Influenza is the most common cause of vaccine-preventable deaths, with associated mortality contributing to approximately 24,000 deaths annually nationwide.1 The annual economic burden of influenza-attributable illness in the United States is estimated to be $87.1 billion, which includes $10.4 billion in direct medical costs for hospitalizations, primary care provider visits, and medications; lost productivity from work absences and death comprise the bulk of the economic burden.2 In 2010, the CDC expanded its influenza vaccination recommendation to include all persons age 6 months and older who don't have contraindications to the vaccine; the previous recommendation for adults had only been for those individuals at high risk and those older than age 50.3
Healthcare providers work in an environment where the potential for exposure to vaccine-preventable illnesses may be routine, thus putting patients, their families, and other providers at risk. The CDC recommends that all eligible healthcare personnel (HCP) receive an influenza vaccine annually.4 Influenza vaccination of healthcare workers has helped reduce staff illness and absenteeism, and improve patient outcomes and organizational cost savings.5 Reports indicate that 77.3% of U.S. HCP received the influenza vaccination during the 2014-2015 season, and 75.2% during the 2013-2014 season.6 Although this is a positive trend, it's far below the Healthy People 2020 goal of 90% healthcare workforce vaccination on an annual basis by the year 2020.7 Here, we'll describe the development, implementation, and evaluation of an influenza vaccination policy with masking requirements for unvaccinated HCP at a cancer treatment center.
Influenza infection is a potential cause of additional morbidity and mortality in patients who are immunocompromised because of cancer or its treatment. Because this is an especially vulnerable population, this project took place at the Cancer Treatment Centers of America (CTCA) at Southeastern Regional Medical Center (SERMC) in Newnan, Ga., which is a facility that treats adult patients with complex and advanced-stage cancers. SERMC includes 50 inpatient beds, surgical suites, radiation and infusion therapy departments, an outpatient clinic, an urgent care center, a rehabilitation and physical therapy department, and onsite residential accommodations for outpatients and their families.
This project aimed to increase the coverage rates of influenza vaccination of HCP at SERMC to greater than or equal to 90%, thus meeting the Healthy People 2020 immunization goal and potentially reducing the transmission of influenza. Since opening in August 2012, HCP vaccination rates are as follows: 70.1% in 2012-2013, 75.6% in 2013-2014, and 69.8% in 2014-2015. HCP are classified as all employees, licensed independent practitioners (LIPs), students, volunteers, and contractors, regardless of clinical responsibility or patient contact.
Multiple organizations recommend mandatory influenza immunization programs for HCP as a condition of employment, professional privileges, or voluntary services. Positions on mandatory vaccination are endorsed by the Association for Professionals in Infection Control and Epidemiology, the Infectious Diseases Society of America, and the Society for Healthcare Epidemiology of America.8-10 To date, less than half of all states have influenza vaccination requirements for HCP, and the scope of the requirements vary greatly.11 For instance, some states only require that employers offer the vaccine to HCP, whereas others require written declination from HCP who refuse vaccination. Some state-level requirements have incorporated stricter policies; New York, for example, requires unvaccinated HCP to wear a surgical or procedure mask when the health commissioner determines influenza is prevalent.
The principal investigator (PI) is in an employed role at SERMC as the director of education and led this project to fulfill degree requirements as a doctor of nursing practice student. After considering options and the diversity among the healthcare workforce at SERMC, the PI proposed a masking requirement for HCP who declined influenza vaccination for the 2015-2016 season. This allowed organizational leaders to preserve individual rights to choose to be immunized, while protecting patients, their families, and staff from potential exposure to influenza from unvaccinated HCP. In August 2015, the executive team received an implementation plan, which included developing an influenza vaccination policy with consequences for noncompliance. This policy required that HCP receive an annual influenza vaccination or, if they declined, wear a mask at all times during a scheduled shift throughout the duration of the influenza season, beginning December 1, 2015. According to influenza surveillance data for the state of Georgia, influenza-like illness typically peaks to high activity levels in early December.12 The target population included all employees, LIPs, contractors, volunteers, and students, regardless of clinical responsibility or patient contact, working at SERMC for at least 1 working day between October 1, 2015, and March 31, 2016.
