Transcription

• Stevon Burrell

  What the 2025 Checklist Edition means for your lab, and CAP accredits the lab of a hospital that goes back to the silver mining boom. Coming up next. This is the Path News Network Daily Edition, powered by the College of American Pathologists. I'm Stevon Burrell. It's Thursday, December 11th, and here are the latest headlines. The CAP's 2025 Checklist Edition delivers updated guidance for digital pathology, remote data review, and the growing role of patient self-collection, giving laboratories clear direction in a fast-moving field. Chair of the CAP Council on Accreditation, Dr. Earle Collum says, Patients can trust that every test is produced under rigorous quality standards. The 2025 checklist edition also incorporates recent CMS clarifications, hoping labs streamline compliance and adopt emerging innovations. We will speak more with Dr. Collum later in the show for more insights. And acute lymphoblastic leukemia, or ALL, and chronic lymphocytic leukemia, or CLL, share a name, but they behave very differently. ALL grows fast in immature white blood cells and often needs urgent treatment. CLL develops in mature lymphocytes and is usually slow-moving. Many patients go years before needing therapy. Dr. Megan Nakashima, chair of the CAP Hematopology Committee, says, quote, CLL cells can also have chromosomal abnormalities, including missing parts of chromosomes 11, 13, and 17, and an extra copy of chromosome. Gila Regional Medical Center's laboratory in Silver City, New Mexico, has earned accreditation from the CAP. The 68-bed public hospital traces its history to an overnight medical facility founded in 1883 called the Ladies Hospital. Today, laboratory director Stephen Duncan says, quote, accreditation by the College of American Pathologists. demonstrates the laboratory's commitment to Gila Regional Medical Center's mission and eye care values, integrity, compassion, accountability, respect, and excellence. And finally, the CAP's 2025 Checklist Edition introduces some of the most significant updates we've seen in recent years. For example, new requirements that strengthen digital pathology workflows and remote data review, clearer guidance on specimen self-collection, and revised expectations tied to CMS. These changes are designed to help laboratories integrate rapidly evolving technologies while maintaining the highest standards in quality inpatient safety. To break down what laboratories need to know, we're joined by Dr. Earle S. Collum, Chair of the CAP Checklist Committee. As labs prepare for 2025. What key checklist updates should they focus on, especially those tied to digital pathology workflows, remote sign-out, and evolving CMS expectations?

• Dr. Earle S. Collum

  Well, there are important changes in digital pathology and remote sign-out. As the use of digital pathology is continuing to rapidly evolve and expand across the laboratories, the CAP continues. to update its requirements to ensure that they reflect changing technology and practice. Any scan slide used as a digital image must have the patient's identifiers soundly linked to it and be able to ensure patient record matching through the workflow across the digital pathology systems. Laboratories must also validate or verify any data or images transmitted elsewhere. especially high-resolution surgical or cytologic images, and digital pathology now needs to be included in the quality management system with items being monitored, such as system availability, scanning failures, and comparing glass versus digital interpretations. In addition to these changes, the 2025 Cytopathology Checklist contains revisions on gynecologic cytology digital image platforms to provide guidance for items such as reporting and workload recording. For remote CyNow, the CMS has continued its enforcement discretion to allow pathologists and others to review digitized images and data remotely under a main laboratory's CLIA certificate for most types of testing. However, in September of 2025, the CMS announced that it will be discontinuing enforcement discretion for digital cytology images review in March of 2026. Note that cytology, that means that laboratories that wish to continue with remote digital cytology will need to obtain separate CLIA certificates for those locations.

• Stevon Burrell

  The CAP is highlighting a new checklist disclaimer about artificial intelligence. Why was this addition necessary and what should laboratories understand about it?

• Dr. Earle S. Collum

  the disclaimer regarding AI. really relates to the rapid implementation of AI in almost everyone's hands so that they take material, they can summarize it, they can reword it, they can publish it, they can post it, they do all sorts of things with AI. But the disclaimer reminds people that use our checklist that they really are not allowed to use AI in the manipulation of our checklist because it's a very valuable piece of intellectual property for the CAP and the amount of time, effort, expertise that has gone into the crafting of these checklists. Really, there's nothing else in the world that requires, that allows a laboratory to have the understanding of best practice. in the laboratory and pathology is our checklist. And it's just too valuable for people to be manipulating it because we just need to remind people that the checklists are the property of the CAP.

• Stevon Burrell

  How can labs prepare and use CAP resources to stay aligned and inspection ready?

• Dr. Earle S. Collum

  The best resource to learn about the new requirements is the Focus on Compliance webinar. It was held on December 10th, but will be posted on CAP.org in eLab Solutions Suite by mid-January. The speakers, Dr. Mahmood, the Chair of the Checklist Committee, and Dr. Karen Rausch, know the checklist inside and out and are excellent speakers. Listening to that session is strongly encouraged. because they present everything laboratories need to understand, the generalities and the details of the upcoming changes.

• Stevon Burrell

  And do you have any final thoughts for CAP-accredited laboratories as they prepare for 2025 edition updates?

• Dr. Earle S. Collum

  Well, I tell you, one of the easy things to do is download the checklist, and there's a great option. When you go to CAP.org, and you go to lab improvement or eLab Solutions and choose your checklist, there's an option to choose the master checklist, the custom checklist. And you can also choose a little radio button in order to download just the checklist changes. So someone who's experienced with the process and really wants to know those changes, they can actually select the checklist. Choose changes only and print the checklist changes for that particular checklist. And that can be a great shortcut to keeping people up to date with all the changes and being able to assist laboratories to prepare for their upcoming inspections.

• Stevon Burrell

  That's all we have for today. You can find us on Apple Podcasts, Amazon Music or Spotify. Subscribe on your favorite platform. Look for more news like this in our weekly newsletters published every Tuesday and Thursday. We're back tomorrow at 5 a.m. Eastern with more CAP News. For the Daily Edition, I'm Stevon Burrell. Have a great day.