January 2, 1989
Administrative Order
No. 55–A series 1989
RULES AND REGULATION GOVERNING THE ACCREDITATION OF
LABORATORIES PERFORMING HIV TESTING
Section 1
Title
These rules and
regulations shall be known as the “Rules and regulations governing the
accreditation of laboratories of laboratories performing HIV testing”
Section 2
Authority
These rules and
regulations are issued in accordance to R.A. 4688 (Clinical Laboratory Law)
and R.A. 1517 (Blood Bank Law) consistent with E.O. 119
(Reorganization Act of the Ministry of Health).
Section 3
Purpose
These rules and
regulations are promulgated to protect and promote the health of the people by regulating
the performance and assuring the quality of HIV testing in laboratories and
blood banks licensed according to the implementing rules and regulation of R.A.
4688 and R.A. 1517
Section 4
Scope
The regulation embodied
herein shall apply to any person, corporation, laboratory or blood bank
performing or seeking to perform HIV testing to the Philippines for the public,
for diagnostic or public health purposes. HIV testing shall include the
determination of the presence of antibody, antigen/protein, viral particles in
a clinical specimen indicating infection by Human Immunodeficiency Virus (HIV)
Section 5
Regulatory Authority
The accreditation of HIV
Testing Laboratories/Blood Banks under these rules and regulations shall be
exercised by the Department of Health through the Bureau of Research and
Laboratories in the Office for Standards and Regulations
Section 6
Laboratory Procedure
Requiring Accreditation
1. Any of the
following laboratory procedure shall require accreditation as a HIV Testing
Laboratory:
(a) Screening test for HIV antibody
(1) Enzyme Immunoassay (EIA)
(2) Particle Agglutination
(3) Others
(b) Supplemental (Confirmatory) Tests for HIV antibody
(1) Western Blot
(2) Immunofluorescence
(3) Radioimmunoprecipitation assay
(4) Others
(c) Other laboratory procedures such as testing for HIV
antigen, culture of HIV, etc.
2. No laboratory
shall be allowed to perform HIV testing without accreditation by the Department
of Health through the Bureau of Research and Laboratories.
3. No HIV clearance
certificate shall be authenticated by the DOH unless the laboratory procedure
has been performed by a laboratory accredited in accordance to these rules and
regulations.
Section 7
Accreditation
requirements for HIV Testing Laboratory
(Technical Standards)
1. All clinical
laboratories or blood banks shall be required to demonstrate compliance with
the following Technical Standards as a requirement of accreditation:
(a) The clinical laboratories or blood bank shall be duly
licensed by the Bureau of Research and Laboratories
(b) The laboratory shall be headed by and under the
direction and supervision of a duly licensed physician who is certified by the
Philippine Board of Pathology or Philippine Board of Hematology and Blood
Transfusion
(c) The laboratory shall be staffed by medical
technologists duly registered with the Board of Medical Technology, who have
undergone acceptable training in HIV Testing duly certified by a training
laboratory.
(d) The physical plant shall be housed in well–lighted and
ventilated, dust–free areas with an adequate supply of water. The space
appropriately furnished, should be sufficient to accommodate the activities
needed for HIV Testing.
(e) Equipment, glassware and supplies
The
HIV Testing Laboratory shall have the appropriate equipment, glassware and
other supplies needed for HIV Testing.
(f) Reagents
The
laboratory shall utilize reagents, such as HIV kits, which have been registered
with the Bureau of Food and Drugs (BFAD)
(g) Report Forms
The
report forms should be clear, objective and indicate the type of HIV kit
(brand/manufacturer) utilized
2. The Bureau of
Research and Laboratories shall evaluate compliance with such technical
standards in accordance to requirements as may be promulgate under these Rules
and Regulations.
Section 8
Reporting
Each HIV testing
laboratory shall report monthly the number of tests done results and referrals
of seroreactive samples in accordance with the format prescribed by the Bureau
of Research and Laboratories. The report shall be accompanied by Xerox copies of
invoices of purchases of HIV kits the previous month.
