October 24, 1988
ADMINISTRATIVE ORDER
No. 49–B series 1988
REVISED RULES AND REGULATIONS GOVERNING THE
REGISTRATION, OPERATION AND MAINTENANCE OF CLINICAL LABORATORIES IN THE
PHILIPPINES
Section 1
Title
These rules shall be known
as “Revised Rules and Regulation governing the registration, 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. 119 (Reorganization Act of the Ministry of Health).
Section 3
Purpose
These rules and
regulations are promulgated to protect the health of the people by preventing
the operation of sub–standard, improperly managed and inadequately supported
clinical laboratories and by improving the quality of the performance of
clinical laboratory examinations.
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 of all
samples of human or animal tissues, fluids, secretions, excretions,
radioactivity, or other material from the body for the determination of the
existence of pathogenic organisms, pathologic processes of conditions in the
person or animals from which such samples are obtained.
2. The following are
not governed by these rules and regulations:
(a) Government laboratories doing routine or minimum
laboratory examinations provided their services are declared as extensions of
covered government regional or central laboratories.
(b) Laboratories being used solely for academic training
and/or for purely research activities.
(c) Physicians doing only simple and routine examinations
(routine hematology, urinalysis, fecalysis and gram staining) for their own
patients only in their own clinics.
Section 5
Regulatory Authority
The Department of Health,
through the Bureau of Research and Laboratories in the Office for Standards and
Regulation, shall exercise the licensing and regulatory functions under these
rules and regulations.
Section 6
Classification of
Laboratories
1. For purpose of
function, clinical laboratories may perform any of all of the following:
(a) Clinical Pathology
(b) Anatomic Pathology
(c) Forensic Pathology
Clinical
Pathology: includes clinical chemistry, hematology, chemistry, microbiology,
parasitology, mycology, clinical microscopy, immunology and serology,
immunohematology and blood banking, radioisotope analysis and laboratory
endocrinology and similar disciplines
Forensic
pathology: includes all medico–legal examinations
2. For purposes of
institutional character, clinical laboratories, are either hospital
laboratories or free–standing (non–hospital) laboratories. Hospital
laboratories operate within a hospital; free standing laboratories operate on
its own or part of an activity other than a hospital.
3. For purposes of
services and level, clinical laboratories are either (1) primary; (2) secondary
or (3) tertiary category depending on the range of laboratory examinations they
perform and the presence of certain manpower, materials and facilities
required. The services required for each respective category of laboratory
shall be:
Primary
Category
(a) Routine hematology (CBC) – hemoglobin mass
concentration, erythrocyte volume fraction (hematocrit), leukocyte number
concentration (WBC) and leukocyte type number fraction (differential count)
(b) Routine urinalysis
(c) Routine fecalysis
(d) Gram staining
Secondary
Category
(a) Routine hematology, urinalysis, fecalysis and gram
staining
(b) Routine chemistry – blood glucose, urea, urate,
creatinine, cholesterol, total protein
(c) Blood typing and cross matching
Tertiary Category
(a) Routine hematology, urinalysis, fecalysis and gram
staining
(b) Routine chemistry
(c) Blood typing and cross matching, donor selection and
blood selection for transfusion
(d) Special chemistry
(e) Special hematology
(f) Culture and sensitivity for bacteria
4. The permit issued
shall clearly state or indicate the type (hospital or non–hospital, and
Category (Primary, Secondary or Tertiary) of the clinical laboratory and other
examinations permitted in addition to these enumerated as minimum requirements
under the category approved.
Section 7
Licensing
No clinical laboratory may
operate without a proper and valid issued by the Bureau of Research and
Laboratories
Section 8
Licensing requirements
(Technical standards)
1. All clinical
laboratories shall be required to demonstrate compliance with the following Technical
Standards as requirements to licensing:
(a) Proper and competent management by a physician,
licensed and duly registered with the Board of Medicine (PRC), qualified in
laboratory medicine and duly authorized by the Undersecretary of Health for
Standards and Regulation
(b) Adequate staffing by qualified and trained personnel
with at least one (1) medical technologist registered with the Board of Medical
Technology (PRC)
(c) Well ventilated, lighted, clean and safe physical
space sufficient to accommodate its activities
(d) Necessary equipment, furniture, glassware, reagents
and supplies to undertake the required services
2. The Bureau of
Research and Laboratories shall evaluate compliance with such technical
standards in accordance to minimum requirements for such category of laboratory
or additional tests applied for as may be promulgated under these rules and
regulations.
Section 9
Management of the
Clinical Laboratory
1. Head of the
Clinical Laboratory
The
head is the person who assumed technical and administrative supervision and
control of the activities in the laboratory.
