QC Flashcards
What are the 4 elements of risk mitigation in the laboratory?
Risk Assessment, Risk Management, Risk Communication, and Review and Monitoring
Reliability
Degree of accuracy and precision over a period of time
Standard/ Calibrator
Used to determine the unknown substance
Control
used to verify accuracy and precision
If there is a bubble is it random or systematic
random
CV formula
SD/Mean x 100% = % in one decimal
Difference between Calibrator and Standard
Calibrator has multiple known analyte and standard only has one (pure)
How to determine which is more precise
Lowest CV
Double check on 4-1s
especially across two levels where it is only 2 days
How does the lab perform precision testing?
Calculate CV by running different levels of controls at least 20x each
TEa
Total Allowable Error - Max error accepted to be considered reliable
TAE
Total Analytical Error - total error, combines both systematic and random errors
Correlation Coefficient (r)
as close of 0.975 as possible
Slope must be what?
0.95-1.10
TAE must be bigger or smaller than TEa
smaller
Clinical Correlation Checks
correlates patient result with possible disorder, Is there a factor affecting abnormal results
Delta Check
Compares lab result from today to different day. Can be programmed into computer to detect error. Eg. The patient has normal creatine level then next day it is extremely low. This is not possible unless they lost a limb.
Limit Check
Check or Flag that let tech know patient result is beyond normal reference range. This check asses wether result is valid or not
Mean of normal
A variation in mean when running patient result may be an error since most patient stay within the mean. This is an alert or check
Pending Report/ Test Completion Check
Result have not been released. This pending report check verifies all test are completed and released.
Reflex Testing
automatic reflex to test for other test when ordering certain test. To save cost and time (like having to recollect)
Lab results must be documented and maintained for how many years?
2
Instrument data such as maintenance, calibration, corrective actions, etc. must be retained for how long?
Life of the intrsument
Procedure manuals and Standard operating procedures (SOPs) are to be kept for how many year after discontinuation of the test.
2
