QC & QA

Question 1

Clinical Laboratory Improvement
Amendments of 1988
(CLIA ’88)

Answer 1

-established minimum threshold for all testing
-definition of a laboratory
-introduced routine QC (quality control)
-min QC requirements for all nonwaived tests

Question 2

Types of Quality Assessment Errors

Answer 2

Active - Healthcare worker to patient

Latent - Organization or lab design

Question 3

Active Errors

Answer 3

-Fail to identify Patient
-MIssing blood vessel during phlebotomy
- Errors with collection tubes
- Errors with transportation system (Pneumatic tube)
-Errors with data entry
-Errors with instrument or computer (Ignore flags)

Question 4

Latent Errors

Answer 4

-Staffing problems (chronic shortage)
-Information technology (no interface)
- Equipment malfunction
-Work environment (design, multitasking)
- Policy & Procedures (relabeling mislabeled tubes)
-Teamwork factors (shift change)
-Management/organization (profits, ignore patient safety/incident reports)

Question 5

Quality Assessment-Phases of Testing

Answer 5

Preanalytical
Analytical
Postanalytical

Question 6

What phase do most Errors happen

Answer 6

Preanalytical and Postanalytical

Question 7

Error-improving strategies

Answer 7

-Formal patient safety training

-Enhanced communication between patients and laboratory staff and providers directly caring for patients

-Quality improvement projects that involve patient outcomes data and feedback

Question 8

QA Considerations

Answer 8

Supervision
Procedure manual
Specimen collection and handling
Result reporting
Reagents, calibration and standards
Controls
Instruments and equipment
Personnel
Physical faciliites
Laboratory Safety

Question 9

Two Components of QA Program

Answer 9

Non-analytical factors
Analysis of quantitative data (QC)

Question 10

Nonanalytical factors of QA

Answer 10

-Qualified personnel
-Established laboratory policies
-Laboratory procedure manual
-Test requisitioning
-Patient identification, specimen procurement, and labeling
-Specimen transportation and processing
-Preventive maintenance of equipment

Question 11

Phases of Testing QA

Answer 11

-Quality Assessment Phases of testing
-Proficiency Testing (CLIA required)

Question 12

What is QC?

Answer 12

Procedures to monitor the accuracy and precision of test performance over time

Question 13

What QC Helps to monitor

Answer 13

-Test system failure
-Adverse environmental conditions
-Variance in operator performance

Question 14

Primary Goals of a QC Program

Answer 14

-Establish, maintain accurate and precise methods
-Determine level of precision
-Maintain reproducibility based on precision
-Instrument stability and performance
-CLIA compliance
-Benchmarks for improvement

Question 15

Quality Control specimens

Answer 15

-A material or solution with a known concentration of the analyte being measured

-Controls can also be time, temperature, speed etc

Question 16

QC For tests of moderate complexity (CLIA)

Answer 16

-perform and document QC using 2 levels of control material each day

-follow manufacturer’s instructions for QC

Question 17

QA Descriptors, Aspects of clinical quality.

Answer 17

Accuracy
Calibration
Control
Precision
Quality control
Reliability (accuracy and precision)
Standards
Variance

Question 18

Tight cluster, on Target

Answer 18

HIGH PRECISION, High Accuracy

Question 19

Spread all around

Answer 19

Low accuracy, low pecision

Question 20

Tight cluster, off target

Answer 20

High precision, low accuracy

Question 21

spread Near target center

Answer 21

High Accuracy, Low precision

Question 22

Sensitivity

Answer 22

-The proportion of cases with a specific disease or condition that gives a positive test result

-sensitivity = among patients with disease, the probability of a positive test

-(true positive no false negatives)

Question 23

Specificity

Answer 23

-The proportion of cases with absence of the specific disease or condition that gives a negative test result

• specificity = among patients without disease (i.e. healthy patients), the probability of a negative test

-(true negative no false positives)

Question 24

Sensitivity %

Answer 24

(True Positives / True Positives + False Negatives) X 100

Question 25

Specificity %

Answer 25

(True Negatives / False Positives + True Negatives) X 100

Question 26

Avoidable False Results

Answer 26

-Inappropriate time
- obsolete test
-test with inherently poor Sensitivity and Specificity.
- rest lacks extensive clinical validation
-test used on population that is different from studied population.
-Population with very high or low prevalence

Question 27

Consequences of false results

Answer 27

-Maybe none
- Cascade of invasive and expensive tests.
- Lengthened hospital stay
- Additional office visits
- Inappropriate therapy
- Psychological Trauma to false belief