Community hospitals keep time on tissue handling

Kevin B. O’Reilly

February 2016—The great promise of genomics and actionable cancer biomarkers relies on cancer tissues being handled in the right way so they are suitable for study. Reducing cold ischemia time and the total time that biospecimens spend in formalin is key to the process, say guidelines from the CAP and the American Society of Clinical Oncology on HER2 and on estrogen receptor and progesterone receptor testing in breast cancer specimens.

To hit the recommended times—less than an hour from excision to when the specimen is put in formalin, and between six and 72 hours of total formalin time—takes multidisciplinary coordination and reexamination of anatomic pathology processes. That was the experience of 30 community hospitals that took part in a seven-year National Cancer Institute project devoted to improving cancer care in the kinds of settings where most patients are diagnosed and treated.

By the time the project concluded, each of the participating hospitals was achieving the tissue handling goals for more than 90 percent of their breast biopsies, lumpectomies, or resections. And they reported the cold ischemia time (or time to formalin) and total time in formalin on each of their pathology reports. The hospitals then moved to a more ambitious goal of the NCI project—to achieve these biospecimen quality goals for all cancer tissues.

Meeting that goal proved more elusive, especially when it came to reporting the relevant times, says James Robb, MD, a consulting pathologist to the NCI who served as the lead of the pathology pillar of the National Cancer Institute Community Cancer Centers Program, or NCCCP. The major obstacle was and continues to be a lack of automation, Dr. Robb says.

“First, you have to know when the specimen comes out of the patient,” he says. “Then you have to record the time when it’s dropped into formalin. That colon can come into pathology and not be looked at until four hours later. So you first have to define that. When it comes out of the patient is pretty well defined in the anesthesia chart, but that’s not available to the LIS in pathology. Then, in pathology you can put in exactly the second it was put in formalin. But, again, there’s no field for that in the LIS, so you have to write it down manually. Then when it comes out of formalin, there’s not a field so you have to write it down manually. It sounds very simple. It’s three numbers, but trying to get them is not easy.”

Coming up with a reliable way to calculate the elapsed times, especially for the total time in formalin, also proved to be a challenge. Not having a functionality to automatically calculate the time in their laboratory information systems, the participating hospitals turned to the Internet for help. A website called TimeandDate.com can perform the calculation but is vulnerable to manual input errors.

At one of the participating community cancer centers, Spartanburg Medical Center in South Carolina, the job had until recently been left to the laboratory’s transcriptionists. The excision time, when the specimen was put in formalin, and the time when it was taken out of formalin were available to them. But they had to manually calculate the times and select which code to place in the pathology reports (for example, “preanalytic factors within CAP/ASCO guidelines” or “preanalytic factors outside CAP/ASCO guidelines; cold ischemia time greater than one hour”).

“We’re doing this on all specimens, except for specimens that have to be decalcified,” says Spartanburg pathologist Rosanna Lapham, MD, giving a sense of the manual workload involved in recording, calculating, and reporting the tissue handling times. “We don’t do this for placentas. We don’t do it for specimens that are received fresh, like amputees—unless the amputation is for a tumor. Every other specimen, every biopsy, every resection specimen, greater than 95 percent of our specimens have it.”

Why take on the job of improving tissue handling for all specimens?

“This is the future,” Dr. Lapham says. “The future is now.”

She says it is difficult to predict, given the rapid discovery of actionable cancer biomarkers and progress in genomics, when optimal tissue handling will prove critical to whether the biospecimen can be studied further in a way that affects the patient’s diagnosis, prognosis, or treatment.

“This is something that most places think they’re never going to do because it’s such a pain,” Dr. Lapham adds. “A lot of people would think it’s an overwhelming task to get it on every single report. You need to work hand-in-hand with an LIS to do it. Now that we’ve put it out there and shown that it can be done, I would think other labs would probably follow suit, especially if you’re going to be a hospital that’s also submitting specimens for research.”

Dr. Lapham says the struggle to work with information technology and vendors to automate the process became a do-or-die proposition.

“They [the transcriptionists] had the brunt of it,” she says. “It was almost to the point where if they couldn’t fix it, it had to stop.”

The first step in automation was to add fields for the relevant time points in the computerized physician order entry system (excision time and time added to formalin, if done in the operating room) and in the LIS. In the CPOE, if the operating room staff does not specify when the tissue was removed from the patient, then no order for anatomic pathology work can be completed.

Several years ago, Dr. Lapham went to the Healthcare Information and Management Systems Society’s annual meeting and, as a representative of the NCCCP, “talked to every single LIS vendor” about whether they had or could add the functionality to document and calculate the optimal tissue handling times. None offered it. Orchard Software, Spartanburg’s vendor, promised to work on the issue as part of its Harvest LIS.

Jim Hannah, a systems analyst in Spartanburg’s information services group, says the request was submitted to Orchard in 2013, and it wasn’t until August 2015 that the functionality was fully implemented within Spartanburg’s LIS.

“The initial problem was that they could not calculate times greater than 24 hours,” Hannah says. “The fields they had developed initially didn’t accommodate the time we might need. When you go from one day to the next, you’re just taking the difference between the two times and not taking into consideration the elapse of more than 24 hours.”

Nancy Stoker, director of product management at Orchard, describes that problem as “an early stumbling block” and emphasizes how the company accommodated Spartanburg’s request at no extra cost.

“We started completely from scratch and created another modality to do this calculation—when the tissue was removed from the body, the time into formalin, and then the end time out of formalin,” she says. “You just enter or scan those in and then our system automatically calculates the cold ischemic and total formalin times.”