Hospitals & Health Networks magazine
Monday May 12, 2003

To Be or Not to Be Vaccinated:
The Smallpox Controversy Plays Out in California Hospitals

By Jan Greene
Nestled at the foot of southern California's dramatic San Gabriel Mountains, a stone's throw from Santa Anita Park racetrack and blocks from the 210 Freeway, Methodist Hospital sits in a pleasant neighborhood of well-tended lawns and palm trees. It's hard to imagine bioterrorists choosing Arcadia, Calif., as a launching point for smallpox.

But world events have forced Methodist Hospital to confront the frightening possibility, and the hospital was among the first in the nation to offer staff volunteers for the controversial smallpox vaccination program. "We felt it was our duty," says Pauline Lopez, an infection control practitioner and organizer of the vaccination campaign at Methodist, a 297-bed community not-for-profit. "There are a lot of ways a terrorist could strike, but this is one we can prepare for."

Methodist, like every other hospital in the nation, had a short time frame in which to weigh a whole host of questions about the vaccination program: Will employees want to volunteer? What are the risks of the smallpox vaccine? Can a vaccinated worker infect another employee or a patient in the weeks after the vaccination? If someone has a bad reaction, who pays for time off and medical care?

At Methodist, the planning began last December, when the Bush administration announced it would ask hospitals to provide names of staff volunteers to be immunized so they could care for smallpox victims in case of an outbreak.

The hospital assembled a task force including infection control, the hospital's safety officer, the vice presidents of nursing and support services, a physician and a nurse manager from the emergency department, and representatives of occupational health and human resources. The group gathered information from sources such as the Centers for Disease Control and Prevention (CDC) and Naval Medical Center San Diego, which was conducting a military-sponsored vaccination program. They were encouraged by what they heard: the Navy had a low complication rate, and the vaccine's risks could be managed without an undue amount of clinicians' time off.

Methodist's planners weren't scared off by worries about liability for bad reactions to the vaccine. They figured that by screening out staffers with risk factors--such as a skin or heart condition or an infant at home--reactions could be kept to a minimum. They decided to allow people who needed time off because of the vaccine to take their regular sick leave. They also decided to take the CDC's advice and not require furloughs or keep staffers away from work for the two to three weeks it might take for the vaccination site to stop being infectious. If the site is covered with dressings and a long-sleeve shirt, it should pose no risk, CDC guidelines say.

It didn't take long for the task force to send a "go" signal to CEO Dennis Lee, who agreed that the vaccinations should take place. "I don't even recall making a decision," Lee says. "It just naturally happened because that's a part of who we are. It's a part of our culture here to carry out our responsibility to the community." Methodist leaders expect their only costs to be sterile dressings and staff time to conduct a solid educational campaign.

Lee acknowledges that not everyone at the hospital agrees with the decision to participate in the vaccination program. "There are people in this organization who feel this is an unnecessary thing to do and an unnecessary exposure to risk," he says. "But we see the risk as small."

After a series of staff education sessions led by Lopez and Emergency Department Manager Catherine Kaliel, about 60 people volun- teered, their confidentiality protected by dropping off a form in a designated box or calling a hot line. Kaliel and Lopez were careful to protect everyone's privacy, but the smallpox question was soon a hot topic of conversation. "Among themselves they've been very open," Kaliel says. "They debate it back and forth: 'Why are you doing that?'"

Kaliel and Michael Agron, M.D., medical director of emergency services, opted to get the immunization. "All of us taking care of patients on the front line are most likely to get exposed" in an outbreak, Agron says. "That's an easy decision for me." The vaccinations began on March 4. One dose of the vaccine is effective for about 10 years.

Cathy Klose, R.N., the hospital's coordinator of health ministries, says she chose to be vaccinated because she would want to help sick people in case of outbreak. She is confident the government wouldn't ask health care workers to get inoculated if it weren't important. "In my heart I can't believe they would advocate or have us do something that was not safe," Klose says. But the feeling is far from universal. Kevern McCarthy, R.N., signed up for the vaccination initially, but changed her mind later when she heard about the numbers of nurses nationally who had chosen not to participate. "Obviously, if there's an [outbreak], we'll all do it," McCarthy says. "It just seemed like an unnecessary risk at this time."

A Different Conclusion

Methodist's smallpox inoculation planners won't criticize hospitals that choose not to participate, but they would like more health care organizations to have immunized staffers on hand in case of emergency.

"I'm kind of disappointed so many hospitals have taken a stand against allowing a voluntary program like this," Agron says. "There have been a lot of concerns about the financial impact on the hospitals. But I don't remember there being a [rule] that the [chief financial officer] has to approve the programs that fit within the hospital's mission statement."

One hospital that declined to participate was Huntington Hospital in nearby Pasadena. Huntington and Methodist share a governing board; the two work together on contracting and some other business functions but operate independently.

Like Methodist, Huntington's leaders set up a multidisciplinary group to decide how to respond to the vaccination program. The group arrived at the opposite conclusion from Methodist. "Cost was one factor that played into our decision--along with the fact that the perception of threat didn't feel it was there to justify this kind of risk-taking," says Mary Mendelsohn, infection control coordinator.

