REYES, Jeanne Claire P.

September, 16, 2020

MMLS 2-1

Administrative Order No. 201 s. 1973

October 26, 1973
REVISED RULES AND REGULATIONS GOVERNING THE REGISTRATION,
OPERATIONS AND MAINTENANCE OF CLINICAL LABORATORIES IN THE
PHILIPPINES
Section 1
Purpose and Title
The Rules and Regulations published and enforced pursuant to Section 3 to Republic
Act 4688 approved on June 18, 1966 are hereby revised and shall be known as
“REVISED RULES AND REGULATIONS GOVERNING THE REGISTRATION IN THE
PHILIPPINES” and promulgated for the purpose of preventing the operation and
maintenance of substandard, improperly managed and poorly equipped clinical
laboratories.

Section 2
Scope
The promulgation embodied herein shall apply to any person, firm or corporation,
operating and maintaining clinical laboratories in which any of all of the following: body
fluids, tissues, secretions, excretions and radioactivity from human beings are analyzed
for the determination of the presence of pathogenic organisms, pathologic processes
and/or conditions of the persons from which they are obtained, provided that
government hospital laboratories doing routine or maximum laboratory examinations are
exempted if their services are declared as extensions of government regional or central
laboratories, and provided further that laboratories being used solely for academic
training and/or for purely research activities are likewise not herein covered.

Section 3
Basic licensure requirements
Any person, firm, or corporation desiring to establish or operate and maintain a clinical
laboratory shall submit to the Secretary of Health, thru the Bureau of Research and
Laboratories, a sworn petition/application, said form prepared and adopted therefore,
and containing among others the following data:
(1) The name, citizenship and domicile of the head of the laboratory;
(2) The place, municipality and province where it is to be established;
(3) The name of establishment
(4) The name, citizenship and domicile of the owner
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(5) Scope and nature of work to be undertaken (see Section 11–c)

(6) Statement that applicant has complied with all business requirements under other
existing laws or ordinances that are necessary in pursuance of the activity for which a
license is herein applied for
(7) A tax clearance for the preceding year

If the applicant is a partnership or corporation it must be duly registered under existing

laws, and that a copy of its registration papers to be attached to the corresponding
petition. An inspector of the Bureau of Research and Laboratories shall, upon receipt of
said application inspect within 60 days the establishment and verify if the applicant has
complied with the requirements prescribed in these regulations. The license will
henceforth be issued, signed and approved by the Secretary of Health, if the application
is found to be meritorious; otherwise the same shall be returned without action.

Section 4
License fees
A fee of one hundred pesos shall be charged for every license issued to open and
operate a clinical laboratory, payable to the Bureau of Research and Laboratories. This
license shall be subject to renewal within the last (2) months of each year upon payment
of a renewal fee of fifty pesos (P50.00). A grace period of (2) month is allowed for
renewal subject to a fine of ten pesos. Thereafter the license will be considered to have
lapsed and new license shall apply for. All government laboratories are exempted from
paying these fees.

Section 5
No Clinical Laboratory is allowed to operate without the proper license from the
Secretary of Health thru the Bureau of Research and Laboratories who are charged with
the responsibility of strictly enforcing the provisions of Republic Act No. 4688 and the
Rules herein promulgated.

Section 6
No person is permitted to manage, administer or supervise a clinical laboratory unless
he is physician, licensed and duly registered with the Board of Medical Examiners of the
Republic of the Philippines, qualified in laboratory medicine as stipulated in Section 7
(b) and duly authorized by the Secretary of Health, such authorization to be renewed
annually. This authorization shall be exempted of any fees.
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Section 7
Definition of Terms
(a) The term “Clinical Laboratories” shall mean to include any or all of the following:

(1) Clinical Pathology

(2) Anatomical Pathology
(3) Forensic Pathology

Clinical Pathology includes

(1) Clinical Chemistry

(2) Hematology
(3) Microbiology
(4) Clinical Microscopy
(5) Serology
(6) Immunohematology
(7) Blood Banking
(8) Radioisotope Laboratory
(9) Endocrine Laboratory

Anatomical Pathology includes Surgical Pathology; cytology and post–mortem

examination
Forensic Pathology includes all medico–legal examination

(b) “Head,” “Chief,” “Director” or “In–charge” of the laboratory should be a duly licensed
physician and registered with the Medical Board Examiners of the Philippines, and
qualified in laboratory medicine by having been certified by the Philippine Board of
Pathology, either in Anatomical Pathology, Clinical Pathology or both; provided that in
some areas where there are no Pathologists, the laboratory may be supervised by a
licensed physician with training in laboratory medicine as the Director of the Bureau of
Research and Laboratories may consider sufficiently adequate depending on the
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activities performed, and that he is authorized by the Secretary of Health as head or in–
charge of such laboratory.

(c) Personnel

(1) Associate Pathologist – a licensed physician and qualified in laboratory medicine a

certified by the Philippine Board of Pathology either in Anatomical Pathology, Clinical
Pathology or both who is under the direct supervision of the Head, Chief, Director or In–
Charge of a clinical laboratory.

(2) Pathology Assistant – a duly licensed physician and registered with the Philippine
Board of Examiners, with at least one (1) year training in laboratory medicine, and who
shall be under the direct supervision of the head.

(3) Medical Technologist – must be a licensed Medical Technologist duly registered in

the Board of Examiners for Medical Technology who shall be directly under supervision
of a registered Pathologist, or a licensed physician authorized by the Secretary of
Health as head of the laboratory in places where there are no Pathologist.

(4) Laboratory Technicians – must have completed at least two years of college work
with at least 12 units of laboratory subjects, and one year of training in an accredited
laboratory; or without college work but with at least ten years training and experience in
a duly approved clinical laboratory. The laboratory technicians will be under the
supervision of the medical technologists and under the over– all supervision of the head
of the laboratory or his associate or assistant.

(5) Laboratory aides – should be at least high school graduates and who shall assist the
medical technologists or laboratory technicians but whose activities should be limited to
non–technician procedures.

(d) “Equivalents” as used in Section 11 – this refers to equipment, supplies and

materials being used in the performance of a laboratory examination which are not the
same as those specified but could serve the purpose as well.
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Section 8
Interpretations
Except as specifically authorized by the Secretary of Health in writing, no interpretation
of the meaning of the regulations or its part by any officer or employee of the Office of
the Secretary of Health other than a written interpretation by the Secretary of Justice will
be recognized to be binding upon the Secretary of Health.

