What this point of care testing?
Those analytical patient testing activities provided within the institution but performed outside the physical facilities of clinical laboratories
CLIA stands for.....
What is Clinical laboratory improvement amendments.
Who is a technical consultant?
The consultant responsible for scientific oversight of the point of care testing
What is the largest error in point of care testing?
a. pre analytical
b. analytical
c. post analytical
a. pre analytical
What is Lab Information Systems (LIS)?
A connection with the laboratory's computer system
What are examples of point of care tests?
Tests for blood glucose, electrolytes, urinalysis, blood gases, hemoglobin A1c etc.
How many types of CLIA certificates exist?
There are 5 types
What is a procedure/policy?
A document including but not limited to principle of test, personnel qualification, reagents, QC and calibrations, reference ranges and interfering substances, etc.
What is connectivity?
Improving or preventing post-analytic errors is achieved by these measures, including bar codes
What is a docking station or data management system?
POCT devices transmit information about tests performed on them through these to the laboratory's LIS
What is a major advantage of point of care testing?
Improving faster delivery of results, thereby allowing physicians to order and perform the tests, and thereby immediately making medical decisions.
What is a Provider-performed microscopy procedure (PPMP)?
A category of point of care testing that involves use of a microscope for labile specimens that may not survive transport to the laboratory.
What are moderate-complexity tests?
POC programs required to have a certain organizational and administrative structure with a qualified and experienced staff
What is the definition of an internal QC?
Quality control that is built into the instrument and performed at specific time intervals or at least daily
What is two-way connectivity?
This is a preferable type of connectivity because it also allows the data management system to upload data to the POCT devices
What our some disadvantages of point of care testing?
Proper integration of test results into patient's electronic medical record, increased cost per test, pre-analytic, and analytic and post analytic issues due to testing by non-laboratory personnel, etc.
What is a waived test?
A category of testing defined by CLIA and are subject to the lowest level of regulation and are clear by the FDA for home use; these are so simple and accurate that chances of erroneous results are negligible and pose no harm to the patient if performed incorrectly...
Who is the laboratory director?
He/she has a broad range of responsibilities including policy making, ensuring of compliance with regulatory standards and administrative duties; who is responsible for analytic performance of tests and continuous quality monitoring
What is QC lockout?
Failure of QC means that the instrument does not allow patient testing until corrective action is performed
What is a glucometer/glucose testing device?
The most commonly use POCT devices are used for testing this analyte
What is the advantage of small sample size in point of care testing?
Use in neonatal and pediatric population with a preference for these under-sized patients, especially if they require frequent testing.
What are the names of the five CLIA certificates?
waiver, registration, PPMPs, compliance and accreditation?
Who is the point of care coordinator (POCC)?
She/he supervises the point of care testing program, including monitoring date of the activities of testing personnel, organizing POC testing, developing training program, oversees the Proficiency testing and on site review of point of care testing
What is competency assessment?
This applies to personnel performing moderate to high complexity tests, is done after initial training and 6 months, and then annually thereafter
What are
Patient, sample, operator and device identifiers
Date and time of specimen collection and analysis
Type of specimen
Test requested and test result with units
Error messages and action messages?
Patient information points that are required by CLSI to accompany patient test results