'Pause Rule' gives board pause

By John Koenig
10/6/2010 © Health News Florida
The string of mistakes would have made for a comedy of errors had it not resulted in a doctor performing a surgical procedure on the wrong patient.

Clearly, two patients shared in the blame. And so did hospital staff. But was the doctor also legally at fault?

An administrative law judge said yes in a recommended order, calling for Dr. Ashaf Shoukry Elsakr of Port Orange to be fined $5,000 for errors that led to performing a cardiac-catheterization on the wrong patient.

But the Florida Board of Medicine ruled last week that he was not, rejecting the judge’s findings and dismissing in an 8-4 vote the complaint against him.

The case, one of several similar issues that went before the board during a two-day meeting, left open a larger patient-safety question: Is the board's so-called "Pause Rule" too vague?
 
The rule, which dates to 2004, is intended to stop errors such as performing surgery on the wrong patient or performing the wrong type of procedure. Immediately before a surgery, the rule requires a medical team to "pause and the physician(s) performing the procedure will verbally confirm the patient’s identification, the intended procedure and the correct surgical/procedure site.”

But even in cases where doctors pause --- such as the Elsakr case --- questions remain about whether the rule should have more detail about the identification of patients and the responsibilities of surgical-team members in preventing errors.

Plastic surgeon Jason J. Rosenberg, who chairs the Board of Medicine's rules committee, said he would welcome suggestions for improving the rule. “It’s been a very good start,” he said of the rule, “but maybe there’s a way to make it better.”

Board attorney Edward Tellechea, however, said he isn't sure further rule revisions would make much difference.

"We could tinker with it always,” he said. “But would it end wrong site surgeries? Probably not.”
 
The series of events that led to the complaint against Elsakr took place in March 2007 at Halifax Medical Center Center in Daytona Beach, where two elderly women shared a semi-private room and were scheduled for cardiac procedures to be performed by Elsakr.

One of the women, an 82-year-old identified only as “F.E.” in medical board files, was scheduled for a cardiac catheterization. The other, an 84-year-old identified only as “M.D.,” was not.

The night before the procedure, one of the women said she could not sleep by the window and the two switched beds, without the change being noted on their charts, according to case files. In the morning, a hospital transporter who was supposed to take F.E. to the catheterization lab mistakenly took M.D. instead, apparently relying only on records on the beds for patient identification.

Case records show that a "pause" did occur in the Halifax catheterization lab before the procedure began. Elsakr stood by the patient’s head, referred to her by F.E.’s first name, and said, “I’m going to get started with your heart cath. OK?”
Even though the patient was M.D., not F.E., the patient responded, “Yes.” The doctor spoke again to the patient, using F.E.’s first name, and the patient again responded without correcting the mistake.

Only after catheterization was completed on the right side of the heart and started on the left did someone alert Elsakr of the error. Board records do not indicate that the mistaken procedure led to medical problems for F.E.

In finding that the doctor violated the Pause Rule, Administrative Law Judge Lisa Shearer Nelson, wrote, “Calling the patient by her first name assumed, rather than confirmed, her identify. There is no evidence in the record that she actually heard him. His assumption was understandable, but his actions fall short of actually verifying her identity.”

However, Elsakr’s attorney, Chobee Ebbetts, told the board Friday that the Pause Rule doesn’t specify how identities are to be confirmed. The issue set off debate among board members about what constitutes proper identification.

“This could have happened to me,” said Rosenberg, the rules-committee chairman.

But board member Elisabeth D. Tucker, an obstetrician/gynecologist, countered that using the patient’s first name was inadequate. “He shouldn’t refer to her only as ‘F.’ He should refer to her as ‘Mrs. Whatever-her-last-name is,’” Tucker said.

Board member Steven Rosenberg, a dermatologist who is not related to Jason Rosenberg, focused on another aspect of the case. “The hospital was entirely responsible (for bringing the wrong patient to the cath lab) and admits it is entirely at fault,” he said.

In the end, a majority of the board voted to dismiss the complaint. Ebbetts said later that the doctor did everything the Pause Rule requires, but he added that the rule "still is not clear.''

Similar questions were raised later Friday when the board considered disciplinary action against Lake Worth surgeon Andrew Justin Shapiro.

In July 2009 at JFK Medical Center in Atlantis, Shapiro performed the right procedure – placement of a subclavian vein chemotherapy port – on the right patient, but in the wrong location. The patient, who had breast cancer, requested that the port be placed on her right side and the surgeon had agreed to that in writing.

During the “pause” before the procedure, Shapiro mistakenly said he would place the port on the patient’s left side, which he then did.

According to case records, a scrub nurse with the procedure team acknowledged hearing Shapiro say “left side” and that she knew that was not what was specified, but she did not correct him because she assumed the surgeon had changed his mind.

That fact prompted board member Jason Rosenberg to comment, “This is a team sport,” and to suggest that the nurse was as much as fault as the surgeon.

A proposed settlement agreement called for Shapiro to be fined $10,000 and to perform 100 hours of community service. But after debating who shared in the blame for the mistake, the board in another 8-4 vote reduced Shapiro’s penalty to a $5,000 fine and 25 hours of community service.

--John Koenig is an independent journalist in Orlando.