MTL part 2 Flashcards by LEDESMA, Anne Gelika

REGULATORY LAWS AFFECTING THE PRACTICE OF MEDICAL TECHNOLOGY

RA 4688
AO 2021-0037
DO 393-E s. 2000
RA 7719
AO 2008-0008

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Clinical Laboratory Act of 1966

RA 4688

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RELATED LAWS, ORDERS, AND ISSUANCES TO MEDICAL TECHNOLOGY

RA 7170
RA 9165
RA 11166

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Clinical Laboratory Act of 1966 (RA 4688) Date of approval

June 18, 1966

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An act regulating the operation and maintenance of clinical laboratories and requiring registration of the same with the DOH, providing penalty for the violation thereof, and for other purposes

Clinical Laboratory Act of 1966 (RA 4688)

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Section 3 of Clinical Laboratory Act of 1966 (RA 4688) indicates that this person shall be charged with the responsibility of strictly enforcing the provisions of the Act and shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions.

Secretary of Health through the BRL, presently HFSRB

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AO no.

New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines

AO 2021-0037

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Classification of Clinical Laboratories is indicated in this Administrative Order

AO 2021-0037

New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines

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Classification of Clinical Laboratories by ownership

Government
Private

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Classification of Clinical Laboratories by institutional character

Institution-based (part of DOH licensed facility, i.e. RHU)
Non-institution based (free standing, i.e. clinic)

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Classification of Clinical Laboratories by function

Clinical
Anatomic
Molecular Pathology

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Classification of Clinical Laboratories by service capability

a. CL for Clinical and Anatomic
b. CL for Anatomic Pathology only
c. CL for Molecular Pathology only

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Allowed tests in Primary Lab

Urinalysis
Fecalysis
Pregnancy test
Wet smear for Trichomonas
Blood chem (glucose, lipid profile, BUN, CREA, UA)
CBC
Blood grouping
Rapid test (dengue, syphilis, hepatitis B and HIV
screening)
TB (govt facility)

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Classifications under CL for Clinical and Anatomic

Primary
Secondary
Tertiary
Limited

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Allowed tests in secondary lab

All allowed tests in primary +
* Electrolytes, ALT, AST
* Coagulation studies
* Gram stain
* PAP smear

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Allowed tests in tertiary lab

All allowed tests in primary and secondary +
* Tumor markers
* Thyroid function test
* Hepatitis profile
* Cytology and Histopathology
* Microbiology

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Allowed tests in limited lab

Specialized tests not classified under anatomic or molecular:
o Trace materials
o Allergy panel
o Tumor markers

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Included in CL for Anatomic Pathology only

Cytology and Histopathology

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General guidelines for laboratory to secure a DOH-LTO

Secured from the DOH regulatory office –
HFSRB through CHD (Regional Health Offices)

Valid only for 1 year

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Licensing Standards for laboratory

RMT – should include a designated Biosafety and Biosecurity Officer

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Included in CL for Molecular Pathology only

Genetics
Immune/hematopathology
Infectious diseases

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Use of digital signature shall be permitted only if properly authenticated by the DICT-PNPKI (Phil. National Public Key Infrastructure) and shall be following the provisions of this RA

RA 8792
Electronic Commerce Act of 2000

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In information management indicated in AO 2021-0037, laboratory reports must contain these:

original signature of the RMT
signature of the pathologist

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Procedures for proper disposal of infectious wastes and toxic and hazardous substances are indicated in this RA

RA 6969
“Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990”

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Shall be permitted only if properly authenticated by the DICTPNPKI (Phil. National Public Key Infrastructure) and shall be following the provisions of RA 8792 or the Electronic Commerce Act of 2000

Digital signature in lab reports

NRL for Parasitology and Microbiology, TTIs

RITM

This created the NRLs

DO 393-E s. 2000

repealed DO 393-E s. 2000

DO 820 s. 2020 – Institutionalizing and Strengthening NRL in the Philippines

NRL for HIV/AIDS, Hepatitis B and C, Syphilis, and STDs

San Lazaro-SACCL

NRL for Drug Testing, Toxicology

EAMC

NRL for Hematology

NKTI

NRL for Clinical Chemistry

LCP

Roles and Responsibilities of NRLs

1. Lab referral services 2. NEQAS administration 3. Training of laboratory personnel 4. Evaluation of In Vitro Diagnostic Medical Devices 5. Surveillance systems to provide critical inputs as a guide to DOH policies and stakeholders’ response activities 6. Technical assistance to the DOH, other govt. agencies, private sector, and international partners as the need arises

NRL for Cardiac markers

PHC

National Blood Services Act of 1994

RA 7719

National Blood Services Act of 1994

An act promoting voluntary blood donation, providing for an adequate supply of safe blood, regulating blood banks and providing penalties for violation thereof

