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While I think it is a good idea to begin to prepare for the changes, none of us has seen the final revisions, as they will not be published until December. I would hold off on the fire drill until then personally, as there may not be a need to make any immediate changes to your current program. Some of my colleagues on this Listserv have personally reached out to their local CLIA office for clarification and were essentially told that all of your current Technical Consultants will be grandfathered in and will not need to stop performing competency assessment. However, the NEW TC's will potentially require a review of coursework taken to satisfy the requirements, because a nursing degree would no longer automatically qualify them. Based on the wide variation of coursework subject matter I have seen when reviewing thousands of BSN transcripts in the past, some nursing degrees would not satisfy the requirements for a TC, while others would more than qualify as those individuals took an adequate number of biology and chemistry courses.
Silka - In everything I am reading, The Final Rule has been published and goes into effect at the end of the year. I haven't read anything that states the changes are in draft form and may still have more changes to them. Am I missing something? CAP has a banner on their website stating they are going to be late with checklists this year due to implementing the changes. I reached out to NYS DOH and they only stated that they will provide guidance soon. We just had our DOH inspection and the inspectors told us the same thing. In true NY fashion, I am sure they will stick exactly to the Final Rule as it is written with little leeway.
As far as I understand it, the grandfather clause only protects the position the person is in, not the person themselves. Should they leave their role and a new person come in, the new person is not covered under the grandfather clause.
My hospital system and I am sure many others, is not one that changes easily or quickly so starting these conversations now is a must, rather than dealing with the actual fire drill that will occur if we don't.
I'm not seeing (or possibly understanding) the semester hour requirements in this final rule. What is the adequate number of biology and chemistry courses for a nursing degree to qualify? We have so much movement in positions, that the grandfathering loophole is not going to be very helpful for me!
I am one of only two and a half POCCs for my health system. We simply don’t have the bandwidth to look over transcripts for CNEs, especially when there is such a high turnover rate. As I read the CMS document, it seems clear to me that these regulations are not changing. It’s far better to have a plan in place earlier rather than scrambling at the end for a workable solution.
The off-label glucometer usage for critically ill patients has been an issue for a long time in our field. It surprised me to see in the SBAR (which is excellent, by the way). Is there wording coming in the CLIA updates about this? If so, I was unaware.
We define the specific disease states / conditions (as listed by the mfr limitations) in our policy that would require lab-drawn glucoses to address this issue.
So is the small box with Semester hours listed for degrees in BIO and CHEM the amount that each nursing degree should have in order to qualify for TC? I have yet to see a defined algorithm.
The ruling is final! It is a good ruling to protect the laboratory and patients. It will never change, and we really don't want to allow non-laboratory staff to qualify as a lab director or technical specialist. We need, as a group, to lobby for changes to the CLIA standard for revisions to the six steps of competency for moderate and high complexity testing for POCT. It was written for staff working in laboratories, and really doesn't fit the POCT setting. We already struggle with the observation piece and the new ruling will make it almost impossible for most health systems to be compliant. This piece will become more difficult as the current grandfathered staff move on their careers leaving fewer and fewer staff to do the competency assessments. Lets put our thinking caps on and figure this out and let CLIA know we need help!
Tianna- this looks great. There have been some CLIA offices that say that more "clarification" will be coming but I think it's important to work out a plan ahead of time! Donna- you read my mind. I understand the pain points that will happen with this change but I wholeheartedly support it. POC has transformed into a true department of the laboratory, and it should come with complete quality oversight and lab support. My personal opinion is that lab gave away it's power with POC a long time ago when it didn't want anything to do with it. Sometimes for good reason. But the POC technology today is different and our POC programs are strong. Let's lobby for regulatory changes that support testing instead of hold it back with PROPER laboratory POC oversight. Thank you for adding this to the discussion! Mary
(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
(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and
(ii) Have at least 4 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.
My hospital system is a bit behind on their understanding of the Accu-chek issues and how to approach it. I am hoping to use these CLIA changes as leverage to move away from Roche and the complicated oversight that using them in a hospital system brings, especialy since the majority of the hospitals in our system use the Nova. Fingers crossed for hopeful silver linings.
https://www.federalregister.gov/documents/2023/12/28/2023-28170/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and
As far as I understand it, the grandfather clause only protects the position the person is in, not the person themselves. Should they leave their role and a new person come in, the new person is not covered under the grandfather clause.
My hospital system and I am sure many others, is not one that changes easily or quickly so starting these conversations now is a must, rather than dealing with the actual fire drill that will occur if we don't.
I'm not seeing (or possibly understanding) the semester hour requirements in this final rule. What is the adequate number of biology and chemistry courses for a nursing degree to qualify? We have so much movement in positions, that the grandfathering loophole is not going to be very helpful for me!
We define the specific disease states / conditions (as listed by the mfr limitations) in our policy that would require lab-drawn glucoses to address this issue.
Donna- you read my mind. I understand the pain points that will happen with this change but I wholeheartedly support it. POC has transformed into a true department of the laboratory, and it should come with complete quality oversight and lab support. My personal opinion is that lab gave away it's power with POC a long time ago when it didn't want anything to do with it. Sometimes for good reason. But the POC technology today is different and our POC programs are strong. Let's lobby for regulatory changes that support testing instead of hold it back with PROPER laboratory POC oversight. Thank you for adding this to the discussion! Mary
Here is the response, which is complicated and sends you in a couple different places. Someone want to check my work on this? :)
Technical consultant qualifications: https://www.federalregister.gov/d/2023-28170/p-amd-29
Scroll down to here: https://www.federalregister.gov/d/2023-28170/p-823
Which reads:
(B) Meet § 493.1405(b)(5)(i)(B); and
493.1405 starts here: https://www.federalregister.gov/d/2023-28170/p-amd-26, which are the Lab Director qualifications for a Moderate Complexity Testing Lab but when you read through and get to 493.1405(b)(5)(i)(B) here: https://www.federalregister.gov/d/2023-28170/p-801, it reads:
(B) At least 120 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either—
My hospital system is a bit behind on their understanding of the Accu-chek issues and how to approach it. I am hoping to use these CLIA changes as leverage to move away from Roche and the complicated oversight that using them in a hospital system brings, especialy since the majority of the hospitals in our system use the Nova. Fingers crossed for hopeful silver linings.