1. بسم الله الرحمن الرحيم

2. Kefaya El-Sayed Mohamed
Quality Management
Kefaya El-Sayed Mohamed
Professor of Clinical Pathology (Clinical Chemistry)
Faculty of Medicine, Mansoura University

3. The Laboratory test begins with a physician deciding which test to order and ends with that physician evaluating the test result. A process of brain to brain transmission of medical in formation.

4. Problems arise primarily from imperfect processes, not from imperfect people.
The quality problems are primarily management problems because only management has the power to change work process.

5. The total system for a health care organization involves the interaction of all of the following processes as well as many others:

7. Physicians might view a health care organization as a provider of processes for:
Patient examination.
Patient testing.
Patient diagnosis.
patient treatment.

8. Health care administrators might view the activities in terms of processes for :
Admitting
Patient services
Discharging patients
Billing for costs of service

9. Laboratory directors might understand their responsibilities in terms of processes for:
Acquisition of specimens
Processing of specimens
Analysis of samples
Reporting of test results

10. Laboratory analysts might view their work as processes for:
Acquiring samples
Analyzing samples
Performing quality control
Releasing patient test results

11. Report Written order Measurement Specimen Specimen preparation
Test request
Interpretation
Report
Calculation
Written order
Measurement
Specimen
Specimen
preparation
Patient preparation

12. Quality Assurance (Q.A)

13. The five Q framework
Defines how quality can be managed using the scientific method or the PDCA cycle Plan do check Act:
Quality planning
QLP
Includes analytical process and the general policies, practices and procedures that define how all aspects of the work get done.

14. e.g.: Linearity checks , reagent and standard checks and procedure.
Q.C.
Statistical.
Non statistical:
e.g.: Linearity checks , reagent and standard checks and procedure.
Q.A. quality assessment concerned with:
Measures and monitors of laboratory performance as:
Turaround
Specimen identification
Patient identification
Test utility
Q.I. quality improvement:
Provides a structural problem-solving process

15. With better analytical quality a lab can eliminate repeat run requests for test (this work is waste).
If quality are improved waste will be reduced which reduce cost and provide a competitive advantage.
If quality means conformance to requirements, then quality costs must be cost of conformance and cost of non-conformance.

16. To customer requirement
PREVENTION
(To prevent problem)
For appraising performance
For poor analytical performance
For analytical quality

17. Essential Elements for Q.A.
Commitment.
Facilities and Resources.
Technical Competence.
Technical Procedures.
Problem solving Mechanism.
Input from QC technologist or supervisors to initiate the mechanism.
In service training program.
Specialized trouble shooting skills.
Quality team responsible for problem solving (small groups).

18. Essential elements for Q.A.

19. Essential elements for Q.A.

20. Essential elements for Q.A.

21. Essential elements for Q.A.

22. Technical procedures

23. Technical procedures
Methodology

24. Standardization and calibration:
Technical procedures
Standardization and calibration:
Reference calibrator material (RCM) (primary calibrator): by definitive method (absolute physical quantity such as mass) e.g. isotope dilution mass spectroscopy.
Test calibrator material (TCM) (secondary calibrator): by reference method and high quality staff.

25. Structure of an accuracy-based measurement system showing relationships among reference methods and materials .

26. Documentation of analytical protocols and procedures.
Technical procedures
Documentation of analytical protocols and procedures.
Monitoring of critical equipment and materials.

27. Q.C. The Monitoring of analytical quality by the use of:
Technical procedures
The Monitoring of analytical quality by the use of:
Q.C.
SD, bias and 6 sigma
Levey – Jennings chart
Westgard multirules
Cum Sum
P.T.

28. Levey Jennings control chart:
Q.C.
Levey Jennings control chart:
Analyze control 20 different days  mean ± SD.
Construct Control chart.
Control limits set as the mean ± 3s. Concentration is plotted on the y-axis versus time (run number) on the x- axis.
Introduce the control into each run & record the value.

29. Control limit:
± 2 SD when the number of observation (n) is one  false rejection problem (Pfr).
± 3 SD when n = 2 or more  error detection (Ped is low).

