It is every client’s desire and expectation that their study report will be completed “On-Time” or better yet, be available ahead of schedule. There are a number of factors that determine whether a pathology report will be early, on time, or in the worst case scenario, delayed. Most situations are readily managed, but in rare circumstances, unanticipated events may lead to delays.
On-Time reporting begins with the creation of a realistic schedule of study events. From pre-study design to the final study report, each step in the process must be carefully considered and planned for accordingly. When work is to be outsourced, arrangements need to be made well in advance of the start date, so the recipient laboratory can schedule appropriately and make other logistical preparations before the samples arrive. Such arrangements include provision of the study protocol and amendments, additional requirements not spelled out specifically in the protocol, specimen inventory lists (if available), and expected timeline milestones that range from the shipment/receipt of samples to delivery of the signed final pathology report. Frequent telephone and/or email communication between the client and CRO is a proven ingredient of a successful study outcome.
Circumstances that tend to impede on-time reporting include delayed receipt of samples, delayed receipt of study documentation (e.g., amendments that officially authorize the laboratory to initiate work), and last minute changes to the project scope. Examples of last minute changes include situations in which samples are received that differ (missing/extra/incorrectly labeled, etc.) from those previously communicated to the laboratory or listed in inventory records. The need to process additional tissue types or dose groups that were not part of the original study requirement can be especially challenging. Understandably, issues that increase the time prior to and during histologic processing may ultimately impact the laboratory’s ability to deliver slides to the pathologist according to schedule. Another potential problem may occur when slides of suboptimal quality are submitted to EPL for pathological review. Poor slide quality can prolong the histopathological evaluation, and lead to an increased number of recut requests from the study pathologist. The slide examination may also be prolonged if the pathologist is required to conduct the initial evaluation in a blinded manner, or if the pathologist receives insufficient information concerning the nature of the test article. Unusually high numbers of unforeseen histopathologic findings (e.g., unexpected target tissues or numerous background lesions) may additionally slow down the histopathologic assessment and interpretation processes. Each of these factors can chip away at the time reserved for the pathologist to read slides and create the pathology report.
When problems develop that may impact study timelines, it is important that the CRO and client communicate as early as possible and as frequently as needed to resolve issues in a timely manner. On-Time reporting is very important to EPL. We strive to meet and exceed pathology report due dates by keeping in close contact with clients and by alerting them when issues arise.
From time to time, EPL receives requests to expedite histology and/or pathology services. On a case by case basis, EPL partners with clients to implement expedited schedules for pathology reports. Every effort is made to honor such requests when feasible. EPL’s size and flexibility allow us to be creative in our approach and deliver a signed pathology report earlier than might otherwise be possible. Please let us know if and when you might require an expedited timeline.
Whether the pathology report is routine or expedited, EPL’s primary goal is to provide a report that is on time, as well as accurate, and which will always fulfill the client’s (and the regulatory agencies) expectations. Contact us today to discuss your next pathology project.
Kerry Crabb, HTL(ASCP)
Manager of NC Laboratory Operations