And in a further easing of requirements, those who have completed their anatomic pathology training and are waiting to obtain their board certification qualify under the regulation for the position of technical supervisors of histopathology, dermatopathology, ophthalmic pathology, oral pathology, and cytopathology, and this is reflected in DRA.10150 on the provision of AP services. “The checklist revision clarifies that if you finished your training and are still working on your certification, you qualify,” Dr. Mahmoud says. “You do not need to have certification from your board to begin practicing pathology.”
In the laboratory general checklist are additional changes stemming from the CMS’ easing or clarifying of its requirements.
One clarification is what is meant by “continuous employment” for those who qualified for and served in a role (e.g. technical or general supervisor, technical consultant, testing personnel) as of Dec. 28, 2024. The CMS revised guidance said that to be considered continuously employed, a person may have no more than six months of break in employment in their position in a two-year period. The CAP added this clarification to the introduction of the section on personnel in the laboratory general checklist, as well as to the introduction of the CAP’s personnel guidance document available online in e-Lab Solutions Suite under Accreditation Resources (www.cap.org, login required).
“We received a lot of questions,” Dr. Gagnon says, such as: What if an individual who only qualifies for a role based on previously serving in the role prior to Dec. 28, 2024 stops working for a period of time and wants to start again? Can they continue to work in the previous role at the same laboratory or move to a different laboratory? The CMS provided its definition of what continuous employment is, and now it’s part of the CAP checklist.
GEN.54750 on nonwaived testing personnel qualifications now, in response to CMS’ revised guidance, lists a nursing degree as a qualifying degree for moderate-complexity testing and includes a limited exception for individuals with a bachelor’s of nursing degree to qualify as testing personnel for high-complexity glucose testing performed on a glucose meter, under an exception defined in the CMS interpretive guideline for 42CFR493.1489(b)(2)(ii). This limited exception does not permit any other type of high-complexity testing to be performed by holders of a bachelor’s of nursing degree, the checklist says, unless the laboratory can demonstrate they have completed the appropriate science coursework in chemical, biological, clinical, or medical laboratory science, or medical technology, to qualify as high-complexity testing personnel.
“One of the changes that took place in December 2024 was that a nursing degree was no longer accepted as a qualifying degree for high-complexity testing personnel,” Dr. Gagnon says. The revised guidance is a limited exception, he emphasizes, one that the CMS restored for glucose testing that becomes high-complexity due to modifications made to the manufacturer’s instructions to allow testing to be performed on patient populations not included in the FDA authorization (i.e. testing performed on critically ill patients), such as in an ICU or other critical care setting.
GEN.55505 on competency assessment frequency for nonwaived testing now permits the direct observation elements to be assessed virtually if it is allowed by national, state (or provincial), and local laws and regulations. (The same statement on virtual assessments is in the point-of-care checklist in the POC.06915 requirement.) Recently, the CAP received clarification from the state of California that it will not grant enforcement discretion to perform virtual direct observation.