1. Pakistan Society Of Chemical Pathologists Zoom Series of Lectures ZT 24. Quality Managent 1 Brig Aamir Ijaz MCPS, FCPS, FRCP (Edin), MCPS-HPE HOD and Professor Chemical Pathology AFIP Rawalpindi

2. Specific Learning Outcome
At the end of this lecture the students will be able to describe the processes involved in Quality Management.

3. Task 1
Write FIVE Qs of total quality management

4. TQM Framework

5. MCQ No 1 A. Quality Assessment
A laboratory manager is concentrating on the measures like reducing turnaround time, specimen identification, patient identification and test utility. Which of the following term best describes these processes:
Quality Assessment
Quality Control
Quality Improvement
Quality Laboratory Processes
Quality Planning
A. Quality Assessment

6. Quality Assurance / Assessment (QA)
An all inclusive / comprehensive system monitoring the accuracy of test results where all steps before, during and after the testing process are considered.
It includes pre-analytic, analytic and post analytic factors
Provides a structure for achieving lab and hospital quality goals

7. Quality Control (QC)
QC systems monitor the analytical process; detect and minimize errors during the analysis and prevent reporting of erroneous test results.
It is like ‘product testing’ in an industry
It uses statistical analysis of test system data
Requires Westgard Rules

8. Types of QC Internal Daily Establishment of reference ranges
Validation of a new reagent lot and/or shipment
Following instrument repair

9. Types of QC External Proficiency Testing
Determination of laboratory testing performance by means of intra-laboratory comparisons
NEQAPP in Pakistan
CAP, CLIA, The Joint Commission requirement
Must be integrated within routine workload and analyzed by personnel who are running the tests.
Ongoing evaluation of results to correct for unacceptable results
Used to access employee competency

10. QC Material

11. Task 2
Please write the following control materials in the order of the accuracy and reliability:
Lyophilized, bovine, un-assayed controls
Lyophilized, bovine, assayed controls
Liquid, human, and assayed controls

12. QC Materials Human or Bovine Lyophilized or Liquid
Assayed or Unasssayed

13. Human or Bovine Why human is better than bovine?
Values are closer to patient values (obviously)
What precaution required in human?
Infection free

14. Lyophilized or Liquid Which is better? Liquid Why? No pipetting error
What is the disavantage
Higher cost

15. Assayed or Unasssayed Why human is better than bovine?
Values are closer to patient values (obviously)
What precaution required in human?
Infection free

16. Some Basic Statistics

17. D. Symmetrical distribution
MCQ No 2
Normal data means:
Labs own generated values
Result of disease free subjects
Result of healthy individuals
Symmetrical distribution
Values within reference range
D. Symmetrical distribution

18. Gaussian/Normal Distribution
All values are symmetrically distributed around the mean
Characteristic “bell- shaped” curve
Assumed for all quality control statistics

19. MCQ No 3 D. Standard Deviation
Which of the following is NOT a measure of central tendency?
Average
Mean
Median
Mode
Standard deviation
D. Standard Deviation

20. Measures Of Central Tendency
Mean (x̄) - the mathematical average of a group of numbers, determined by adding a group of numbers (events) and dividing the result by the number of events
Median - determined as the ‘middle’ of a group of numbers that have been arranged in sequential order. That is to say, there are an equal number of numbers on either side of the ‘middle’ number. In an odd # of observations, it is the middle observation. In an even # of observations, average the two middle values.
Mode - the number that appears most frequently in a group of numbers. There can be more than mode, or none at all.

21. Standard Deviation (SD)
Is a mathematical expression of the dispersion of a group of data around a mean.

22. Standard Deviation :
n = the number of observations (how many numerical values )
Σ = the sum of … in this case, the sum of
= the mean value
X = the value of each individual observation
The Standard Deviation is an expression of dispersion … the greater the SD, the more spread out the observations are

23. Standard Deviation and Probability
For a set of data with a normal distribution, a value will fall within a range of:
+/- 1 SD 68.2 % of the time
+/- 2 SD 95.5% of the time
+/- 3 SD 99.7% of the time

24. Which is a Better Assay? FSH Concentration SD 1 0.09 5 0.25 10 0.40 25
1.20
100
3.80

25. Coefficient of Variation (CV) %
Analyte:
FSH Concentration SD CV 1
0.09
9.0 5
0.25
5.0 10
0.40
4.0 25
1.20
4.8
100
3.80
3.8
The smaller the CV, the more reproducible the results: more values are closer to the mean.
Useful in comparing 2 or more analytical methods
Ideally should be less than 5 %

26. Coefficient of Variation (CV)
Indicates what percentage of the mean is represented by the standard deviation
Reliable means for comparing the precision or SD at different units or concentration levels
Expressed as a percentage
CV% =
Standard deviation X 100
mean

27. Establishment of a QC System
Two or three levels of control material used
A control is a material or preparation used to monitor the stability of the test system within predetermined limits
Measure of precision and reproducibility
Purpose: verify the analytic measurement range of instrument for a specific analyte

28. Establishment of a QC System
Collecting data
Run assay on control sample & manually enter control results on chart
One chart for each analyte and for each level of control

29. Collecting Data For QC Charting techniques
Levey Jennings chart is a graph that plots QC values in terms of how many standard deviations each value is from the mean

30. Use of Standard Deviation
Once you have determined the standard deviation, must use the information to evaluate current/ future analysis.
Most labs make use of ± 2 SD or 95% confidence limit. To put this into a workable form, you must establish the range of the ± 2 SDs

31. So, How Do We Determine The Range Of Acceptable Results ?
Scenario
Mean of group of control values = 104 mg/dL
Standard Deviation = ± 5 mg/dL
Determine the Range of ± 2SD; (which will allow you to evaluate acceptability of performance of the control on subsequent days.)
Is a control value of 100 mg/dL acceptable?

32. Thank You