July 1, 2012 marks the deadline for full implementation of IC.02.04.01, which requires hospitals to offer vaccinations against influenza to all hospital staff, including members of the medical staff (“Licensed Independent Practitioners” or LIPs), and to establish incremental goals to achieve a 90% vaccination rate by 2020.
The new standard does not mandate vaccination; rather, the standard requires organizations to either vaccinate staff members or require staff members to submit a declination. Organizations are then encouraged to add these two groups—vaccinated staff and staff who submit a declination—together and use this number as the numerator in calculating vaccination rates.
To meet the new standard, hospitals have two choices: take the simpler road and comply with TJC standards by maintaining voluntary programs that count actual vaccinations and declination forms equally or take the more difficult road and mandate vaccination as a condition of employment.
The Option to Decline
There is no requirement that a declination be based on a medical or religious rationale. Healthcare personnel can submit any reason for declination, and hospitals are required to collect and analyze the reasons given. The theory is that once hospitals understand the reasons healthcare personnel are declining, vaccination rates can be significantly improved by addressing these reasons; however, experience shows this approach has not been effective.
Voluntary programs have historically sought to increase vaccination rates by ensuring that the vaccine is conveniently available and free of charge, and by providing influenza-prevention education and incentives or rewards to improve participation. Many voluntary programs include the use of signed declination statements coupled with education about the benefits and risks of being immunized. These programs rarely achieve more than a 60% vaccination rate.
Mandatory Vaccination Programs
Mandatory vaccination is not a new idea. Schools have long required certain immunizations for entry, and healthcare institutions often mandate tuberculosis screening and testing as a condition of employment.
Advocates of a rigidly enforced mandatory vaccination program cite the overwhelming scientific evidence supporting vaccination as the most effective preventive measure available against influenza. Vaccination of healthcare personnel has been shown to prevent numerous illnesses, deaths, and losses in productivity, as it has been noted that there is no “magic number” for herd immunity (or population immunity) in a healthcare institution. One person with an infectious case can spread the disease; however, high rates of actual vaccination significantly lower the risk to patients.
Critics believe that mandatory programs infringe upon civil liberties; however, states do have the power to require immunization if it is necessary for public health or the safety of the people. Ironically, many healthcare personnel do not object to being vaccinated—they only object to the “mandatory” part. Many view free influenza vaccinations given at a convenient time in a convenient location as a benefit.
First, Do No Harm
One idea that isn’t up for debate is that an influenza vaccination supports the basic ethical principle of medicine: “First, do no harm.”
Patients should be able to expect that healthcare personnel will not inflict avoidable harm in the course of delivering care and treatment. Even though healthcare personnel may be reasonably healthy and able to avoid becoming seriously ill from influenza, many of their patients are vulnerable to severe complications from influenza viruses carried and transmitted by unvaccinated workers.
The Decision to Mandate
Despite the scientific and ethical rationale for influenza vaccinations, hospitals remain reluctant to adopt mandatory vaccination programs for many reasons.
First, the practice of terminating healthcare employees over refusals to be vaccinated just doesn’t seem to make sense for the employee or the organization, especially when critical shortages exist in key clinical positions. Additionally, the work required to develop and implement a well thought-out program—including review and approval of medical and religious declinations—is intensive and resource consuming. Finally, a decision to implement a mandatory vaccination program must have the full support of hospital leadership.
Once a hospital commits to a mandatory vaccination program, there are several key points to consider when developing and implementing the plan:
- There must be clear, consistent, ongoing messages regarding the details of the plan. The plan must be publicized at all levels on a regular basis.
- Each plan must be individualized to the organization, with consideration of any potential language barriers; available financial, clinical, and educational resources; and the culture of the organization.
- Education programs must include information about the influenza vaccination and the organization’s plan. Ideally, educational sessions should include a “question and answer” component.
- Vaccines must be offered free of charge, and both vaccinations and education must be provided at convenient times and locations. The organization should consider expanding the available hours to receive the vaccine and increase the number of locations where the vaccine is given, including various “gathering” places within the organization.
- Declination forms should be universal with defined acceptable medical and religious exemptions, as well as any other exemptions the organization is willing to grant. Such forms are more effective, concrete, and uniform than simply requiring a note from a physician.
- The plan must include clear guidelines for the management of staff who have been granted exemptions through the declination program during the influenza season. For example, will these employees be restricted from patient care or required to wear a mask while performing patient care? Who will be responsible for ensuring exempted employees comply with the guidelines? What are the consequences for noncompliance? What process will be used to identify ill healthcare personnel?
As hospitals increasingly adopt mandatory influenza vaccination programs, more information will be forthcoming regarding strategies that are most often associated with successful programs. For now, the considerations outlined above provide a framework for organizational discussions regarding which approach the organization will take to comply with the new standard by July 1, 2012.
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