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Treatment process begins after hep C outbreak at McKay-Dee, Davis hospitals

By Mark Shenefelt, Standard-Examiner Staff - | Apr 10, 2016

A staggering cost for treatment, on top of an uncertain health outlook, is putting the victims of a hepatitis C outbreak at McKay-Dee Hospital and Davis Hospital and Medical Center in a rare and difficult place. 

There doesn’t seem to be much closure in sight, either. No public pronouncements have been made about what consequences, if any, the hospitals could face after more than 7,200 patients were exposed to the virus, allegedly by way of a nurse who worked at Davis and McKay-Dee between June 2011 and November 2014.

At least 16 people were found to be infected, the Utah Department of Health announced Monday, April 4, at the conclusion of a five-month investigation of the outbreak.

BACKGROUND: Investigators: 16 hepatitis C cases identified at McKay-Dee and Davis hospitals

State and hospital officials say the investigation should bolster confidence in the public health system, but its culmination also left questions about whether the overall regulatory response is sufficient, particularly for the people who contracted the virus.

TREATING OUTBREAK PATIENTS

The U.S. Centers for Disease Control and Prevention says hepatitis C is a short-term illness for some, but 70 to 85 percent of those infected face a long-term, chronic illness that in some cases results in death.

There is no vaccine, but a new drug showed in clinical trials to achieve an 80 to 95 percent effective cure rate after 12-24 weeks of treatment. The catch is that a 12-week treatment of the drug, Sovaldi, costs $84,000 or more — about $1,000 per day for a 400-milligram pill. That high cost actually spawned a U.S. Senate investigation over alleged price-gouging by the manufacturer, Gilead Sciences.

McKay-Dee spokesman Chris Dallin said Wednesday the hospital will consider paying for hepatitis C treatments for at least some of the 15 people who tested positive at the Ogden hospital.

“Each patient’s circumstances will be evaluated individually,” Dallin said. “For some patients, the hospital will be offering the costs of treatment.”

He said the hospital will review “a lot of circumstances” to determine whether individual cases related directly to the central case. “After all of that is over and done, we will be offering to cover the costs” for at least some of the patients, he said.

Diane Townsend, business development director for Davis Hospital, said, “We are treating and covering the cost of care for the one individual with hepatitis C” linked to the Layton hospital in the state probe.

Dallin and Townsend both emphasized the need for more of the affected 7,200 to come in for free hepatitis C screening. UDOH said only 3,731 people have been tested so far.

“If you haven’t been tested, come in and get a test,” Dallin said. “It’s free. Hepatitis C is a serious health issue. We encourage our patients to rule it out, and if not, if it is discovered, we can make arrangements for them to get proper treatment.”

OPERATIONS AND ACCREDITATIONS

The outbreak was linked to Elet Neilson, a nurse who worked at both hospitals and was fired by McKay-Dee in December 2014 after diverting narcotics meant for patients. UDOH told McKay-Dee in September 2015 Neilson and a patient treated in the ER were both infected with the same hepatitis C genotype, meaning the two infections could be related. 

Investigators will never know conclusively whether the patient or Neilson was infected first and state has limited authority to delve into hospital operations, said UDOH spokeswoman Jenny Johnson. 

Those on state and federal levels who worked with the hospitals said the objective of the investigation was to identify the extent of the outbreak and see that those exposed are tested for the potentially serious viral affliction. They were not there to specifically examine the hospitals infectious disease best practices or other management matters.

“With hep C, the reason we started looking into it was for an epidemiological investigation, not a regulatory one,” Johnson said. “But when things happen, we can look into that to see if there are any compliance issues.”

She said the state Bureau of Health Facility Licensing and Certification received a complaint related to the outbreak and did a regulatory investigation of hospital practices.

“There was not anything found to be deficient. Even if there was, we may not have authority to do anything about it,” Johnson said.

Bureau Director Joel Hoffman did not return phone calls, but the bureau website lists its mandated duties according to state law:

  • Perform regular on-site inspections of Utah health care providers participating in the Medicare and Medicaid programs to ensure compliance with federal health, treatment and safety standards;

  • Conduct background screenings on all direct care staff in certain health care industries, as required by law.

  • Investigate complaints from the public about poor care or unsafe conditions in all licensed and/or certified facilities or providers.

  • Assure facility correction through requiring Plans of Correction, follow-up inspections, use of sanctions, (fines, bans on admissions, closure) and on-site monitoring.

National entities also play large roles in hospital regulation. Chiefly, the U.S. Centers for Medicare and Medicaid Services are charged with seeing that federal funds are spent properly in hospitals and that standards on infection control and other key areas are upheld.

Hospitals also must live up to accreditation standards set by non-profit entities such as the Joint Commission or DNV GL Healthcare. Those accreditations are recognized by government agencies, so losing accreditation could cause state or federal regulatory trouble for a hospital.

McKay-Dee is accredited by the Joint Commission. Davis Hospital is accredited by DNV GL. 

“It gets kind of complicated,” Johnson said.

Asked if McKay-Dee has been sued or taken to arbitration over the outbreak, Dallin had no comment and referred inquiries to the hospital’s outside counsel. The attorney did not return a phone call.

You can reach reporter Mark Shenefelt at mshenefelt@standard.net or 801 625-4224.

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