Pathology may be all in a day's work for you, but as this case illustrates, each biopsy contains a possibly life-altering finding for the patient awaiting the path report.

Sample falls through the cracks
In August 2002 an Indiana woman grew concerned as a mole on her left foot began to grow, itch and turn red. She went to her family physician who, 2 weeks later, removed the mole and ordered that the specimen be sent to a pathology lab. He handed the sample to the assisting nurse for preparation in sending it to the lab.

A few weeks later, when it was time for the sutures to be removed, the woman called her family physician to ask if a doctor at the medical group where she worked could remove the sutures. The family physician agreed. A year later, the mole returned to her foot. The patient requested that her medical records be transferred to the doctor in the medical group where she worked. When the records arrived, she discovered that there was no pathology report for the removed mole and that the facility where the mole was removed never sent the specimen to the path lab. In September 2003, the new physician referred the plaintiff to a podiatrist, who removed the re-growth of the mole and sent it to a lab. The sample tested positive for malignant melanoma.

The woman sued the family physician and the facility where the biopsy was taken. In the malpractice suit, she claimed that the facility was negligent because it didn't send the first mole to the lab and because no one noticed that a pathology report was never received. She claimed that the delay in diagnosis increased the likelihood of recurrence and other complications.

The family physician who removed the mole blamed the failure on the medical group where the patient worked, while the medical group blamed the the physician. The physician claimed that the plaintiff had been instructed to return to the office and didn't do so. Before the trial, the parties entered into an agreement, which resulted in the physician being dismissed from the case and his facility's administrators admitting that they committed malpractice. The case then went to trial solely on the issues of causation and damage. (The defendant had already admitted to duty and failure to perform duty.) The jury returned a $3.25 million judgment against the facility, according to the Indiana Jury Verdict Reporter. With that case in mind, here are 3 areas to develop or improve your pathology processes.

1. Procurement and preparation. How is the tissue handled from the time it's removed until it leaves your department? In the case of the missing mole pathology, the problem occurred early in the process because the removed tissue never made it past procurement and preparation. The facility's process had many additional flaws. Nobody at the facility knew that the biopsy was missing until the patient's chart was transferred to another facility a year later.

From beginning to end, your facility should have a specific and consistent process for treating biopsies. The nurse or technician preparing the room should plan for biopsies and gather the required supplies, including a container, fixative, labeling equipment and a biohazard baggie.

Once the physician removes the tissue, he and the assistant should discuss the plan for the sample. The assistant should label the sample immediately to prevent any mix-up of samples. At the end of the case, the labeled, bagged biopsy material should be placed in a designated bin. Add the patient's information to a running list of biopsies for the day.

At some point before the biopsies are sent to the lab, procedure reports should be attached to the bags to provide needed information for the pathologist. A list of completed, prepared biopsies should be compiled and compared to the working list made during the day. Ideally, more than 1 person completes this part of the process in order to double-check the accuracy of the list of samples to be sent to the lab.

A copy of this list should be re-checked and filed in a biopsy book at the facility. Fax or e-mail an additional copy to the lab. A third copy should accompany the biopsies sent to the lab.

2. Transit and analysis. How is the biopsy sent from your facility, processed and returned with a report? By the time the biopsies leave your facility, the pathology process is about a third complete. When the lab receives your samples, it should create its own list and compare that to the list your facility sent by fax or e-mail. The lab should then verify that all the specimens have been received.

3. Reporting. What happens to information when the biopsy is completed and the report is available? When the pathology reports come back to your facility, someone must verify, based on the original list, that each biopsy that was sent out has a report. Finally, you need to create a reliable system to ensure that pathology reports are appropriately reported to the physicians and patients and then added to the medical chart.

Involve the patient from the beginning. During the procedure (or after, if the patient is anesthetized), inform the patient that tissue has been removed and will be sent for analysis. Make biopsy information a part of the procedure report and discharge instructions that the patient takes home. Give the patient a time frame in which results are expected. Encourage patients to call if they have not heard the results by a specified time.

Build a system that involves checks and balances, within your department and between the facility and the lab. Make sure that once you receive the report, the patient receives the results as well. If a mistake happens, find out where the breakdown occurred and re-evaluate that part of the process.

Finally, if you have a policy of not notifying patients of normal results, reconsider this policy. In the past, many facilities have told patients, "No news is good news." But malpractice cases have shown that sometimes no news is just no news, which is negligence.