Quality Management – Flashcards
Unlock all answers in this set
Unlock answers| Quality |
-Degree of Excellence - Conformance to the requirements of users or customers; satisfaction to the needs of the customer |
| Cost |
-Related to Quality -Quality Increase, Cost Decrease
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| Types of Quality Costs |
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 |
Total Quality Management [TQM] |
| A management philosophy for organizational development as well as a management process for improving quality in all aspects [satisfy customer] |
| TQM involves what? |
| Processes in the lab |
| 5Q Framework |
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?; |
| Controlling Variables |
1)Preanalytical Variables 2) Analytical Variables |
| Preanalytical Variables |
Must be carefully controlled for (for all Qs); -Factors that affect specimen before they get to the lab |
| Analytical Variables |
Must be controlled for to ensure accurate measurements (for QA;QC) -Affect specimen while still in the lab -Stat procedures monitor these |
| Statistical Quality Control (QC) |
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 |
| How to check on QC procedures and materials: |
| Use stimulated serum and test to see if it falls in interval. |
| Control Charts Include: |
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. |
Westgard's Multi-Rules |
Criteria that detect subtle change in control data -Improves quality and decreases subjectivity in data analysis -Includes rejection criteria -1st check analytical method! |
| WEST Rules |
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Patient Data: Non-Statisitical QC |
-Most direct form of QC (Correlation of test results with other patient data)
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| Patient Data: Procedures |
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. |
| Instrument Maintenance |
| Records of all maintenance procedures must be kept for all equipment |
| QUALITY ASSURANCE |
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 |
| QA apart of ? required by ? and ? Score |
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 |
| Proficiency Testing (PT) |
•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 |
| Important Aspects of PT |
•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 |
| 2 Types of Error |
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 |
| Random Error |
No trend; cant predict when it will happen; chance experiences -Cause include pipette errors, poor transfer; temp changes; poor sample prep |
| Systematic Error |
–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 |
| Kinds of Systematic Error |
–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 |
| Westgard Rules and Error Type |
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 |
| Precision |
•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 |
| Analytical Range |
•range of analyte concentratons that a method can measure and still remain linear |
| Analytical Sensitivity |
• ability of a method to produce a change in signal for change in quantity; this will detect small changes in concentration of an analyte |
| Analytical specificity |
•related to accuracy; ability of a method to determine only the analyte it’s supposed to without being subject to interferences |
| Important Aspects of QA: Clinical Sensitivity |
•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 |
| How to calculate CSens: |
•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 |
| Clinical Specificity |
•the ability of a test to correctly predict the number of individuals without a specific disease |
| How to calculate CSpec: |
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 |
| Inspections by outside agencies: |
•Inspections by outside agencies –JCAOH –CAP –HCFA –ASCP – •Inspectors assess recordkeeping, QC, comments of customers |
