To my Fellow Laboratory Professionals in Maryland:
You may or may not be aware that, as part of a large update to personnel regulations, enforcement and fees, the Centers for Medicare and Medicaid Service (CMS) have proposed a rule that would allow those who hold a bachelor's degree in nursing to perform high complexity testing. Affecting the outcome of this issue will take some time to read and an effort to respond. But it is critical that you do so!
ASCLS, other laboratory groups, and virtually every laboratory professional understands how this change would harm patients, and we as a community need to convince CMS to remove this language before it issues the final rule later this year. The laboratory community needs to have a strong, patient-centered message that this rule is reckless and is likely to harm patients.
If you've just thought to yourself, "someone should do something about this," I agree! YOU are that SOMEONE.
What Can You Do?
Thoughtful and individualized comments from experts in the laboratory will carry many times the weight of mass-produced comments. ASCLS has already submitted a formal comment on behalf of the Society and laboratory professionals throughout the country. This document is attached to the email you received for reference, but can also be found here:
https://ascls.org/wp-content/uploads/2022/08/ASCLS_Comments_Docket_CMS-3326-P_Nursing_FINAL.pdf
However, to change the course of this regulation, laboratory professionals need to accept the mantle of their expertise and take action.
To take meaningful action, you are encouraged to provide your own, personalized comment on the Regulations.gov website (ideas on what to say listed below). The deadline to submit comments is Thursday, August 25, so time is of the essence!
The specific regulation as well as the place to provide comments (click on Comment button) can be found at this link:
https://www.regulations.gov/document/CMS-2022-0119-0001
What Should You Say?
The typical construction of a comment can be as little as three paragraphs:
- Introduce yourself and include relevant degrees, certifications, and experience that informs your comments. This section should also include current employer and position.
- Provide points of agreement or disagreement with the proposed rule along with relevant supporting content (e.g. examples, experiences, simple case studies, or data). This should be responsive to the rule, so focus on the justifications CMS is using for this change (see information below).
- Describe the impact of the proposed rule on patients. What are some common high-complexity tests you perform and what would the impact be on individual patients if the clinicians providing them care received invalid results?
Practical Matters
You will find it easiest to construct comments in Word (or a similar program) and copy and paste them into the portal. There is a 5,000 character limit, but up to 20 files can be attached (each must be <10Mb). You may upload a comment as a document if it is more than 5,000 characters. You can also provide a shortened version of your longer comment in the comment box and attach a fuller, longer comment in a file (Word or PDF). Charts or other data (including Excel files) can also be attached.
Context
CMS justifies this change in the rules with the following:
"As testing practices and technologies have evolved, point of care testing has become a standard of practice in many health care systems, allowing laboratory results to be delivered to the treating health care provider as rapidly as possible. We recognize that in many health care systems, nurses perform the majority of the point of care testing in many different scenarios (for example, bedside, surgery centers, end-stage renal disease facilities). We do not have any reason to believe that nurses would be unable to accurately and reliably perform moderate and high complexity testing with appropriate training and demonstration of competency."
Two Key Points to Address:
You are encouraged to relate your own experiences, insight, and expertise as it relates to two key points that are responsive to CMS:
- Nursing performance of waived testing in point of care settings falls below standards often and is among the most cited deficiencies under CLIA. Most laboratory professionals have experiences to share in this area.
- High complexity testing is fundamentally different than waived testing provided in point of care settings. By definition, high complexity testing requires specialized skills, processes, and procedures. Nursing competencies are in other areas and they typically lack the training and/or experience to safely perform high complexity training.
In addition, our colleagues in nursing don't want this. 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. Comments should focus on these areas and not delve into others that might distract from our argument. All comments should be focused on the impact on patient outcomes.
Background
This issue is not new.
When the standards for the CLIA 88 law were written and implemented in the 1990s, a fateful decision was made by administrators to allow nurses to perform some laboratory roles where there was no available laboratory professional as an "unwritten rule." When new administrators were appointed in 2015, part of a cleanup of the interpretive guidelines to the rules, the agency issued Survey and Certification memo 16–18–CLIA in April 2016 saying it would accept a bachelor's level nursing degree as equivalent to a biology, chemistry, or clinical laboratory science bachelor's degree. ASCLS and other laboratory groups have demonstrated to CMS for six years that the degrees were not equivalent. CLIAC (the advisory committee on these issues at the federal level) weighed in on the issue confirming that nursing degrees are not equivalent.
Rules are laws, which means that the agencies must go through this formal, rule-making process where they must consider all the perspectives submitted and respond to justify their decisions.
ASCLS and other laboratory groups will be providing formal comments about this proposed rule, which will cover technical aspects of this process and our objections. Laboratory professionals should focus on the areas of their expertise, which is the most valuable element of the commentary.
Advocating for the Future of Laboratory Professionals
I hope that you will consider writing a comment by August 25th and that you find the provided information helpful as you construct your comments. Another helpful resource with tips on how to write an effective comment can be found here (see Commenter’s Checklist):
https://www.regulations.gov/commenton/CMS-2022-0119-0001
As of the time of this writing, there are less than 13,500 comments on the website – imagine the impact if all laboratory professionals left a comment! Now is the time to advocate and speak together as members of a unified profession!
Thank you for your time and for your dedication as a laboratory professional.
Christina Camillo, EdD, MLS(ASCP)CM
President, ASCLS-Maryland