Safety shortcomings spotted in Sunrise catheter case

Analysis of catheter lines that came apart in the Neonatal Intensive Care Unit at Sunrise Children's Hospital -- when it was done and how thoroughly -- is at the center of new criticism from national safety experts.

They say that if hospital officials had acted earlier to determine why at least a dozen lines frequently separated, it is possible one child would not have had to endure a life-saving operation last spring and another would not have died in July.

They also say that, in the wake of the harm to the children, an exhaustive product failure analysis should have been carried out, not an incomplete one that they believe may have unfairly led law enforcement authorities to call registered nurses Sharon Ochoa-Reyes and Jessica May Rice each a "person of interest" in a criminal investigation into "intentional patient harm."

"This is a failure of hospital leadership," said Debora Simmons, head of the Houston-based National Center for Cognitive Informatics and Decision Making in Healthcare.

Like other safety officials around the country, she is following the Sunrise situation through the media.

"An investigation should have been done the first time they saw a broken catheter line. It's no different than my brakes failing as I go through a stoplight. Do I just say, 'Whoops,' and keep going until I have an accident and kill someone?"

Sunrise officials say they have done the right thing from the beginning, taking immediate action as soon as problems were discovered and hiring a forensic expert to test the lines.

In early July, the public first began to learn what transpired at Sunrise. In a press release, hospital officials said they had asked police to investigate 14 incidents of "disrupted catheters. "

In the weeks that followed, the public learned that Ochoa-Reyes and Rice had their licenses summarily suspended by the state nursing board after law enforcement authorities informed the board that the nurses were part of a criminal investigation. Sunrise officials fired them.

In September, however, the nursing board reinstated their licenses, saying subpoenaed documents from the hospital did not provide evidence of wrongdoing. Thousands of documents reviewed by the Review-Journal do not point to either nurse as having deliberately harmed a patient. No hospital employee accuses them of anything in the documents.

To attorney George Kelesis, the attorney for Ochoa-Reyes, the reason Sunrise acted as they did with the nurses is simple: "They had problems for a long time that they did nothing about and they want to reduce liability."

Sunrise provided incident reports for only 10 of the 14 disruptions. Of those, three involved Rice and four mentioned Ochoa-Reyes, either as witness to a problem or having had a patient with a problem.

Though Rice and Ochoa-Reyes were on duty at the hospital when the incident occurred that resulted in the death of 2-month-old Miowne Obote, Rice was doing charting work nearby and Ochoa-Reyes did not work on the baby, according to the documents.

Sunrise officials refuse to rehire the nurses.

A Las Vegas police investigation continues, according to spokeswoman Barbara Morgan, who said Thursday, "We can't say anything about it at this time."

Ochoa-Reyes said Thursday she was one of the first nurses to alert supervisors that something had to be done about catheter lines.

"I helped make sure we saved them so they could be tested later," she said.

The subpoenaed hospital documents, obtained by the Review-Journal, often are at odds with statements by Sunrise officials who said they acted quickly when problems with catheters were discovered.

Sunrise officials said in a press release that the incidents of disrupted catheters tracks back to February, but hospital records released to the nursing board reveal that incidents actually began in December.

And records also reveal that it wasn't until one child was injured in April and another in May that Sunrise had a forensic expert examine catheters.

"We're talking about a culture where tolerance of patient harm was allowed to develop," Simmons said. "You have to fix a problem before you kill somebody."

Baby Obote, whose umbilical catheter fell apart on May 22, died in July.

The other baby who was harmed when a broken catheter migrated to the heart was able to go home after a surgeon successfully retrieved the tubing.

Sunrise officials have never said what happened to the other dozen children involved in the incidents of disrupted catheters.

In an e-mail sent this month to Sunrise employees that was obtained by the Review-Journal, Sylvia Young, president of the Sunrise Health System, wrote that the hospital had been doing "product assessments" on catheter lines since early January and made changes to catheter lines "in an effort to isolate a potential product issue as the cause of the disruptions."

