732635
research-article2017
AJMXXX10.1177/1062860617732635American Journal of Medical QualityNemerofsky et al
Article
Sustained Improvement in Administration of the Hepatitis B Vaccine Birth Dose: A Quality Improvement Initiative
American Journal of Medical Quality 1–8 © The Author(s) 2017 Reprints and permissions: sagepub.com/journalsPermissions.nav https://doi.org/10.1177/1062860617732635 DOI: 10.1177/1062860617732635 ajmq.sagepub.com
Sheri L. Nemerofsky, MD1, Bolanle Akingboye, DO1, Claudia Ferguson, BS, MPH2, and Dawn Africa, BSN, MS2
Abstract The New York State Department of Health recommends the administration of the hepatitis B vaccine birth dose within 12 hours of life (HOL) for all full-term babies irrespective of maternal hepatitis B status. The primary and secondary aims of the project were to improve the timeliness of vaccine administration and increase the total number of infants vaccinated prior to discharge. Multiple Plan-Do-Study-Act cycles were performed. Statistical process charts of percentages of vaccination within 12 HOL and prior to discharge were constructed with 3-σ (data within 3 standard deviations from a mean) control limits. These control limits were adjusted after achieving significant improvements in performance over time. Administration within 12 HOL improved from 13% to ≥65% within 6 months, and has been sustained for >1 year. Vaccine administration prior to discharge increased from 94% to 98%. Quality improvement methods can rapidly improve adherence to newborn vaccine recommendations and these effects are sustainable. Keywords hepatitis B vaccine, quality improvement, vaccine, newborn Since 1990, the Centers for Disease Control and Prevention (CDC) has made numerous recommendations regarding the optimal time of administration of the hepatitis B vaccine birth dose.1-5 The current recommendations by the CDC are dependent on the maternal serologic status and birth weight of the infant. Infants born to hepatitis B–positive women should receive the vaccine and hepatitis B immunoglobulin (HBIG) within 12 hours of life (HOL) irrespective of their birth weight. Full-term infants born to mothers with unknown hepatitis B status should be given the vaccine within 12 HOL; depending on the birth weight—2000 grams—the HBIG should be administered within 12 HOL or by 7 days of life, respectively. The most recent guidelines endorsed by the CDC recommend administration of the hepatitis B vaccine birth dose within 24 HOL to infants born to hepatitis B–negative mothers.6 In 2006, the Commissioner of Health of the New York State Department of Health (NYSDOH) issued a statement that birthing hospitals should administer the hepatitis B vaccine within 12 HOL to all newborns in order to decrease the risk of hepatitis B infection and its long-term consequences, including cirrhosis, cancer, and death.7 Though this timing is earlier than the CDC recommendation, NYSDOH supports vaccination of all infants within 12 HOL as best practice.
Delay in administration of the hepatitis B vaccine birth dose increases the risk of hepatitis B infection in infants and children and is associated with a decrease in overall vaccine compliance. A national survey, published in 2013, found that less than 40% of newborns received the hepatitis B vaccine birth dose.8 According to the NYSDOH, the percentage of hospitals that vaccinated more than 90% of newborns before discharge in New York City and New York State (NYS) were 60% and 63%, respectively.9,10 The hepatitis B virus is transmitted by blood and other bodily fluids containing blood. In newborns and children, exposure may occur during the perinatal period or by contact with an infected person. In addition, the virus may live outside the body for up to 7 days. Most of these infections are preventable with vaccine administration.11 Hepatitis B infections continue to be a significant 1
Albert Einstein College of Medicine, Children’s Hospital at Montefiore, Bronx, NY 2 Montefiore Medical Center, Bronx, NY Corresponding Author: Sheri L. Nemerofsky, MD, Children’s Hospital at Montefiore, Albert Einstein College of Medicine, 600 East 233rd Street, 3rd Floor, Bronx, NY 10466. Email: [email protected]
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Figure 1. Fishbone diagram depicting factors affecting hepatitis B vaccine administration.
