Latest checklist takes quality management to next level

Valerie Neff Newitt

November 2021—In the latest edition of the laboratory general checklist, released in September, the requirements of the CAP Accreditation Programs have been edited to be more aligned with CAP 15189 (ISO 15189) accreditation requirements.

A CAP ISO 15189 Synergy Project Team, with members drawn from the CAP’s Checklists, CAP 15189, and Quality Practices committees, has been working to build a philosophical and practical synergy between the CAP’s Accreditation Programs and the ISO 15189 standard. Checklist changes made with this coordination in mind will ease the learning curve for laboratories that wish to seek CAP 15189 accreditation after earning accreditation through the CAP Laboratory Accreditation Program.

In the new checklist edition, the term “quality management program” has been replaced with “quality management system,” and the requirements will make clear that finding and documenting quality gaps must be followed by effective corrective actions.

The decision to use the term “system” instead of “program” is not just a semantic juggle aimed at an adoption of ISO language, say those on the project team. Rather, it indicates the team’s collective thinking at the core of these checklist revisions.

“Our thought process was that a ‘system’ designation helps all of us think in terms of bringing together a host of quality efforts in an interacting system of various components,” explains Joe C. Rutledge, MD, a member of the ISO 15189 Synergy Project Team and CAP 15189 Committee. “We don’t want checklist requirements that are just ‘things to get done and out of the way.’ If you move away from just checking off the boxes, you can build a better, more functional, and more effective system.”

Checklists Committee chair Harris S. Goodman, MD, a member of the ISO 15189 Synergy Project Team and the CAP Commission on Laboratory Accreditation, says a quality management system is “more encompassing.”

“In a system you have your core processes and procedures—preanalytic, analytic, postanalytic. But you also have processes and procedures that support those core components, as well as procedures for monitoring core processes, including quality indicators, quality control and proficiency testing results, self-inspections, external inspections, accrediting inspections.”

A quality management system must also include procedures for improving processes, says Dr. Goodman, chief of the Department of Pathology, Alameda Health System Highland Hospital, Oakland, Calif. “That includes a big one we tackled in 2019—investigation of nonconforming events. Now in 2021 we also must have an evaluation of the effectiveness of corrective actions. After all, if a corrective action doesn’t work, you haven’t accomplished anything. Phrases like ‘we will continue to monitor’ when a target is missed will not be enough. This is a significant change in mindset and in the requirements.”

ISO 15189 project team member James H. Nichols, PhD, D(ABCC), says use of the term “system” strengthens the connection with ISO 15189 and that “system” is more frequently used across an international pathology population that has become familiar with ISO language.

“So while we are adopting the more international language, we are also emphasizing that a system must stretch across all areas of the laboratory and encompass all processes. This overarching inclusiveness may not have been quite as evident within the concept of a ‘program,’” says Dr. Nichols, a member of the CAP’s Quality Practices and Point of Care Testing committees, medical director of clinical chemistry and POC testing at Vanderbilt University Medical Center, and professor of pathology, microbiology, and immunology, Vanderbilt University School of Medicine.

The Quality Management System section of the laboratory general checklist defines a QMS as “a set of processes, policies, procedures, and resources designed to ensure high quality in an organization’s services.”

The GEN.13806 requirement for a quality management system is a “significantly altered requirement that doesn’t look very much like its original form,” Dr. Goodman says. The revised requirement says a laboratory must have a document that describes its overall QMS, and that it can be based on an existing model (such as CLSI QMS01, ISO 15189, ISO 9001 series) or of the laboratory’s own design. It also says such a design must include components that “accurately reflect the operations of the laboratory.”

The checklist requirement provides examples of such components, one of which is “core process and procedures”: preanalytical, such as test ordering and specimen collection; analytical, such as testing results review, equipment validated, quality control; postanalytical, such as results reporting and archiving specimens. Another is “support process and procedures”: document control, information management, contacts/agreements with external vendors and suppliers, and training.

“This checklist item is the backbone, the very core, requirement for a QMS,” Dr. Goodman says, adding that many labs are already doing most if not all of what is required. “Now we’re organizing them and bringing them all into one system,” he says.

Many of the components found in GEN.13806 were “woven throughout different parts of the checklists in the past,” Dr. Nichols says, but have now been brought together as a way to consider various parts of the QMS as one entity. “The examples offered will get a system started. But there are other examples offered on the CAP website to help build a more comprehensive system,” he says. (Log in to “e-Lab Solutions Suite” under “Accreditation Resources–Quality Management” for QMS document examples and other resources for CAP-accredited labs.)

When Dr. Rutledge began to practice pathology years ago, he says a quality management program was one type of QC activity in one area, another type of QC in another area, as well as proficiency testing. “That was it. Now evolution is building an entire robust system, with a document that ties together this broad array of interrelated processes, extending past traditional areas,” he says.

He believes greater attention to “support process and procedures” is integral to building a better system. “We have to go beyond the traditional preanalytical, analytical, and postanalytical concerns. As the COVID-19 pandemic pointed out, you can have a great analytical system, but if you can’t get supplies like PPE in the door, it’s not going to work. A lab could incorporate risk management into its QMS by addressing the ‘what ifs.’ What if we can’t get supplies? What if the computer goes down? What if the top three people in the lab can’t get there because of a snowstorm? In short, you must be able to address your support systems, and often laboratories do not do that.”

The QMS document will be a living document that changes as new procedures, technology, and understanding emerge, Dr. Rutledge says. “It cannot be something that is written, signed, then retained by the upper echelon of the lab or institution. Instead, it must be something for the frontline staff who keep our systems running.”

“It can also be used as an educational resource for onboarding new employees,” he adds.

GEN.13820 Scope of Service is a new requirement (“and a direct transfer from ISO 15189,” Dr. Rutledge says) that says laboratories must have a document that describes “the patient care and client services offered by the laboratory (eg, tests offered, hours of operation, turnaround times).” The document (paper or electronic) must be available to the patients and clinicians the laboratory serves. The requirement says the lab’s user manual and/or collection manual may meet the intent of this requirement, and that the document does not include financial or business arrangements between the pathology group and institution.