Initially, executive leaders expressed concern about approving a masking requirement for unvaccinated HCP. Naturopathic medicine is an important part of the integrative care model at CTCA, and vaccination has historically been a controversial issue for some naturopathic providers.13 After reviewing the evidence related to benefits of improving HCP vaccination rates, leaders voted in favor of implementing a masking requirement for unvaccinated personnel during the 2015-2016 influenza season.
Institutional Review Board approval of exempt status was granted for the vaccination initiative. The existing SERMC policy “Immunization Requirements for Healthcare Workers” was revised to include a section specific to the influenza vaccination and facemask mandate for unvaccinated HCP. Policy revisions were approved by the quality committee, which consists of leaders from nursing, medical, and ancillary departments. SERMC's president and CEO e-mailed all personnel, announcing the policy requirements for those who declined vaccination. A consent/declination document was created, along with an informational handout about SERMC's 2015-2016 influenza vaccination program, a badge identifier sticker, and signage informing patients and visitors of the new HCP masking requirement to prevent the spread of influenza from unvaccinated personnel.
A campaign team of staff from occupational health and infection prevention held a kick-off event to generate support, awareness, and enthusiasm, as well as to remind HCP of the importance of vaccination and policy requirements for noncompliance. As with previous vaccination seasons, an influenza vaccine was provided at no cost to HCP directly employed by SERMC, as well as to volunteers. All HCP were required to do one of the following: sign a consent to receive the influenza vaccination at SERMC, provide documentation of receiving the vaccine through another provider, or complete a declination statement that identified the reason for refusal. Before signing the consent, education was provided to all individuals, along with a copy of the CDC's Vaccine Information Statement. For individuals who declined the vaccine, educational material specific to SERMC's vaccination policy was provided, which included questions and answers regarding the masking requirement and guidelines for properly applying the mask. Declination forms were used to identify what proportion of staff were reached and offered the vaccine, and assist in further educational efforts. HCP received a sticker to place on ID badges at the time of vaccination or upon presenting documentation of vaccination received elsewhere. This identifier indicated that they had received the vaccine for the current influenza season. For the first 6 weeks, mobile carts were used during all work shifts to take the vaccine to individuals in their respective departments, affording the opportunity for face-to-face interaction with providers and an opportunity to further educate staff and answer questions.
Influenza vaccines were preordered in February 2015, with anticipated delivery in mid-September 2015. The campaign team worked with the SERMC pharmacy department to order additional vaccines for the 2015-2016 season. The inactivated quadrivalent single-dose vaccines available to HCP included the I.M. vaccine (age 3 to 18) and the intradermal vaccine (age 18 to 64). The inactivated vaccine is contraindicated in patients who are severely allergic to components of the vaccine, including egg proteins, and for individuals with a history of Guillain-Barré syndrome within 6 weeks after receiving the vaccine. The recombinant trivalent vaccine was available for HCP age 18 and older with allergies to egg products. Another available option was the live attenuated quadrivalent intranasal vaccine (age 2 to 49), approved for individuals who aren't pregnant, allergic to eggs, or immunocompromised. The live attenuated vaccine isn't recommended for providers who care for severely immunosuppressed patients who require a protective environment, therefore, it wasn't given to providers working on the stem cell unit. The inactivated trivalent multidose vaccine was also ordered as a back-up plan if the demand exceeded supply, or in case the other vaccines were delayed.
On December 1, mask stations were placed at employee entrances and various other locations throughout the facility. Each station included a box of masks, hand sanitizers, and instructions for applying the facemask properly. Large 24” x 46” foam boards were placed on easels at visitor entrances and in common areas, such as waiting areas and the hospital lobby, promoting the HCP masking requirement as a safety initiative to protect patients and visitors. This signage also emphasized the importance of receiving an annual vaccine and practicing hand hygiene to prevent the spread of influenza.
