BACKGROUND AND OBJECTIVES:

When given within 24 hours of birth, the hepatitis B vaccine is up to 90% effective in preventing perinatal infection. The American Academy of Pediatrics now recommends administration within 24 hours for infants with a birth weight >2 kg, but a national benchmark for compliance with this time frame has not been established. We aimed to increase the monthly average of eligible newborns receiving the vaccine on time from 40% to 80% over a 9-month period.

METHODS:

A series of plan-do-study-act cycles were conducted to improve timeliness of hepatitis B vaccine birth dose administration among newborns in the level 1 nursery at our academic community hospital. Interventions included staff education, nurse-driven consent and vaccine ordering, and earlier initial newborn assessments performed by nursing staff. Our primary outcome was the monthly percentage of newborns receiving the vaccine within 24 hours of birth, and our secondary outcome was the frequency of nonvaccination events. Statistical process control was used to analyze the effectiveness of interventions.

RESULTS:

Our mean monthly rate of vaccine administration within the 24-hour time frame increased from 40% to 92%. Predischarge vaccination rate improved from a mean of 13 to 61 cases between infants discharged without vaccination.

CONCLUSIONS:

Nurse-led interventions, including the ability to obtain consent and incorporation of the vaccine into our nurse-activated admission order set, were significant contributors to improvement in the timeliness of hepatitis B vaccine administration. We propose a mean of 90% compliance with the American Academy of Pediatrics recommendations as a benchmark for other institutions.

Perinatal transmission of the hepatitis B virus (HBV) leads to chronic infection and liver disease in 80% to 90% of infected infants.1  When given within 24 hours of birth, the hepatitis B vaccine (HepB) alone is 75% to 95% effective in preventing perinatal HBV infection.2,3  The HepB birth dose protects against undiagnosed cases of maternal HBV and household exposure and represents the first in a series that will lead to lifelong immunity. Recent increases in new HBV infection rates underscore the need for universal immunization in all age groups.4 

Historically, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) offered families the option of deferring the HepB birth dose to their outpatient pediatric provider; however, because of suboptimal rates of birth dose administration5  and lack of improvement in perinatal HBV transmission rate,6  this recommendation was revised. In 2016, the ACIP began recommending HepB administration within the first 24 hours of life and no longer endorsed vaccine deferral7 ; in 2017, the American Academy of Pediatrics (AAP) issued a policy statement supporting this change.8 

Although Healthy People 2020 measures the coverage level of the HepB birth dose (defined as within the first 3 days of life)9  and the Immunization Action Coalition recognizes hospitals with a predischarge vaccination rate of 90% or higher,10  to our knowledge, no national benchmarks exist measuring compliance with the updated ACIP and AAP guidelines for vaccination within 24 hours of birth. Two recent single-center improvement projects achieved rates of 65% and 43% of infants being vaccinated within the first 12 hours of life (per New York State recommendations)11,12 ; however, it is unknown how these efforts affected vaccination within the nationally recommended 24-hour time frame.

Baseline data at our institution from January 1, 2017, to December 31, 2018, revealed suboptimal compliance with the nationally and state-recommended13  24-hour time frame (mean 40% of eligible newborns). These data revealed common cause variation over time, indicating that fundamental change was necessary for improvement. On the basis of this observation, we initiated a quality improvement project starting in January 2019, the aim of which was to increase the mean monthly average of eligible infants receiving HepB within the first 24 hours of life to 80%, within 9 months. In the absence of an established national benchmark, our clinical team estimated a mean of 80% to be a reasonable initial goal.

Our hospital is a 282-bed urban tertiary care facility in a community hospital network, affiliated with several local educational institutions. In 2019, 48.7% of mothers on the Maternal and Child Health (MCH) service were white, 67.1% had public insurance, 69.2% were aged <35 years, and 64.2% delivered vaginally. Only 0.35% of mothers were positive for Hepatitis B surface antigen. Additional demographics are shown in Table 1. Approximately 900 deliveries occur at our hospital per year, with ∼80% of infants cared for on the mother-baby unit. Trainees on the mother-baby unit include nursing and physician assistant students. Newborn hospitalists provide care during the day, with overnight in-house coverage provided by in-house neonatologists from the institution’s Level 3 NICU. Infants born at <36 weeks’ gestation or with birth weight <1800 g are routinely admitted to the NICU for a period of observation.

