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Infection control also will have critical follow-up duties
Infection control professionals in the vast majority of hospitals in the country are expected to be offered smallpox vaccine as part of a new "pre-attack" bioterrorism response plan to vaccinate some 510,000 health care workers. Approved Oct. 16, 2002, by advisors to the Centers for Disease Control and Prevention (CDC), the plan cites ICPs and hospital epidemiologists as key members of an immunized "smallpox care team" to be formed at virtually every acute care hospital in the nation.
The CDC’s Advisory Committee on Immunization Practices (ACIP) approved a plan that calls for smallpox immunization of roughly 100 health care workers per hospital. ICPs are considered critical members of the smallpox care teams.
"It would be really up to the hospital as to how many infection control people they want to vaccinate," says Jane Siegel, MD, who advised ACIP on the issue as a member of the CDC’s Healthcare Infection Control Practices Advisory Committee. "But the infection control professionals are absolutely key in the first response." Asked if that means at least one ICP should be immunized in every hospital in the United States, she said, "I would say so."
In an example team composition listed at the meeting, ACIP recommended that the team include at least a core group of 40 health care workers per hospital, including the hospital epidemiologist and infection control professional(s). The list cited 15 emergency department physicians and nurses, eight intensive care unit (ICU) nurses for adult patients, eight pediatric ICU nurses, a dermatology consultant, four respiratory therapists, four radiology technicians, two engineers, and selected staff from the security and housekeeping departments. In allowing for backup personnel, vacations, and such, the 500,000 figure essentially projects about 100 workers per acute care hospital. Of course, the numbers will vary by hospital and local policy.
"ACIP is providing guidance for developing a hospital care team prepared to respond and take care of the first smallpox patients," Siegel says. "[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 it will be [on the team]."
William Schaffner, MD, chairman of the department of preventive medicine at the Vanderbilt University Medical Center in Nashville, TN, has previously expressed concerns about vaccinating too many people because they may transmit the vaccinia virus to those contraindicated for the vaccine. A liaison member of the ACIP committee representing the Infectious Disease Society of America, he says the recommended strategy is a "walk-before-you-run" approach that involves immunizing workers over time. "If we do this deliberately and carefully, we can do it as safe as possible," he tells Hospital Infection Control. "We don’t want to start a huge program immediately. We’re going to have to learn to do it right before we expand it, so I hope there is a gradualist approach."
As a result, state and local health departments may be in the vaccination business for a long time, gradually vaccinating workers so that hospitals are not beset with personnel losses due to side effects. That means ICPs not only will be offered vaccine, but will be involved in the ongoing work practice policies, Schaffner notes. Data presented at the meeting indicate vaccinated people typically feel worse about seven to nine days after smallpox immunization, and thus that time period is the most likely to require administrative leave. If health care workers feel alright, they may work after vaccination if the "take" site is carefully bandaged and covered by a shirt sleeve, the committee indicated.
"I think that’s a good decision. But they will want to stagger those [potential] absentees out," he says. "It looks like to me, in large communities, this could involve steady vaccination activities over a year or more. It puts a lot of responsibilities on hospitals to select people, help them with their education, screening and monitoring them afterward. Tending to all the infection control implications will require an additional effort on the part of infection control and occupational health people for a substantial period of time."
Will ICPs step forward to be immunized? Given the potential adverse effects, it will not be an easy decision for some. Others are ready to roll up their sleeves. "This is in keeping with what we do," says Judith English, RN, MSN, CIC an ICP at the National Naval Medical Center in Bethesda, MD. We will be in the first group of people. I was vaccinated as a child, so they only need to stick me two or three times [with the bifurcated needle for revaccination.]"
Indeed, health care workers with a history of prior smallpox vaccination should be given preference for selection to the hospital care team because they are less likely to have serious side effects, Siegel points out.