But subpoenaed e-mails show that Sunrise officials were not talking to manufacturers about changing brands on catheter lines early in the year, but about changing the filters, ports and IV tubing to which a catheter line can be attached.

Subpoenaed minutes of a Neonatal Intensive Care Meeting in March show supervisors thought "the adding of a small filter" would solve the problem with the catheter lines.

It wasn't until May 11, according to an e-mail in the subpoenaed records, that a Sunrise official contacted manufacturer Becton Dickinson about "issues with our PICC lines breaking over the last couple of months."

In May, catheter lines were changed out in the neonatal unit.

"They should have consulted with safety experts and the FDA (Food and Drug Administration) early on," Simmons said. "They might have found failures with similar devices around the country. "

In August, the FDA issued a newsletter describing 46 adverse events with peripherally inserted central catheters, the kind that Sunrise said "disrupted" at the hospital 13 times. Becton Dickinson, Sunrise's supplier of that kind of catheter for years, led the list of manufacturers listed by the FDA with adverse event reports.

More than half of the adverse events were caused either by catheter breaks, structural defects or fractures.

Two years ago, the FDA issued a similar newsletter describing 36 adverse events with umbilical catheters, the kind used on baby Obote. Twenty-five of the events, with more than half involving device breakage or a defective device, were connected to Covidien, the manufacturer of Sunrise's product.

"They (Sunrise officials) should have recognized that they didn't have the expertise to deal with this right away," Simmons said. "The way they handled this was a tragedy."

How Sunrise officials share information with authorities about the broken catheter lines is unclear. When the nursing board subpoenaed records about the hospital's investigation, Sunrise officials said no records of any kind were made of employee interviews.

It is also unknown how many catheter lines may have broken at the hospital since 2008. Sunrise officials said the nursing board's request for such information was "irrelevant."

In Young's e-mail to employees, she referenced the hiring of a forensic engineer to examine the catheter lines. His report, she said, "showed the lines had been cut."

"The evaluation performed by the forensics expert," she said, "was sufficient for us to immediately notify the Metropolitan Police Department at which time they took possession of the lines."

Why the forensic expert's work led to Sunrise getting the police involved is unknown.

Dan Davidson, a vice president for the hospital, said that information is now part of the police investigation.

Bruce C. Hansel, executive director of forensic investigation with the ECRI Institute, a nonprofit organization based in Pennsylvania, said it is important that people never rush to judgment regarding cut catheters.

"They can be cut accidentally with scissors and scalpels in both applying and removing dressings," Hansel said Thursday.

W. Don Bunn, the failure analysis expert for Oklahoma-based Sherry Laboratories that was hired by Sunrise, told the Review-Journal earlier this month that he had been asked to see if the catheters could have been cut.

"I would have had to do more tests to see if there could have been product failure," he said.

Contacted again Thursday, Bunn said any further questions from the media would have to be addressed to a Sherry Laboratories lawyer. Asked about what he told the Review Journal earlier, he was clear: "I stand behind what I said."

In an e-mail to the Review-Journal on Thursday, Sunrise spokesman Davidson wrote: "We did not limit the scope or nature of his examination. Any suggestion to the contrary is patently false."

Though in subpoenaed documents Bunn wrote that "it was requested that the mode of the catheter(s) examined at Sunrise Hospital & Medical Center be determined," the only tests he did regarding the devices had to do with simulating cuts in catheters that he photographed at Sunrise.

Subpoenaed documents reveal that Bunn found he was able to simulate cuts with scissors that were "consistent" with what he saw in highly magnified photographs of five catheters. On another sample in which he used a razor blade and tubing cutter, he was able to make cuts that were "consistent" with another photographed catheter. For one catheter he was unable to simulate the cut.

Regardless of what he found in his tests, Bunn reiterated that he cannot rule out product failure.