TABLE 1

Demographics

Characteristicn (%)
Maternal age  
 15–19 13 (1.5) 
 20–24 53 (6.2) 
 25–29 197 (23.1) 
 30–34 327 (38.4) 
 35–39 198 (23.2) 
 40–44 58 (6.7) 
 45+ 6 (0.7) 
Maternal Race (multiple selections allowed)  
 American Indian 2 (0.2) 
 Asian 95 (11.2) 
 Black 138 (16.2) 
 Hispanic Black 27 (3.2) 
 Hispanic white 92 (10.8) 
 Hispanic other 73 (8.6) 
 White 415 (48.7) 
 Other Pacific Islander 2 (0.2) 
 Other 17 (2.0) 
 Not reported 26 (3.1) 
Maternal education  
 12th grade or less (no diploma) 61 (7.2) 
 High school or GED 107 (12.6) 
 Some college, certificate, or associate degree 219 (25.7) 
 Bachelor’s degree 237 (27.8) 
 Master’s, doctorate, or professional degree 208 (24.5) 
 Not reported 20 (2.4) 
Insurance  
 Public 572 (67.1) 
 Private 268 (31.4) 
 Self-pay or none 12 (1.4) 
Delivery mode  
 Vaginal 547 (64.2) 
 Cesarean delivery 301 (35.3) 
 Missing data 4 (0.5) 
Characteristicn (%)
Maternal age  
 15–19 13 (1.5) 
 20–24 53 (6.2) 
 25–29 197 (23.1) 
 30–34 327 (38.4) 
 35–39 198 (23.2) 
 40–44 58 (6.7) 
 45+ 6 (0.7) 
Maternal Race (multiple selections allowed)  
 American Indian 2 (0.2) 
 Asian 95 (11.2) 
 Black 138 (16.2) 
 Hispanic Black 27 (3.2) 
 Hispanic white 92 (10.8) 
 Hispanic other 73 (8.6) 
 White 415 (48.7) 
 Other Pacific Islander 2 (0.2) 
 Other 17 (2.0) 
 Not reported 26 (3.1) 
Maternal education  
 12th grade or less (no diploma) 61 (7.2) 
 High school or GED 107 (12.6) 
 Some college, certificate, or associate degree 219 (25.7) 
 Bachelor’s degree 237 (27.8) 
 Master’s, doctorate, or professional degree 208 (24.5) 
 Not reported 20 (2.4) 
Insurance  
 Public 572 (67.1) 
 Private 268 (31.4) 
 Self-pay or none 12 (1.4) 
Delivery mode  
 Vaginal 547 (64.2) 
 Cesarean delivery 301 (35.3) 
 Missing data 4 (0.5) 

Before initiation of this improvement project, the process for HepB administration involved the following: (1) the postpartum nurse informing parents of the need for HepB and distributing the vaccine information sheet; (2) the newborn provider (physician or nurse practitioner) obtaining verbal parental consent for vaccine administration; (3) the newborn provider ordering the vaccine; and (4) the postpartum nurse administering the vaccine. Although a standing HepB order existed as part of the preapproved Newborn Admission Order Set (which was subsequently cosigned by the provider), nurse activation of this order was not common practice.

An interdisciplinary quality improvement team composed of newborn hospitalists and neonatologists, the level 1 nursery medical director, the MCH nurse manager, and a newborn nurse educator was assembled for this project. The team identified key drivers affecting the timeliness of vaccine administration (Fig 1). Change ideas were developed on the basis of these drivers.

FIGURE 1

Key driver diagram. MBU, mother-baby unit; MD, doctor of medicine; RN, registered nurse; WBN, well-baby nursery.

FIGURE 1

Key driver diagram. MBU, mother-baby unit; MD, doctor of medicine; RN, registered nurse; WBN, well-baby nursery.

Close modal

Using the model for improvement,14  the team conducted a series of tests of change plan-do-study-act (PDSA) cycles; if no adverse events were noted and staff reported acceptance, the intervention was implemented as standard process. Interventions included staff education on the importance of HepB birth dose and timing of administration, removing obstacles to obtaining timely consent for and ordering of vaccines, and performing earlier newborn admission tasks (Supplemental Information). Team discussion and high baseline overall HepB completion rate suggested that parental vaccine hesitancy was not a significant barrier to vaccine administration; as such, initial interventions did not focus on this driver.

For the first intervention, staff education, the team shared updated ACIP and AAP guidelines regarding recommended vaccination time frame via a weekly newsletter published by MCH nursing leadership and circulated to all staff on the labor and delivery unit, postpartum unit, and NICU, and through e-mails to providers. Ongoing reinforcement was provided by reminder e-mails, a lecture provided by the department of public health, and 1-on-1 staff education. Observations indicated general staff acceptance of and motivation to comply with the recommended 24-hour time frame; however, obstacles to obtaining consent and ordering vaccines remained.

