2012 CLIA Update: Mission Possible Competency Assessments

Transcription

1 Speakers Association of Public Health Laboratories Teleconference Series 2012 CLIA Update: Mission Possible Competency Assessments Diana Fairbanks, BS, MT(ASCP) Laboratory Consultant Department of Health & Human Services Centers for Medicare/Medicaid Services Region VII Division of Survey, Certification & Enforcement Kansas City, MO 3/27/2012 1:00 2:00 PM ET Nancy Grove, BS, MT(ASCP) CLIA Compliance Manager State Hygienic Laboratory Iowa CLIA Laboratory Program Iowa City, IA Kristine Rotzoll, BS, MT(ASCP) CLIA Compliance Specialist State Hygienic Laboratory Iowa CLIA Laboratory Program Iowa City, IA Objectives At the conclusion of this program, participants will be able to: Explain each of the CLIA regulations for assessing the competency of laboratory testing personnel who are responsible for moderate and/or high complexity testing. Provide examples and ideas to assist the laboratory in its mission to be compliant with the regulations. Continuing Education Credit The Association of Public Health Laboratories (APHL) is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. Program. Participants who successfully complete this program will be awarded 1 contact hour of continuing education credit. Florida CEU credit will be offered based on 1 contact hour. Continuing education credits are available to individuals who successfully complete the program and evaluation by 4/27/2012. The evaluation password is 910ro. Detailed directions for completing the evaluation and printing your certificate are on Archived Program The archived streaming video will be available within two weeks. Anyone from your site can view the Web archived program and/or complete the evaluation and print the CEU certificate for free. To register for the archive program go to and use the complementary discount code 910ro in the discount box during registration. Comments, opinions, and evaluations expressed in this program do not constitute endorsement by APHL. The APHL does not authorize any program faculty to express personal opinion or evaluation as the position of APHL. The use of trade names and commercial sources is for identification only and does not imply endorsement by the program sponsors. This program is copyright protected by speaker(s) and APHL. The material is to be used for this APHL program only. It is strictly forbidden to record the program or use any part of the material without permission from the author or APHL. Any unauthorized use of the written material or broadcasting, public performance, copying or re-recording constitutes an infringement of copyright laws. The Association of Public Health Laboratories (APHL) sponsors educational programs on critical issues in laboratory science. For more information, visit

2 2012 CLIA UPDATE Mission Possible Competency Assessments March h27, 2012 Sponsored By Association of Public Health Laboratories and State Hygienic Laboratory at the University of Iowa 1 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: Diana.Fairbanks@cms.hhs.gov 2 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 3 1

3 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: 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. 5 CLIA Regulations Code of Federal Regulations: 42 CFR 493 Centers for Medicare & Medicaid id Services State Operations Manual, Appendix C Interpretative Guidelines for Laboratories and Laboratory Services 6 2

4 42 CFR 493 Subpart K, Part 1- General Systems Standard: Personnel competency assessment policies. i 7 42 CFR 493 Subpart M Personnel Requirements MODERATE Complexity Testing Laboratory Director Responsibilities: (e)(11) & (12) Technical Consultant Responsibilities: (b)(7) & (8) 8 42 CFR 493 Subpart M Personnel Requirements HIGH Complexity Testing Laboratory Director Responsibilities: (e)(12) & (13) Technical Supervisor Responsibilities: (b)(7)(8) & (9) General Supervisor Responsibilities: (b)(3) & (4) 9 3

5 Training vs. Competency Definitions: Training: process to provide and develop knowledge, skills, and behaviors to meet established requirements Competence: application of knowledge, skills, and behaviors in performance 10 WHY perform training and competency assessments? Ensure that laboratory staff report tests promptly, accurately and proficiently. Ensure that t laboratory staff are competent t to perform test procedures. Ensure that satisfactory performance of test procedures remains consistent. 11 WHO performs training and competency assessments? 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. 12 4

6 WHO Laboratory director may delegate this responsibility, in writing, to: Moderate complexity testing - Technical Consultant High complexity testing - Technical Supervisor or General Supervisor 13 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. 14 Job Duties & Responsibilities 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. 15 5

7 Prior to Implementation of Training Policies & Procedures 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. 16 Prior to Implementation of Training Policies & 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. 17 Prior to Implementation of Training Policies & Procedures When establishing training policies & procedures consider: Identify training materials Operator s manuals, manufacturer s instructions, practice materials (samples), requisitions, and forms, etc. 18 6

8 Prior to Implementation of Training Documentation 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 19 Implementation of Training Identify Training 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). 20 Prior to Assessing Competency Policies & Procedures 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. 21 7