RA 7719 National Blood Services Act of 1994

one who donates blood of one’s own volition/initiative and without monetary compensation

Voluntary blood donor

An individual included in the list of qualified voluntary blood donors who is ready to donate blood when needed in his/her community

Walking blood donor

Dse which may be transmitted as a result of blood transfusion, including AIDS, Hepa B, Syphilis, Malaria

Blood transfusion transmissible diseases

Section of RA 7719 which includes definition of terms

section 3

Section 5 of RA 7719

National Voluntary Blood Services Program (NVBSP)

Section 7 of RA 7719

Phase-out of Commercial Blood Bank

Section 8 of RA 7719

Non-Profit Organization

Section 9 of RA 7719

Regulation of Blood Services

Rules and Regulations Governing the Regulation of Blood Service Facilities

AO 2008-0008

Section 14 of RA 7719

Repealing Clause – This act shall supersede RA 1517 (1956)

Classification of Blood Service Facilities by Service Capability

* Blood Station * Blood Collection Unit * Blood Bank * Blood Center

Classification of Blood Service Facilities

Ownership Institutional Character Service Capability

* Provision of whole blood and PRBC * Storage, issuance, transport and distribution of whole blood and PRBC * Compatibility testing of red cell units (if hospital-based)

Blood Station

* Recruitment, retention, and care of donors * Screening and selection of donors * Conduct of health education and counseling services * Blood collection from donors (mobile/hospital) * Blood transport to BC for testing and processing * Compatibility testing of red cell units (if hospital-based)

Blood Collection Unit

* Recruitment, retention, and care of donors * Screening and selection of donors * Conduct of health education and counseling services * Collection of blood from donors (mobile/hospital) * Processing and provision of blood components * Storage, issuance, transport and distribution of whole blood and/or blood products * Testing blood units for TTIs i.e. Philippine Red Cross

Blood Center

* Storage, issuance, transport and distribution of whole blood and PRBC * Compatibility testing of red cell units * Performs Direct Coomb’s test & red cell Ab screening * Investigation of transfusion reactions * Assist the HBTC in the conduct of post-transfusion surveillance

Blood Bank

Philippine Red Cross is an example of

Blood Center

Date of approval of Organ Donation Act of 1991 (RA 7170)

Jan 7, 1992

Organ Donation Act of 1991

RA 7170

deceased individual, including a still-born infant or fetus

Decedent

Individual, of legal age, who makes a legacy of all or part of his body

Testator

An individual authorized to donate all part of a decedent (next of kin, of legal age)

Donor

An individual who receives a legacy or donation

Legatees or Donees

T/F Persons who may become legatees or donees: any hospital, physician or surgeon, accredited medical or dental school, college or university, organ bank storage facility, and any specified individual

Comprehensive Dangerous Drugs Act of 2002

RA 9165

Date of approval of Comprehensive Dangerous Drugs Act of 2002 (RA 9165)

June 7, 2002

RA 9165 repealed this RA

RA 6425 (Dangerous Drugs Act of 1972)

Policy-making and strategy formulating body indicated in RA 9165 (Comprehensive Dangerous Drugs Act of 2002)

DDB

Implementing arm of the Board indicated in RA 9165 (Comprehensive Dangerous Drugs Act of 2002)

PDEA

Drug testing center regulatory body indicated in RA 9165 (Comprehensive Dangerous Drugs Act of 2002)

HFSRB

IRR Governing the Accreditation of DTLs in the Philippines Adopted and approved by DDB through?

Board Regulation No. 2 s. 2003

Classification of DTLs according to service capability

a. Screening Laboratory – qualitative b. Confirmatory Laboratory – quantitative

Types of drug testing

Mandatory Random

MANDATORY drug testing are performed to:

a) Applicants for driver’s license b) Applicants for firearm license c) Officers of the military, police, and other law enforcers d) Persons charged before the prosecutor’s office with a criminal offense having an imposable penalty of imprisonment of not <6 years and 1 day e) Candidates for public office f) Persons apprehended/arrested for violating the provisions of this Act

RANDOM drug testing are performed to:

a) Students of secondary and tertiary schools b) Officers/employees of public & private offices whether domestic or overseas

Philippine HIV AIDS Policy Act

RA 11166

Date of approval of Philippine HIV AIDS Policy Act (RA 11166)

Dec. 20, 2018

Repealed RA 8504 (Phil. AIDS Prevention and Control Act of 1998)

Philippine HIV AIDS Policy Act (RA 11166)

Planning, policy-making, and implementing body indicated in Philippine HIV AIDS Policy Act (RA 11166)

Phil. National AIDS Council (PNAC)

