March 6, 1992
ADMINISTRATIVE ORDER
No. 118 – B series 1992
RULES AND REGULATIONS GOVERNING THE ACCREDITATION OF
CLINICAL LABORATORIES FOR TRAINING OF MEDICAL TECHNOLOGY INTERNS
Section 1
Title
These rules and regulation
shall be known as the “Rules and Regulations governing the accreditation
of clinical laboratories for training of Medical Technology interns.”
Section 2
Authority
These rules and
regulations are issued in accordance to Section 13 of Republic Act 5527
(Medical Technology Act of 1969) and consistent with Executive Order 119
(Reorganization Act of the Ministry of Health) and R.A. 4688 (Clinical
Laboratory Law), R.A. 1517 (Blood Bank Law).
Section 3
Purpose
These rules and
regulations are promulgated to upgrade the training of medical technology
interns to maintain the quality of laboratory services, and to properly utilize
the medical technology interns during their training. Only those laboratories
which are accredited for training shall be utilized for the affiliation of
medical technology interns.
Section 4
Scope
The rules and regulations
embodied herein shall apply to all clinical laboratories performing
examinations for the diagnosis of diseases or for public health purposes as
defined in R.A. 4688 and utilized as training laboratories for medical
technology interns from universities and colleges offering medical technology
courses.
Section 5
Regulatory Authority
The accreditation of
training laboratories for medical technology interns 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 Regulation.
Section 6
Accreditation Requirements
for a Training Laboratory for Medical Technology Interns
1. All clinical
laboratories must be required to demonstrate compliance with the following
technical standards as requirements for accreditation.
a. The Clinical Laboratory shall be duly licensed by the
Bureau of Research and Laboratories (BRL).
b. The laboratory shall be headed by and under the supervision
of a duly licensed physician who is certified by the Philippine Board of
Pathology.
c. The laboratory shall be staffed by at least one (1)
medical technologist, duly registered with the Board of Medical Technology for
each of the sections of Clinical Chemistry, Clinical Microscopy, Microbiology,
Hematology, Blood Banking and Serology and Histopathology
d. The physical plant shall have adequate laboratory
space to accommodate both laboratory staff and medical technology interns.
e. There should be sufficient equipment and supplies
necessary depending on the volume and type of examinations as well as the
number of interns to be trained by the laboratory.
f. A section of the laboratory can be utilized for
training only if it has a sufficient volume of laboratory examination adequate
for training of at least one Medical Technology Intern.
g. The laboratory should have a written training program
for the Medical Technology interns.
2. The BRL shall
evaluate compliance to the technical standards in accordance with the
requirements including the minimum number of examination of samples required of
each section as the BRL may promulgate.
Section 7
Training Program
The training program
for Medical Technology interns should include the following:
1. The person
responsible for the training program must be a duly licensed physician
certified by the Philippine Board of Pathology. He shall be assisted by a
registered medical technologist with previous experience in training medical
technology interns.
2. The program shall
provide for an objective measure or evaluation of the baseline skills and
knowledge prior to allowing or utilizing interns to handle actual specimens
from patients.
3. The program shall
include the (1) objective of training, (2) laboratory methods or procedures to
be taught, (3) principles and clinical applications of the laboratory
procedures, (4) right work attitudes and ethical values, (5) required quota of
tests to be performed to develop accuracy and precision (6) objective evaluation
of performance in each section (7) time schedule (8) lecture seminars and
conferences and (9) methodology of training.
4. Not more than 20%
of the number of Medical Technology interns but not to exceed (10) interns
shall be allowed to train during the night shift. Provided further that no
intern shall be allowed to train without a registered Medical Technologist on
duty to supervise them.
5. There should be
at least one (1) registered Medical Technologist with adequate skills and
expertise in training for every group of interns not exceeding five (5) in each
section.
6. The staff and
personnel of the laboratory shall be assisted by a laboratory instructor who
must be a registered Medical Technologist from the sending university or school
especially tasked to monitor individual attendance, behavior and performance of
students.
7. A monthly
conference by the Pathologist, laboratory staff and laboratory instructor of
the school shall be held to evaluate the implementation of the program, the
problem that have been encountered and changes that have been instituted.
Section 8
Reporting
Each accredited clinical
laboratories shall render an annual report of the number of Medical Technology
interns training, the number of examinations performed and other activities in
accordance with the format prescribed of the BRL.
Section 9
Affiliation of Medical
Technology Interns from Universities, Colleges and School of Medical Technology
Accredited clinical laboratories
shall be allowed to accept for affiliation Medical Technology interns from
universities, schools or colleges of Medical Technology who have met the
requirements specified in the Department of Health Administrative Order No.
70–A series 1989.
Section 10
Basic accreditation
requirements
Any clinical laboratory
desiring to train Medical Technology interns shall submit to BRL a sworn
petition/application on the prescribed form containing /attaching among others:
1. Name of
establishment
2. Place,
municipality and province where it is to be established
3. Name, citizenship
and domicile of the head of the Clinical Laboratory
4. Name, citizenship
and domicile of owner
5. Copy of a valid
permit to operate a clinical laboratory or blood bank from the Department of
Health
6. The training
program for Medical Technology interns
7. Volume of
examination performed in the previous year for each section
Section 11
Application for
Accreditation
1. An application
for accreditation shall be filed in a form “Application for Accreditation of
Laboratories for Training Medical Technology Interns” 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 owner or a person duly authorized
to act for and of his behalf.
