CLIA Certificate Management
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Does anyone have the added responsibility of maintaining CLIA certificates for their entire health system?
I have been in my current role for about six months, and am one of two point of care coordinators for a 4 hospital, 20+ clinic system that is growing rapidly. I have recently been handed responsibility for managing all of the CLIA certificates for the entire system--hospitals and clinics. The person who previously performed this function worked on the billing side of the laboratory, and as I work through a list of items identified as needing attention that were never completed, I'm finding this task is essentially a separate full-time endeavor.
I am trying to revamp the process for completing the CMS 116s, specifically listing testing performed at each site. Does anyone have an example of a CMS-116 with waived urinalysis testing? Do you list each analyte separately? For instance, we have sites that (for reasons unknown to me) are performing both manual urine dipsticks and using a Clinitek Status (our clinic sites are not interfaced due to IT challenges, but that's a separate mess). I'm wondering if I need to list SG, pH, leuk, blood, etc. . . individually, or if I just document that both the Clinitek Status and Siemens Multistix 10 or 8SG are being used.
I appreciate any expertise you can share! For what it's worth, we are still trying to work out how to perform correlations on our entire fleet of iSTATs (over 60), and our state inspector has made it clear that the expectation is that they are all correlated (not just a sampling) every 6 months. I'm not sure how, logistically, we are going to get that done. But I digress.
Thank you!
I have been in my current role for about six months, and am one of two point of care coordinators for a 4 hospital, 20+ clinic system that is growing rapidly. I have recently been handed responsibility for managing all of the CLIA certificates for the entire system--hospitals and clinics. The person who previously performed this function worked on the billing side of the laboratory, and as I work through a list of items identified as needing attention that were never completed, I'm finding this task is essentially a separate full-time endeavor.
I am trying to revamp the process for completing the CMS 116s, specifically listing testing performed at each site. Does anyone have an example of a CMS-116 with waived urinalysis testing? Do you list each analyte separately? For instance, we have sites that (for reasons unknown to me) are performing both manual urine dipsticks and using a Clinitek Status (our clinic sites are not interfaced due to IT challenges, but that's a separate mess). I'm wondering if I need to list SG, pH, leuk, blood, etc. . . individually, or if I just document that both the Clinitek Status and Siemens Multistix 10 or 8SG are being used.
I appreciate any expertise you can share! For what it's worth, we are still trying to work out how to perform correlations on our entire fleet of iSTATs (over 60), and our state inspector has made it clear that the expectation is that they are all correlated (not just a sampling) every 6 months. I'm not sure how, logistically, we are going to get that done. But I digress.
Thank you!
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I'd love to talk more with you and tell you how our system works effectively. Are you headed to Anaheim for the ADLM Annual meeting? We can talk there or...you can email me to connect anther time.
deatone@bronsonhg.org
Erika
Suggest- include the brand since the visual may be a different brand than what is used on the Clinitek (ours is) and I state the specific strip, e.g. Chem 10, Chem 7, Chem 2.
Good luck with the CLIAs/116s new or changing LD, etc. As others offered, I am also happy to be contacted pmann@utmb.edu and don’t hesitate to ask about PPMPs in ambulatory if those seem even more confusing to wrestle.
PS please you tell whomever you reach out to what State you are in. I checked and can’t since your contact is a personal email.
I am in QA position and keep up with CLIA revisions and recertification. You do not need to name each individual test performed as part of urinalysis in the CMS form, but name the strip brand and manufacturer.