1. Quality Control and Record Keeping Flashcards
What is quality assurance?
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
What does quality assurance address?
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
How can we define quality control program?
a review of all aspects of a process to ensure that results are accurate
How can we define accuracy
how close a measurement is to the true value (measures systemic errors)
How can we define precision?
is the reproducibility or repeatability of results (measures random error)
how can we define reliability
the ability of a method to be accurate and precise
How can we define control?
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
How can we define standards?
are non-biological materials used for calibrating equipment
what are the 3 common categories of errors?
preanalytic, analytic, postanalytic
How do we classify preanalytic variables?
classes as biological or non-biological
What are preanalytic variables?
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
What are are classed as analytic variables?
occurs when the sample is run through the analyzer
In preanalytic variables, what are some clerical errors that are avoidable
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
What are analytic variables?
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
Wht are some factors that cause analytic errors?
unstable reagents
using a test method unsuitable for sample/species evaluated - nonspecifity of a test method
nonstandard sera
How are post analytic variables classified
usually related to errors in data entry and record keeping
What are some random errors in quality control?
caused by variations found in glassware and pipettes
electronic and optic variations of instruments
due to variations in temp controls and timing
What are some basic principles of lab work?
- 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)
What is a normal range or reference range?
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
What do we look for to make sure our results are reliable?
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?
You’ve been told you can’t make a diagnosis, but, what SHOULD you do?
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?
What is our responsibility for lab work?
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
What are 6 lab standards
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
What does a good quality control program include?
- Standard SOP’s for each procedure performed in the lab
- Maintenance records for the equipment - required by SVMA
- Documentation of all samples run
- Quality control log
- Problem solving protocols
- Manuals for all equipment
For a good quality control program, what might a good SOP need?
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
What do we need to document when running samples?
name of operator, date, patient ID, results w/ proper units, and lot # of controls or calibrators
What do you need to write into a quality control log?
documents results of all calibrations and controls whether within accepted values or not
What are the benefits of a good quality control program?
- Provide a continuous record of the precision and accuracy of lab results
- Give early warning of trends and shifts in control results
- increased confidence in the results provided
- improved customer confidence/satisfaction
- Allow for comparisons btw diff testing methods
- monitor equipment performance
- Provide some indication of technologist’s analytical skill
What percent is accepted for reproducibility?
95% or +/- 2.5 SD
What does analyzing of control material’s benefit?
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
How are control materials analyzed and run?
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
What should we do with the results of control material analysis?
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
What do you do when the results have been rejected?
- check for obvious problems like - wrong sample type/anticoagulant, expired products, wrong operating temp, human error, sample contamination
- repeat control assay - use another aliquot of same control material, use freshly reconstituted control material, new lot of reagents, then recalibrate
- run routine maintenance, recalibrate equipment and repeat controls
- consult manufactrer
What does a quality control long need?
date, time, operator, equipment used, test method, analyte, description of problem, resolution, what was done with the patient sample