For
all categories of clinical laboratories, the head shall be a licensed physician
certified by the Philippine Board of Pathology or both provided that:
(a) This shall be mandatory for all categories of free–standing
clinical laboratories; all tertiary category hospital laboratories and for all
secondary category hospital laboratories located in areas with the sufficient
available pathologists.
(b) This shall be voluntary for all primary category
hospital laboratories and secondary category of hospital laboratories in areas
where pathologists are not sufficient. For those hospital laboratories unable
to comply with the above requirements, they shall be headed by a licensed
physician with training of at least 3 months in laboratory medicine, quality
control and laboratory management and authorized by the Bureau of Research and
Laboratories.
2. A laboratory
providing clinical pathology and/or anatomic pathology service must have at
least one pathologist certified in the subspecialty offered as head or
associate.
3. A certified
pathologist is authorized to manage/supervise or be an associate in not more
than four (4) clinical laboratories/blood banks.
4. A physician under
Section 9.1 paragraph 2 may be authorized to head only one (1) hospital
laboratory.
5. Any change in the
head during the period covered by a valid license shall be reported in writing
to the Bureau of Research and Laboratories within 15 days after such change.
Section 10
Quality Control Tests
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 or these regulations, for the control of operations and as criteria
for the renewal of licenses.
Section 11
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 consultation reports and
shall bear the name of the Pathologist or his associate. No person in clinical
laboratory shall issue a report, orally or in writing whole or portions thereof
without a directive from the pathologist or his authorized associate and only
to the requesting physician or his authorized representative except in
emergencies when the results may be released as authorized by the pathologist.
Section 12
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 and succession number in addition to patient’s personal
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 (1) year provided the original report is on file in the
patient’s medical records. Records of anatomic and forensic pathology should be
kept permanently in the laboratory.
Section 13
Laboratory rates
The rates of laboratory
fee to be charged by a clinical laboratory for examination shall be within the
range of the usual rates 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 procedures or examination shall be rated separately and
not included in the laboratory rate.
Section 14
Basic license
requirements
Any person, firm or
corporation desiring to establish or operate and maintain a clinical laboratory
shall submit to the Bureau of Research and Laboratories a sworn
petition/application on the prescribed form containing among others the
following data:
1. Name, citizenship
and domicile of the Head of the Laboratory
2. Place,
municipality and province where it is to be established.
3. Name of
establishment
4. Name, citizenship
and domicile of the owner
5. Scope of the
nature of work to be undertaken
6. Statement duly
notarized 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.
If the applicant is a
partnership or corporation, the duly registered papers must be attached to the
corresponding petition.
Section 15
Application of License
1. Application shall
be filed by the owner or his duly authorized representative 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 with the Bureau
of Research and Laboratories for screening and approval.
2. Each petition
shall be signed under oath and affirmation by the applicant or a person duly
authorized to act for and in his behalf.
3. Upon receipt of
said application together with the license fee, an inspector of the Bureau of
Research and Laboratories shall inspect within 60 days the establishment and
verify if the applicant has complied with the requirements prescribed in these
regulations.
4. Any material or
false statement in the application or failure to comply with the requirements
may serve as basis for the Director of BRL to refuse recommending the issuance
of a license to operate a clinical laboratory.
Section 16
License fees
1. A non–refundable
fee shall be charged for every application for a license issued to open and
operate a clinical laboratory both government and private.
2. A non–refundable
fee is charged on application for renewal filed during three (3) months of each
year.
3. All fees shall be
payable to the Bureau of Research and Laboratories in accordance with the
following schedule
For
new licenses
Primary category P 200.00
Secondary category P 300.00
Tertiary category P 500.00
For
renewal of licenses
Primary category P 100.00
Secondary category P 150.00
Tertiary category P 250.00
4. A penalty of
P100.00 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
March 31.
5. After the fifth
month, un–renewed licenses shall be considered lapsed, and a new license shall
be applied for.
Section 17
Inspection
Clinical laboratories and
their facilities shall be subject to regular inspection and records made
available to determine compliance with above regulations
1. Each license
shall afford to give the Director of the Bureau of Research and Laboratories or
his duly authorized representative at any reasonable time opportunity to
inspect the premises and facilities wherein the laboratory examinations are
being processed.
2. Each license
shall make available to the Director of Bureau of Research and Laboratories or
his duly authorized representative for inspection, records kept by him pursuant
to those regulations.
3. The Director of
the BRL or his representative may be assisted by experts from professional
associations in such inspection.
4. Directors of
Regional Health Offices, Provincial, City and Municipal Health Officers are
hereby empowered to report the existence of unlicensed clinical laboratories or
any private party performing laboratory examinations without proper permit or
license and/or violations of these rules to the Bureau of Research and
Laboratories.
