VELA, CHRISTINE JANE V.

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
(5) Scope and nature of work to be undertaken (see Section 11–c)
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(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.

Section 7
Definition of Terms
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(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 activities performed, and that he is authorized by the
Secretary of Health as head or in–charge of such laboratory.

(c) Personnel
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(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.

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.
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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 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.
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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
(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:
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(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
(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
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(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:

(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
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(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.

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.
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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.

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.
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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 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.
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(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 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
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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:

Revised rules and regulations governing the registration, operations, and maintenance of
clinical laboratories in the Philippines stated in Administrative Order No. 201 s. 1973 main
purpose is to ensure that the laboratories company here in the Philippines are securing their
respective machine and equipment’s up to date. For me, this revised law is very good because its
stated very clearly from what are needed personnel and their qualifications, machines needed to
operate the laboratories, tax that the companies or firm needed to pay every year, what licensed
needed to operate the firm or companies and also the violations from this law.
Overall this law will help many people or patients to put their mind to ease because this
law can ensure that every equipment they used to them is fully updated and maintain and also the
personnel that will help them is fully equip with knowledge and experience in their line of works
because law stated that the personnel that will used the equipment must have a one year
experience in their works.
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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 supervision of a medical technologist hired as such, or a pathologist or
physician–in–charge as authorized by the Department of Health.
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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

Administrative Order No. 290 s. 1976 clearly stated the requirements for the clinical
laboratories to fully operate in terms of their personnel. The requirements must be followed to
ensure the safety of the patients in their laboratories. For me this is understandable because next
to equipment the personnel must be good and fully known to what their doing. Like for example
the personnel must be approved or registered by 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 supervision of a medical
technologist hired as such, or a pathologist or physician–in–charge as authorized by the
Department of Health.
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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
(4) Blood typing – hospital based
(5) Quantitative platelet determination – hospital based
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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.

5. The clinical laboratory shall provide adequate and appropriate safety practices for its
personnel and clientele.
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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:

Region
Schedule of application for
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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.

6. Inspection
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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.

c. Refusal to allow inspection of the clinical laboratory by the person(s) authorized by the BHFS
during reasonable hours.

d. Gross negligence.
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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.

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
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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.

MANUEL M. DAYRIT
Secretary of Health
REACTION ON Administrative Order No. 59 s. 2001
Administrative Order No. 59 s. 2001 stated that the clinical laboratories must have proper
and adequate resources and equipment in their respective laboratories that can comply with
quality standard to ensure the safety of the patients. This law also stated the difference of the
laboratories to classification by functions, classifications by Institutional Character and
Classification by service capability. It also stated the renewal of the license and their respective
region and their penalties or violations to this law.
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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

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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 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.
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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 provision of referral services
VELA, CHRISTINE JANE V. September 16, 2020
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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

(b) Secondary Category – provides the minimum service capabilities of a primary category

laboratory plus the following:
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(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

A laboratory that offers highly specialized laboratory services that are usually not provided
by a general clinical laboratory.
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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;

(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.
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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.

(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
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(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

(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.
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(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.

(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.
VELA, CHRISTINE JANE V. September 16, 2020
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(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.

(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.
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(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
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.
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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.

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.
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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.

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
VELA, CHRISTINE JANE V. September 16, 2020
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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:

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;

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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;

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
VELA, CHRISTINE JANE V. September 16, 2020
MMLS 2-1

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.

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
VELA, CHRISTINE JANE V. September 16, 2020
MMLS 2-1

REACTION ON Administrative Order No. 2007 – 0027

Administrative Order No. 2007 – 0027 focused on the public health and safety its also
ensure access to quality and affordable health products, devices, facilities, and services,
especially those commonly used by the poor. This law stated the laboratories must have a proper
licensed to operate which also includes their personnel and staffs. Also, this law stated that the
clinical laboratories must attend any event that the DOH specified or ordered to them and when
the clinical laboratories cannot attend the must have a proper punishment to the violations. This
law also stated that the renewal of LTO must be do in beginning on the first day of October until
the last day of November of the current year whether you are hospital based or Non-hospital
based.
For me this revised law is very good in terms of public safety and it ensure the patients
particularly the poor because this law stated or 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.