Quality control

Question 1

What does quality assurance refer to

Answer 1

Refers to procedures used to ensure that clinical testing is performed in compliance with industry, SVMA, and CVMA standards
It is used to ensure that results are properly recorded according to provincial and federal regulations
Used to verify accuracy and precision of lab test results

Question 2

What does quality assurance address

Answer 2

It addresses all aspects of the operation of the clinical lab
Staff qualifications
SOP
Care and use of all supplies and equipment
Sample collections and handling
Method and frequency of quality control testing
Record keeping procedures
This means being careful and using due diligence when performing every aspect of testing, from collection, storage, handling and running the sample to DOCUMENTATION
For reliable test results, everyone must be committed to quality assurance

Question 3

Quality control program def

Answer 3

: reviews all aspects of a process to ensure that results are accurate

Question 4

Accuracy def

Answer 4

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

Question 5

Precision def

Answer 5

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

Question 6

Reliability def

Answer 6

the ability of a method to be accurate and precise

Question 7

Control def

Answer 7

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

Question 8

Standards def

Answer 8

are non-biological materials used for calibrating equipment

Question 9

Errors are influenced by and categorized by

Answer 9

Influenced by several factors
Are categorised as being one of the following types of errors
Preanylatic
Analytic
Postanalytic

Question 10

Preanalytic variables is and examples

Answer 10

Can be classified as biological or nonbiological
Biological variables that are out of our control
-Includes breed, age, gender of the patient
-Need to be considered by the vet when interpreting results
Biological variables that can be controlled
-Includes proper fasting before collecting the sample
Non Biological variables
-Includes clerical errors, sample collection and handling
-Some of these can also be classified as post analytic errors or factors
Clinical eros are avoidable
-Include delays in processing, labelling, incorrect calculations, sampling the wrong patient, wrong sample type, etc.
-Exasperate when people are overworked, tired, stressed, ill or poorly trained

Question 11

Analytic variables are

Answer 11

These variables occur when the sample is run through the analyzer (ex. Serum analyzer)
They are often seen as a gradual shifts in your control results in one direction
Seen as lowering or rising of the mean
These errors are difficult to discover and correct
Also known as systemic error

Question 12

Some factors that cause systemic errors include

Answer 12

Unstable reagents
Using a test method that is unsuitable for the sample species being evaluated- non specificity of a test method
Nonstandard sera

Question 13

Postanalytic variables are

Answer 13

Usually related to errors in data entry and record keeping

Question 14

Radom errors are caused by

Answer 14

Caused by variations found in glassware and pipettes
Electronic and optic variations of instruments
Due to variations in temp controls and timing

Question 15

Basic principles of lab work

Answer 15

Concentration or “levels” of a particular analyte are measured and compared with a normal range
An abnormal value is usually observed due to a physiological change
This change may cause clinical signs to be seen in the patient
Results are usually quantitative and must have the correct units
Results by themselves are not diagnostic
The validity of your test results are crucial to the care a patient will receive
You need to make sure that your results are reliable
It is the responsibility of the technologist to ensure that they produce reliable results
Part of this responsibility involves the development and use of an adequate quality control program
Quality control programs provide confidence in the validity of the test result

Question 16

What is nromal range

Answer 16

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 17

How to make sure results are reliable

Answer 17

Correct patient
Correct sample for the test being performs
Correct test procedure
Accurate record keeping, including math
Do the results make sense given the patient’s age, gender, history and physical exam finding → does your assessment of the situation make sense

Question 18

Lab standards

Answer 18

The first step in any quality control program is to have high standards for the lab area itself:
Keep the lab area clean
Have a cleaning schedule for the lab and each piece of equipment
Use SOP’s to clarify what needs to be done
The schedule should be initialed by the person who performs the task
The lab area should be well lit
Keep the lab uncluttered
Have the lab well organized
Regularly maintain equipment
Regularly update software
These steps will aid in eliminating random errors

Question 19

What does a quality control program include

Answer 19

Standard SOP for each procedure preformed in the lab
Maintenance records for the equipment
Quality control log
Problem solving protocols
Manuals for all equipment

Question 20

What does on SOP include

Answer 20

Name of the specific test (including synonyms of any)
What it is testing for (rationale)
An explanation of unique terms
Necessary equipment and reagents required
Step by step instructions
Logs associated with the procedure
Quality control procedures specific for that test
Gives an entry level RVT enough info to run the test

Question 21

Maintenance records for the equipment include

Answer 21

Instrument name
Serial and model numbers
Purchase and model numbers
Purchase date
Points to be checked
Frequency of checks
Record of test readings
Changes made- cost and time associated with repairs and restoration
Name or initials of person performing maintenance

Question 22

Quality control log includes

Answer 22

Documents of all calibrations and controls whether within accepted values or not

Question 23

Benefits of quality control program

Answer 23

Provide a continuous record of the precision and accuracy of lab results
Give early warning of trends and shifts in control results
-Corrective action can be taken before a serious loss of precision occurs
Increased confidence in the results provided
Improved customer satisfaction and confidence
-They stay!
Allows for comparisons to be made between different testing methods- an educated choice between methods can then be made
Monitor the performance of equipment, especially automated analyzers
Provide some indication of technologists analytical skills

Question 24

Quality control program is what

Answer 24

Even when a test is performed with the greatest of skill and using the very best equipment available, successive measurements on the sample will differ
It is not possible to reach 100% reproducibility
It is generally accepted that good quality control is that which gives a reproducibility of 95% or +- 2.5 SD

Question 25

Quality control program: analysis of control materials is

Answer 25

Control serum assess 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
Controls are usually obtained commercially
They are processed exactly as a patient sample would be
The controls should test normal as well as abnormal ranges
Results must be recorded in a log book each time they are run
Results should not vary significantly
Results must fall within the manufacturers established range for that machine and that procedure
-If the control results fall out of the expected range the results should be rejected

Question 26

What to do once quality control results are rejected

Answer 26

Check for obvious problems
Wrong sample type or anticoagulant
Expired products
Wrong operating temp
Human error
Sample contamination
Repeat the control assay
Use another aliquot of the same control material
Use freshly reconstituted control material
Use a new lot of reagents, then recalibrate
Run routine maintenance, recalibrate equipment and repeat controls
Consult manufacturer

Question 27

What to record for quality control

Answer 27

Date
Time
Operator
Equipment used
Test method
Analyte
Description of the problem
Resolution
What was done with the patient sample

Question 28

Why would the quality results be done

Answer 28

Patient samples should periodically be sent to a reference lab to monitor your results
Will their results be exactly the same as yours?
Unless quality assurance procedures are followed then testing in clinics is inaccurate and unreliable and should be sent OUT!