MTAP - MEDTECH LAWS AND BIOETHICS

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AN ACT REQUIRING THE REGISTRATION OF MEDICAL
TECHNOLOGISTS, DEFINING THEIR PRACTICE, AND FOR REPUBLIC ACT # 5527
OTHER PURPOSES
REPUBLIC ACT # 5527 IS ALSO CITED AS: Philippine Medical Technology Act of 1969
REPUBLIC ACT # 5527 is approved on June 21, 1969
REPUBLIC ACT # 5527 is approved by Ferdinand Marcos Sr.
DEFINITION OF TERMS IS UNDER SEC. 2, PD 498
An auxiliary branch of laboratory medicine which deals with the
examination by various chemical, microscopic, bacteriologic and
other medical laboratory procedures which will aid the physician Medical Technology
in the diagnosis, study and treatment of disease and in the pro-
motion of health in general.
all healthcare providers will go hand and hand for better diagnosis
Alma Ata Declaration
and treatment of patient
A duly registered physician who is specially trained in methods
of laboratory medicine, of the gross and microscopic study and
interpretation of tissues, secretions and excretions of the human
Pathologist
body and its functions in order to diagnose disease, follows its
course, determine the effectiveness of treatment, ascertain cause
of death and advance medicine by means of research.
A pathologist must pass the ____________ Philippine Board of Pathologist (PBP)
The pathologist is the __________________________________
Head/owner/manager/supervisor
of the laboratory
A person who engages in the work of medical technology under
the supervision of a pathologist or licensed physician authorized Medical Technologist
by the Department of Health
Registered Medical Technologists are also known as the Medical detectives or clinical eye of the physicians
Clinical Research
Other practices of MedTech Clinical Laboratory quality control
Pharmaceutical and Medical services
The Board of Examiners for Medical Technology Board
Compositions of board of examiners is explained in Section 7, PD 498, RA 5527 S. 1969
Composition of board of examiners Chairman and two members
Current Board Chairman Dr. Marilyn A. Cabal-Barza
pathologist/ M.D
Chairman of the board of examiners must be a
appointed by the president of the Philippines
One of the two Members of the MedTech board Dr. Leila M. Florento
Other member of the Board who is on leave
Dr. Grace J. Dela Calzada
(not in the handout; posted by PRC on 23 March, 2022 )
2 RMTs appointed by the president of the Philippines Two Members of the board of examiners
QUALIFICATIONS OF THE BOARD EXAMINERS are explained
Section 8, PD 498
in
Filipino citizen (Dual citizen is accepted)
With good moral character
A qualified pathologist or duly registered medical technologist of
the Philippines
Qualifications of the board of examiners
Has been in the practice of laboratory medicine or medical tech-
nology for at least 10 years (Currently, it was reduced to 5 years)
not a member of the faculty of any medical technology school or
have any pecuniary interest
Qualified pathologist or duly registered medical technologist of the Bachelor of Science in Medical Technology or Bachelor of Science
Philippines with the degree of ____________________________ in Hygiene/BSPH/BSMLS

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Has been in practice of laboratory medicine or medical technology
for at least 10 years prior to his appointment (Currently, it was 5 years
reduced to____________)
Is not a member of the faculty if any medical technology school or
have any pecuniary interest; give up/resign for _______ prior to 2 years
appointment
FUNCTIONS/RESPONSIBILITIES/ DUTIES of the board of ex-
Section 11, PD 498
aminers are explained in
Administrative Investigation - Revocation or Suspension of Cer-
Section 24, PD 498
tificates/ Administrative Policies are explained in
BOMT - 3/3 Unanimous vote
BOMT - 3/3: Unanimous vote Revocation of license
BOMT - 2/3 Majority vote
BOMT - 2/3: Majority vote Suspension of License
Negligence
Malpractice
Beneficience
Bioethical considerations
Maleficience
Respect for Autonomy
Justice
no doings Negligence
wrong doings Malpractice
do no harm; duty or obligation to act in the best interest of the
Beneficience
patients
do with harm Maleficience
act of freewill Respect for Autonomy
act of fairness Justice
Council - The Council of Medical Technology Education is ex-
Section 3, PD 498
plained in
refers The Council of Medical Technology Education Council
minimum requirements for the standardization on BSMT/ BMLS/
The Council of Medical Technology Education
BSPH/ BS Hygiene curricula
Chairman
Vice-Chairman Members of the Council
2 Members
Chairman of the Council For Public Institution Secretary of Education-CHED
Chairman of the Council For Private Institution Director/ President of University/ School
Director of Bureau of Research and Laboratories of the Depart-
Vice-Chairman of the Council
ment of Health
a. Dean/ representatives/ heads of private schools of medical
technology
2 Members of the Council must be
b. Presidents of the Philippine Association of Medical Technologist
(PAMET) and the Philippine Society of Pathologist (PSP)
Shall be at least 4 years
Minimum required course
12-month satisfactory internship in accredited laboratories
Qualification for Examination is explained in Section 16
In good health and of good moral character
What are the Qualification for Examination
Has completed at least 4 years of BSMT or any equivalent courses
Scope and Coverage of Examination & Passing Requirements/
Section 17
Conditions are explained