The second intervention involved a hospital policy amendment permitting nursing staff to obtain consent for HepB. This change was communicated to staff through e-mails and in-person education. After observing adoption of this intervention over a 1-month period, a formal policy was uploaded to our online policy library and hard copies were shared with nursing staff and posted in the postpartum unit. However, after this process change, the team observed consistent requests for providers to place a HepB order, despite its inclusion in a preapproved admission order set.

With the third intervention, we aimed to facilitate a nurse-driven vaccine-ordering process. Formal approval was obtained for nurses to activate the HepB order as part of the Newborn Admission Order Set (to be cosigned later by the provider). This practice change was broadcast through the weekly staff newsletter, e-mails, and individual education. Screenshots outlining the vaccine-ordering process were also posted on the postpartum unit, and just-in-time teaching was provided by nurse educators, physicians, and nurse peers. After consistent activation of the HepB order along with admission orders, a delay in order set activation persisted because of delays in the overall newborn admission process.

With the final intervention, we focused on earlier newborn admission processes. Before this intervention, postpartum nurses performed newborn admission assessments (including interviewing the family and obtaining vaccine consent) and activated order sets on arrival of the stable mother and newborn dyad to the postpartum unit. Maternal complications requiring extended observation on the labor and delivery unit led to delays in this process. As such, hospital policy was revised to require the newborn admission assessment to be completed within 4 hours of life, regardless of the newborn’s physical location. Tests of change included postpartum nurses assisting labor and delivery nurses with newborn assessments and order set activation and educating labor and delivery nurses regarding newborn care during the transitional period.

As part of the auditing and feedback process in the implementation PDSA cycles, monthly updates on progress toward stated goals were shared with MCH staff and providers through department newsletters, charts posted on each unit, and periodic e-mail correspondence with providers.

The team built a monthly electronic report that listed the date and time of each birth and HepB administration for infants in the level 1 nursery. Data were exported to Microsoft Excel,15  in which hours of life at time of vaccine administration were calculated for each newborn. Baseline data were collected retrospectively via review of monthly reports, and ongoing data were collected monthly and used to inform future interventions.

The primary outcome was the monthly percentage of newborns receiving HepB within the first 24 hours of life. This was calculated by dividing the number of infants receiving the vaccine on time each month by the total number of eligible infants per month, including those who did not receive HepB at all because of parental preference. We excluded infants initially admitted to the NICU for any length of time because factors outside of the control of nursery leadership dictated appropriateness of vaccine timing. We also excluded infants weighing <2 kg at birth because the recommended vaccine time line is different for this population. The secondary outcome was birth dose compliance; because of rarity of events, this was represented as cases between nonvaccination events. Age at the time of HepB order was tracked as a process measure. Vaccine administration errors, including duplicate administrations, administration to ineligible infants, or administration without consent, as reported by our institutional incident reporting system, were monitored as balancing measures.

Statistical process control charts using established health care rules were used to determine the stability of the system, establish control limits, evaluate the impact of our interventions, and monitor for sustained improvement.16  The primary outcome, monthly percentage of newborns receiving HepB within the first 24 hours of life, was plotted by using a P chart. The secondary outcome, discharge without vaccination, was analyzed with a G chart. A run chart was used to display the process measure, newborns’ age at time of vaccine order.

This improvement project was reviewed by the hospital’s institutional review board and approved as exempt from formal review.

Baseline data were collected from January 2017 through December 2018, with 1421 eligible infants out of 1855 total births. Study data collected from January 2019 through September 2020 included 1070 eligible infants out of 1613 births.

Educational interventions were tested from January to February 2019. Policy change enabling nurses to obtain consent was approved in June 2019 and formally disseminated in July 2019. Interventions aimed at nurse-activated HepB ordering were tested from July to August 2019. Policy change requiring a 4-hour time frame for newborn admission processes was tested from September to December 2019.

Primary Outcome

Baseline data were collected from January 2017 to December 2018. Control limits were calculated after 20 data points, and, because those data revealed common cause variation with a mean of 40% of infants receiving the vaccine on time, the centerline was fixed and extended (Fig 2). Special cause variation indicating improvement was identified starting in September 2018, 3 months before any planned tests of change, and continued throughout the intervention period. After the team discussed potential reasons for this improvement before the intervention period and the impact of interventions leading to special cause variation, the centerline was adjusted with a new mean of 61%. Special cause variation indicating improvement was again identified in August 2019; thus, the centerline was adjusted once more (92%). The monthly subset size ranged from 42 to 102 patients.

