1. Hospital-based clinical laboratory
- The LTO must specify authorization for renewals follow the One-Stop-Shop
HIV testing or drinking water analysis Licensure System for Hospitals.
- The clinical laboratory and its satellite 2. Non-hospital clinical laboratories must
services within the same compound renew their LTO between October and
shall have one (1) LTO. November, with a discount for timely
- A satellite laboratory MUST obtain a applications.
separate LTO. 3. Renewal for compliant clinical
- Mobile clinical laboratories are licensed laboratories must be processed within
under the main laboratory, can only (5) working days after license
collect specimens, and must operate expiration.
within a 100km radius. 4. The LTO of a clinical laboratory is
- Significant changes to a clinical automatically cancelled if it fails to
laboratory must be reported in writing to submit the application and payment by
the CHD within (2) weeks. the expiration date.
- The LTO may be revoked, suspended,
or modified for false statements, D. Inspection
inspection units, or rule violations.
1. The CHD may conduct announced
licensure inspections at any reasonable
SECTION 7: Procedural Guidelines time.
2. The licensee must allow CHD
A. Registration for Special Clinical inspections of the laboratory premises
Laboratories, National Reference at any reasonable time.
Laboratories, Research and Teaching 3. The licensee must keep all relevant
Laboratories records available for CHD inspection.
4. An inspection tool with standards and
- Applicants can obtain registration form requirements will be used for LTO
from the BHFS, CHD, or the DOH issuance.
website.
- The completed form and required E. Monitoring
documents must be submitted to the
BHFS or CHD with a non-refundable 1. All clinical laboratories shall be
registration fee. monitored regularly.
 2. The BHFS or CHD may conduct SECTION 10: Investigation of Complaints
monitoring visits to clinical laboratories
at any reasonable time BHFS/CHD Investigate complaints
3. Clinical laboratories must provide Director or and verify the personnel
records, premises, and facilities for Representatives that is accountable
BHDS or CHS inspections to ensure CHD Director or Suspend, cancel, or
compliance. Representatives revoke LTO licenses.
4. Non-compliant clinical laboratories will
receive a Notice of Violation
immediately after monitoring. SECTION 11: Penalty
5. The CHD must submit a quarterly report
to the BHFS listing clinical laboratory Imprisonment – Not less than 1 month
violations and actions taken.
6. Local health officers must report Fine – 1,000 to 5,000 pesos
unlicensed clinical laboratories or
violations to the BHFS/CHD.
SECTION 12: Appeal

SECTION 8: Schedule of Fees DECISION OF THE BHFS/CHS:

Non-refundable fee – charged for the initial - May be appealed to the OFFICE OF
application or renewal of license to operate. THE HEALTH SECRETARY
- Appeal: within 10 DAYS after the
All fees, or checks are paid in person or receipt of notice was given
through postal money order. - FINAL AND EXECUTORY

All fees, subcharges, discounts follow

current DOH prescribed schedule of fees SECTION 13: Repealing Clause

All acts or parts that are inconsistent within the

SECTION 9: Violations Act shall be repealed.

RED FLAG TIP

SECTION 14: Separability Clause
R – Refusing to participate in EQAP
E – Erroneous reporting or release of results If any section or part is found inconsistent or
D – Deviating from standard test procedures invalid, the judgment by the court will not
affect, impair, or invalidate the other sections
F – Falsifying test results or parts.
L – Lending the lab’s name to unlicensed lab
A – Allowing unauthorized staff to perform
G – Giving or receiving kickbacks for patient SECTION 15: Effectivity
referrals
This Order shall take effect fifteen (15) days
T – Transferring external test results onto the after its approval
referring lab’s form
I – Illegally using a pathologist’s or tech’s name Published in the official gazette or newspaper
to secure LTO of general circulation
P – Performing tests outside the lab’s licensed
specialty