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TEXT: Dear Chief Executive Officer and Administrators: This correspondence is to provide additional direction to hospitals and Diagnostic and Treatment Centers regarding changes forthcoming for clinical laboratory personnel requirements.
On December 28, 2023, the federal Centers for Medicare and Medicaid Services (CMS) issued a Final Rule regarding Fees, Histocompatibility, Personnel and Alternative Sanctions. This Final Rule focuses specifically on the changes for who can perform clinical laboratory testing. The New York Clinical Laboratory Evaluation Program (CLEP) has been granted a CLIA Exemption, pursuant to Subpart E of Title 42, Part 493 of the Code of Federal Regulations, and must maintain requirements that are at least as stringent as the federal rules governing clinical laboratories.
The federal Final Rule for Personnel will take effect on December 28, 2024. The changes include the allowance for nurses to perform clinical laboratory testing. Prior to this Final Rule and in accordance with a CMS memo issued April 1, 2016, individuals with a baccalaureate or associate degree in nursing were authorized to perform testing of any complexity; where complexity in federal regulations is defined as waived, moderate, or high. Upon implementation of this Final Rule, a nursing degree will continue to qualify nurses to perform waived and moderate complexity testing. However, a nursing degree alone will not be sufficient to qualify a nurse to perform high complexity testing. Rather, the nurse must demonstrate completion of 60 semester hours from an accredited institution that includes 6 hours of chemistry, 6 hours of biology and 12 hours of a combination of chemistry, biology and/or medical laboratory technology and a total of three months of training in high complexity testing for each category in which testing will be performed.
This change may impact testing performed by nurses at point-of-care in medical facilities. Pointof-care testing includes both waived and non-waived testing and it cannot be assumed that a test is waived simply because it is performed at patient bedside. The federal Food and Drug Administration assigns the complexity of testing for each testing device they assess. The complexity for a test for the same analyte may be assigned differently for a different manufacturer. Best practice is to perform a search for the test device in use at your facility, based on manufacturer and device name, to determine the complexity. Links to the FDA database is provided below. CMS has explained that nurses authorized to perform high complexity testing prior to December 28, 2024 will be allowed to continue such testing so long as they maintain continuous employment in their position. Note that CLEP does not maintain a listing of point-of-care testing personnel. It will be the facility’s responsibility to document the status of their staff to demonstrate compliance with this provision. This will be reviewed during the next CLEP on-site inspection of your facility.
How does this affect the ability of nursing to act as technical consultants and train (recertify) other nurses in the use of moderately complex devices? I read no to highly complex testing. Do technical consultants fall under the umbrella of high-complexity testing?
CAP's POC.6920 8/24/2023 seems to have embraced the Language from the CMS document- where nurses can not be technical consultants, and therefore, cannot perform the competency assessments.
Thanks for all the great information on this platform!
I also read this as "no" to nurses with BS degrees performing high complexity testing, only. I don't see any mention of changes to technical consultant roles. I am not seeing how the current wording of the CAP standard POC.6920 indicates a change - it still indicates Technical Consultant meets the qualifications requirements. If you download the "changes only" version of the checklist, nothing is crossed out or added from the old question. I guess the only question is whether CLIA may no longer consider nursing to be a biological science?
● Moderate complexity testing: Technical consultant or individual meeting those qualifications (GEN.53625)
For moderate complexity testing, the individual assessing competency must have a minimum of a bachelor's degree in a chemical, physical, biological, clinical laboratory science, or medical technology, with at least two years of training and/or experience in nonwaived testing in the designated specialty or subspecialty area of service for which the individual is responsible
According to CMS as of December 28 a nursing degree is no longer the equivalent of a biological degree. In order for a nurse to qualify as a technical consultant they must meet certain educational requirements. Those that currently perform competency assessment are grandfathered in as long as they do not leave their role. This is quite problematic as without the ability of nurses to perform competency assessment on my moderate complexity devices it may fall squarely on me and my coworker to complete for four hospitals within our health system which is a tall order. Will be investigating ways this could feasibly be accomplished.
I posted an SBAR a few weeks ago and in that thread, I outlined how you can follow the changes to come to the conclusion that the majority of nurses will not qualify as TC. Here is the link. The part you want is one of the comments towards the end.
My lab director contacted DHS a few weeks ago, and they confirmed that a nursing degree will no longer qualify a team member to be a technical consultant. They've established an educational algorithm where if they've completed a certain number of credit hours in a certain number of categories then they can qualify, but if your sites are anything like mine, it's hard enough to get a diploma, much less a transcript. And even if they were able to supply that, a nursing degree likely wouldn't meet these standards either.