Section 9
Application for license shall be filed by the owner of his duly authorized representatives
in a form “Petition to Establish, Operate and Maintain a Clinical Laboratory” together
with the “Information Sheet” to be filled by the Physician–In–Charge, prepared for the
purpose, with the Bureau of Research and Laboratories for the necessary screening
and approval. Each petition shall be signed under oath on affirmation by the applicant or
a person duly authorized to act for and in his behalf.

Section 10
Terms and Conditions of License
Neither the license shall be assigned or otherwise transferred to an authorize party in
violation of the provisions of these regulations. Any owner, administration or any clinical
laboratory desiring to transfer the physical location of his registered clinical laboratory to
another place should inform in writing the Bureau of Research and Laboratories within
15 days after transfer has been completed. His laboratory in its new location shall be
subject to re-inspection and should comply with these rules. Any change in ownership
or change in head of the laboratory shall likewise be reported within 15 days in writing
by the persons concerned to the Bureau of Research and Laboratories for notation and
approval, failure to do so automatically revoke the license of the clinical laboratory.

Section 11
Requirements for a Clinical Laboratory
A. Personnel
Clinical Laboratories shall be under the direction and supervision of the head of the
laboratory. The employment of associate pathologists, pathology assistants, medical
technologists, laboratory technicians and laboratory aides is optional to the head of the
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laboratory; its number should depend on the needs and services of the laboratory.
However, a clinical laboratory must employ at least one (1) medical technologist.

A pathologist maybe authorized to manage and supervise and/or be an associate

pathologists not more than four (4) clinical laboratories and/or blood banks contiguously
located in the particular area. In localities without qualified pathologists, a licensed
physician as authorize under Section 7–b may head only one (1) clinical laboratory.

B. Physical Plant

1. A clinical laboratory should be situated in a place separate from any commercial or

non–medical establishment or residential quarters. It should be housed in a permanent
building constructed of strong materials, preferably concrete or semi –concrete, tiled or
linoleum finish.
2. The working space of the clinical laboratory of a hospital must correlate with the bed
capacity and type of hospital it serves as well as the services it offers to support the
needs of the medical care of the confined and out–patients of the hospital.
3. Adequate physical provisions for the safety of the laboratory personnel must be
provided for especially considering exposure to contamination to infectious materials
and obnoxious gases as well as dangers due to inflammable reagents and fires or
radioisotope substances.
4. If needed, provisions must be made for sleeping quarters separate form laboratory
area.
5. Laboratory space cannot be utilized as bleeding area or reception rooms for a blood
bank.

C. Minimum equipment and apparatuses

1. Basic equipment – all clinical laboratories in order to be given a license must at least
be provided with the following equipment:
(a) For clinical laboratories doing only routine examinations of stool, urine, blood,
sputum and other body fluids, blood grouping and matching, the following equipment or
their equivalents are required:
(1) Microscope with oil immersion lens and sub stage lamp
(2) Centrifuge, clinical
(3) Hemocytometer
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(4) Hemoglobinometer
(5) Urinalysis set
(6) Burner
(7) Stop watch
(8) Supplies as may be required including glassware and reagents

(b) If Chemistry examination is done, the following equipment or their equivalents are
required:

(1) Photometer or Spectrophotometer

(2) Burner
(3) Water bath
(4) Clinical sterilizer
(5) Small drying oven
(6) Refrigerator
(7) Interval timer
(8) Balances, analytical and rough
(9) Supplies as may be required including glassware, reagents and standards

(c) If bacteriologic examinations are done, the following equipment or their equivalents
are required:

(1) Autoclave
(2) Incubator
(3) Hot air oven
(4) Centrifuge
(5) Microscope
(6) Water bath
(7) Burner
(8) pH meter
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(9) Balances
(10) Supplies as may be required including glassware

(d) If serological examinations are done, the following equipment or their equivalents
are required:

(1) Water bath – 37 and 56 degrees centigrade

(2) Refrigerator
(3) Clinical instrument sterilizer
(4) Centrifuge
(5) Interval timer
(6) VDRL Rotator
(7) Supplies as may be required including glassware

(e) If pathological examinations are done, the following additional equipment or their
equivalents are required:

(1) Microtome set

(2) Microscope
(3) Paraffin oven
(4) Staining dishes
(5) Water bath
(6) Interval timer
(7) Supplies including glassware, reagents and stains as may be required

Clinical laboratories that will undertake examinations other than those mentioned above
but either than blood bank shall consult with the Bureau of Research and Laboratories
which shall prescribe the minimum requirements thereof.

Depending on the nature and scope of the work to be undertaken as grouped below, the
places of equipment and apparatus needed should be adequate to perform or all of the
following:
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(a) Routine test which include Urinalysis, Blood count, feces, blood grouping and
matching

(b) Routine blood chemistry which includes sugar, NPN, creatinine, urea, nitrogen, uric
acid, cholesterol, bilirubin, serum protein (quantitative) and special hematology

(c) Special biochemistry and serology which includes electrolytes, steroids, enzymes,
hormones, Widal, Khan, Kolmer and VDRL

(d) Bacteriology which includes smear and culture of blood, urine, sputum, vaginal and
conjunctival secretions

(e) Mycology which includes smears and cultures from clinical materials for isolation
and identification of pathogenic fungi

(f) Parasitology which includes protozoal and zoological diagnosis – detection and
determination of different species, genus, family and habitat of parasite

(g) Anatomic pathology which includes gross and microscopic examination of pathologic
specimens and necrosis; preparation of paraffin and frozen section and pathological
specimens and cytology

(h) Radioisotope examinations including determination of RAI and other isotope

compounds, tracing and scanning of body organs, etc.

The permits issued will clearly state the services authorized to operate or if limited
service, authorized specific tests allowed be specified.
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Section 12
Reporting
All laboratory requests shall be considered as consultations between the requesting
physician and the pathologist of the laboratory. As such all laboratory reports on various
examinations of human specimens shall be construed as consultations. No person
working in an approved clinical laboratory shall issue a report, orally or in writing or
portions thereof without the actual signature of the Pathologist of his authorized
associate or assistants, to the requesting physician or his authorized representative
except in emergencies when the results may be released as authorized by the
Pathologist.