OB, obstetric providers; Peds, pediatric providers; FM, family medicine providers; IT, information technology.
worldwide public safety health issue. The prevalence of chronic hepatitis B carriers range from 0.1% to 0.5% in the United States to 5% to 10% in sub-Saharan Africa and East Asia.12 The recommendation for prenatal hepatitis B screening for all pregnant women was reaffirmed by the American College of Obstetrics and Gynecology in 2016 and is mandated by NYS public health law.13,14 In 2014, at one of the affiliated hospitals, the NYSDOH audited newborn charts to determine the incidence and timeliness of the hepatitis B birth dose vaccination. This event prompted the research team to investigate the hepatitis B vaccine practices at the Wakefield division; the team discovered that 13% of the patients were vaccinated within 12 HOL. This quality improvement (QI) work involved implementation of evidence-based practice to provide the hepatitis B vaccine in a timely fashion and comply with NYSDOH recommendations. There were no new interventions involved that affected the patients. Medical records were accessed by QI team members. No personal health information was shared outside of Montefiore Medical Center. This study was approved by the QI review board.
Methods Setting The Children’s Hospital at Montefiore (Wakefield Division) is located in the Bronx, New York, and provides treatment to more than 2200 live births annually. The hospital serves a diverse, urban, largely immigrant and socioeconomically disadvantaged population at extremely high risk for hepatitis B infection. In the last year at the study institution, the prevalence of obstetric patients who were known hepatitis B carriers at the time of delivery was 0.7%. In addition, approximately 10% of the population arrives without documented maternal serology and there is a 0.6% ambulant birth rate.
The Wakefield division’s mother-child health (MCH) department is staffed with trainees, nurse practitioners, physician assistants, and attending physicians from obstetrics, pediatrics, neonatal, and family medicine services. Additionally, medical students rotate through the department throughout the year. Patient flow after delivery is structured as dyadic mother-baby care. In this setting, the baby remains with the mother throughout the hospitalization and one nurse cares for both the mother and baby following delivery.
Aims A QI project was initiated in the newborn nursery with a goal of increasing administration of the hepatitis B vaccine birth dose within 12 HOL from 13% to 60%, and to 90% of all newborns prior to discharge every month. At one year, the study team reviewed the ongoing performance to assess sustainability.
Interventions A multidisciplinary team was formed to identify, evaluate, and implement Plan-Do-Study-Act (PDSA) cycles to correct factors contributing to suboptimal rates of hepatitis B vaccine administration within 12 HOL and prior to nursery discharge. The team included pediatricians, neonatologists, MCH nurses, family medicine and obstetrical trainees, attending physicians, information technology (IT) staff, and pharmacists. A fishbone diagram was created depicting all the potential areas that affect and may cause delay in vaccine administration (Figure 1). After developing the fishbone diagram, the team developed key drivers (Figure 2) with potential interventions to address the drivers identified. The first PDSA cycle included educational sessions and discussions with postpartum nurses and physician staff on the importance of early vaccination and how to discuss
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Figure 2. Driver diagram defining key points to improve timeliness of vaccine administration.
NYSDOH, New York State Department of Health; IT, information technology; OB, obstetricians; HOL, hours of life.
vaccine recommendations with parents. This included empowering the nursing staff with instructions on how to obtain consent for the vaccination. This process includes the distribution of the mandated vaccination information sheet, discussing the risks and benefits of the vaccine, and documenting the verbal consent from the mother. If parents refused after the initial nursing discussion, a physician would then address the families’ concerns and encourage vaccination. Additionally, the staff was educated on the NYS public health law and the complications of hepatitis B infection for newborns. After discovering that the timely administration rate remained low, it was discussed that often the newborns arrived to the postpartum unit after 12 HOL. Though the education was valuable, it was clear it did not affect timeliness, and it was felt that the wrong group may have been targeted for education. The team quickly recognized the plan needed an adjustment that would involve including providers from other services to discuss the vaccine beginning at the time of the maternal admission onto the labor floor. This second PDSA involved a discussion between nurses and families in the labor room regarding the importance of timely vaccine administration. The nursing team voiced their concerns regarding the inability to give the vaccine without an order. The newborn nursery is not staffed by in-house pediatric providers overnight for routine care, which caused a significant gap for timely order entry of the vaccine. The third PDSA cycle focused on educating the family
medicine physicians and obstetricians about the NYS requirements and importance of the hepatitis B vaccine birth dose in order for these physicians to place the hepatitis B vaccine order right after delivery. There still was no significant change in the vaccination rate following this educational intervention. Although the obstetrical staff had the right intentions, remembering to place the order and finding the correct order within the computerized order entry system remained a challenge. The fourth PDSA cycle involved the IT department. The team believed it would increase compliance if the system was more automated. The obstetric department agreed to amend the obstetrical post-delivery newborn order set to include the order for the hepatitis B vaccine for all newborns. Regular didactic sessions were conducted with the day and night staff to reinforce the reason for the change and inform them about the necessity of a timely vaccination. Additionally, monthly meetings were held with the team to share the results of these interventions.
