Case Examples


Systems-Based Solutions Build Partnerships for Patient Safety

David G. Hicks, MD, FCAP
David G. Hicks, MD, FCAP

In 2008, the University of Rochester Medical Center (URMC) Perioperative Safety Committee was having concerns about specimen label accuracy. David G. Hicks, MD, FCAP, a member of the committee and director of surgical pathology, volunteered to investigate.

At the time, Dr. Hicks was participating in a collaborative effort of the American Society for Clinical Oncology (ASCO) and the CAP to standardize breast cancer predictive factors testing. The group believed that cold ischemic time was a factor in specimen degradation and might affect the quality of hormone receptors and other biomarkers available for analysis. A patient safety initiative around specimen labeling at URMC, Dr. Hicks reasoned, could also address other variables—such as cold ischemic time during transit between the 40 operating rooms (ORs) and the laboratory.

Dr. Hicks and his laboratory team partnered with URMC surgeons, OR nurses, and surgical technicians to develop a quality improvement project targeting specimen handling between removal from the patient and fixation in formalin. Their collaboration resulted in a new approach that resolved the labeling issue, protected specimen integrity by reducing cold ischemic time, and drove a rewarding paradigm shift.


Dr. Hicks is professor of pathology and laboratory medicine at the University of Rochester School of Medicine and former director of anatomic pathology at Roswell Park Cancer Institute in New York. A breast pathologist with an interest in molecular diagnostics, he is a member of the National Cancer Institute Biospecimen Research Network Scientific Steering Committee.

It was obvious that OR nurses responsible for specimen transmission to the laboratory were doing so while juggling a dozen tasks; what was most urgent would always come first. At the same time, Dr. Hicks realized, pathology owned those elements of patient safety related to specimen management. And the best way to take ownership would be to take responsibility for the control of specimen management.

The laboratory team's success would require buy-in from their surgical colleagues, who would have crucial responsibility for initiating the handoff of surgical specimens. Rather than critique the surgical team’s specimen management, the laboratory staff created a new system. They wrote an eight-point patient safety checklist to be completed before any specimen left the OR. They gave dedicated cell phones to the nurses and surgical technicians, who would call the laboratory as soon as the surgeon had released the specimen. A pathologyaccessioning technician was assigned to retrieve the specimen, ensure label compliance with the patient safety checklist, and transport the specimen to the laboratory's accessioning table.

The team launched a two-week trial during which they audited the lapse of time from specimen collection to gross dissection and placement in formalin; at the start, the average time from OR to formalin was 138 minutes. With the new system, Dr. Hicks says, "They were able to bring the cold ischemic time down from 138 to 41 minutes on average, including performing the eight-point safety check."

The hospital administration, recognizing that improved specimen quality would generate improved outcomes, agreed to add additional laboratory full-time equivalents (FTEs), which enabled Dr. Hicks to extend the new procedure for all specimens. On August 18, 2008, the laboratory staff assumed responsibility for label verification and transport of all specimens.


Properly constructed guidelines can enable pathologists to identify and document those laboratory findings most useful to their clinical partners. Intentional communication within medical teams will further free up physicians' collective bandwidth by creating a continuous feedback loop that informs and educates all parties about how best to share what they know and what they need to know. Patients benefit, efficiencies multiply, economies emerge. People start thinking about doing things differently. And from there, as the saying goes, the sky's the limit.

Inevitably, as the procedure became routine, turnaround times slipped; it's a human factors issue. To manage it, Dr. Hicks attends the Thursday staff meeting for OR nurses and surgical techs several times each year. They talk about their progress and its direct link to improved patient outcomes. Afterward, specimen transit minutes invariably tighten up.

Dr. Hicks, who received the 2011 CAP Excellence in Education Award for design, development, and presentation of the Breast Predictive Factors Testing Advanced Practical Pathology Program, says that it will soon be possible to quantify more precisely the role of specimen thermolability by confirming the team's observation of lower estrogen receptor (ER-positive rates when cold ischemic times are longer. "At room temperature, if the tissue is not stable, a portion will degrade," he says. "The ER is critically important in determining who gets endocrine therapy and who does not. We may be missing ER-positive breast cases when the tissue sits around, and that relates directly to outcomes."

It relates to staff morale, too.

"One of the surgeons told me that I changed the culture in the OR because now everyone is focused on that specimen and the importance of timing," Dr. Hicks says. "I told the OR nurses that what happens to that tissue has the potential to have a profound impact on what happens to that patient and how they get treated. And they got it."


Pathologists are highly trained in pattern discernment and well positioned to identify systems-based solutions. As physicians who care for all patients and work with all specialists, they are skilled advocates for creative thinking around patient safety.

Hear the CAPcast