Summary
The 2025 CAP accreditation checklists include new requirements for humidity, specimen self-collection, body fluid crystal analysis, and pneumatic tube transport of blood specimens. Humidity monitoring is now required for all test systems with specified humidity ranges, and laboratories must record any corrective actions taken if humidity falls outside the allowable range. Additionally, the revised requirement for thermometric standard devices mandates recalibration or replacement before the expiration date or after two years for devices without a defined expiration date.
Valerie Neff Newitt
January 2025—In the 2025 edition of the CAP accreditation checklists are new requirements on humidity, specimen self-collection, body fluid crystal analysis, and pneumatic tube transport of blood specimens for platelet aggregation or other platelet function testing. The new checklist edition was released last year on Dec. 9.
“Our Checklists Committee is always trying to make the checklists as efficient as we possibly can for an inspector to use, and so we try, wherever we can, to consolidate” to avoid duplication among the various checklists, says Greg Gagnon, MD, vice chair of the CAP Checklists Committee. “We also try to identify gaps in our checklists.”
New to the all common checklist is COM.30580 Humidity, which requires test systems to be operated within manufacturer-specified humidity ranges. The requirement applies only to test systems for which the manufacturer specifies a humidity range, and where this is the case, the laboratory must record humidity each day of use. If it’s outside the allowable range, the remedial or corrective action must be recorded.
“Humidity can be challenging to laboratories, depending on their overall environment and the part of the country they are in. It’s an issue that can fly under the radar,” says Amer Mahmoud, MD, chair of the CAP Checklists Committee and clinical associate professor of pathology at the University of New Mexico.
It seems to have done so for a number of laboratories “because CMS inspectors were citing it more and more frequently,” Dr. Gagnon says. “Even though manufacturers of various kits and instrument systems would define a range for humidity, many times laboratories were monitoring humidity but were not necessarily within the correct range for the systems in their lab. To get more of our inspectors’ eyes on humidity throughout the lab, we decided we would move the humidity requirement from the laboratory general checklist to the all common checklist.”
“We hope that will give humidity more visibility,” says Dr. Mahmoud, who is with Pathology Associates of Albuquerque and Presbyterian Hospital’s Department of Hematopathology and Molecular Genetic Pathology, and is CLIA medical director, TriCore Laboratories. With the move of the requirement to the all common checklist, he says, inspectors for each of the lab sections will now have to check humidity in parallel with their temperature checks. And the requirement encompasses the entire test system, “not just instruments,” he says, adding, “It incorporates reagents as well as any other type of equipment where there is a manufacturing instruction for humidity range.”
Recording the remedial or corrective action has been a source of confusion for laboratories, Dr. Mahmoud says. His advice: Start with the manufacturer’s instruction to ensure that the correct humidity range is understood. “Number two, understand your environment. What is the likelihood of humidity being out of range, and what risk does humidity impose on the instrument and test system you have? Understanding the impact and risk will inform what kind of action you need to take and how far you need to take it.”
One way to reach that understanding, he says, is to look at historic data when humidity was out of range. “Did you start to see some kind of failure? Did your instrument give you any kind of errors? Were there QC failures?” Another tip: Ask the manufacturer what to expect if humidity is out of range. “If there is no clear identifiable risk and it seems the system will still perform even when humidity goes out of range, then run a QC, or review some results for that day to make sure no unusual trend has happened,” Dr. Mahmoud says.