Measures and Data Collection The intervention was monitored on a monthly basis by determining the percentage of administration of the hepatitis B vaccine within 12 HOL. The statistical process chart was utilized using 3-σ (data within 3 standard deviations) control limits to identify special cause variation.
4 Baseline data for hepatitis B vaccine administration within 12 HOL and prior to discharge was collected from January through November 2014. Excel spreadsheets were utilized to determine time of birth, HOL when the vaccine was ordered, whether or not the vaccine was administered, and, if so, the HOL it was given. This intervention began in December 2014. Approximately 200 infants are born each month. During the baseline and intervention phases, the first 50 healthy infants born each month were audited. Because data were manually extracted, this method was chosen. Data were collected on about 25% of all healthy newborns. Newborn infants admitted to the neonatal intensive care unit were excluded. The average time of order placement was determined on a monthly basis. The incidence of timely administration and administration prior to discharge during the baseline and intervention phases was determined by dividing the number who received the vaccine by 50. At the conclusion of the intervention phase, audits were conducted for 12 months. During this period, every fifth chart was reviewed. Statistical process control (SPC) charts were used for further analysis.
Results The baseline year showed a stable process with common cause variation and an average rate of vaccination within 12 HOL of 13%. The relationship of various interventions to 12-hour administration of hepatitis B vaccine is shown on the annotated SPC chart (Figure 3). During the first 3 months of the project, there was no significant improvement in timeliness of the vaccination. Over this time period, the team continued to grow as they realized the extent of workflow that would be affected by what initially seemed to be a simple change in practice. The average time to order entry of the vaccine was 10 HOL. The most significant process change was the implementation of the vaccine on the obstetric post-delivery newborn order set in mid-April 2015. This decreased the average time of order entry after birth to 30 minutes. This step led to special cause variation and an increase from an average of 13% to 65% within 12 HOL (Figure 3). Vaccination prior to discharge increased to 98% by mid-March 2015 (Figure 4). However, in August 2015 there was a decrease in timeliness of vaccine administration to 38% that created special cause variation (Figure 3). By one year, 79% of newborns received the vaccine within 12 HOL. There were no incident reports filed for duplicate vaccinations or vaccination administration without assent. Overall, 3% to 6% of newborns did not receive the vaccination prior to discharge because of parental refusal.
American Journal of Medical Quality 00(0) During the auditing year, the vaccine rate within 12 HOL ranged from 59% to 79%. The lowest rate was in June 2016. The hospital’s new electronic medical record was implemented at this time, though there was no special cause variation at this time. The vaccination rate prior to discharge remained ≥90% throughout the year.
