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Definition
-Degree of Excellence
- Conformance to the requirements of users or customers; satisfaction to the needs of the customer |
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Definition
-Related to Quality
-Quality Increase, Cost Decrease
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1) Cost of conformance- anything spent to eliminate waste and improve productivity
2) Cost of non-conformance- anything spenf because of wastes or wasteful practices |
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Term
Total Quality Management
[TQM] |
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Definition
| A management philosophy for organizational development as well as a management process for improving quality in all aspects [satisfy customer] |
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Term
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Definition
1)QLP- general procedures, policies, practices
2) *QC- emphasis on stats control procedures
3)QA- broad monitoring of all lab processes
4)QI- id's problems and offers solutions
5)QP- are problems solved and requirements met? |
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Term
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Definition
1)Preanalytical Variables
2) Analytical Variables |
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Term
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Definition
Must be carefully controlled for (for all Qs)
-Factors that affect specimen before they get to the lab |
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Definition
Must be controlled for to ensure accurate measurements (for QA&QC)
-Affect specimen while still in the lab
-Stat procedures monitor these |
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Term
| Statistical Quality Control (QC) |
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Definition
Monitors performance of analytical methods thru use of stat analysis of:
1) QC procedures and materials
2) Control Charts
3)Westgards multi-rules
4)Sending specimen to other labs to check accuracy |
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Term
| How to check on QC procedures and materials: |
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Definition
| Use stimulated serum and test to see if it falls in interval. |
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Term
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Definition
1)Levey-Jennings Charts: x-y plot that uses the average and SD of control values
2) Cumulative sum chart: examines scatter of all values around the mean
Examined for trends and analyzes stat. |
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Term
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Definition
Criteria that detect subtle change in control data
-Improves quality and decreases subjectivity in data analysis
-Includes rejection criteria
-1st check analytical method! |
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Term
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Definition
- 12s: 1 control value exceeds the mean +/-2s
- 13s: 1 control value exceeds the mean +/-3s
- 22s: 2 consective controls exceed the mean +/-2s
- 41s: 4 consecutive controls exceed the mean +/-1s
- R4s:1 control observations exceeds the mean +2s and other exceeds -2s
- 10x: 10 consecutive controls exceed the mean +/-1s
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Term
Patient Data:
Non-Statisitical QC |
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Definition
-Most direct form of QC (Correlation of test results with other patient data)
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Term
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Definition
1) Average of normals: statistically assesing all patient values to assess stability
2) Delta check: Compares one specimen results with previous results from same patient
3) Pattern Recognition: Special checks that detect unlikely combinations of test values. |
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Term
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Definition
| Records of all maintenance procedures must be kept for all equipment |
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Term
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Definition
QA is practice of assuring that everything related to the lab meets quality standars
-products to customers
-Control values to agencies
-procedure manuals to the lab itself |
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Term
| QA apart of ? required by ? and ? Score |
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Definition
Quality control procedures are a statistical part of QA, required by CLIA ’88
–A score of 80% must be attained on three consecutive external proficiency tests for a lab to continue patient testing |
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Term
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Definition
•Specimens sent to laboratories by non-profit organizations that evaluate the adequacy of lab performance
•PT validates internal QC programs; PT is also called “external QC”
•Sanctions are severe for cheating, failing to get an 80%, failing to participate, failure to return results on time |
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Term
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Definition
•Accuracy: the closeness of the agreement between a measured value to the “true” value;
Error is used to assess accuracy
•Error: deviation from what is correct; caused by the introduction of “variables”
–Westgard rules determine what type of error has occurred |
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Term
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Definition
1) Random Error: affects precision (repeated measurements) and is the basis of the varying differences of repeat measurements.
2) Systematic Error: arises from factors that contribute to a constant diff or trend to a value |
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Term
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Definition
No trend; cant predict when it will happen; chance experiences
-Cause include pipette errors, poor transfer; temp changes; poor sample prep |
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Term
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Definition
–affects the estimate of the mean
–causes include poorly made reagents, bad calibration, failing instruments, poorly written procedures, interferences in samples
–is considered to be a measure of the agreement between the measured quantity and the true value |
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Term
| Kinds of Systematic Error |
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Definition
–Constant systematic error: stays the same distance from the mean even as the analyte concentration changes
–Proportional systematic error: changes in relation to the concentration of the analyte |
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Term
| Westgard Rules and Error Type |
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Definition
12s - warning only (probably random)
13s - detection of random error
22s - detection of systematic error
41s - detection of systematic error
R4s - detection of random error
10 - detection of systematic error |
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Term
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Definition
•ability of a method to produce the same value for many measurements of the same sample (also called “reproducibility”)
–many kinds of precision checked when new methods or equipment are used |
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Definition
•range of analyte concentratons that a method can measure and still remain linear |
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Definition
• ability of a method to produce a change in signal for change in quantity; this will detect small changes in concentration of an analyte |
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Term
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Definition
•related to accuracy; ability of a method to determine only the analyte it’s supposed to without being subject to interferences |
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Term
| Important Aspects of QA: Clinical Sensitivity |
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Definition
•the ability of a specific test to diagnose a specific disease...it is stated as the proportion of individuals with a disease that test positively for it |
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Term
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Definition
•How to calculate: in patients with the disease
# with a positive result = true positives (TP)
# with a negative results = false negatives (FN)
Clinical Sensitivity % = [TP / (TP+FN)] X 100 |
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Definition
•the ability of a test to correctly predict the number of individuals without a specific disease |
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Term
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Definition
How to calculate: in patients without the disease
# with a positive result = false positive (FP)
# with a negative result = true negative (TN)
Clinical Specificity % = [TN / (FP+TN)] X 100 |
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Term
| Inspections by outside agencies: |
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Definition
•Inspections by outside agencies
–JCAOH
–CAP
–HCFA
–ASCP
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•Inspectors assess recordkeeping, QC, comments of customers |
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