VA colonoscopies put Miami vets at risk

Feb 26, 2011 Issues: Veterans

Posted on Sat, Feb. 26, 2011

VA colonoscopies put Miami vets at risk

By Fred Tasker
ftasker@MiamiHerald.com
PATRICK FARRELL / MIAMI HERALD STAFF

Vietnam veteran Dan Shannon got two colonoscopies at Miami's VA hospital with improperly cleaned equipment, and has lived ever since in fear of HIV or hepatitis.
When U.S. Army veteran Juan Rivera turned 55 and decided it was time for a colonoscopy, he turned to the Veterans Administration hospital in Miami. He had the test, got a clean bill of health and didn’t give it another thought.
A year later, he received a chilling letter from the VA. It said the equipment used in the procedure might have been contaminated. And it asked him to come in for viral testing.
He came up HIV positive.

“He’s shocked and mortified. He feels the government has given him a death sentence,” said lawyer Ira Leesfield, who has filed suit against the VA for $20 million on Rivera’s behalf. “He has a wife and four children. He led a risk-free life, and he tested positive. There’s only one possible source: the colonoscopy.”

Rivera’s suit is one of 45 filed against the VA so far in Miami, with 113 more in line to sue after filing the notice required when a government agency is involved.
There could be many more suits to come. Rivera was among 11,000 veterans who had colonoscopies performed in Miami, Tennessee and Georgia between 2004 and 2009 with equipment that the VA has acknowledged may have been improperly cleaned. The VA says 2,539 Miami vets are “potentially at risk for infection” from the colonoscopies but insists that “there is currently no evidence to suggest these infections were acquired from the endoscopic equipment.”

So far, five Miami-area vets who had colonoscopies at the VA during the five years have tested positive for HIV, eight for hepatitis C and one for hepatitis B.
For vets like Rivera — an Army truck driver for 13 years in Korea, Germany, Honduras and Panama — the idea that the VA’s actions may have put them at risk for disease or death is difficult to handle.
“He served his country for so many years, and now his life is impacted forever,” said Leesfield, Rivera’s lawyer.

Flawed, inadequateHow could it happen? Twenty-three months after the scandal broke, interviews, court documents and a VA investigative report obtained by The Miami Herald through public records laws show that the flawed colonoscopies were performed in an environment of inadequate training, lack of supervision and communication failures. Technicians and nurses performed procedures for which they were not adequately trained and failed to read manufacturers’ instructions. Equipment vendors bypassed VA approval processes and delivered instrument samples directly to operating rooms.

According to the VA report, the problems in Miami came to light in 2009 after VA technicians heard about improperly cleaned colonoscopy equipment at VA hospitals in other states. The technicians took apart the water tubes on some of the endoscopes that had probed the veterans’ intestines for cancerous polyps.

The tubes were supposed to be clean, ready for use. Instead, the technicians found “discolored liquid and debris.”

They also discovered that some of the tubes, which were supposed to be sterilized with steam and chemicals after each use, had only been rinsed. They hadn’t been properly cleaned in the five years since they were acquired in 2004, according to a report by the VA’s Clinical Risk Assessment Advisory Board. Other endoscopes lacked a crucial valve to keep contaminated liquids from flowing back toward the patient.
Three days later, the life-altering letters went out to 2,600 South Florida vets to tell them they were at risk and should come in for testing.
But that wasn’t the end of it. Sixteen months later, the Miami VA disclosed that its 2009 notification process had missed 79 vets who also had the flawed colonoscopies.
And six months after that, on Feb. 8, the VA announced its notices had missed another 12 veterans who potentially had been exposed to deadly diseases — diseases that doctors say are most effectively treated with early detection.

“I was heartbroken, you know,” Mary Berrocal, Miami VA hospital director, said after the first reports of trouble. She said she disciplined 10 employees. She wouldn’t say whom or how. She did not comment for this story.
VA officials won’t even confirm whether anyone was disciplined. “We cannot confirm or deny whether actions have been taken against employees,” said spokeswoman Mary Kay Hollingsworth.
Broward veteran Dan Shannon got one of the letters. A self-described “ground-pounder,” or infantryman, in Vietnam, he had colonoscopies at the Miami VA hospital in 2007 and 2008.
“The anxiety and anguish put a real strain on me,” says Shannon, now 61. “I was already in their [post-traumatic stress disorder] program.”

Shannon, now a volunteer at the Veterans of Foreign Wars post in West Park, was tested for HIV and hepatitis at the VA hospital, and then, because he no longer trusted the VA, by a private doctor as well.
“What really gets me is that my wife had to get tested, too,” he said. “We were looking at each other cross-eyed for a while.”
So far the couple has tested negative. Shannon is now among the veterans suing the VA.

