QUALITY CONTROL IN HEMATOLOGY BSC. MLS 3RD

QUALITY CONTROL IN HEMATOLOGY DEPARTMENT

1. QUALITY CONTROL Presented by: Arun Kumar Yadav Assistant Professor Medical Laboratory Sciences department Sri. Sukhmani Institute of hospitality & Management , Derabassi

2. Quality control (QC) Qc is a technique that is used to detect and correct errors before they result in a defective product or service.

3. QC emphasizes statistical control procedures and also includes reagent and standard checks, linearity checks etc. QC must be practical, achievable and affordable.

4. Five ‘Q’ Framework

5. QP- Provides the planning step QLP- establish std. processes for doing thing QC & QA-provide measures for checking how well thing are done QI- provide a mechanism for acting on these measures

6. Quality assurance It is the total process whereby the quality of laboratory reports can be guaranteed. Summarized as: • Right results, at the right time • On the right specimen • From the right patient • With the result interpretation based on correct reference data • At the right price

7. Quality Assurance vs. Quality Control An overall management plan to guarantee the integrity of data (The “system”) A series of analytical measurements used to statistically assess quality of the analytical data (The “tools”) Quality Assurance Quality Control

8. Pre Analytical Quality Control (QC) Internal Quality Control Analytical Post Analytical External Quality Control

9. terminologies Accuracy It is the percentage of the difference between measured value and true value or closeness of the measured value to the true mean. An accurate method gives correct result.

10. Precision It refers to reproducibility of a result whether accurate or inaccurate within a definite frame of time. A precise method gives same results if repeated.

11. Accuracy and precision

12. Internal Quality Control (IQC) IQC primarily ensures precision and reliability of results and is based on methods in actual use in laboratory. The primary tool for internal quality control is called a control. A control is a specimen with a predetermined range of result values, called control values, that is processed in the same manner as a patient sample. Control samples are processed with each series or run of patient samples.

13. Pre Analytical variables It includes following processes Test ordering and utilization: • Inappropriate tests • Bad handwriting • Wrong patient identification • Delayed order of tests • Inappropriate control of ‘stat’ tests

14. Patient preparation during sample collection Specimen collection, acquisition and patient identification: •Incorrect tube •Incorrect anticoagulant •Incorrect patient identification •Inadequate volume •Sample deterioration (hemolysed) •Improper transportation Sample storage

15. Analytical variables Selection of inaccurate methods Instrument precision Uncalibrated instruments Reagent problem (expired, deteriorated, contaminated, improperly stored, etc.) Sample problem (sample mix up, inadequate volume etc.)

16. Post analytical variables COMPUTER ENTRY OF DATA Reports should be accurate & in a standard format established by the lab. REPORT GENERATION Reports should be in a format that is readable & easily understandable. REPORT DELIVERY Should be timely & to the correct patient. Turn around time (TAT) important factor affecting patient satisfaction. Computerization has made TAT more manageable

17. Labs should appropriately dispose of bio hazard materials LABORATORY ENVIRONMENT It should meet standard requirements necessary for safe, rapid & efficient performance. SPECIMEN DISPOSAL Finally, documented records of all aspects of QC programmed --- maintained—retrievable upon request

18. External quality control is the objective evaluation by an outside agency of the performance by a number of laboratories on material which is supplied specially for the purpose is usually organized on a national or regional basis analysis of performance is retrospective the objective is to achieve comparability with results of other labs.

19. standardization Refers to both materials and methods A material standard or reference preparation is used to calibrate analytic instruments and to assign a quantitative value to calibrators A reference method is an exactly defined technique which provides sufficiently accurate and precise data for it to be used to assess the validity of other methods

20. The main international authorities concerned with primary standards in hematology are the : - World health organization (WHO) - International council of standardization in hematology (ICSH)

21. Control materials Specially prepared It may be anticoagulated Whole blood; preserved pooled red cells, plasma or serum It can be used to check for accuracy if the value has been reliably determined ( e.g. : reference Centre ) Should have controls of high, normal and low values

22. Controls for hematology Low Normal High

23. Control materials At least 1 control specimen should be used for every batch If large specimens, use 1 control for every 20 specimens The same material is used for EQC or also as calibrator

24. Reference standard Substance ( e.g.: Hb std ) that has been characterized by chemical or physical means and has specific values International standard These standard are manufactured by or on behalf of an international organization (e.g. : WHO and International Council for Standardization in Hematology [ ICSH ])

25. Reference material substance ( e.g. : plasma ) or device ( e.g. : reference beads ) that conform to national or international reference std. This material is used to ensure accuracy of the test procedure Calibrator substance or device that conforms to a reference standard or specification. It is used to calibrate an apparatus or to adjust a measurement to obtain accurate results

26. RANDOM ERRORS Indicates that factors affecting precision should be examined. Include fluctuations in sample & reagent volumes, excessive temperature or voltage fluctuations, dirty optics & poor mixing of samples or reagents

27. Next to excellence comes the appreciation of it.