Section 13
Recording
An adequate and effective system of recording all requests and reports of all human
specimens submitted to and examined in the laboratory should be maintained to include
provisions for filing, storage, indexing and accession number in addition to patient’s
personal and clinical information to prevent erroneous reporting and permit ready
identification and retrieving. All requests and reports in clinical laboratory shall be kept
on file for at least one year provided a duplicate copy is on file for the patient’s medical
records. Records of anatomic and forensic pathology should be kept permanently in the
laboratory.

Section 14
Laboratory fees
The rate of laboratory fees to be charges by clinical laboratory for examination shall be
within the range of the usual fees prevailing at the time and particular place taking into
consideration costs of production and quality control of various laboratory procedures.
Professional services rendered to the patient in the performance of special procedure of
examination shall be treated separately and not included in the laboratory fee.
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Section 15
Publicity
Publicity of approved laboratory should be within the normal, ethical and professional
concepts of acceptable medical practice. Only the name of the laboratory, address,
telephone number of the laboratory, pathologists and assistants and field of work
covered by the licensure shall appear on the letterhead and other information media.
Advertising matter should be directed exclusively to physician through recognized
professional bulletins or medical journals. No laboratory shall make advertisement on
medical pad, fictitious and unproven claim misleading statements and to advocate
directly or by any means of subterfuge unreliable and inconclusive laboratory
procedures which may prove detriment to patient care.

Section 16
Exhibition of Certificate of Approval and license and rules and regulations
The license of the clinical laboratory must be placed in a conspicuous place within the
laboratory. The physician–in–charge must likewise place his or her license and authority
together with his certificate of proficiency in the specialty in a prominent place in the
laboratory. A copy of the rules and regulations should be readily available for guidance
of all staff and personnel in the laboratory.

Section 17
Expiration
Each specific license shall expire on the last day of December of the year stated
therein, including the authorization given to the Head, Director or Physician–in–charge
of the clinical laboratory.

Section 18
Renewal
Application for renewal of license shall be filed in accordance with the preceding Section
3 & 4. The Bureau of Research and Laboratories shall process applications for license
or renewal immediately upon receipt thereof, provided, however, that such clinical
laboratory may continue operation during the pendency of the final action of their
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applications unless otherwise or ordered or advised by the Secretary of Health to cease

operation.

Section 19
Inspection
It shall be the duty of the Secretary of Health or his representative to conduct periodical
inspection of clinical laboratories

(1) Each license shall give the Secretary of Health or his duly authorized
representatives the opportunity at all reasonable time to inspect the premises and
facilities of the clinical laboratory.

(2) Each license shall make available all records kept him pursuant to those regulations
for inspection by the Secretary of Health of his authorized representatives.

(3) Directors of Regional Health Office, Provincial, city or municipal Health Officers are
required to report the existence of unlicensed clinical laboratories, and/or violations of
these rules to the Bureau of Research and Laboratories.

Section 20
Quality Control Test
The Director of the Bureau of Research and Laboratories or his representative is hereby
authorized to conduct such quality control tests as he deems appropriate or necessary
for the administration of these regulations for the control of operation.

Section 21
Modification and Revocation of Licenses
The terms and conditions of each license shall be subject to amendment for
modification by means of amendments to these regulations as the Secretary of Health
may deem fit to suit. Any license may be revoked, suspended or modified in full or in
part from any material false statement of the applicant, or as shown by the record of
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inspection which will serve as basis for the Secretary of Health to refuse issuance of
license on an original application or for violation of, or failure to observe any of the terms
and provisions of these regulation. Except in cases of willful or repeated violation hereof
or where public health interest or safety requires otherwise, no license shall be
modified, suspended, or revoked unless prior notice has been made and the
corresponding investigation conducted.

Section 22
Investigation of Charges or Complaint
Upon the filling of a complaint or charges duly sworn by any person interested party or
corporation, against a clinical laboratory or any of its personnel to the effect that one or
more of such personnel of an approved laboratory have violated or are violating R.A.
no. 4688 or the provisions of these regulations, the Secretary of Health or his duly
authorized representatives shall investigate the complaint or charge and verify if the
laboratory concerned or any of its personnel is guilty of the charges. If upon
investigations, a person or persons are found violating the provision of R.A. No. 4688 or
any of these regulations, the Secretary of Health shall cancel or revoke for a definite or
indefinite period of time the license of the laboratory and the authority of the offending
person or persons, without prejudice to taking the case to judicial authorities for criminal
action.

Section 23
Violations
Any person who violated any provisions of these rules and regulations shall be
punished with imprisonment for not less than one month but not more than one year or
a fine of not less than one month but not more than one year or a fine of not less than
one thousand pesos (P 1,000.00) but not more than five thousand (P5, 000.00) pesos,
or both such fine and imprisonment at the discretion of the court. Provided, however,
that if the offender is a firm or corporation, the managing head and/or owner thereof
shall be liable to the penalty imposed herein.

Section 24
Effectivity
These rules and regulations shall take effect upon approval and publication as required.
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REACTION ON Administrative Order No. 201 s. 1973 :

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Administrative Order No. 290 s. 1976

August 5, 1976
AMENDING SECTION II SUBSECTION A OF ADMINISTRATIVE ORDER NO. 201,
SERIES OF 1973 CONCERNING REQUIREMENTS FOR A CLINICAL LABORATORY

Section 1
The provision of Section II, Subsection a of Administrative Order No. 201 series of 1973
are hereby amended to read as follows:

Section II
Requirements for a Clinical Laboratory

A. Personnel

A Clinical Laboratory shall be under the direction and supervision of the hard of the
laboratory who possesses all the qualification required under these rules. In the
employment of associate pathologists, pathology assistants, medical technologists,
medical laboratory technicians and laboratory aides, the head of the laboratory must
observe the following:

1. Any clinical laboratory whether attached or unattached to a hospital or clinic

performing not more than 800 examinations a month should have at least one medical
technologist and for every additional 800 or fraction thereof, another medical
technologist should be hired.

2. In an automated laboratory the ration between the number of examinations

performed per month and the required number of medical technologist to be hired shall
be determined on a case to case basis by the Director of Bureau of Research and
Laboratories.

3. All medical technologists and medical laboratory technicians hired in the laboratory
should be registered with the Board of Medical Technology and should perform only
duties of the position for which they are hired. A medical technologist hired as a medical
technician must perform the duties of said position only. A medical laboratory
technician, may, however, perform the laboratory examinations within the specified
workload mentioned above provided that he or she should be under the direct
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supervision of a medical technologist hired as such, or a pathologist or physician–in–

charge as authorized by the Department of Health.

