ABB Gen Knowledge Flashcards
Clin Lab Director study set
The lab director is responsible for what three functions?
1) employing personnel who are competent to perform test procedures
2) recording and reporting test results promptly, accurately, and proficiently
3) assuring compliance with applicable regulations
What is the equation for standard deviation
square root of sum (mean - X)squared over n-1
Given the following data points: 3,7,7,19, calculate the SD
6.928
What is the equation for coefficient of variation
CV = (SD/mean) x 100
What are the confidence intervals for 1SD, 2SD, 3SD
1SD = 68% 2SD = 95% 3SD = 99.73% 6SD = 99.997%
Given that the mean is 9.8 and the SD = 2, calculate the 95% confidence limits for the control
9.4 - 10.2
What is the westguard rule for random error
1 3S
What is the Westguard rule for systematic error
2 2S
Define variance
Describes the factors that affect the measurement of an analyte
How is reference range defined
range of values derived from a group of normal persons free from disease.
95% of the population of “normal” persons; mean +/- 2 SD
Examples for chain-of-custody use
DUI DOT drug test Paternity testing DNA analysis Rape cases Med Examiner cases Transfer of embryos for IVF Blood typing and cross match
Procedure for specimen collection
Wear PPE
Obtain patient consent
Record date, time and initials of collector
Seal specimen with tamperproof security seal for COC
Procedure for specimen receipt in lab
1) verify that specimen label matches requisition form
2) Log specimen (date,time,name, signature of handler) into the lab
3) Assess specimen integrity
4) Verify specimen acceptability
5) Store specimen in locked area until the specimen is processed for COC
How many levels of controls are to be run each day of testing
At least 2
How long are QC records kept for immunohematology vs a standard lab
Immunohema 6 yrs
Std 2 yrs
Define trend
progressive drift or reported values from a prior mean or movement of values in one direction over six or more analytical runs. This can result from regent deterioration
Westguard Rules are generally used with how many control measurements per run?
2 or 4, when 2 different control materials are measured 1 or 2 times
What is a Z score
Also referred to as the standard deviation index and tells how many SDs a control result is from the mean. The equation is Result - mean over the SD
Calculate the z score when the control result is 112, the control mean is 100, and the SD is 5
2.4
An infectious substance is regulated as a hazardous material under what US DOT Hazardous Materials Regulation
HMR; 49 CFR parts 171-180
List the four exceptions to the two tiered classification system for infectious substances
1) blood, blood plasma, and blood components collected for the purpose of blood transfusion
2) dried blood spots or specimens for fecal occult blood detection on absorbent paper
3) A Cat B when materials are transported by a private or contract carrier in a motor vehicle used exclusively to transport materials
4) patient specimens for which there is minimal likelihood that pathogens are present (exempt human specimens)
List several examples of exempt human specimens
1) blood or urine tests to measure cholesterol,
2) blood glucose levels
3) hormone levels
4) prostate-specific antigens
5) pregnancy testing
6) drug/alcohol testing
7) cancer biopsies
A shipper’s declaration is required for what category(s) of infectious substances?
A
What is quality assurance?
A proactive process that identifies problems and the necessary corrective actions to resolve them
What is the purpose of a quality assurance program?
1) assess and improve the reliability and efficiency of the lab
2) ensure that the highest possible quality of service is provided
3) Comply with regulatory requirements
