Flu vaccine shortage creates ethical issues, safety challenges

Quality managers on interdisciplinary committees make hard choices

Even though the flu vaccine shortage has yet to have an impact in terms of an anticipated surge of patients, quality managers and other hospital professionals already are feeling its effects. Tough decisions are being made every day, and they're not always restricted to patient and staff safety issues.

"We had a powerful and positive decision to make in terms of ethics," says Janna Hoff, RN, BSN, MSA, director of quality management at William Beaumont Hospital in Troy, MI. Like many hospitals across the country, William Beaumont found itself short of flu vaccines, but its situation was unique.

"We were 400 doses short," she says. "We had earmarked for patients the shots that were coming from Chiron [the manufacturer whose vaccines were recalled], and those for employees were from another [manufacturer]." The result: There was an adequate supply for staff but only 50 shots for patients. "That was a huge rub," Hoff explains.

St. Vincent Medical Center in Portland, OR, faced another ethical dilemma, reports Nancy Church, RN, BSN, CIFC, infection control manager.

"The ethical question is: What if we have more patients arrive than we have space for, and then we get more from the area nursing homes? On any given day, if we have 50 extra people come in, we will have a world of hurt; we won't have enough available staff or beds for the patients," she explains.

The other ethical challenge Church faced, she adds, were which patients and staff to immunize first, given the shortage.

Decision made by committee

In the quality department at William Beaumont, patient safety is part of the quality committee. So, in facing the ethical dilemma posed by the shortage, "We wanted to ensure the highest-risk people received immunization," Hoff explains.

"We sat down with employee health, inpatient services, nursing, and our infection control physician and hammered out an agreement on an initial allocation of these shots. We took a look at what we anticipated for use, generously thought what we would need for patients and put that aside, then took the remainder and assessed its use for staff," she continues. "We further agreed that in a month we would look at what we had left."

It was, Hoff says, "a total struggle every step of the way," with employee health, for example, arguing for more employee doses so there would be adequate staff available to treat patients.

In terms of patient care, the vaccine slush fund, she notes, "is the best part of what we did. It's a variable pot, so if we have a real influx of patients, we would move it over to the patient side. This variable pot of doses helped us be responsive to those who needed the vaccine the most."

Part of the response at Providence was aimed at avoiding the necessity of making those tough ethical decisions.

"We were not planning to [immunize] patients here, but we did have a plan to do employees," Hoff explains. "Last year, we gave over 2,300 doses; this year, we started out with 750, which has increased slightly since. Still, we are also trying to get some out to high-risk areas like nursing homes."

If the potential influx of such patients is not curtailed to some degree, she notes, "we may have to triage them to comfort care, since there are only so many people we can hold. That's why, after setting up a meeting with our intensivists, we decided to try to get to those pockets first."

An ethicist sat on the Providence committee that determined exactly how the scant supply would be apportioned, Church says.

"Some doses were sent off right away to high-risk areas - we identified clinics where they treat HIV patients, and a bunch went to dialysis patients, so we are immunizing patients who don't belong to us," she points out. "We're keeping a list of those facilities who call in and say they do not have any for their high-risk patients, such as the homebound and nursing home patients."

The committee approach to such issues makes sense, says Judy Homa-Lowry, RN, MS, CPHQ, president of Homa-Lowry Healthcare Consulting in Metamora, MI.

"It should be a collaborative event with infection control and patient safety both involved," she asserts.

Providence also is making some vaccines available for outside specialists, such as neonatologists, Church says. "We want to make sure we have some services available; it is most critical to have the staff to care for the patients," she notes.

Homa-Lowry adds that, in terms of those patients who are in the hospital, "You should have a way in the census to identify who would be at higher risk - the elderly or the young, those predisposed to respiratory conditions, and so on. You might also go to case management and to your physicians to examine comorbidities - and make sure the hospital is supportive of your decisions."

Who gets immunized?

This, in turn, leads to another dilemma: Which staff should be immunized? In addition to ethical and quality considerations, there is a set of guideline available from the Centers for Disease Control and Prevention (CDC) at www.cdc.gov/flu.

