More on Kaiser's rush to harvest

Report tells of errors in organ case
U.S. regulators detail how a potential donor was given huge doses of sedatives and painkillers as six people watched.
By Tracy Weber and Charles Ornstein, Times Staff Writers
March 2, 2007

Related Stories
- Police probe death in organ donation case
- Organ Transplant Programs

- Rationing Lives: Organ Transplant Programs

It was to be the final medical procedure for Ruben Navarro, an altruistic end to the life of a critically ill 26-year-old who doctors said had no chance to recover.

Staffers at Sierra Vista Regional Medical Center in San Luis Obispo were to disconnect him from the machine pumping oxygen into his lungs. After his heart stopped, transplant surgeons were to remove his organs so they could be used to save the lives of others.

But in the late night quiet of an operating room Feb. 3, 2006, plans for that dignified end went terribly awry, according to a 76-page report by federal inspectors released this week in response to a Freedom of Information Act request from The Times.

Police and the state medical board are now investigating whether the transplant surgeon brought in to retrieve Navarro's organs attempted to hasten the patient's death by ordering him pumped full of massive amounts of narcotic painkillers and sedatives. If true, the allegation would constitute a grave breach of the nation's transplant rules.

In a stark recounting, federal regulators detailed how at least six people in the room, including Navarro's treating doctor, stood by without intervening, even though some later said they were disturbed by the actions of the surgeon and a nurse administering the drugs. The regulators from the U.S. Centers for Medicare and Medicaid Services have been looking into the hospital's role in the case.

The amounts of the painkiller morphine and the sedative Ativan that the report says were given to Navarro were "between 10 and 20 times a usual dose of these drugs," said Dr. Philip S. Barie, president-elect of the Society of Critical Care Medicine, who was not involved in the preparation of the document.

"I don't think I've ever given doses of either drug in that amount," said Barie, professor of surgery and public health at Weill Medical College of Cornell University in New York.

According to regulators, the mistakes began almost from the moment Navarro was wheeled into the operating room from the intensive care unit, where he had been on life support after arriving at the hospital in cardiac and respiratory arrest Jan. 29. Navarro, who suffered from severe mental retardation, had been living at a nearby long-term care home.

In the operating room that night were the transplant surgeon and a colleague, both from Kaiser Permanente's now-defunct kidney program in San Francisco, as well as a nurse and coordinator from the regional organ procurement group that serves most of Central and Northern California, the report said. Also on hand were the doctor treating Navarro at Sierra Vista, the patient's intensive care nurse, an operating room nurse and other staff.

At 11:10 p.m., a transplant surgeon ordered 100 mg of morphine and 40 mg of Ativan for Navarro, the report said. The surgeon is not mentioned by name, but several sources confirmed his identity as Hootan Roozrokh.

At some point soon after, Navarro's breathing tube was removed.

Legal restriction

According to state law, Roozrokh might already have crossed a line. Transplant doctors are not to direct the treatment of potential organ donors before they are declared dead. This restriction is designed, in large part, to ensure that organ retrieval does not take priority over patient care.

Moreover, the report said, Roozrokh was not authorized to care for patients or order drugs at the hospital, according to the hospital's own policies.

When Navarro's heart did not stop, Roozrokh ordered another 100 mg of morphine and 40 mg of Ativan, which the ICU nurse administered, the report said.

Navarro still did not die. After about 30 minutes off life support — the time limit set to ensure the viability of the organs — the process was ended. Navarro was returned to the intensive care unit, where he died early the following morning. His organs were not retrieved.

Later, the report said, the hospital's operating room nurse told inspectors that she had never seen narcotics or sedatives given to a patient during an organ donation procedure and that she "repeatedly asked" the ICU nurse and representatives from the organ procurement group about the medications. But she did not alert her superiors or attempt to intervene.

The nurse's supervisor told inspectors she would have "gone to the OR and stopped the events" if the nurse had called, according to the report. (Operating room staff reported concerns about the incident days later.)

Navarro's treating physician told inspectors she was "surprised at the quantity of the medications" given to her patient. Another nurse, who obtained the medications for the ICU nurse, said that the amount of drugs was "a red flag."

According to critical care specialist Barie, 5 mg of Ativan an hour is enough to keep a desperately ill patient in an intensive care unit "very heavily sedated."

He and other experts said doses of medication can vary depending on each patient's circumstances.

