2012 CLIA UPDATE Mission Possible Competency Assessments

Transcription

1 2012 CLIA UPDATE Mission Possible Competency Assessments March 27, 2012 Sponsored By Association of Public Health Laboratories and State Hygienic Laboratory at the University of Iowa Speakers Diana Fairbanks, BS, MT (ASCP) Laboratory Consultant Department of Health & Human Services Centers for Medicare & Medicaid Services Region VII Kansas City, MO Tel: Fax: i 1 2 Analysis,Answers,Action Speakers Kristine Rotzoll, BS, MT (ASCP) CLIA Compliance Specialist Iowa CLIA Laboratory Program State Hygienic Laboratory at University of Iowa Iowa City, IA Tel: or IOWA Fax: kristine-rotzoll@uiowa.edu Speakers Nancy Grove, BS, MT (ASCP) CLIA Compliance Manager Iowa CLIA Laboratory Program State Hygienic Laboratory at University of Iowa Iowa City, IA Tel: or IOWA Fax: nancy-grove@uiowa.edu 3 Analysis,Answers,Action 4 Analysis,Answers,Action Agenda Discuss requirements for training & competency. Explain why the mission is necessary. Review who performs the mission. Understand when mission must be completed. Detail what criteria to be assessed during the mission. Describe how to accomplish the mission. Evaluate the mission effectiveness. CLIA Regulations Code of Federal Regulations: 42 CFR 493 Centers for Medicare & Medicaid Services Statet Operations Manual, Appendix C Interpretative Guidelines for Laboratories and Laboratory Services 5 Analysis,Answers,Action 6 Analysis,Answers,Action

2 42 CFR 493 Subpart K, Part 1- General Systems 42 CFR 493 Subpart M Personnel Requirements MODERATE Complexity Testing Standard: d Personnel competency assessment policies. Laboratory Director Responsibilities: (e)(11) & (12) Technical Consultant Responsibilities: (b)(7) & (8) 7 Analysis,Answers,Action 8 Analysis,Answers,Action 42 CFR 493 Subpart M Personnel Requirements HIGH Complexity Testing Training vs. Competency Laboratory Director Responsibilities: (e)(12) & (13) Technical Supervisor Responsibilities: (b)(7)(8) & (9) General Supervisor Responsibilities: (b)(3) & (4) Definitions: Training: process to provide and develop knowledge, skills, and behaviors to meet established requirements Competence: application of knowledge, skills, and behaviors in performance 9 Analysis,Answers,Action 10 Analysis,Answers,Action WHY perform training and competency assessments? WHO performs training and competency assessments? Ensure that laboratory staff report tests promptly, accurately and proficiently. Ensure that laboratory staff are competent to perform test t procedures. Ensure that satisfactory performance of test procedures remains consistent. Laboratory director is ultimately responsible for ensuring that laboratory personnel are trained and competent prior to reporting patient test results regardless of the complexity of testing. 11 Analysis,Answers,Action 12 Analysis,Answers,Action

3 WHO Laboratory director may delegate this responsibility, in writing, to: Moderate complexity testing - Technical Consultant High complexity testing ti - Technical Supervisor or General Supervisor Prior to Assessing Training & Competency- Delegation of Job Duties & Responsibilities Laboratory Director must specify, in writing, the responsibilities and duties of each consultant and person engaged in the performance of all phases of testing. 13 Analysis,Answers,Action 14 Analysis,Answers,Action Job Duties & Responsibilities Prior to Implementation of Training Policies i & Procedures Identifies which examinations and procedures each individual is authorized to perform and report (including instrument maintenance, reagent preparation, calibration, troubleshooting, etc.); Whether supervision is required for specimen processing, test performance or results reporting; and Whether consultant or director review is required prior to reporting patient test results. Laboratory must establish and follow written policies and procedures to monitor and assess each individual s competency and identify remedial training or continuing education needs. 15 Analysis,Answers,Action 16 Analysis,Answers,Action Prior to Implementation of Training Policies i & Procedures Prior to Implementation of Training Policies i & Procedures When establishing training policies & procedures consider: Objectives for training (expectations once training complete) Identify methods for training (means used to conduct training) Direct observations, video/computer based exercises, lecture, retesting of known specimens, etc. When establishing training policies & procedures consider: Identify training materials Operator s manuals, manufacturer s instructions, practice materials (samples), requisitions, and forms, etc. 17 Analysis,Answers,Action 18 Analysis,Answers,Action

