CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Valerie Neff Newitt
August 2020—For quality management in the laboratory, it’s not enough to have checks and balances. The checks and balances have to work to improve quality.
That’s how Stephen J. Sarewitz, MD, vice chair of the CAP Checklists Committee, characterizes the changes to the quality management requirements in the 2020 laboratory general checklist, released in June. They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards.
“We’re closing the loop on quality management wherever we can,” Dr. Sarewitz says.
Significant progress has been made in laboratory quality over time, thanks to people, instrumentation, and processes, says Joe C. Rutledge, MD, member of the CAP 15189 Committee and professor of laboratory medicine, University of Washington.
“It’s been fantastic,” he says. “But now we can take it to the next level by embracing what other industries have done—adopt a quality management system that is robust and living—and continually ask the questions, ‘Are we effective with our improvements and with our corrections? Are we serving our customers—patients, clinicians, hospitals, and others—in the best way possible?’
Dr. Rutledge
“It’s not a leap for anyone. Everybody wants to do this,” Dr. Rutledge continues. “Now we are giving labs structure through our Laboratory Accreditation Program by changing the requirements around quality management and gently pushing them to the next level of excellence.”
One of the changes is GEN.20318 “Corrective and Preventive Action,” a new requirement that says a lab’s quality management program must include processes for recording corrective and preventive actions taken for errors and incidents (i.e. non-conforming events) and for quality indicators that do not meet defined targets, as well as for evaluating the effectiveness of the actions taken.
These requirements were implicit in the prior edition of the checklist, Dr. Sarewitz says. “For the purposes of clarity, this requirement was added and includes ISO concepts, the point being that not only does a laboratory have to record corrective and preventive actions taken for non-conforming events and quality indicators that do not meet targets, but the lab also must evaluate how effective its corrective and preventive actions are. It’s not enough just to have taken an action; it has to have made a difference. That’s a key to closing the loop when dealing with problems in the laboratory.” Evidence of compliance requires records of actions taken and of the effectiveness evaluation.
Dr. Goodman
Harris S. Goodman, MD, Checklists Committee chair and clinical laboratory director, Alameda Health System Highland Hospital, Oakland., Calif., says GEN.20318 underscores that there is no point in taking actions that do not accomplish anything. “There are several reasons why it could happen,” he says. “It may be that you chose the wrong action or the action was never implemented. Perhaps there is another action that is better. Possibly the action taken is applied to a problem you thought was present, though all the while it was another problem that was present and causing problems. To uncover and understand all the possibilities, you must evaluate the effectiveness of your actions.”
The new requirement follows the addition in 2019 of GEN.20310 “Investigation of Non-conforming Events,” which Dr. Goodman calls “a significant movement toward the introduction of ISO concepts to the CAP checklists. It says a root cause analysis must be performed for sentinel events. It is something that should have been done without the requirement, but this makes it crystal clear it must be done,” he says.
It also introduced the term “non-conforming event,” which is an ISO term for an error or problem that results from a laboratory procedure or process not having gone as it should have. “Sentinel events require a root cause analysis to determine the cause and prevent recurrence. Less severe non-conforming events require investigation but not a full root cause analysis,” Dr. Sarewitz says.