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

Charles Yaple

Tue Mar 26, 2024 at 5:07PM

So, this is where I think future BSN's are excluded from being TC's. "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."

In 493.1423 the testing personal qualifications section - nursing is specifically listed.
In 493.1411 the technical consultant qualifications section - nursing is not specifically listed

Karen Smeck

Tue Mar 26, 2024 at 5:44PM

I am one of two POCC at a hospital in Visalia, CA and we were cited by CAP for using BSNs to assess competency for non waived tests. We were inspected in December 2023 and the inspector specifically referenced a CDPH document that stated that CA was using more stringent TC qualifications for assessing non waived tests. Not sure how it is for other states...This is what they referenced:

ISSUES SPECIFIC TO CALIFORNIA CLINICAL LABORATORY LAW California Department of Public Health Laboratory Field Services

A moderate complexity technical consultant must be licensed to perform high
complexity testing in California or to practice medicine and must have two years
of experience in moderate or high complexity testing in the specialty or
specialties for which he or she is consulting. (17 CCR § 1036.2)

We are now only using POCC and trained CLS to do all non waived competency assessments.
We have Actim Prom, iSTAT, GEM 5000, Hemochron and Avoximeter with around 500 staff
to assess.

Melissa Willcox

Tue Mar 26, 2024 at 5:53PM

Brian and Deb Murtach, I finally found the wording about the BSN not being equivalent to a biological science degree. Therefore, they can not be a technical consultant:

Melissa Willcox

Tue Mar 26, 2024 at 6:05PM

Karen, it would seem that the federal government is coming more in line with what is happening in California. This will be a problem for a lot of hospitals across the US that don't already have stricter laws about who can perform competency assessment. As we were brainstorming, the lab VP mentioned using existing laboratory personnel to help the POCCs do the CA. My impression is that there is no appetite or funds to higher more POCCs at this time. That being said, I actually put some data together for our system to explain the amount of time doing CA would require at MLH. I allowedd 20 minutes for established employees and up to 45 minutes if doing an initial training and competency. Take a look:
Total # of Non-Waived observations 1225

Karen Smeck

Tue Mar 26, 2024 at 7:06PM

Yes, it is already a strain for our POC team. We have one FT POCC and I help out working about 20 hrs/week. We did the same type of calculations and we're hoping to get some more help. Maybe the budgeted hours for BSNs to do competency assessments can be transferred to POC??

Debra Howard

Wed Mar 27, 2024 at 8:26AM

I think that "clinical or medical laboratory science", means CLS or MLS, depending on the institution since medical technology is listed right after that. Clinical psychology is technically "clinical" but would not qualify.

I am hopeful that we will be able to keep our BSN moderately complex trainers. Like everyone else, I am highly interested in the bottom line of all the "legalese", especially CAPs input since we fall under them. They held out for quite a while regarding the BSN at the beginning.

Deborah Martuch, MLS(ASCP), CPP

Wed Mar 27, 2024 at 10:44AM

Thank you!!

Melissa Willcox

Wed Mar 27, 2024 at 11:15AM

FYI all, CIAC is meeting virtually on April 10 and on the agenda is a discussion about this document.
Maybe they will address how they are expecting POC laboratories to comply with the changes.
CLIAC Meeting page [t.emailupdates.cdc.gov] and look for the agenda link.

Ken Charpie

Wed Mar 27, 2024 at 12:06PM

ooooof.
I like Mary's idea of posting your CLIA's office response here. As much as I love all of your opinions, I really only care what CLIA reps are telling us to make of these new silly words.

I have a pending request for clarification with the Oregon CLIA office and will post their response here. Thank you all for being on top of this. I don't know what I'd do without this community to help keep me abreast of the latest regulatory developments.

Jennifer Hayes

Wed Mar 27, 2024 at 1:58PM

Hello. When I oversaw 60+ mobile labs across the US, I had 4 technical consultants that covered 4 US regions. Each lab would take turns videoing observations. They each staff member was responsible for sending their video to their regional technical consultant. We did have a lot that had to be repeated due to not being staff obscuring the iStat or kit and the TC not being able to fully witness. But overall, this piece of competency assessment was easily achieved via video and we were able to keep the records intact if we ever needed to reference it.

