R.A.

4688
The clinical laboratory
law and its
implementing rules and
regulations
An Act Regulating the
Operation and Maintenance
of Clinical Laboratories and
Requiring the Registration of
the Same with the
Department of Health,
Providing Penalty for the
Violation Thereof, and for
Other Purposes
 Clinical
laboratories play a vital
role in medical practice. These
are indispensable facilities in
delivering quality health care
since laboratory work-ups
provide information and services
that are necessary for detecting,
diagnosing, treating, and
monitoring diseases.
 In the Philippines, clinical laboratories are
regulated by the Department of Health
(DOH). The history of this regulatory
power can be traced back as early as
1958, when the Bureau of Research and
Laboratories (BRL) was created.
 The power to regulate clinical laboratories
was strengthened and vested to the BRL
in 1966, when the R.A. No. 4688 was
enacted.
 In 2001, the BLR was renamed as the
Bureau of Health Facilities and
Services (BHFS). Through the
approval of the DOH Rationalization
Plan in 2014, the name Bureau of
Health Facilities and Services was
changed to Health Facilities and
Services Regulatory Bureau
(HFSRB).
 Republic Act No. 4688 is the law regulating the
operation and maintenance of clinical
laboratories and requiring the registration of
the same with the DOH, through the HFSRB.
The main objective of regulating clinical
laboratories in the Philippines is to ensure access
to quality and affordable health products,
devices, facilities, and services, especially those
commonly used by the poor.
WHAT IS' REPUBLIC ACT NO. 4688?
A clinical laboratory is a facility
where tests are done on specimens
taken from the human body to
obtain information about the health
status of a patient for the
prevention, diagnosis, and
treatment of diseases.

CLINICAL LABORATORY AND ITS

CLASSIFICATIONS
 Ownership
• Government –operated by the national government or a local
government unit
• Private – owned and established by an individual, corporation or
association or organization

Function
• Clinical Pathology – Clinical Chemistry, Hematology, Immuno-
hematology, Microbiology, Molecular Biology, Clinical Microscopy,
Cytogenetics, Toxicology, Drug Monitoring
• Anatomic Pathology – surgical pathology, cytology, Immuno-
histopathology, Autopsy, Forensic Pathology and Molecular
Pathology
CLASSIFICATION OF LABORATORY
Institutional Character:
• Institution Based – operates within the premises of an institution
such as hospital, clinic, school, medical facility
• Free Standing – does not form part of any institution

Service Capability
• A. General Clinical Laboratory ****–
• Primary Category - Routine Hematology ( CBC – Hgb., Hct., RBC
Ct., WBC Ct., Diff. Ct.,) Qualitative Platelet Determination, Rt.
Urinalysis, Rt. Fecalysis, Blood Typing
• Secondary Category – Services provided by Primary Category
Laboratory, Rt. Chemistry ( Bld. Glucose, Bld. Urea, Bld. Uric Acid,
Bld. Creatinine, Total Protein, Total Cholesterol Conc.) Quantitative
Platelet Det., Cross Matching, Grams Staining, KOH Smear
 Tertiary Category – Services provided by secondary
category, Special Chemistry, Special Hematology
including Coagulation Procedures; Immunology,
Microbiology( Culture and Sensitivity)
 Limited Service Capability – under any of the above
category permitted to offer services
Hematology,Urinalysis, Fecalysis, Grams Staining, RT.
Chemistry( Blood Glucose, BUN, UA, Chole, Total Pro.)
Blood Typing and Cross Matching
 B. Special Clinical Laboratory – offers highly
specialized laboratory offers services not provided by
general clinical laboratory
 1. A pre-analytical process that handles specimen
collection and handling
 2. An analytical process that encompasses testing
procedures, instrumentation and equipment, reagents,
quality control, personnel, and facilities
 3. A post-analytical process that deals with reporting the
results and disposal of the waste products