4. A medical technologist can supervise the work of two medical laboratory technician at
one time.

5. in clinics, with in–patients and hospitals with less than 50 beds, the physician–in –
charge of the laboratory may assume the responsibilities for covering the night duty in
the laboratory.

6. No medical laboratory technician may be assigned on duty at any time without a

medical technologist or physician– in–charge of the laboratory or pathologist to
supervise the work rendered.

A pathologist may be authorized to manage and supervise and/or be an associate

pathologist in not more than (3) clinical laboratories and/or blood banks contiguously
located in the particular area. In localities without qualified pathologist, a licensed
physician is authorized under Section 7 (b) may head only one (1) clinical laboratory.

Section 2

This amendment shall take effect upon approval and publication as required

CLEMENTE S. GATMAITAN, M.D., M.P.H

Secretary of Health
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REACTION ON Administrative Order No. 290 s. 1976

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Administrative Order No. 59 s. 2001

November 19, 2001
RULES AND REGULATION GOVERNING THE ESTABLISHMENT, OPERATION
AND MAINTENANCE OF CLINICAL LABORATORIES IN THE PHILIPPINES

Section 1
Title
This Administrative Order shall be known as the “Rules and Regulations Governing the
Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines.”

Section 2
Authority
These rules and regulations are issued to implement R.A. 4688: Clinical Laboratory
Law consistent with E.O. 102 series 1999: Redirecting the Functions and
Operations of the Department of Health. The Department of Health (DOH), through
the Bureau of Health Facilities and Services (BHFS) in the Health Regulation Cluster,
shall exercise the regulatory functions under these rules and regulations.

Section 3
Purpose
These rules and regulations are promulgated to protect and promote the health of the
people by ensuring availability of clinical laboratories that are properly managed with
adequate resources, with effective and efficient performance through compliance with
quality standards.

Section 4
Scope
1. These regulations shall apply to all entities performing the activities and functions of
clinical laboratories which shall include the examination and analysis of any or all
samples of human and other related tissues, fluids, secretions, radioactive, or other
materials from the human body for the determination of the existence of pathogenic
organisms, pathologic processes or conditions in the person from whom such samples
are obtained.
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2. These regulations do not include government laboratories doing laboratory

examinations limited to acid fast bacilli microscopy, malaria screening and cervical
cancer screening, provided their services are declared as extension of a licensed
government clinical laboratory.

Section 5
Classification of Laboratories
1. Classification by Function

a. Clinical Pathology – includes Hematology, Clinical Chemistry, Microbiology,

Parasitology, Mycology, Clinical Microscopy, Immunology and Serology,
Immunohematology, Toxicology and Therapeutic Drug Monitoring and other similar
disciplines.

b. Anatomic pathology – includes Surgical Pathology, Immunohistopathology,

Cytology, Autopsy and Forensic Pathology.

2. Classification by Institutional Character

a. Hospital–based laboratory – a laboratory that operates within a hospital.

b. Non–hospital–based laboratory – a laboratory that operates on its own.

3. Classification by Service Capability

a. Primary – provides the minimum service capabilities such as:

(1) Routine Hematology (Complete Blood Count or CBC) – includes Hemoglobin Mass

Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocyte Number
Concentration (WBC count) and Leucocyte Type Number Fraction (Differential Count),
Qualitative Platelet Determination
(2) Routine Urinalysis
(3) Routine Fecalysis
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(4) Blood typing – hospital based

(5) Quantitative platelet determination – hospital based

b. Secondary – provides the minimum service capabilities of a primary category and

the following:

(1) Routine Clinical Chemistry – includes Blood Glucose Substance Concentration,

Blood Urea Nitrogen Concentration, Blood Uric Acid Substance Concentration, Blood
Creatinine Concentration, Blood Total Cholesterol Concentration

(2) Cross matching

c. Tertiary – provides the secondary service capabilities and the following:

(1)   Special Chemistry
(2)   Special Hematology
(3)   Immunology/Serology
(4)   Microbiology

Section 6
Policies
1. An approved permit to construct and design lay–out of a clinical laboratory shall be
secured form the BHFS prior to submission of an application for a Petition to Operate.

2. No clinical laboratory shall be constructed unless plans have been approved and
construction permit issued by the BHFS.

3. A clinical laboratory shall operate with a valid license issued by BHFS/CHD, based on
compliance with the minimum licensing requirements (Annex A).

4. The clinical laboratory shall be organized and managed to provide effective and
efficient laboratory services.
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5. The clinical laboratory shall provide adequate and appropriate safety practices for its
personnel and clientele.

Section 7
Requirements and Procedures for application of Permit to Construct and License
to Operate
1. Application for Permit to Construct

The following are the documents required:

a. Letter of Application to the Director of BHFS

b. Four (4) sets of Sited Developmental Plans and Floor Plans approved by an architect
and/or Engineer.
c. DTI/SEC Registration (for private clinical laboratory)

2. Application for new license

A duly notarized application form “Petition to Establish, Operate and Maintain a Clinical
Laboratory”, shall be filed by the owner or his duly authorized representative at the
BHFS.

3. Application for renewal of license

A duly notarized application form “Application for Renewal of License to Establish,

Operate and Maintain a Clinical Laboratory” shall be filed by the owner or his duly
authorized representative at the respective CHD.

a. Renewal of License:

Application for renewal of license shall be filed within 90 days before the expiry date of
the license described as follows:
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Schedule of application for

Region
Renewal of License

NCR January to March

1,2,3 & CAR February to April
4,5 & 6 March to May
7,8 & 9 April to June
10, 11, 12, CARAGA & ARMM May to July

4. Permit and License Fees:

a. A non–refundable license fee shall be charged for application for permit to construct,
and for license to operate a government and private clinical laboratory.

b. A non–refundable fee shall be charged for application for renewal of license to
operate.

c. All fees shall be paid to the Cashier of the BHFS/CHD.

d. All fees shall follow the current prescribed schedule of fees of the DOH.

