Summary
The 2025 accreditation checklist edition, released December 9, includes revisions to address the use of digital pathology platforms in laboratories. The revised checklist emphasizes the need for patient safety while utilizing digital platforms, including requirements for remote data assessment and ensuring correct patient identification. Laboratories are required to validate or verify digital pathology systems used for clinical diagnostic purposes, including those used at remote sites.
Valerie Neff Newitt
February 2026—Changes made to the 2025 accreditation checklist edition, released Dec. 9, make it clear that while digital pathology platforms improve efficiency in laboratories, there’s a simultaneous need to protect patient safety by ensuring the platforms work as intended.
In gynecologic cytopathology practice, too, the use of digital image platforms made revisions to the existing cytopathology checklist requirements necessary to address the newer technology.
In the laboratory general checklist, there is now a revised section titled “Digital Pathology Including Remote Data Assessment,” previously titled “Telepathology and Remote Data Assessment.” One of the reasons for the revisions to the requirements in this section, says Karen Roush, MD, MBA, CAP Checklists Committee member, “is to keep abreast of the myriad changes that have come and are coming in the digital algorithmic and artificial intelligence arenas.”
She adds, “We wanted requirements to be current for what’s happening today and be able to incorporate what we know is coming relatively quickly.”
The CAP formed a project team composed of representatives of several committees reporting to three CAP councils—Council on Accreditation, Council on Scientific Affairs, and Council on Informatics and Pathology Innovation, known as CIPI—to update the requirements relating to digital pathology practices.
“In the laboratory general checklist,” says Andrew Evans, MD, PhD, a member of CIPI and the project team, “we wanted to contemporize and update requirements where technology is used to review and evaluate images remotely.” In that work, he says, he and other members of the project team devoted much time to developing a comprehensive definition of remote review. “Doing that was more difficult than one would think,” says Dr. Evans, medical director and pathologist-in-chief at Mackenzie Health in Vaughan, Ontario, Canada.
In the introduction to the revised digital pathology section, a remote assessment facility is defined as a location where digitized images and/or data are reviewed, interpreted, and/or reported on a recurrent or regular basis by qualified personnel not located at the laboratory’s CLIA address from which the image or data originated.
In anatomic pathology, it continues, remote assessments include the review and diagnostic interpretation of tissue by pathologists using digital pathology, such as whole slide images. In the clinical laboratory, remote assessments involve the interpretation of laboratory data by pathologists or other qualified personnel, and this may also include images.
“And there are a couple of other points labs should be aware of,” Dr. Evans says, one of which is the following: The patient report must indicate the remote site location using the address or a coding system to designate the site. “You could put a specific address in the report, but if it is a home address,” he says, “most pathologists would not want to do that. Alternatively, they can use a coding system set up by the lab such that if there were ever any issue about where a given diagnostic interpretation took place, the code will pinpoint the location.”
The other point is that if review and interpretation occur at a site with its own CLIA certificate, the laboratory is considered a separate laboratory. “It is, in effect, a referral laboratory,” the checklist says.