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Teaching and Training in Clinical Laboratories

Teaching-and-Training-in-Clinical-Laboratories

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0% found this document useful (0 votes)
18 views

Teaching and Training in Clinical Laboratories

Teaching-and-Training-in-Clinical-Laboratories

Uploaded by

lyenoise
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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MT LAWS

Teaching and Training in ⮚


Clinical Laboratories
⮚ Any clinical laboratory should first be categorized as a
tertiary type before it can be considered an accredited (b) The training program should prepare in
training and teaching laboratory. coordination with the training officer of the hospital or
health region and submit to the Committee on
AO 274 s 1976 Affiliation with the contract of affiliation
⮚ rules and regulations governing affiliation of medical
technology schools, colleges and universities in (c) The program should provide for an objective
government hospitals under the department of health training, measure or evaluation of the baseline skills and
⮚ January 27, 1976 knowledge prior to allowing or utilizing interns to
handle actual specimen from patients
⮚ Health laboratory services of the Department of Health
have been established primarily to give the adequate
(d) The program should include the (1) the objective of
laboratory support to the clinicians in the diagnosis and
the training (2) methods or procedures to be taught (3)
therapy of patients and to help detect pathologic
principles that go with the methods, (4) right work
changes prior to its manifest signs and symptoms.
attitude and ethical values, (5) required quota of tests
However, it has been long been aware that while
to be performed to develop accuracy and precision, (6)
accomplishing this primary objective, it plays an
objective evaluation of performance in each section, (7)
important role in the training of medical technology
time schedule and (8) lectures, seminars, and
interns. A balance must be had at all times so that
conferences and (9) methodology of training
service and training can go hand in hand effectively. In
line thereof with the policies of fully maximizing the
7. The minimum number of examinations or samples of
effectivity of laboratory services, of upgrading the
each section to accommodate interns are as follows:
training of medical technology interns and of properly
utilizing the medical technology during training, the
(a) Clinical Chemistry – 3000 examinations/annum
Department of Health hereby promulgates the following
rules and regulations to be strictly observed and
(b) Clinical Microscopy
complied with in the affiliation of medical technology
(1) Urinalysis – 1500 samples / annum
interns in the Department of Health laboratories:
(2) Parasitology (direct fecal smear and
concentration test or Kato thick smear) – 1500
I. RESPONSIBILITIES OF THE DEPARTMENT OF HEALTH
samples/annum
LABORATORIES
⮚ Laboratories designated by the Secretary of Health (c) Microbiology
where medical technology interns may affiliate to (1) Gram Staining, Acid fast staining
obtain the necessary skills and knowledge in clinical – 800 samples/annum
laboratory practice must meet the following (2) Isolation and identification of organisms
requirements: – 1000 samples/annum
1. The laboratory should be duly licensed as specified
by the law on Clinical Laboratories, R.A. 4688 (d) Hematology
2. The position of medical technologist should be (1) Peripheral blood study to include hemoglobin
provided for each of the section of Clinical white cell count, Schilling hemogram and red cell
Chemistry, Clinical Microscopy (Urinalysis and morphology or CBC – 1200 samples/annum
Parasitology), Microbiology (Bacteriology), (2) Sedimentation rate, platelet count, bleeding
Hematology, Blood Banking and Serology and and clotting time, malarial smears and other tests –
Histopathology 800 samples / annum
3. There should be an adequate laboratory space to
accommodate both the staff and the medical (e) Blood Banking and Serology
technology interns (1) Typing – 900 test/annum
4. There should be sufficient equipment and supplies (2) Complete cross matching – 600 tests/annum
necessary depending on the volume and type of (3) Serology
examinations as well as the number of interns to be VDRL – 300 tests/annum
trained by the laboratory Widal test – 300 test/annum
5. Each section of the laboratory can be utilized for
training only if it can accommodate at least two (f) Histopathology – 500 tissues/annum
interns at any one time. Cytology – 500 tissues/annum