4 Prior to Implementation of Training Documentation ti A training guide packet should be prepared for each individual/training event including: Instructions for the trainer Instructions for the trainee Training schedule Training/direct observation checklists Written quiz Trainee evaluation form Implementation of Training Identify Training i Training must be performed and documented: For new employees, to learn processes and procedures; For all employees, when organizational or technological changes affect work process; and When other training needs are identified (e.g. unsuccessful proficiency testing or the personnel fails to meet competency criteria). 19 Analysis,Answers,Action 20 Analysis,Answers,Action Prior to Assessing Competency Policies i & Procedures Competency Assessment versus Performance Evaluation Laboratory must establish and follow written policies and procedures to monitor and assess each individual s competency and identify remedial training or continuing education needs. Includes all laboratory staff, including consultants and supervisors. Competency Assessment only monitors and assesses the individuals competency to perform and report laboratory tests and examinations. Performance Evaluation evaluates other behaviors and attributes as they relate to the position and job (e.g. internal & external customer relations, initiative, etc.) includes competency assessment. 21 Analysis,Answers,Action 22 Analysis,Answers,Action WHEN are competency assessments performed? Twice during first year of employment; Annually thereafter; and When there are test methodology or instrumentation changes and with the addition of new test systems. WHAT to include in competency cy assessments? e 1.Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling and processing; 2.Direct observation of instrument maintenance and function checks; 23 Analysis,Answers,Action 24 Analysis,Answers,Action

5 Direct Observations Application & adherence to all elements of test method/instrument procedure Specimen handling & processing Preparation/assessment of reagent & control materials Direct Observations Interpretation and acceptance of test reactions & results Documentation of results Review QC 25 Analysis,Answers,Action 26 Analysis,Answers,Action Direct Observations Instrument operation, function checks, monitoring & maintenance Utilization & appropriate demonstration of laboratory skills & practices Adherence to safety requirements LIS knowledge & abilities 27 Analysis,Answers,Action WHAT to include in competency cy assessments? e 3. Monitor recording and reporting test results; 4. Review: - intermediate test results and/or worksheets, - quality control records, - proficiency testing results, and - preventive maintenance records. 28 Analysis,Answers,Action WHAT to include in competency cy assessments? e WHAT to include in competency cy assessments? e 5. Assessment of test performance through testing previously analyzed specimens, internal blind samples or external proficiency testing samples; and 6. Assess problem solving skills. Case study problems; Theory questions; Technique questions; Interpretation questions; Problem solving questions 29 Analysis,Answers,Action 30 Analysis,Answers,Action

6 HOW to perform competency cy assessments? e Evaluate/assess only what employee is responsible for; May utilize checklists to collate information; Designate what will and was observed Collect copies of corrective actions for solved problems. HOW Collect data throughout the year and document: Quality control record review, Proficiency testing results review, Patient result review, and Preventive maintenance records review. 31 Analysis,Answers,Action 32 Analysis,Answers,Action Evaluation of Competency Program If problems are detected, what is done? Retraining? Re-evaluation? Review/revision of procedures and/or processes? Future monitoring? Examples Refer to your handouts: Training i & Competency Checklists Personnel Competency Assessment Forms & Checklists 33 Analysis,Answers,Action 34 Analysis,Answers,Action Mission Accomplished Development and implementation of training and competency assessment program by the laboratory is a important contribution to ensuring the quality of its services. Consistent, predictable and high-quality outcomes in the delivery of laboratory test results are possible only when the laboratory personnel are appropriately trained and competent. References Appendix C, Survey Procedures and Interpretative Guidelines for Laboratories and Laboratory Services; Centers for Medicare and Medicaid Services; Published January 12, CLSI Document CP21-A3, Training and Competence Assessment; Approved Guideline Third Edition (February 2009). 35 Analysis,Answers,Action 36 Analysis,Answers,Action

7 Websites Centers for Medicare & Medicaid Services Centers for Disease Control Clinical Laboratory Standards Institute State Hygienic Laboratory at the University of Iowa 37 Analysis,Answers,Action

