Dr Dinah Parums. Quality Assurance (QA) in Histopathology. 2001.

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Dr Dinah Parums. Consultant Histo/Cytopathologist, 2001. Teaching handout for trainees in Pathology, Biomedical Scientists and hospital managers.

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Dr Dinah Parums. Quality Assurance (QA) in Histopathology. 2001.

  1. 1. Quality Assurance in Histopathology Dr Dinah V Parums M.A.,PhD,B.M.,B.Ch.,FRCPath.,FCCP Consultant Histo/Cytopathologist, 2001 U.K.
  2. 2. Objectives  Satisfy RCPath requirements:     Trainees will have some knowledge of QC, QA, CQI and professional QA as applied to Anatomic/Surgical Pathology Success at Royal College exams Enjoy a safe professional practice Prepare for lab management role
  3. 3. QA in AP  QA program structure     Core QA elements     Driving forces CPA general requirements Local reporting structure Autopsy Cytology Surgical Pathology Introduction to error management in anatomic pathology
  4. 4. QA: driving forces     Mandated for lab accreditation  Accreditation: CPA  Assessment: EQA Financial Incentive  Cancer Unit/Centre status  Coroner’s Office requirements Medical “standard of care”  Litigation protection (CMPA)  Complaint/license protection (CPSO)  Hospital privileges Technical “good lab practices”
  5. 5. Clinical Pathology Accreditation (CPA)   Specifies general organizational structure of Lab QA program (quality manager, manuals) Extensive documentation requirements     Personnel qualifications & training Equipment, reagents, supplies Communications & LIS Specimen handling & reporting  Etc.
  6. 6. CPA QA requirements  General (apply to all lab areas)     “appropriate quality indicators monitored…” “QC processes shall consist of goals, policies, procedures, tolerance limits and corrective actions…” [labs] “shall establish clinically appropriate turnaround times for each examination” Specific (apply to individual labs)   Practice standards (e.g. surgical path specimen containers shall have adequate volume of fixative) Activities (e.g. HSIL pap/histology correlation)
  7. 7. Core QA elements: Autopsy     TAT monitored weekly and audited semiannually (std 80% in 8 wks, max. 10 wks) Case rounds (aut conf, MMR, ML rds) Provincial centralized forensic case review CPA requirements    Consent, identification, paperwork Block & slide retention times (20yrs adult, 50 yrs child) Report to include gross, micro, major findings, information needed to determine cause of death
  8. 8. Core QA elements: Cytology  CPA mandated activities         Overdue case tracking 10% negative pap’s rescreened before sign-out (targeted and random) 3 yr back rescreen for new HSIL+ Cyto-histo correlation (pap HSIL, non-gyne) Diagnostic category rates (neg, ascus, sil) TAT (monitored semi-annually, 2wks for paps, 3 days for non-gyne) False negative rate (rescreen SIL : initial neg) EQA slide surveys
  9. 9. Core QA elements: Cytology  CPA standards           Separate screening area Instructions for specimen collection to providers Requisitions include clinical & pap history, LMP Accepted staining methods used Contamination prevention procedures Separate gyne/non-gyne staining All paps screened by techs Techs may finalize neg/benign change only Abnormal areas marked & tech comments retained Pathologists provide feedback to techs
  10. 10. Core QA elements: Surg Path  CPA mandated activities    Overdue case tracking TAT (monitored semi-anually, std 2 days for bx’s, 3 days for routine + extra for IP/specials) EQA   IP and special stain testing Patterns of practice surveys
  11. 11. Core QA elements: Surg Path  “Standard of care activities”      Frozen section/final diagnosis correlation Addendum/amended correlation Mandated second review rate Case rounds/tumour board review rate “Good lab practices” activities  “Incident” reporting and tracking    labeling, pickups, no tissue, lost tissue etc Daily staining QA log Customer satisfaction surveys
  12. 12. Core QA elements: Surg Path  CPA mandated standards            Adequate volumes of fixative Labels have name, unique ID & tissue site FS manual covers specific specimen types FS results communicated directly and recorded Addendums for special studies Appropriate IP controls IP slides kept with other case slides Log time slides delivered to pathologists Document IP slide results Pathologists evaluate slide quality List of specimens on report
  13. 13. Core QA elements: Surg Path  CPA mandated standards (cont’d)  Report includes:        gender, DOB, pt location, attending & submitting MD, dates of procedure, accessioning & reporting Clinical history Gross description including block list FS diagnosis Microscopic as relevant Final diagnosis (indicate if gross exam only) Pathologists signature or electronic equivalent
  14. 14. Core QA elements: Surg Path  CPA mandated standards (cont’d)  Lab has appropriate slide, block, report and tissue retention guidelines   Wet tissue 4+ wks after report issued Blocks and reports :    20 yrs for adults 50 yrs for children Slides :   10 yrs for adults 10 yrs after 18th birthday for children
  15. 15. Introduction to Diagnostic Error Management in Anatomic Pathology   No generally accepted definition of what an “error” is Definition issues include:    Hindsight bias “Expert” opinion Viewpoint   Clinical: significant vs insignificant Legal: negligent vs reasonable
  16. 16. Error Classification   Planning: wrong plan, right execution Cognitive: right plan, problem in execution  Slips & Lapses    Slip: error of commission (e.g. pick up slide from wrong case, mislabel slide) Lapse: error of omission (e.g. miss a slide, miss a gross lesion, don’t label block, forget to include margin status in report) Mistakes: knowledge, rule and “thought” based errors
  17. 17. Mistakes  Lack of knowledge   Misinterpretation of data   Unaware of an entity, of classification or process rules Unable to apply good data and good rules Application of bad rules  Inevitable disagreements resulting from bad rules considered “errors” (e.g. ASCUS)
  18. 18. Slips/lapses      More frequent Near misses If notice error can recognize and fix Self corrected Very difficult to eradicate vs Mistakes     Less frequent May recognize a problem but not consider it an error Not self corrected Easier (but still difficult) to eradicate
  19. 19. Approaches to error management  Use systems rather than person approach   Recognize human fallibility and structure operational systems around this Safe systems     Simplify tasks, add visual cues, reduce reliance on memory Design for reversibility and recovery Stress educational rather than punitive environment Monitor errors and near misses and respond
  20. 20. Medical-legal aspects of error  Malpractice   Negligence   Injury resulting from negligence Medical practice which falls below the “standard of care” Standard of care  Peer based in theory although in practice often expert based “best practice”
  21. 21. Pathology malpractice  Low frequency of claims     8.3% of U.S. pathologists per year: average pathologist has one claim every 12 years (compare to 55% of U.S. neurosurgeons per year) Probably about half these rates in U.K. High success of claims High severity (cost) of claims, particularly in U.S.
  22. 22. Pathology Claims Analysis   15% “random” 85% “systematic”   Mainly cancer diagoses: 63% false negative (FN), 22% false positive (FP) Top 5 types (57% of claims) were:      breast (15%) FP = FN melanoma (13%) 95% FN Pap smears (12%) 98% FN gyne (9%) 85% FN, 42% ovarian tumours operational (6%) specimen mix-ups & losses, typo’s etc
  23. 23. Pathology Error Management     Mandatory prospective second review of high risk cases documented in report Retrospective review at tumour boards and teaching rounds with case tracking Subspecialty sign-out Synoptic and template based reporting
  24. 24. Conclusion: QA in Histopathology  Driven by    Structured accreditation requirements Unstructured expectations of good medical care Includes    Standards of lab practice Quality activities (audits, indicator monitoring) A systems based error management program targeting high risk operational and diagnostic areas

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