CAP and ADASP Recommend Secondary Review of Anatomic Pathology Cases

Current reforms for the health care system aim to increase quality of services. In keeping with that objective, a new guideline aims to reduce errors in pathology. The College of American Pathologists (CAP) and the Association of Directors of Anatomic and Surgical Pathology (ADASP) have developed a “new evidence-based guideline to provide recommendations for secondary and timely reviews of surgical pathology and cytology cases to improve patient care.” The guideline, titled “Interpretive Diagnostic Error Reduction in Surgical Pathology and Cytology,” was published on the website of the Archives of Pathology & Laboratory Medicine as an Early Online Release. The guideline addresses the analytical phase in which pathologists interpret slides. That interpretation differs from clinical diagnostic testing and requires subjective, “inherent judgment” of the pathologist. Identifying a need for a process to catch potential errors—because the analytical phase doesn’t have formal review processes similar to those implemented in pre- and post-analytical phases—CAP and ADASP created an expert panel of pathologists which studied the issue and recommends in the guideline that secondary case reviews be consistently implemented to find potential diagnostic errors. “To assist anatomic pathologists, we developed five high-level recommendations and expert consensus statements to formalize a process for the review of surgical pathology and cytology cases, which pathologists can implement as added quality measures into their institutions and quality assurance programs,” said Raouf Nakhleh, M.D., FCAP, CAP’s guideline co-chair and a surgical pathologist at the Mayo Clinic (Jacksonville, Fla,), in the press release announcing the guideline. The guideline notes: “Although numerous studies have shown that case reviews help detect interpretive diagnostic errors, there have been no efforts to formalize this practice as a strategy to reduce errors.” The panel studied the impact of differing types of review or no review on error detection, researching literature discussing pathology quality and case reviews through Medline, Google Scholar and manual review of pathology journals. With regard to errors, the panel also considered the “clinical impact on a patient” assessing whether the error led to a change in diagnosis, treatment or patient outcome. Draft recommendations were posted on CAP’s website for comment between December 2, 2013 and January 21, 2014. Five recommendations resulted from the panel’s efforts:

1. Anatomic pathologists should institute a procedure for review of cases by at least one other pathologist to “detect disagreements” or errors in interpretation.
2. Reviews should be timely. Ideally, review should occur prospectively, prior to diagnosis, but timely retrospective reviews are also valuable. The guideline stated the ideal time for secondary review “is before cases are signed out.” The panel indicated that communication with the treating clinician could justify lengthier timelines for a review if treatment can be deferred until after the review. (The guideline cautioned that this preference for prospective review shouldn’t be taken as a reason to stop retrospective reviews that are standard procedure).
3. Review processes should be crafted with consideration of the needs and limitations of the specialty and practice setting involved. The guideline does recommend that the review process should require documentation of case reviews.
4. “Anatomic pathologists should continuously monitor and document the results of case review.” The guideline also suggests it may be appropriate to audit specific case types that are subject to review.
5. Pathologists should take steps to improve areas in which review indicates there is “poor agreement” through methods such as setting diagnostic criteria and holding “intradepartmental consensus conferences with the acceptance and use of uniform diagnostic criteria.”

CAP designated the first two statements as a “recommendation” which means that the described action is recommended but there is “[s]ome limitations in quality of evidence … balance of benefits and harms, values, or costs” but there is “sufficient evidence” to justify a recommendation. The third, fourth and fifth statements are designated “expert consensus opinion” which means there were “serious limitations in quality of evidence … balance of benefits and harms, values or costs, but panel consensus is that a guideline is necessary.” The panel concluded: “We recommend that surgical pathology and cytology laboratories adopt a system of secondary timely case reviews that is suited to their practice and helps detect or prevent diagnostic interpretive errors.” The guideline will be reviewed every four years unless new evidence arises that could substantially impact the guideline recommendations. Takeaway: While not stipulating specific details of implementation, a CAP and ADASP created panel of experts reports that secondary reviews of anatomic pathology cases can help detect errors and processes for these reviews should be established.