October 26, 1973
ADMINISTRATIVE ORDER
No. 201 series 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)
(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
(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
(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.
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 reinspection 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.
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 substage 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:
(1) Photometer or Spectrophotometer
(2) Burner
(3) Waterbath
(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)
Waterbath
(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) Waterbath – 37 and 56 degrees centrigrade
(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) Waterbath
(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
(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.
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.
Section 16
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.
(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 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.
CLEMENTE S. GATMAITAN,
M.D, M.P.H.
Secretary of Health
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