5. Penalties

a. A penalty of one thousand pesos (P1, 000.00) for late renewal shall be charged in
addition to the renewal fee for all categories if the application is filed during the next two
(2) months after expiry date.

b. An application received more than two (2) months after expiry date shall be fined one
hundred pesos (P100.00 for each month thereafter in addition to the P1, 000.00 penalty.
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6. Inspection

a. Each license shall make available to the Director of the BHFS/CHD or his duly
authorized representative(s) at any reasonable time, the premises and facilities where
the laboratory examinations are being performed for inspection.

b. Each license shall make available to the Director of the BHFS/CHD or his duly
authorized representative(s) all pertinent records.

c. Clinical laboratories shall be inspected every two (2) years or as necessary.

7. Monitoring

a. All clinical laboratories shall be monitored regularly and records shall be made
available to determine compliance with these rules and regulations.

b. The Director of the BHFS/CHD or his authorized representative(s) shall be allowed to

monitor the clinical laboratory at any given time.

c. All clinical laboratories shall make available to the Director of the BHFS or his duly
authorized representative(s) records for monitoring.

8. Issuance of License

The license shall be issued by the Director of the CHD or his authorized representative,
if the application is found to be meritorious.

9. Terms and conditions of License

a. The license is granted upon compliance with the licensing requirements.

b. The license is non–transferable.

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c. The owner or authorized representative of any clinical laboratory desiring to transfer a

licensed clinical laboratory to another location shall inform the CHD in writing at least 15
days before actual transfer.

d. The laboratory in its new location shall be subject to re–inspection and shall comply
with the licensing requirements.

e. An extension laboratory shall have a separate license.

f. Any change affecting the substantial conditions of the license to operate a laboratory
shall be reported within 15 days in writing by the person(s) concerned, to the
BHFS/CHD for notation and approval. Failure to do so will cause the revocation of the
license of the clinical laboratory.

g. The clinical laboratory license must be placed in a conspicuous location/area within

the laboratory.

Section 8
Violations
1. The license to operate a clinical laboratory shall be suspended or revoked by the
Secretary of Health upon violation of R.A. 4688 or the Rules and Regulations issued in
pursuance thereto.

2. The following acts committed by the Owner, President, Managers, Board of

Trustees/Director, Pathologist or its personnel are considered violations.

a. Operation of a clinical laboratory without a certified pathologist or without a registered

medical technologist.

b. Change of ownership, location, and head of laboratory or personnel without informing

the BHFS and/or the CHD.
REYES, Jeanne Claire P. September, 16, 2020
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c. Refusal to allow inspection of the clinical laboratory by the person(s) authorized by

the BHFS during reasonable hours.

d. Gross negligence.

e. Any act or omission detrimental to the public.

3. The Provincial, City and Municipal Health Officers are authorized to report to the CHD
and BHFS the existence of unlicensed clinical laboratories or any private party
performing laboratory examinations without proper license  and/or violations to these
rules and regulations.

Section 9
Investigation of Charges or Complaints
The BHFS/CHD or his duly authorized representative(s) shall investigate the complaint
and verify if the laboratory concerned or any of its personnel is guilty of the charges.

1. If upon investigation, any person is found violating the provision of R.A. 4688, or any
of these rules and regulations, the BHFS/CHD or his duly authorized representative(s)
shall suspend, cancel or revoke for a determined period of time the license, as well as
the authority of the offending person(s), without prejudice to taking the case to judicial
authority for criminal action.

2. Any person who operated a clinical laboratory without the proper license from the
Department of Health shall upon conviction be subject to imprisonment for not less than
1 month but not more 1 year or a fine of not less than P1, 000.00 and not more than P5,
000.00 and not more than P5, 000.00 or both at the discretion of the court. Provided,
however, that if the offender is a firm or corporation, the Managing Head and/or owner/s
thereof shall be liable to the penalty imposed herein.

3. Any Clinical Laboratory operating without a valid license or whose license has been
revoked/cancelled shall be summarily closed upon order issued by the BHFS/CHD or
his duly authorized representative. The BHFS/CHD may seek the assistance of the law
enforcement agency to enforce the closure of any clinical laboratory.
REYES, Jeanne Claire P. September, 16, 2020
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4. The closure order issued by the DOH shall not be rendered ineffective by any
restraining order and injunction order issued by any court, tribunal or agency or
instrumentalities.

Section 10
Modification and Revocation of License
1. A license maybe 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 a
violation of, or failure to comply any of the terms and conditions and provisions of these
rules and regulations.

2. No license shall be modified, suspended or revoked unless prior notice has been
made and the corresponding investigation conducted except in cases of willful, or
repeated violations hereof, or where public health interest or safety requires otherwise.

Section 11
Repealing Clause
These rules and regulations shall supersede all other previous official issuances hereof.

Section 12
Publication and List of Licensed Clinical Laboratories
A list of licensed clinical laboratories shall be published annually in a newspaper of
general circulation.

Section 13
Effectivity
These rules and regulations shall take effect 15 days after its publication in the Official
Gazette, or in a newspaper of general circulation.
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MANUEL M. DAYRIT
Secretary of Health
REACTION ON Administrative Order No. 59 s. 2001
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Administrative Order No. 2007 - 0027

August 22, 2007
REVISED RULES AND REGULATION GOVERNING THE LICENSURE
AND REGULATION OF CLINICAL LABORATORIES IN THE PHILIPPINES

I.     RATIONALE
One of the main thrusts of current health sector reforms under Formula One (F1)
for health is regulation. The main objective of regulatory reforms is to ensure
access to quality and affordable health products, devices, facilities and services,
especially those commonly used by the poor.

Physicians utilize laboratory work–ups in aid of diagnosis and management of

patients. Accuracy of laboratory results is important in assuring and improving
the quality of patient care. Republic Act No. 4688 s. 1966, “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”, mandated the DOH to look after public
welfare by effectively enforcing and updating the current regulations to improve
laboratory performance.

Advances in technology necessitate the need to update the minimum standards

and technical requirements for clinical laboratories. Current regulatory issuances
on this matter may no longer be relevant. One of these is Administrative Order
No. 59 s. 2001, entitled: “Rules and Regulations governing the Establishment,
Operation and Maintenance of Clinical Laboratories in the Philippines”. Thus, this
Order revises such issuance in order to ensure the quality of services of clinical
laboratories nationwide.

II.    OBJECTIVE
This Order is promulgated to prescribe a revised minimum standard for clinical
laboratories. This shall also ensure accuracy and precision of laboratory
examinations in order to safeguard public health and safety.