8 LaboratoryPersonnelCompetencyAssessment Tracking/Evaluation LaboratorySection/Department: LaboratoryPersonnelName: Annual: TestName/Method/Instrument: Sixmonth: AspectofCompetencyAssessed Date Reference/AdditionalInformation 1.Directlyobservedperformanceofroutine patienttesting,includingspecimenhandling, processingandtesting. 2.Monitoredtherecordingandreportingof testresults(includingcalculations). 3.Reviewedintermediatetestresultsor worksheets,qualitycontrolrecords,proficiency testingresultsandpreventivemaintenance records. 4.Directlyobservedperformanceof instrumentmaintenanceandfunctionchecks. 5.Assessedperformancethroughtesting previouslyanalyzedspecimens,internalblind testingorexternalproficiencytesting. 6.Assessedproblemsolvingskills.Reference datesinproblemlogorattachcopies. 7.Proficiencytesting(PT)performanceis acceptableandcompletedwithintimeframe. 8.FollowsSOPsaswritten. 9.Complieswithsafetypractices. Listanyobserveddeficiencies: Additionaltrainingrequiredanddate(s)oftraining: LaboratoryPersonnelSignature: SupervisorSignature: Date: Date:

9 TRAINING&COMPETENCYCHECKLIST TESTSYSTEM/TEST TRAINEE/TESTINGPERSONNELME ACTIVITY COMPLETED [YES,NOor] COMMENTS Knowslocationofandhasreadprocedure,operators manualand/orpackageinsert. Describesspecimencollection,labeling,handlingand storagerequirements. Performsanddocumentsinstrumentmaintenance. Setsupinstrument(dailystartup) Performsanddocumentsqualitycontrolprocedures. Performsanddocumentscalibrationand,if applicable,calibrationverification. ExplainsappropriateactiontotakewhenQCor calibrationisunacceptable. Performstestingaccordingtoestablishedprocedure. Knowshowtointerpretandreportpatienttest results. Knowscriticalvaluesandappropriateactiontobe taken. Understandsbasictroubleshootingprocedures. Canexplainlimitationsandprecautionsforthe procedure. TrainingCompleted&CompetencyMetDate Trainer LaboratoryDirectoryReview(ifapplicable) Date

10 Training Checklist Test/Test System Trainee Name: Training Date: Principles of the procedure Contents of each kit or reagent(s) & storage/expiration requirements Precautions Specimen collection, labeling, handling, & storage requirements Test procedure(s) Interpretation and reporting test results Quality control requirements Maintenance/equipment requirements Calibration/calibration verification Record retention (QA, PM, calibration, patient) Demonstrate competency Additional Comments Trainer Name: Training Completed & Competency Met Date: Laboratory Director Review (if applicable) Date

11 TestingPersonnelCompetencyAssessment Employee Name: Completion Date: Six Month Annual Assessment Categories: 1. Direct observation 4. Direct observation of instrument maintenance/function checks 2. Monitoring the recording/reporting of test results 5. Blind testing/proficiency testing 3. Review of test records, worksheets, QC, PM 6. Evaluation of problem-solving skills Section Skill/Task/Knowledge Assessment Categories Read and follows procedure manual 3,6 Operating hematology analyzer in open and closed modes 1 Hematology Reporting and notification of critical values 2, 6 Performs and documents daily start up 1, 3 Performs and documents quality controls 1, 3 Performs and documents preventive maintenance and troubleshooting 4 Of analyzer Performs and documents calibration 3, 4 Performing CBC on hematology analyzer 1, 5 Read and follows procedure manual 3, 6 Coagulation Reporting and notification of critical values 2, 6 Performs and documents quality controls 1, 3 Performs and documents preventive maintenance and troubleshooting 4 Of analyzer Performs PT or PTT on coagulation analyzer 1, 5 Read and follows procedure 3, 6 Urinalysis Performs and documents quality controls 1, 3 Performs and documents preventive maintenance and troubleshooting 4 Of the analyzer Performs calibration 3, 4 Performs urinalysis macro (dipstick) and micro exam 1, 5 Problem solves: Understands when reflux testing is needed for urine 2, 6 Microscopic and urine cultures. Date Evaluated Remedial Training

