Improving Compliance With Revised Newborn Hepatitis B Vaccination Policy

This quality improvement study adhered to the Standards for Quality Improvement Reporting Excellence 2.0 guidelines.⁸  The study was approved as exempt with a waiver of consent by our institutional review board.

Our hospital is the largest maternity center in our city, with ∼5000 annual deliveries, a 54-bed postpartum mother-baby unit (MBU), and a 50-bed level III NICU. Our hospital was designated as a Baby-Friendly Hospital in December 2015.⁹  Healthy infants born at ≥36 weeks’ gestation with birth weight ≥2000 g, room-in with their mothers on the postpartum floor. The mother-infant dyad is cared for by the same postpartum nurse. During the study period, 80% of well newborns were cared for by in-house neonatologists present 24 hours per day and the remaining by 1 of 3 private pediatric groups who conduct morning rounds. The study population was restricted to infants born ≥36 weeks’ gestation with birth weight ≥2000 g and cared for on the MBU throughout their hospital stay, without need for intensive care.

The project team obtained input from representative members who provide routine care for mother-infant dyads in the MBU, including labor-room and postpartum nurses, neonatologists, pediatricians, and advance care practice providers to identify care processes involved in hepatitis B vaccine administration. In discussing vaccination with the mother, both the MBU nurse and the medical providers noted that they presented hepatitis B vaccination in the birth hospital as a convenient way to begin infant vaccination but also presented vaccination in the pediatric office as an equivalent option. The vaccine order is placed by the medical team (physician and advance care practice providers) on admission of the newborn as part of the admission order set. Preintervention, the MBU nurse provided the Vaccine Information Statement (VIS) and written consent form to the mother for consideration at variable times before discharge. The MBU nurse released the vaccine order when it was available to her and administered vaccine after written consent was obtained, at a time that was viewed as convenient for the specific mother and infant dyad.

Baseline rate of eligible infants administered hepatitis B vaccine within 24 hours after birth from November 1, 2016, to January 6, 2018, was ∼35%, and timing of vaccine administration did not meet the revised AAP recommendations in the majority of infants.

In October 2017, the project team presented the rationale for and content of the revised AAP guidance to the standing perinatal quality improvement committee composed of representatives from nursing leadership, nurse education, clinical nursing, neonatology, pharmacy, and information technology. We reached consensus for an improvement project with the following Specific, Measurable, Applicable, Realistic, and Timely aim: Administer hepatitis B vaccine to 70% of eligible newborns within 24 hours after birth by June 30, 2018. Preintervention data also revealed that 85% of eligible newborns were receiving hepatitis B vaccine before hospital discharge. Stakeholders were concerned that an unintended consequence of approaching families early for vaccine administration could result in increased refusal and a decline in overall vaccine acceptance. We agreed that the overall vaccination rate before hospital discharge would be a prespecified balance measure.

The stakeholder team identified key drivers (Fig 1) and, on the basis of these, formulated change ideas (Supplemental Table 3). Four key drivers identified were vaccine order availability, competing nursing tasks, documenting consent for vaccine administration, and education regarding the way vaccine information was presented to the families.

When discussing vaccine order availability, we recognized that the postpartum nurse is charged with numerous tasks unavoidably clustered in the first 24 hours after delivery. This may impede vaccine administration within 24 hours after birth on the postpartum floor even if vaccine orders were available. Because both vaccine order availability and competing nursing care tasks are key drivers of timing for hepatitis B vaccine administration, our first attempt was to address both of these drivers simultaneously by having the vaccine administered by labor-floor nurses at the time of vitamin K administration. This approach required the hepatitis B order to be entered by the labor-floor nurses, and was abandoned because of limitations on the type and number of per-protocol medication orders that can be directly placed by the nursing staff without pharmacy review. The alternate approach was to ensure timeliness of vaccine orders placed by the medical team that were typically placed at the time of admission. An infant born overnight may not have admission orders placed until the next morning when the day team examines and admits the infant to the MBU, potentially delaying order availability in the first 24 hours after birth. This issue was resolved by leveraging neonatology providers who are on-site at our institution 24 hours a day and who agreed to place admission orders for newborns born in evenings and nights to ensure order availability. We considered using overnight calls for vaccine order placement as an additional balance measure. Given the difficulty in measuring the number of overnight calls specifically for vaccine order requests, we requested informal feedback during monthly staff meetings from members of the overnight team. In November 2017, local policy change incorporated strong recommendations for the vaccine to be offered to all well newborns and orders placed within 24 hours after birth.

Consensus was reached that hepatitis B vaccine administration would continue to be performed by postpartum nurses but incorporated within other routine procedures that occur within the first 24 hours after birth. For example, the first infant bath is typically given within the first 24 hours and is used as an opportunity for nurses to interact with and provide education to families. This allows bundling of routine care with vaccine administration. Education regarding the need for such bundling and processes involved were conducted by nurse educators during “huddle flashes” starting December 2017.

