1. CLMA MN Chapter Winter Meeting 2011 February 11, 2011 College of American Pathologists David J. Blomberg, MD

2. 2 CAP Frequently Cited Deficiencies What Constitutes Compliance? P olicy/procedure (P/P) to address the checklist item Actual P ractices match the written P/P D ocumentation of the practices Processes contribute to culture of quality

3. 3 Lab General GEN.55500 Has competency been assessed? –9.7 % GEN.20375 Does lab have a document control system? –7.6% GEN.70250 Are fire drills conducted? – 7.1%

4. 4 Items Common to All Checklists Alternative & ungraded PT For tests for which CAP does not require PT, does the laboratory at least semiannually 1) participate in external PT, or 2) exercise an alternative performance assessment system for determining the reliability of analytic testing? –HEM.10160: 4.1% –LSV.00425: 3.9% –MIC.00130: 3.2 % –URN.10525: 2.0% –IMM.10050: 1.5%

5. 5 Are reagents & solutions properly labeled, as appropriate, with the following elements? –Content and quantity, concentration or titer –Storage requirements –Date prepared or reconstituted by laboratory –Expiration date –LSV.36820: 10.7% –POC.04800: 8.6% –HEM.24000: 4.8% –CHM.12400: 3.7% –MIC.143500: 2.3% –URN.24000: 2.1%

6. 6 Evidence of Annual Review Is there robust documentation of at least annual review of all policies and procedures by the current laboratory director or designee? LSV.01800: 9.9% CHM.11100: 7.6% TRM.31150: 6.3% MIC.12110: 4.8% POC.04100: 4.6% HEM.21070: 4.3% URN.21200: 2.6% IMM.31100: 2.6%

7. 7 Transfusion Medicine TRM. 30866 Agreement between transfusion service and clinical areas to ensure provision of blood/components/tissues: 4.4% TRM.41850 Potential hemolytic transfusion reaction immediate investigation: 3.7% TRM.30550 Program to ensure risks of mistransfusion are monitored/continual process improvement: 2.8%

8. 8 POCT POC.06900 Is there a documented program to ensure competence? – 6.5 % POC. 04500 Are patient results reported with reference ranges? – 5.6% POC.07300 Are controls run daily? –4.9%

9. 9 Anatomic Pathology ANP.12087 Is there a policy for the routine decontamination of cryostat? –4.9% ANP.08216 Are vapor concentrations maintained below maximum limits? –3.3% ANP.11713 Is there documented evidence of daily review of technical quality of histo preps? –2.4%

10. 10 Cytopathology CYP.08500 Is there a documented workload policy? –3.0% CYP.05285 Is there documented procedure for handling workload instrument failure? –1.9% CYP.02800 Have a system documenting personnel are knowledgeable about procedure manuals? –1.6%

11. © 2010 College of American Pathologists. All rights reserved. 11 Checklist Redesign June 2010

12. Accreditation Standards Laboratory Director and personnel Physical resources Quality Management Participation in the Accreditation Program (Administrative)

13. Help laboratories more efficiently and effectively meet their accreditation requirements Help inspectors conduct more efficacious inspections by providing a more consistent tool with guidance for interpretation of checklist requirements leading to a more consistent, higher quality inspection Effective and efficient dialogue and interpretation between inspector and inspectee Enhanced content and updated design © 2010 College of American Pathologists. All rights reserved. 13 Key Benefits

14. Inspector Version – ROAD and EoC

15. © 2010 College of American Pathologists. All rights reserved. 15 Evidence of Compliance

16. Technical Assistance Line: –Phone: 800-323-4040, option 1 –Email: accred@cap.orgaccred@cap.org Thank you! © 2010 College of American Pathologists. All rights reserved. 16 Questions?

17. Other Inspection Issues On-time inspections –5 years ago – approximately 70% –2010 - >90% Uncommon inspection issues –N/R inspections –Complaint inspections –Validation inspections