COVERAGE OF THE TOTAL TESTING

PROCESS IN A CLINICAL LABORATORY
 A primary clinical laboratory must have a
minimum technical working area of at least 10
square meters.
 A secondary clinical laboratory requires a
minimum technical working area of at least 20
square meters.
 Finally, for a tertiary clinical laboratory, it must
have a minimum technical working area of at least
60 square meters.
DEPARTMENT MEMORANDUM NO.
148, SERIES OF 2003
 Any person, firm or corporation, operating and
maintaining a clinical laboratory in which body fluids,
tissues, secretions, excretions and radioactivity from beings
or animals are analyzed for the determination of the
presence of pathologic organisms, processes and/or
conditions in the persons or animals from which they were
obtained, shall register and secure a 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 the provisions
of this section if their services are extensions of government
regional or central laboratories.
SECTION
1
 A license is a document issued by the
DOH to an individual, agency,
partnership, or a corporation that
operates a clinical laboratory upon
compliance with the requirements set
forth by the law. It is also called License
to Operate (LTO).
WHAT IS A LICENSE?
General rule: All clinical laboratories, operating and
maintaining, shall register and secure a license annually at
the office of the Secretary of Health.
Exemption to the rule: government hospital laboratories
doing routine or minimum laboratory examinations if
their services are extensions of the government regional or
central laboratories.
• Government Clinical Laboratories,
• Research Laboratories
• Laboratories for Teaching purposes (Academic)
• Special Laboratories
• NRL (National Reference Laboratory),
• POL (Physician Office Laboratory)
 Those exempted from both securing the
license and registration under the provisions of
this section are government clinical laboratories
doing microscopy work only for specific DOH
programs such as, but not limited to:
 a. Malarial screening
 b. Acid-fast bacilli microscopy
 c. Tests for sexually transmitted infections
 d. Cervical cancer screening using Pap smears
 Those exempted from securing a license but are
required to register under the provisions of this
section are the follow:
 a Clinical laboratories that are operated and
maintained exclusively for research and teaching
purposes
 b. Special clinical laboratories operating independent
of a clinical laboratory
 c. An NRL physically, independent from the clinical
laboratory
 a. The LTO issued to a clinical laboratory is valid
for one year, unless suspended or revoked
earlier than its due date.
 b. The LTO is issued in the name of the licensee
and is non-transferrable. It is not valid for
any premises or location other than what is
provided.

GUIDELINES FOR OBTAINING AN LTO

 c. The LTO issued to a non-hospital-based clinical
laboratory shall specially provide the following: -
 i. Name of the clinical laboratory
 ii. Name of the owner or operator in Head of the
laboratory
 iv. Service capability
 v. Period of validity
 vi. License number
 vii. Location where the procedures will be conducted
 d. The LTO issued to a Non-hospital-based
clinical laboratory must be displayed at all
times at a prominent place within the
laboratory premises.
 e. Hospital-based clinical laboratories
shall be licensed as part of the hospital
through the One Licensure for Hospitals
and are not required to obtain a separate
license.
GUIDELINES FOR OBTAINING AN LTO
 f.
The capability to perform HIV
testing and/or drinking water
analysis shall be specifically
indicated in the LTO.
 g.
The clinical laboratory and its
satellite services within the same
compound' shall have one LTO.
 h. A satellite laboratory outside the premises of
the central laboratory is required to secure a
separate LTO.
 i. Mobile clinical laboratories are licensed as part of
the main clinical laboratory and are permitted to
collects specimens only. These are allowed to
operate within a 100-kilometer radius from its
main laboratory only.

GUIDELINES FOR OBTAINING AN LTO

 j. Charges that would substantially affect the
conditions of a clinical laboratory, as set
forth in its LTO must be reported within
two weeks from the initial date of
implementation.
 k. The LTO may be revoked, suspended, or
modified in full or in part for any material
false statement by the applicant, or as shown
by the record of inspection, or for violation or
failure to comply with any of the terms and
conditions and provisions of the
implementing rules.
 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 in the preceding
paragraph.

SECTION 2
 Every clinical laboratory must be
headed and managed by either as a
clinical pathologist, an anatomic
pathologist, or both by the Philippine
Board of Pathology.
WHO HEADS AND MANAGES A
CLINICAL LABORATORY?
 A clinical laboratory is usually headed by a
pathologist. This applies to all general
laboratories, whether government or private,
institution-based or freestanding. The
pathologist has direct supervision and
control of over other laboratory professionals
such as RMTs and MLTs.

