AAPA Template Response

to the Federal Register

regarding personnel requirements

Instructions:

Use this AAPA template response to submit you comment on the CMS websitebefore the deadline of March 12, 2018, at 5 pm EDT. You may also upload your file through the website or send a letter as noted at the end of this template.

Attention: CMS-3326-NC(file code required)

Thank you for the opportunity to comment regarding the proposed personnel changes related to Clinical Laboratory Improvement Amendments of 1988 (CLIA).

It is my position; the position of the American Society for Clinical Pathology (ASCP), American Society for Clinical Laboratory Scientists (ASCLS); and the American Association of Pathologists’ Assistants (AAPA) that a nursing degree is NOT equivalent to a biological sciences degree for purposes of performing non-waived high complexity testing. I also have grave concerns regarding individuals performing laboratory testing including the macroscopic examination of human tissues without adequate and appropriate training.

As a highly trained Pathologists’ Assistant (PA), I perform high complexity testing including the macroscopic examination of human tissue and perform postmortem examinations. I have specific training in macroscopic and microscopic anatomy; pathophysiology of disease, and autopsy pathology that are very different and far less general than nursing courses, even at the Bachelor’s degree level. While many nursing programs include anatomy and physiology, as well as microbiology; the extent of the material covered is not as broad as traditional biological science degree programs. The latter requires additional advanced studies. Current PA training programs are master’s level with in-depth clinical training rotations in surgical and autopsy pathology, knowledge of cancer staging, advanced dissection techniques, biobanking, pathology resident training and more.

It is widely recognized that laboratorians and nurses have different educational backgrounds, and the precisions and methodologies behind laboratory specimen collection, preparation, and testing are often misunderstood by those without the educational component that stresses these concepts.

While many laboratory tests are automated, macroscopic examination of surgical pathology specimens and autopsy prosection are not among them. These tasks require much attention to detail and the application of scientific method that is the cornerstone of the biological sciences.

Without the knowledge of laboratory methods, patients will certainly be put at risk. If nurses are allowed the same rights to perform moderate and high complexity testing as certified laboratory professionals, it would certainly create issues of poor quality laboratory testing and put patients’ health in danger. Protecting the public and patient safety is my main concern.

The stark differences in the Pathologists’ Assistant profession and the Nursing profession are clear. No patient would want a nurse to perform their high complexity testing or examine their surgical specimen. Conversely, no patient would want a pathologists’ assistant or medical technologist to be their nurse. The level of compulsory experience to be capable at either of these professions is too great to be able to perform both jobs well.

Once again, thankyou for the opportunity to provide feedback regarding this important issue.

Sincerely,

CMS ADDRESSES:

In commenting, refer to file code CMS-3326-NC. Because of staff and resource limitations, they cannot accept comments by facsimile (FAX) transmission.

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Please allow sufficient time for mailed comments to be received before the close of the comment period.

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