Submit Comments on Proposed CLIA Personnel Rule Changes
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Submit Comments on Proposed CLIA Personnel Rule Changes

The Centers for Medicare and Medicaid Services (CMS) issued a Notice of Proposed Rulemaking (NPRM) on July 16th that would, among other changes, make several significant revisions to the CLIA personnel regulations. CMS has established an extraordinary short, 30-day comment period to accept comments from the public on the proposed rule changes.

AMT will submit organizational comments on the NPRM. However, we encourage individual AMT members also to submit their own personalized comments on two aspects of the revised personnel rules. Specifically, AMT urges its members to:

 

Support

CMS’s proposal to add a route by which an individual with an associates degree in medical laboratory science and four years’ experience in non-waived testing can qualify as a Technical Consultant (TC) in a lab performing moderate complexity testing.
 
Currently, only individuals with a bachelor’s degree can qualify as TCs, meaning that MLTs with an associate’s degree cannot perform competency assessments (CA) on moderate complexity testing personnel. This results in an anomaly under the CLIA rules, because persons with an associate’s degree and experience can qualify as General Supervisors in a high-complexity lab and may perform CA on high-complexity testing personnel, but not on moderate complexity personnel. The proposed rule change, which is widely supported throughout the lab community, would resolve that anomaly and would help alleviate staffing crunches in health systems that could henceforth use MLTs to assess competencies of personnel who perform moderately complex point-of-care testing.
 

Oppose

CMS’s proposal to allow individuals with a bachelor’s degree in nursing to perform high complexity testing. Although CMS agrees that a BSN degree is not equivalent to a bachelor’s degree in biology, chemistry, or clinical laboratory science, CMS nevertheless proposes to create a separate route by which nurses with a BSN may perform highly complex testing without any additional training. Please tell CMS that:
  • While nurses play a vital role in performing waived and moderately complex testing in point-of-care (POC) settings, high complexity testing is fundamentally different. By definition, high complexity testing requires specialized skills, processes, and procedures. Nurses’ competencies are in other areas and they typically lack the training and/or experience to safely perform high complexity training.
  • Nurses do not want to perform high complexity testing. As proposed, this rule would be an open license for healthcare administrators to push more complex and risky testing on an already dangerously under-resourced nursing workforce. This translates into a serious risk to patient health and safety.

Commenting is Easy

The government has made it simple to submit comments on proposed rules. Click here to go directly to the NPRM on the Regulations.gov portal. From the link click on the blue button in the upper left corner labeled “Comment,” then fill-in the requested information about yourself and type (or paste) in your comments. All comments must be received by this Thursday, August 25 at 5 pm EST.
 
Your voice is important! This is the first time CMS has proposed a significant change to the CLIA personnel rules since the mid-1990s, and it may be the last revision for a long time. It’s important that the agency gets it right. Act today!
 
 
 
 
 
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