Hematology, Rodak: 2 Quality Assurance In Hematology And Hemostasis Testing (Ajfb)

Front 1

Ability to provide accurate, reproducible assay results that offer clinically useful information

Back 1

Quality

Hint 1

- Assay results must be reliable

Reliability - Requires vigilance and effrort

Front 2

Components of Quality Assurance

Back 2

- Analytical

- Pre-analytical

- Post-analytical

Hint 2

Quality Assurance:

Clinical Query Systems - Guide clinicians in lab assay selection

Reflex Assay Algorithms

Front 3

Are employed to document

- Assay Validity, accuracy, and precision

Including external quality assessment, publication of RIs, and therapeutic ranges, and lot-to-lot validation

Back 3

Quality Control Processes

Hint 3

RIs - Reference Intervals

Front 4

Pre-analytical Variables

Back 4

1. Assay selection based on px indication

2. Implementation of assay selection

3. Patient ID and Preparation

4. Specimen collection equipment and technique

5. Specimen transport, preparation and storage

6. Monitoring of specimen condition

Front 5

Analytical Variables

Back 5

1. Lab Staff competence

2. Assay and instrument selection

3. Assay and instrument validation

4. Internal Quality Control

5. External Quality Assessment

Hint 5

Assay and instrument validation includes

1. Linearity

2. Accuracy

3. Precision

4. Analytical Measurement Range

5. Specificity

Front 6

Post-analytical Variables

Back 6

1. Accurate transcription and filing of results

2. Content and format of lab report, narrative report

3. Reference Interval and Therapeutic Range

4. Timeliness in communicating critical values

5. Px and physician satisfaction

6. Turnaround Time - TAT

7. Cost Analysis

8. Physician application of lab results

9. Px outcome

Front 7

Laboratory Staff Responsibility:

Preanalytical Component -

Test Orders

Back 7

- Conduct continuous utilization reviews to ensure that physician-generated orders are comprehensive and appropriate to px indications

- Inform physician about lab test availability and ways to avoid unnecessary orders

- Reduce unnecessary rpt testing

Front 8

Laboratory Staff Responsibility:

Preanalytical Component -

Test Request Forms

Back 8

- Are requisition forms legible?

- Can phlebotomist confirm px identity?

- Are physician orders promptly and correctly interpreted and transcribed?

- Is adequate diagnostic, treatment, and px prep information provided to assist the lab staff to appropriately test and interpret results?

Front 9

Laboratory Staff Responsibility:

Preanalytical Component -

STAT orders and Timeliness

Back 9

- Do turnaround time expectations match clinical necessity and ensure that STAT orders are reserved for medical emergencies?

- Does lab management meet established TAT requirements?

Front 10

Laboratory Staff Responsibility:

Preanalytical Component - Specimen Collection

Back 10

- Is the px correctly identified, prepared, and available for spx collection?

- Is fasting and therapy status appropriate for the assay?

- Is the tourniquet correctly applied and released at the right time?

- Are venipuncture sites appropriately cleansed?

- Are timed spxs collected at specified intervals?

- Are spx tubes collected in the specified order?

- Are additive tubes properly mixed?

- Are spx tubes labeled correctly?

Front 11

Laboratory Staff Responsibility:

Pre-analytical Component - Specimen Transport

Back 11

- Are specimens delivered intact, sealed, and within specified time limits?

- Are spxs maintained at the correct temp?

Front 12

Laboratory Staff Responsibility:

Preanalytical Component - Specimen Management

Back 12

- Are spx centrifuged correctly?

- Are tests begun within specified times?

- Are spx and aliquots stored properly?

- Are coagulation spx consistently platelet-poor?

Front 13

Laboratory Staff Responsibility:

Postanalytical Component - Publication of Reports

Back 13

- Are results accurately transcribed into the information system?

- Are they reviewed for errors by additional lab staff?

- If autoverification is in effect, are correct parameters employed?

- Do reports provide reference intervals?

- Do they flag abnormal results?

- Are result narratives appended when necessary?

- Does lab staff conduct in-service education to support test result interpretation?

- Are critical values provided to nursing and physician staff?

- Are verbal reports confirmed with feedback?

- Are anomalous findings resolved?

Front 14

Laboratory Staff Responsibility:

Postanalytical Component - Timeliness

Back 14

- Are turnaround times recorded and analyzed?

- Are lab reports being posted to px charts in timely fashion?

Front 15

Laboratory Staff Responsibility:

Postanalytical Component: Patient Satisfaction

Back 15

- Does the institution include lab care in px surveys?

- Was spx collection explained to the px?