This study required comparing SERMC HCP influenza vaccination rates from the 2015-2016 vaccination season with rates from the previous three vaccination seasons (2014-2015, 2013-2014, and 2012-2013). A retrospective review of employee/agent influenza vaccination documentation forms was conducted. To determine vaccination compliance, the total number of HCP who received an influenza vaccination was added to the total number of HCP who provided written documentation of influenza vaccination outside SERMC since the influenza vaccine became available for the 2015-2016 season. This number was divided by the total number of HCP working at SERMC for at least 1 working day between October 1 and March 31, and then multiplied by 100 to obtain a percentage. The SERMC HCP workforce consists of 1,286 employees, 227 LIPs, 124 student and volunteers, and 210 contract personnel, totaling 1,847 HCP for the 2015-2016 influenza vaccination season. (See Table 1 and Figure 1 for specific results and participation breakdown.) For specifics regarding cost and route of administration, see Table 2.
The aim of this project was to achieve at least a 90% influenza vaccination rate for HCP at SERMC for the 2015-2016 influenza season. Implementing a masking requirement for unvaccinated HCP allowed the organization to achieve this goal for the first time since opening in 2012, but there were barriers encountered along the way. The first glitch occurred in mid-November when all variations (intradermal, intranasal, and I.M.) of the single-dose vaccine were administered but the next shipment wasn't expected to arrive for 2 weeks. Three hundred doses of the trivalent multidose I.M. vaccine were ordered earlier in the season as a back-up plan. The influenza vaccine campaign team promoted vaccine uptake by announcing that the single-dose vaccines were preservative-free, safe, and effective.
The mercury-based preservative thimerosal is used in trace amounts in multidose vials to prevent bacterial contamination of the vial. Since single-dose vaccines are intended for one-time use, they don't contain thimerosal. (There have been concerns about the potential health risks associated with thimerosal-containing vaccines, such as neurologic disorders and autism.14) Numerous organizations, including the CDC, Institute of Medicine, Advisory Committee on Immunization Practices, and FDA have studied the safety of thimerosal in vaccines and found no evidence that the trace amounts of thimerosal in vaccines is harmful.15 Despite the consensus from experts, we found that some HCP weren't comfortable receiving the thimerosal-containing vaccine and, therefore, wanted to wait to receive the preservative-free vaccine.
Another barrier encountered was that the multidose I.M. vaccine provided trivalent protection, whereas the single-dose I.M. vaccine provided quadrivalent coverage. The difference is the quadrivalent influenza vaccine offers protection against four different viruses (two influenza type A strains and two influenza type B strains), whereas the traditional trivalent vaccine only protects against three different viruses (two influenza type A strains and one influenza type B strain). Again, we found that some HCP wanted to wait until the quadrivalent vaccine arrived to be vaccinated. Other employees reported being fearful of needles and opted to wait until the intranasal or intradermal vaccines were available. The shipment was delivered in late November; since the masking requirement was going into effect just days later, there was a rush of HCP reporting to the occupational health office to get their vaccine the morning of December 1. This caused an inconvenience because the occupational health nurses had a busy day of scheduled annual HCP physical appointments and couldn't accommodate the steady flow of walk-ins. The campaign team devised a plan to have available team members administer vaccines for individuals awaiting vaccination. SERMC's president and CEO e-mailed all personnel announcing that the masking requirement for unvaccinated HCP was in effect, and that employees could receive an influenza vaccine without an appointment during occupational health office hours all week. Since influenza vaccine orders are typically placed in the winter preceding the vaccination season, these barriers may be avoided by conducting preliminary estimates of vaccine types and quantities needed for the next influenza season, and ordering accordingly.
