MODULE 4 Flashcards
RA 4688 and date of approval
Clinical Laboratory Law
May 19, 1996
a head of a registered clinical laboratory must be a……….
licensed physician duly qualified in laboratory medicine and authorized by the secretary of health
An act regulating the operation and maintenance of Clinical Laboratories
RA 4688 (Clinical Laboratory Law)
known as the New rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines
DOH A.O 2021-0037
when was DOH A.O 2021-0037 published?
June 11, 2021
A facility that is involved in the preanalytical, analytical, and post-analytical procedures
CLINICAL LABORATORY
a facility where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases
clinical laboratory
A classification by function of CL wherein it deals with the chemical and cellular analyses of blood and other body fluids
CLINICAL PATHOLOGY
classification of ownership of CL wherein it is operated and maintained, partially or wholly, by the national government
Government
A classification by function of CL wherein it provides processing and examination of surgical specimens as to the physical appearance and microscopic structure of tissues
ANATOMIC PATHOLOGY
A classification by function of CL wherein it deals with the analysis of certain genes, proteins, and other molecules from organs, tissues or bodily fluids
MOLECULAR PATHOLOGY
Institution-based laboratories are laboratories located within the premises and operates as part of a DOH licensed health facility —> true or false
true
classification by institutional character by CL wherein it operates independently and is not attached to any DOH licensed health facility
non-institution based
refers to an extension of the main CL located within the facility’s compound or premises
SATELLITE CLINICAL LABORATORY
a lab testing unit that is capable of performing limited CL diagnostic procedures. it also moves from one testing site to another
MOBILE CLINICAL LABORATORY
all CL are not required to secure DOH-LTO from DOH regulatory office –> true or false
false, all CL are required to secure DOH-LTO
validity of DOH-LTO
1 year only
the mobile CL must be at a maximum of _______ kilometers from the main laboratory
100 kilometers
the main laboratory must be a DOH licensed laboratory –> true or false
true
the DOH-licensed CL shall not perform any examinations or testing beyond its authorised service capability –> true or false
true
what is required for CL who operates exclusively for research and teaching purposes?
DOH-HFSRB
the CL must register for DOH-HFSRB
the highest level of laboratory in the Philippines performing highly complex procedures, including confirmatory testing
NRL (National Reference Laboratory)
the highest level of laboratory that is responsible for facilitation NEQAS to ensure standards for regulation and licensing of all laboratories in the Philippines
NRL (National Reference Laboratory)
an EQAP activity conducted by NRL to assess the quality of performance and accuracy of the results of laboratories
NEQAS
National External Quality Assessment Scheme
refers to the doctor’s office/clinic wherein CL examinations are performed for purpose of monitoring the doctor’s patients only
Physician’s Office Laboratory (POL)
POL who is not within the premises of a DOH-regulated facility shall not be under the supervision of the CL –> true or false
true
pg 11 of Module 4
refers to diagnostic testing done at or near the site of patient care rather than in the CL
Point of Care Testing (PCOT)
who is designated as the POCT coordinator?
the senior staff
the reagents and test-kits must be DOH-approved –> true or false
false
it must be FDA-approved
type of tests that are done on urgent cased, the result of which shall be released immediately
STAT tests
how many hours must STAT tests release
within 1 hr only
refers to panic values originally described as “life-threatening”
CRITICAL VALUES
all lab reports must have the name of the RMT –> true or false
true
refers to CL tests that are either sent out or outsourced to other DOH-licensed CL with the same or higher service capability
REFERRAL TESTS
refers to the permit issued by the DOH through HFSRB or CHD-HFSRB to an applicant who will establish or operate a hospital or other health facility
DOH-PTC
Department of Health - Permit to Construct
DOH-PTC are only for new, renovated, change in ownership and transfer of location —> true or false
true
how many days can the laboratory comply with the deficiencies?
within 30 days
if the laboratory was not able to comply with the deficiencies for 30 days, what will happen?
the application will be denied
DOH-LTO is transferable –> true or false
FALSE
it is non-transferable
what is COR required for
for RESEARCH and teaching laboratories
validity of DOH-LTO
1 YEAR
COR for CL shall be required to register with the DOH-HFSRB every
3 years
who prescribes all the fees
DOH
CL that is operated and maintained exclusively for research and teaching purposes shall issue official results for diagnostic purposes. –> true or false
false
they cannot issue official results for diagnostic purposes because it is beyond of their capabilities
Who is responsible for the penalization of a CL
HFSRB / CHED Director
what is the validity of CL that is operated and maintained exclusively for research and teaching purposes?
3 years