Melissa Willcox

Thu Mar 28, 2024 at 3:52PM

Hi all,
I contacted the PA department of Health as they issue our CLIA licenses and here is my email and their (not helpful) response.
Hi Pam,

Main Line Health’s assistant VP of the laboratory forwarded the above document to all of the Lab supervisors, including the POCCs.

The document was a brutal read and I want to make sure that I am taking away the correct interpretation concerning nursing testing personnel and as competency assessors.

As 12/28/2023, CMS adopted and made effective changes to the qualifications to both testing personnel and competency assessors.

In short ( and I am really condensing this down) the take aways that the POC committee took away from the document was that a BSN Nursing degree curriculum does not typically include enough of the science and/or laboratory science credits to be the equivalent of bachelors in a biological science (as previously defined by CLIA ’88).

The possible consequences of that decision are:

BSN nurses can no longer perform high complexity testing
BSN nurses no longer qualify as a technical consultant.
BSN nurses are no longer qualified to be competency assessors.

It was noted that any BSNs that are currently performing high complexity testing and competency assessments can continue to perform those functions until they leave that position and thus are ‘grandfathered’.

In addition, if a nurse has all of the required science/laboratory credits (if we want to dig through the college transcript) they can continue to perform high complexity testing and competency assessment.

This would be problematic as most health systems are using the primary source verification for new hires and thus don’t see the educational transcripts

Finally, the changes will be ‘enforced’ on Dec 28, 2024.

As the state CLIA representatives, has the department of health received any additional understanding or guidance about these changes?

Are there any additional understanding that you can share with us about any key points that you have identified?

And their response

From: Obaweya, Oyenike <oobaweya@pa.gov>
Sent: Thursday, March 28, 2024 3:27 PM
To: Willcox, Melissa <WillcoxM@MLHS.ORG>
Subject: RE: [External] CMS document Vol. 88, No.248 - Personnel qualifications

Good morning Melissa,

As you are aware the new rules will not take effect till 12/28/2024.

We do not have any guidance about the changes at this time.

Thank you.

Abiola

Autilia Sisti

Mon Apr 01, 2024 at 11:07AM

In as much as I can understand where the commentators spoke from- maintaining the science of Laboratory Technology as a highly specialized field- POC relies on Nursing to work with our department, and our goals align: The best care for the patient.
I know I am speaking to the masses here when I say that disallowing BSNs from acting as TCs would devastate my department and hospital system.

Tianna Stein

Mon Apr 01, 2024 at 11:23AM

Here is the response from NYS DOH:

Good Morning,

The Department of Health anticipates providing guidance to facilities prior to the implementation of the new CLIA rules.

Thank you,

Compliance Unit

Clinical Laboratory Evaluation Program

Wadsworth Center, New York State Department of Health

Ken Charpie

Mon Apr 01, 2024 at 7:34PM

I hope the revision committee is hearing from all their field offices and re-thinking the revisions for clarity on Moderate Complexity Competency Assessors in Point of Care. Wonder if they have any POCCs on the team. Doubt it. Hoping for the best and preparing for the worst. I sure would need to get off the bench if all these direct observations land back on me.

Reine Makiya

Tue Apr 09, 2024 at 2:31PM

This was the reply to my question regarding BSN performing competency assessments.

Good Morning Reine,

The revised CLIA regulations will be effective December 28, 2024. This was outlined in a GovD announcement that was distributed on 1/4/2024 (attached). Please sign up for the Department of Health Services GovD Listserv if you have not already done so to ensure of receiving timely communications.

Here is a link to how the specific regulations will read when they are implemented: https://www.govinfo.gov/content/pkg/FR-2023-12-28/pdf/2023-28170.pdf

The Technical Consultant qualification language starts on page 65. You are correct in what you’ve heard that CMS will no longer consider a BSN to meet the regulatory requirements of a chemical or biological degree.

There is a new regulation (493.1411(7)). This will allow individuals that were previously qualified as a TC and serving in a TC role as of 12/28/24 to continue to do so.

Angela Mack, MLS (ASCP)

Health Services Management Section Manager | Licensing, Certification, CLIA Section

Division of Quality Assurance | Bureau of Health Services

D: 608-266-7485 | C: 608-216-3065 | F: 608-283-7460

General CLIA office email: dhsdqaclia@wi.gov

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CMS qualifications for Competency Assessors