HANDOUT – Nature of Clinical Laboratory authorized to issue such rules and regulations as

may be necessary to carry out its provision.

Clinical Laboratory - main task is to provide
accurate and reliable information to medical
doctors for the diagnosis, prognosis, treatment DOH Administrative Order No. 2007-0027
and management of disease. Also, a place where Subject: Revised Rules and Regulations
specimens are collected from individuals are Governing the Licensure and Regulation of
processed, analyzed, preserved and properly Clinical Laboratories
disposed.

Republic Act 4688 • Basic License Requirements

• “Petition to Establish, Operate
• Approved on June 18, 1966 and Maintain a Clinical
• Approved during the incumbency of Laboratory”
Pres. Ferdinand Marcos. • Inspection of Laboratory
• This has 8 sections. The most important • w/in 60 days after filling of
sections are Sec. 1, 2 and 3. application
• Renewal of License
Sec.1 Any person firm of corporation, • Every last 2 months of the year
maintaining or operating a clinical laboratory, and must be processed not later
shall register and secure license annually at the than 5 days prior the expiration
office of the Secretary of Health. of license.
• Expiration of License
Provided, that government hospital • Every last day of December of
laboratories doing routine or minimum the year
laboratory examinations shall be exempt from
provisions of this section. I. Rationale
Sec.2 it shall be unlawful for any person to be  The registration operation and
professionally in charge of a registered clinical maintenance of Clin. Lab. In the Phils.
laboratory unless he is a licensed physician duly  Preventing substandard, Improperly
qualified in laboratory medicine and authorized managed and poorly equipped clinical
by the Secretary of Health, such authorization laboratories
to be renewed annually.
II. Objective
No license shall be granted or renewed
by the Secretary of Health for the operation and  Promulgated to prescribe a revised
maintenance of a clinical laboratory unless such minimum standard for clinical
laboratory is under the administration, direction laboratories
and supervision of an authorized physician, as
III. Scope & Coverage
provided for on the preceding paragraph.
 Applies to all entities performing the
Sec.3 The Secretary of Health, through the
activities and functions of clinical labs
Bureau of Research and Laboratory, shall be
 Excludes government laboratories doing
charged with the responsibility of strictly
laboratory examinations limited to AFB
enforcing the provisions of this Act and shall be
microscopy, malaria screening and
 cervical cancer screening; declared as other Viral exanthems,
extension of a licensed government Mycology, Enteroviruses,
clinical lab (RHUs) Antimicrobial resistance
and Emerging Diseases.
IV. Definition of Terms
• NRL for confirmatory
 Applicant – who intends to operate testing of blood units, i.e.
a clinical lab Hepatitis B Virus, Hepatitis
 Clinical Laboratory - A Clinical C Virus, Human
Laboratory is a facility where tests Immunodeficiency Virus,
are done on specimens from the Syphilis and Malaria.
human body to obtain information
about the health status of a patient • San Lazaro Hospital
for the prevention, diagnosis and (SLH) - HIV/AIDS,
treatment of diseases. Hepatitis, Syphilis and
other Sexually
 License – document issued by DOH
Transmitted Infections
to applicant upon compliance
(STls).
 Licensee – whom the license is
issued • East Avenue Medical
 LTO – license to operate Center (EAMC) -
 Mobile Clinical Laboratory – moves Toxicology and
from testing site but affiliated with Micronutrient Assay; Drug
base lab Testing; Water Analysis.
 Monitoring Examinations – series of
tests done on patients • National Kidney and
 NRL – National Reference Transplant Institute
Laboratory; gov’t hospital lab (NKTI) - Hematology /
designated by DOH and may or may Immunohematology
not be a part of general clinical lab
(CREST) • Lung Center of the
o Confirmatory testing; Philippines (LCP) -
o Resolution of conflicting Biochemistry
results;
o Evaluation of diagnostic kits • Philippine Heat Center
and reagents; (PHC) - Anatomic
Pathology for Cardiac
o Surveillance;
Diseases
o Training and research.
• POL – Physician’s Office
NRLS:
Laboratory
• Research Institute for
Tropical Medicine (RITM) - • POCT – Point of Care Testing (at
Dengue, Influenza, TB and or near the site of the patient)
Malaria and other
parasites, Bacterial enteric • Routine Test – basic, commonly
diseases, Measles and requested tests
 • Satellite Testing Site – any secondary lab services
testing site that performs lab +; special chemistry;
exams outside the physical special hematology;
im-munology/ sero-
confines of the base lab
logy; Micro- biology
• STAT Tests – urgent tests and to (C/S)
be released within one hour D. Limited Service
after procedure Capability (for
institution based
• V. Classification of Laboratories (OFIS) only)
A. Classification by Ownership – i.e. dialysis centers
• Government & social hygiene
• Private clinics
B. Classification by Function
• Clinical Pathology 2. Special Clinical Laboratory –
• Anatomic Pathology offers highly specialized laboratory
services that are usually not
•
provided by a general clinical
C. Classification by Institutional
laboratory, i.e. Anatomic
Character Pathology, Forensic Pathology,
• Institution-based Molecular Biology, Molecular
• Freestanding Pathology, Assisted Reproduction
D. Classification by Service Technology Labs, and Molecular
Capability and Cellular Technology.
1. General Clinical
• VI. Guidelines
Laboratory
A. Primary A. General Guidelines
Routine hematology
(CBC) – Hb, Hct, WBC 1. The LTO shall be
& Differential count; issued only to clinical
Qualitative platelet labs that comply with
determination; standards and technical
Routine urinalysis; reqts formulated by the
Routine fecalysis; HFSRB
Blood typing.
B. Secondary 2. Clinical labs operated
primary lab services +; and maintained for
Routine clinical research and teaching
chemistry – includes purposes – exempted
blood glucose, BUN, but needs to be
BUA, Crea & total
registered w/ HFSRB
cholesterol;
Quantitative platelet 3. POL – license is
determination; Cross required if doing any or
matching; Gram all of the ff:
staining; KOH
C. Tertiary – • Issue official lab
results
 • Perform more depend on the workload
than monitoring and working hours. The
exams working hours vary from a
minimum of eight (8)
• Cater not only hours to a maximum of
to physician’s twelve (12) hours. In so
own patients determining the number
of laboratory professionals
B. Specific Guidelines the following guidelines
must be observed:
1. Standards • A single
• Human Resour- laboratory test is
ces estimated to be
• Equipment processed within
• Glassware, Re- 10 minutes (10
agents & Supplies minutes/test).
• Administrative
• Manual Testing:
Policies &
50 tests/RMT/8
Procedures
hours
• Technical Pro-
• Manual Testing:
cedures
75 tests/RMT/12
• Quality
hours
Assurance Pro-
• Automated
gram Testing: 100
• Communication tests/RMT/8
& Records hours
• Physical faci- • Automated
lities/ Work Envt Testing: 150
• Referral of tests/RMT/12
Examinations
hours
Outside of the
• Total number of
Clinical Lab staff include
• Staffing reliever/s
• Managed by licensed
Physician certified by the • Physical Facilities
Philippine Board of • Well-ventilated, adequately
Pathology. lighted, clean & safe
• Work space reqt’s (at least)
• NB: in places where • Primary - 10 m2
pathologists are not • Secondary - 20 m2
available, a physician with • Tertiary - 60 m2
3 months training on clin.
lab. Medicine may manage • Reporting
a primary/secondary
• Bear the name & signature
category clin. Labs.
of Pathologist & RMT