6. The laboratory should have a training program for
medical technology interns.
⮚ For each additional intern, another half of the
requirement shall be added.
(a) The person responsible for this program should be a
member of the specialty society in the laboratory
medicine.
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PRELIMS|LECTURE
MT LAWS
Teaching and Training in ⮚
Clinical Laboratories
8. At least one member of the professional staff of the implementing the approved training program for the
laboratory to every group of interns not exceeding duration of the training of the interns.
ten (10) in each section should be provided. 2. Pay or replace damage, breakages or loss by the
9. The staff and personnel of the laboratory will be medical technology interns or laboratory property
assisted by a laboratory instructor experienced in equipment and supplies.
actual laboratory work from the sending University 3. See to it that all medical technology interns before
or College to assist especially to monitor individual beginning the internship in any section must have
attendance, behavior, performance or the students completed the theoretical aspect of that particular
including guidance in reading and application of the section
theoretical knowledge taken up in school to actual 4. Pay the hospital thirty five pesos (P35.00) for each
practice. intern each month. Payment is done within the first
10. No more than 10 medical technology interns shall five days of the month.
be allowed to train during the night shift in 5. Make a request for affiliation to the Chief of
understaffed hospitals and so certified by the Hospital accomplishing the appropriate standard
director of the same, such interns should have a form of contact of affiliation (6 copies) and coursed
medical technologists to work with them. No intern through proper channels to the Secretary of Health,
is to be assigned without the regular professional through the Chairman, Accreditation Committee on
staff of the laboratory on duty at the same time. Training and Student Affiliation. Contracts shall be
11. The allotment derived from the intern’s affiliation subject for renewal every year by the Chief of
fee for the laboratory must be spent for the Hospitals
laboratory needs utilized exclusively for training 6. See to it that the laboratory instructor and students
and not payment of furniture or appliances of the observe and abide with the policies, rules and
laboratory. regulations of the hospital and that discipline is
12. The Director of the hospital is responsible for the maintained at all times.
admission of the number of interns approved by the 7. See to it that the students and instructor are in their
Committee. He should not enter into any contract of proper uniforms and provided with a laboratory
affiliation with any College, university or school for gown.
medical technology if any of the conditions set forth
in this Administrative Order are not complied with. III. JOINT RESPONSIBILITIES OF AFFILIATION UNIVERSITIES,
13. Quarterly reports on the affiliation fees received SCHOOLS AND COLLEGES OF MEDICAL TECHNOLOGY
showing the percentage of each category or AND THE LABORATORIES
personnel and the budgetary outlay showing the
proposed amount for each personnel participating in 1. The training program shall be prepared by the
the affiliation program must be submitted to the Pathologist–in–charge of the laboratory in
Secretary of Health thru the Accreditation coordination with the training officer of the hospital.
Committee together with the narrative report on Its implementation shall be the joint responsibility
the status and/or problems of the Affiliation of the Pathologist, staff and personnel of the
Program. laboratory and the laboratory instructor of each
university, school or college assigned to the
II. RESPONSIBILITIES OF THE AFFILIATING laboratory for the duration of the internship of their
UNIVERSITIES/SCHOOLS/COLLEGES OF MEDICAL respective students.
TECHNOLOGY 2. The internship schedule shall be properly
⮚ All universities, schools, colleges or Medical Technology apportioned to the different section of the
must have met the following requirements before laboratory service as follows:
applying for affiliation to any clinical laboratory of the (a) Clinical Chemistry – 2.5 months
Department of Health (b) Microbiology – 2.5 months
1. Approval from the Department of Education and the (c) Clinical Microscopy – 3 months
Board of Medical Technology (d) Hematology – 2 months
2. Compliance with the provision of R.A. 5527 and (e) Blood Banking & Serology – 1 month
Presidential Decree No. 498 (f) Histopathology – 1 month