All stakeholders agreed that if verbal consent was allowable, instead of requiring written consent, this would reduce the task burden and allow for workflow flexibility. In November 2017, the local policy was changed to allow verbal consents for newborn hepatitis B vaccine administration. Our electronic medical record system (Epic; Epic Systems Corporation, Verona, WI) was modified to allow electronic documentation of verbal consent and whether the vaccine was given or deferred.

Education was started at the stakeholder meeting, in which updated guidelines, scientific rationale, and burden of disease were discussed, with references made available for further reading and distribution. A standardized script for presenting vaccine information to the families was made that changed messaging from one based on the option for vaccination to the recommendation for vaccination. In December 2017, a meeting of neonatologists, pediatricians, and advanced practice providers who care for infants on the MBU was held. The change in national guidelines, new local policy, and planned process changes were reviewed with the medical providers. From December 2017 through January 2018, the nursing staff received a series of e-mails and formal huddle flashes on each shift with the rationale for the change, the suggested workflow for early administration, changes in documentation, and scripting for obtaining verbal consent. The go-live date for the new standard of care was January 7, 2018.

We recognized that vaccine refusal during the birth hospitalization can be due to process issues or family preferences. Our improvement interventions primarily targeted process issues and were less focused on community education. Determining factors associated with vaccine refusal after optimization of vaccine delivery processes would be important for planning next steps for continued improvement. We extracted specific demographic and clinical characteristics from the electronic medical record of all newborns in the postintervention period. We examined self-identified race and ethnicity as a variable for vaccine refusal because of revealed variation in acceptance for other preventive measures in neonates, such as vitamin K administration after birth,¹⁰  and for other vaccines in children and adults by race.^11,12  We also collected vitamin K administration data to assess for refusal of other preventive interventions.

The main outcome measure was proportion of eligible infants receiving the hepatitis B vaccine within 24 hours after birth. Age at vaccination was calculated as the difference between time of vaccination (captured in the pharmacy database as time when medication is scanned before administration) and time of delivery. The balance measure was proportion of infants receiving the vaccine anytime during the birth hospitalization. We also obtained informal feedback from medical staff during monthly staff meetings regarding burden of overnight calls for vaccine placement orders. Downloadable reports with relevant variables were created within Epic to allow automated data collection. The postintervention study period included infants born from January 7, 2018, to June 30, 2019, and outcomes were compared with the preintervention period. In the postintervention period, we assessed demographics and basic characteristics of families who declined vaccine receipt during hospitalization. Changes in vaccination rates before and after policy change were assessed by using statistical process control (SPC) methods. Because our outcome measure was binomial with variable denominator, we chose a p-chart to visualize the changes over time (measured per month). Mean proportion and 95% upper and lower confidence limits of change in outcome measures were calculated during the study period by using an SPC-macro Excel add-in provided by the Intermountain Health Delivery Institute. Common-cause variation was established with preintervention data from July 2017 to January 2018 for biweekly rates of vaccine administration. More than 8 consecutive estimates above the central mean line was used to identify special-cause variation.¹³  Comparisons between groups were made by using χ² test, Fisher’s exact test, and Student’s t test, as appropriate. All analyses were conducted using Microsoft Excel and Stata (StataCorp, College Station, TX).

During the study period, 13 334 live-born infants were delivered at our hospital; 10 887 (81.6%) infants remained well enough to room-in with their mothers during the entire birth hospitalization. The preimplementation period (November 1, 2016, to January 6, 2018) included 4895 newborns, and the postimplementation period (January 7, 2018, to June 30, 2019) included 5992 newborns. Basic demographics and routine care delivered to the study population is shown in Table 1.

SPC analysis of monthly vaccination rates reveals special-cause variation in vaccination rates both for infants administered the vaccine within 24 hours after birth (Fig 2) and for those administered before discharge (Fig 3) concomitant with our planned interventions that went live in January 2018. Proportion of infants administered hepatitis B vaccine within 24 hours after birth increased from 35.5% to 78.8% and those administered the vaccine anytime during hospitalization from 86.5% to 92.3% after policy change. The proportion of all eligible infants who received the vaccine at ≤24 hours after birth increased by 122%. In addition, there was a 5.8% increase in the total proportion of infants administered vaccine before hospital discharge. Therefore, earlier vaccination at our center did not negatively impact overall vaccination rates. The general feedback we received from the overnight team regarding burden of calls for vaccine orders was neutral. We attributed this to the fact that there is an assigned provider available to admit newborns delivered from 8 am to midnight, resulting in few infants requiring admit orders to be placed by the overnight call team between midnight and 8 am.

