2025 checklist
Valerie Neff Newitt
May 2026—In the laboratory general accreditation checklist in the 2025 edition, released last December, is new emphasis on a prospective risk assessment process in the laboratory’s quality management system.
The intent is for laboratories to begin developing the process when they implement a new method, instrument, or workflow, says Greg Gagnon, MD, vice chair of the CAP Checklists Committee.
The emphasis on this process is in new requirement GEN.20315 Risk Management, which says the QMS must use a prospective risk management process that includes identification, control, and monitoring of risks throughout the laboratory.
While CAP checklist requirements for the most part carry the phase one or phase two designation, GEN.20315 is different in that it is designated as phase zero, making it not an accreditation requirement per se but one used at this time for data collection only.
“It’s designed to introduce an educational type of issue,” Dr. Gagnon explains.
Assigning phase zero provides an opportunity for the laboratory to understand what compliance looks like in this instance, he says, “because there’s a bit of nuance with risk management.
“We talk about nonconforming events and doing investigations and developing an action plan to address these nonconforming events,” he continues. “But the risk management concept is to anticipate these problems rather than just react to the problems.”
A laboratory that establishes a new procedure, for example, can develop a risk management component to the procedure when implementing it, Dr. Gagnon says, so it does not have to wait for noncompliance and nonconforming processes to arise. “You do an upfront analysis to anticipate the areas that could cause problems,” whether it is in specimen handling, reagent stability, instrument calibration, reporting, or other areas.
The expectation is gradual adoption. “Over time,” he says, “labs may expand the approach to additional processes as part of their broader quality management systems.”
Prospective risk management is not new to the laboratory, notes Vipul A. Trivedi, MD, former chair of and now advisor to the CAP 15189 Committee. “We do proficiency testing. We do quality control. Self-inspections allow labs to identify and correct deficiencies before formal evaluations occur. Even IQCP is a risk assessment. The new checklist item seeks to bring these scattered practices into a more deliberate and structured framework,” he says.
Encouraging laboratories to approach it in a more formalized way is the aim, Dr. Trivedi says, and a simple approach is acceptable. “You could get into as much detail as you want. Some programs develop extensive risk matrices, which is great, but it doesn’t have to be that elaborate.”
It could be as simple as facilitating conversation with those in the laboratory, which Dr. Trivedi calls a risk alleviation factor. “Daily huddles, for example, are an opportunity for people to bring up possible issues that may occur. These are cultures where you want people to be able to talk about problems that could occur or have occurred so that the laboratory can improve its methods.” Encouraging staff to speak openly about potential issues, he says, can itself function as a risk mitigation strategy.