Ebola prompts changes, creates new risk management challenges
EMTALA, employment among the most difficult issues
The nation’s healthcare system was challenged by the recent cases of Ebola in the United States, but the clinical treatment and infection control were not the only difficult issues to emerge. Risk management issues regarding potential liability, staff training, and regulatory compliance continue to complicate Ebola care, and hospitals not yet affected by the disease are urged to review their capabilities while they can.
As the first day of Ebola response for U.S. healthcare workers unfolded on Sept. 24, 2014, it soon became clear that those responsible for helping the infected were the most at risk. Seventy-six healthcare workers who helped treat Liberian Ebola patient Thomas Eric Duncan at Texas Health Presbyterian Hospital Dallas were monitored for potential Ebola exposure. Two contracted the disease but recovered. Duncan died. Amid nationwide concern about the adequacy of the nation’s response to the Ebola infections, healthcare workers involved in Duncan’s treatment complained that inadequate education, training, and equipment put them at risk of infection.
The Centers for Disease Control and Prevention (CDC) confirmed claims that the Dallas nurses and physicians had to learn on the fly how to control the deadly virus, initially using CDC protocols that left the caregiver’s neck exposed to the patient’s copious amounts of highly infectious vomit and diarrhea. The nurses treating Duncan worked for days without proper protective gear and faced constantly changing protocols, according to a statement released by National Nurses United, the largest U.S. nurses’ union. Nurses were forced to improvise improvements, using medical tape to secure openings in their flimsy garments, the union claims. The hospital soon changed its protocol to include more extensive gear that completely covered the clinician. (See the story on p. 124 for a timeline of Duncan’s treatment and the subsequent infections.)
Quarantines, or the lack thereof, became a heated issue. U.S. nurse Kaci Hickox was quarantined at a hospital by the state of New Jersey upon returning from hands-on treatment of Ebola patients in Sierra Leone. She was released to self-quarantine at home in Maine after she publicly derided the precaution and obtained a high profile attorney to sue the state. President Barack Obama also criticized the quarantine as unnecessary. Hickox flagrantly violated the home quarantine and convinced a federal judge to overturn the order.
Texas Health Presbyterian Hospital Dallas confirmed that it settled with Duncan’s family regarding the delayed diagnosis. The settlement was for a "substantial amount," says the family’s attorney, Les Weisbrod, JD, of the Dallas law firm of Miller Weisbrod. In addition, Texas Health Resources Foundation agreed to create a charitable trust in Duncan’s memory intended to eventually create a state-of-the-art treatment facility for Ebola patients in Africa. The hospital also agreed not to charge Duncan’s family for his medical care.
The hospital still could be facing lawsuits related to the nurses’ infections and the emotional stress suffered by not only those two healthcare workers who were infected, but everyone else involved in Duncan’s care or exposed to him after his initial visit to the hospital.
Duncan began experiencing symptoms on Sept. 24, 2014, and he arrived at the Texas Health Presbyterian Hospital emergency room (ER) at 10:37 p.m. on Sept. 25. A nurse recorded a fever of 100.1 degrees F but did not inquire as to his travel history, as this was not triage protocol at the time. Another nurse later asked about his travel history, but she did not follow through when the electronic health record (EHR) indicated that information should be reported to the physician. Early the next morning, Duncan was diagnosed with sinusitis and abdominal pain. He was sent home at 3:37 a.m. with a prescription for antibiotics.
Duncan returned to the hospital on Sept. 28 and was diagnosed with Ebola. The delay between those hospital visits could prompt lawsuits from anyone exposed in the interim, says R. Stephen Trosty, JD, MHA, ARM, CPHRM, president of Risk Management Consulting in Haslett, MI, and a past president of the American Society for Healthcare Risk Management (AHRM) in Chicago. "There was a clear misdiagnosis or missed diagnosis in the ER when the patient first went there. This raises potential liability issues for the hospital relative to the family and others who came in contact with him between the time he was improperly discharged from the ER until he was readmitted," Trosty says. "But you would have to show some damage resulting from this, although it could be any expense incurred, any lost wages, any resulting mental anguish. They might also have to show some accompanying actual loss, injury, or damage."