In the postintervention period, fewer families declined the vaccine for the infant. Mothers who declined were significantly more likely to be single and of Black race and higher parity, used public insurance, delivered via vaginal route, and breastfed their infant. Infants of mothers who declined vaccination were more frequently of female sex and higher gestational age at birth. These families were also significantly more likely to decline vitamin K (Table 2).

We identified that hepatitis B vaccine was not being administered within 24 hours from birth in the majority of eligible infants at our center, as recommended by national guidelines. We approached changing practice to standardize the timeliness of vaccine administration using quality improvement methods, first, by outlining the problem statement, establishing key drivers, and obtaining buy-in from the key stakeholders. Postpartum care is multifaceted and time sensitive, involving the care of both the recovering mother and the transitioning newborn. The postpartum nurse has the critical task of coordinating this complex care, along with providing the family with education tailored to their concerns regarding newborn vaccination, obtaining consent, and administering the vaccine. In this setting, buy-in from the entire multidisciplinary team is important, but collaboration with the nursing staff and integrating the policy change into the nursing workflow is crucial.

Recently, reports on the strategies adopted to ensure standardized times for hepatitis B vaccination of well newborns^14–16  and infants admitted to the NICU¹⁷  have been published. Two of the reports targeting well infants were aimed to implement the New York Department of Health mandate of administering the vaccine within 12 hours after birth, and the third targeted the national recommendations of 24 hours after birth. All 3 identified order availability and increased education as key drivers. A key intervention that was used in these studies, that we did not implement, was nurse-driven processes for ordering hepatitis B vaccine to increase early vaccination rates.^15,16  We instead leveraged buy-in from the medical team to ensure timely vaccine order entry.

Our experience in implementing this policy change can help other centers align their practice with current recommendations. We believe that our interventions were successful because of unified messaging from medical and nursing leadership and a high degree of nursing stakeholder buy-in. Although a policy change may effect a temporary improvement, sustained improvement requires support from the providers closest to the change. Factors, beyond the scientific rationale for the change, identified by the nursing staff as most helpful to gaining their ongoing support included the bundling of care (encouraging vaccine administration with other tasks that already happen within 24 hours after birth) and making the documentation of verbal consent straightforward. Another key to successful implementation is order availability. As previously mentioned, our coverage is set up such that admission orders are virtually always placed well before an infant is 24 hours postbirth, so we were able to achieve reliable hepatitis B vaccination order availability by minimal change to routine processes. Since completing this study, we have created a standardized order set, including an order for hepatitis B vaccination, that the postpartum nurse can place on the infant’s arrival to the mother-infant floor. This will eliminate any potential delay in delivering the vaccine secondary to a delay in order placement. It will also allow the postpartum nurse more flexibility to cluster the vaccine with other infant care that routinely happens on arrival.

Increasing proportion of children not receiving routine vaccinations is a public health threat of dire consequences.^18,19  In the case of hepatitis B vaccination, many parents may feel ambivalent about early vaccination. If a mother feels confident about her hepatitis B status at the time of delivery, even if she fully intends to vaccinate her child to hepatitis B, she may not be compelled to vaccinate her infant in the first 24 hours after birth, believing that the risk of exposure for her child is minimal. However, illustrative, real-life scenarios ranging from missed opportunities to medical errors provide strong support for the 24-hour birth dose.²  The coverage from early hepatitis B vaccination is meant to be applied universally so that infants who are at increased risk, known and unknown, at the time of birth and infants who will become at risk over time are all protected. Many families may find such early vaccinations counter to their preferences. In a study surveying 659 families, the most common reason for declining vaccine was that the parents planned to have the infant vaccinated at the 2-week pediatrician visit.⁷  Over 70% of those who declined felt their infant was too young. We wanted to ensure overall hepatitis B vaccination rates before discharge were retained because we began offering the vaccine early after birth. We not only maintained our overall rate of vaccination but found a significantly increased uptake of the vaccine that may be attributable to increased vaccine awareness among staff with the new quality improvement project. The increased rates were retained over a year postimplementation.

In this initial approach to improving vaccine timeliness, we did not attempt community outreach for improving vaccine uptake among families but recognize this as an important area for future research and further improvement.^14,20  We describe the common characteristics of families who refused hepatitis B vaccine in the postimplementation period that may enable potential next steps of improving educational outreach. As described by others, hepatitis B vaccine refusal rates cluster with refusal of other preventive measures, such as vitamin K administration.¹⁰  We are limited by the retrospective design of our study that does not provide parent perspective for vaccine refusal.

The rate of newborn hepatitis B vaccination at our center after implementation of the current AAP policy increased to 79% within the first 24 hours after birth and 92% at the time of discharge, exceeding the national reported rate of ∼70%.¹⁹  The successful implementation of this AAP recommendation is feasible and may increase overall hepatitis B vaccination rates.

We acknowledge all Pennsylvania Hospital MBU staff who engaged enthusiastically in making possible the successful implementation of the revised neonatal hepatitis B vaccination policy.