Written consent must be secured from the person taking the test or from the parent or legal guardian if the person is mentally incapacitated or is <15 y.o. No need for parent/guardian’s consent if the child is: 15-18 y.o. or <15 y.o. but is pregnant or engaged in high-risk behavior

Voluntary HIV Testing

Shall be conducted by a social worker, a health care provider, or other health care professional accredited by DOH or DSWD before HIV testing

Proper counseling

Compulsory HIV Testing is applicable to:

a) Persons charged with serious and slight physical injuries, rape, or simple seduction b) Resolution of issues under “The Family Code of the Philippines” c) Blood and organ donors

How is confidentiality maintained in Philippine HIV AIDS Policy Act (RA 11166)

a) Disclosure of HIV-Related Test Results – only to the individual who submitted to the test or to the parent/guardian (if minor), when applicable b) Media Disclosure – requires prior written consent of the subjects consistent with Data Privacy Act of 2012 and Cybercrime Prevention Act of 2012

Exceptions to confidentiality in HIV testing

– Reportorial DOH requirements – Informing health workers directly involved in treatment of care of a PLHIV – Responding to a subpoena issued by a court

PAMET means

Philippine Association of Medical Technologist

Established on September 15, 1963 by Mr. Crisanto G. Almario at the Public Health Laboratory in Sta. Cruz, Manila

Philippine Association of Medical Technologists (PAMET)

PAMET establishment Who? When? Where?

Who: Crisanto G. Almario (Father of PAMET) When: September 15, 1963 Where: Public Health Laboratory in Sta. Cruz, Manila

1st President of PAMET

Charlemagne Tamondong

Only APO of RMTs in the Philippines when PRC was created on June 22, 1973

Philippine Association of Medical Technologists (PAMET)

PAMET LOGO: Symbolizes the continuous involvement where practice and education must always be integrated

Circle

PAMET LOGO: Trilogy of love, respect, and integrity

Triangle

PAMET LOGO: Symbolize the science of MT profession

Microscope & Snake

PAMET LOGO: Color of health

Green

PAMET LOGO: Year of first PAMET election

1964

President during Recognition of PAMET

Charlemagne Tamondong

Second president of PAMET

Nardito Moraleta

President of PAMET during approval of RA 5527

Nardito Moraleta

PAMET president during PAMET News: The first official newspaper of the Association

Nardito Moraleta

3rd PAMET president

Felix Asprer

PAMET president during amendment to Teves Law (salaries of medical professionals)

Bernardo Tabaosares

First lady PAMET president

Angelina Jose

Has the shortest term of office as PAMET president (Jan. – Sept. 1973)

Angelina Jose

She did not finish her last term as PAMET president because of her plans to leave for the U.S.

Venerable Oca

Seventh president and served PAMET from the unfinished term of Ms. V. Oca

Carmencita Acedera

PAMET president during there was an inclusion of all Med. Techs to “Hazard Pay”

Marilyn Atienza

PAMET president during the Publication of the official newspaper of association “Lab News”

Marilyn Atienza

The official journal of the PAMET

Philippine Journal of Medical Technology during Marilyn Atienza's term

16th PAMET president (RECENT)

Luella Virtucio

PASMETH means

Philippine Association of Schools of Medical Technology and Public Health

National organization of all registered SMT in the Philippines

Philippine Association of Schools of Medical Technology and Public Health (PASMETH)

They organized an association of Deans of SMT and Hygiene on May 13, 1970

Dr. Serafin Juliano Dr. Gustavo Reyes

First organizational meeting of PASMETH held at UST

June 22, 1970

First annual meeting of PASMETH held in UST

May 7, 1971

First president of PASMETH

Dr. Gustavo Reyes

Current national president of PASMETH, 2023-2025

Dr. Jose Jurel Nuevo

Sets forth the principles by which health care professionals practice their profession

CODE OF ETHICS OF MEDICAL TECHNOLOGY

In Code of Ethics of MT, sets forth the principles by which health care professionals practice their profession, based on:

* Duty to patient * Duty to colleagues and the profession * Duty to society

Newborn Screening Act of 2004

RA 9288

Continuing Professional Development Act of 2016

RA 10912

Universal Health Care Act

RA 11223

Fourth PAMET president

Bernardo Tabaosares

5th PAMET President

Angelina Jose

Sixth PAMET President

Venerable Oca

8th PAMET President

Marilyn Atienza

9th PAMET president

Norma Nunez Chang

10th PAMET President

Agnes Medenilla

11th PAMET President

Shirley Cruzada

12th PAMET president

Leila Monserrat–Florento

13th PAMET President

Romeo Joseph Ignacio

14th PAMET president

Rolando Puno

MTL part 2 Flashcards

(128 cards)