A Roadmap for Competency Assessment ASCLS-NJ Spring Seminar April 24, 2014

Transcription

1 A Roadmap for Competency Assessment ASCLS-NJ Spring Seminar April 24, 2014 Dickie Nichols, MT(ASCP)SBB Technical Marketing Manager with Regina Castor BS MT(ASCP) SBB cm Area Technical Consultant, East Immucor, Inc.

2 Objectives Discuss requirements related to competency assessment Differentiate between competency and proficiency Describe what assessors, inspectors, and surveyors look for as evidence of compliance Identify methods to meet the requirements for competency assessment

3 Competency vs. Proficiency Competency Individual level New employee twice per year Incumbent annually 6 CLIA elements per test Proficiency Lab level Minimally twice per year per test Every test in system Results only

4 Why Competency Assessment? Dedicated Staff Complacency SOP drift Rotating Staff Loss of familiarity Infrequent activities SOP /Methodology Changes Required by Federal regulations

5 Why Competency? CMS has alerted us its on their Radar CLIA website: Regulatory Agencies are looking at your compliance with CLIA requirements

6 What is CLIA? Federal Standard Compliance required Federal payment Assessed through various means CMS currently grants deemed status to: CAP AABB TJC (Joint Commission) Others

7 CLIA Competency Assessment Key Requirement (b)(8)(9) & 1451(b)(8)(9) Technical Consultant/Supervisor Responsibilities Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently

8 CLIA Competency Assessment 6 assessment elements Must be performed for each test Must be performed for each tech who performs the test Must be performed twice during first year of performing the test Must be performed at least annually thereafter

9 CLIA: Element 1 Competency for all tests must include: Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing

10 CLIA: Element 2 Monitoring the recording and reporting of test results

11 CLIA: Element 3 Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records

12 CLIA: Element 4 Direct observation of performance of instrument maintenance and function checks

13 CLIA: Element 5 Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples

14 CLIA: Element 6 Assessment of problem solving skills

15 CAP GEN Competency Assessment The competency of each person to perform his/her assigned duties is assessed CLIA elements cited NOTE: The competency of each person to perform the duties assigned must be assessed following training before the person performs patient testing.

16 AABB STD Training The blood bank or transfusion service shall have a process for identifying training needs and shall provide training for personnel performing critical tasks. TASKS NOT JUST TESTS!

17 AABB STD Competence Evaluations of competence shall be performed before independent performance of assigned activities and at specified intervals.

18 What Do Assessors / Inspectors Look For? Training Competency Assessment

19 Road Map to Inspection Is there a policy process or procedure Is it adequate Is it being followed

20 3P s: Policy, Process or Procedure Addressing Training and Competency Laboratory General policies CLIA elements incorporated All tests/test systems Blood Bank SOPs specific for the testing performed

21 Compliance with Policy/Process/Procedure Who assessed competency? Was it defined? Assessors have to assessed What constitutes an assessment? Tools, Checklists Is it defined in the policy or procedure What tests are being evaluated? Must include all tests/systems every year Can t pick and choose How is it documented? Does practice match SOPs?

22 Beware of the Regulations! Testing Personnel All tests All CLIA elements MUST be used for evaluation Other Personnel Facility-specified

23 Considerations New employees Competency assessment separate from training Assessed twice in the first year Incumbents Annual assessment Documentation for staff that work on all shifts Tests being evaluated Is there any distinction made for testing that may be provided on day shift vs after hours? Special testing

24 Competent or Not? Does documentation show tech is competent? Minimum passing score defined? Statement or check-box indicating competence? If not competent, what was done? Does practice match 3P s?

25 I don t have time for this!!!

26 PART II Pathways

27 Route #1 Combine multiple elements into a single assessment

28 Let s Go Back to Basics Element 1: Direct observation of performance Element 2: Monitoring recording and reporting of test results Element 3: Review of worksheets, QC records, PT results, PM records Element 4: Direct observation of instrument maintenance/function checks Element 5: Testing of previously analyzed specimens Element 6: Assessment of problem solving skills

29 Route #2 SOP Checklist

30 Direct Observation Checklist Make a checklist from your SOP Use at conclusion of training on that SOP Use for 6 month/90-day competency assessment Annual competency assessment

31 Donor Center Audit Checklist: *PPE *Bag Inspected *Bag hung properly *Tubing inserted *Hemostat applied *Sample port remains below donor arm etc.

32 Issuing Blood

33 Initial Training

34 Route #3 Use Tracer Audits

35 Tracer Audits Effective at looking at a variety of documents, staff Can be Retrospective Following a unit being transfused back to time of collection, reagents used, QC, equipment used, results recording, etc. Can be forwarded looking Ex: following equipment from purchase to discontinuation Crossmatch sample collection through transfusion Donor collection through processing/labeling Tracer audits can easily incorporate several elements of CLIA by looking at a variety of records

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37 Route #4 Use existing maintenance schedules to plan assessments

38 Let s Go Back to Basics Element 1: Direct observation of performance Element 2: Monitoring recording and reporting of test results Element 3: Review of worksheets, QC records, PT results, PM records Element 4: Direct observation of instrument maintenance/function checks Element 5: Testing of previously analyzed specimens Element 6: Assessment of problem solving skills

39 Instrument Maintenance Direct observation of performance of instrument maintenance and function checks Which instruments? Who does it?

