Multiple Outbreaks of Hepatitis B Virus Infection Related to Assisted Monitoring of Blood Glucose Among Residents of Assisted Living Facilities — Virginia, 2009–2011

Between February 2009 and November 2011, the Virginia Department of Health (VDH) was notified of acute hepatitis B virus (HBV) infections occurring in residents of four separate assisted living facilities (ALFs) in the Central Health Planning Region of Virginia. In each outbreak, the initial acute HBV infections were identified through routine viral hepatitis surveillance. VDH conducted epidemiologic and laboratory investigations of these reports. Infection control practices, particularly surrounding assisted monitoring of blood glucose (AMBG), were assessed by direct observation and staff member interviews. Further investigation and subsequent screening of ALF residents for hepatitis B uncovered additional acute HBV infections at each of the ALFs. ALF residents screened for HBV infection were categorized on the basis of published criteria as having acute or chronic infection, or being susceptible or immune to infection (1). All acute HBV infections were among residents receiving AMBG for management of diabetes. AMBG is safe when properly performed, but lapses in infection prevention practices during AMBG were identified at three of the four facilities. These outbreaks highlight the role of hepatitis B surveillance in detecting disease outbreaks and the need for a comprehensive strategy to prevent HBV transmission in ALFs, including vaccination, improved infection control oversight at ALFs, appropriate training of staff members performing AMBG, and prompt investigation of acute HBV infections.

Facility A. Facility A was primarily an elder-care ALF. Median resident age was 85 years (range: 61–97 years). In February 2009, VDH was notified of one case of acute HBV infection in a resident, aged 71 years, who was receiving AMBG (Figure). On-site observations did not identify any infection control lapses related to AMBG. In May 2009, VDH was notified of another case of acute HBV infection in a facility A resident receiving AMBG. An investigation was initiated, and 41 of the 47 residents were screened for HBV; two additional acute HBV cases and five previously unidentified chronic infections were identified. With the availability of additional laboratory results, a case initially misclassified as a chronic infection in an October 2008 surveillance report was determined to have been an acute infection. Residents in all five acute cases and four of the five chronic cases were receiving AMBG. Full HBV genomic sequencing was successful for isolates from three acute cases and four of the residents found to have chronic infection at screening. All but one of these residents had received AMBG. All sequences shared 99.9%–100.0% genetic identity, suggesting patient-to-patient transmission through cross-contamination among the acute and chronic cases.

Facility B. Facility B was an ALF that primarily housed residents with neuropsychiatric disorders in two adjacent buildings. Median age of residents was 59 years (range: 28–93 years). In January 2010, VDH received reports of two HBV infections (one acute and one chronic) among residents aged 59 years and 62 years. Screening of 126 of the 139 residents for HBV infection detected 13 additional acute cases, and one previously known and four newly identified chronic infections. Of 19 residents with diabetes, 13 received AMBG, among whom 12 (92%) had acute HBV infection. HBV molecular sequencing identified clusters within each building. Three related cases (two acute and one chronic) occurred among residents of one building, and 11 related cases (nine acute and two chronic) occurred among residents of the other building. In each cluster, cases shared 99.8%–100.0% nucleotide identity across the entire genome. The two clusters were not related to each other, suggesting patient-to-patient transmission of HBV within each building. One previously identified chronic case did not belong to either cluster. The investigation found that multiple procedural breaches by various staff members occurred during AMBG, including shared use of penlet-style reusable fingerstick devices (intended only for a single patient) between more than one resident, failure to perform hand hygiene consistently, and failure to clean and disinfect shared blood glucose meters (glucometers) used for more than one resident.

Facility C. Facility C was primarily an elder-care ALF. Median resident age was 83 years (range: 44–105 years). In June 2010, VDH received a report of an acute HBV infection in a resident, aged 76 years, who received AMBG at the facility. Through screening in October 2010, two additional acute HBV infections were diagnosed in residents receiving AMBG who lived on the same floor, although investigation later revealed one of these residents actually had a chronic HBV infection. Review of medical records revealed that the resident with chronic HBV infection had transferred from facility B in October 2009, shortly after a diagnosis of acute HBV. Among persons who had resided in facility C at any time during October 2009–October 2010, 131 current residents and 100 former residents were identified. Among those 231 persons, 151 were screened, and three additional acute HBV infections were identified. All cases had received AMBG at facility C. HBV sequences of three acute cases and the chronic case shared a 99.8%–100.0% genetic identity with one of the HBV clusters previously identified at facility B. The investigation revealed that each resident had a dedicated blood glucose meter and fingerstick device, but that staff members occasionally used the same penlet-style fingerstick device for more than one resident. Staff members also occasionally reused blood glucose meters for more than one resident without cleaning and disinfection. Fingerstick devices are designed for single resident use and should never be used on more than one person. CDC recommends using a dedicated blood glucose meter for each person; however, the devices may be reused if cleaned and disinfected between persons, as per manufacturers' instructions.*