Section 18
Issuance of License
1. The license will
be issued, approved by the Undersecretary for Standards & Regulation if the
application is found to be meritorious and the license fees duly paid,
otherwise the same shall not be approved.
2. A provisional
license may be granted to hospital laboratories in areas where there are
insufficient pathologists while the Physician–in–charge is undergoing training
as provided in Section 9. The provisional license is granted only once and
valid for one (1) year.
(The
validity for only one year shall be enforced 3 years after promulgation of the
Revised Rules)
Section 19
Terms and Conditions of
License
1. It is emphasized
that the license is granted on the basis of specific circumstances, conditions
and limitations established during the inspection and defined by the issuance
of the license.
2. The license as
herein granted as well as any right under the license shall not be assigned or
otherwise transferred directly or indirectly to an unauthorized party
3. The owner or the
owner’s representative of any clinical laboratory desiring to transfer a
registered clinical laboratory to another place shall inform the Bureau of
Research and Laboratories in writing within 15 days after transfer has been
completed. The laboratory in its new location shall be subject to re–inspection
and should comply with these rules.
4. Any change
affecting the substantial conditions of the license to operate the laboratory
shall likewise be reported within 15 day in writing by the persons concerned to
the Bureau of Research and Laboratories for notation and approval. Failure to
do so will cause the revocation of the license of the clinical laboratory.
Section 20
Exhibition of
Certificate of Approval and License and the Rules and Regulations
The license of the
clinical laboratory must be placed in a conspicuous place within the laboratory
must likewise place his certificate of proficiency in the specialty. A copy of
the rules and regulation should be readily available for guidance of all staff
and personnel in the laboratory.
Section 21
Expiration
Each specific license
shall expire on the last day of December of the year stated herein, including
the authorization given to the head of the clinical laboratory
Section 22
Renewal
Application for renewal of
license shall be filled during the 1st three (3) months of the year
in accordance with Section 16. The Bureau of Research and Laboratories shall
process application for license renewal immediately upon receipt thereof
subject to inspection upon the discretion of the Director; provided, however,
that such clinical laboratory may continue operation during the pendency of the
final action on its application, unless otherwise revised or ordered by the
Director, BRL to cease operation.
Section 23
Publication of Licensed
Laboratories
1. A list of
licensed laboratories according to their categories shall be published
periodically and made available to any person, agency or organization for
legitimate purposes.
2. The results of
quality control tests shall likewise be published
Section 24
Modification and
Revocation of Licenses
The terms and conditions
of each license shall be subject to amendments or modification by means of
amendments to these regulations, as the Secretary of Health may deem necessary.
Any license may be revoked, suspended or modified in full or in part for any
false statement in the application as revealed by the statement of the
applicant, or as shown by the record of inspection or for a violation of, or
failure to observe any of the terms and provisions of these regulations. Except
in cases of willful, or repeated violations 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
investigations conducted.
Section 25
Violations
1. The license to
operate a clinical laboratory may be suspended or revoked by the Undersecretary
of Health for Standards and Regulation upon violation of R.A. 4688 or the rules
and regulations issued in pursuance thereto or the commission or operating a
clinical laboratory and the persons under their authority.
(a) Operation of a
Clinical Laboratory without a certified Pathologist or qualified licensed
physician authorized by the Undersecretary of Health or without employing a registered
medical technologist or employing a person not registered as a medical
technologist in such a position
(b) Change of
ownership, location, Head of Laboratory or personnel without informing the
Bureau of Research and Laboratories
(c) Refusal to allow
inspection of the laboratory by the persons authorized by the Bureau of
Research and Laboratories during reasonable hours;
(d) Refusal to
perform tests on quality control samples required by the Bureau of Research and
Laboratories
2. Any person who
operates a clinical laboratory without the proper license from the Department
of Health shall upon conviction be subject to imprisonment for not less than
one (1) month but not more than (1) year or a fine of not less than P1,000.00
and not more than P5,000.00 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 owners thereof shall be liable to the
penalty imposed herein.
Section 26
Investigation of
Charges of Complaints
Upon filing of a complaint
or charges duly sworn to by any person, interested party or corporation,
against a clinical laboratory or any of its personnel of an approved laboratory
have violated or are violating R.A. 4688 or the provisions of these
regulations, the Undersecretary of Health for Standards and Regulation or his
duly authorized representative(s) shall investigate the complaints or charges
and verify in the laboratory concerned or any of its personnel is guilty of the
charges. If upon investigation, a person or persons are found violating the
provisions of R.A. 4688 or any of these regulations, the Undersecretary of
Health for Standards and Regulation shall suspend for a definite or indefinite
period of time or cancel or revoke 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 27
Effectivity
These rules and
regulations shall take effect 15 days after its publication in the Official
Gazette, or in newspaper of general circulations and shall supersede all
issuances inconsistent thereof.
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