quality control in clinical pathology

quality control set up

1. QUALITY CONTROL IN PATHOLOGY QUALITY CONTROL IN PATHOLOGY

2. Quality Assurance in Healthcare All management systems are now focused on getting the job done. All promise more efficient and effective management Some have been effective in making larger profits while others have been effective in providing a better service to the client

3. DEFENITION Quality Control - QC refers to study of those errors which are the responsibility of the laboratory and the procedures used to recognize and minimize them. This study include all errors arising with in the laboratory b/w receipt of specimen and dispatch of the report.

4. Quality assurance : It is the sum total of all lab activities that are undertaken to ensure generation of accurate and reliable results .

5. The Quality Assurance Cycle Pre-Analytic Analytic Post-Analytic Data and Lab Management Safety Customer Service Patient/Client Prep Sample Collection Sample Receipt and Accessioning Sample Transport Quality Control Record Keeping Reporting Personnel Competency Test Evaluations Testing

6. Purchasing & Inventory Assessment Occurrence Management Information Management Process Improvement Customer Service Facilities & Safety The Quality System Organization Personnel Equipment Documents & Records Process Control (QC & EQA) & Specimen Management

7. Quality systems Objectives To prevent risks To detect deviations To correct errors To improve efficiency To reduce costs How : By establishing a quality manual defining Organizational structure – Staff Responsibilities Procedures and processes Resources Documentation

8. Factors influencing quality: Pre analytical Analytical Post analytical Right Specimen Laboratory professionals Recording Right collection Reagents Interpretation Right labeling Equipment Turnaround time Right quantity Selection of test - SOP Report to right user Right transport Records Right storage Bio-Safety

9. Areas of Phlebotomy subject to QC Patient preparation procedures Specimen collection procedures Identification Equipment Puncture device Evacuated tubes Labeling Technique Collection priorities Delta checks

10. Specimen rejection mislabeled/unlabeled improper transport temp. or container/medium quantity not sufficient (QNS) leaking delay in transport (> 2 hrs unpreserved) inappropriately received in fixative, or received dried up MUST COMMUNICATE WITH CARE TEAM

11. User manual Example of QA documentation Chart or type form Contains information on minimum amount of specimens required, special handling desired, reference values, TAT etc.

12. Procedure Manual Standardization purposes Must be updated annually Written in a special format – NCCLS States laboratory policy and procedures that apply to each test in the lab

13. Information found in a Procedure Manual Purpose of the procedure Specimen type and collection method Equipment and supplies required Detailed step-by-step procedure Limitations and variables of the method Corrective actions Method validation Normal values and references

14. Internal Quality control: IQC Nature: Concurrent performed by: lab staff Objective: Reliable results on a daily basis External quality assessment: EQA Nature: Retrospective to evaluate IQC Performed by: Independent agency Objective: Ensure inter laboratory comparability Components of Quality assurance

15. IQC Based on monitoring the test procedures. Measurements on specially prepared materials Repeated measurements on routine specimens. Daily statistical analysis of data obtained Eliminates differences in random and systematic errors between samples and standards

16. EQC Evaluation by an outside agency of the performance by numerous laboratories of specially supplied samples. National schemes are known as – NEQUAS (National External Quality Assessment Scheme).

17. STANDARDISATION Encompass both materials and methods Standard material/ reference preparation- Used to calibrate an analytical instrument. Reference method – Technique that is used in association with a reference preparation. Working method – Intended to use in routine practice.

18. National Standard and Regulatory Agencies World Health Organization( WHO ) Joint Commission on Accreditation of Healthcare Organizations ( JCAHO ) College of American Pathologists ( CAP ) Clinical Laboratory Improvement Amendments of 1988 ( CLIA ’88) National Committee for Clinical Laboratory Standards ( NCCLS ) National Accrediting Agency for Clinical Laboratory Sciences ( NAACLS )

19. QC Hematology Cytology Clinical pathology Histopathology

20. QC IN HEAMATOLOGY

21. Preanalytical phase category Variables Sample collection Patient identification, labeling Phlebotomy technique Volume Sample collection tube Sample Handling Storage Agitation, centrifugation Transportation Patient Factors Physiological variables Pathological states

22. Types of control materials Assayed mean calculated by the manufacturer must verify in the laboratory Unassayed less expensive must perform data analysis “Homemade” or “In-house” pooled sera collected in the laboratory characterized preserved in small quantities for daily use

23. REFERENCE PREPARATION Red Blood cells ACD/CPD added blood Red cells stabilized with gluteraldehyde Suitable sized particles White Blood Cells Fixed & concentrated human blood. Turkey /Chicken red cells

24. Hemoglobin standardized haemolysate Platelet platelets separated by centrifugation (200g for 10') ,fixed by gluteraldehyde.

