Where's the Beef? Recipes to "Beef Up" Those Weak Areas in Your Transfusion Service

1. Where's the Beef? Recipes to "Beef Up" Those Weak Areas in Your Transfusion Service • Assessment/inspection report statistics show that there are certain standards and requirements that Transfusion Services struggle with the most. • This session will address those weaknesses and how you can identify areas in your own Transfusion Service that need some attention. • Practical ideas and examples will be shared on ways you can strengthen, control and "beef up" those vulnerable weak spots in your operations and quality systems.

2. Where’s the Beef? Recipes to "Beef Up" Those Weak Areas in Your Transfusion Service

3. The Meat of the Matter Nancy M. Shotas, MT(ASCP)BB, CQA(ASQ) AABB Staff Lead Assessor NShotas@aabb.org

4. Learning Objectives • Identify the elements and processes in Transfusion Services that are most often found to be weak or out-of-compliance at inspection time. • Describe ways to pinpoint weaknesses in your own department and develop an action plan to correct them. • Discuss and share examples of documents and tools that can be used to "beef up" your operations and quality systems.

7. CLIA

8. CLIA

9. CMS’ Top 10 Condition Level Deficiencies: Jan. 2013 (Jan.2012) - D6000 Mod. complexity LD qual./resp (1) - D2016 Successful PT participation (2) - D2000 PT enrollment (3) - D6076 High complexity director qual./resp (4) - D5400 Analytic Systems (QC) (6) https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html CLIA

10. CMS’ Top 10 Condition Level Deficiencies: Citation explanations D6000 (42CFR493.1403) Moderate complexity LD qual./resp. The laboratory must have a director who meets the qualification requirements of 493.1405 and provides overall management and direction in accordance with 493.1407 D2016 (42CFR493.803) Successful PT participation Each laboratory performing nonwaived testing must successfully participate in a PT program approved by CMS as described in subpart I of this part for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. D2000 (42CFR493.801) PT enrollment Each laboratory must enroll in a PT program that meets the criteria in subpart I and is approved by HHS. The laboratory must enroll for each specialty and subspecialty, and must test the samples in the same manner as patients’ specimens D6076 (42CFR493.1441) High complexity director qual./resp. The laboratory must have a director who meets the qualification requirements of 493.1443 and provides overall management and direction in accordance with 493.1445 D5400 (42CFR493.1250) Analytic Systems (QC) Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed

11. CMS’ Top 10 Condition Level Deficiencies -D6063 Mod. complexity TP (5) -D6033 Technical consultant qual./resp. (7) -D5024 Hematology (8) -D6168 High complexity TP (10) -D6108 Personnel High Complexity (?? ) CLIA

12. CMS’ Top 10 Condition Level Deficiencies: Citation explanations D6063 (42CFR493.1421) Mod. Complexity Testing Personnel The laboratory must have sufficient number of individuals meeting the qualifications of 493.1423, to perform the functions specified in 493.1425 for the volume and complexity of tests performed D6033 (42CFR493.1409) Technical consultant qual./resp. The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 and provides technical oversight in accordance with 493.1413. D5024 (42CFR493.1215) Hematology If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269 and 493.1281 through 493.1299. D6168 (42CFR 493.1487) High complexity Testing Personnel The laboratory must have sufficient numbers of individuals who meet the qualification requirements concerning State licensure, if applicable, and the educational requirements for High complexity personnel as defined in §493.1489 to perform the functions of high complexity personnel as defined in §493.1495 for the volume and complexity of testing performed D6108 (42CFR 493.1447) High Complexity Testing Personnel (Technical Supervisor) The laboratory must have a technical supervisor who meets the qualification requirements as defined in 493.1449 and provides technical supervision in accordance with 493.1451.

13. CMS’ Top 10 Deficiencies • D5413 Policy for proper reagent storage (1) • D5217 Verify accuracy non-PT’d tests (2) • D5791 Analytic Systems’ QA (3) • D5403 Procedure manual (4) • D5411 Follow mfgr’s. instructions (6) • D6000 Mod. complexity LD qual./resp. (9) • D5439 Calibration verification (5) • D5805 Gen lab systems QA (7) • D5417 Use of expired reagents (10) • D6021 Personnel moderate complexity (??) Source CMS CLIA database 2/2012 CLIA

15. Biologics FY 2012 Inspectional Observation Summaries (FY 2010) http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm#biologics

16. Biologics FY 2012 Inspectional Observation Summaries (FY 2010) http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm#biologics

17. Biologics FY 2012 Inspectional Observation Summaries (FY 2010) http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm#biologics

