MTY1201: PMLS 1
TOPIC 8.0: NATURE OF CLINICAL
LABORATORY
GENERAL GUIDLINES
LEGEND FOR HEADERS
MAIN TOPIC
SUBTOPIC
SUB-SUBTOPIC
CLINICAL LABORATORY
● main task is to provide accurate and
reliable information to medical
doctors for the diagnosis, prognosis,
treatment and management of
disease. Also, a place where
specimens are collected from
individuals are processed, analyzed,
preserved and properly disposed.
Republic Act 4688 / Clinical
Laboratory Law
• Approved on June 18, 1966
• Approved during the incumbency
of Pres. Ferdinand Marcos.
• This has 8 sections. The most
important sections are Sec. 1, 2
and 3.
Sec. 01
• Any person firm of corporation,
maintaining or operating a clinical
laboratory, shall register and
secure license annually at the
office of the Secretary of Health.
• Provided, that government
hospital laboratories doing
routine or minimum laboratory
examinations shall be exempt
from provisions of this section.
Sec. 02
• It shall be unlawful for any person to
be professionally in charge of a
registered clinical laboratory unless
he is a licensed physician duly
qualified in laboratory medicine
and authorized by the Secretary
of Health, such authorization to
be renewed annually.
• No license shall be granted or
renewed by the Secretary of
Health for the operation and
maintenance of a clinical
laboratory unless such laboratory
is under the administration,
direction and supervision of an
authorized physician, as provided
for on the preceding paragraph.
Sec. 03
• The Secretary of Health, through
the Bureau of Research and
Laboratory, shall be charged
with the responsibility of strictly
enforcing the provisions of this
Act and shall be authorized to
issue such rules and regulations
as may be necessary to carry
out its provision.
DOH Administrative Order No. 2007-
0027
Subject: Revised Rules and Regulations
Governing the Licensure and Regulation of
Clinical Laboratories
• Basic License Requirements
o “Petition to Establish,
Operate and Maintain a
Clinical Laboratory”
AFUAN, S. 1

• Inspection of Laboratory
o w/in 60 days after filling
of application
• Renewal of License
o Every last 2 months of
the year and must be
processed not later than
5 days prior the
expiration of license.
• Expiration of License
o Every last day of
December of the year
I. Rationale
• The registration operation and
maintenance of Clin. Lab. In the
Phils.
• Preventing substandard, Improperly
managed and poorly equipped
clinical laboratories
II. Objective
• Promulgated to prescribe a revised
minimum standard for clinical
laboratories
III. Scope & Coverage
• Applies to all entities performing the
activities and functions of clinical
labs
• 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 (RHUs)
IV. Definition of Terms
• Applicant – who intends to operate
a clinical lab
• Clinical Laboratory - A Clinical
Laboratory is a facility where tests
are done on specimens from the
human body to obtain information
about the health status of a patient
for the prevention, diagnosis and
treatment of diseases.
• 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 done 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
(CREST)
o Confirmatory testing;
o Resolution of conflicting
results;
o Evaluation of diagnostic kits
and reagents;
o Surveillance;
o Training and research.
NRLS:
Research Institute for Tropical
Medicine (RITM) - Dengue,
Influenza, TB and Malaria and other
parasites, Bacterial enteric diseases,
Measles and
other Viral exanthems, Mycology,
Enteroviruses, Antimicrobial
resistance and Emerging Diseases.
NRL for confirmatory testing of blood
units, i.e. Hepatitis B Virus, Hepatitis
C Virus, Human Immunodeficiency
Virus, Syphilis and Malaria.
San Lazaro Hospital (SLH) -
HIV/AIDS, Hepatitis, Syphilis and
other Sexually Transmitted
Infections (STls).
East Avenue Medical Center
(EAMC) - Toxicology and
Micronutrient Assay; Drug Testing;
Water Analysis.
AFUAN, S. 2
 National Kidney and Transplant
Institute (NKTI) - Hematology /
Immunohematology
Lung Center of the Philippines
(LCP) - Biochemistry
Philippine Heat Center (PHC) -
Anatomic Pathology for Cardiac
Diseases
• POL – Physician’s Office Laboratory
• POCT – Point of Care Testing (at or near
the site of the patient)
• Routine Test – basic, commonly
requested tests
o Ex. Urinalysis , CBC
• 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 (OFIS)
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
A. Primary Routine hematology (CBC) –
Hb, Hct, WBC & Differential count;
Qualitative platelet determination; Routine
urinalysis; Routine fecalysis; Blood typing.