• At present, the number of • No report orally or

laboratory professionals in writing without
 directive from o Capability to perform HIV
pathologist or testing and /or drinking H2O
associate except in analysis shall be specifically
emergency cases indicated in the LTO
o Mobile labs permitted to collect
• Recording
specimens only & operate w/n
• All requests and 100 kms radius from base lab
reports of all o Any substantial changes shall be
specimens sub- reported to CHD w/n 2 wks in
mitted and writing
examined
VII. Procedural Guidelines
• Kept in file for at
A. Registration for Special Clinical Labs,
least 1 year.
NRL, Research & teaching Labs
• Anatomic and
B. Procedures for Application for
forensic pathology
Initial/Renewal of LTO
reports are kept
permanently. C. Renewal of LTO

• Quality Control Program • Hospital-based –

processed under the
• Internal QC
One-Stop-Shop
• External QC Licensure System for
Hospitals
• All labs shall
participate in an • Non-hospital based –
EQAP given by beginning 1st day of
designated NRL October until end of
November of current
• Satisfactory year
performance rating
– criteria for • Automatic cancellation
renewal of license of LTO

• Refusal to • Failure to
participate in EQAP- submit duly
NRL – basis for accomplished
suspension/revocati form
on of license
• Non-Payment
 LTO of proper fee on
o Issued in the name of licensee or before
and is non-transferrable expiration date
o Valid for 1 year
D. The HFSRB / CHD or their
o Expires on the date set forth by
representatives:
CHD
 • Inspect; Mon- • Performing and reporting tests
itor; Investigate in a specialty or subspecialty in
violations; Sus- which the lab is not licensed
pend / cancel /
• Giving and receiving any
revoke LTO of
commission, bonus or kickback
Clinical labo-
or rebate or engaging in any
ratory
split-free for referral to clinical
• IX. Violations
labs licensed by DOH
• Refusal on any clinical lab to
participate in EQAP • XI. Penalty
• Issuance of a report, orally or in
writing which is not in • Imprisonment of not < 1 month
accordance w/ documented but not >1year; or Fine not < PhP
procedures 1,000 but no > PhP 5,000; or
• Permitting unauthorized Both
persons to perform technical • If a corporation- managing head
procedures or owner is liable
• Incompetence
• Deviations from standard test • XII. Appeal
procedures • Office of the Health Sec w/n 10
• Lending or using the name of days after receipt of notice of
licensed lab or head or RMT to decision
an unlicensed lab
• Decision is final & executory
• X. Investigation of Charges or
• XIII. Repealing Clause
Complaints
• XIV. Separability Clause
• HFSRB/CHD Dir. or rep. shall
investigate the complaint • XV. Effectivity

• 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

• 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