Any caregivers delegated as technical consultant as of December 28th, 2024 will be grandfathered in, but anyone new to the position will need to meet the new requirements. We're quite a large system and are going to be severely cutting back on moderately complex POC testing across all markets, since it will eventually fall completely to POC personnel to sign off on ALL competencies for moderately complex testing. This is definitely going to be interesting!
Dear Chief Executive Officer and Administrators: This correspondence is to provide additional direction to hospitals and Diagnostic and Treatment Centers regarding changes forthcoming for clinical laboratory personnel requirements.
On December 28, 2023, the federal Centers for Medicare and Medicaid Services (CMS) issued a Final Rule regarding Fees, Histocompatibility, Personnel and Alternative Sanctions. This Final Rule focuses specifically on the changes for who can perform clinical laboratory testing. The New York Clinical Laboratory Evaluation Program (CLEP) has been granted a CLIA Exemption, pursuant to Subpart E of Title 42, Part 493 of the Code of Federal Regulations, and must maintain requirements that are at least as stringent as the federal rules governing clinical laboratories.
The federal Final Rule for Personnel will take effect on December 28, 2024. The changes include the allowance for nurses to perform clinical laboratory testing. Prior to this Final Rule and in accordance with a CMS memo issued April 1, 2016, individuals with a baccalaureate or associate degree in nursing were authorized to perform testing of any complexity; where complexity in federal regulations is defined as waived, moderate, or high. Upon implementation of this Final Rule, a nursing degree will continue to qualify nurses to perform waived and moderate complexity testing. However, a nursing degree alone will not be sufficient to qualify a nurse to perform high complexity testing. Rather, the nurse must demonstrate completion of 60 semester hours from an accredited institution that includes 6 hours of chemistry, 6 hours of biology and 12 hours of a combination of chemistry, biology and/or medical laboratory technology and a total of three months of training in high complexity testing for each category in which testing will be performed.
This change may impact testing performed by nurses at point-of-care in medical facilities. Pointof-care testing includes both waived and non-waived testing and it cannot be assumed that a test is waived simply because it is performed at patient bedside. The federal Food and Drug Administration assigns the complexity of testing for each testing device they assess. The complexity for a test for the same analyte may be assigned differently for a different manufacturer. Best practice is to perform a search for the test device in use at your facility, based on manufacturer and device name, to determine the complexity. Links to the FDA database is provided below. CMS has explained that nurses authorized to perform high complexity testing prior to December 28, 2024 will be allowed to continue such testing so long as they maintain continuous employment in their position. Note that CLEP does not maintain a listing of point-of-care testing personnel. It will be the facility’s responsibility to document the status of their staff to demonstrate compliance with this provision. This will be reviewed during the next CLEP on-site inspection of your facility.
CAP's POC.6920 8/24/2023 seems to have embraced the Language from the CMS document- where nurses can not be technical consultants, and therefore, cannot perform the competency assessments.
Thanks for all the great information on this platform!
Ugh - wish I knew. I am going to follow up the DOH.
I am not seeing how the current wording of the CAP standard POC.6920 indicates a change - it still indicates Technical Consultant meets the qualifications requirements. If you download the "changes only" version of the checklist, nothing is crossed out or added from the old question. I guess the only question is whether CLIA may no longer consider nursing to be a biological science?
● Moderate complexity testing: Technical consultant or individual meeting those qualifications (GEN.53625)
For moderate complexity testing, the individual assessing competency must have a minimum of a bachelor's degree in a chemical, physical, biological, clinical laboratory science, or medical technology, with at least two years of training and/or experience in nonwaived testing in the designated specialty or subspecialty area of service for which the individual is responsible
I posted an SBAR a few weeks ago and in that thread, I outlined how you can follow the changes to come to the conclusion that the majority of nurses will not qualify as TC. Here is the link. The part you want is one of the comments towards the end.
https://poct.groupsite.com/topics/794596#reply_1390577
Any caregivers delegated as technical consultant as of December 28th, 2024 will be grandfathered in, but anyone new to the position will need to meet the new requirements. We're quite a large system and are going to be severely cutting back on moderately complex POC testing across all markets, since it will eventually fall completely to POC personnel to sign off on ALL competencies for moderately complex testing. This is definitely going to be interesting!