Risk managers face a host of unanswered questions and potential liabilities as hospitals gear up for the smallpox vaccinations recently urged by advisors to the Centers for Disease Control and Prevention (CDC) in Atlanta.
The CDC’s Advisory Committee on Immunization Practices (ACIP) approved a plan that calls for smallpox immunization of some 510,000 health care workers. As outlined at the meeting, all hospitals should designate a "smallpox care team" that will be immunized prior to any release of the virus. ACIP recommends that the team include about 40 health care workers per hospital, including the epidemiologist, infection control staff, 15 emergency department physicians and nurses, eight intensive care unit (ICU) nurses for adult patients, eight pediatric ICU nurses, one infectious disease consultant, one dermatology consultant, four respiratory therapists, four radiology technicians, two engineers, and selected staff from the security and housekeeping departments.
"ACIP will provide guidance for developing a hospital care team prepared to respond and take care of the first smallpox patients," says Jane Siegal, MD, who advised ACIP on the issue as a member of the CDC’s Healthcare Infection Control Practices Advisory Committee. "[This is the] suggested composition of the team. I think individual hospitals have to look at that and look at the types of patients they see, the type of care they provide, and decide who will be [on the team]. This provides some guidance."
Health care risk managers will face a number of potential problems related to the smallpox vaccinations, says Gina Pugliese, RN, MS, vice president of the Premier Safety Institute in Chicago and a risk manager. Further guidance expected from the ACIP may make the job easier, but she says the smallpox vaccination will be a major undertaking for any hospital. For starters, risk managers should involve themselves in the multidisciplinary committee that will decide exactly which health care workers get vaccinated, Pugliese says. That group will be different at each facility, but she recommends thinking beyond just the obvious choices. Key security personnel and even some housekeeping staff might need to be included, she adds.
"There will be lots of issues to consider because we’re doing this for the first time," Pugliese says. "I wouldn’t waste any time before starting to think about these issues."
Employee furloughs could be the biggest and most immediate problem for hospitals, says Denny Thomas, director of risk management for St. Joseph’s Hospital in Marshfield, WI. Because employees could spread the virus to others for up to 19 days after vaccination, the hospital must take some sort of precaution. That most likely will mean sending the employee home with pay.
"In an industry that is already facing horrendous human resources shortages, this will greatly compound that," he says. "This is going to be a major project to implement, and there are right now a lot of questions about how to do it."
Pugliese and Thomas raise these points to consider:
- How will you screen employees for a history of eczema or immunosuppression, or for a current pregnancy, all of which can make them ineligible for the vaccination? If you don’t screen them properly and harm results, the hospital could be held responsible.
- Can you maintain confidentiality? If the employee or a family member is HIV-infected, for instance, you must know that before allowing the vaccination. Do you have a system for protecting that information?
- Informed consent must be obtained, but that means you must adequately disclose the potential complications from the vaccination. Remember that many people are wary of smallpox vaccination because of hype about the risks, so that could produce lawsuits from any adverse outcome. A hospital should protect itself up front with a thorough informed consent process.
- How far does the hospital’s potential liability extend? In theory at least, the hospital could be liable for harm extending far beyond its own employee. If the employee sheds virus in the days after vaccination and infects a family member or even a complete stranger, the hospital can be accused of wrongdoing for not taking adequate steps to prevent the transmission.
"We haven’t seen a case of smallpox on this planet in 25 years," warns Paul Offit, MD, ACIP member and infectious disease chief at the Children’s Hospital of Philadelphia. "Would it not be reasonable to put this system in place — make the vaccine and get it out there under lock and key, make guidelines [stating] clearly who should be vaccinated — [and then implement it] following a single documented case?
"If you immunize 500,000 people, there will be people who have serious adverse events. There will be contacts of [immunized] people who will have serious adverse events," he adds. "We will do more harm. I wonder if we could jump with a [safety] net a little bit by waiting for just the first confirmed case, but be ready when that happens."
However, other committee members warned that last year’s anthrax attacks showed how vulnerable the nation is to agents of bioterrorism. The prevailing opinion is the price of unpreparedness against smallpox would be immense. Offit’s was the only dissenting vote on the 12-member panel.
Risk managers face a host of unanswered questions and potential liabilities as hospitals gear up for the smallpox vaccinations recently urged by advisors to the Centers for Disease Control and Prevention (CDC) in Atlanta.
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