12 Read and follows procedure manual 3, 6 Chemistry Reporting and notification of critical values 2, 6 Performs and documents quality controls 1, 3 Performs and documents preventive maintenance and troubleshooting 4 Of the analyzer Performs and documents calibration and calibration verification 3, 4 Performs testing for at least one analyte on all chemistry analyzers 1, 5 Read and follows procedure manual 3, 6 Blood Performs and documents quality controls 1, 3 Banking Completes component disposition records 1, 3 Performs and documents preventive maintenance of equipment 4 Performs ABO-Rh, antibody screen, and compatibility testing 1, 5 Problem solves: Understands steps to take when have incompatible 2, 6 Crossmatch, positive antibody screen, and transfusion reactions, etc. Read and follows procedure manual 3, 6 Microbiology Performs and documents quality control (media and reagents) 1, 3 Performs and documents preventive maintenance and troubleshooting 4 Of the analyzer Performs set up and interpretation of cultures 1, 5 Reporting and notification of critical values 2, 6 Problem solves: Understands which specimens need to reported to 2, 6 IDPH and SHL Read and follows procedure manual 3,6 Manual Performs and documents quality control 1, 3 Methods Reporting and notification of critical values 2, 6 Performs each type non-waived manual method (i.e. gram stain Manual white blood cell differential, etc.) Attach documentation supporting the findings of compliance, and corrective action for findings of needs improvement and remedial training. 5 Testing Personnel Signature: Date: Laboratory Director (designee) Signature: Date:

13 PreAnalyticCompetencyAssessment Employee Name: Completion Date: Six Month Annual Assessment Categories: 1. Direct observation 4. Direct observation of instrument maintenance/function checks 2. Monitoring entry of information in LIS/HER 5. Evaluation of knowledge and problem solving skills 3. Review of records, worksheets, QC, PM 6. Customer feedback Section Skill/Task/Knowledge Assessment Categories Identifying and processing orders in laboratory information system (LIS) or electronic health records (EHR)order entry Customer Service 1, 6 Registration Registering patient in EHR 2 And Order Entering orders into LIS or EHR 5 Entry Performing call back procedure 3 Correcting test orders and cancellations 2 Problem solving: Common registration and test order entry problems 5 (written) Follows patient identification procedure before collecting specimen 1, 6 Specimen Collecting blood specimen using venipuncture and capillary technique 1 Collection Selecting correct tube order 1, 5 Problem solving: Understands how to deal with potential problems (i.e. 5 (written) Difficult draws, patient s fainting during collection, etc.) Processing/storing specimens correctly (including specimens sent to Reference laboratory) 1 Date Evaluated Specimen Performs and documents refrigerator temperatures 1, 3 Processing Problem solving: Understands what to do if an error was discovered 5 (written) While processing specimens. Operating centrifuge 4 Special Performs and documents centrifuge maintenance 3, 4 Procedures Problem solving: Understands steps to take when problems with the 5 (written) Centrifuge arise (i.e. broken tube, imbalanced bucket, etc.) Attach documentation supporting the findings of compliance, and corrective action for findings of needs improvement and remedial training. 1 Remedial Training Testing Personnel Signature: Date: Laboratory Director (designee) Signature: Date:

14 LaboratoryPersonnelCompetencyAssessment Employee Name Completion Date: 6 month Annual Current tools available for assessment Specimen Processing Diagnostic Immunology 1. Direct Observations of routine patient test performance including patient identification and preparation, specimen collection, handling, processing and testing. Chemistry Hematology Coagulation 2. Monitoring the recording and reporting of test results, including reporting of critical results. Corrected result reports and critical call reports 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and maintenance records. QC, proficiency testing and maintenance records 4. Direct observation of performance of instrument maintenance and function checks. 5. Assessment of test performance through testing previously analyzed specimens, blind testing samples, or previously tested proficiency samples. Proficiency testing and internal blind testing samples 6. Evaluation of problem-solving skills. Written quiz and variance reports 1 P a g e

15 Urinalysis Immunohematology Microbiology Date Attach documentation supporting the findings of compliance. For testing personnel that receive the finding of needs improvement document the performance issue and corrective action taken below; include documentation of remedial training. Competency Assessment Corrective Action Date Performance Issue Competency Reassessment Date Completed Further training Date Completed Date Completed Further training Further training Testing Personnel Signature: Date: Laboratory Director (designee) Signature: Date: 2 P a g e