Reference Laboratories of IRAN Hematology Lab. Dr. Atoosa Shariat Torbaghani

3. Quality Assurance Programme Internal Quality Control (IQC) Procedures External Quality Assessment (EQA) Quality Management

4. Internal Quality Control Done during daily routine work Provides an immediate control Errors are corrected immediately

5. External Quality Assessment Evaluates past performance Testing of unknown samples Compare performance with others Provides a forum for improvements and correction of errors

6. Quality Management Training of laboratory staff The use of SOPs Standard supply management Standard equipment management Supervision and organization

7. Why do we need Internal Quality Control? Ensure that test results are reliable Ensure that test results are reproducible Control quality of daily routine work

8. Why do we need External Quality Assessment? To detect hidden problem To receive help and support from the NPHL To compare our performance with others and improve quality

9. Why do we need Quality Management? Enable us to produce quality results Ensure that test results are affordable Ensure that test results are relevant Ensure that test results are interpreted correctly

10. Quality Control: Operational techniques and activities that are used to fulfill requirements quality for quality Quantitative and statistical AIM to reduce both systematic and random error Quality Assurance: All those planed and systematic actions necessary to provide adequate confidence that a product, process or service will satisfy requirements for quality

11.  Non-analytical QC control of procedures not directly associated with the measuring of a parameter Analytical QC control of procedures directly associated with the measurement of a parameter

12. Quality Assurance Targets Preanalytical Process Patient preparation, Specimen collection, Anticoagulant, labeling, storage, transportation Postanalytical Process How report, speed of report,� *never rely on a single value (out of reference range) to make a diagnosis *oslers rule: Try to attribute all abnormal findings to a single case Analytical Process Internal QC External QC

13. Statistical procedure Mean=sum of all measurement divided by the number of measurement Median=point on the scale at which there is an equal number of observation that are above and below Mode = the most frequently occurring result in the set SD CV

14. mean

15. median

16. 

17. Normal Distribution CurveGaussian Curve 1SD=68% 2SD=97% 3SD=99%

18.  ?(x - x ) Variance =S2 = n - 1 Standard deviation = ?S2 SD x 100% Coefficient of Variation = x

19. Quality assurance programme a)At all time: *Correlation system -Blood film with blood count -Blood count with clinical data

20. Correlation system

21. �.QA prog. b) Daily Test on control specimen Levey jenning control chart 2. Duplicate test on patents specimen 3. Check test 4. Delta test 5. Daily mean

22. Quality Chart Control mean+2sd mean mean-2sd days

23. Control Chart : example

24. Example

25. Westgard Rules : 1 2s warning 1 3s Reject 2 2s � 4 1s � R 4s � 6 or 10 warning

33. 

34. 1 2s RE 1 3s RE 2 2s SE shift 4 1s SE R 4s RE shift 6 or 10 X SE

35. Error Random error: variance Increase scatter of value about the true value Results of chance(eg.sampling error) Don�t affect an entire batch of specimens Are not be detected by control samples Systematic error: bias not due to chance eg.deteriorating reagents

36. Random Error Incomplete mixing Bubble or particle in reagent Probe and syringe variation Optical problem Sample line problem ���.

37. Systematic Error Inaccurate standard Poor calibration Inadequate blank Improperly prepared reagents Degradation of reagent Drift of detector Degradation of instrument components Improper setting of temperature bath ���..

38. Duplicate Test

39. Check Test Similar to Duplicate Test But for samples of same day Detection deterioration of apparatus and reagent between tests Suitable for Hg & Rbc ( 4-5 samples)

40. Delta Test Hg > 10% RBC > 10% WBC > 20-25% Plat > 50%

41. Daily Mean  (Bull`s Method)) Assume the population sampled each day remains constant Automation MCV,MCH,MCHC Manual MCHC If has minimum 100 sample/day Mean each Bach (n=20) > 2sd ? systemic error

42. Example

43. �..QA prog. D) Monthly Reagent & Kits check (storage, expire date) Sample collection, anticuagulant,storage Precision of cell counter Blood film ( distribution, staining)

44. �.QA prog. E) Every six month: (Photometer & spectrophotometer,�) calibration (Sampler & pipette) calibration Other instruments

45. External Quality Assessment Consensus method: Sd , 2sd , mean Deletion results > mean + 2sd Again sd , 2sd , mean

46. Deviation index <0.5 excellent <1 satisfactory 1-2 satisfactory but borderline careful watch) 2-3 requires review of techniques check on calibration >3 require urgent investigation

47. Standard Operating Procedure SOP is an important part of QA It is instruction protocol that include all aspects of laboratory practice SOP helps prevent mistakes rather than detecting them

48. SOP have the following features: Accordance with a standard format In simple language, readily understood by employees Contain sufficient details to perform Sop are written by qualified & experienced lab officer It must be followed exactly by all staff It must be given a title, identification number and date Sop reviewed and update on a regular basis

49. SOP include: Title & id number & date Staff able to perform test Principle of the test method Clinical significance of the test Specimen Equipment requirements Reagent & Stain requirement Test procedure instruction( step by step) Calculation & Expected value Reporting and interpretation of results Internal quality control procedures and Sources of error Reference

50. Blood film must be examine in: First time blood count with any abnormal parameters Hematology out-patients at every visit Weekly on Oncology clinic patients Weekly on patients undergoing radiotherapy or cytotoxic drug treatment All neonatal and pediatric patient

51. ����.. Patients with lymphadenopathy , hepatosplenomegaly , or with glandular fever or flu-like symptoms Patients with fever in or coming from malaria area ( unless diagnosis of malaria has already been confirmed) When the blood count by an automated analyzer has been flagged � e.g. because of microcytosis, agglutination, cell fragments, platelet clumps.

52. Data & specimen Retention Request forms 3 months Copies of records 3 m Result work-book 5 year Blood group 10 year EDTA blood specimen 7 days (hg) at 4�C Citrated blood sample 3 weeks at 4�C Blood films 5 years

55. EDTA Mechanism Increase / decrease effect Storage & transport Kinds of : EDTA-Na2,2H2o ? 1.4-2 mg/ml solid EDTA-K2,2H2o ? 1.5-2.2 mg/ml � EDTA-K3 ? 1.5-2.2 mg/ml liquid

56. Calculation Concentration 1.5 mg/1cc blood 3 mg / 2 cc EDTA solution 3% ? 3gr/100cc or 30gr/1000cc or 30000mg/1000cc 1000cc 30000mg X=3000/30000=0.1 X 3mg ? =100 ?l for 2cc blood EDTA solution 1% 1gr/100cc or 10g/1000cc or 10000mg/1000cc 1000 10000mg X=3000/10000=0.3cc X 3mg ? =300 ?l

57. �EDTA NEVER add EDTA powder directly to the sample bottle Shrinkage of RBC Destroy WBC& plt NEVER add the blood before EDTA solution completely dried Dilution blood and destroy RBC