Pathology News Roundup: August 31, 2022

CAP Opposes CLIA Lab Director Proposals. The College of American Pathologists (CAP) is opposing several changes to the Centers for Medicare & Medicaid Services (CMS) staffing qualifications recommendations in a proposed 2023 CLIA regulation. These adverse changes included the qualifications for doctorate level scientists, the consideration of the doctor of clinical laboratory scientist (DCLS), the expansion of other degree types eligible to be laboratory directors, and technical supervisor qualifications for immunohematology qualifications.

Overall, the CAP was supportive of many of the regulatory changes proposed by the CMS. However, there were areas of concern. In an August 29 letter to the CMS, the CAP outlined its opposition to the updated CMS qualifications for laboratory directors. The CAP firmly opposed the inclusion of a DCLS degree and the expansions of other types of degrees, such as a master’s degree, as qualifications to lead laboratory teams. In the letter, the CAP said, “While the CAP supports the agency effort to clarify doctorate-level degrees within CLIA, we strongly oppose the inclusion of the DCLS degree as a qualifying degree under CLIA.”

Additionally, the CAP opposed lowering the standards to include other degrees to qualify for Technical Supervisor Qualifications for Immunohematology. The CAP also disagreed with the CMS’s proposal for nurses as high-complexity personnel.

The CAP said it believed a nursing degree is not equivalent to a bachelor’s degree necessary to perform high-complexity testing, and therefore it should be a separate qualifying degree. Nurses perform laboratory-related functions such as point-of-care testing (POCT), specimen collection, and test ordering, which are not their primary job functions, but rather secondary tasks performed outside of the central laboratory. Unlike laboratorians in the central laboratory, nurses often have minimal time to reflect on the total testing process. In addition, nurses may have the understanding in terms of clinical knowledge but not in the laboratory medicine practice, which we believe a separate qualifying degree will better provide the skills, experience, and training necessary to perform these limited laboratory-related functions.

Nevertheless, the CAP was supportive of many of the regulatory changes proposed by the CMS. For instance, the CAP supports the CLIA proposals that address practice and technology changes, such as the updates to the Histocompatibility regulations, especially the recognition of virtual crossmatching; the creation of qualification algorithms for testing personnel instead of specific degrees; allowance of respiratory therapists with an associate degree to qualify as a technical consultant; the removal of the physical science degree; and, allowing military trained individuals to qualify as testing personnel once they move to the private sector.

Last week, the CMS extended the comment period for the proposed CLIA regulation to September 26 to give stakeholder more time to offer input. The CAP had joined an effort led by the American Society for Clinical Pathology (ASCP) to successfully urge the agency to move the deadline.

ASIP Leadership Academy. Today is the final day to apply for the American Society of Investigative Pathology (ASIP) Leadership Academy.

The ASIP recognizes the need to provide leadership training for its members to ensure the development of effective leaders within the field of experimental pathology, at individual research institutions, and within the Society itself. To address the need for leadership training, the ASIP Council set aside financial resources to support the development and implementation of the ASIP Leadership Academy.

The primary goal of the ASIP Leadership Academy is to encourage the development of leadership skills among young investigators who have entered into their first professional positions by provision of practical training designed to enhance their ability to understand the challenges faced by leaders, productively communicate and interact with leaders, and effectively serve as leaders – both at their own institutions and within the Society.

The first ASIP Leadership Academy training event will be held in Rockville MD on October 2-4, 2022. Applicants must be a Regular or Next-Generation member of the ASIP and employed as an entry level tenure-track or nontenure-track academic faculty positions (assistant professor or equivalent) or similar positions in non-academic institutions (government, industry, or biotech).

Applications may be submitted online and are due by midnight tonight (PST) August 31st.

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