Unit 1

Question 1

What is quality assurance used for

Answer 1

Ensures clinical testing is performed in compliance within the SVAM/CVMA standards

Ensures results are recorded according to provincial/feral regulations

Used to verify the accuracy and precision of laboratory results

Question 2

What aspects of operation does quality assurance address

Answer 2

Staff qualifications
Standard operating procedures
Care and use of supplies/equipment
Sample collection/handling
Record keeping procedures
Method and frequency of quality control testing

Question 3

For reliable test results, everyone must be committed to ____

Answer 3

Quality assurance

Question 4

define quality control program

Answer 4

Reviews all aspects of a process to ensure that realists are accurate

Question 5

Define accuracy

Answer 5

How close a measurement is to the true value

Measures systematic errors

Question 6

Define precision

Answer 6

The reproducibility of results

Measures random error

Question 7

Define reliability

Answer 7

The ability of a method to be accurate and precise

Question 8

Define control

Answer 8

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 9

define standards

Answer 9

Non biological materials used for calibrating equipment

Question 10

What are the 3 categorizations of errors

Answer 10

Pre-analytic

Analytic

Post-analytic

Question 11

What are some biological preanalytic variables

Answer 11

Out of control: breed, age, gender

Can be controlled: proper fasting

Question 12

What are some non biological preanalytic variables

Answer 12

Clerical errors, sample collection and handling errors (may also be classified as postanalytic errors)

Question 13

What are clerical errors

Answer 13

Avoidable errors

Includes delays in processing, labelling, incorrect calculations, sampling the wrong patient, wrong sample etc

Exasperated when people are overworked, Tired, improperly trained etc

Question 14

What are analytic variables (aka systemic errors)

Answer 14

Occur while the sample is in the machine/instrument

Often seen as gradual shifts in your control results in one direction

Difficult to discover and correct

Some factors that cause systemic errors: unstable reagents, improper test methods or species evaluated

Question 15

What are postanalytic variables

Answer 15

Usually related to errors in data entry and record keeping

Question 16

What are random errors

Answer 16

Caused by variation dL found in glassware and Pipettes

Electronic and optic variations of instruments

Due to variations in temperature controls and timing

Question 17

What is the normal range (aka reference range)

Answer 17

A set of values compiled statistically from healthy animals of a particular breed/age/test method etc

Each analyte has its own range

Concentrations or levels of analytes are compared with the normal ranges

Question 18

Define analyte

Answer 18

A substance whose chemical constituents are being identified or measured

Question 19

True or false
results from comparison of an analyte to a normal range are diagnostic

Answer 19

FALSE

they must be used in conjunction with history and physical exam findings to make a diagnosis

Question 20

What is the first step in a quality control program

Answer 20

To have high standards for the lab area itself

Cleanliness, SOPs, lighting, organization, maintaining equipment, updated software etc

Question 21

What are the 6 steps of a good quality control program

Answer 21

Standard SOPs for each procedure performed in the lab

Maintenance records for the wquipment

Documentation of all samples run

Quality control log

Problem solving protocols

Manuals for all equipment

Question 22

What should a standard SOP include

Answer 22

Name of specific tests
What it is testing for
Explanation of unique terms
Equipment and reagents required
Step by step instructions
Logs associated with the procedure
Quality control procedures

Question 23

What are some benefits of a good quality control program

Answer 23

Continuous record of precision and accuracy of results

Gives early warning of trends and shifts in control results

Increased confidence of results

Improved customer satisfaction and confidence

Allows for comparisons between different testing methods

Monitors the performance of equipment

Provides some indications of technologists analytic skills

Question 24

True or false
When using the best skill and equipment, successive measurements in a sample will give the same result

Answer 24

False

Successive measurements will differ

It is not possible to reach 100% reproducibility

Question 25

What is the generally accepted reproducibility range

Answer 25

95% of +/- 2.5 SD

Question 26

Control materials assess both the ___ and the ____

Answer 26

Instrument and technologist

Question 27

When should control tests be run

Answer 27

Regularly (based on manufacturer’s guidelines)

When new batches of reagents, test sliders or rotors are ordered or when a problem is suspected

Question 28

If control results fall out of the expected rangers the results should be rejected, once they are rejected what should you do?

Answer 28

Check for obvious problems (wrong sample, expirations, wrong temps, contamination etc)

Repeat the control assay

Run routine maintenance, recalibrate equipment and repeat controls

Consult manufacturer

Question 29

Define assay

Answer 29

To determine the content or quality of something

Question 30

Results of control tests should be recorded every time they are done, what does this include

Answer 30

Every step of the test, date, time x operator, equipment used, test method, analyte, description of the problem, resolution, patient sample