Obtaining accurate rosters of all employees, LIPs, students, volunteers, and contractors working at least 1 working day during the influenza vaccination season is imperative to calculating precise outcome data. An opportunity to consider when planning for future vaccination seasons is the hospital's ability to track LIP vaccination status. One recent study found that almost half of hospitals encounter problems related to obtaining LIP vaccination data.16 The SERMC campaign team sent e-mails to LIPs requesting that they return vaccination status documentation; however, other options may be more effective, such as placing phone calls to practitioners' offices to obtain information for nonresponding LIPs.17 Since LIPs typically work at several facilities, establishing a process for sharing LIP vaccination data with other facilities may be beneficial.16
It's worth noting that the campaign team didn't require HCP who received the vaccine after December 1 to wear a mask while protective immunity was developing, which is typically 2 weeks after vaccination. For the 2016-2017 influenza season, the team moved the masking requirement to November 1 from December 1 to allow time for protective immunity to develop before peak influenza activity. In addition, to further demonstrate a commitment to protecting the health and safety of vulnerable patients, as well as their families, visitors, and personnel, leaders implemented a mandatory vaccination requirement for HCP. Only individuals with approved medical or religious exemptions can decline, in which case they're required to wear a protective mask while in the facility for the duration of the influenza season. Only three individuals provided declinations due to medical or religious exemptions, and zero employees chose automatic termination. This resulted in a vaccination rate of nearly 100% for the 2016-2017 season. The mandatory vaccination policy remains in effect for the 2017-2018 season.
Protection for all
Promoting annual influenza vaccinations for HCP protects both staff and patients, and reduces disease burden and healthcare costs. Effective components to include in hospital HCP influenza vaccination programs include seeking strong administrative support to make influenza vaccination a workplace expectation; ensuring convenient access by using mobile vaccination carts on each unit during all shifts; encouraging vaccination for all employees, whether or not they provide direct patient care; providing influenza vaccine education and giving employees opportunities to ask questions one-on-one; and requiring unvaccinated HCP to wear a mask at all times during a scheduled shift through the duration of the influenza season.
1. Thompson MG, Shay DK, Zhou H. Estimates of deaths associated with seasonal influenza—United States, 1976-2007. MMWR Morb Mortal Wkly Rep
2. Molinari NA, Ortega-Sanchez IR, Messonnier ML, et al. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine
3. Fiore AE, Uyeki TM, Broder K, et al. Prevention and control of influenza with vaccines: recommendations of the advisory committee on immunization practices (ACIP), 2010. MMWR Recomm Rep
4. Shefer A, Atkinson W, Friedman C, et al. Immunization of health-care personnel: recommendations of the advisory committee on immunization practices (ACIP). MMWR Recomm Rep
5. Music T. Protecting patients, protecting healthcare workers: a review of the role of influenza vaccination. Int Nurs Rev
6. Black CL, Yue X, Ball SW, et al. Influenza vaccination coverage among health care personnel—United States, 2014-15 influenza season. MMWR Morb Mortal Wkly Rep
7. U.S. Department of Health and Human Services. Immunization and infectious diseases. www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases
8. Greene LR, Cox T, Dolan S, et al. APIC position paper: influenza vaccination should be a condition of employment for healthcare personnel, unless medically contraindicated. www.apic.org/Resource_/TinyMceFileManager/Advocacy-PDFs/APIC_Influenza_Immunization_of_HCP_12711.PDF
9. Infectious Disease Society of America. IDSA policy on mandatory immunization of health care workers against seasonal and pandemic influenza. www.idsociety.org/HCW_Policy
10. Talbot TR, Babcock H, Caplan AL, et al. Revised SHEA position paper: influenza vaccination of healthcare personnel. Infect Control Hosp Epidemiol
11. CDC. State immunization laws for healthcare workers and patients. http://www2a.cdc.gov/vaccines/statevaccsApp/AdministrationbyVaccine.asp
13. Ernst E. Rise in popularity of complementary and alternative medicine: reasons and consequences for vaccination. Vaccine
. 2001;20(suppl 1):S90–S93.
16. Kalayil EJ, Dolan SB, Lindley MC, Ahmed F. Influenza vaccination of health care personnel: experiences with the first year of a national data collection effort. Am J Infect Control
17. CDC. Methods and strategies used to collect healthcare personnel influenza vaccination data. www.cdc.gov/nhsn/pdfs/hps-manual/vaccination/general-strategies-hcp-groups.pdf