Competency assessment clarification - mod and highly complex

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Hi everyone -
Asking a question for a friend who's being inspected right now. Looking for interpretive help for CLIA and CAP guidelines.

Say I've worked in the hospital lab for 20 years, performing waived, mod, and highly complex testing. I'm also qualified to be a competency assessor for multiple departments. Heme brings in a new coag instrument from a different manufacturer. I get trained on it and then like normal, have my annual competency assessment for everything I do, 1 year later.

Should I have had a 6 month and 1 year competency on this platform because it's new to me, even though I've been performing this type of testing for 20 years? Or does the CLIA reg apply to "new" employees only?

8 Replies

Brandy Kenny

Thu Nov 14, 2024 at 9:46AM

Yes, because it is a new platform.

Patsy Gunn

Thu Nov 14, 2024 at 9:47AM

yes, new test system/platform

Angel Lorenzo

Thu Nov 14, 2024 at 9:49AM

Agree. Must have initial, 6month and yearly thereafter.

There is a gray area for this requirement from what I see in this conversation.
New System Initiates - "Initial, 6month, yearly " Is what I believe is the thought is.

Ashlee Holland

Thu Nov 14, 2024 at 10:10AM

I have asked this question to CAP directly and their response was that if it is a new platform but the employee has been performing moderate complexity testing for greater than 1 year, only initial training on the new platform and adding the new instrument to the employee's annual competency is required. The 6-month competency requirement is only for new employees, new to moderate complexity or that have been performing for <1 year. I would suggest they reach out to CAP to clarify for their situation if the inspector is stating differently.

+ 1 more

Autilia Sisti

Thu Nov 14, 2024 at 10:14AM

I concur- yes to the 6-month if you are not a laboratory technologist.
The best advice is to ask CAP directly.

Danyel Olson

Thu Nov 14, 2024 at 10:23AM

I have the same viewpoint as Ashlee. The CAP checklist GEN.55500 says "new employees". CLIA regs say that if a test or method is changed, the individuals performance must be re-evaluated prior to reporting patient results. I interpret that as training.

I'll have to see where they left things and we will need to contact CAP.

Don Tran

Thu Nov 14, 2024 at 11:28AM

I agree with Ashlee. The 6-month requirement only applies to NEW employees to your institution, not new instruments.

Melissa Willcox

Thu Nov 14, 2024 at 12:21PM

The POCCs for our system specifically sent CAP a question about this and did get a written response stating that if the employee is not a new hire then they don't need the 6 month and the can just go to the annual competency. I would suggest sending them an email so that you receive that in writing to show an inspector as we did.

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Competency assessment clarification - mod and highly complex