"There's no way I could do that with what I did," he said.

Surveyors with the Nevada State Health Division were under the impression that Bunn had done a complete product failure test, even saying so in a written report that absolved the hospital of fault for the series of catheter incidents.

Clark County Coroner Mike Murphy reiterated Thursday that Bunn's work played a key role in his office's ruling that baby Obote's death was a homicide. His office did not do product failure tests of its own. Murphy said new information about the catheter incidents could change the homicide ruling to an accident. A government lab is expected to test the catheters for police.

That product failure wasn't ruled out before action was taken against the nurses troubles Mike Cohen, head of the Institute for Safe Medication Practices, a nonprofit agency that sends out regular safety bulletins that reach over 2 million health professionals and consumers in the United States.

"A full forensic investigation should occur before it's suggested nurses could have done something criminal," Cohen said. Just the incorrect placement or removal of a catheter can sometimes cause it to break, he said.

That would not be criminal, but rather a procedural problem that requires education, said Cohen, who served recently as a member of the prestigious Institute of Medicine's Committee on Identifying and Preventing Medication Errors.

When the hospital turned over what Simmons sees as incomplete information to police, the chance to find out what really happened may have lessened. Police do criminal investigations, not medical safety investigations, she said.

Forensic experts contacted by the Review-Journal from the nonprofit, academic and commercial sector said product failure analysis can include tests for product fatigue, tension failure, structural defects, flexibility and whether it was exposed to the wrong solution.

They also said it is important to know if the product was stuck in a patient or subjected to excessive fluid pressure.

A full investigation can include whether the product had been stored properly, according to the forensic experts.

"If it's hot outside and the catheters are stored at the top of a truck, it could be 165 degrees and that's not good for them," said Edward Elson, head of IDCO Forensic Services in Anaheim, Calif.

He said the heat could make the devices more brittle.

The testing can be expensive. Most labs cost about $150 an hour and experts $250 to $450 an hour, Elson said, and clients often are working on a budget.

Hundreds of thousands of dollars can be spent on a full product failure analysis, Elson said.

He said it is not uncommon that after a microscopic visual examination an accomplished forensics expert will just try to duplicate what his expertise tells him was a cut.

Elson said forensics experts often check with the FDA to see if similar medical products have failed.

Subpoenaed reports of Sunrise's forensic expert show no evidence that he checked with the FDA.

Guohao Dai, professor of engineering at Rensselaer Polytechnic Institute, the nation's oldest technological university in Troy, N.Y., said it is always critical for a forensics expert to know the history of a catheter, whether it was twisted, for instance, in getting into or out of a patient, an action that could cause a catheter to weaken or break.

The ECRI Institute's Hansel said excessive force can snap a catheter.

In an interview with the Review-Journal, nurse Rice said that on the May evening that baby Obote's catheter was found broken, Dr. Martin Blahnik told those nearby that the feverish attempts to resuscitate the baby with forceful compressions might have broken the fragile catheter. Attempts to reach Blahnik have been unsuccessful.

To Simmons, it's important for hospitals to report their difficulties publicly so others can learn from them. While they are supposed to do that, there is no mechanism in place to force them to do so.

"Unfortunately, we have problems with hospitals reporting adverse events," she said. "They suppress whatever they can. They're afraid of the news media. They won't look past blaming someone. What we see in device failures is that we have them failing across the country, the same problem with the same device, and no one knows it. That doesn't help patient safety."

Subpoenaed records show that the only time Sunrise reported instances of broken catheters to the FDA is after the two babies got hurt.

Simmons said her heart goes out to the nurses. Without substantial evidence, "they have been ruined. That is horrific."

She said the fact that the nursing board gave Ochoa-Reyes and Rice their licenses back should really make people think.

"A nursing board is very conservative. Their mission is to protect the public safety. They err on the side of safety."

Contact reporter Paul Harasim at pharasim@reviewjournal.com or 702-387-2908.