Front 16

Quality Control relies on the initial computation of

Back 16

- Central Tendency

- Dispersion

Front 17

States that there is no difference between or among the means or variances of the populations being compared

Back 17

Null Hypothesis

Front 18

States that there is no difference between or among the means or variances of the populations being compared

Back 18

Null Hypothesis

Hint 18

Alternative (Research) Hypothesis - Logical opposite of null hypothesis

Front 19

Defined as its ability to reject the null hypothesis if the null hypothesis is false

Back 19

Power of a statistical test

Hint 19

Power is expressed as P which stands for probability that the test is able to detect an effect

P Scale - Ranges from 0 to 1

Front 20

Power is determined by the

Back 20

- Sample size (number of data points, n)

- The design of the research study

- Study’s ability to control for extraneous variables

Front 21

Sum of the individual data values divided by the number of data points

Back 21

Arithmetic Mean or Average

Hint 21

- STANDARD expression of central tendency

- Profoundly affected by outliers and is unreliable in a skewed population

Front 22

A data set that represents a single population

Back 22

Sample

Front 23

A data set that represents a single population

Back 23

Sample

Front 24

Defined as a single data point within a data set (sample)

Back 24

Specimen

Hint 24

In the clinical lab - Specimen often means a tube of blood or a fragment of tissue collected from a px which provides a single data point

Front 25

The n root of the product of n individual data points and is used to compute means of unlike data sets

Back 25

Geometric Mean

Hint 25

n = number of data points

Front 26

Data point that separates the upper half from the lower half of a data set (sample)

Back 26

Median

Hint 26

- ROBUST expression of central tendency in a skewed distribution because it minimizes the effects of outliers

Front 27

How to find the Median

Back 27

- Arrange data set in numerical order and select the central data point

Hint 27

- If the data set has an even number of data points, the median is the mean of the two central points

Front 28

Data point that appears most often in the sample

Back 28

Mode of a data set (sample)

Hint 28

- Not a true measure of central tendency because there is often more than one mode in a data set

Front 29

Measures of Central Tendency

Back 29

- Mean

- Median

-Mode

Front 30

Expresses the deviation of each data point from its expected value, usually the mean of the data set (sample) from which the data point is drawn

Back 30

Variance

Hint 30

Measures of Dispersion:

- Variance

- Standard Deviation

Front 31

- The square root of the variance

- The mean distance of all the data points in a sample from the sample mean

- States the confidence, or degree of random error, for statistical conclusions

Back 31

Standard Deviation

Hint 31

- Most commonly used Measure of Dispersion

- The larger the SD of a sample, the greater deviation from the mean

- SD of an assay is an expression of its quality based on its inherent dispersion or variability

Front 32

- The normalized expression of the SD, ordinarily articulated as a percentage

- Most commonly used measure of dispersion in lab medicine

Back 32

Coefficient of Variation

Front 33

Before patient testing can begin, each

- new instrument

- assay modification, or

- instrument-assay combination

must be ____________

Back 33

Validated

Hint 33

- To confirm the intended results

Front 34

Method Validation includes

Back 34

1. Proof of Accuracy

2. Proof of Precision

3. Reportable Ranges - Including AMR

4. Detection of interfering substances

Hint 34

AMR - Analytical Measurement Range

- Multiple identical instruments and test systems require individual evaluation and approval

Front 35

Additional requirements with modifications to FDA-approved assays and lab-developed tests (LDTs)

Back 35

1. Analytical Sensitivity

2. Analytical Specificity

3. Specimen and reagent stability

4. Carryover

Front 36

- Measure of agreement between an assay value and the theoretical "true value" of its analyte

- Magnitude of error separating the assay result from the true value

Back 36

Accuracy

Hint 36

In Hematology - Testing for accuracy is often not applicable comparability may take the place of accuracy in these situations

Front 37

How to test for Comparability

Back 37

1. Lab professional employs the laboratory's current reagent-instrument system as the reference assay for comparison to a new reagent-instrument system.

2. Alternatively, the operator compares a reagent-instrument system to a previously validated, external reference method

Front 38

Expression of reproducibility or dispersion about the mean, often expressed as SD or CV%

Back 38

Precision

Hint 38

Accuracy - Easy to define but difficult to establish and maintain

Precision - Relatively easy to measure and maintain

Front 39

A material of known, fixed composition that is prepared in pure form, often by determining its dry mass on an analytical balance

Back 39

Primary Standard

Hint 39

- Lab professionals employ primary standards to establish accuracy

- Lab professional dissolves the weighed standard in an aqueous solution, prepares suitable dilutions, calculates the anticipated conc of each dilution, and assigns the conc to assay outcomes

Front 40

Primary Standards in Hematology and Hemostasis

Back 40

- Cyanmethemoglobin

- Fibrinogen

- Factor VIII

- Protein C

- Antithrombin

- Von Willebrand Factor

Front 41

Maybe a previously employed well-controlled assay, or an assay currently being used by an alternate laboratory

Back 41

Reference Method

Front 42

Statistics available to compare results of new or modified assay to a reference method

Back 42

- Student T-test

- Analysis of Variance (ANOVA)

- Linear Regression

- Pearson Correlation Coefficient

- Bland-Altman Plot