MTL part 2 Flashcards
REGULATORY LAWS AFFECTING THE PRACTICE OF MEDICAL TECHNOLOGY
RA 4688
AO 2021-0037
DO 393-E s. 2000
RA 7719
AO 2008-0008
Clinical Laboratory Act of 1966
RA 4688
RELATED LAWS, ORDERS, AND ISSUANCES TO MEDICAL TECHNOLOGY
RA 7170
RA 9165
RA 11166
Clinical Laboratory Act of 1966 (RA 4688) Date of approval
June 18, 1966
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)
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
AO no.
New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines
AO 2021-0037
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
Classification of Clinical Laboratories by ownership
Government
Private
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)
Classification of Clinical Laboratories by function
- Clinical
- Anatomic
- Molecular Pathology
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
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)
Classifications under CL for Clinical and Anatomic
Primary
Secondary
Tertiary
Limited
Allowed tests in secondary lab
All allowed tests in primary +
* Electrolytes, ALT, AST
* Coagulation studies
* Gram stain
* PAP smear
Allowed tests in tertiary lab
All allowed tests in primary and secondary +
* Tumor markers
* Thyroid function test
* Hepatitis profile
* Cytology and Histopathology
* Microbiology
Allowed tests in limited lab
- Specialized tests not classified under anatomic or molecular:
o Trace materials
o Allergy panel
o Tumor markers
Included in CL for Anatomic Pathology only
Cytology and Histopathology
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
Licensing Standards for laboratory
RMT – should include a designated Biosafety and Biosecurity Officer
Included in CL for Molecular Pathology only
Genetics
Immune/hematopathology
Infectious diseases
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
In information management indicated in AO 2021-0037, laboratory reports must contain these:
original signature of the RMT
signature of the pathologist
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”
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
- Lab referral services
- NEQAS administration
- Training of laboratory personnel
- Evaluation of In Vitro Diagnostic Medical Devices
- Surveillance systems to provide critical inputs as a guide to DOH policies and stakeholders’ response activities
- 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
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
T
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