3. Within sixty (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 these regulations.
4. Any material
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 12
Accreditation Fees
1. A non–refundable
fee shall be charged for every application for accreditation for the training
of Medical Technology interns for government and private laboratories.
2. A non–refundable
fee is charged on application of renewal of accreditation 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
initial application P500.00
For
renewal of accreditation P250.00
4. A penalty of
P200.00 for late renewal shall be charged in addition to the renewal fee when
filed within ninety (90) days after expiration of accreditation.
5. Ninety (90) days
after expiration of accreditation, un–renewed certificates shall be considered lapsed,
and a new certificate shall be applied for (initial application).
Section 13
Inspection
Clinical Laboratory for
training of Medical Technology intern’s facilities and records shall be subject
to regular inspection to determine compliance with the above regulations.
1. The Director of
Bureau of Research and Laboratories or his duly authorized representative(s)
shall be given reasonable time and opportunity to inspect the premises and facilities
wherein the training of Medical Technology interns 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 associations in such inspections.
4. Directors of
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 clinical laboratories training Medical Technology
interns or any private party performing such training without a proper
accreditation certificate.
Section 14
Issuance and Exhibition
of Certificate of Accreditation
1. The certificate
shall be issued and signed by the Undersecretary of Health for Standards and
Regulation upon compliance with the requirements prescribed herein and provided
the corresponding fees are duly paid.
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 15
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 clinical laboratory training Medical Technology interns desiring
to transfer to another place shall inform the Bureau of Research and
Laboratories in writing, stating the new place and site of establishment within
fifteen (15) days after such transfer. The new facilities shall be subject to
re–inspection before it can resume operation.
3. Any laboratory
desiring to cease training Medical Technology interns should notify the Bureau
of Research and Laboratories stating the said date of termination.
4. Any Pathologist
who decides to terminate his 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 fifteen (15) days any change in conditions of Accreditation
will be cause for suspension or revocation of the certificate of accreditation
of the laboratory.
Section 16
Expiration of
Accreditation Certificate
Each accreditation
certificate shall expire two years after the date of approval which is
indicated in the upper right hand corner of the certificate.
Section 17
Renewal
Application for renewal of
certificate shall be filed at least sixty (60) days before its expiration. 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 clinical laboratory may continue
operation pending action on their application, unless otherwise advised or
ordered by the Director, of the Bureau of Research and Laboratories or his duly
authorized representative to cease operation.
Section 18
Publication of List of
Accredited Laboratories
1. A list of
laboratories and blood banks accredited for training Medical Technology interns
under these rules and regulations shall be published periodically and be made
available to any person, agency or organization for legitimate purposes.
Section 19
Modification and
Revocation of Certificate
The terms and conditions
of each certificate shall be subject to amendment or modification as may be
provided by any 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 20
Violations
1. The certificate
of accreditation of a laboratory to train Medical Technology interns shall be
suspended or revoked by the Undersecretary of Health for Standards and
Regulation for any violation of these Rules and Regulations, including the following
acts:
a. Training Medical
Technology interns without a qualified Pathologist or Medical Technologist.
b. Any material
false statement in the application.
c. Failure to
correct deficiencies within a reasonable time after due notice from the Bureau
of Research and Laboratories.
d. Refusal to allow
inspection of the laboratory by persons authorized by the Bureau of Research
and Laboratories during reasonable hours.
e. Repeated failure
to submit an annual report to the Bureau of Research and Laboratories.
2. Any clinical
laboratory that violates these rules and regulations shall be liable under the Medical
Technology Act (R.A. 5527) and Clinical Laboratory Law (R.A. 4688),
and shall suffer penalties provided for in these laws and the Revised Rules and
Regulations issued pursuant to such laws. Such violations shall be the basis
for sanctions including suspension or revocation of the license to operate the
Clinical Laboratory.
Section 21
Upon the filing of a
complaint or charge duly sworn to by any person or interested party against a
clinical laboratory or of any of its personnel for violating any provisions of
this regulations, the Undersecretary of Health for Standards and Regulation or
his duly authorized representative(s) shall investigate the complaint or
charges and verify if the laboratory concerned or any of its personnel is
guilty of the charges. If upon investigation, a person or persons are found
violating any of the provision of this rules and regulations, the
Undersecretary of Health for Standards and Regulations shall suspend for a
definite or indefinite period of time or cancel or revoke the accreditation of
the laboratory without prejudice to taking the case to judicial authorities for
criminal action.
Section 22
Seperability and
Repealing Clause
1. In the event that
any rule, section, paragraph, sentence, clause or word of this Order is
declared invalid for any reason, the other provisions thereof shall not be
affected thereby.
2. All pertinent
rules and regulations which are inconsistent with the provisions of this Order
are hereby repealed or amended accordingly.
Section 23
Effectivity
These rules and
regulations shall take effect within fifteen (15) days after its publication in
the Official Gazette of in newspaper of general circulation.
ANTONIO O. PERIQUET,
M.D.
Secretary of Health
No comments:
Post a Comment