When the scandal first broke, national VA officials reacted quickly. They set up hotlines that veterans could call for information and advice. They provided free testing. They staged surprise inspections at 42 of 56 VA hospitals around the country. The result: 43 percent failed to meet standards for cleanliness and safety. Miami wasn’t part of the inspections because it already was under investigation.
South Florida legislators reacted with anger.

“This is inexcusable,” said U.S. Rep. Ileana Ros-Lehtinen, R-Miami, who demanded a congressional hearing.
In the June 2009 hearing, Gerald Cross, acting undersecretary for health at the VA, said he was “distraught” at the poor results of the surprise inspections. “We did something wrong, and I expect it to be corrected,” he said.
The VA announced it would spend $26 million to buy new equipment, institute better training and tighten procedures.

What went wrong?In April 2009, the VA had sent a five-member Administrative Investigation Board (AIB) to Miami to look into what went wrong. The 24-page report — only now made public through Freedom of Information laws, with six VA staffers’ names blacked out — describes a morass of confusion, inadequate training and lack of supervision. Among its findings:

•  Technicians and nurses responsible for setting up and cleaning endoscopic equipment used for colonoscopies had not been instructed that it had to be sterilized after each use, and were only rinsing it. “Technicians and nurses do not routinely read manuals, but go more on experience,” the report noted.

•  When technicians were not available due to vacation or illness, nurses would set up and clean endoscopic equipment, though they weren’t trained to do it.

•  Twenty percent of the time, staffers testified, medical equipment for colonoscopies was delivered directly to operating room doctors without going through VA approval processes. Staffers called it “coming in through the back door” and said it was “a nightmare.”

•  Equipment that was formally entered into inventory was often mislabeled. An electroencephalography machine was called a “hard drive” in hospital records.
In the Senate hearings, Berrocal, the Miami VA hospital director, described steps she was taking to improve safety. A patient safety officer had been hired, reporting directly to her. A new clinical nurse was being hired to supervise technicians using endoscopic equipment. Nurses, technicians and supervisors had completed 40-hour training courses by Olympus, manufacturer of the equipment. Vendors no longer could go directly to the operating room with equipment. A clearer chain of command was set up.

In July 2010, a year after his HIV diagnosis, Rivera filed suit against the VA. He remains well with treatment from the VA and referred questions to his lawyer.
Assistant U.S. Attorney Lawrence Rosen, representing the VA, acknowledged in court papers that thousands of colonoscopies over five years had been improper. But he said it couldn’t be proved that Rivera’s VA colonoscopy had given him HIV.

“There has been no confirmed circumstance when HIV has been passed by endoscopy, including colonoscopy,” Rosen said in court papers.
But in a March 2009 report by the VA’s own Clinical Risk Assessment Advisory Board, VA infectious disease experts said the VA’s practices in handling the colonoscopies “pose a low but significant risk for cross-contamination of blood-borne pathogens.”

Leesfield expects a trial in September.

Another Miami-based suit was filed in federal court last August, listing 42 veterans who had received the letters from the Miami VA hospital warning that their colonoscopies might have been done with improperly cleaned equipment. The suit was for “negligent infliction of emotional distress.”

Of the 42 who filed, 26 had been told when they went to the VA for testing that they had been contacted in error, because the risky equipment had not actually been used on them. The other 16 were tested and found to be currently without disease.

U.S. District Judge K. Michael Moore dismissed the cases of the 26, saying that the emotional toll of merely receiving the erroneous letter was not sufficient to sue. He let the case continue for the others.
In Tennessee, Nashville lawyer Mike Sheppard has filed suit in federal court for three veterans treated at the VA hospital in Murfreesboro, Tenn., and has filed formal notice of suit for 18 more. One of his clients has HIV and 18 have hepatitis C or B, he says.

For the VA, the problems didn’t end with the initial discovery of the flawed colonoscopies. Sixteen months later, when the Miami VA announced it had missed 79 veterans, Berrocal, the Miami VA hospital director, was reassigned to duty outside the hospital. Thomas Cappello, Gainesville VA hospital director, took temporary control.

Cappello said the VA’s Administrative Investigation Board would hold new hearings and report back in 30 to 60 days.

In October, Berrocal was reinstated as Miami VA director without public notice. She declined interview requests. The new investigative report that was due by Sept. 6 was not released to the public. On Oct. 30, The Miami Herald submitted a public records request for the report. The request is still pending.

The names of the other 12 veterans who weren’t notified for almost two years about the improper colonoscopies were discovered in paper records kept in addition to the VA’s state-of-the-art electronic records system. It was an inquiry by the U.S. attorney’s office, related to the lawsuits, that prompted the discovery, the VA said.

VA officials said they plan no discipline or new investigation.

 

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