Chapter 8 Flashcards
POCT is also known as- (2)
-near patient testing
-decentralized testing
POCT is defined as-
lab assays performed near patient
POCT has a reduced-
turnaround time, but at a higher cost
Importance of decentralized Lab POCT Assays- (2)
-WHO identified 147 essential lab tests (EDLs)
-19 lab tests with highest number of applications to essential medicine have been ranked
WHO list of top 19 EDLs for application-
-CBC
-liver enzymes
-renal function
microscopy
-urinalysis
-nucleic acid testing (micro)
-electrolytes
-micro culture & sensitivity
-glucose
-antigen testing in micro
-serology
-human chronic gonadotropin
-bacterial biochemical typing
-lipid panel
-CD4+ lymphocyte count
-blood gases
-coag testing
-hemoglobin A1C testing
-calcium
advantages of POCT- (7)
-patient convenience
-smaller blood specimen required
-faster turnaround time
-testing performed near patient
-reduction of length of hospital stay
-improved patient care management
-easy to operate equipment
use of instruments with stable calibration curves is-
important
QC program should be available from-
manufacturer
all sites performing lab testing are regulated under-
CLIA 88 & must be licensed to perform any testing
CLIA has granted deemed status to approve-
accreditation organizations & allows these entities to accredit or license testing sites
states & city governments may enact mandatory regulations, including-
qualifications of personnel performing the tests, which may be more but not less stringent than federal regulations
POCT procedure categories- (4)
-waived test
-moderately complex tests
-highly complex tests
-provider performed microscopy
termed a waived test by TJC-
diagnostic testing not performed within a traditional lab
a site performing only waived tests must- (2)
-have a “certificate of waiver”
-adhere to manufacturers’ instructions for performing the test
all lab testing must meet the same quality standards regardless of-
where it is performed
for moderately complex POCT, in addition to requirements for waived tests instrument validation is required for-
each new instrument
control of POCT resides with-
CLIA certified lab
CLIA certified lab requires-
at least one lab staff member with credentials & on site to be responsible for each POCT program
written policies & procedures must be available for- (7)
-patient prep
-specimen collection & preservation
-QC & remedial actions
-instrument calibration
-test performance
-equipment performance evals
-results reporting & recording
in 2016, FDA published new final guidelines- (2)
-blood glucose monitoring test systems for prescription point of care use
-self monitoring blood glucose test systems for over the counter use
the FDA 2016 new final guidelines was the first time the performance guidelines clearly differentiated the requirements for-
both types of CLIA waived devices self-monitoring blood glucose devices vs. blood glucose monitoring systems for professional/prescription use in a hospital or professional care setting
US FDA approved marketing for-
23 & me personal genome service genetic health risk tests
approval of 23 & me is the first direct to consumer test that-
analyze DNA from users’ saliva to calculate their genetic predisposition for 10 different diseases/conditions
23 & me 10 different diseases/conditions-
-alpha-1 antitrypsin deficiency
-celiac disease
-early onset primary dystonia
-factor XI deficiency
-gaucher disease type 1
-glucose 6 phosphate dehydrogenase deficiency
-hereditary hemochromatosis
-hereditary thrombophilia
-late onset alzheimer disease
-parkinson disease