FIGURE 2

P chart: percentage vaccinated within 24 hours of life. CL, control limit; LCL, lower control limit; UCL, upper control limit.

FIGURE 2

P chart: percentage vaccinated within 24 hours of life. CL, control limit; LCL, lower control limit; UCL, upper control limit.

Close modal

Further analysis of infants not vaccinated within the recommended time frame from August 2019 to September 2020 revealed that 50% were due to parental vaccine hesitation, thereby delaying HepB until after the 24-hour threshold or ultimately deferring vaccination during birth hospitalization. Thirty percent were due to delays in patient transfer from labor and delivery to the postpartum unit, underscoring the need for ongoing work on the last intervention aimed at earlier newborn admission assessments and order placement. The remaining 20% were due to individual characteristics, including per diem or float nursing staff who were unfamiliar with recent practice changes, or staff members who required targeted education.

Secondary Outcome

The secondary outcome, number of cases between newborns being discharged without vaccination, is represented in Fig 3. Given the relatively frequent occurrences at baseline, data for this measure are represented only from January 2018 onwards. Improvement in this measure is indicated on the G chart by higher values (ie, more cases between discharges without vaccination) over time. Special cause variation indicating improvement was detected starting in August 2018 and continuing through the intervention period. After the team discussed potential reasons for this improvement before the intervention period and the impact of interventions leading to special cause variation, the centerline was adjusted from a mean of 13 cases between infants being discharged without vaccination to a new mean of 29 cases between events. Special cause variation in the direction of improvement was again identified in July 2019, and thus the centerline was adjusted once more to a mean of 61 cases between events.

FIGURE 3

G chart: cases between unvaccinated discharges. CL, control limit; UCL, upper control limit.

FIGURE 3

G chart: cases between unvaccinated discharges. CL, control limit; UCL, upper control limit.

Close modal

Process Measure

A run chart was used to study variation in age at time of HepB order placement and the relationship of this measure to time of vaccine administration (Fig 4). This process measure was monitored in bimonthly subgroups, allowing for early identification of significant changes. Age at vaccine order decreased after interventions aimed at reducing obstacles to nurses obtaining consent for and ordering HepB. There was also a strong relationship between mean age at time of vaccine order and mean age at time of vaccine administration, which remained consistent throughout the baseline and intervention phases; a scatterplot corroborated this strong positive linear relationship (R2 = 0.87) (Supplemental Fig 5). Given the strength of this relationship and improvement after targeting ordering practices only, the team concluded that vaccine ordering had been the predominant failure mode. As such, data collection for this process measure was discontinued, and thereafter the team relied on statistical process control analysis of the primary outcome measure rather than applying run chart rules.

FIGURE 4

Run chart: age at time of vaccine order versus age at time of vaccine administration.

FIGURE 4

Run chart: age at time of vaccine order versus age at time of vaccine administration.

Close modal

Balancing Measures

There were no documented cases of vaccine administration errors during the project period.

Contextual Elements

The initiation of this improvement project coincided with a significant change in the local staffing model; before 2019, the level 1 nursery was staffed by community-based pediatricians, who rounded on newborns every morning and were otherwise available by telephone only. In January 2019, pediatric hospitalists began providing coverage for 10 hours a day for 95% of level 1 patients (community pediatricians covering the remaining 5%), with in-house neonatologists covering overnight.

At the beginning of 2020, after completion of data collection for the 2018 and 2019 calendar years, our hospital applied for inclusion in the Immunization Action Coalition’s Hepatitis B Birth Dose Honor roll, which recognizes institutions achieving an overall immunization rate of 90% of all infants before hospital discharge, regardless of birth weight or gestational age.10  This element was not shared with newborn providers or nursing staff until our acceptance in February 2020; given the late introduction of this factor into our project time line, it is unlikely to have interacted with the above interventions but it may be responsible in part for sustained improvement.

Finally, the most recent months of this project coincided with the 2019 novel coronavirus disease pandemic, which resulted in many hospital policy and practice changes. Major changes affecting the well newborn service included social distancing measures, which resulted in decreased face-to-face time between providers and staff and families, cessation of the practice of bringing newborns to a nursery to perform routine interventions, and an increase in early maternal discharges, resulting in many newborns being discharged shortly after 24 hours of life. These changes had the potential to both negatively impact our outcomes because of reduced ability to interact with and provide education to families and positively impact outcomes because of expediting of newborn screening items in anticipation of earlier discharges. Although we did not observe a significant change in our primary outcome, we did see a slight increase in nonvaccination events; however, there are insufficient data to determine special cause variation.