25. TEST PROCEDURES Measurement of prepared materials. Repeated measurement/Replicate testing. Duplicate testing. Short hand checking Delta check Daily statistical analysis.

26. Analysis of Control Materials Need data set of at least 20 points, obtained over a 30 day period Calculate mean, standard deviation, coefficient of variation; determine target ranges Develop Levy-Jennings charts, plot results

27. Levy-Jennings Chart A graphical method for displaying control results and evaluating whether a procedure is in-control or out-of-control Control values are plotted versus time Gaussian distribution curve Cusum chart

28. ANALYSIS OF EQA DATA Deviation index Target value & bias Youden XY plot - same analysis on two diff. control and plot on X & Y axis

29. QUALITY CONTROL IN HISTOPATOHLOGY

30. Quality assurance in HISTOPATHOLOGY Concept of QC in histopathology lab is relatively young It may be due to, descriptive nature of report lack of objective numerical data Individual judgment and bias No uniformity of reporting pattern

31. QUALITY ASSURANCE This make assessment and implementation of QC is more difficult in histopathology Even though we can implement QC in histopathology it may be Analytical Post analytical Pre analytical

32. A good quality histological section is the starting point of an accurate histopathology result According to CAP, 1. Preanalytical part - all process for generation of good section 2. Analytical part - interpretation of slide and accurate diagnosis 3. Post analytical part - proper dispatching of result, storage

33. Pre analytical All process up to submission of slide majority errors occur in this stage Sample accession and identification errors Avoided by barcode technology Maintain a good referral form with all possible details and that should make available in sample collection area

34. Good fixation is very necessary for good result Fixation problems are, S hould be fixed immediately Volume of fixative Conc. & type of fixative Adequate time of fixation Space in the container It should be cut open for proper internal after grossing Leakage of fixative

35. Decalcification problem Should remove any traces of calcium salt from the tissue Always maintain proper time good decalcifying fluid check end point of decalcification

36. Tissue processing and embedding A lways maintain good quality reagent Periodical changing of processing fluid Maintain a appropriate treatment time If tissue processor used, Ensure complete working Use closed type processor Temp. of paraffin wax Use Tissue Teck system for embedding

37. Section cutting Use good quality microtome Sharp knife Proper adjustment of angle Periodic calibration of micrometer Cryostat proper handling of sample correct temperature anti-roll plate position

38. s taining Control is used parallel with each batch of staining Maintain good quality of regent Standard operating procedure Filter stain regularly Special stains are done with suitable controls If automatic stainer used, check their working

39. Mounting and labeling Use appropriate good mounting media dilute DPX if it become very thick with xylene Label should be affixed with serial number Writing should be legible Label ideally carry name of laboratory Prefer to bar code labeling system

40. Analytical errors Assessment of analytical errors are not an easy task Maintained by, Intradepartmental consultation ; review selected cases by colleague Comparison with other reports (cytology, frozen) RBRC © by same person – for precision © diff. person – for accuracy Slide transferring and examination between two institution

41. Post analytical QC Involves, Report generation without any transcription error Double checking of printed report Counter signed by consultant pathologist Report dispatch to right person Storage of reported material Disposal of specimen Monitor TAT

42. EQC in histopathology *CAP and UK- NQAS – international programmer In India , Indian College Of Pathology with collaboration with Association of Pathologist in North America(AIPNA) run EQC as a part of NABL accreditation Inter-Laboratory Quality Assessment Programe for Histopathology (ILQA-HP) under ILQA- Bangalore

43. EQA programme involves Scheme divided in to two categories asses pre analytical aspect asses analytical aspect

44. Pre analytical assessment Done by sending a bit of formalin fixed tissue measuring made from a common source to each of participating lab They process ,cut and stain the tissue in their set up Stained section are send back for assessment

45. Analyses as, Stained section are examined by 5 experts & Score as , score 1 - unsatisfactory score 3 - average score 2 - poor score 4 - good score 5 - excellent Give mark as processing - 5 mark sectioning - 5 mark staining - 5 mark total 15 mark lab that mark below 3 will take immediate action

46. Analytical aspects, Section obtained in one common source is stained with H&E and distribute to lab along with all details pathologist examine and report was returned to nodal centre for assessment