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Relative weights for
Clinical Chemistry
Microbiology (70%) and Parasitology (30%) 20%
Hematology
Blood Banking (50%) and Serology (50%
Relative weights for
Clinical Microscopy (Urinalysis and other body fluids)
10%
Histopathologic Techniques, Cytopathology (70%), MTLaws
(30%)
1st day of exam subjects CC, Micro/ Para, CM
2nd day of exam subjects Hema, IS/BB, HT/MTLE
Major subjects 20% relative weight
Minor subjects 10% relative weight
How to Compute GWA GWA= Sum of (Rate x Relative weight/ per subject)
Ratings in the Examinationis explained in Section 19
PASSING SCORE per subject 75.00% or above
No rating below ___________ in any of the MAJOR SUBJECTS fifty percent
Has not failed in _________ of the subjects computed according
at least 60%
to their relative weights
Considered FAILED, due to low rates in _____________, which
has 20% relative weight= 20 x 3= 60%
3 major subjects
Example: CC: 91%; Micro: 72%; Hema: 51%; ISBB: 63%; CM:
95%; HTMLE: 93%
those who have gotten a rating of 70.00% to 74.4% Registered Laboratory Technicians (RLTs)
Assists RMTs in lab assays, and trained phlebotomist RLTs
If the examinee failed __________, he/she should undergo a
3 times
12-month refresher course
Utilize the highest level of attainment after passing the boards RLTs ’ RMTs
If you are already an RLT, then you passed on 2nd try to be an
voided
RMT: your RLT license is __________
Oath-taking is explained on Section 20
Issuance of Certificate of Registration explained on Section 21
All successful examines shall be required to take a
professional oath
______________
No Certificate of Registration (COR) shall be issued to any suc-
Twenty-one (21)
cessful applicant who has not attained the age of _____________
Certificate of Registration (COR) Lupon ng Medikal Teknolohiya
placed in front of the walking areas
Certificate of Registration (COR)
non-transferrable and non-expirable license
non-transferrable but valid only for 3 years PRC license
Continuing Professional Development Act (CPD) law RA 10912 s. 2016
CPD is Proposed by ___________ and approved by ____
Trillanes, Duterte
condition on renewal of license
__________________ must be gained for 3 years 45 credit units (CPD units)
medical professional salary of MTs are Php 15 000 to 20 000 Teve's Law
Roster of Medical Technologists is explained in Section 28
A roster of Medical Technologists shall be prepared annually by
Secretary of the Board
the _____________

