Course 108 Unit 5- Quality Assurance/ Management Flashcards
What is quality assurance?
Systemic process used to monitor, document and regulate the accuracy and reliability of laboratory measurements
What are the quality management regulatory and accreditation agencies?
- Centers for Medicare and Medicaid Services (CMS)
- Clinical Laboratory Improvement Act/Amendments (CLIA)
- College of American Pathologists (CAP)
- Joint Commission (JC)
- Clinical Laboratory Improvement Program (CLIP) —> military version of CLIA
- National Committee of Clinical Laboratory Standards (NCCLS)
- Local operating instructions
What is some preventive maintenance procedures for Quality Assurance?
Preventive maintenance:
- clean blood spills from exterior with appropriate cleaning solution
- empty waste bottle
- check supply levels and replace if necessary: wash and cleaning solutions, calibration buffer solutions, calibration gas tank pressure
- note always wear gloves
What are some non-scheduled quality assurance procedures?
Non Scheduled maintenance:
- repair or replace as required: electrodes, electrode solution, electrode membrane, pump tubing
- clean and replace dust filters as needed
What are the calibration quality assurance procedures?
Equipment is adjusted or corrected to match the control standards: performed on electrodes before analyzing samples to establish the accuracy of results
What is the calibration standards for quality assurance?
specific blood gas values are used to set the machine to read linearly over the expected range of results:
-buffer solution: use for calibrating pH elctrodes; 6.84 (zero point) and 7.384 (slope point)
-gases: used for calibrating the PO2 and CO2 electrodes: Tank 1 contains 5 percent CO2 and 12 percent or 20 percent
Tank 2 contains 10 percent CO2 and 0 percent O2 the rest is nitrogen
What is a one point calibration?
- Calibrates the electrode to one point
- Performed before every blood sample is run
- Automatically runs every 30 minutes
- Manually run after performing maintenance
What is a 2 point calibration?
- Calibrates the electrodes at two points (low and high)
- Performed every 8 hours
- Manually run after performing maintenance
What is a 3 point calibration?
- Performed every 6 months
- Checks machine for linearity
What is quality control?
Test performed to determine accuracy and precision of a device against a known standard
What is accuracy?
A measure of how closely the measured results reflect the actual value (within 2 SD standard deviations)
What is precision?
An index of dispersion of repeated measurements (all in same area hit same target repeatedly)
What types of controls are there for quality control?
- Gases
- Tonometered liquids
- Aqueous buffers
- Whole blood
- Commercially prepared controls (most common)
What is internal quality control?
Controls are samples with known values that are run to ensure the analyzer is operating correctly -Have specific ranges: -Level 1. Normal -Level 2. Acidotic -Level 3. Alkalotic -Level 4. High PO2 * only used when routinely analyzing very high PO2; operating room ECMO
How often is quality control samples run and where?
- QC samples run in pairs every 8 hours for 24 hour labs
- Before the start of the duty day to lunch and end of the duty day in a clinic
How are QC results maintained and evaluated?
Maintained in statistical databases and evaluated to detect the changes in analyzer performance
What is the statistical terminology?
- Mean: average; divide the sum of a group by numeric entries of the group
- Standard deviation: is a measure that is used to quantify the amount of variation or dispersion of a set of data values
- Coefficient of variation: ratio of standard deviation to the mean; shows the extent of variability in relation to the mean of the measured population
What is the Levy-Jennings chart?
A graphic representation of each control run on each electrode
What are the Westguard rules?
Specific criteria and actions to be taken based on the results of QC samples:
- in control= no action required
- random error=closely monitor
- out of control= must perform corrective action
- systematic error=recurrent measurable deviation from mean
What is random error?
One measurement outside of 2 SD (monitor it)
What is Rule of Two’s?
Two consecutive points outside 2 SD (recalibrate to see if something needs to be replaced/cleaned before recalibrating
What is Rule of Three?
One measurement is 3 SD’s outside of range
What is Rule of four “1’s”?
Four measurements are 1 SD outside of range
What is Rule of Ten’s?
Ten consecutive control measurements fall on one side of mean (erratic 10 consecutive points)
What is external quality control?
- proficiency testing
- system that compares the accuracy of results from a lab with the results obtained from other labs
- identical blind (unknown) samples are sent from an outside agency (CAP) to participating labs
- samples are analyzed and returned to the sending agency
- the results are compared to known values and results from other labs
What are the analyzer controls for co-oximeter maintenance?
- assures the reliability of blood sample values
- values should be within manufacturers standard deviation
- controls should be ran every eight hours
- once before the start of a normal day, 8 hour shift (pulmonary laboratory)
- once every 8 hours, if running an around the clock laboratory ( respiratory therapy)
How often are the sampling chamber and tubing supposed to be cleaned for the co-oximeter?
Once a day with manufacturers recommended cleaning agent (cholorox =chlorine)
*all system maintenance and or QA/QC will be documented on appropriate log sheet
What is the College of American Pathologists?
- Introduced in late 1940’s
- Outside agency for inspection/ accreditation
- Inspections are impartial and fair
What is the primary purpose of CAP?
- Assess the state of the art in all clinical laboratory practice
- Promote laboratory improvement through peer comparison
- Satisfy regulatory requirements of credentialing agencies ( CLIA= Clinical Laboratory Improvement Act/Amendment, CLIP= Military version of CLIA, The Joint Commission)
What are the requirements for CAP accreditation?
- Quality management program
- Laboratory safety plan
- Document control plan
- Competency assessment program (make sure manager is giving an assessment annually)
- Laboratory director oversight documentation
- Specific requirements for a laboratory information system
- Standardizes the operation of different laboratories
- CAP inspections are every 2 years
What is external quality control for CAP?
Proficiency testing or CAP surveys:
- system that compares the accuracy of results rom a lab with results obtained from other labs
- identical blind (unknown) samples are sent from an outside agency (CAP) to participating labs (consists of 5 to 10 controls; limits and standard deviations are only known to CAP)
- the samples are analyzed and returned to CAP
- the results are compared to the known values and results from the other labs