⮚ These universities, schools and colleges shall: ⮚ Under no circumstances is the duration of internship in
1. Provide a laboratory instructor experience in actual any section be prolonged or shortened.
laboratory work to monitor individual attendance,
behavior and performance of the students including 3. A monthly conference should be held to evaluate
guidance in reading and application of theoretical the implementation of the program and institution
knowledge obtained from school to actual practice of changes by the Pathologist, laboratory instructor
and to assist the Pathologist and professional staff in and staff of the laboratory and for problems that
might arise during the implementation.

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PRELIMS|LECTURE
MT LAWS
Teaching and Training in ⮚
Clinical Laboratories
4. Maintenance of cooperation and harmonious ⮚ Section 6: Accreditation Requirements for a Training
working relations at all times among the students Laboratory for Medical Technology Interns
and staff of the hospital.
1. All clinical laboratories must be required to
⮚ This Administrative Order superseded all issuances on demonstrate compliance with the following
this matter and shall take effect immediately. technical standards as requirements for
accreditation.
⮚ CLEMENTE S. GATMAITAN, M.D., M.P.H.
Secretary of Health a. The Clinical Laboratory shall be duly licensed by the
Bureau of Research and Laboratories (BRL).

AO 118 s 1992 b. The laboratory shall be headed by and under the


⮚ rules and regulations governing the accreditation of supervision of a duly licensed physician who is certified
clinical laboratories for training of medical technology by the Philippine Board of Pathology.
interns
⮚ March 6, 1992 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
⮚ Section 1: Title
Chemistry, Clinical Microscopy, Microbiology,
These rules and regulation shall be known as the “Rules
Hematology, Blood Banking and Serology and
and Regulations governing the accreditation of clinical
Histopathology.
laboratories for training of Medical Technology
interns.”
d. The physical plant shall have adequate laboratory
space to accommodate both laboratory staff and
⮚ Section 2: Authority medical technology interns.
These rules and regulations are issued in accordance to
Section 13 of Republic Act 5527 (Medical Technology e. There should be sufficient equipment and supplies
Act of 1969) and consistent with Executive Order 119 necessary depending on the volume and type of
(Reorganization Act of the Ministry of Health) and R.A. examinations as well as the number of interns to be
4688 (Clinical Laboratory Law), R.A. 1517 (Blood Bank trained by the laboratory.
Law).
f. A section of the laboratory can be utilized for training
⮚ Section 3: Purpose only if it has a sufficient volume of laboratory
These rules and regulations are promulgated to upgrade examination adequate for training of at least one
the training of medical technology interns to maintain Medical Technology Intern.
the quality of laboratory services, and to properly utilize
the medical technology interns during their training. g. The laboratory should have a written training
Only those laboratories which are accredited for program for the Medical Technology interns.
training shall be utilized for the affiliation of medical
technology interns. 2. The BRL shall evaluate compliance to the technical
standards in accordance with the requirements
⮚ Section 4: Scope including the minimum number of examination of
The rules and regulations embodied herein shall apply samples required of each section as the BRL may
to all clinical laboratories performing examinations for promulgate.
the diagnosis of diseases or for public health purposes
as defined in R.A. 4688 and utilized as training ⮚ Section 7: Training Program
laboratories for medical technology interns from The training program for Medical Technology interns
