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


Specimen labeling errors are a longstanding and serious patient safety concern in pathology laboratories.[13] Incorrect labeling can result in inappropriate treatment due to diagnostic mix-ups and/or cause significant inconvenience and emotional harm to patients and families.

Complex measures and barcoding technologies have been developed to improve labeling accuracy in laboratories.[14] However, unlike most clinical laboratories where barcoding and on-demand label-printing technologies may potentially serve as "silver bullets" for specimen labeling problems, challenges remain in the highly manual frozen-section laboratory.

First, it is not uncommon for intraoperative consultation specimens to arrive in the frozen-section laboratory with only paper requisitions rather than electronic orders. Second, specimens typically have not yet been accessioned into pathology laboratory information systems when received for IOC, making pathology barcode labeling challenging. Third, the natural time pressure built into the intraoperative consultation service creates hurried labeling practices vulnerable to error and safety events. Finally, the complexity, highly manual nature, and necessity for verbal information handoffs in the frozen-section laboratory make IOC error prone. The pathology team may deviate from their normal procedures due to distraction, interruption, or other challenges particular to the case, leading to potential error and safety events.

The frozen-section laboratory environment is similar to airplane cockpits where pilots must perform difficult tasks while handling multichannel, multilevel communication. An IOC checklist derived from the idea of a preflight checklist was chosen in this study to address these shared challenges. Checklist implementation has proven effective in mitigating patient safety risks, specifically labeling error in our laboratory. We experienced a statistically significant decrease in the number of slide labeling defects, with an overall 68% reduction in cases that were defective in at least one form of slide labeling (Figure 2).

Checklist design and effectiveness was carefully considered by integration into the existing IOC workflow. Checklist item order layout followed typical IOC workflow, including specimen receipt, specimen workup, slide labeling, diagnosis rendering, and results communication. Checklist items served as a reminder to users of each essential step, a process known as "prospective memory."[15] Prospective memory is the ability to plan, retain, and retrieve an intention to act as planned.[16] Forgetting to carry out an action as planned is a failure of prospective memory. For example, a pathology trainee has the intention to label the slides as soon as the IOC specimen arrives, but he or she is called into another operating room by the surgical team for an inquiry and may forget to label the slide when returning to the frozen-section laboratory. Errors such as these are not infrequent. However, the checklist can be a valuable safeguard against these prospective memory slips. It provides users with a second chance to identify and rectify glitches in real time. If "box 3" on the IOC checklist is left unchecked, a visual prompt exists as an empty field. An example of correct slide labeling is present on the checklist itself to facilitate and encourage correct labeling format. In addition, checklists increase accountability and improve sense of ownership during the IOC process by mandating a single user to fill out and initial the checklist.

The standardized IOC checklist improved fidelity of slide labeling in our frozen-section laboratory, but it also enabled integration of other quality and patient safety metrics into the IOC process.Table 2 TAT was more accurately captured by calculating the time difference between specimen receipt and result reporting, a safe results read-back policy was implemented and monitored, cases for teaching conferences were prospectively identified, and documentation of IOC-permanent diagnostic discrepancies was captured. Data abstracted from the checklist are tabulated into a quality performance dashboard and reviewed on a quarterly basis by medical directors, managers, technologists, and laboratory leadership Figure 3.[17]

Figure 3.

Intraoperative consultation (IOC) dashboard quality metrics monitored by trend lines and/or signals. Sparklines are created to monitor trends over time and to identify significant deviations in the process. If the quality metric has a predetermined benchmark, the signal light remains green when target is met; otherwise, it turns red. TAT, turnaround time.

Our results indicate the addition of a standardized checklist to the IOC workflow did not cause significant delay in the IOC process. While postintervention TAT (23.2 minutes) was slightly longer than preintervention TAT (21.6 minutes), the difference was not statistically significant. We did, however, notice an interesting pattern of self-reported TAT. Before checklist implementation, 55% of pathologists self-reported a TAT of exactly 15 or 20 minutes, likely an estimation of true TAT. Prior studies have shown a bias for reporting numbers on common delineations, such as pathologic measurements on 0.5-cm increments or rounding birth weights by common intervals.[18–20] During our preintervention phase, a self-reported TAT estimation was collected as an absolute number. During the postintervention phase, the time of specimen receipt was recorded, and the time the diagnosis was rendered was recorded; TAT was then calculated post hoc by a separate party during data abstraction. The percentage of pathologists who self-reported an exact TAT of 15 or 20 minutes decreased to 35% with a more normal distribution, suggesting increased reporting accuracy of true TAT. Prior to 2011, the CAP mandated monitoring of IOC TAT with a recommended target of 20 minutes for simple cases.[1] Since that time, monitoring of IOC TAT is no longer mandated, and no specific TAT target exists. At our institution, we continue to monitor IOC TAT as an internally mandated quality metric, with a focus on trends rather than specific TAT targets. Different variables can affect optimal and realistic TAT such as case complexity and pathologist travel time to the operating room site. An understanding of true TAT performance, monitoring of upward trends, and feedback from surgical colleagues are all central to successful overall pathology quality programs.

Although the IOC checklist improved labeling accuracy, it did not eliminate all labeling defects. We allowed a 1-month transition time period for checklist education and implementation, but following this period the compliance rate for checklist utilization did not reach 100%. Unlike pilots who view checklists as part of routine daily work, trained to integrate them from flight school throughout their careers, physicians are still unaccustomed to standard work and checklists. Compliance rates as associated with organizational and local cultures of patient safety have been previously described.[21] A robust patient safety culture takes time and requires leadership commitment, frontline engagement, and effective tools. Positive outcomes can be expected only over a longer rather than a shorter time period, with repeated, thoughtful, and data-driven interventions.[22] Moreover, the checklist itself was not designed to serve as a "hard stop" to prevent all types of error. Checklists have limited impact unless they are coupled with safety culture and widespread adoption and compliance.[23]

In summary, our innovative IOC standardized checklist focused on addressing preanalytic and nondiagnostic patient safety events in the IOC workflow. Implementation of the IOC checklist significantly reduced the rate of slide labeling defects in our laboratory, did not adversely affect TAT, and may have improved TAT reporting accuracy. Checklist implementation is a significant step in a greater effort to adopt a culture of safety and allows laboratory leadership to reliably collect additional meaningful quality metrics associated with an overall quality management plan.