Similarly, ICPs with a history of smallpox vaccination as children may be less reluctant to be immunized. One such ICP is Barbara Ann Hohf, RN, infection control coordinator at St. Mary’s Hospital in Passaic, NJ. "I also do disaster medical assistance and work in the ER on per diem," she tells HIC. "So my thought is that I would take the vaccine so I could be a resource for the hospital. The problem with the vaccine is there are a lot of contraindications — those with autoimmune disease such as lupus, rash [problems] — and all of that. If you look at the nursing force that is out there today, we are all over 40 and most of us have some sort of chronic medical condition."
At least 20% are out
In discussion of the issue, ACIP estimated that about 20% of Americans are contraindicated for smallpox vaccine because of various immune deficiency and skin conditions. That would include health care workers, and there is some question of how many will step forward to join the hospital care teams.
"I usually pride myself on having a reasonably clear crystal ball about how a program will be implemented and what sort of success it will have," Schaffner says. "I’m absolutely perplexed at the moment. I have no idea whether we will have few volunteers, many volunteers, or something in the middle. It may vary from hospital to hospital." For his part, Schaffner is ready to volunteer for smallpox immunization. "I qualify on every score. I work with the state health department in infection control; I’m an older infectious disease physician who was previously vaccinated; and I’m one of the few people in my neck of the woods who has ever seen smallpox."
In making the recommendation, the committee was well aware of the possible adverse effects of giving people vaccinia virus (cowpox) to protect them from variola virus (smallpox). Progressive vaccinia, a potentially fatal complication of vaccination, has occurred almost exclusively among immunocompromised people. Approximately 15% to 25% of vaccinees who develop postvaccinal encephalitis die, and 25% have permanent neurological sequelae. Most deaths caused by vaccination are the result of postvaccinal encephalitis or progressive vaccinia. Overall historical death rates are approximately one death per million people on initial vaccinations and 0.25 deaths per million revaccinations. The decision to immunize 500,000 people against a disease that no longer occurs in the wild was worrisome to some.
"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. 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 was that the price of unpreparedness against smallpox would be immense. Offit’s was the only dissenting vote on the 12-member panel. With abstentions for various conflicts of interest, the vote was 8 to 1 in favor of the plan. "If there is not a case of smallpox, we will be doing more harm than good," Offit says. "I guess at this point, we don’t know whether or not there will be a case of smallpox. This is like a case study in how terrorism works."
The CDC recommendation awaits the approval of the Department of Health and Human Services and top government officials, who have been mulling the pros and cons of immunizing all or portions of the populace. However, the tone of discussions at the ACIP meeting indicated a full expectation that the government is preparing to move ahead with smallpox immunization of health care workers. The process of licensing the vaccine is expected to be completed by the end of the year, and health care immunizations may follow early next year, committee discussion indicated.
"We’re anticipating — since licensure seems to be close — that none of this vaccination will start until the vaccine is licensed," Siegel says. "I think if it was going to be a long time and the president made his decision [to go ahead], we have been operating under the idea that we would start under an IND [investigational new drug]."
The hospital recommendations are designed to complement, not necessarily replace, previous ACIP recommendations to immunize state-based smallpox response teams. Although the June 2002 recommendations have yet to be approved by the government, the end result is expected to be some combination of immunizing public health response teams and hospital-based teams. What the CDC clearly is moving away from is the concept of "designated" smallpox hospitals. In addition to logistical concerns with that plan, there was little interest among hospitals in volunteering for the duty, ACIP discussions revealed.
However, there remains some confusion because the new ACIP recommendations come with an emphasis that hospitals with negative-pressure rooms (i.e., for tuberculosis or measles patients) should place a particular emphasis on immunizing staff. As a practical matter, however, most would concede that people with smallpox are not going to be calling ahead to determine which facilities have negative-pressure rooms.
"Not every hospital, but most hospitals do have an airborne infection isolation room," English says. "Realistically, people will go to the place that they feel is their primary care provider. They will not [follow] an instruction and go to a certain place. They may not know what they have, and it is unrealistic that they would go to a designated health facility."
In addition, hospital architectural groups are advising that all newly constructed and renovated acute-care hospitals have an airborne infectious isolation area in their triage area of their emergency department.