Outbreak at central Arkansas clinic a mystery at first; files show how agencies tracked bacteria

Cancer patient Robert Mingo holds the armload of drugs and supplements he takes daily. He says he still suffers the effects of an infection that he contracted last year.
Cancer patient Robert Mingo holds the armload of drugs and supplements he takes daily. He says he still suffers the effects of an infection that he contracted last year.

Robert Mingo used to travel once a week from his home in Dumas for chemotherapy treatments at Arkansas Cancer Institute.

Mingo, 56, had been going to the Pine Bluff clinic for about a year for treatment of his multiple myeloma, which is a cancer of the plasma cells. It had been going "all right," he said. He'd gotten to know the other patients a little, and it was more convenient than going all the way to Little Rock.

Until August, that is, when something went wrong.

The trouble began with an unusually bad reaction to a treatment, which put him in bed for a few days with chills and stomach pain. He told a nurse about it when he went back for his next treatment -- after which he was taken away in an ambulance.

"I felt like I was dying," he wrote in a statement about the incident. "My whole body was in pain." He wrote that he was hot, cold, throwing up and had "severe weakness."

Mingo was transported to Jefferson Regional Medical Center, where he spent seven days fighting a mysterious infection that he says left him bedridden for two weeks after he got out of the hospital. He later learned that he was one of more than 50 people, mostly cancer patients, who were infected in a bacterial outbreak at Arkansas Cancer Institute.

Months have passed since the peak of that outbreak, during which the Arkansas Department of Health, the federal Centers for Disease Control and Prevention, the clinic and nearby Jefferson Regional Medical Center engaged in rapid-fire correspondence as the health organizations worked to respond to the situation, emails and meeting and call records show. Those records were obtained by the Arkansas Democrat-Gazette through an Arkansas Freedom of Information Act request.

More recently, the state Health Department's investigation of the outbreak, which identified a new species of bacteria, has moved into an academic phase that could lead to publication of a scientific article.

Things aren't back to normal for Mingo, who said his health hasn't returned to where it was before the infection he contracted at the clinic.

When he was sick, his lungs filled with fluid, and now "they don't hold air like they used to," he said. He can't walk as far without pain. Sometimes it's tough to walk the few hundred feet to his mailbox. And the overall effect on his immune system meant he had to skip "about six" chemotherapy treatments, he said.

That's part of why he's among three patients who have joined a medical malpractice lawsuit against Arkansas Cancer Institute, he said. He calls what he went through "unnecessary" and said that "whoever's in charge" should be held accountable.

The cancer clinic called him shortly after the hospitalization in August, he said.

"They wanted to set up an appointment. I told them that 'I don't think we'll be doing no business.' I explained to them that I didn't feel safe."

INSIDE AN OUTBREAK

Alarm bells didn't go off at the Health Department initially.

Health officials at first suspected that a Jefferson Regional Medical Center laboratory's discovery of an unusual bacterial infection was an error.

Mycobacterium parafortuitumis is rare and wasn't thought to cause disease in people, state epidemiologist Dr. Dirk Haselow said in a recent interview.

"It was somewhat discounted, because no one knew what to do with it," Haselow said. "As we started seeing more infections, we realized something was wrong."

On Sept. 5, Jefferson Regional Medical Center staff members reported to the Health Department a cluster of infections among patients that had appeared during the last two weeks of August. The reported constellation raised the number of cultures showing the unusual bacteria to 13.

Within days of that report, investigators were able to trace the outbreak to Arkansas Cancer Institute and identify its source: saline flushes, which the clinic used on patients who had chemotherapy ports, devices implanted under the skin that helps in giving medications.

In a Sept. 6 email to other officials, Kelley Garner, program coordinator and epidemiology supervisor for the state's health care-associated infections program, wrote:

"Yesterday, [Arkansas Cancer Institute] requested blood cultures be performed on 11 patients who were having fever, chills and nausea and as such missed their oncology appointments.

"We spoke with the medical director of the clinic, who reported that patients would come into the clinic ok, but after 30 mins after accessing the port would become severely ill and were taken to the Emergency Department at the acute care hospital at which point some were hospitalized," Garner wrote.

The next day, a Friday, a Health Department team conducted site visits at Jefferson Regional Medical Center and Arkansas Cancer Institute. A written recap of those visits describes "a few non-standard practices observed at [Arkansas Cancer Institute]," including the saline flushes.

According to Health Department documents and correspondence, the cancer clinic was preparing saline flushes by filling syringes from a large bag of saline fluid and storing them for up to seven days for later use, rather than using factory-sealed, single-use syringes pre-filled with saline.

On Sept. 10, an infection-control nurse at Jefferson Regional Medical Center wrote to the Health Department to say that the hospital's lab had tested saline bags and syringes from Arkansas Cancer Institute. She wrote: "4 of the 5 syringes showed GROWTH very similar to what we have seen from the blood cultures, leading [the lab] to believe that it is the mycobacterium."

On Sept. 13, a letter of formal recommendations to control the outbreak went out from the Health Department to Arkansas Cancer Institute. Topping the list of recommendations was an advisement to "replace saline flushes drawn from a larger bag of saline with sealed, pre-drawn saline flushes. Discontinue future use of locally-filled flushes," two officials wrote. "This appears to have taken place on Tuesday September 11, 2018, but we would like confirmation from you that no more homemade flushes are being used."

In an email exchange with Arkansas Cancer Institute administrator Michael Legate on Sept. 18, Arkansas-based CDC epidemic intelligence service officer Dr. Sarah Labuda explained that neither the federal agency's nor the Association for Professionals in Infection Control and Epidemiology's guidelines recommend pre-drawing of saline for flushes, and that syringes of that type would be considered good for only 24 hours in a pharmacy.

