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Home E-Weekly May 31, 2016

Did Specimen Mix-Up Lead to Unnecessary Cancer Treatment?

Published: May 27, 2016

A New York jury has awarded a woman $2.5 million for the pain and suffering she endured while undergoing chemotherapy to treat a cancer she didn't have. An alleged pathology specimen mix-up at Richmond University Medical Center (RUMC) in Staten Island led to the unnecessary treatment and sparked a legal battle over whether blame lies with the independent pathologist who analyzed the specimen, or the hospital staff who prepared the tissue for analysis.

In October 2010, Zoraida Zambrana underwent exploratory surgery at RUMC to have a mass that was found in her chest biopsied. The surgical team sent a frozen section of the mass to Central Pathology Services, an independent lab staffed by RUMC employees that sits 2 floors below the operating rooms. A pathologist employed by Central Pathology Services diagnosed the growth as cancerous.

Ms. Zambrana then endured 3 months of chemotherapy at Memorial Sloan Kettering Hospital in New York City before a surgeon there removed the mass. Sloan Kettering's head of pathology says the mass showed no sign of cancer. The surgeon who operated on Ms. Zambrana testified that on occasion chemotherapy successfully removes cancer from the mass, but that the disease's footprints — scarring and inflammation, for example — often remain.

That apparent discrepancy prompted Sloan Kettering to send the specimen slide prepared at RUMC and a control sample taken from Ms. Zambrana to RedPath Labs for DNA testing. RedPath Labs founder and pathologist Sydney Finkelstein, MD, testified that the DNA from the specimen on the RUMC slide did not match the sample taken from Ms. Zambrana. "It was from a different person," he says.

Court records show that pathology protocols at RUMC include placing specimens collected during surgery in a bag sealed with scotch tape and labeled with the names of the surgeon and patient. The specimen is then hand-delivered to Central Pathology Services, or sent there through a pneumatic tube. The lab's registration clerk records the receipt of the specimen and walks the tissue to the on-duty pathologist, who compares the labeled specimen bag to the lab's requisition form and prepares the sample for analysis. A hospital-employed pathology tech inserts a stainless steel disc containing samples into a cryostat, which freezes the tissue for direct observation under a microscope. According to court records, a tech cleans the cryostat daily and after each use, and cleans the lab each morning. A technician employed by RUMC testified that she always wears gloves while completing the tasks.

The jury based its verdict on its decision to hold the RUMC employees — who prepared the specimen slides and cleaned the cryostat and lab — responsible and not the pathologist who observed the specimen under a microscope.

In court documents, RUMC says there is no evidence showing its staff was responsible for the "alleged tissue mix-up" and notes that an expert pathologist who testified on behalf of Ms. Zambrana said pieces of tissue can "sometimes in the best of circumstances get into other blocks … there is even with good procedure the possibility of contamination."

Thomas P. Giuffra, attorney for Ms. Zambrana, disagrees. "There was an indisputable breakdown of quality control in the pathology department at RUMC which could have been easily avoided if standard tissue handling and equipment cleaning protocols been actually been followed," he says.

Attorneys for RUMC and Central Pathology Services did not respond to requests for comment.

Daniel Cook

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