Cancer patients may have been undiagnosed at UW – because researchers took tumor samples

When cancer tissue is removed from a patient, doctors are supposed to hand it over to someone to form diagnosis and treatment recommendations.

Leftover tissue goes to research.

But an employee at the University of Washington Medical Center told KUOW that in some cases, pieces of tissue were taken for research first. They say that made it harder for physicians to then diagnose their cancer patients.

Dr. David Lewin, president of the American Society of Clinical Pathology, said the policy at his hospital dictates surgeons must send cancer tissue directly to the pathology lab.

“We get first crack at it,” Lewin said. “The clinical side comes first, and then we deal with the research side of things.”

Lewin works at the Medical University of South Carolina. The Joint Commission, which accredits hospitals, and recently reaccredited the UW Medical Center, also requires that all tissues removed in surgery be submitted to the lab. The UW says it has the same policies, which adhere to federal regulations and Joint Commission standards.

Lewin says pathologists need to see the entire tumor sample, because they’re giving surgeons feedback on two critical questions.

One is identifying the lesion – to be sure they’ve taken out the appropriate tissue.

“The second question is a question of looking at the edges or the margins of it; have they taken the entire tumor out?” he said.

If pieces of tissue are missing from the tumor's margins, it can be impossible for pathologists to know whether the whole tumor has been removed.

After the diagnosis takes place, Lewin says leftover tissue can go to research.

The UW employee, who spoke to KUOW on the condition of anonymity, said in practice, patient diagnosis has not always been given priority.

Over the last three years, that employee estimated that in dozens of cases, tissue samples were taken for research before pathologists could examine them.

The employee said privacy protections make it impossible to disclose the names of patients harmed by the practice. Those patients would simply have a note in their file saying, “We couldn’t make an accurate evaluation” of the cancer tissue, the employee said.

They said they were troubled that those patients “had their care compromised. They didn’t even know,” they said. The employee tried to raise these concerns with superiors but didn’t see any results.

Officials at the UW Medical Center declined to be interviewed for this story. But spokeswoman Susan Gregg released a statement acknowledging how tissues were handled: “UW Medicine has addressed and corrected the issues involving the handling of clinical tissue specimens. We are strengthening our policies and providing ongoing education to our clinicians on requirements.”

She added, “We do not believe that patient care was compromised and have made these improvements to prevent similar issues from happening in the future.”

Last May, UW pathology professor Benjamin Hoch sent an e-mail to colleagues in which he acknowledged “ongoing challenges” in this area.

Hoch wrote that hospital leadership was developing a policy similar to the one Dr. Lewin described, requiring that “any tissue removed for clinical reasons must be examined in pathology before any tissue can be taken for research purposes.”

Gregg, the spokeswoman, said each UW Medicine facility has had its own policy language and now a single, unified policy is being finalized “as opposed to individual entity policies and to further clarify current regulatory and accreditation standards.”

Several staff at UW say the medical center has generally improved its practices around tissue collection in recent years by creating a tissue bank called Northwest BioTrust. They say it formalized and centralized the process.

Linda Harrison coordinated research for the UW Department of Surgery from 2006 to 2015. She said Northwest BioTrust tried to foster better collaboration between the departments of surgery and pathology, which she compared to competitive siblings.

“It’s almost like the Brady Bunch bringing two families together and learning how to work together,” Harrison said. “But it’s worked out.”

Northwest BioTrust archives all the research tissue, which surgeons are supposed to buy back for use in their studies. But staff said some surgeons have resisted doing this because of the cost.

Instead those surgeons have continued to acquire research tissue from consenting patients in the course of surgery, as they did before Northwest BioTrust. This circumvents pathologists and the tissue bank.

Harrison said in her time at UW, she never saw tissue handled in a way that would hurt the patient’s diagnosis or care. But she said the process was fairly informal.

“I’ve never seen an instance where the clinical aspect has been affected by a patient being in a research study,” she said, “but I could see how it could be possible.”

She said if surgeons ever took tissue prematurely, it was probably more a result of bad communication with pathology.

“I think there’s a stereotype of cavalier, rogue surgeons going out there and doing whatever they want because ‘It’s their world,’” she said.

“It makes me laugh because I can see how that stereotype exists, but realistically I think they’re altruistic too, and they want what’s best for everybody. But without the right communication, you don’t know that you might be interfering with somebody else’s project.”

Two medical center employees who spoke to KUOW on condition of anonymity said the transition to Northwest BioTrust was chaotic in part because UW laid off someone who had established good communication.

Claire Hagger worked as a pathologists’ assistant at UW from 2011 to 2013.

“I kind of saw myself as a liaison between pathology, the researchers and the surgeons, because I had to interact with all three,” she said. “I was actually going into the (operating room) to collect the tissue.”

Hagger’s job was to make sure pathologists and then researchers got the tissues they needed. If there wasn’t enough tissue, because all of it was needed for diagnostic purposes, she made sure to tell researchers why they couldn’t get what they wanted.

“I was kind of the voice for pathology,” she said, “making sure the specimen was handled properly.”

But when Hagger’s position was eliminated in 2013, the employees said the chain of custody for tissue specimens became less clear. They said those duties fell to less-experienced pathology residents.

Harrison, who now works at Fred Hutchinson Cancer Research Center, said implementation of the new policy will be crucial.

“You can tell people policies all day long, they’re really not going to remember them unless you put them into practice,” she said, “unless you have somebody actually showing you how it’s supposed to be done.”

UW spokeswoman Susan Gregg said as the unified policy is finalized across UW Medicine, clinicians will receive ongoing education on how to follow it.