1. Competency/Training and CLIA
Anne Chenoweth, MBA, MT(ASCP)CM, CQA(ASQ)
May 2015

2. Agenda Background CLIA regulations – Training and Competency

3. Background 1995: AABB granted deemed status by CMS for CLIA
BBTS Standards equal to or more stringent than CLIA condition level requirements
AABB assessment takes the place of routine government inspections mandated by CLIA
Deemed status granted for up to 6 years
2014 AABB granted deemed status for BB/TS, IRL, MT and Cellular Therapy Standards for 6 years

4. When AABB  CLIA Assessment Tool CLIA Verification Form
Inclusion of assessor questions
Inclusion of CLIA regulation
CLIA Verification Form
Specific questions related to CLIA regulations
Lead assessor packet and website

5. AABB CLIA Verification Form
Use when AABB is the CLIA provider
Included in Lead Assessor packet
Lead is responsible for completion based on feedback from team members

6. AABB Standards Medical Director (on CLIA certificate)
Review of new or revised procedures
Meets CLIA requirements found in CFR

7. Competency 2. Monitoring the recording and reporting of test results;
42 CFR , 42 CFR (b)(8)(9)
1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
2. Monitoring the recording and reporting of test results;
3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;
4. Direct observations of performance of instrument maintenance and function checks;
5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
6. Assessment of problem solving skills.

8. Regulated Analytes ABO Rh Antibody Transfusion
Antibody Non Transfusion (prenatal)
Antibody Identification
Compatibility Testing

9. Element 1
Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;

10. Element 2 Monitoring the recording and reporting of test results;

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

12. Element 4
Direct observations of performance of instrument maintenance and function checks;

13. Element 5
Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and

14. Element 6
Assessment of problem solving skills.

15. Training and Competency

16. Semi Annual

17. Frequency
At least semiannually during the first year the individual tests patient specimens
At least annually thereafter unless test methodology or instrumentation changes
Prior to reporting patient test results, the individual's performance must be re-evaluated to include the use of the new test methodology or instrumentation

18. Who Is Responsible for Performing Competency Assessment?
Technical Consultant – moderate complexity testing
Can be performed by other personnel meeting TC qualifications
Technical Supervisor – high complexity testing
Can be delegated, in writing, to a General Supervisor meeting qualifications as GS for high complexity testing
“Peer testing personnel who do not meet the regulatory qualifications of a TC, TS, or GS cannot be designated to perform competency assessments.”
~CMS

19. Qualifications Technical Consultant
Bachelor’s degree in chemical, physical or biological science or medical technology AND
Have at least 2 years of laboratory training or experience, or both, in non-waived testing
General Supervisor
Qualify as testing personnel under 42CFR (b)2 AND
Have at least 2 years of laboratory training or experience, or both, in high complexity testing

20. Step 1 Define the tests These are NOT tests: Unit confirmation
ABO Rh
Ab Screen/ID
Crossmatch
DAT
Antigen typing
FMH screen
Prenatal titer
These are NOT tests:
Unit confirmation
Prenatal workup
Cord blood workup
Transfusion reaction investigation

21. Define methodology(ies) Tube Manual gel Automation Echo ProVue
Step 2
Define methodology(ies)
Tube
Manual gel
Automation
Echo
ProVue

22. Step 3 Identify equipment Exclude equipment not related to testing
Cell washer
Incubator
Centrifuge
Provue
Echo
Exclude equipment not related to testing
Refrigerator
Freezer
Plasma Thawer
Platelet Incubator

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

24. Have You Defined What Tasks Are Critical?
Sample collection
Sample evaluation
Component preparation
Thawing FFP
Making aliquots
Washing red cells
Irradiating products
Issue of blood products
Others?

25. What To Assess Deviation reporting Customer complaints
Staff complaints
High risk activities
Low frequency activities
You decide!

26. Document What was assessed Who was assessed Method of assessment
Who performed assessment
When
Competent Y/N

27. Design a form

28. Example Competency Statements
(employee sign/date)___________ certify that I am fully trained and competent to perform the roles listed above
(assessor sign/date)___________ attest that the staff member listed above is fully trained and competent to perform the roles listed above

29. Questions?