Our aim was to increase the percentage of eligible newborns receiving HepB within the recommended 24 hours after birth to a goal of 80%. We achieved this goal, reaching a new stable process with 92% of newborns safely vaccinated by 24 hours of life. We also observed more consistent HepB administration before discharge, now with an average of 61 cases between missed vaccinations.

The improved compliance with the AAP recommendation for HepB birth dose timing aligns with our expectations because significant change was achieved soon after addressing 2 key drivers: nurses’ ability to obtain consent and order vaccines. This observation is consistent with findings by Nemerofsky et al, who found an improvement from 13% to 65% of infants receiving HepB within 12 hours of life after adding the vaccine to the admission order set. Our project is unique in its focus on nurse-driven interventions, which revealed significant improvement with minimal additional resources, suggesting this work could be widely replicated at sites where routine newborn care is similarly nurse-driven. A local culture of nursing empowerment may also have contributed to the success of this project. Previous improvement projects focusing on pediatric influenza vaccination rates have similarly revealed that nurse-driven interventions, including consent and ordering of vaccines, can lead to improvement.17,18 

Although we focused interventions on improving our primary outcome, our secondary outcome was also improved by streamlining of vaccine consent and ordering processes as well as staff education regarding HepB birth dose best practices. Providers observed anecdotally that many parents initially refusing the vaccine consented after learning of the updated AAP guidelines. However, the decline in time between nonvaccination events in recent months, along with the high percentage of delayed vaccination events, attributed to parental vaccine hesitancy, does suggest that this obstacle may limit further improvement of both primary and secondary outcomes. Potential future interventions could target parental vaccine hesitancy.

Special cause variation was observed in both the primary and secondary outcomes before the initiation of our improvement project. After thorough review, we were unable to specify the cause of this variation. Possible contributing factors include a delayed impact of the 2016 ACIP and 2017 AAP guidelines; an informal culture change, in which some nurses began obtaining verbal consent ahead of the policy change; increased provider presence and/or nursing vigilance in anticipation of the change in staffing model; or an additional unidentified cause. However, after revising control limits, the process stabilized with our first intervention and subsequently underwent a second process change, suggesting that planned interventions were primarily responsible for the observed improvement.

A potential limitation to the generalizability of this project was the change in the level 1 nursery staffing model. Increased availability of pediatric providers to address parental concerns surrounding HepB and to facilitate vaccine ordering may have contributed to the sustained improvement seen at the start of 2019. However, the additional improvement seen after nursing-based interventions suggests that hospitalist presence alone was not responsible for the changes observed, and thus our interventions ought to be generalizable to other centers. Demographics of our hospital may represent another limitation to generalizability because nonvaccination has been associated with higher maternal education, increased maternal age, and white race.19,20  However, our population had significant representation in all 3 of these categories, and we still achieved high overall vaccination rates. Finally, the presence of nursing students on the postpartum unit may have positively impacted nursing workflow.

We observed significant improvement in the percentage of infants meeting the ACIP and AAP guidelines for HepB birth dose administration within 24 hours of life. This was largely attributable to nurse-led interventions, including ability to obtain vaccine consent and incorporation of the vaccine into our nurse-activated admission order set. Institutions wishing to achieve similar goals could consider these interventions. Given that national benchmarks for administration within this 24-hour time frame are not yet established, we propose a mean of 90% compliance as a benchmark for other institutions.

The authors thank Dr John Co and Dr Brett Nelson for their thoughtful review and commentary of this article, Ms Theresa Jassett and Mr Michael Fiske for their assistance with development of the data collection tool, and Mr David Smith for his assistance with data calculations and article proofreading.

Dr Sarathy conceptualized and designed the study, designed the data collection instruments, collected data, conducted initial data analysis, drafted the initial manuscript, and reviewed and revised the manuscript; Ms Cirillo and Dr Dehn conceptualized and designed the study, designed the data collection instruments, and reviewed and revised the manuscript; Dr Lerou oversaw study design and critically reviewed the manuscript for important intellectual content; Dr Prendergast oversaw study design, collected data, conducted data analysis, and reviewed and revised the manuscript; and all authors approved the final manuscript as submitted.

FUNDING: No external funding.

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Competing Interests

POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.

Supplementary data