18. Biologics FY 2012 Inspectional Observation Summaries (FY 2010) http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm#biologics

20. AABB:General Summary of Most Common Nonconformances • Organization Participation in Management reviews are missing Processes are not written SOPs are not followed as written • Resources Training: missing documentation Competency : Missing annual competency Not performed twice within the first year of employment Competence assessments do not include all CLIA requirements Missing review or approval from those designated to review task Inclusive dates of employment missing • Supplier and Customer Issues No documentation or omitted documentation of inspection at receipt

21. AABB (cont): General Summary of Most Common Nonconformances • Equipment No record of what is considered critical equipment Equipment omitted from the critical equipment list Equipment lacking a unique ID number Do not follow manufacturer’s instructions Qualification of Equipment: IQ, OQ, PQ No evidence of investigation & follow-up Alarm set for the limit (either high or low temp) that would sound/alert when the storage temp is out of range and considered unacceptable

22. AABB (cont.):General Summary of Most Common Nonconformances • Process Control No documentation of process validation Incomplete documentation of changes made to existing procedures Change control process not followed as per SOP No set process for determining if PT is performed for each CLIA regulated test Review of QC results are not done in a timely manner or not performed at all. Corrective action for out of range results are not documented and/or not documented properly Incorrect storage temp ranges Failure to follow manufacturer’s instructions RBC appropriate temperature verified on returned units (or validated process)

23. AABB (cont.):General Summary of Most Common Nonconformances • Documents and Records Processes & procedures for document control are not complete Use of only current and valid documents not demonstrated Reviews are incomplete or not timely No list of labels No list of forms or forms omitted from the master list No review or missing annual reviews Using outdated references / No process for review of current references

24. AABB (cont.):General Summary of Most Common Nonconformances • Process Improvement through Corrective and Preventative Action Evaluation to ensure corrective action taken is effective is not documented • Assessments: Internal and External Transfusing facility does not monitor Ordering Practices

26. CAP Top Deficiencies

27. CAP Top Deficiencies

28. CAP Top Deficiencies

29. College of American Pathologists: Most Common Accreditation Deficiencies: 2011Transfusion Medicine

30. College of American Pathologists: Most Common Accreditation Deficiencies: 2011Transfusion Medicine

31. College of American Pathologists: Most Common Accreditation Deficiencies: 2011Transfusion Medicine

32. College of American Pathologists: Most Common Accreditation Deficiencies: 2011Transfusion Medicine

33. College of American Pathologists: Most Common Accreditation Deficiencies: 2011Transfusion Medicine

35. TJC: Top Standards Compliance Issues for 2012Laboratory and Point-of-Care Testing

36. TJC: Top Standards Compliance Issues for 2012Laboratory and Point-of-Care Testing

37. TJC: Hospital Requests For Improvement Jul-Dec 2011

38. TJC: Hospital Requests For Improvement Jul-Dec 2011

39. TJC: Laboratory Requests For Improvement Jul-Dec 2011

40. TJC: Laboratory Requests For Improvement Jul-Dec 2011 (cont)

41. TJC: Tissue Findings- Lab Jul – Dec 2011

43. Most Frequent Deficiencies for CY 2011 AOA-HFAP

44. Additional information from AOA-HFAP • 6% of laboratories surveyed were cited for CMS Condition-Level deficiency related to Personnel Competency Assessment. • Repeat Deficiencies: • The top 3 repeat deficiencies for CY 2011. • 03.01.00 Facilities. The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. §493.1101(a) • 06.08.06 Calibration / Control Failures. The laboratory must document all corrective actions taken, including actions taken when results of control or calibration materials, or both, fail to meet the laboratory’s established criteria for acceptability. All patient test results obtained in the unacceptable test run and since the last acceptable test run must be evaluated to determine if patient test results have been adversely affected. The laboratory must take the corrective action necessary to ensure the reporting of accurate and reliable patient test results. §493.1282(b)(2) • 06.08.01 Comparison of Test Results. If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. §493.1281(a)

46. COLA : Most Frequent Deficiencies for 2008-2010

47. COLA: Most Frequent Deficiencies for 2008-2010

48. The Meat of the Matter is????

49. Meat of the matter? • Qualifications: leadership & personnel • Proficiency Testing • Competency Assessment • Process control • Procedures, Records and Document control • QA: Variance tracking including thorough documentation &, if needed, investigations • Equipment / test: calibration, accuracy verification

50. Where Did the Beef Come From? Suzanne H. Butch, MA, MLS(ASCP)CM, SBBCM University of Michigan Hospitals & Health Centers butchs#@umich.edu