30. Q.C.
Levey Jennings chart
M+3SD
M+2SD
M+1SD
Mean
Concentrations M
M-1SD
M-2SD
M-3SD
Run number

31. Westgard Multirules Chart
Q.C.
Westgard Multirules Chart
If the control is within mean ± 2SD  in control:
I2s one excced mean ± 2SD ( warning that initiate testing of other control rules).
I3s one excced mean ± 3SD ( Random error )
22s 2 consecutive control excced mean ± 2SD (systemic error)
R4s 2 consecutive excced mean plus and minus 2SD)
( Random error)
41s 4 consecutive excced mean ± 1SD ( syst. errors )
10x` consecutive deviation Less than 1SD on one side (system errors)

32. Q.C Westgard chart Run number
13s (random)
M+3SD
12s (warning )
22s systemic
4s (Random)
M+2SD
41s systemic
M+1SD
Mean
Concentrations M
M-1SD
M-2SD
M-3SD
Run number

33. Pfr is kept low Ped is improved Westgard Multirule Chart
A word from Dr. Westgard
Westgard Multirule Chart
Pfr is kept low
Ped is improved

34. Introduce two control specimens into each analytical run :
Q.C
Westgard chart
Introduce two control specimens into each analytical run :
When both fall with 2s limits accept the analytical run and report the patient results.
When one exceeds 2s limit hold the patients results and inspect the control data using l3s, R45, 22s and 10x-
When one of these rules is out of control, reject the analytical run & don’t report the analytical results .
When all of these rules indicate that the run is in control , accept the analytical run and report the patient results

35. This effectively increases n and improve the Ped of the procedure
Q.C
Westgard chart
R4s is applied only within a run –between Run interpritted as RE
Rule may be applied "across" materials one observations can be on the low, concentration and the other on the high concentration as long as they are within the same run .
Rules 22s, 41s and 10x rules can be applied across runs and materials.
This effectively increases n and improve the Ped of the procedure

36. Systemic error: caused by variations in:
Q.C.
Systemic error: caused by variations in:
Instruments
Technique
Reagents or other material
Random error:
Appear despite, Tightly Controlled, Analytical method
Sample piptting
Dissolving reagent
Mixing sample and reagents
Baths temp instability.

37. Q.C.
The overall objective of these rules is to obtain a high probability of error detection and a low frequency of false rejection of runs:
If the rules are violated it must:

38. QC performance characteristics
Different QC procedures have different sensitivities or capabilities for detecting analytical errors.
The best is that with lowest Pfr and highest Ped.

41. Cumulative sum CUSUM chartQC
Cumulative sum CUSUM chart
Calculate difference between mean & the result (e.g. mean 100 , result 110 the diff = 10) -add this difference to the following each day.
Interpret the chart data .
Steep slope of the Cusum Line, suggest systemic errors and the run is out of control.

42. QC
CUSUM

43. QC
CUSUM
The Same as before but the difference is calculated between the estimated control value and k1 or ku (mean ±SD):
The cusum calculation do not start until a control value exceeds a certain threshold above (Ku) or below (K1) of the expected mean (X).

44. This difference summated for 2 weeks QC
CUSUM
This difference summated for 2 weeks
If the summation exceed the control Limit  the method out of control
If the sign changed (+  - or the reverse  the calculation stopped  the method is in – control
changed to

45. QC
CUSUM
Calculations and Tabular Record for Decision Limit Cusum For Control Material.
With X=100, S=5.0, kU = 105 , K1 =95,hu=13.5,h1=13,5).

46. (Its efficiency is relatively low)
Q.C using patients data
(Its efficiency is relatively low)
Clinical correlation:
Correlate clinical diagnosis with laboratory test results e.g. impossible test result such as normal serum bilirubin in a highly jaundiced patients.
Correlation with other laboratory tests e.g. T4 and TSH, urea and creatinine.

47. Inter laboratory duplicate:
Q.C using patients data
Inter laboratory duplicate:
Divide sample into 2 aliquots and do analysis.
This is a simple Q.C. procedure used in absence of stable control material.

48. Delta checks with previous test:
Q.C using patients data
Delta checks with previous test:
To detect certain errors e.g. identification or labelling.
Compare laboratory test results with value obtained on previous specimens from the same patients.
Delta check limit based on 3-day interval in term % of change from the initial value e.g. Na+ 5%, CK 99%.

