Complying With CLIA Competency Requirements

1. Complying With CLIA Competency Requirements Eileen S. Licuanan, MHR, MT(ASCP), CLS Quality Assurance Specialist Transfusion Services, UC San Diego Health

2. Objectives • Discuss the six minimum requirements for competency assessment and methodologies • Describe the development and scope of an effective CLIA competency program

3. Regulatory and Accreditation Requirements • CLIA/FDA - 42 CFR 493.1235 and 42 CFR 493.1451(b)(8)(9) • CAP (GEN.5550) • AABB (2.1.3)

4. What is competency and CLIA competency Assessment? Competency is the ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly. Competency assessment is used to ensure that the laboratory personnel are fulfilling their duties as required by federal regulation. Competency is the application of the knowledge, skills and behaviors for performance. Training happens before someone begins testing and competency assessment confirms that the individual is doing the testing correctly.

5. CLIA/FDA Requirements 42 CFR 493.1407 Standard; Laboratory director responsibilities. Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improveskills. 42 CFR 493.1451 Standard: Technical supervisor responsibilities.Identifying training needs and assuring that each individual performing testsreceives regular in-service training and education appropriate for the type and complexityof the laboratory services performed;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.

6. 42 CFR 493.1451 cont. • Evaluating and documenting the performance of individuals responsible for highcomplexity testing at least semiannually during the first year the individual tests patient specimens. High Complexity Tests examples: ABO/Rh Antibody Screen Antibody Identification Compatibility Testing • Thereafter, evaluations must be performed at least annuallyunless test methodology or instrumentation changes, in which case, prior to reportingpatient test results, the individual's performance must be reevaluated to include the use ofthe new test methodology or instrumentation.

7. 42 CFR 493.1451 cont. Minimal regulatory requirements for assessment of competency for all tests performed: • Direct observations of routine patient test performance, including patientpreparation, if applicable, specimen handling, processing and testing • Monitoring the recording and reporting of test results • Review of intermediate test results or worksheets, quality control records,proficiency testing results, and preventive maintenance records; • Direct observation of performance of instrument maintenance and functionchecks • Assessment of test performance through testing previously analyzed specimens,internal blind testing samples or external proficiency testing samples; • Assessment of problem solving skills

8. Developing a competency program • People • Processes • Resources

9. Considerations when developing an (effective) competency program People: • Establish a team who will develop the program or re-evaluate the existing policies • Define who is responsible for performing and documenting competency assessments (if delegated, shall be in writing) • Define the qualifications of designated individuals assessing competency Education Experience Complexity of Testing • Primary and Secondary trainer/assessor • Competency assessment of designees • Testing and Non-testing personnel

10. Considerations when developing an (effective) competency program, cont. Processes: • Define the frequency of assessment Semiannually during the first year the individual tests patient samples At least annually thereafter • Identify the critical points in processes and procedures • Develop test systems (i.e. automated testing, manual testing, etc) • Design records to document competency assessment • Address “procedural drift”

11. Considerations when developing an (effective) competency program, cont. Processes: • Requirement to complete competency assessment prior to and after implementation of changes • Provisions when competency assessment cannot be completed within the established timeframe • Timeline for completion of assessment • Need for re-training and re-evaluation of competency • High risk, low frequency test or procedure • Upgrades on Blood Bank Information System • Policies, procedures and forms are current and reflect bench practices • Effectiveness Check (QA Unit)

12. Considerations when developing an (effective) competency program, cont. Resources: • Quality Variance Reports, Blood Product Deviation Reports • QA Audits • Impact on Workload • TIME, TIME, TIME • Staffing shortages • Career and casual employees • Finance

13. Automated Platform Quality Control and Maintenance (Direct Observation and Review of QC Records) Consumables and Reagents (Problem Solving Skills) Specimen Criteria (Direct Observation and Problem Solving Skills) ABO, Rh, Antibody Screen and Antibody Identification (Review of worksheets) Review of Results (Direct Observation and Problem Solving Skills) Recording of Results (Direct Observation and Monitoring recording and reporting of test results) Use of patient samples, proficiency samples (assessment of test performance)

14. Manual Platform Quality Control Instructions for Use Storage Requirements ABO/Rh (Blood Type discrepancies) Cord Blood testing DAT Antibody Screen (enhancement solutions) Donor Retype Preparation of 0.8% reagents Serofuge Cell Washer (Manual Washing) Antibody Identification (use of expired panel cells) Compatibility Testing Selection of components (Irradiation, antigen negative)

15. Equipment:Quality Control CalibrationTemperature MonitoringUse of equipmentProblem Solving – when not in use, documentationRecords Review

16. Special Testing Platform Direct Observation Discussion and Verbal questions Written exam Review of records Unknown or proficiency samples • Elution • Fetal Bleed Screen • KleihauerBetke • Antibody Titration • EGA Treatment • DTT Treatment

17. Non-Test Related Blood Bank Activities • Neonatal Aliquot • Exchange Transfusion • Emergency Release • Massive Transfusion • Inventory Management • Blood Issue, Return

18. Effectiveness Check of the Competency Program • Internal Audits • Quality Variance Reports and Blood Product Deviation Reports • Customer feedback • Employee feedback

19. References • Document Review: Centers for Medicare and Medical Service (CMS), What Do I Need to Do to Assess Personnel Competency, November 2012 • CLIA Regulations, http://wwwn.cdc.gov/clia/regs • Quality Management Focus on Competency Assessment, Joan S. Boyd, October 2017 • Competency Assessment in the Transfusion Service: Tips and Tools, Medical Laboratory Observer, October 2013