1.6.1 RA 4688 Flashcards
A.O 2021-0037: New Rules and Regulations Governing the regulation of Clinical Lab in the Philippines
T or F
T
To ensure accountability of the laboratory on generation of accurate, precise and reliable laboratory results in a timely manner through continuos compliance
A.O 2021-0037
Rules and Regulations Governing the Licensure of Primary Care Facilities in the Philippines
A.O 2020-0047
The Central government agency authorized to regulate the operation and maintenance of the lab
DOH (Through the BRL)
Formulates the rules and regulations:
Secretary of ______ through the director of _____
DOH
BRL
Designation of NRL and Transfer of corresponding equipment, instruments, supplies, specimens, records from the BRL to the designated NRL
a. Department Order No. 393
b. AO 59 s. 2001
c. AO 27 s. 2007
a
Rules and Regulation Governing the Establishment, operating and maintenance of Clinical Laboratories in the Philippines
a. Department Order No. 393
b. AO 59 s. 2001
c. AO 27 s. 2007
b
Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
a. Department Order No. 393
b. AO 59 s. 2001
c. AO 27 s. 2007
c
A Laboratory testing unit capable of performing limited CL diagnostic procedures. Moves from one testing set to another with DOH-licensed CL as its main laboratory (within 100m)
a. Mobile Clinical Lab (MCL)
b. Physician’s Office Lab (POL)
c. Satelite Clinical Lab (SCL)
a
Refers to an extension of the main CL located within the facility;s compound or promises
a. Mobile Clinical Lab (MCL)
b. Physician’s Office Lab (POL)
c. Satelite Clinical Lab (SCL)
c
Refers to a doctor’s office / clinic wherein CL examinations are performed for the purpose of MONITORING the docotr’s patients only where in NO official results shall be issued
a. Mobile Clinical Lab (MCL)
b. Physician’s Office Lab (POL)
c. Satelite Clinical Lab (SCL)
b
Expiration of license for clinical lab?
1 year
Expiration of license for CL exclusive for research and teaching purposes
3 years
They required to register with DOH-HFRSRB
a. CL exclusive for research and teaching purposes
b. Confimatory testing lab of HIV-certified by the NRL-SLH/SACCL
c. G6PD Deficiency confirmatory Lab
a
A tertiary CL certified by the NSRC to perform this enzyme
a. CL exclusive for research and teaching purposes
b. Confimatory testing lab of HIV-certified by the NRL-SLH/SACCL
c. G6PD Deficiency confirmatory Lab
c
The Laboratory allowed to confirm HIV test
a. CL exclusive for research and teaching purposes
b. Confimatory testing lab of HIV-certified by the NRL-SLH/SACCL
c. G6PD Deficiency confirmatory Lab
b
For application of LTO or CL, issues DOH LTO, inspect, monitor
a. HFSRB
b. NRL
a
Provide reference / referral services for confirmatory testing
Train lab personnel
Maintain the National External Quality assessment scheme
Perform technical Eval of reagents and Diagnostic kits
a. HFSRB
b. NRL
b
National Ref Lab (NRL):
Dengue, Influenza, TB, Malaria
NRL for confirmatory of Blood units
a. RITM
b. SLH
a
HIV/AIDS, Hepa, Syphilis, other STI
a. RITM
b. SLH
b
Toxicology and micronutrient
a. East Avenue MC
b. NKTI
c. Lung Center of the Philippines
a
Hematology/Immunohematology
a. East Avenue MC
b. NKTI
c. Lung Center of the Philippines
b
Biochemistry
a. East Avenue MC
b. NKTI
c. Lung Center of the Philippines
c
Certified by the PSP that there is no patho in the area
Completed training in Clinical Lab medicine and Laboratory Management
Physician
In Laboratory, at least 1 MT per Section
T or F
T
Req Number of Lab professionals and other guidelines:
10 mins / Single test
Manual testing:
- 50 test/RMT/__ hours
- 75 test/RMT/__ hours
Automated testing:
- 100 test/RMT/__hours
- ____ test/RMT/12 hours
8
12
8
150
Reporting:
Bear the name and Signature of _____ and RMT
Pathologist
Reporting:
No report orally or in writing without directive from pathologist or associate except in emergency cases
T or F
T
Recording:
All requests and reports are kept in file at least ___ year
1
Recording:
All requests and reports of Anatomic and Forensic pathology reports are kept ______
Permanent
Complains about Clinical laboratory:
Investigation shall be made by _______ of ______
HFSRB or the CHD director
Complains about Clinical laboratory:
After investigation, they shall suspend, cancel or revoke LTO of the licensees who are found violating the provision of R.A _____
4688
Complains about Clinical laboratory:
The decision may be appealed to the Office of Health secretary within ___ days
10
Complains about Clinical laboratory:
The decision of the Office of the Health Secretary is Final and Executory
T or F
T
