Quality Assurance In

Hematology
Outline
 Basic Components of QA in Hematology
 Quality Assurance Cycle
 Proficiency Testing
 Competency Testing
 Standards, Calibration and Control
 Quality Control
 Stages of Quality Control
 Objectives
At the end of this chapter, the students will be able to:
• Recognize the importance and application of quality
assurance (QA) in hematology.
• Describe the basic components of quality
assurance.
• Define proficiency testing.
• Define competency testing.
• Define different quality control terms.
• Describe the use of quality control procedures to
determine if patient results are acceptable.
 Basic Components of QA in Hematology

• Pre-analytical
– are those components that occur prior to the testing
procedure
• Analytical
– Incorporate the testing process and procedure
• Post-analytical
– are those variables that occur after the testing process
has been completed
 Pre-analytical Components
• Patient identification

• Patient requisition or test orders

• Patient preparation

• Specimen collection

• Specimen transport and handling

• Specimen processing

• Specimen storage
 Analytical Components
• Test procedure or method

• Internal Quality Control

• External Quality Control

• Instrumentation maintenance

• Linearity

• Reference Ranges
 Post Analytical Components
• Review of patient results

• Maintenance of patient results

• Notification to the physician of critical values

• Monitoring turn-around time

• Maintaining all documentation

• Posting or transcription of patient results

 The Quality Assurance Cycle

Patient/Client Prep
Sample Collection
Personnel Competency
Reporting • Data and Lab Test Evaluations
Management
• Safety
• Customer Sample Transport
Service

Record Keeping Sample Receipt and

Accessioning
Quality Control Testing
 Proficiency Testing

• An external quality control that monitors the accuracy of

different test systems and procedures

• Samples are sent to the laboratory from a provider at

specified time intervals. They are tested along with
patient samples.

• The results are returned to the provider and the provider

determines if the results are acceptable.
 Competency Testing

• Competency assessment evaluates personnel’s

knowledge and performance of test procedures

• A new employee is tested twice the first year and then

annually

• Types of testing
– Direct observation
– Random assignments
– Proficiency testing
 Standards, Calibration and Control

• Standards
– Substances of a known composition or reference
material that is used to calibrate an instrument.
• Calibration
– Is the comparison of an instrument measurement to a
know constant.
• Control
– Represents a specimen with a known value or a
predetermined assay value.
 Quality Control Terms

• Mean
• Median
• Mode
• Standard Deviation
• Confidence Intervals
• Coefficient of Variation
• Control Range
 Cont’d

• Mean
– Mathematical average calculated by taking the sum of
values and dividing by the number of values or the
average

• Median
– Is the middle value of your data list

• Mode
– Is the most frequently occurring value
 Cont’d

• Accuracy
– that the value obtained is the closest to the correct
value or the true value

• Precision
– relates to reproducibility or how close the test
results are to one another when performed
repeatedly
 Cont’d

• Reference Range (Interval)

• Every laboratory should determine its own reference

values
• They are determined by:
- Type of instrument
- Sex
- Age
 Control Ranges

• Three levels of control

are run on each shift

• Control material have

known values
– Normal
– Low
– High
 Levey-Jennings Chart

• Extension of Gaussian
curve, with time
expressed on x axis.

• The y axis is scaled to

provide a concentration
made from x ± 3 SD.

• The 2SD lines

correspond to the 95%
limits.
 Case Study 1: Calculations
Hematology Control: Level low
QC Chart: Glucose Control #1 (mg/dl)

May 2009 May 2009 May 2009 May 2009

Day Result Day Result Day Result Day Result
1 2.3 9 2.1 17 2.7 25 2.4
2 2.5 10 3.0 18 2.6 26 2.2
3 2.1 11 2.9 19 2.9 27 2.1
4 2.8 12 2.8 20 2.5 28 2.4
5 2.0 13 2.7 21 3.0 29 2.3
6 3.9 14 2.6 22 4.0 30 2.0
7 2.3 15 2.5 23 2.3 31 2.3
8 1.9 16 2.7 24 1.8
 Calculate Mean

Mean = the calculated average of the values

• The sum of the values (X1 + X2 + X3 … X31) divided by
the number (n) of observations, e.g.,
(2.3 +2.5 + 2.1…) divided by 31

• The mean of these observations is

(77.5  31) = 2.5 g/dl
 Calculation Standard Deviation

• Calculate the Standard Deviation with your calculator

– Instructions to be provided

SD (s) = 0.50
 Calculation the Coefficient of Variation

• Calculate the Coefficient of Variation with your calculator

• Formula is: % CV = SD X 10
mean

% CV = 0.5 x 10 = 2.0%
2.5
 Calculate 95% Confidence Limits
( Typical QC range)

Lower 95% Conf Limit= Mean ( x ) – 2 x SD (s)

= 2.5 – (2 x 0.5)
= 1.5 g/dL
Upper 95% Conf Limit= Mean ( x ) + 2 x SD (s)
= 2.5 + (2 x 0.5)
= 3.5 g/dL