III. SCOPE AND COVERAGE

This Administrative order shall apply to all individuals, agencies, partnerships or
corporations that operate clinical laboratories in the Philippines performing
examinations and analysis of samples of tissues, fluids, secretions, excretions,
or other materials from the human body that would yield relevant laboratory
REYES, Jeanne Claire P. September, 16, 2020
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information, which physicians use for the prevention, diagnosis, and treatment of
diseases, and the management and promotion of personal and public health.

Government clinical laboratories, doing microscopy work only for specific DOH
programs such as but not limited to malaria screening, acid fast bacilli
microscopy, test for sexually transmitted infections, and cervical cancer
screening using Pap smears, shall be exempted from the provisions of this Order.

IV.   DEFINITION OF TERMS

For purposes of this Order, the following terms and acronyms shall have the
following definition:

1. Applicant – a natural or juridical person who intends to operate a clinical

laboratory

2. BHFS – acronym for the Bureau of Health Facilities and Services

3. CHD – acronym for the Center for Health Development

4. Clinical laboratory – a facility where tests are done on specimens form the
human body to obtain information about the health status of a patient for the
prevention, diagnosis and treatment of diseases. These tests include, but are not
limited to, the following disciplines: clinical chemistry, hematology,
immunohematology, microbiology, immunology, clinical microscopy,
histopathology, cytology, toxicology, endocrinology, molecular biology, and
cytogenetics. Other functions of the clinical laboratory are to provide consultative
advisory services covering all aspects of laboratory investigations. Facilities that
are involved in the pre–analytical processes, such as the collection, handling or
preparation of specimens, or act as a mailing or distribution center, such as in a
laboratory network or system are also considered to be a part of a clinical
laboratory. The total testing process includes pre–analytical, analytical and post–
analytical procedures.

5. 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.
REYES, Jeanne Claire P. September, 16, 2020
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6. DOH – acronym for the Department of Health

7. EQAP – acronym for External Quality Assessment Program. It is a program

where participating laboratories are given unknown samples for analysis. These
samples are to be treated as ordinary human specimens for the usual processing
and examination. The quality of performance of the laboratory shall be assessed
through the closeness of its results to be pre–determined value or to the
reference value generated by the participating laboratories through peer group
analysis.

8. Inspection tool – the checklist used by the regulatory officers during inspection
visit(s) to evaluate compliance of a clinical laboratory to the minimum standards
and technical requirements.

9. Institution – a corporate body or establishment organized for an educational,

medical, charitable or similar purpose.

10. License – the document issued by the DOH to an individual, agency,

partnership or corporation that operates a clinical laboratory upon compliance
with the requirements set forth in this Order.

11. Licensee – the individual, agency, partnership or corporation to whom the

license is issued and upon who rests compliance with this Order.

12. LTO – acronym for License to Operate. It also refers to the license.

13. Mobile Clinical Laboratory – a laboratory testing unit that moves from testing
site to another testing site, or has a temporary testing location. It shall have a
base laboratory.

14. Monitoring Examinations – tests done in series on patients as a guide for

treatment or follow–up of their condition.

15. NRL – acronym for the National Reference Laboratory. It is a laboratory in a

government hospital which has been designated by the DOH to provide special
functions and services for specific disease areas. These functions include
REYES, Jeanne Claire P. September, 16, 2020
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provision of referral services such as confirmatory testing, surveillance,

resolution of conflicting results between or among laboratories; training;
research, implementation of EQAS; evaluation of diagnostic kits and reagents. An
NRL may or may not be part of a general clinical laboratory.

16. POL – acronym for Physician’s Office Laboratory. It is an individual doctor’s

office/clinic wherein laboratory examinations are performed.

17. POCT – acronym for Point of Care Testing. It is a diagnostic testing at or near

the site of patient care rather than in the clinical laboratory. It includes bedside
testing, outpatient and home care.

18. Routine Tests – the basic, commonly requested tests in the laboratory, the
results of which are not required to be released immediately upon completion. It
shall follow the usual procedures and system in the laboratory.

19. Satellite Testing Site – any testing site that performs laboratory examinations
under the administrative control of a licensed laboratory, but performed outside
the physical confines of that laboratory.

20. STAT Tests – tests done on urgent cases, the results of which shall be
released immediately, within one (1) hour after the procedure. STAT is an
abbreviation “sta’tim” which means immediately.

V.    CLASSIFICATION OF CLINICAL LABORATORIES

A. Classification by Ownership

1. Government – operated and maintained, partially or wholly, by the national

government, a local government unit (provincial, city or municipal), any other
political unit or any department, division, board or agency thereof

2. Private – owned, established and operated by any individual, corporation,

association or organization

B. Classification by Function
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1. Clinical Pathology – includes Clinical Chemistry, Hematology,

Immunohematology, Microbiology, Immunology, Clinical Microscopy,
Endocrinology, Molecular Biology, Cytogenetics, Toxicology and Therapeutic
Drug Monitoring and other similar disciplines

2. Anatomic Pathology – includes Surgical Pathology, Immunohistopathology,

Cytology, Autopsy, Forensic Pathology and Molecular Pathology

C. Classification by Institutional Character

1. Institution Based – a laboratory that operates within the premises and as part
of an institution, such as but not limited to hospital, medical clinic, school,
medical facility for overseas and seafarers, birthing home, psychiatric facility,
drug rehabilitation center

2. Freestanding – a laboratory that does not form part of any other institution

D. Classification by Service Capability

1. General Clinical Laboratory

(a) Primary Category – provides the following minimum service capabilities:

(1) Routine Hematology [Complete Blood Count – includes Hemoglobin Mass

Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocyte Number
Concentration (White Blood Cell or WBC count) and Leucocyte Number Fraction
(Differential count)
(2) Qualitative Platelet Determination
(3) Routine Urinalysis
(4) Routine Fecalysis
(5) Blood typing – for hospital based
REYES, Jeanne Claire P. September, 16, 2020
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(b) Secondary Category – provides the minimum service capabilities of a primary

category laboratory plus the following:

(1) Routine Clinical Chemistry – includes Blood Glucose Substance

Concentration, Blood Urea Nitrogen concentration, Blood Uric Acid Substance
Concentration, Blood Creatinine Concentration, Blood Total Cholesterol
Concentration
(2) Quantitative Platelet Determination
(3) Cross matching – for hospital based
(4) Gram Staining – for hospital based
(5) KOH – for hospital based

(C) Tertiary Category – provides the minimum service capabilities of a secondary

category laboratory plus the following:

(1) Special Chemistry
(2) Special Hematology, including coagulation procedures
(3) Immunology
(4) Microbiology – culture and sensitivity

· Aerobic and anaerobic (for hospital and non–hospital based)

A clinical laboratory, licensed under any of the above category, shall be permitted
to offer laboratory services other than the respective stipulated minimum
services, provided that, they comply with the requirements with respect to staff,
equipment, reagents and supplies for such additional services, provided further,
that such additional services are listed under its LTO.