Officials continued to study the outbreak in subsequent days and weeks, looping in infectious-disease specialists from the University of Arkansas for Medical Sciences and the CDC.

A new wrinkle appeared when a CDC analysis clarified that the bacteria was not mycobacterium parafortuitum, but a new, related organism temporarily dubbed mycobacterium sp. FVL 201832.

As the investigation into the cause of the infections continued, Arkansas Cancer Institute worked to contact and collect samples from more than 150 patients thought to have been exposed to the bacteria, though only about a third of those ended up testing positive for the infection.

Legate and clinic president Dr. Omar Atiq declined interview requests for this article, referring questions to an attorney.

Records show that the clinic's formal communications with affected patients did not always make clear the source of the infection.

A conference call invitation set for Sept. 14 between Jefferson Regional Medical Center, the Health Department and Arkansas Cancer Institute calls for "each organization to have people on the phone that can discuss risk management strategies and make high level communication decisions."

A patient notification letter from the clinic dated Sept. 20 went through several revisions and ultimately did not mention saline flushes, citing work with state and federal health regulators "to determine the cause of the infection and to put in place steps to prevent it in the future."

An undated, 11-step script for calls to summon patients for screening ("How are you doing today? Have you had any fever or shakes lately?") also does not refer to the investigation into the cause of the infection.

Health Department officials had been investigating the outbreak for almost two months by the time the first news report about it, a segment on Little Rock television station KARK, appeared around Halloween. By that time, three patients who had been infected with the bacteria had died, though their deaths could not be explicitly linked to the infection.

In interviews and statements at that time, the clinic began acknowledging the saline flush issue to media.

"While the specific cause of contamination is still unknown, the source has been determined to be the saline flushes that are no longer in use. The process Arkansas Cancer Institute used for 27 years without any complications has been replaced with a different process to prevent future infections," an October news release said.

THE LAWSUIT

In December, Steven Edwards of Lincoln County filed a lawsuit against the cancer clinic in Jefferson County Circuit Court, saying he was among patients sickened in the outbreak. Court documents show that the saline flushes are central to the complaint.

Initial and amended complaints filed by Little Rock attorney Gary Green allege negligence in several areas, including sanitation, adherence to infection control protocols, "failure to properly educate and train staff regarding sterile saline flush procedures" and "failure to comply with the manufacturers instructions regarding sterile saline flush procedures."

Green said he now represents several people who were affected and has requested class-action certification for the more than 150 people potentially exposed to the bacteria, though just three have been named as plaintiffs and only Mingo agreed to speak with the Democrat-Gazette.

Although he said he finds medical malpractice cases generally tricky and feels that doctors are "formidable adversaries," Green said the case is worth pursuing.

In a phone interview at the time of the lawsuit's first filing, clinic administrator Legate urged patients to reach out to the clinic before seeking legal counsel.

"We still very much care for them and their families, and we want to do everything we can to ensure that they have the highest quality of life possible," he told a reporter.

Written responses to the lawsuit from the clinic's attorneys deny allegations of negligence and departure from the standard of care "generally and specifically," and argue that the suit does not meet requirements for a judge to certify it as a class-action case.

Those filings also argue against claims of punitive damages, saying that a lack of formal standards for that type of damages in the state means an award would violate the clinic's due-process rights.

The clinic's attorney, David Glover of the Wright Lindsey Jennings law firm, declined to comment, citing pending litigation.

THE AFTERMATH

Health Department officials say the outbreak has underlined the importance of keeping Arkansas health care providers up to date about infection control practices.

Department officials have gone on more than 100 infection-control visits to hospitals and nursing homes in recent years, and lately expanded those visits to include clinics -- which it doesn't have exclusive authority over -- "because of a variety of reasons, including this one," Haselow said.

Labuda said work to connect with cancer clinics across the state, share recommended guidelines and offer infection-control visits is underway.

The Health Department is still analyzing information from the outbreak -- to try to understand, for instance, why some people who were exposed got infected and some people didn't. One emerging trend suggests that the more saline flushes people received, the more likely they were to test positive for the bacteria, which also seemed to infect more women, Labuda said.

At Jefferson Regional Medical Center, which initially identified the infection cluster, chief medical officer Dr. Reid Pierce praised the hospital's lab for its ability to spot an unusual organism. One takeaway from the episode is the need for health care providers to be in "constant communication" with one another.

In November, Mingo was well enough to resume regular chemotherapy treatments, this time at UAMS in Little Rock. His wife, Brenda, is usually the one who drives him -- a roughly 97-mile one-way trip, which he says is starting to get expensive.

He also had some out-of-pocket costs related to his hospital stay as he fought the infection, though insurance and Medicaid covered much of it, he said.

Seated in a double recliner in his living room just after Christmas, he said he'd never previously had something like this happen with a medical provider. The experience rattled his wife, who became frightened when she heard that some people who had been infected had died, and his four children, who "get mad when you mess with Daddy."

On good days, he helps out at Bethlehem Worship Center in Dumas, writing holiday and black history plays and, once, putting on a puppet show for Easter.

But since the infection, he hasn't had as many good days, he said.

"I was already weak, but I'm a lot weaker now," he said. "I hope that nobody else had to go through it, because it's a lot of pain."

photo

Arkansas Democrat-Gazette

At his home Wednesday in Dumas, Robert Mingo shows the scar on his chest from a chemotherapy central line. Mingo said doctors told him the line is probably how he contracted a painful bacterial infection in August. He and two other patients have joined a malpractice lawsuit against Arkansas Cancer Institute in Pine Bluff.

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