CMS qualifications for Competency Assessors

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Hello Fellow POCCs.

MLH is 4 hospital system with 2.2 POCCs to manage 4000 operators.  1358 observations need to be completed on an annual basis as part of competency.
In the current process, we had nurses, who had a BSN and 2 years' experience with the test method, functioning as competency assessors (technical consultant), so that nurses could complete the direct observation on each other.
BSN Nurses were also doing training and competency for new hires.

CMS December 2023 changes have now stated that a BSN is no longer the equivalent to a BS in biology making them now ineligible to be competency assessors.
Thus, we are searching for manageable ways to complete the competency process other than having 2 POCCs have to do competency observations.

Please share with me any discussions and particularly solutions your system is considering addressing this (outside of using the POCCs) to perform all competency passements for non-waived testing.

Appreciatively,

Melissa Willcox
MT ASCP
POCC
Main Line Health
willcoxm@mlhs.org

30 Replies

Afternoon Melissa, do you have a link or reference for the CMS change you discussed?

Hello,
I am the POCC at Einstein Philadelphia. With regard to assessing competency, the nurse educators do the direct observation for the Accuchek Inform II, the Cliniteks are used in the ED and the nurse educator for that department takes care of that population. Most departments have a nurse educator who performs the assessments for ACT, Blood Gases, POC PT/INR, HgbA1c, urinalysis by dipstick and urine pregnancy testing etc. some areas have superusers who are trained by the manufacturer. I perform the initial training for the ED residents for occult blood testing, microscopic examinations and ocular pH testing for chemical contamination. I also train the OB/GYN residents for the premature rupture of membranes using the Amnio test and the ROM Plus. I am the only person in the POC department and there is no way that I could ever accomplish this on my own.
Bonnie Coccagna MS, MT(ASCP)
Jefferson Einstein Healthcare Network
Point of Care Coordinator
215-456-6811
________________________________

Hi Melissa,

Before going further, I wanted to confirm which rule is being discussed.  Is this in reference to the following?

Final Rule- Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326-F)

Here is the link to CMS-3326-F below:
Federal Register :: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories


EDIT:  If you follow the link to the rule and look under the section § 493.1411 Standard; Technical consultant qualifications.  the language reads as follows:

(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or
(B) Meet § 493.1405(b)(5)(i)(B); and
(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or

This leads me to think that a nursing degree is acceptable as a "clinical" degree under this guideline for Technical Consultant.

Hi! This was one of the first things I asked of our CLIA office.  They stated that removing the BSN option for personnel requirements did not affect their ability to be a technical consultant for moderate POC testing.
Here is his reply:
Mary,
 
I have an answer for you regarding TC's and BSN degrees!
 
While CMS removed the physical science wording from ALL personnel qualifications, they have NOT changed any other qualifications for a TC. For moderate complexity testing a BSN is still fine to serve as TC, however for high complexity I would need to do a credit hour audit from transcripts to verify scientific credit hours.
 
So if anyone has questions about this, I think you should go directly to your CLIA office and then post the reply here.  I feel like this is super messy and, while I'm happy to go by what Adam told me, I'm still skeptical because honestly, that isn't how I read it.  Let's pool some answers here!
Mary
 

Attachment.
image.png
Here is the title you can google. The real interesting parts start on page 89998 section B personnel Requirements.

As I read this document and as my laboratory director in charge of POCC read the document, the people who are currently working in those positions are grandfathered in and can continue to perform competency assessment, but as those individuals leave those positions and new ones are hired, the new hires will not be able to perform competency assessment. Same goes for nurses performing high complexity testing. As long as they continue on in their position they can keep doing it.

this refers to non-waived competency assessment only- not waived competency assessment.

On page 90010 of the CMS document, it specifically addresses in section 6. Technical Consultant Qualifications. What is at issue is the credits and training/experience needed in a laboratory science, which most nurses don't have. 

Melissa- I’m with you…I felt like it meant that anyone new that had a BSN would not be allowed to be a TC. That’s why I asked our state office to clarify. I would really love it if others ask their state offices  to clarify as well because I’m just not sure I read it the way he stated. And yes, I read all 69 pages, quite unwilling, haha. 

These are dynamic changes.
1. The 12/28/2024 Final ruling https://www.federalregister.gov/d/2023-28170 seems to state the TC changes go into effect at the end of 2024 
Attachment.
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Attachment.
image.png
2. Nurses as Technical Consultants - I agree with Mary Hammel the wording seems to state no nursing degrees for Mod complex TC.  I will also be asking for clarification from our CLIA folks in New Mexico.
3. Associate degrees as TC.
Attachment.
image.png
4. Blood gas analysis TC changes - Will this limit Blood gas testing at the POC in the future? 
Attachment.
image.png

Oh and one last caveat concerning respiratory therapy being qualified to be TC.
There is a gray area if you blood gas menu contains chemistry analytes such as glucose, lactate, Na+ etc.
Certainly an RT can sign off on pH, pCO2 and O2 and the rest of the ABG parameters, but what about the chemistry ones?

I could not find, in the new proposed changes, that state exactly that a BSN is not equivalent to a BS in biology when it comes to competency assessment for moderate complex testing.
Can you provide that information?
 
Under this final rule, individuals with nursing degrees will only be able to qualify for personnel positions listed in
subpart M when a nursing degree is specifically listed in the regulatory qualifications. For
example, revised § 493.1423 includes nursing degrees for moderate complexity testing
personnel.
 
I did see that a BSN is not equivalent to a degree in biological science as it relates to high complex testing:
CMS received over 19,750 comments from laboratory personnel groups (including AMT) and individual laboratorians opposing the agency’s proposal to allow persons with a bachelor’s degree in nursing (BSN) to perform high complexity testing. The July 2022 proposed rule already had acknowledged that a BSN is not equivalent to a degree in a biological or chemical science. But the agency had nevertheless proposed a separate route by which BSNs could perform high complexity testing – without any additional documented training. In response to the overwhelming opposition, CMS determined not to finalize its proposal to qualify BSNs for high complexity testing. Individuals with a nursing degree may still qualify as moderate complexity Testing Personnel, which covers most point-of-care testing, but cannot serve as Lab Directors or Technical Consultants in those settings.

CAP is currently revising their standards based on these revised CMS regs so hopefully there will be more clarifications as we get closer to the
December effective date.

Hi Deb,

The issue is here:
In response to the overwhelming opposition, CMS determined not to finalize its proposal to qualify BSNs for high complexity testing. Individuals with a nursing degree may still qualify as moderate complexity Testing Personnel, which covers most point-of-care testing, but cannot serve as Lab Directors or Technical Consultants in those settings.

If I understand this correctly, BSNs can perform moderately complex testing, but not perform high complexity testing AND they can not be technical consultants which is what you need to be able to be a CA for non-waived testing.

Mary, I will ask our state office as well.

When I saw this I had to go investigate lol.  I think Melissa you are correct that any BSN that are currently equivalent to TCs can continue to do it but after Dec any new ones have to meet the criteria.  It refers back to 493.1405(b)(5)(i)(B) which says the specific courses needed.
I definitely need to look further into this.

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