In their report, federal inspectors said the hospital was unprepared for the organ donation to take place.

Most organ donations involve patients who have been declared brain dead. In cases like the one handled that night, known as "donation after cardiac death," the donor has suffered a devastating brain injury and has no hope of recovery, but still has minimal brain function. Removal of life support ultimately causes the heart to stop.

Although Navarro was the hospital's first experience with such a case, two key operating room staffers — the nurse and technician — told inspectors that they were not given information about the procedure until that day.

Regulators reported other lapses as well. ICU nurses typically do not administer medications in the operating room, but the hospital had no policy prohibiting that. In fact, the ICU nurse never documented that the medications had been administered at all, regulators found.

'Very confused'

In an interview with inspectors, the hospital's pharmacy director said he was "very confused by the whole situation." He told inspectors he later doubted that the amount of drugs ordered had been given to one patient.

Later, he said, he was told that the hospital's risk management department was going to investigate what happened with the drugs and he was to "keep his hands off the situation," according to the report.

Critical care and transplant experts said they were appalled at the case.

The allegation that a transplant surgeon was dictating end-of-life care decisions is "scary," said Dr. Charles G. Durbin Jr., professor of anesthesiology and surgery at the University of Virginia Health System.

"I don't think you can act in the best interest of the patient if you are in fact trying to harvest the organs for another patient," he said. Still, some experts said, it may be hard for authorities to prove that Navarro died as a direct result of the medications, because he survived for several hours after being taken back to his intensive-care room.

Dr. Kevin Dushay, an assistant professor of medicine at the Brown University School of Medicine and a trustee of his regional organ bank, said he did not condone what allegedly took place.

But "it's not like the patient woke up and said, 'I want to live' and somebody pushed a lot of drugs in them and killed them anyway," he said.

An investigation into the manner and cause of Navarro's death by the San Luis Obispo County sheriff-coroner is expected to be finished next week.

Roozrokh's colleague, transplant surgeon Arturo Martinez, is also under investigation by the Medical Board of California for his possible role in the incident. Neither doctor was working on behalf of Kaiser that night, but rather on behalf of the regional organ procurement group, as is common among transplant surgeons.

Roozrokh's attorney, M. Gerald Schwartzbach, said there was plenty of blame to go around in the case. He said the coordinator from the procurement group and Navarro's treating physician could have asked Roozrokh to stop but didn't.

Phyllis Weber, chief executive of the California Transplant Donor Network, the procurement group involved, declined to comment in detail on the conduct of the coordinator.

But she said it was "unfair" for Schwartzbach to suggest that the coordinator did not intervene. "She did a great job under the circumstances that she was presented with," Weber said. "When all the details become available, I think we will be able to demonstrate that."

Letter of reprimand

Weber's group was issued a confidential letter of reprimand by the United Network for Organ Sharing, the federal contractor charged with ensuring the safety and equity of the nation's transplant system.

Joel Newman, a spokesman for UNOS, said he expects the issue of how to handle such donations to be taken up in detail at the group's meeting later this month.

Transplant experts and lawmakers nationwide are agonizing over the potential impact that the alleged breach of transplant ethics could have on organ donations.

"These allegations are terribly upsetting," said Sen. Charles Grassley (R-Iowa), who has been investigating oversight of the nation's transplant network.

"It's the kind of thing that erodes public trust in the transplant system and demands a thorough investigation," he said.

The Navarro incident has proved even more problematic for Sierra Vista, a 165-bed hospital owned by Tenet Healthcare Corp. While investigating the transplant case, regulators discovered serious violations in many areas and threatened to pull the hospital's Medicare funding last fall. After Sierra Vista promised changes, the Centers for Medicare and Medicaid Services relented.

Sierra Vista spokesman Ron Yukelson declined to comment on individual failings identified by regulators, including major problems in its pharmacy.

The nurse cited in the report as giving Navarro the drugs was reassigned to administrative duties pending completion of an investigation, and the conduct of Navarro's treating physician was examined as part of a confidential peer review process, Yukelson said.

The physician, who was not named, remains in good standing on the staff, the spokesman said.

The pharmacy director, who was not named either, has since left the hospital for another job, Yukelson said.

"This event was triggered by an outside physician that came into our hospital and violated our policies," the spokesman said. "Deficiencies were noted. We addressed them."

*

--------------------------------------------------------------------------------
tracy.weber@latimes.com

charles.ornstein@latimes.com