The QC range is: 1.5 – 3.5 g/dL

Review questions
• What is quality assurance
• List the basic components of quality assurance
• Define different quality control terms
 Bibliography
• 1. Baker, F.J. and Silverton, R.E. Introduction to Medical
Laboratory Technology 6th Edition Butterworths and Co. 1985
• 2. Dacie, John V and Lewis, S.M. Practical Hematology 8th
Edition Churchill-Livingstone 1999.
• 3. Evatt, Bruce L., Gibbs, William N., Lewis, S.M. and
McArthur, James R. Fundamental Diagnostic Hematology:
Anemia 2nd Edition Published Jointly by US Department of
Health and Human Services and the World Health
Organization 1992.
• 4. Evatt, Bruce L., Gibbs, William N., Lewis, S.M. and
McArthur, James R. Fundamental Diagnostic Hematology: The
Bleeding and Clotting Disorders 2nd Edition Published Jointly
by the US Department of Health and Human Services and the
World Health Organization 1992.
 Bibliography Cont’d
• 5. Fischbach, Frances A Manual of Laboratory and
Diagnostic Tests 4th Edition J.B. Lippincott Co. 1992.
• 6. Hayhoe, F.G.J. and Flemans R.J. A Color Atlas of
Hematological Cytology 3rd Edition Wolfe Publishing Ltd. 1992.
• 7. Hall, Roger and Malia, Robert G. Medical Laboratory
Hematology Butterworths and Co. 1984.
• 8. Henry, John B. Clinical Diagnosis and Management by
Laboratory Methods 17th Edition W.B. Saunders Co. 1984.
• 9. Hoffbrand, A.V. and Pettit, J.E. Essential Hematology 3rd
Edition Blackwell Science 1993.
• 10. Koepke, John A. Laboratory Hematology Churchill
Livingstone 1984.
 Bibliography Cont’d
• 11. Luzzatto, Lucio (Editors) Clinics in Hematology: Hematology in
Tropical Areas Volume 10 Number 3 W.B. Saunders Co. Ltd. 1981.
• 12. Raphael, Stanley S. Lynch’s Medical Laboratory Technology 4th
Edition Igaku-Shoin/Saunders International Edition 1983.
• 13. Robinson, Stephen H. and Paul Reich, R. Hematology:
Pathophysiologic Basis for Clinical Practice 3rd Edition Little- Brown
and Co. 1993.
• 14. Sigma. Quantitative Colorimetric Determination of Hemoglobin in
Whole Blood. 1984
• 15. Wintrobe, Maxwell M. Clinical Hematology 8th Edition Lea and
Febiger, Philadelphia 1981.
• 16. WHO Manual of Basic Techniques for a Health Laboratory 1981.
• 17. Bridges KR, Pearson HA. Anemias and Other Red Cell Disorders.
McGraw-Hill Co. Inc. 2008.
 Bibliography Cont’d
• 18. Bain BJ. Blood Cells: A Practical Guide. 4th Ed. Blackwell Publishing,
Inc. Massachusetts, USA. 2006.
• 19. Provan D. ABC of Clinical Hematology. 2nd Ed. BMJ Publishing Group.
London. 2003.
• 20. H. Theml, H. Diem, T. Haferlach. Color Atlas of Hematology. 2nd
Revised Ed. Thieme, New York. 2004.
• 21. SM Lewis, BJ Bain, I Bates. Practical Hematology. 10th Ed. Churchill-
Livingstone. 2007.
• 22. AC Guyton. Text Book of Medical Physiology. 11th Ed. Elsevier, Inc.
Philadelphia, USA. 2006.
• 23. DL Kasper, AS Fauci, DL Longo, et al. (Editors). Harrison’s Principles of
Internal Medicine. 16th Ed. McGraw-Hill Co., Inc. USA. 2005.
• 24. BJ Bain. Leukemia Diagnosis. 3rd Ed. Blackwell Publishing Ltd.,
London. 2003.
• 25. RS Hillman, KA Ault, HM Rinder. Hematology in Clinical Practice. 4th
Ed. McGraw-Hill, London. 2005.
 Bibliography Cont’d
• 26. RH Hoffman. Hematology: Basic Principles and Practice.
5th Ed. Churchill-Livingstone. 2008.
• 27. MA Lichtman, E Beutler, U Seligsohn, K Kaushansky, TO
Kipps (Editors). William’s Hematology. 7th Ed. McGraw-Hill Co.
Inc. 2008.
• 28. Zewdineh S. Lecture Notes on Hematology. 1st Ed. Jimma
University – USAID. 2003.
• 29. Yared A, Alemayehu A, Zewdineh S. Lecture Notes on
Hematology. 2nd Ed. Jimma University – USAID. 2006.
• 30. Abbott (http://www.abbott.com)
• 31. ABX Diagnostics (http://www.abx.com)
• 32. Beckman-Coulter (http://www.beckmancoulter.com)
• 33. Sysmex (http://www.Sysmex.com)