1. Quality Control and Record Keeping

Question 1

What is quality assurance?

Answer 1

procedures to ensure testing is compliant w/ the industry, SVMA, and CVMA standards.
used to ensure results are properly recorded
used to verify accuracy and precision of lab results

Question 2

What does quality assurance address?

Answer 2

staff qualifications
SOP’s
care and use of all supplies and equipment
sample collection and handling
method and frequency of quality control testing
record keeping procedures

Question 3

How can we define quality control program?

Answer 3

a review of all aspects of a process to ensure that results are accurate

Question 4

How can we define accuracy

Answer 4

how close a measurement is to the true value (measures systemic errors)

Question 5

How can we define precision?

Answer 5

is the reproducibility or repeatability of results (measures random error)

Question 6

how can we define reliability

Answer 6

the ability of a method to be accurate and precise

Question 7

How can we define control?

Answer 7

is any device, compound or solution which has >1 known characteristics. it is used to verify the accuracy and precision of measurements in unknown samples

Question 8

How can we define standards?

Answer 8

are non-biological materials used for calibrating equipment

Question 9

what are the 3 common categories of errors?

Answer 9

preanalytic, analytic, postanalytic

Question 10

How do we classify preanalytic variables?

Answer 10

classes as biological or non-biological

Question 11

What are preanalytic variables?

Answer 11

include breed, age, gender and must be considered. Not our control
includes proper fasting b4 collecting sample can be controlled.
non-bio variables - clerical errors, sample collection and handling. Some of these can also be classified as postanalytic errors or factors

Question 12

What are are classed as analytic variables?

Answer 12

occurs when the sample is run through the analyzer

Question 12

In preanalytic variables, what are some clerical errors that are avoidable

Answer 12

includes delays in processing, labelling, incorrect calculations, sampling the wrong patient, wrong sample type, etc
exasperated when people are overworked, tired, stressed, ill or poorly trained

Question 13

What are analytic variables?

Answer 13

often seen as gradual shifts in your control results in one direction (lowering or rising of the mean)
difficult to discover/correct, AKA systemic error

Question 14

Wht are some factors that cause analytic errors?

Answer 14

unstable reagents
using a test method unsuitable for sample/species evaluated - nonspecifity of a test method
nonstandard sera

Question 15

How are post analytic variables classified

Answer 15

usually related to errors in data entry and record keeping

Question 16

What are some random errors in quality control?

Answer 16

caused by variations found in glassware and pipettes
electronic and optic variations of instruments
due to variations in temp controls and timing

Question 17

What are some basic principles of lab work?

Answer 17

• Abnormal value normally due to physiological change (may have clin signs)
• results usually quantitative and must have correct units
• Results not diagnostic by themselves (ex. use hx)

Question 18

What is a normal range or reference range?

Answer 18

conc/ “lvls” of a particular analyte are measured and compared with a normal range.
normal range: is a set of values compiled statistically from healthy animals of a particular breed, age, etc using a specific test method
each analyte has its own normal range
also called a reference range

Question 19

What do we look for to make sure our results are reliable?

Answer 19

correct patient, sample for the test being performed, test procedure, accurate record keeping and math
do the results make sense given the patients age, gender, hx and pe findings and does your assessment make sense?

Question 20

You’ve been told you can’t make a diagnosis, but, what SHOULD you do?

Answer 20

Should be able to assess test results and be able to anticipate a plan of care for the patient

do results make sense?
Are they dehydrated?
Are they hypothermic?

Question 21

What is our responsibility for lab work?

Answer 21

our responsibility to ensure that they produce reliable results and involves the development and use of an adequate quality control program
Quality control programs provide confidence in the validity of the test results -allow dvm to make effective medical decisions

Question 22

What are 6 lab standards

Answer 22

1 - keep lab area clean (have cleaning schedule for lab/equipment, use SOP’s to clarify what needs to be done)
2 - lab area well lit
3 - keep the lab uncluttered
4 - have the lab well organized
5 - regularly maintain equipment
6 - regularly update software

Question 23

What does a good quality control program include?

Answer 23

1. Standard SOP’s for each procedure performed in the lab
2. Maintenance records for the equipment - required by SVMA
3. Documentation of all samples run
4. Quality control log
5. Problem solving protocols
6. Manuals for all equipment

Question 24

For a good quality control program, what might a good SOP need?

Answer 24

Should give an entry level RVT enough info to run the test
includes - name of specific test + synonyms
what is testing for (rationale)
an explanation of unique terms
necessary equipment and reagents required
stepbystep instructions
logs associated w/ procedure
quality control procedures specific for test

Question 25

What do we need to document when running samples?

Answer 25

name of operator, date, patient ID, results w/ proper units, and lot # of controls or calibrators

Question 26

What do you need to write into a quality control log?

Answer 26

documents results of all calibrations and controls whether within accepted values or not

Question 27

What are the benefits of a good quality control program?

Answer 27

1. Provide a continuous record of the precision and accuracy of lab results
2. Give early warning of trends and shifts in control results
3. increased confidence in the results provided
4. improved customer confidence/satisfaction
5. Allow for comparisons btw diff testing methods
6. monitor equipment performance
7. Provide some indication of technologist’s analytical skill

Question 28

What percent is accepted for reproducibility?

Answer 28

95% or +/- 2.5 SD

Question 29

What does analyzing of control material’s benefit?

Answer 29

control serum assesses both the instrument and the technologist
acquiring valid results using control materials ensures that machines and reagents are working properly and that the procedure was carried out correctly

Question 30

How are control materials analyzed and run?

Answer 30

obtained commercially, processed same as patient sample (run regularly, or run with new batches of reagents, test slides or rotors are ordered or when problem)
control should test normal as well as abnormal range

Question 31

What should we do with the results of control material analysis?

Answer 31

results must be logged each time run, shouldn’t vary much
must fall within manufactures range for machine/procedure
if outside of range, results should be rejected

Question 32

What do you do when the results have been rejected?

Answer 32

1. check for obvious problems like - wrong sample type/anticoagulant, expired products, wrong operating temp, human error, sample contamination
2. repeat control assay - use another aliquot of same control material, use freshly reconstituted control material, new lot of reagents, then recalibrate
3. run routine maintenance, recalibrate equipment and repeat controls
4. consult manufactrer

Question 33

What does a quality control long need?

Answer 33

date, time, operator, equipment used, test method, analyte, description of problem, resolution, what was done with the patient sample