40 Use QA schedules to determine who and what to observe

41 Route #5 Delegate Assessments

42 Who Can Assess? Someone who Has been trained Can determine competent vs non-competent behavior Is motivated to do it right Must meet CLIA requirements It Doesn t Always Have to Be the Supervisor!!

43 Who to Consider Secret Shoppers Lead Techs Techs trained to task Others

44 Just Remember Those who assess competency must also have their competency assessed IF they perform critical tasks! And That Includes the Supervisor!!

45 Route #6 Use tasks for assessment that are already being performed

46 Let s Go Back to Basics Element 1: Direct observation of performance Element 2: Monitoring recording and reporting of test results Element 3: Review of worksheets, QC records, PT results, PM records Element 4: Direct observation of instrument maintenance/function checks Element 5: Testing of previously analyzed specimens Element 6: Assessment of problem solving skills

47 Aren t You Doing This Already?! Include as part of the competency policy Include items already being reviewed: Recording and reporting of test results QC records Preventive maintenance records Worksheets Document!

48 All Routine Tasks 2011 Blood Bank Competency Assessment Summary 1. Direct Observation of routine patient test performance CLIA Element Tech 1 Tech 2 Tech3 Tech4 Tech5 Tech 6 Tech 7 ABO/Rh and 12/23/201 antibody screen 11/1/ /1/ /1/ /1/2011 Sep-11 12/6/ Other Accession # of test reviewed 2. Monitoring, recording and reporting of test results CLIA Element Tech 1 Tech 2 Tech3 Tech4 Tech5 Tech 6 Tech 7 ABO/Rh 0223IH9 0223IH IH ;IH IH13 12/6/ ;IH30 Antibody Screen 0223IH9 0223IH IH ;IH IH13 12/6/ ;IH30 Compatibility 0223IH9 0223IH IH ;IH IH13 12/6/ ;IH30 Antigen Typing 2/26/11 6/30/11 1/18/11 2/25/11 7/23/11 NA NA Antibody ID 0105IH IH IH6 0801;IH21 NA NA TRXN 0317;IH IH24 Courtesy of Lea Tolzmann, Winter Haven Hospital, Winter Haven, FL

49 Route #7 Sample Resources

50 Let s Go Back to Basics Element 1: Direct observation of performance Element 2: Monitoring recording and reporting of test results Element 3: Review of worksheets, QC records, PT results, PM records Element 4: Direct observation of instrument maintenance/function checks Element 5: Testing of previously analyzed specimens Element 6: Assessment of problem solving skills

51 Element 5: Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples

52 Previously Analyzed Specimens Patient/Donor samples Unique Samples Routine Samples Variable results depending on storage and use Less Cost Large resource availability Hematology Chemistry Document Results

53 Internally Prepared Samples Doctored patient/donor samples Can you get enough sample for multiple techs? Stability and reproducibility Can be time consuming to prepare Less Cost Document results

54 Externally Prepared Samples Available from some Blood Suppliers as a value added service Purchased tech competency products (as opposed to Lab Proficiency products) Scalable CEUs offered Can be used for multiple techs Proficiency products- more flexibility on how used

55 How can these products be used? They do not have to be treated in the same manner as routine testing ( Lab Proficiency) Direct observation potential Can be used by staff who have not completed a wet challenge Can be ordered as needed when new staff are hired Can be used for initial competency assessment Can be ordered as needed when methods are changed Use as corrective action for Laboratory PT failures Can be used regardless of test methodology being used Use as corrective action for near-miss events, Root cause analysis, etc.

56 Proficiency Samples May be used to fulfill competency requirement All labs have Limited volume/stability Unknown results May not be available when competency assessment is needed CE credits may be available

57 Limitations When Using Proficiency Samples for Competency Testing Rotating Lab Proficiency surveys does not satisfy all 6 of the CLIA requirements Proficiency samples must be treated like routine patient/donor samples Samples cannot be shared until results are received

58 Documentation of Proficiency Testing as Competency

59 Route #8 Problem Solving

60 Let s Go Back to Basics Element 1: Direct observation of performance Element 2: Monitoring recording and reporting of test results Element 3: Review of worksheets, QC records, PT results, PM records Element 4: Direct observation of instrument maintenance/function checks Element 5: Testing of previously analyzed specimens Element 6: Assessment of problem solving skills

61 Assessment of Problem Solving Skills Written test or quiz Case Studies Scenarios: What would you do if? Staff narrative

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63 Could include What if questions to satisfy Problem solving requirement

64 Unsuccessful Result Process for Remediation Actions to take Removing employee from testing until competency is demonstrated Documentation Recurrence Re-assessment Determination Completion at end of each assessment

65 Documentation Trackable and Traceable Checklist not sufficient Each assessment requirement must be documented Direct observation checklists Title and date of record review Title, date, sample ID if using PT Graded test/quiz Assessor name(s) and dates Employee name

66 For more information CLIA website: Regulations may be found at

67 THANK YOU!!

68 Contact Information Dickie Nichols Regina Castor