Trosty notes that Duncan’s family would have found it difficult to prove that the delay in diagnosis made a difference in the outcome. "The plaintiff would have to prove that medical malpractice occurred by showing that some standard of care existed, that it was not met, there was some injury, and the resulting injury was the proximate result of the failure to adhere to standard of care," Trosty explains. "In order to do this, it probably would be necessary to establish that his death was caused by the failure to admit him from the ER. With a disease that has a fatality rate of at least 50%, there would be a strong defense to that claim."
The exposure of the medical staff is another potential source of litigation. CDC protocols were changing rapidly, and the initial instructions to the Dallas clinicians plus the gear that was available proved inadequate.
"There is the potential issue of whether adequate protective gear and isolation policies existed, whether staff was adequately trained, and were [policies] adhered to," Trosty says. "This can directly relate to the issue of the percent of the body that was and was not covered by the protective gear. I believe that in this case, not all of the body, neck, and/or face were covered. This raises a potential issue of whether the proper policies existed."
Was hospital liable?
Because the protective gear later changed to cover the body more completely, and the CDC guidelines subsequently changed on this issue, it is difficult to know if a liability existed for the hospital relative to its existing policies and procedures and if it complied with existing CDC guidelines, Trosty notes. This situation opens up the issue of whether the hospital should have known better, if there were other places using more complete protective gear, and if hospitals can look to the CDC as the final word on protection.
"This issue could arise for staff personnel who contracted the disease as a result of treating the patient but who were not given the complete protective gear that should have been and subsequently was worn," Trosty says. "This could be a new area of actual or potential liability for the hospital and maybe even the CDC, but this is specifically, as of now, some unchartered legal territory."
Still another worry for risk managers is how Ebola could complicate efforts to comply with the Emergency Medical Treatment and Labor Act (EMTALA). A potential Ebola patient still must be stabilized even if transfer to a more capable hospital is appropriate, yet the extreme isolation needed could strain the abilities of some smaller emergency departments. (See the story on p. 126 for more on the EMTALA challenge.)
Another concern that has arisen is the potential for environmental liability. Transport companies that manage the disposal of hazardous waste for your hospital might be alarmed at the exposure and liability, says Maureen Archambault, RN, MBA, HRM, CPHRM, FASHRM, managing director and west zone healthcare practice leader for Marsh Risk and Insurance Services in Los Angeles. As a result, they might refuse pick up, or there might be delays while they consider options and establish a protocol.
"This is an area that can be easily overlooked in the planning stage," Archambault says. "Environmental services flies under the radar for most people, but it becomes a very important issue when you have highly infectious waste piling up in your hospital. The hospital is ultimately responsible for what happens to that waste, so it is important to work with your contractor beforehand to make sure they are capable of responding and that they won’t be caught off guard if this scenario develops."
The risk manager’s response to Ebola should follow the principles of enterprise risk management, Archambault suggests. Look at every potential outcome and assess your contingency plans, reaching far into the more mundane aspects of treatment and infection control that can determine a successful response. For example, when assessing your hospital’s ability to respond to Ebola or another infectious disease, don’t stop with confirming that you have an adequate supply of gloves, gowns, masks, and other gear, Archambault says. What will happen if you suddenly start going through that disposable gear at 10 or 20 times the normal rate? Do you have an adequate supply chain that can respond?
Even though Ebola is unlikely to hit any particular hospital, many of the same concerns apply to other infectious diseases. Taking the proper steps to prepare is akin to having good contingency plans for a fire, flood, or tornado, Archambault notes. The plans might never be used, but the consequences of not planning for that event are too great to allow complacency.
Liability will not arise until you actually have an Ebola experience and someone is damaged in some way, but even then the claimant would have to prove negligence, notes Gigi Norris, managing director with Aon Risk Solutions’ Western Region Healthcare Practice in San Francisco. What constitutes negligence with Ebola still is unclear because negligence is relative to the standard of care, she notes, and that situation has been changing from day to day.
"Even a lot of what we call negligence is really just bad luck. This poor hospital in Dallas was first, and everybody was caught short — not just the hospital, but the CDC, everyone," Norris says. "They were the unlucky first hospital, and we have to hope that everyone else learns from what they went through. It’s kind of black swan situation where you’re not going to see it very often, but if it happens to you, it’s a very serious issue."