“The CMS had long required that direct observation needs to be performed in person,” Dr. Mahmoud says. “With emerging technology and if done properly, virtual observation can be as good as being onsite. So CMS received feedback about the restriction.”
Dr. Gagnon points out that each assessment for nonwaived testing has to be done at the location where the individual works. “So if a technologist works at four different nonwaived satellite locations and all four have different CLIA numbers, assessments must be done at all four, not just one.” (For further detail, see CAP TODAY’s December 2025 Q&A column, https://bit.ly/CT_1225-QA.)
All of the preceding personnel qualification revisions are reflected in the CAP personnel guidance document that was introduced with the 2024 checklist edition. It summarizes all supervisory and laboratory personnel qualifications and is available to CAP-accredited laboratories.
In an additional personnel-related change to the director assessment checklist, DRA.11425 was revised to address frequently asked questions and oft-cited deficiencies related to the delegation of duties. The requirement says that if specific laboratory director functions listed in the note in the requirement are delegated, the delegation must be in writing (by name or job title) and the director must ensure the functions are performed properly by a qualified person.
The documentation requirement applies to a review of quality control data, proficiency testing performance, competency assessment, and test methodology performance studies. “These four tasks have been spelled out as the tasks that require written evidence of delegation,” Dr. Mahmoud says. For other tasks not listed in the requirement, written documentation of delegation is generally not needed, especially for simple ones such as temperature checks.
There are functions that may not be delegated: personal onsite assessment of physical and environmental conditions and the adequacy of staffing on a periodic basis, as defined in written policy; the approval of individualized QC plans and new technical policies and procedures and substantial changes to existing documents; and providing appropriately trained supervisory and technical staff and identifying their responsibilities.
Says Dr. Gagnon, “We tried to clarify what broad functions need to be delegated and to leave a lot of the day-to-day activities like recording temperatures or carrying out and recording QC results daily to individuals who meet the testing personnel qualifications.” Inspectors will verify that laboratories are following their own policies for the delegation of functions.
Delegation documentation of duties can be done by name or job title, he says. “If people delegate by name and an inspector doesn’t see the name that was on the delegation document signed off on one of the monthly reviews of QC or monthly instrument function checks, the inspector might cite that.” Therefore, using job titles is a good documentation alternative.
DRA.11425 will be revised further if experience suggests more specifics or clarification are needed, Dr. Gagnon says. Under consideration is an educational offering to provide more guidance on effective delegation. If it’s shown to be needed, he says, “we will pursue that.”
Valerie Neff Newitt is a writer in Audubon, Pa.