November 19, 2001
ADMINISTRATIVE ORDER
No. 59 series 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.
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
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.
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
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
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.
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, 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.
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
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
ANNEX A
The Clinical Laboratory
shall be organized to provide effective and efficient laboratory services.
I. STAFFING
1. The Clinical Laboratory shall be managed by a licensed
physician certified by the Philippine Board of Pathology.
In
areas where Pathologist are not available, a physician with three (3) months
training on clinical laboratory medicine, quality control and laboratory
management, may manage a primary/secondary category clinical laboratories. The
BHFS shall certify such training.
2. The clinical laboratory shall employ qualified and
adequately train personnel. Work assignment shall be consistent with the qualification
of the concerned personnel.
a. A clinical laboratory shall have sufficient number of
registered medical technologists proportional to the workload and shall
available at all times during hours of laboratory operations. For hospital–based
clinical laboratory, there shall be at least one registered medical
technologist per shift to cover the laboratory operation.
3. There shall be staff development and appropriate
continuing education program available at all levels of organization to upgrade
the knowledge, attitudes and skills of staff.
II. PHYSICAL
FACILITIES
1. The clinical
laboratory shall be well–ventilated, adequately lighted, clean and safe.
2. The working space
shall be sufficient to accommodate its activities and allow for smooth and
coordinated work flow.
3. There shall be an
adequate water supply.
4. The working space
for all categories of clinical laboratories (both hospital and non–hospital
based) shall have at least the following measurements:
Category space in sq.m.
Primary
10
Secondary 20
Tertiary
60
III. EQUIPMENT/INSTRUMENTS
1. There shall be
provisions for sufficient number and types of appropriate equipment/instruments
in order to undertake all the activities and laboratory examinations. This
equipment shall comply with safety requirements.
2. For other
laboratory examinations being performed, the appropriate equipment necessary
for performing such procedures shall be made available.
IV. GLASSWARES/
REAGENTS/SUPPLIES
All
categories of clinical laboratories shall provide adequate and appropriate glassware,
reagents and supplies necessary to undertake the required services.
V. WASTE
MANAGEMENT
There
shall be provisions for adequate and efficient disposal of waste following
guidelines of the Department of Health and the local government.
(copies
of which are available at respective CHDs and DOH – BHFS and local government
offices)
VI. QUALITY
CONTROL PROGRAM
All
clinical laboratories shall have a functional Quality Assurance Program
1. Internal
Quality Control Program
a. There shall be a
documented, continuous competency assessment program for all laboratory
personnel.
b. The program shall
provide appropriate and standard laboratory methods, reagents & supplies
and equipment.
c. There shall be a
program for the proper maintenance and monitoring of all equipment.
d. The program shall
provide for the use of quality control reference materials.
2. External
Quality Control Program
a. All clinical
laboratories shall participate in an External Quality Assurance Program given
by designated National Reference Laboratories and/or other recognized reference
laboratories.
b. A satisfactory
performance rating given by a National Reference Laboratory shall be one of the
criteria for the renewal of license.
c. Any refusal to
participate in an External Quality Assurance Program given by the designated
National Reference Laboratories shall be one of the bases for
suspension/revocation of the license of the laboratory.
VII. REPORTING
Laboratory
requests shall be construed as consultation between the requesting physician and
the Pathologist of the laboratory and as such laboratory results shall be
released accordingly.
1. All laboratory reports on various examinations of
specimens shall bear the name of the registered medical technologists and the
Pathologist and duly signed by both.
2. No person in the clinical laboratory shall issue a
report, orally or in writing, whole or portions, thereof without a directive
from the Pathologist or his authorized associate to the requesting physician or
his authorized representative except in emergency cases when the results may be
released as authorized by the Pathologist.
VIII. RECORDING
There
shall be a system of accurate recording to ensure quality results.
1. There shall be an
adequate and effective system of recording requests and reports of all
specimens submitted and examined.
2. There shall be
provisions for filing, storage and accession of all reports.
3. All laboratory
records shall be kept on file for at least one (1) year.
a. Records of
anatomic and forensic pathology shall be kept permanently in the laboratory.
IX. LABORATORY
FEES
The
laboratory and professional fees to be charged for laboratory examination shall
be at the prevailing rates.
1. The rates shall
be within the range of the usual fees prevailing at the time and the particular
place, taking into consideration the cost of testing and quality control of
various laboratory procedures.
2. Professional
services rendered to the patient in the performance of special procedures or
examinations shall be charged separately and not included in the laboratory
fee/s.
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