Facility D. Facility D was an ALF primarily serving residents with neuropsychiatric disorders. Median age of residents was 56 years (range: 20–83 years). In November 2011, VDH received a report of acute HBV infection in a resident aged 55 years. In the course of the initial case investigation, VDH identified a second hospitalized resident, aged 64 years, with acute HBV not yet reported. Screening of 103 of the 120 current residents identified six additional acute cases (including two recently resolved cases) and four chronic HBV infections. Molecular analysis revealed that eight residents with HBV infections, including the index case, matched into a cluster; five with acute HBV infection and three with chronic infection, indicating patient-to-patient transmission for the acute and chronic cases. Insufficient viral material was available for genetic sequencing from three patients with resolving acute infection and one patient with chronic infection. Although one of the chronic cases involved a patient who had been a resident at facility B, HBV genome sequencing demonstrated a distinct phylogenetic cluster from those identified in facilities B and C. All residents with acute or chronic HBV infections had received AMBG. The investigation revealed infection control lapses similar to those identified at the other facilities, despite a policy for use of single-use, auto-disabling, disposable lancets and available supplies at the facility.

Overall, 121 of 536 (23%) residents of the four ALFs had diabetes (Table). Of the 121 residents with diabetes, 109 (90%) were tested for hepatitis B serologic markers. Among the 109 tested, at least 73 (67%) were susceptible to HBV infection before the outbreaks (Table). Of 73 residents initially susceptible to HBV infection, 16 (22%) were aged <60 years. By facility, attack rates among susceptible residents with diabetes ranged from 14.3% to 71.4%, and when analysis was restricted to residents with diabetes receiving AMBG, attack rates by facility ranged from 16.7% to 92.3%. Newly identified chronic infection cases at each facility were not included in the calculation of attack rates. However, those newly identified chronic infections that matched the molecular genetic clusters likely represent outbreak-related cases. Given the extended incubation period of hepatitis B (6 weeks to 6 months), and that elderly persons are more likely to progress to chronic infection than other adults, the outbreaks might have been ongoing for several months before investigations began.

Staff members who provided patient care at two of the facilities (A and D) also were screened. At all facilities, staff member HBV vaccination status was assessed and recommendations made to ensure that unvaccinated patient-care staff members receive vaccination. No HBV cases were reported or detected among staff members at facilities B, C, and D. At Facility A, two of 17 staff members tested had acute HBV. Investigators identified that after performing AMBG, personnel manually removed used, exposed lancets from the fingerstick device, placing themselves at risk for exposure via a sharps injury. Neither staff member had received HBV vaccination.

Reported by

Yeatoe G. McIntosh, MPH, Timothy A. Powell, MPH, Margaret Tipple, MD, Okey Utah, MBBS, MPH, Jessica R. Watson, MPH, Angela M. Myrick-West, MPH, Virginia Dept of Health. Anne C. Moorman, MPH, Yury E. Khudyakov, PhD, Jan Drobeniuc, MD, PhD, Fujie Xu, MD, PhD, Div of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention; Matthew E. Wise, PhD, Priti R. Patel, MD, Div of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infections; Thomas J. Bender, MD, EIS Officer, CDC. Corresponding contributor: Anne C. Moorman, amoorman@cdc.gov, 404-718-8567.