9 Competency Assessment versus Performance Evaluation 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. 22 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. 23 WHAT to include in competency assessments? 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; 24 8

10 Direct Observations Application & adherence to all elements of test method/instrument procedure Specimen handling & processing Preparation/assessment of reagent & control materials 25 Direct Observations Interpretation and acceptance of test reactions & results Documentation ti of results Review QC 26 Direct Observations Instrument operation, function checks, monitoring & maintenance Utilization & appropriate demonstration of laboratory skills & practices Adherence to safety requirements LIS knowledge & abilities 27 9

11 WHAT to include in competency assessments? 3. Monitor recording and reporting test results; 4. Review: - intermediate t test t results and/or worksheets, - quality control records, - proficiency testing results, and - preventive maintenance records. 28 WHAT to include in competency assessments? 5. Assessment of test performance through testing previously analyzed specimens, internal blind samples or external proficiency testing samples; and 29 WHAT to include in competency assessments? 6. Assess problem solving skills. Case study problems; Theory questions; Technique questions; Interpretation questions; Problem solving questions 30 10

12 HOW to perform competency assessments? 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. 31 HOW Collect data throughout the year and document: Quality control record review, Proficiency testing results review, Patient result review, and Preventive maintenance records review. 32 Evaluation of Competency Program If problems are detected, what is done? Retraining? Re-evaluation? Review/revision of procedures and/or processes? Future monitoring? 33 11

13 Examples Refer to your handouts: Training & Competency Checklists Personnel Competency Assessment Forms & Checklists 34 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. 35 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)

14 Websites Centers for Medicare & Medicaid Services Centers for Disease Control asp Clinical Laboratory Standards Institute State Hygienic Laboratory at the University of Iowa

15 Laboratory Section/Department: Laboratory Personnel Name: Annual: Test Name/Method/Instrument: Laboratory Personnel Competency Assessment Tracking/Evaluation Six month: Aspect of Competency Assessed Date Reference/Additional Information 1. Directly observed performance of routine patient testing, including specimen handling, processing and testing. 2. Monitored the recording and reporting of test results (including calculations). 3. Reviewed intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records. 4. Directly observed performance of instrument maintenance and function checks. 5. Assessed performance through testing previously analyzed specimens, internal blind testing or external proficiency testing. 6. Assessed problem solving skills. Reference dates in problem log or attach copies. 7. Proficiency testing (PT) performance is acceptable and completed within timeframe. 8. Follows SOPs as written. 9. Complies with safety practices. List any observed deficiencies: Additional training required and date(s) of training: Laboratory Personnel Signature: Supervisor Signature: Date: Date:

16 TRAINING & COMPETENCY CHECKLIST TEST SYSTEM/TEST TRAINEE/TESTING PERSONNEL ME ACTIVITY Knows location of and has read procedure, operators manual and/or package insert. Describes specimen collection, labeling, handling and storage requirements. Performs and documents instrument maintenance. Sets up instrument (daily startup) Performs and documents quality control procedures. Performs and documents calibration and, if applicable, calibration verification. Explains appropriate action to take when QC or calibration is unacceptable. Performs testing according to established procedure. Knows how to interpret and report patient test results. Knows critical values and appropriate action to be taken. Understands basic troubleshooting procedures. Can explain limitations and precautions for the procedure. COMPLETED [YES, NO or ] COMMENTS Training Completed & Competency Met Date Trainer Laboratory Directory Review (if applicable) Date

17 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

18 Testing Personnel Competency Assessment 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 2, 6 Problem solves: Understands when reflux testing is needed for urine Microscopic and urine cultures. Date Evaluated Remedial Training

19 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:

20 Pre Analytic Competency Assessment 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. Difficult draws, patient s fainting during collection, etc.) Processing/storing specimens correctly (including specimens sent to Reference laboratory) 1 5 (written) Specimen Performs and documents refrigerator temperatures 1, 3 Processing Problem solving: Understands what to do if an error was discovered While processing specimens. 1 5 (written) Operating centrifuge 4 Special Performs and documents centrifuge maintenance 3, 4 Procedures Problem solving: Understands steps to take when problems with the 5 (written) Date Evaluated 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. Remedial Training Testing Personnel Signature: Date: Laboratory Director (designee) Signature: Date:

21 Laboratory Personnel Competency Assessment Employee Name Completion Date: 6 month Annual Current tools available for assessment Specimen Processing Date completed Diagnostic Immunology 1. Direct Observations of routine patient test performance including patient identification and preparation, specimen collection, handling, processing and testing. Date completed Chemistry Date completed Hematology Coagulation Date completed 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 age

22 Urinalysis Date completed Immunohematology Date completed Microbiology Date completed Date Date completed 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 age