(d) Limited Service Capability (for institution–based only) – provides the

laboratory tests required for a particular service in institutions such as but not
limited to dialysis centers and social hygiene clinics.

2. Special Clinical Laboratory

REYES, Jeanne Claire P. September, 16, 2020
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A laboratory that offers highly specialized laboratory services that are usually not
provided by a general clinical laboratory.

VI.   GUIDELINES
A. 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 laboratories that are not subject to the provisions of other
administrative orders, such as but not limited to, Assisted Reproduction
Technology Laboratories, Molecular and Cellular Technology, Molecular Biology,
Molecular Pathology, Forensic Pathology, Anatomic Pathology laboratories
operating independent of a clinical laboratory are required to register with the
BHFS without being licensed under the provisions of this Order. Such procedure
shall subsist until the appropriate regulation for such purpose is subsequently
promulgated. A pathologist or a licensed physician who is trained in the
management, principles and methodology of the specialized services that are
being provided shall head this type of laboratory.

4. The NRL designated by the DOH shall be covered by the license of the clinical
laboratory of the hospital where they are respectively assigned. The NRL that is
physically independent from the clinical laboratory of the hospital where they are
respectively assigned shall be allowed to register only with the BHFS, provided
that, they are duly accredited or certified by an international accrediting or
certifying body, such as but not limited to, the Center for Disease Control of the
U.S.A. and the World Health Organization and/or local accrediting or certifying
body recognized by the DOH.

5. A POL is required to secure a clinical laboratory license when it undertakes any
or all of the following activities:

(a) Issue official laboratory results;

REYES, Jeanne Claire P. September, 16, 2020
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(b) Perform more than monitoring examinations; and

(c) Cater not only to the Physician’s own patients

Examinations performed in a POL shall only be permitted when they are used for
monitoring patients.

6. A POCT, conducted in a hospital, is required to be under the management and

supervision of the licensed clinical laboratory of the respective hospital.

B. SPECIFIC GUIDELINES

1. Standards

Every clinical laboratory shall be organized to provide quality, effective and

efficient laboratory services.

(a) Human Resource

(1) 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.

(2) The head of the laboratory shall have administrative and technical supervision
of the activities in the laboratory.

(3) The head of the laboratory shall supervise the staff in accordance to the
standards set by the Philippine Society of Pathologists.

(4) 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.
REYES, Jeanne Claire P. September, 16, 2020
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(5) 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

(1) There shall be available and operational equipment to provide the laboratory

examinations that the laboratory is licensed for.

(2) There shall be a calibration, preventive maintenance and repair program for

the equipment.

(3) There shall be a contingency plan in case of equipment breakdown.

(c) Glassware, Reagents and Supplies

(1) There shall be available reagents, glassware and supplies for the laboratory
examinations to be provided.

(2) There shall be an inventory control of the reagents, glassware and supplies.

(3) The reagents, glassware and supplies shall be stored under the required
conditions.

(d) Administrative Policies and Procedures – The clinical laboratory shall have

written policies and procedures for the provision of laboratory services and for
the operation and maintenance of the laboratory.

(e) Technical Procedures – there shall be documented technical procedures for

services provided in each Section of the laboratory, which will ensure the quality
of laboratory results.

(f) Quality Assurance Program

REYES, Jeanne Claire P. September, 16, 2020
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(1) There shall be an Internal Quality Assurance Program which shall include:

I.      An Internal Quality Control Program for technical procedure

Ii.     An Internal Quality Assurance Program for inputs, processes and outputs
iii.    A Continuous Quality Improvement Program covering all aspects of
laboratory performance.

(2) The clinical laboratory shall participate in an EQAP administered by

designated NRL or in other local and international EQAP approved by the DOH.

(g) Communication and Records

(1) There shall be procedures for the receipt and performance of routine and
STAT requests for laboratory examinations.

(2) There shall be procedures for the reporting of results of routine and STAT
laboratory examinations, including critical values that would impact on patient
care.

(3) All laboratory reports on various examinations of specimens shall bear the

name of 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.

(4) There shall be procedures for the reporting of workload, quality control,

inventory control, work schedule and assignments.

(5) There shall be procedures for the reporting and analysis of incidents, adverse
events and in handling complaints.

(6) The retention of laboratory records shall be in accordance to the standards

promulgated by the DOH or by competent authorities for such purposes.
REYES, Jeanne Claire P. September, 16, 2020
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(h) Physical Facilities/Work Environment

(1) The clinical laboratory shall conform to all applicable local and national
regulations for the construction, renovation, maintenance and repair of clinical
laboratories.

(2) The laboratory shall conform to the required space for the conduct of its
activities.

(3) There shall be well–ventilated, lighted, clean, safe and functional areas based
on the services provided.

(4) There shall be a program of proper maintenance and monitoring of physical

plant and facilities

(5) There shall be procedures for the proper disposal of waste and hazardous
substances.

(6) There shall be policy guidelines on laboratory biosafety and biosecurity.

(I) Referral of Examinations outside of the Clinical Laboratory – when laboratory

examinations are referred to and provided by an outside laboratory, the head of
the referring clinical laboratory shall obtain assurance of the quality of services
provided through a Memorandum of Agreement or its equivalent with a licensed
clinical laboratory performing the laboratory services needed.

2. LTO (License to Operate)

(a) The LTO is issued in the name of the licensee and is non–transferable,

whether voluntarily and involuntarily, through sale, assignment or any other
means. The license is not valid for any premise/location other than that which is
stipulated therein.
REYES, Jeanne Claire P. September, 16, 2020
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(b) The LTO is issued to a clinical laboratory, unless sooner suspended or

revoked, is valid for one year and expires on the date set forth by the CHD, as
stipulated on the face of the license.