PATHOLOGIST AS THE SUPERVISOR OF THE LABORATORY

 The basis of this supervisory authority is
enshrined under clinical laboratory law, which
provides that;
 1. It shall be unlawful for any person to be professionally
in-charge of a registered clinical laboratory unless he/she
is a licensed physician duly qualified in laboratory
medicine. (par.1, section 2 of R.A. 4688)
 2. 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. (par.2, section 2 of R.A. 4688)
 Based on this twin mandate of the clinical laboratory law,
the DOH implements the following guidelines:
 a. Every clinical laboratory shall be headed and managed by
a pathologist, certified either as clinical pathologist, an
anatomic pathologist, or both by the Philippine Board of
Pathology.
 b. The head of the laboratory shall have the administrative
and technical supervision of the activities in the laboratory.
 c. The head of laboratory shall supervise the staff in
accordance to the standards set by the Philippine Society
of Pathologists.

ADMINISTRATIVE ORDER NO. 2007-0027

 In areas where there is no pathologist
available, a physician with complete
training in Clinical Laboratory Medicine
and Laboratory Management, and is
certified as such, may manage one primary
clinical laboratory. Provided that, there is a
certification from the Philippine Society
of Pathologists (PSP) that there is no
pathologist in the area.
IF NO PATAHOLOGIST AVAILABLE..
 An anatomic pathologist or a licensed physician with
residency training in clinical pathology for at least
two(2) years may manage a clinical laboratory if
a clinical pathologist is not available.
 Provided that there is a certification from the
Philippine Society of Pathologists (PSP) that
there is no clinical pathologist available. Provided
further that for a licensed physician, he/she may
only manage one(1) primary clinical laboratory.

IF NO PATAHOLOGIST AVAILABLE..
PROCESS OF APPLICATION OF LTO,
REGISTRATION AND RENEWAL
 The application for registration and issuance of an
LTO is filed with the HFSRB or through the
Center for Health Development (CHD) of the
DOH that has jurisdiction over the existing or
proposed clinical laboratory. Thereafter, the HFSRB
or CHD shall evaluate the due execution of the
application and completeness of the attachments.

WHERE IS THE APPLICATION FOR LTO FILED?

 The renewal of hospital-based clinical laboratories
shall be in accordance with the licensing process
under the One-Stop-Shop Licensure System
for Hospitals.
 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.

WHERE IS THE APPLICATION FOR LTO FILED?

 If it fails to submit a duly accomplished
application form and pay the proper fee
on or before the expiration date stated in its
license, the LTO of a clinical laboratory shall
be automatically cancelled without
notice.

WHERE IS THE APPLICATION FOR LTO FILED?

INSPECTION AND MONITORING
 The HFSRB and the CHD, through its director or his/her
authorized representative, are tasked to inspect and
monitor clinical laboratories within their respective
jurisdiction.
 All clinical laboratories shall be inspected and monitored
regularly. The HFSRB or the CHD director or his/her authorized
representative(s) shall inspect and monitor clinical laboratories
through visits to the laboratory at any reasonable time
 An inspection tool, which prescribes the standards, criteria, and
technical requirements for the issuance of LTO, shall be utilized.
WHO INSPECTS AND MONITORS CLINICAL
LABORATORIES?
  All clinical laboratories shall ensure that all laboratory
records, premises, and facilities are made available to
the HFSRB or the CHD director or his/her authorized
representative(s) in order to determine compliance with
the provisions of this regulation
 A notice of violation for non-compliant clinical
laboratories shall be issued immediately after
monitoring the clinical laboratory.

WHO INSPECTS AND MONITORS CLINICAL LABORATORIES?

 It is mandated that all clinical laboratories must
participate with the External Quality Assessment
Program (EQAP) of the NRL.
 In addition, clinical laboratories must submit to the
DOH their Certificates of Performance or Certificates
of Proficiency as a requirement for the renewal of
their licenses.
 Failure of clinical laboratories to submit proof Of
participation in the EQAP shall be a basis for non-
renewal of LTO.
QUALITY ASSURANCE
 The Secretary of Health, through the Bureau of
Research and Laboratories(renamed as Health
Facilities and Services Regulatory Board/
HFSRB) 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 provisions.