49. Q.C using patients data
Limit checks:
Patients test results should be reviewed to check that they are within the physiological ranges compatible with life.
Low warning
High warning
S. Albumin (g/dl)
1.5
6.0
S. Uric acid (mg/dl)
1.0
12.0
S. Sodium (mmol/L)
120.0
150

50. External Q.C. Analyze the same Lot of control material: N. ± 1-1.5.
> 2 Indicate that the Lab is not in agreement with the test of other Laboratories in the program.
Must correct any test method instrum. trouble shooting.

51. SDI for the same instruments and techniques:
External Q.C.
SDI for the same instruments and techniques: =

52. Comparison of Lab. Mean and group mean by t-test.
External Q.C.
Comparison of Lab. Mean and group mean by t-test.
If significant (<0.05), the Lab. Result is biased.

53. Role of proficiency testing (PT) in Accreditation
According to Clinical Laboratory Improvement Amendments (CLIA88)
Study 5 samples 3 times per year so as to improve the capability of detecting "unacceptable“ performance.
The lab. must produce correct results on 4 out of 5 specimens for each of the analytes in that category and have an overall score of at least 80% for 3 consecutive challenges.

54. The criteria of PT failure is:
Two of five incorrect results on two of three consecutive PT surveys
If there are 2 incorrect results for any analyte , The Lab. is considered "on probation " Lab .
Suspended Lab:
If the lab .has 2 or more incorrect results for any analyte or has any score less than 80% on two of three consecutive surveys.
Suspended Lab. must cease all analytes in that specialty category until it is reinstated .

55. Target value (% or absolute value):
The mean of all responses after removal of outliers (more than 3SD).
Or the mean established by definitive or reference method (acceptable by the national committee of standard NCS).
Comparative method may be used in absence of the former methods.

56. Post Analytical Goals and Clinical Interpretation of Lab. Procedures
The following questions must be asked for test results:
Screening : Is an apparent disease present ?
Pathoghysiology : What is the disease process ?
Confirmation : How can Confidence in the tentative diagnosis be increased ?
Prognosis : How Severe is the disease process ?
Monitoring : Has a change occurred since the Last observation ?

57. Is it significantly different from previous result ?
The probability that the difference between two result is analytically significant (p< 0.05) is 2.8 times the analytical SD (SDA of repeated measurements of a single quality normal control serum).
To decide whether an analytical change is clinically significant, it is necessary to consider the extent of natural biological variation (means of SDB for repeated measure ments made at weekly intervals in healthy subjects over 10 weeks).

58. The effects of analytical and biological variation can be assessed by calculating the overall standard deviation of the test by:
If the difference between two test results exceeds 2.8 times the SD of the test, it can be considered of potential clinical significant:

59. Is it consistent with clinical findings ?

60. LAB. TESTING PROCESSES AND THEIR POTENTIAL ERRORS

61. LAB. TESTING PROCESSES AND THEIR POTENTIAL ERRORS
ordering
Inappropriate test
Handwriting not legible
Wrong patient identification
Special requirements not specified
Cost or delayed order

62. LAB. TESTING PROCESSES AND THEIR POTENTIAL ERRORS
Specimen
acquisition
Incorrect tube or container
Incorrect patient identification
Inadequate volume
Invalid specimen (e.g. hemolyzed or too dilute)
Collected at wrong time
Improper transport conditions

63. LAB. TESTING PROCESSES AND THEIR POTENTIAL ERRORS
Analytical
measurement
Instrument not
calibarted correctly
Specimen mix –up
Incorrect volume of specimen
Interfering substance present
Instrument precision problem

64. LAB. TESTING PROCESSES AND THEIR POTENTIAL ERRORS
Test reporting
Wrong patient identification
Report not posted in chart
Report not legible
Report delayed
Transcription error

65. LAB. TESTING PROCESSES AND THEIR POTENTIAL ERRORS
interpretation
Interfering substances not recognized
Specificity of test not understood
Precision limitations not recognized
Analytical sensitivity not appropriate
Previous values not available for comparison

66. Six Sigma

67. Six Sigma What is six sigma
Today’s competitive environment leaves no room for error
This is why six sigma quality must be a a part of our culture.
What is six sigma
It is a process that helps us focus on developing and delivering near perfect products and services.

68. Six Sigma
Why sigma
The word is a statistical term that measures how far a given process deviates from perfection.
The central idea behind six sigma is that you can measure how many” Defects” you have in a process, you can systematically figure out how to eliminate them and get as close to “zero defects” as Possible.

