Frozen-Section Checklist Implementation Improves Quality and Patient Safety

Yigu Chen, MPH; Kevin R. Anderson, MD, PhD; Jia Xu, MD; Jeffrey D. Goldsmith, MD; Yael K. Heher, MD, MPH


Am J Clin Pathol. 2019;151(6):607-612. 

In This Article

Abstract and Introduction


Objectives: An intraoperative consultation (IOC) checklist was developed and implemented aimed at standardizing slide labeling and monitoring metrics central to quality and safety in surgical pathology.

Design: Data were collected for all IOC cases over a 9-month period. Slide labeling defect rates and IOC turnaround time (TAT) were recorded and compared for the pre- and postimplementation periods.

Results: In total, 839 IOC cases were analyzed. Preintervention slide labeling showed that 85% of cases contained at least one defect (n = 565). Postintervention data revealed that 27% of cases contained at least one defect (n = 274). The improvement was statistically significant (P < .001). Mean TAT was 21.6 minutes preintervention vs 23.2 minutes postintervention, and the change was insignificant (P = .071).

Conclusions: The implementation of a standardized IOC reduced slide labeling error. This improvement did not affect mean TAT and may have the increased quality of IOC TAT data reporting. Other metrics affecting patient safety and quality were monitored and standardized.


Intraoperative consultation (IOC) is an integral part of surgical pathology and surgical patient care, providing critical real-time information to help guide intraoperative clinical decision making. As a result of the IOC's significant impact on patient care, the College of American Pathologists (CAP) laboratory accreditation program mandates correlation between frozen-section and final diagnoses to ensure the quality of IOC service.[1] Monitoring IOC diagnostic discrepancies is also recommended by the Association of Directors of Anatomic and Surgical Pathology as a key analytic quality indicator.[2] Extensive research on the accuracy of IOC diagnosis has been published to identify analytic issues and to improve diagnostic performance.[3–5] However, little or no attention has been paid to the preanalytic and nondiagnostic process vulnerabilities in the frozen-section laboratory. Time pressure is built into the IOC process, with the pathology team attempting to provide a diagnosis as quickly as possible to the surgical team while the patient is under anesthesia. Considerations of diagnostic speed can lead to process shortcuts and workarounds, with subsequent patient safety risk, including labeling errors and mix-ups. Although appropriate slide labeling is universally recognized as an essential part of laboratory workflow, IOC practices vary considerably between institutions and are an underreported source of error and near misses. Busy operating rooms may have dozens of IOC requests per day, and with centralized, manual case processing, vulnerability for specimen mix-ups should remain a major concern for anatomic pathology leadership.

In our institution, a labeling error involving the serious misdiagnosis of a patient with a brain biopsy to rule out metastatic adenocarcinoma led us to examine and redesign our IOC workflow. We chose to use a design and implement a validated patient safety tool: the checklist.

In the 1930s, the Boeing Corporation introduced checklists to the aviation industry to aid pilots when performing step-by-step safety checks for takeoff, flight, landing, and taxiing.[6] Since then, checklists have been widely adopted by high-reliability organizations in aviation, aerospace, and nuclear power industries to prevent failures.[7] But the benefits of using the checklist as a safety tool in health care remained unknown until Peter Pronovost devised a short checklist for central line insertion, and its implementation led to a significant decrease in infection rate.[8] The concept was gradually accepted by the medical community, particularly after the landmark publication of the WHO Safe Surgical Checklist and Checklist Manifesto by Harvard surgeon and public health advocate Atul Gawande.[9] In recent years, applications of the checklist in a variety of clinical settings, primarily the operating room and procedure areas, have shown systematic improvement in preventing error, increasing reliability, and improving patient safety.[10,11]

In our study, using input from various pathology, surgery, nursing, and administrative stakeholders, we were able to design and implement a custom checklist that was built into the IOC pathologist workflow. The checklist was aimed at standardizing IOC workflow with a focus on reliable and reproducible quality and patient safety.