General Laboratory Flashcards
(43 cards)
What do Quality Assurance Programs usually involve?
- Regular checks for all instruments and equipment
- Making sure all parts are in working order and are performing as expected
- Monitoring of of specimen collection and labeling
- Review of all laboratory supplies, equipment, and water
- Assurance of all laboratory results and analyses
- Participation of external survey programs
What is a Standard?
A material, that has a known composition and a high degree of purity, and are usually described by its chemical and physical character.
What are Standards used for?
To identify and describe other materials or samples.
What is a Control?
A substance that contains known concentrations and amounts of the materials that will be measured in a particular test. (Will often have a chemical and physical character that is similar to samples being tested.)
What steps do you take when there are out of control test results?
- Check any and all calculations that have been made
- Visually inspect all reagents that have been used
- Inspect all instruments and equipment that were used
- Rerun a set of test with a new sample of the control
What steps should you NOT take when there are out of control test results?
- Inform the doctor of the out of control results
- Change batches of standards or reagents used
What does CLSI stand for?
Clinical and Laboratory Standards Institute
What does CLSI do?
Provides standards for a wide range of performance and testing. They cover all types of laboratory functions and microbiology.
What standards does CLSI provide?
- Labeling
- Security/Information technology
- Toxicology/Drug testing
- Statistical quality control/Quantitative measurements
- Performance Standards for various types of antimicrobial susceptibility testing.
CLSI Labeling standards
2 in x 1 in and contain the required elements; patient name (in upper left corner), unique identifier, birth date, date and time of collection, and collector’s signature or ID
CLSI Security/Information technology standards
Technical operational and implementation requirements for ‘in vitro’ analytical equipment and data management mist be followed and essential elements included and de-identification practices utilized.
CLSI Toxicology/Drug testing standards
Protocols for collecting, analyzing, interpreting, and reporting results of drug testing should be used as the basis for development of procedures.
CLSI Statistical quality control/Quantitative measurement standards
Provides guidance for quality control of different measurements procedures to ensure accuracy and safety of laboratory personnel.
Measures to ensure Quality Control
- Checking all the equipment is working properly
- Check for proper instrument handling
- Ensuring that appropriate organisms are used for sensitivity testing
- Double-checking negative reports (especially in parasitology) by supervising personnel
- Evaluating processing time to ensure samples are tested within the appropriate window
- Correlating results, such as reviewing both hemoglobin and hematocrit
- Maintaining accurate and appropriate records
- Preparing a quality control chart
- Establishing standards and controls for daily laboratory operation
- Establishing standards and protocols for acceptance or rejection of samples and analysis
- Applying Westgard’s rule to determine acceptable variation in control before rejecting test results
- Determining is a run has occurred to indicate results are out of control and should be rejected
When does a Shift occur on a Quality Control Chart?
- When the control values on a quality control chart appear to have changed suddenly.
- When control values on the chart are consistently being higher or lower than the mean value (w/in 2SD) on several says in a row.
When does a trend occur on a Quality Control Chart?
- A gradual or slow change in control values over a time period of several days.
What could cause an Upward Shift?
Change in a new standard that has a lower concentration than what is required for the particular test being performed.
What could cause an Downward Shift?
The change to a new standard that has a higher concentration than what is required for the particular test being preformed.
What could cause a trend on a quality control chart?
A slow deterioration or breaking down of an instrument, piece of equipment, or a reagent, and can be wither downwards or upwards.
When it comes to statistical terminology what does Accuracy refer to?
The ability of a test to obtain a true (or accurate) result.
What are Random Errors?
Any departures from the true or accurate value. They can be caused by errors that are inherent in all laboratory analyses and test and the exact causes are not able to be determined.
When it comes to statistical terminology what does Precision refer to?
Reproducibility of results obtained from a particular test. If a repeated test provides the same results time after time, then there is said to be a high degree of precision.
What is Standard Deviation?
A value that estimates the random errors that are inherent in any test or analytical procedure.
What does Standard Deviation do?
It gives insight into how much the obtained data values deviate form the mean (or average) value.
