ABB Gen Knowledge Flashcards

Clin Lab Director study set

1
Q

The lab director is responsible for what three functions?

A

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

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2
Q

What is the equation for standard deviation

A

square root of sum (mean - X)squared over n-1

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3
Q

Given the following data points: 3,7,7,19, calculate the SD

A

6.928

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4
Q

What is the equation for coefficient of variation

A

CV = (SD/mean) x 100

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5
Q

What are the confidence intervals for 1SD, 2SD, 3SD

A
1SD = 68%
2SD = 95%
3SD = 99.73%
6SD = 99.997%
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6
Q

Given that the mean is 9.8 and the SD = 2, calculate the 95% confidence limits for the control

A

9.4 - 10.2

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7
Q

What is the westguard rule for random error

A

1 3S

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8
Q

What is the Westguard rule for systematic error

A

2 2S

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9
Q

Define variance

A

Describes the factors that affect the measurement of an analyte

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10
Q

How is reference range defined

A

range of values derived from a group of normal persons free from disease.
95% of the population of “normal” persons; mean +/- 2 SD

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11
Q

Examples for chain-of-custody use

A
DUI
DOT drug test
Paternity testing
DNA analysis
Rape cases
Med Examiner cases
Transfer of embryos for IVF
Blood typing and cross match
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12
Q

Procedure for specimen collection

A

Wear PPE
Obtain patient consent
Record date, time and initials of collector
Seal specimen with tamperproof security seal for COC

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13
Q

Procedure for specimen receipt in lab

A

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

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14
Q

How many levels of controls are to be run each day of testing

A

At least 2

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15
Q

How long are QC records kept for immunohematology vs a standard lab

A

Immunohema 6 yrs

Std 2 yrs

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16
Q

Define trend

A

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

17
Q

Westguard Rules are generally used with how many control measurements per run?

A

2 or 4, when 2 different control materials are measured 1 or 2 times

18
Q

What is a Z score

A

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

19
Q

Calculate the z score when the control result is 112, the control mean is 100, and the SD is 5

A

2.4

20
Q

An infectious substance is regulated as a hazardous material under what US DOT Hazardous Materials Regulation

A

HMR; 49 CFR parts 171-180

21
Q

List the four exceptions to the two tiered classification system for infectious substances

A

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)

22
Q

List several examples of exempt human specimens

A

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

23
Q

A shipper’s declaration is required for what category(s) of infectious substances?

A

A

24
Q

What is quality assurance?

A

A proactive process that identifies problems and the necessary corrective actions to resolve them

25
Q

What is the purpose of a quality assurance program?

A

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