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 and 42 CFR (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 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 improve skills. 42 CFR Standard: Technical supervisor responsibilities. Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of 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 cont.
Evaluating and documenting the performance of individuals responsible for high complexity 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 annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.

7. 42 CFR cont.
Minimal regulatory requirements for assessment of competency for all tests performed:
Direct observations of routine patient test performance, including patient preparation, 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 function checks
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 Calibration Temperature Monitoring Use of equipment Problem Solving – when not in use, documentation Records Review

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

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,
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