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