universities and colleges offering medical technology should include the following:
courses.
1. The person responsible for the training program
⮚ Section 5: Regulatory Authority must be a duly licensed physician certified by the
The accreditation of training laboratories for medical Philippine Board of Pathology. He shall be assisted
technology interns under these rules and regulations by a registered medical technologist with previous
shall be exercised by the Department of Health, through experience in training medical technology interns.
the Bureau of Research and Laboratories in the office
for Standards and Regulation. 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
PRELIMS|LECTURE
MT LAWS
Teaching and Training in ⮚
Clinical Laboratories
3. The program shall include the (1) objective of 2. Place, municipality and province where it is to be
training, (2) laboratory methods or procedures to be established
taught, (3) principles and clinical applications of the 3. Name, citizenship and domicile of the head of the
laboratory procedures, (4) right work attitudes and Clinical Laboratory
ethical values, (5) required quota of tests to be 4. Name, citizenship and domicile of owner
performed to develop accuracy and precision (6) 5. Copy of a valid permit to operate a clinical
objective evaluation of performance in each section laboratory or blood bank from the Department of
(7) time schedule (8) lecture seminars and Health
conferences and (9) methodology of training. 6. The training program for Medical Technology interns
7. Volume of examination performed in the previous
4. Not more than 20% of the number of Medical year for each section
Technology interns but not to exceed (10) interns
shall be allowed to train during the night shift. ⮚ Section 11: Application for Accreditation
Provided further that no intern shall be allowed to 1. An application for accreditation shall be filed in a
train without a registered Medical Technologist on form “Application for Accreditation of Laboratories
duty to supervise them. for Training Medical Technology Interns” with the
Office of the Bureau of Research and Laboratories
5. There should be at least one (1) registered Medical for screening and approval.
Technologist with adequate skills and expertise in
training for every group of interns not exceeding 2. Each application shall be signed under oath or
five (5) in each section. affirmation by the owner or a person duly
authorized to act for and of his behalf.
6. The staff and personnel of the laboratory shall be
assisted by a laboratory instructor who must be a 3. Within sixty (60) days after receipt of said
registered Medical Technologist from the sending application together with the accreditation fee, an
university or school especially tasked to monitor inspector from the Bureau of Research and
individual attendance, behavior and performance of Laboratories shall inspect the establishment and
students. verify if the applicant has complied with the
requirements prescribed in these regulations.
7. A monthly conference by the Pathologist, laboratory
staff and laboratory instructor of the school shall be 4. Any material false statement in the application or
held to evaluate the implementation of the failure to comply with the requirements may serve
program, the problem that have been encountered as basis of the Director of the Bureau of Research
and changes that have been instituted. and Laboratories to refuse recommending the
issuance of a certificate of accreditation.
⮚ Section 8: Reporting
Each accredited clinical laboratories shall render an ⮚ Section 12: Accreditation Fees
annual report of the number of Medical Technology 1. A non–refundable fee shall be charged for every
interns training, the number of examinations performed application for accreditation for the training of
and other activities in accordance with the format Medical Technology interns for government and
prescribed of the BRL. private laboratories.