Roster of Medical Technologists

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Name, address and citizenship, date of registration or issuance of
certificate
THE CLINICAL LABORATORY LAW OF 1966 RA 4688
An Act of Regulating the Operation and Maintenance of Clini-
cal Laboratories & Requiring The Same with The Department of
THE CLINICAL LABORATORY LAW OF 1966
Health, Providing Penalty for The Violation Thereof, And for Other
Purposes
Date of approval of the RA 4688 June 18, 1966
AO 59 s. 2001
Implementing Guidelines of RA 4688 AO 27 S. 2007
AO 37 s. 2021
Rules and Regulations Governing the Establishment, Operation
AO 59 s. 2001
and Maintenance of Clinical Laboratories in the Philippines
Revised Rules and Regulations Governing Licensure and Regu-
AO 27 S. 2007
lation of Clinical Laboratories in the Philippines
New Rules and Regulations Governing the Regulation of Clinical
Laboratories in the Philippines: (Licensing tools in the implemen- AO 37 s. 2021
tation and establishment of general clinical laboratories)
Currently used
Strict compliance to: Permit to construct (PTC) first, then, License AO 37 s. 2021
to Operate (LTO)
requires Site development plan & Floor Plan PTC
After acquiring PTC, you can go to LTO:
requires Document review & Assessment tools
__________________________________________
A place where blood, body fluids, and other biological specimens
Clinical Laboratory
are tested, analyzed or evaluated (Walters et.al.)
To determine the character and quantity of the various chemical
substances in the blood and other body fluids, tissues, secretions Primary purpose
and excretions (Rabor)
Clinical Laboratories plays a ___________ in healthcare as lab-
central role
oratory medicine
_______ of all medical decisions are based on laboratory results 70%
________ different clinical manifestations (S/S); patient's human
30%
aspect of the body and its clinical history
Clinical Laboratories are at the ________ in education, research,
forefront
information and technology design
Clinical Laboratories facilitates the implementation of
laboratory networking
________________ and quality control management
Use of software
HIS/LIS: Hospital or Laboratory information system Laboratory Networking
To store patient records and results in a long period of time
Examples of HIS Bizbox, MAGIS
= Quality Control + Quality Assurance Total Quality Management (TQM)
a process that monitors the outcomes of lab services; daily before
Quality Control
running patient samples
Laboratory counters width: 2 ft. 6 inches
Laboratory counter-to-wall clearance: 4 feet
Laboratory counter-to-counter clearance: 7 feet
Desk height: 30 inches
Keyboard drawer height: 25-27 inches
Desk space: 3 square feet
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CLASSIFICATIONS OF A CLINICAL LABORATORY BASED ON CLINICAL PATHOLOGY
FUNCTIONS ANATOMICAL PATHOLOGY
clinical services CLINICAL PATHOLOGY
gross examination of tissue/ organs used in advanced medicine ANATOMICAL PATHOLOGY
Hematology
Immunology and Serology
Blood Banking
sections under clinical pathology Clinical Microbiology
Parasitology
Mycology and Virology
Clinical Chemistry
Forensic Pathology
Immunohistopathology
Surgical Pathology
Sections under Anatomical Pathology
Cytology
Autopsy
Molecular Biology
Primary Laboratory
TYPES OF CLINICAL LABORATORY BASED ON MINIMUM RE-
Secondary Laboratory
QUIREMENTS
Tertiary Laboratory
Technical lab Primary Lab
10 sq. m (current: 60sqm.)
Working Space (sq.m) in primary laboratory separate CR (1 for px, & 1 for staff)
sink per section & extraction area
Microscope w OIO
Microhematocrit centrifuge
Hemoglobinometer
Hemocytometer
Differential cell counter
Equipment & Instruments of primary laboratory
Clinical centrifuge
Refrigerator
Timer on any equivalence
Photometer (for CC)
Water bath ((for CC)
Urinalysis
Fecalysis
Fecal occult blood test (FOBT)- screening for colorectal carcino-
ma
Pregnancy test (Rapid kits/ lateral flow)
Wet smear for Trichomonas
Service capability of primary laboratory
Additional for endemic areas: Malaria, Schistosomiasis
Routine CC Tests
ABO and Rh typing (tube method)
CBC w Quantitative Plt count
Serology: Dengue, Syphilis, Hepatitis B & HIV (Screening)
For government facilities ONLY : TB (DSSM)
Conventional Lab with semiautomated machines Secondary Laboratory
20 sq.m.
Working Space (sq.m) of Secondary Laboratory separate CR (1 for px, then 1 for staff)
sink per section & extraction area
All equipment from 1° lab
Coagulation machine (APTT/PT, INR)
Secondary Laboratory and Equipment & Instruments
Gram stain set
KOH reagent
All from 1° lab
Serum electrolytes (Na, K, Cl)
ALT/ SGPT
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AST/ SGOT
PT/APTT
Service capability of Secondary Laboratory
Gram Stain
KOH Determination
Sophisticated Lab with automated machines Tertiary Laboratory
60 sq.m.
Working Space (sq.m) of Tertiary Laboratory separate CR (1 for px, then 1 for staff)
sink per section & extraction area
All from 1° and 2°
Biosafety cabinet
Balances (triple/ analytical)
Rotator
Equipment & Instruments for tertiary lab Incubator
Serofuge
Drying oven
Agglutination viewer
Arterial blood gas analyzer (hospital based only)
All from 1° and 2°
Any machine-based immunological and serological testing and
Service capability of Tertiary Laboratory not limited to:Tumor markers, Thyroid fx tests , Hepatitis profile
Culture and Sensitivity (Aerobic/ Anaerobic)
Hospital-based: Arterial blood gas
FBS, RBS, OGTT, Lipid profile (TC, Total TAG, HDL-C, LDL-C,
Routine CC Tests
VLDL-C), Creatinine, BUN, BUA
Dengue (NS1Ag, IgM, IgG), Syphilis (Reactive/ NR), Hepatitis B,
Serology Tests
HBsAg (Screening), HIV (Screening): Rapid kits/ ELISA
NRL for microbiological tests, Dengue, Influenza, TB, and other
Mycobacteria, Malaria and other parasites, Bacterial enteric dis-
Research Institute for Tropical Medicine (RITM)
ease. Measles and other viral exanthems, Mycology, Enterovirus-
es, Antimicrobial resistance and engineering diseases
San Lazaro Hospital (SACCL) STD/AIDS Cooperative Central
NRL for HIV/ AIDS, Hepatitis, Syphilis and other STIs
Laboratory
NRL for Environmental and Occupational Health; Toxicology and
Micronutrient assay East Avenue Medical Center
Water testing Analysis, Drug testing Analysis
NRL for Hematology, Immunohematology and Immunopathology
National Kidney and Transplant Institute (NKTI)
and Anatomic Pathology
NRL for Pathology for Cardiac Disease Philippine Heart Center
Atomic Pathology for Pulmonary Diseases; Biochemistry Lung Cancer of the Philippines

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