69. Six Sigma
The principles of Six Sigma go back to Motorola’s approach to TQM in the early 1990s and the performance goal that “6 sigmas or 6 standard deviations of process variation should fit within the tolerance limits of the process”; hence, the name Six Sigma.

70. Six Sigma

71. Methods of sigmametric measurement
Six Sigma
Methods of sigmametric measurement

72. Tea = tolerable error or allowable total error (determined by CLIA)
Six Sigma
Sigma = (Tea – bias)/cv
Tea = tolerable error or allowable total error (determined by CLIA)
Bias = inaccuracy

73. Six Sigma
A shift or bias of 1.5 sigma would hardly cause any defects in a six sigma process. The actual rates that are expected are as follows:
3.4 DPM for a six-sigma process;
233 DPM for a five-sigma process;
6210 DPM for a four-sigma process;
66,807 DPM for three-sigma; and
308,537 DPM for a two-sigma process

74. Six Sigma

75. Six Sigma

76. Six Sigma

77. Six Sigma

78. Methods with 6 sigma performance are considered “World class”.
Six Sigma
Methods with 6 sigma performance are considered “World class”.
Methods with sigma performance less than 3 are not acceptable for production.

79. Chemistry Test or Analyte CLIA Acceptable Performance
Six Sigma
Chemistry Test or Analyte
CLIA Acceptable Performance
Five-Sigma Precision
Six-Sigma Precision
Blood gas pCO2
5 mm Hg or 8% (greater)
1 mm Hg or 1.6%
0.8 mm Hg or 1.3%
Blood gas pH
0.04 pH units
0.008 pH units
pH units
Calcium, total
1.0 mg/dL
0.2 mg/dL
0.17 mg/dL
Chloride 5%
1.0%
0.83%
Cholesterol, total
10%
2.0%
1.7%
Cholesterol, HDL
30%
6.0%
5.0%
Creatine kinase
Creatinine
0.3 mg/dl or 15% (greater)
0.06 mg/dL or 3.0%
0.05 mg/dL or 2.5%

80. Chemistry Test or Analyte CLIA Acceptable Performance
Six Sigma
Chemistry Test or Analyte
CLIA Acceptable Performance
Five-Sigma Precision
Six-Sigma Precision
ALT
20%
4.0%
3.3%
Albumin
10%
2.0%
1.7%
Alkaline Phosphatase
30%
6.0%
5.0%
Amylase
Bilirubin, total
0.4 mg/dL or 20% (greater)
0.08 mg/dL or 4%
0.067 mg/dL or 3.3%

81. Six Sigma
Glucose
6 mg/dL or 10% (greater)
1.2 mg/dL or 2.0%
1.0 mg/dL or 1.7%
Iron, total
20%
4.0%
3.3%
LDH
Magnesium
25%
5.0%
4.2%
Potassium
0.5 mmol/L
0.1 mmol/L
0.08 mmol/L
Sodium
4 mmol/L
0.8 mmol/L
0.67 mmol/L
Total protein
10%
2.0%
1.7%
Urea Nitrogen
2 mg/dL or 9% (greater)
0.4 mg/dL or 1.8%
0.33 mg/dL or 1.5%
Uric acid
17%
3.4%
2.8%

82. Toxicology Test or Analyte
Alcohol, blood
25%
5.0%
4.2%
Blood lead
10% or 4 mcg/dL (greater)
2.0% or 0.8 mcg/dL
1.7% or mcg/dL
Carbamazepine
Digoxin
20% or 0.2 ng/mL (greater)
4.0% or ng/mL
3.3% or ng/mL
Ethosuximide
20%
4.0%
3.3%
Gentamicin
Lithium
0.3 mmol/L or 20% (greater)
0.06 mmol/L or 4.0%
0.05 mmol/L or 3.3%
Phenobarbital
Phenytoin
Primidone
Procainamide
Quinidine
Theophylline
Tobramycin
Valproic acid

83. Hematology Test or Analyte Partial thromboplastin time
Six Sigma
Hematology Test or Analyte
Erythrocyte count 6%
1.2%
1.0%
Hematocrit
Hemoglobin 7%
1.4%
Leukocyte count
15%
3.0%
2.5%
Platelet count
25%
5.0%
4.2%
Fibrinogen
Partial thromboplastin time
Prothrombin time

84. THANK YOU