⮚ Section 9: Affiliation of Medical Technology Interns 2. A non–refundable fee is charged on application of


from Universities, Colleges and School of Medical renewal of accreditation if filed at least sixty (60)
Technology days before the accreditation expires.
Accredited clinical laboratories shall be allowed to
accept for affiliation Medical Technology interns from 3. All fees shall be payable to the Bureau of Research
universities, schools or colleges of Medical Technology and Laboratories in accordance with the following
who have met the requirements specified in the schedule:
Department of Health Administrative Order No. 70–A • For initial application P500.00
series 1989. • For renewal of accreditation P250.00

⮚ Section 10: Basic accreditation requirements 4. A penalty of P200.00 for late renewal shall be
Any clinical laboratory desiring to train Medical charged in addition to the renewal fee when filed
Technology interns shall submit to BRL a sworn within ninety (90) days after expiration of
petition/application on the prescribed form containing accreditation.
/attaching among others:
5. Ninety (90) days after expiration of accreditation,
1. Name of establishment un–renewed certificates shall be considered lapsed,

4
PRELIMS|LECTURE
MT LAWS
Teaching and Training in ⮚
Clinical Laboratories
and a new certificate shall be applied for (initial be subject to re–inspection before it can resume
application). operation.

⮚ Section 13: Inspection 3. Any laboratory desiring to cease training Medical


Clinical Laboratory for training of Medical Technology Technology interns should notify the Bureau of
intern’s facilities and records shall be subject to regular Research and Laboratories stating the said date of
inspection to determine compliance with the above termination.
regulations.
4. Any Pathologist who decides to terminate his
1. The Director of Bureau of Research and Laboratories services or transfer supervision should inform the
or his duly authorized representative(s) shall be Bureau of Research and Laboratories within fifteen
given reasonable time and opportunity to inspect (15) days after such termination or transfer.
the premises and facilities wherein the training of
Medical Technology interns is being performed. 5. Failure to report in writing within fifteen (15) days
any change in conditions of Accreditation will be
2. Each laboratory shall make available to the Director cause for suspension or revocation of the certificate
of the Bureau of Research and Laboratories or his of accreditation of the laboratory.
duly authorized representative all records kept
pursuant to these regulations for inspection. ⮚ Section 16: Expiration of Accreditation Certificate
Each accreditation certificate shall expire two years
3. The Director of the Bureau of Research and after the date of approval which is indicated in the
Laboratories or his representative may be assisted upper right hand corner of the certificate.
by duly designated experts from professional
associations in such inspections. ⮚ Section 17: Renewal
Application for renewal of certificate shall be filed at
4. Directors of Regional Health Offices, Provincial, City least sixty (60) days before its expiration. The Bureau of
and Municipal Health Officers are hereby directed to Research and Laboratories shall process applications for
report to the Bureau of Research and Laboratories renewal immediately upon receipt thereof subject to
the existence of unaccredited clinical laboratories inspection upon the discretion of the Director; provided,
training Medical Technology interns or any private however, that such clinical laboratory may continue
party performing such training without a proper operation pending action on their application, unless
accreditation certificate. otherwise advised or ordered by the Director, of the
Bureau of Research and Laboratories or his duly
⮚ Section 14: Issuance and Exhibition of Certificate of authorized representative to cease operation.
Accreditation
1. The certificate shall be issued and signed by the ⮚ Section 18: Publication of List of Accredited
Undersecretary of Health for Standards and Laboratories
Regulation upon compliance with the requirements 1. A list of laboratories and blood banks accredited for
prescribed herein and provided the corresponding training Medical Technology interns under these
fees are duly paid. rules and regulations shall be published periodically
and be made available to any person, agency or
2. The accreditation certificate should be placed in a organization for legitimate purposes.
conspicuous place within the laboratory. A copy of
the rules and regulations shall be readily available ⮚ Section 19: Modification and Revocation of Certificate
for the guidance of the staff in the laboratory. The terms and conditions of each certificate shall be
subject to amendment or modification as may be
⮚ Section 15: Terms and Conditions of Accreditation provided by any amendments to these regulations as
1. The certificate as herein granted or any right under the Secretary of Health may deem necessary. Except in
the certificate shall not be assigned or otherwise cases of willful or repeated violations hereof, or where
transferred directly or indirectly to an unauthorized public health interest or safety requires otherwise, no
party. certificate shall be modified, suspended or revoked
unless prior notice has been made and the
2. The owner or manager of any clinical laboratory corresponding investigation conducted.
training Medical Technology interns desiring to
transfer to another place shall inform the Bureau of ⮚ Section 20: Violations
Research and Laboratories in writing, stating the 1. The certificate of accreditation of a laboratory to
new place and site of establishment within fifteen train Medical Technology interns shall be suspended
(15) days after such transfer. The new facilities shall or revoked by the Undersecretary of Health for

5
PRELIMS|LECTURE
MT LAWS
Teaching and Training in ⮚
Clinical Laboratories
Standards and Regulation for any violation of these CHED Memorandum 6 s 2008
Rules and Regulations, including the following acts: ⮚ The Commission on Higher Education Memorandum 6,
s 2008 extends the expiration of accreditation in
a. Training Medical Technology interns without a clinical laboratories whose permit is set in 2007 and
qualified Pathologist or Medical Technologist. 2008. This extension was given to allow ample time in
b. Any material false statement in the application. transferring the accreditation program of teaching and
c. Failure to correct deficiencies within a reasonable training clinical laboratories from the Department of
time after due notice from the Bureau of Research Health to the Commission on Higher Education (CHED).
and Laboratories. For new applicants for accreditation, application can be
d. Refusal to allow inspection of the laboratory by secured from the Commission on Higher Education
persons authorized by the Bureau of Research and Office for Programs and Standards.
Laboratories during reasonable hours.
e. Repeated failure to submit an annual report to the LAWS DURING COVID
Bureau of Research and Laboratories.  CHED COVID-19 ADVISORY NO 06
 CHED COVID-19 ADVISORY NO 07
2. Any clinical laboratory that violates these rules and  CMO NO 04 S 2020
regulations shall be liable under the Medical  JMC NO 2021-001
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: Separability 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
6
PRELIMS|LECTURE

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