"We really stepped back to what the CDC was recommending - their revised guidelines - and this is what we are actually going to follow," says Hoff. "You can't make a better decision than them."

The key question to address is, "How do you define `direct health care workers' who give hands-on patient care?" she notes. (Part of CDC's newest guidelines.)

"We said, `If you are in close enough proximity that you can reach out and touch a patient three times a day, we consider you a direct caregiver,'" Hoff explains.

"We also instituted an immunization assessment form; we had to design it for our pneumonia core measure," she continues.

In light of the CDC's revised guidelines, the staff changed the assessment form to match the CDC criteria exactly. "We will start screening using the revised criteria until we run out," Hoff adds.

At Providence, the initial cut of immunized staff was the emergency department (ED) - people from 0.6 full-time equivalent (FTE) to one FTE. "We also immunized ED docs, nurse practitioners, and CNAs [certified nursing assistants] who would work there, as well as respiratory therapists, hospitalists, and the residents," says Church.

Any such method of prioritization is bound to create angst among the employees not chosen to receive the vaccine, she adds.

"We initially told them to get shots at local shopping centers, but some were unsuccessful, and then the state started putting restrictions on who could get it," Church notes.

"So, we got together with two other hospitals and defined the population to be immunized in the first two weeks." Now, all three hospitals in the Portland service area use the same guidelines. "This helps limit the anger of the employees," she adds.

According to Homa-Lowry, there's a legal limit as to how much you can really know about the conditions of individual employees.

In fact, while many of the important decisions will be made based on ethics, ultimately they probably will need to be blessed by your attorneys, she says.

"I know of a hospital where some of the people were able to get in and get the vaccine before the shortage, but they were nondirect health care workers," Homa-Lowry adds.

"It's almost more like a legal issue - how do you cut the number [of people getting the vaccine] down if there was a real need? I think it might involve a committee that really does not typically get used - the bioethics committee. But once a decision has been made there, it will probably need to be reviewed by the hospital legal team so it is not seen as a discriminatory process," she continues.

The best-laid plans . . .

Despite optimal planning, the bottom line is that the shortage remains, and at some point, there will be no more vaccines available. "We anticipate we'll be out in the middle of the season," Hoff predicts.

Is there anything else quality managers can do to minimize the impact of the shortage? Other preventive measures may help, she says.

"We immediately put an article in the hospital newsletter about the shortage, explaining the CDC criteria and other employees who would meet our criteria - such as an asthmatic nurse," Hoff says.

"But for patients or employees who can`t get the shot, we provide tips to avoid influenza - hand washing, covering your mouth, respiratory hygiene, and so on. We stress to staff that if they are not in the high-risk group, they should just practice the avoidance techniques we've give them," she adds.

And beyond that?

"I get the feeling it may be a mild flu season, but we have a pandemic plan in place and would implement it if we needed to," Hoff notes.

"Who knows what kind of flu season we will have?" Church adds.

"If we have a big one, it will bring up a whole list of issues. We would have the ethicist there; at what point do you say, `We will let you in, but we won't let you in? It's a decision we can't make," she points out.

Providence also is stressing respiratory etiquette to those staff not receiving the vaccine, including wearing masks and teaching patients to cough into tissues.

"We've got a big push all over the hospital and signage asking visitors who are ill [with the flu] not to come in," Church adds.

If it is a bad flu season, she continues, one important element will be missing.

"The National Guard is all in Iraq, and they are the most well-trained people," Church says. "They have the ability to run massive drills, and they could have been a huge resource for something like this."

Need More Information?

For more information, contact:

Judy Homa-Lowry, RN, MS, CPHQ, President, Homa-Lowry Healthcare Consulting, 560 W. Sutton Road, Metamora, MI 48455. Phone: (810) 245-1535. E-mail: homalowry@earthlink.net.

Nancy Church, RN, BSN, CIFC, Infection Control Manager, St. Vincent Medical Center, Portland, OR. Phone: (503) 216-4955. E-mail: nancy.church@providence.org.

Janna Hoff, RN, BSN, MSA, Director of Quality Management, William Beaumont Hospital, Troy, MI. Phone: (248) 964-5089.