Training for waived testing

I believe that only applies to non-waived testing (that the training has to be done at the facility where the CLIA certificate resides).

 Here is TJC's response to an inquiry we sent in August:

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6 August 2019

Case Number: 00100419 0819AGUIH4779-1

Thank you for your inquiry.  Below you will find the response to your original submitted question(s).

The following question was submitted:

Hello,

In regards to training and competency - if we have staff trained for a waived test in one of our facilities and they either transfer or work additional hours at another facility (with a different CLIA waived license) would they need to do training again? The staff is still within our hospital system. 

The Joint Commission response:

CLIA regulations do not recognize systems. Each CLIA Certificate represents a separate and distinct laboratory. All documentation required by Joint Commission Standards and CLIA Regulations must be specific to each CLIA number. The direct answer to the inquiry is documentation of training and competence to perform laboratory tests must be maintained for each CLIA Certified testing location where an employee performs testing.

I hope you will find this information helpful. 

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I believe others have fulfilled this requirement by listing all applicable CLIA numbers on competency documents.

I was told by our CLIA inspector that listing all sites on competency documents would not fill the requirement. Separate documents for separate facility. I have four clinics and in order to cover shifts most of staff float to at least 2 clinics. I have casuals that go to all four. The kit tests are what do not make sense - if it is the same platform, waived, same procedure, why would you have to do competencies everywhere? Especially if the staff member works there at least half time.  Oh well, I have put on my big girl lab coat and will do competencies over, and over, and over.....

Are these 30 sites under Clia Waived certificates and no Accreditation?

Sent via Groupsite Mobile.

Chris Caron - yikes, separate documents for separate facilities?  What if you're doing electronic learning modules as so many large health systems are doing?  Are you supposed to enroll people 30 times?  That is just beyond absurd.

This must be TJC. CLIA doesn't require waived test competency. Only you are accredited by TJC then you need to do it each at location or each CLIA #. Why would you accredited all locations for waived test anyway?

Interesting question, Kompan Hallman [why would you accredit all locations for WT anyway?]. I bet if you ask 5 POCCs, you get 5 different responses!

In our case, our 4 hospitals in the health system use TJC Accreditation. Since TJC Accreditation includes a Waived Testing Chapter, both inpatient and outpatient/ambulatories - all clinical waived testing sites within the health system regardless if it's on or off a hospital campus- are set up to meet TJC WT standards (if they are performing nonwaived then they are set up to meet CAP standards).

My response then to the question is that it's part of our quality plan to ensure all patient care delivered meets TJC standards for providing that direct patient care. For us, POCT is considered part of the whole package in offering and delivering direct patient care.

Hi all,

I came back to this thread to see if anyone had posted the 'legal' wording from CLIA to show that neither initial competency nor annual competency is required for waived tests- except under an accreditation. I don't see it in any post.   

Or is it the lack of 'legal' wording that denotes 'it's not required because it's not in the rule that it's required'?

I can't find the resource power point from a federal government speaker that I used to have. I thought the slide stated 'training must be provided'. Second CLIA reg in WT is that MIFU must be adhered to. But 'competency' per se is not required as initial or annual (if not under an accreditation).

Does anyone who is inspected by CLIA/their state have that wording from the fed register (or wherever it's cited)?

Thanks!

Hi Peggy-  lots of resources for you:

from CLIA brochure on competency:

If my laboratory only performs waived testing, do I need written
policies for assessing personnel competency?
CLIA does not require policies for assessing personnel competency for waived
testing. Even though CLIA has no specific requirements for personnel performing
waived testing, you need to ensure that patient testing results are correct to assist
in making an accurate patient diagnosis. You will need to ensure that testing
personnel are following all manufacturers' instructions. Testing personnel who are
properly trained and performing the test correctly will aid the physician/provider
in making an accurate patient diagnosis. If your laboratory is accredited, you may
need to consult your accrediting organization's standards.

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf

from the CFR:

§493.15(e) Laboratories eligible for a certificate of waiver must--
(1) Follow manufacturers' instructions for performing the test; and
(2) Meet the requirements in subpart B, Certificate of Waiver, of this part.

subpart B just specifies how to get a certificate of waiver

Here are a couple of quotes from READY? SET? TEST! put out by the CDC:

Under Purpose: "...waived testing needs to be performed correctly, by trained personnel and in an environment where good testing practices are followed." (emphasis mine)

Under Know How to Do the Test the Right Way: "Practice all tests, while an experienced person watches, before testing patient samples and reporting patient results. Document training on all tests in staff personnel files."

Marcia gives more extensive information above. The web address to the booklet I refer to is http://wwwn.cdc.gov/clia/Resources/WaivedTests/