Course 108 Unit 5- Quality Assurance/ Management

Question 1

What is quality assurance?

Answer 1

Systemic process used to monitor, document and regulate the accuracy and reliability of laboratory measurements

Question 2

What are the quality management regulatory and accreditation agencies?

Answer 2

• 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

Question 3

What is some preventive maintenance procedures for Quality Assurance?

Answer 3

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

Question 4

What are some non-scheduled quality assurance procedures?

Answer 4

Non Scheduled maintenance:

• repair or replace as required: electrodes, electrode solution, electrode membrane, pump tubing
• clean and replace dust filters as needed

Question 5

What are the calibration quality assurance procedures?

Answer 5

Equipment is adjusted or corrected to match the control standards: performed on electrodes before analyzing samples to establish the accuracy of results

Question 6

What is the calibration standards for quality assurance?

Answer 6

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

Question 7

What is a one point calibration?

Answer 7

• Calibrates the electrode to one point
• Performed before every blood sample is run
• Automatically runs every 30 minutes
• Manually run after performing maintenance

Question 8

What is a 2 point calibration?

Answer 8

• Calibrates the electrodes at two points (low and high)
• Performed every 8 hours
• Manually run after performing maintenance

Question 9

What is a 3 point calibration?

Answer 9

• Performed every 6 months

- Checks machine for linearity

Question 10

What is quality control?

Answer 10

Test performed to determine accuracy and precision of a device against a known standard

Question 11

What is accuracy?

Answer 11

A measure of how closely the measured results reflect the actual value (within 2 SD standard deviations)

Question 12

What is precision?

Answer 12

An index of dispersion of repeated measurements (all in same area hit same target repeatedly)

Question 13

What types of controls are there for quality control?

Answer 13

• Gases
• Tonometered liquids
• Aqueous buffers
• Whole blood
• Commercially prepared controls (most common)

Question 14

What is internal quality control?

Answer 14

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

Question 15

How often is quality control samples run and where?

Answer 15

• 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

Question 16

How are QC results maintained and evaluated?

Answer 16

Maintained in statistical databases and evaluated to detect the changes in analyzer performance

Question 17

What is the statistical terminology?

Answer 17

• 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

Question 18

What is the Levy-Jennings chart?

Answer 18

A graphic representation of each control run on each electrode

Question 19

What are the Westguard rules?

Answer 19

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

Question 20

What is random error?

Answer 20

One measurement outside of 2 SD (monitor it)

Question 21

What is Rule of Two’s?

Answer 21

Two consecutive points outside 2 SD (recalibrate to see if something needs to be replaced/cleaned before recalibrating

Question 22

What is Rule of Three?

Answer 22

One measurement is 3 SD’s outside of range

Question 23

What is Rule of four “1’s”?

Answer 23

Four measurements are 1 SD outside of range

Question 24

What is Rule of Ten’s?

Answer 24

Ten consecutive control measurements fall on one side of mean (erratic 10 consecutive points)

Question 25

What is external quality control?

Answer 25

• 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

Question 26

What are the analyzer controls for co-oximeter maintenance?

Answer 26

• 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)

Question 27

How often are the sampling chamber and tubing supposed to be cleaned for the co-oximeter?

Answer 27

Once a day with manufacturers recommended cleaning agent (cholorox =chlorine)
*all system maintenance and or QA/QC will be documented on appropriate log sheet

Question 28

What is the College of American Pathologists?

Answer 28

• Introduced in late 1940’s
• Outside agency for inspection/ accreditation
• Inspections are impartial and fair

Question 29

What is the primary purpose of CAP?

Answer 29

• 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)

Question 30

What are the requirements for CAP accreditation?

Answer 30

• 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

Question 31

What is external quality control for CAP?

Answer 31

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