It was Huntington's analysis of the scientific and legal issues that drove its decision. Huntington's leaders were concerned about paying for time off for complications from the vaccine and questioned whether the state workers' compensation program would cover employees with more severe reactions. They also worried about newly vaccinated staff members passing an illness called vaccinia to patients. "All the directions say it's not an issue if you have the site covered. But we haven't put that to a widespread test. And we have a much different population today," Mendelsohn says, noting that more of their patients live with compromised immune systems.

Another obstacle at Huntington was lack of enthusiasm among the staff. "People are not interested," Mendelsohn says. "Had we said 'yes' and gone full-bore, I'd be lucky if I had a dozen people [volunteer]." But she's comfortable with the decision that her sister hospital made. "We just had key people with different viewpoints," Mendelsohn says.

Part of the difference may lie in how likely it is that the region will ever see a case of smallpox. Huntington's leaders believed that risk wasn't high enough to put its staff through an immunization program, while those at Methodist could imagine a traveler exposed to the virus falling ill on the nearby 210 Freeway and ending up in their ED. Kaliel has attended some national emergency preparedness meetings and expects the worst. "When it comes to terrorism, it's not a matter of if, but when," she says.


Jan Greene is a writer based in Alameda, Calif.

Exploring the Issues
The nation's hospitals, handed the same set of facts about participating in the federal smallpox inoculation program, have come to surprisingly different conclusions about how to respond.

Some decided the risk of the smallpox vaccine outweighs the benefit of having front-line hospital workers vaccinated against the disease, and publicly declared they will not participate. Others, citing civic duty, are pushing ahead, providing lists of volunteers to local health departments that are coordinating the inoculations. Another group of hospitals has agreed to participate, but is being stalled either by a state or local health department that is not ready, or by the lack of willing volunteers on its staff.

As of Trustee's press date in early April, the Centers for Disease Control and Prevention (CDC) was recommending that people with known heart disease or with three or more cardiac risk factors be excluded from the voluntary immunization program while it gathered more information on reported cases of cardiac adverse events following immunization. The CDC sent updated information on the program to states on April 2.

When all is said and done, only about one-third of the nation's hospitals are participating in the early stages of the government's smallpox vaccination program, estimates Jim Bentley, senior vice president for strategic policy planning at the American Hospital Association. The rest either will not or cannot participate. "It is moving very slowly right now," Bentley says.

Those declining to do it cite a host of reasons. Many say they don't believe the threat of bioterrorism is great enough to justify using a risky vaccine on healthy workers. Northwestern Memorial Hospital, Chicago, is ready with a list of volunteers to be vaccinated but won't move forward until its leaders see a definite smallpox threat. "It's very difficult to think of vaccinating people against a disease that does not exist in the world today," says spokeswoman Kelly Sullivan. "The risk of the disease is zero. The risk of vaccinating people is not zero." Others worry about the risk of passing the illness to patients from employees who have been inoculated. Some are stymied by resistance from labor unions; Kaiser Permanente, based in California, halted its planned vaccinations in late February to resolve labor's concerns about compensation for employees who experience physical reactions to the vaccine.

The number of hospitals offering volunteers is likely to increase if the vaccination program continues with a low number of severe reactions or transmissions of disease. Reluctant hospital staffers may also feel better if the federal government creates a compensation fund to cover severe reactions or deaths caused by the vaccine. The Bush administration has proposed a plan that would pay $262,100 to health care workers (or their survivors) killed or disabled by the vaccine and would give workers some lost wages and reimbursement for medical expenses in less serious cases.

Some hospitals that jumped right in say they saw participation as being linked to their mission to serve the community, and were able to resolve liability concerns. "We asked ourselves, 'How are we going to provide the care if we don't participate in the program?' " says Nancy Posey, loss control director for 26-hospital system Sutter Health, Sacramento, Calif. "With that decision kind of out there, the rest of the questions are logistics or operational."

The system then researched time off and liability issues. Sutter checked with its workers' compensation and health insurance carriers to be sure employees would be covered if they suffered a reaction. Risk managers determined that a flood of patient lawsuits would be unlikely because officials would take care to protect patients from workers who might be infectious, and because a federal law provides immunity to hospitals and health care workers participating in the smallpox program.

Sutter decided the medical risks were also relatively small. Risk managers sought guidance from an advisory committee for immunization practices in the CDC.

Kaiser Permanente decided on behalf of its vast national medical network to participate, but only after an analysis by a relatively new part of the organization known as the Department of Healthcare Continuity. The department had already formed several work groups to deal with biological emergencies, and they were ready to go when the government announced the smallpox vaccination program. "We decided that it is in the best interest of our staff and members and communities we serve that we go forward and participate in Phase I on a voluntary basis," says Skip Skivington, director for health care continuity for Kaiser Permanente.

Unlike Sutter, which had a relatively easy time deciding to participate, the risk-benefit equation wasn't simple for Kaiser. But the organization ultimately accepted the federal government's opinion that the risk of bioterrorism is real. "We have to accept the risks even though they're not all clear," Skivington says. "We're going into uncharted waters."--J.G.

This article 1st appeared in the May, 2003 issue of Trustee Magazine.