Section 9
Referral of Seroactive
Serum samples
1. All serum samples
reactive in screening tests (EIA or PA) by private laboratories shall be
referred to the Research Institute of Tropical Medicine for confirmation.
2. All serum samples
reactive in screening test (EIA or PA) by government laboratories shall be
referred to the Bureau of Research and
Laboratories for confirmation.
3. The name, age,
sex and addresses of persons confirmed to be seropositive (by WB/IF/RIPA) shall
be reported to AIDS registrar, Health Intelligence Service, DOH in accordance
to Department Circular 11, series 1987 dated March 11, 1987
4. Such person shall
be informed of the implications of a seropositive test and the requirement of a
confidential report to the AIDS Registry
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 of these regulations, for the control of operations and as criteria
for the renewal of certificates.
Section 11
Inspection
HIV testing laboratory
facilities and records shall be subject to regular inspections to determine
compliance with the above regulations.
1. The Director of
the Bureau of Research and Laboratories or his duly authorized representative
shall be given reasonable time and opportunity to inspect the premises and
facilities wherein the HIV Testing is being performed.
2. Each laboratory
shall make available to the Director of the Bureau of Research and Laboratories
or his duly authorized representative all records kept pursuant to these
regulations for inspection.
3. The Director of
the Bureau of Research and Laboratories or his representative may be assisted
by duly designated experts from professional association in such inspections.
4. Directors or
Regional Health Offices, Provincial, City and Municipal Health Officers are
hereby directed to report to the Bureau of Research and Laboratories the
existence of unaccredited HIV testing laboratories or any private party
performing such test without a proper accreditation certificate.
Section 12
Basic Accreditation
Requirements
Any person, firm or
corporation desiring to perform HIV Testing shall submit to the Bureau of
Research and Laboratories, a sworn petition/application on the prescribed form
and containing among others, the following data:
1. Name, citizenship
and domicile of the Head of the HIV Testing 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. Copy of a valid
permit to operate a clinical laboratory or blood bank from the Department of
Health, and;
6. Scope of the
nature of work to be undertaken
Section 13
Application for
Accreditation
1. An application
for accreditation shall be filed in a form “Application for Accreditation of
Laboratories performing HIV testing” with the Office of the Bureau of Research
and Laboratories for screening and approval.
2. Each application
shall be signed under oath or affirmation by the applicant or a person by the
applicant or a person duly authorized to act and on his behalf.
3. Within 60 days after
receipt of said application together with the accreditation fee, an inspector
from the Bureau of Research and Laboratories shall inspect the establishment
and verify if the applicant has complied with the requirements prescribed in
those regulations.
4. Any false
statement in the application or failure to comply with the requirements may
serve as basis of the Director of the Bureau of Research and Laboratories to
refuse recommending the issuance of a certificate of accreditation.
Section 14
Accreditation fees
1. A non–refundable
fee shall be charged for every application for an accreditation certificate
issued for the performance of HIV Testing for government and private
laboratories
2. A non–refundable
fee is charged on application of renewal if filed at least sixty (60) days
before the accreditation expires
3. All fees shall be
payable to the Bureau of Research and Laboratories in accordance with the
following schedule:
For
new certificate P500.00
For
Renewal of Certificate P 250.00
4. A penalty of
P200.00 for late renewal shall be charged in addition to the renewal fee when
filed within sixty (60) days after expiration of accreditation
5. Sixty (60) days
after expiration of accreditation, unrenewed certificates shall be considered
lapsed, and a new certificate shall have to be applied for
Section 15
Issuance and Exhibition
of Certificate of Accreditation
1. The certificate
will be issued and signed by the Undersecretary of Health for Standards and
Regulation if the application is found to be meritorious and the fees duly
paid; otherwise the same shall not be approved.
2. The accreditation
certificate should be placed in a conspicuous place within the laboratory. A
copy of the rules and regulations shall be readily available for the guidance
of the staff in the laboratory.
