Quality Assesment And Quality Control

Question 1

What organization established minimum QC for all high complexity testing in 1988

Answer 1

CLIA

Question 2

What are active errors

Answer 2

Errors from healthcare worker to patient

Question 3

What are latent errors

Answer 3

Errors from organization or lab design

Question 4

What are some examples of active errors

Answer 4

Failing to ID patient, missing blood vessel in phlebotomy, errors with data entry, errors in instrument or computer

Question 5

What are examples of latent errors

Answer 5

Staffing problems, information technology, equipment malfunction

Question 6

What are the phases of testing process

Answer 6

Preanalytical
Analytical
Postanalytical

Question 7

In what phase of test processing do most errors occur

Answer 7

Preanalytical and post analytical phases

Question 8

What are some error improving strategies

Answer 8

Formal patient safety training, communication between staff and providers, quality improvement projects

Question 9

What is the purpose of college of American pathologists (CAP) quality assessment considerations

Answer 9

Attempt to reduce and eliminate lab errors

Question 10

What are the two major components of quality assessment program

Answer 10

1) non-analytical factors
2) analysis of quantitative data (qc)

Question 11

What are some non analytical factors in quality assessment

Answer 11

Maintaining certification/having certified personnel, established lab policies (SOPs), lab procedure manual etc

Question 12

How is quality control assessed by an outside body

Answer 12

They monitor every step of sample acquisition, processing and return

Question 13

What is proficiency testing

Answer 13

Assessment process that tests unknown specimens from outside source to ensure lab test results

Question 14

In proficiency testing how is accuracy determined

Answer 14

By comparing results across labs

Question 15

What are the ranges of acceptance

Answer 15

1) out of range: failing proficiency test
2) failure once: recheck or re test
3) failure twice: lose ability to perform that form of testing

Question 16

What isQC

Answer 16

Procedures to monitor the accuracy and precision of test performance over time to monitor system failure, adverse environmental conditions and variance in operator performance

Question 17

What are the goals of QC program

Answer 17

Establish, maintain accurate and precise methods; determine level of precision; CLIA compliance

Question 18

What are control specimens

Answer 18

Material or solution with known concentration of analyte being measured

Question 19

For tests of moderate complexity what is different with QC

Answer 19

Preform and document using 2 levels of control material each day based on manufacturer or CLIA

Question 20

Define accuracy

Answer 20

How close to test result is to true value

Question 21

Define calibration

Answer 21

Comparing instrument reading to known constant

Question 22

Define control

Answer 22

Substance with known value that should be tested same way as a patient with similar matrix of that sample

Question 23

Define precision

Answer 23

Reproducibility of test result

Question 24

Define quality control

Answer 24

Use of controls to test for accuracy and precision

Question 25

What is reliability

Answer 25

Accuracy and precision Close to true value and reproducible results

Question 26

Define standards

Answer 26

Highly purified substances of known composition different from control

Question 27

Define variance

Answer 27

Amount of change

Question 28

Define sensitivity

Answer 28

True positives, no false negatives The proportion of cases with a specific disease or condition that gives a positive result

Question 29

Define specificity

Answer 29

True negative, no false positives The proportion of cases with absence of the specific disease or condition that gives a negative test result

Question 30

Assaying for sensitivity and specificity, what elements are needed

Answer 30

Tests positive (false) Tests negative (false) Disease present (positive) Disease absent (negative)

Question 31

How do you calculate sensitivity of a test

Answer 31

Sensitivity%= (true pos)/(true pos+false neg)

Question 32

How to calculate specificity

Answer 32

%=(true neg)/(false pos+true neg)

Question 33

What are some common avoidable causes of false pos and false neg

Answer 33

Use of test at inappropriate time, use of obsolete test, test with inherently poor sensitivity or specificity