B. Secondary primary lab services +;
Routine clinical chemistry – includes blood
glucose, BUN, BUA, Crea & total
cholesterol; Quantitative platelet
determination; Cross matching; Gram
staining; KOH
C. Tertiary – secondary lab services +;
special chemistry; special hematology; im-
munology/ sero- logy; Micro- biology (C/S)
D. Limited Service Capability (for
institution based only)
– i.e. dialysis centers & social hygiene
clinics
2. Special Clinical Laboratory – offers
highly specialized laboratory services that
are usually not provided by a general
clinical laboratory, i.e. Anatomic Pathology,
Forensic Pathology, Molecular Biology,
Molecular Pathology, Assisted Reproduction
Technology Labs, and Molecular and
Cellular Technology.
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 HFSRB
2. Clinical labs operated and
maintained for research and
teaching purposes – exempted but
needs to be registered w/ HFSRB
3. POL (Physician Office Laboratory)
– license is required 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
B. Specific Guidelines
1. Standards
• Human Resources
• Equipment
• Glassware, Reagents &
Supplies
• Administrative Policies &
Procedures
• Technical Procedures
AFUAN, S. 3
 • Quality Assurance Program
• Communication & Records
• Physical facilities/ Work Envt
• Referral of Examinations
Outside of the Clinical Lab
• Staffing
• Managed by licensed Physician
certified by the Philippine Board of
Pathology.
• NB: in places where pathologists are
not available, a physician with 3
months training on clin. lab.
Medicine may manage a
primary/secondary category clin.
Labs.
• At present, the number of laboratory
professionals
• depend on the workload and working
hours. The working hours vary from
a minimum of eight (8) hours to a
maximum of twelve (12) hours. In so
determining the number of
laboratory professionals the
following guidelines must be
observed:
o A single laboratory test is
estimated to be processed within 10
minutes (10 minutes/test).
o Manual Testing: 50
tests/RMT/8 hours
o Manual Testing: 75
tests/RMT/12 hours
o Automated Testing: 100
tests/RMT/8 hours
o Automated Testing: 150
tests/RMT/12 hours
o Total number of staff include
reliever/s
• Physical Facilities
• Well-ventilated, adequately lighted,
clean & safe
• Work space reqt’s (at least)
• Primary - 10 m2
• Secondary - 20 m2
• Tertiary - 60 m2
• Reporting
• Bear the name & signature of
Pathologist & RMT
o No report orally or in writing
without directive from pathologist or
associate except in emergency
cases
• Recording
• All requests and reports of all
specimens sub-mitted and examined
• Kept in file for at least 1 year.
• Anatomic and forensic pathology
reports are kept permanently.
• Quality Control Program
• Internal QC
• External QC
o All labs shall participate in an
EQAP given by designated NRL
o Satisfactory performance
rating – criteria for renewal of license
o Refusal to participate in
EQAP-NRL – basis for
suspension/revocation of license
LTO
o Issued in the name of licensee and is
non-transferrable
o Valid for 1 year
o Expires on the date set forth by CHD
o Capability to perform HIV testing and /or
drinking H2O analysis shall be specifically
indicated in the LTO
o Mobile labs permitted to collect
specimens only & operate w/n 100 kms
radius from base lab
o 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
AFUAN, S. 4
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 1st
day of October until end of
November of current year
• Automatic cancellation of LTO
• Failure to submit duly
accomplished form
• Non-Payment of proper fee
on or before expiration date
D. The HFSRB / CHD or their
representatives:
• Inspect; Monitor; Investigate
violations; Sus-pend / cancel /
revoke LTO of Clinical laboratory
IX. Violations
• Refusal on any clinical lab to
participate in EQAP
• Issuance of a report, orally or in
writing 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
X. Investigation of Charges or
Complaints
• HFSRB/CHD Dir. or rep. shall
investigate the complaint
• HFSRB/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
• Unauthorized use of the name and
signature of Pathologist and RMT to
secure LTO ( license to operate)
• 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
XI. Penalty
• Imprisonment of not < 1 month but
not >1year; or Fine not < PhP 1,000
but no > PhP 5,000; 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
• Provision repeals modifies the
previous regulations with respect to
clinical lab. rules and regulation
XIV. Separability Clause
• If one is lawful/illegal it will not affect
other provision
• Each and every provision is a law
XV. Effectivity
AFUAN, S. 5
AFUAN, S. 6