Editorial Note

ALFs provide housing and care to persons unable to live independently in their own homes, but who do not require the level of care provided at a nursing home. ALF capacity in the United States is approximately 1 million beds, with this number expected to grow in response to an aging population and a shift in custodial care from nursing homes to assisted living (2). Although ALFs primarily provide support for activities of daily living, health care (including AMBG) routinely is delivered on-site at ALFs by various unlicensed or licensed personnel, including medication aides, nurses, and others (3). In the United States, 27 (93%) of the 29 HBV outbreaks involving adults in long-term–care facilities reported to CDC since 1996 have been among residents with diabetes receiving AMBG (4), and in recent years, the majority of these outbreaks have occurred in ALFs (5). Other avenues of infection have included infection control breaks during podiatry or the provision of other health care, and sexual or other person-to-person household transmission. The four outbreaks in Virginia demonstrate the challenges in implementing infection prevention and control measures during AMBG in ALFs, despite ongoing efforts by VDH to enhance infection control education and oversight in ALFs.† These outbreaks lend support to an increasing body of evidence suggesting the need for a comprehensive strategy to ensure safe AMBG in ALFs.

Hepatitis B is a vaccine-preventable disease. In October 2011, the Advisory Committee on Immunization Practices recommended that adults aged 19–59 years with diabetes mellitus (type 1 and type 2) be vaccinated against HBV. In addition, adults aged ≥60 years with diabetes may be vaccinated at the discretion of the treating clinician (6,7). A high proportion of residents with diabetes in the four ALFs in this report were susceptible to HBV infection, although many residents of these facilities were aged ≥60 years. Decisions to vaccinate adults with diabetes in this age group should be made after considering the patient's diminished likelihood of responding to vaccine and the likelihood of acquiring HBV infection, including the risk posed by an increased need for AMBG in long-term–care facilities (6,7). The risk for progression to chronic infection, morbidity, and mortality from acute HBV infection is higher among the elderly than other adults (8). Vaccination alone is unlikely to completely eliminate HBV transmission risk in ALFs. In addition to HBV vaccination, other interventions should include improving infection control oversight at ALFs, training staff members to appropriately perform AMBG, and ensuring that each ALF has a sufficient number of trained personnel to perform AMBG 7 days per week (9).

In nursing homes, which are regulated by the federal Centers for Medicare and Medicaid Services, practices such as shared use of fingerstick devices for multiple patients can result in a loss of billing privileges for the nursing home. In contrast, ALFs are regulated by state agencies. VDH recently has begun working with the Virginia Department of Social Services to incorporate assessment of infection control practices into ALF inspections. Similar activities by other health departments and facilities will help ensure that ALF staff members nationally are performing AMBG appropriately.

Because of pervasive lack of awareness of the risks for bloodborne pathogen transmission related to AMBG, CDC issued updated guidance on infection control practices during AMBG in 2011, including recommendations for the use of single-use, auto-disabling, disposable lancets and dedication of blood glucose monitors to individual patients when possible. Persons responsible for providing AMBG in any setting should be trained to use proper procedures, but maintaining a trained group of ALF staff members is hindered by high turnover and a lack of licensed health-care personnel employed by ALFs (2). Following an outbreak of HBV infections among ALF residents in North Carolina that resulted in six deaths (10), the North Carolina Department of Health and Human Services worked with legislators and industry representatives to update infection control requirements for ALF staff members.§ Studies of evidence-based approaches to address the persistent problem of maintaining appropriate levels of infection control training among ALF staff members also are needed.

Acute hepatitis B surveillance requires laboratory and provider reports of potential acute hepatitis B cases to health departments, which conduct follow-up to supplement important epidemiologic information. Because of the long incubation period of hepatitis B (6 weeks to 6 months), and given that most hepatitis B cases (>50%) are asymptomatic, these outbreaks are very difficult to detect. The four ALF outbreaks in Virginia were detected by an effective hepatitis B surveillance system accompanied by prompt and thorough epidemiologic and laboratory investigation of acute HBV infection reports by VDH, with assistance from CDC. Investigation of these reports plays an essential role in identifying unsafe practices and implementing appropriate control measures. A systematic approach to guide investigations and public health response in these situations was developed with collaboration between CDC and state and local health departments.¶ The delivery of health care, whether in a hospital, nursing home, or ALF, should offer no avenue for transmission of viral hepatitis. To ensure patient safety in ALFs, a strategy that incorporates viral hepatitis surveillance, HBV vaccination, improved infection control oversight at ALFs, appropriate training of staff members performing AMBG, and prompt investigation of acute HBV infections is needed.

Acknowledgments

Susan Fischer Davis, MD, Richmond; C. Diane Woolard, PhD, Virginia Dept of Health. Joseph F. Perz, DrPH, Mary Beth White-Comstock, MSN, Div of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infections, CDC.

References

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