SECTION 3
 Any person, firm or corporation who violates any
provisions of this Act or the rules and regulations
issued thereunder by the Secretary of 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
discretion of the court.
SECTION 4
VIOLATIONS AND PENAL
PROVISIONS
 The Secretary of Health, through the
HFSRB, shall be charged with 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 provisions. (Sec 3 of R.A. No. 4688)

WHO IS TASKED TO ENFORCE THE

PROVISIONS OF THE CLINICAL LABORATORY
LAW AND ITS IMPLEMENTING RULES?
 A. Refusal of any clinical laboratory to participate in an EQAP
conducted by the designated NRL or other external proficiency
program approved by the DOH.
 B. Issuance of a report, orally or in writing, in whole or portions
thereof, which is not in accordance with the documented
procedure approved by the head of the laboratory
 C. Permitting unauthorized persons to perform technical
procedures.
 D. Demonstrating incompetence or making consistent errors in
the performance of clinical laboratory examinations and procedures.

VIOLATION OF R.A. NO. 4688

 E. Deviating from the standard test procedures, including
use of expired reagents
 F. Reporting/release of erroneous results
 G. Lending or using the name of the licensed clinical
laboratory or the head of the laboratory or medical
technologist to an unlicensed clinical laboratory
 H. Unauthorized use of the name and signature of
the pathologist and medical technologists to secure LTO
 I. Reporting a test result for a clinical specimen even if
the test was not actually performed.
 J. Transferring results of tests done in an
external clinical laboratory to the result form of
the referring laboratory
 K. Performing and reporting tests in a
specialty or subspecialty in which the laboratory is
not licensed
 L. Giving and receiving any commission,
bonus, kickback, or rebate or engaging in an
split-fee arrangement in any form whatsoever
with any facility, physician, organization, agency,
or person, either directly or indirectly, for patients
referred to an clinical laboratory licensed by the
DOH
 The HFSRB or the CHD Director or, his/her
authorized representative(s) shall investigate the
complaint.
 The CHD Director or his/her authorized representative(s),
after investigation, shall suspend, cancel, or revoke for
a determined period of time the LTO of licensees who are
found violating the provision of R.A. 4688 or its
implementing rules, without prejudice to taking the case
to judicial authority for criminal action. The CHD shall seek
the assistance of any law enforcement agency to execute
the closure of any erring clinical laboratory, when
necessary.
WHO WILL INVESTIGATE THE COMPLAINT LODGED AGAINST A CLINICAL LABORATORY?
 The decision of the HFSRB/CHD may be appealed
to the Office of the Health Secretary within 10
days after receipt of the notice of the decision.
Thereupon, the HFSRB shall promptly certify and
file a copy of the decision, including all documents
and transcripts of hearings on which the decision is
based, with the Office of the Health Secretary for
review. The decision of the Office of the
Health Secretary is final and executory.
Penalty: Fine - P1,000.00 to
P5,000.00

Imprisonment – 1 month to 1
year
END OF 4688
 #1
 A.TRUE
 B.FALSE
THE SUPERVISORY AUTHORITY OF THE
PATHOLOGIST IS ENSHRINED UNDER R.A.
4689
 B. FALSE

ANSWER
 #2
 A. TRUE
 B. FALSE

THE LTO IS ISSUED IN THE NAME OF

THE LICENSEE AND IS
TRANSFERRABLE
 B. FALSE

ANSWER
 #3
 A. TRUE
 B. FALSE

THE LTO ISSUED TO A CLINICAL

LABORATORY IS VALID FOR 3 YEARS
 #4
 A. HFSRB
 B. CHD
 C. BOTH
 D. NEITHER
___________ SHALL BE IN 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 PROVISIONS IN RA 4688.
 A. HFSRB

ANSWER
 #5
 A.ONE STOP SHOP
 B. 1ST DAY OF OCTOBER UNTIL LAST DAY OF
NOVEMBER
 C.BOTH
 D. NEITHER

RENEWAL OF LICENSED TO
OPERATE (LTO) ON A NON-
HOSPITAL BASED IS:
 B. 1ST DAY OF OCTOBER UNTIL
LAST DAY OF NOVEMBER

ANSWER