(c) The LTO issued to a non–hospital based clinical laboratory shall specifically

stipulate the following: name of the clinical laboratory, name(s) of the owner or
operator, head of the laboratory, service capability, period of validity, license
number, and location wherein the laboratory procedures are to be performed.

(d) The LTO issued to a non–hospital based clinical laboratory must be displayed

at all time at a prominent place within the laboratory premises.

(e) Hospital based clinical laboratories shall be licensed as part of the hospital

through the One–Stop–Shop Licensure for Hospitals and are therefore not
required to obtain a separate license.

(f) The capability to perform HIV testing and/or drinking water analysis shall be
specifically indicated in the LTO, as issued by the CHD.

(g) The clinical laboratory and its satellite services within the same compound
shall have one (1) LTO.

(h) A satellite laboratory outside the premises where the central laboratory is
situated shall be required to secure a separate LTO.

(I) Mobile clinical laboratories shall be licensed as part of the main clinical

laboratory and shall be permitted to collect specimens only. It shall be allowed to
operate only within one hundred (100) km radius from its main laboratory.

(j) 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 of, or failure to comply with any of the terms and conditions and
provisions of these rules and regulations.

VII. PROCEDURAL GUIDELINES
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A.Registration for Special Clinical Laboratories, National Reference Laboratories,

Research and Teaching Laboratories

1. Applicants can acquire the prescribed Application Form for Registration from
the BHFS, CHD that has jurisdiction over the existing or proposed clinical
laboratory or at the DOH website (www.doh.gov.ph).

2. The accomplished form together with the necessary attachments is to be

submitted to the BHFS or through 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 Certificate of Registration upon submission of the
accomplished form and documentary requirements.

3. The BHFS shall evaluate and accept applications based on due execution of
forms and completeness of attachments.

B.Procedures for Application for Initial/Renewal of LTO

1. Applicants can acquire the prescribed application form for LTO form the BHFS,
CHD that has jurisdiction over the existing or proposed clinical laboratory, or at
the DOH website (www.doh.gov.ph).

2. 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.

3. 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

1. Renewal of hospital based clinical laboratories shall be in accordance with the

licensing process under the One–Stop–Shop Licensure System for Hospitals.
REYES, Jeanne Claire P. September, 16, 2020
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2. 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 filed during this period.

3. Renewal of license for compliant clinical laboratories shall be processed not

later than five (5) working days after the expiration date of its license.

4. The LTO of a clinical laboratory shall be automatically cancelled without notice

when it fails to submit a duly accomplished application form and to pay the
proper fee on or before the expiration date stated in its license.

D. Inspection

1. The CHD shall conduct an announced licensure inspection at any reasonable

time.

2. The licensee shall ensure the accessibility of the premises and facilities where
the laboratory examinations are being performed for the inspection of the CHD
Director or his authorized representative(s) at any reasonable time.

3. The licensee shall ensure the availability of all pertinent records for
checking/review of the CHD Director or his authorized representative(s).

4. An inspection tool, which prescribed the standards, criteria and technical
requirements for the issuance of LTO, shall be utilized.

E. Monitoring

1. All clinical laboratories shall be monitored regularly.

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2. The BHFS or the CHD Director or his authorized representative(s) shall monitor
clinical laboratories through monitoring visits to the laboratory at any reasonable
time.

3. All clinical laboratories shall ensure that all laboratory records, premises and
facilities are made available to the BHFS or the CHD Director or his authorized
representative(s) in order to determine compliance with the provisions of this
Order.

4. A Notice of Violation for non–compliant clinical laboratories shall be issued

immediately after monitoring the clinical laboratory.

5. The CHD concerned shall submit a quarterly summary of the violations to the
BHFS stating the name of the clinical laboratory, location, its corresponding
violation and the course of action taken.

6. The Provincial, City and Municipal Health Officers are enjoined to report to the
BHFS /CHD the existence of unlicensed clinical laboratories or any private party
performing laboratory examinations without proper license and/or violations to
these rules and regulations.

VIII. SCHEDULE OF FEES
A. A non–refundable fee shall be charged for the initial application /renewal of
license to operate a clinical laboratory, either government or private.

B. All fees/checks shall be paid to the order of DOH in person or through postal
money order.

C. All fees, surcharges and discounts shall follow the current DOH prescribed
schedule of fees.

IX.   VIOLATIONS
Violation of Republic Act 4688 or these rules and regulations and/or commission
of the following acts by personnel operating the clinical laboratory under this
authority shall be penalized:
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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;

E. Deviation 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 of results of tests done in an outside 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;
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L. Giving and receiving any commission, bonus, kickback or rebate or engaging

in a split–fee arrangement in any form whatsoever with any facility, physician,
organization, agency or person, either directly or indirectly, for patients referred
to a clinical laboratory licensed by the DOH.

X.    INVESTIGATION OF COMPLAINTS

A. the BHFS or the CHD Director or his authorized representative(s) shall
investigate the complaint and verify if the laboratory concerned or any of its
personnel is accountable for an alleged violation.

B. the CHD Director or his 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 this Order, 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.

XI.   PENALTY
Any person who operates a clinical laboratory without the proper license from the
DOH shall upon conviction be subject to imprisonment for not less than one (1)
month or a fine of not less than PhP 1,000.00 and not more than Php 5,000.00 or
both at the discretion of the court. Provided, however, that if the offender is a firm
or corporation, the managing head and/or owner(s) thereof shall be liable to the
penalty imposed herein.

XII. APPEAL
The decision of the BHFS/CHD may be appealed to the Office of the Health
Secretary within ten (10) days after receipt of the notice of the decision.
Thereupon, the BHFS 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.

XIII. REPEALING CLAUSE
Provisions from previous issuances that are inconsistent or contrary to the
provisions of this Order are hereby rescinded and modified accordingly.
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XIV. SEPARABILITY CLAUSE
In the event that any provision or part of this Order be declared unauthorized or
rendered invalid by any court of law or competent authority, those provisions not
affected by such declaration shall remain valid and effective.

XV. EFFECTIVITY
This Order shall take effect fifteen (15) days after its approval and publication in
the Official Gazette or newspaper of general circulation

FRANCISCO T. DUQUE III, M.D., MSc

Secretary of Health
REYES, Jeanne Claire P. September, 16, 2020
MMLS 2-1

REACTION ON Administrative Order No. 2007 - 0027