Section 16
Terms and Conditions of
Accreditation
1. The certificate
as herein granted or any right under the certificate shall not be assigned or
otherwise transferred directly or indirectly to an unauthorized party.
2. The owner or
manager of any HIV testing laboratory desiring to transfer to another place
shall inform the Bureau of Research and Laboratories in writing, stating the
new place and site of the establishment within fifteen (15) days after such
transfer. The new facilities shall be subject to re–inspection before it can
resume operation.
3. Any HIV antibody
laboratory desiring to stop operation should notify the Bureau of Research and
Laboratories stating the said date of termination.
4. Any Pathologist
who decides to terminate services or transfer supervision should inform the
Bureau of Research and Laboratories within fifteen (15) days after such
termination or transfer.
5. Failure to report
in writing within 15 days any change in conditions of Accreditation will be
cause for suspension or revocation of the certificate of Accreditation of the
laboratory.
Section17
Expiration of
Accreditation Certificate
Each accreditation
certificate shall expire one year after the date of approval of the certificate
such date being indicated in the upper right hand corner of the certificate
Section 18
Renewal
Application for renewal of
certificates shall be filed at least sixty (60) days before the expiration of
the certificate in accordance to Section 14. The Bureau of Research and
Laboratories shall process applications for renewal immediately upon receipt thereof
subject to inspection upon the discretion of the Director; provided, however,
that such HIV testing laboratory may continue operation pending action on their
application, unless otherwise advised or ordered by the Director, Bureau of
Research and Laboratories or his representative to cease operation.
Section 19
Publication of List of
Accredited Laboratories
1. A list of
laboratories and blood banks accredited for HIV Testing under these rules and
regulations shall be published periodically and be made available to any
person, agency or organization for legitimate purposes.
2. The results of
quality control costing shall likewise be published.
Section 20
Modification and
Revocation of Certificate
The terms and conditions
of each certificate shall be subject to amendment or modification by means of
amendments to these regulations as the Secretary of Health may deem necessary.
Except in cases of willful, or repeated violations hereof, or where public
health interest or safety requires otherwise, no certificate shall be modified,
suspended or revoked unless prior notice has been made and the corresponding
investigation conducted.
Section 21
Violations
1. The certificate
of accreditation of a laboratory to perform HIV Testing shall be suspended or
revoked by the Undersecretary of Health for Standards and Regulations for any
violation of these Rules and Regulations, which may include among others:
(a) Operating an HIV Testing Laboratory without a
qualified pathologist or hematologist or medical technologist.
(b) Any false statement in the application.
(c) Utilizing unregistered HIV Testing kits.
(d) Repeated failure to submit a monthly report with
accompanying Xerox copies of invoices to the Bureau of Research and
Laboratories.
(e) Failure to submit seroreactive samples for
supplemental (confirmatory) testing to the Research Institute of Tropical
Medicine or Bureau of Research and Laboratories.
(f) Failure to report confirmed seropositive cases to the
AIDS Registry, BRL, DOH.
(g) Refusal to allow inspection of the laboratory by
persons authorized by the Bureau of Research and Laboratories during reasonable
hours.
(h) Refusal to perform tests on quality control samples
required by the Bureau of Research and Laboratories.
(i) Failure to correct deficiencies within a reasonable
time after due notice from the Bureau of Research and Laboratories.
2. Any HIV Testing
Laboratory that violates these rules and regulations shall be liable under the
Clinical Laboratory Law (R.A. 4688) or Blood Bank Law (R.A. 1517) and suffer
penalties provided for in the law and the Revised Rules and Regulations issued
pursuant to such law. Such violations shall be a basis for sanctions including
suspension or revocation of the license to operate the Clinical Laboratory or
Blood Bank
Section 22
Effectivity
These rules and
regulations shall take effect fifteen (15) days after its publication in the
Official Gazette or in a newspaper of general circulation
ALFREDO R.A. BENGZON,
M.D.
Secretary of Health
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