47. QUALITY CONTROL IN CYTOLOGY

48. Cytopathology QC Will Require: Observation of technical procedures Review of QI program and indicators On-site microscopic review standardization in reporting format

49. Cytopathology QC General Elements of QI Technical and procedural (QC) Professional/diagnostic activities of cytotechnologists and pathologists (QI) Quality of the diagnostic report (QC/QI)

50. Specimen Collection and Receipt Specimens properly identified Instructions available for preferred specimen collection/preparation Requisition: complete data requested including date, source, physician, LMP, pertinent clinical information, etc. Criteria for specimen rejection and notification of unacceptable specimens

51. Cytology Stains Stains labeled and dated Cytology stains: new requirement for annual inventory to ensure proper storage and quality (many stains do not expire) Papanicolaou stains filtered or replaced regularly Papanicolaou stain prepared with good reagent Regular monitoring of stain characteristics

52. Instrumentation Evidence of active review of results of instrument maintenance and function (II) Automated instruments (Phase II) Documentation of adherence to manufacturer-recommended protocol for implementation Documentation of appropriate technical and interpretive training Written procedure to verify diagnostic & adequacy performance of screening instrument

53. Instrumentation Automated screening systems If tolerance limits exceeded, is there documentation of corrective action? Documented procedure for handling workload during instrument failure Documented procedure for handling slides not successfully processed “Negative” slides subject to 5 year retro review

54. On-Site Microscopic Review Not meant to be comprehensive rescreen or competency review, but a means of facilitating evaluation of overall procedures 10 -15 case review recommended including: > Unsatisfactory > Reactive > Positive for all abnormality reported “ Must have written criteria”

55. On-Site Microscopic Review Evaluate adequacy, technical quality, labels Determine if significant cells identified Compare with written interpretive report Check requisition for complete information Discrepancies analogous to PAP program Team leader should discuss significant discrepancies with laboratory director Record specimen category & discrepancies

56. Cytopathology Reports Name/unique identifier/accession number Birth date / age Physician / clinic Anatomic source / type of specimen Collection, receipt, and reporting dates Description of specimen on receipt Interpretation (descriptive terminology) Space for comments / recommendations

57. Retention Guidelines ALL slides 5 years FNA slides 10 years Reports 10 years Accession logs / worksheets 2 years Maintenance records 2 years QC / QA records 2 years Service / repair records instrument life

58. Slide Storage Stored in accessible manner Documented policy for protecting and preserving the integrity of original slides Policy to ensure defined handling and documentation of referral, transfer, receipt of original slides for availability Documentation when material is loaned to programs such as PAP (including receipt)

59. Cytopathology Quality Improvement Correlation with clinical findings Reconciliation of Disparities Documentation of consultations Documentation of technical quality Participation in PAP program or CLA-approved alternative program

60. Pap Rescreening Laboratory must rescreen a minimum of 10% of each cytotechnologist’s initially judged as negative Performed by individual qualified to be supervisor (3 years experience) Must include both high risk and randomly selected cases Cases not reported until rescreening complete Pathologists exempt (but rescreening advised)

61. EQA IN CYTOLOGY Exchange of slide programme A set of gynecological and nongynecological smears are distributed to diff. lab rechecking or reassessment of slide 2.Laboratory accreditation and certification Indian Academy of cytologist

62. Accreditation of IAC is based on, Workload Staff pattern Report generation and methodology Screening of specimen Diagnostic verification Follow-up Filing of report and slide Continuing education

63. QUALITY CONTROL IN CLINICAL PATHOLOGY

64. QA in CLIP > Still in dormant state > Require great attention > International and national agency should come forward

65. QC in urine analysis Specimen Collection First morning voiding (most concentrated) Record collection time Type of specimen (e.g. “clean catch”) Analyzed within 2 hours of collection Free of debris or vaginal secretions

66. analysis Performed person should be well trained Maintain good quality reagents for chemical examination with suitable control Microscopy recheck if needed Maintain an uniformity in reporting

67. Microscopic UA Correlate with cloudiness and other findings Quality control Consistent volume Centrifugation Well mixed fresh specimen Microscopy (wet mount, use low light)

68. Accreditation Bodies College of Pathologists ( CAP ) , USA Joint Commission on Accreditation of Hospitals ( JCAHO ), USA Clinical Pathology Accreditation ( CPA ), UK Ltd National Association of Testing Authorities ( NATA ), Australia Department of Standards ( DSM ) Malaysia –

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