Technical Consultant Assessment

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Good morning,


 


We were recently inspected by CLIA and were sited for competency assessment for 2 things:


No TC assessment and signed off by Pathologist


The whole BG panel was not included on the user assessment (only one analyte).


 


Does anyone have a TC assessment that they can share?


Thanks!

4 Replies

Was given heads up to be expecting this for future CLIA inspections down here in rural Georgia.  Am responsible for about a dozen practices. Among other things I must assess employees who use Medonics CBC analyzers(3 sites) and Fastpak PSA Immunoassay system(1 site).


As I do not run these analyzers at my own hospital, have been wondering about this same issue 1) do I need to prove my own competency? and 2) who assesses me?


 


Appreciate any and all feedback

Paula,


 


From what this CLIA inspector said you have to have a competency assessment for a TC that is signed off on by the medical director.  You do not have to have a competency assessment for the devices to run the testing unless you perform testing.

The CMS brochure on competency (https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf) has a section on precisely what needs to be assessed for the technical consultant doing the competency assessments.


Marcia

Attachment. Technical Consultant or Supervisor Competency.docx


 


They are referring to something like this.

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