GEN.20315 says in its accompanying note, “A laboratory culture of transparency, process orientation rather than personal blame, open communication, and strong leadership support is essential to a successful risk management process.”
It was the CAP’s ISO Synergy project team that put forward GEN.20315. It’s a group composed of members of three CAP committees: Checklists, 15189, and Quality Practices. The team works together to identify opportunities to build synergies between the CAP’s 15189 program and its Laboratory Accreditation Program. In practice, it means incorporating concepts from the ISO 15189 standard into the accreditation program checklists, where appropriate, and identifying and creating education that complements and supports those changes.
The CAP 15189 Accreditation Program provides accreditation to the ISO 15189 standard, an international standard to recognize the competence of medical laboratories to improve the quality of their services. The standard was updated in 2022 to put greater emphasis on risk management.
“This isn’t to make the Laboratory Accreditation Program like ISO,” Dr. Trivedi says. “It’s just to help bring some of the concepts into it.”
“We want them to be complementary of each other,” Dr. Gagnon says of the two programs.
Concepts of risk management were incorporated into several CAP Laboratory Accreditation Program requirements that predated the 2025 checklist edition, and they remain in the checklists. They are COM.50300 Risk Assessment (on the IQCP), GEN.73400 Safe Work Practices Review, GEN.73800 Emergency Preparedness and Response, and GEN.77400 Emergency Eyewash.
GEN.20315 is not likely to add to laboratories’ workload, Dr. Trivedi says. “We just need to formalize what we’re doing. It’s to ensure laboratories implement a structured prospective risk assessment of their quality management system.”
In time, GEN.20315 could lose its phase zero designation, Dr. Gagnon says. “At some point after the educational process has been in place and after the phase zero requirement has been in the field for a period, the intent will be to move this along to at least a phase one if not a phase two requirement.” For now, he adds, the intent is an extensive educational process.
For that, the resources are in place in the CAP’s e-Lab Solutions Suite (www.cap.org, login required) under Accreditation Resources>Quality Management>Risk Management. They include a webinar that explains risk management concepts and how to use the QMS to manage and mitigate risks. It is titled “Risk Management: A Tool for Quality Improvement and Business Growth.” Other resources consist of two posters, one on risk management best practices and another on building a culture of quality. There is a new risk management module that is now part of the CAP’s Laboratory Inspection Preparation Course (under Accreditation Resources). In addition, a Focus on Compliance webinar on risk management will take place Nov. 18 (register at www.cap.org/laboratory-improvement/accreditation/educational-resources).
Central to GEN.20315 is avoiding an unfortunate event, Dr. Trivedi says, something that could have gone wrong but was prevented. “I think it’s a good way to make all of our laboratories better,” he says.
Valerie Neff Newitt is a writer in Audubon, Pa.