Discussion This QI initiative addresses a significant need with the study institution’s high-risk obstetric population. At this time, babies are discharged only after the staff have confirmed negative serology during the current pregnancy or the baby received the vaccine and HBIG. None of the patients are discharged before 24 HOL. In the last year, 1.5% of the newborn population received HBIG either because of positive maternal serology or an unknown status at the time of discharge. This is higher than the national average and is a significant problem in this patient population. The study team successfully designed and implemented a QI project to improve the timeliness and overall vaccination rate to newborns. Within 6 months, and after extensive planning and support by obstetrics colleagues, the obstetric post-delivery newborn order set was amended by adding the order for the hepatitis B vaccine birth dose to be placed at the time of delivery. This joint effort immediately remedied delays in order entry by more than 9 hours. This also eased the process for the nurses significantly. For hospitals without 24-hour inhouse pediatric coverage, this will improve timeliness of vaccination significantly. The study team identified a drop in timely administration during the eighth month of the intervention phase, though the rate was still significantly higher than the baseline phase. The following month, while reviewing the data, the team realized that patient volume in August was higher than previous months and the nurse manager of that department along with a significant number of other nursing staff were on vacation the first 2 weeks of the month when charts were being audited. The time invested and team approach to this initiative led to the achievement of the primary and secondary aims by 6 months. This collaborative effort led to recognition of the hospital for 2 consecutive years by the Immunization Action Coalition, a nonprofit organization, as one of the 14 named birth hospitals in NYC to receive honor roll recognition for successful vaccination of more than 90% of newborns annually prior to discharge.15 The biggest improvement occurred after the implementation of adding the vaccine to the obstetric post-delivery newborn admission order set. This indicates that streamlining the ordering process is a high-yield intervention, particularly when primary pediatric providers are not readily
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Figure 3. Statistical process chart for hepatitis B vaccine administration within 12 hours of life. The baseline and one year intervention period included 50 patients per month causing constant control limits. The following year every fifth chart was audited each month. The denominator over these months ranged between 29 and 40 patients. Abbreviation: IT, information technologist; LCL, lower control limit. 1. Inform postpartum nurses and pediatric providers. 2. Inform labor and delivery room nurses and families. 3. Inform family medicine physicians and obstetricians. 4. Work with IT and amend the post-delivery newborn order set. 5. Educate the nursing staff. 6. Educate the nursing staff. *High patient volume and high staff vacation. **New electronic medical record introduced. This did not cause special cause variation; it maintained within the control limits.
available to place admitting orders for infants around the clock. This is a common occurrence throughout the country, and standing orders for nurses to implement or for the obstetric team to assist in the absence of 24-hour pediatric in-house coverage are keys to its success. There were several key stakeholders, particularly MCH nurses, who led this initiative to achieve vaccine administration within 12 HOL. They took on the role to help educate other nurses and provide vaccinations to newborns upon admission to their unit. Educating families prenatally on the benefits of early hepatitis B vaccine administration will also yield higher compliance during the birth hospitalization. One of the reasons families
declined the vaccine was the preference of receiving it in their pediatrician’s office. This is one factor to tackle with the community physicians. The aims of this project are achievable and sustainable, and the value is immeasurable. As a public health initiative, there is an association between overall vaccine compliance and the timing of the hepatitis B vaccine birth dose.16,17 According to WNYC public radio, which provides vaccination rates among school-age children, the immunization rate in the Bronx is higher than 95%.18 However, on a national level, hepatitis B birth dose vaccine compliance remains a significant problem.19 Future investigations as to how this project affects long-term
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Figure 4. Statistical process chart for hepatitis B vaccine administration prior to discharge. The process during the auditing year remained stable while reducing variation within the system.
vaccine compliance have not yet been conducted, but the study team hopes the association found by Yusuf and Lauderdale persists and this project aids in promoting a culture of vaccine acceptance.16,17 Though the refusal rate is low, the team will continue to strive to do more for these patients. This initiative led to new innovations among the nursing and physician staff regarding QI work and specifically the effects of the hepatitis B virus on the study community. This project highlighted the importance of perinatal hepatitis B prevention. Additionally, some of the staff were unaware of the high incidence of hepatitis B infection in the institution’s population and unfamiliar with the consequences of acquired perinatal infection. They also are now aware of the current New York Public Health Law that includes maternal testing within the current pregnancy and that the date and serology results should be in the maternal and neonatal chart. Some members of the team were new to the QI process. Many understood the idea of being part of a team, but learned much more on how to implement system and
behavior changes. This also included determining which changes made an impact on the system. The group learned about auditing a system and, in particular, special cause variation. This project increased the collaborative work effort among the nursing staff of the 3 separate units and helped make the transition of transferring patients from the labor and delivery unit to the newborn nursery and neonatal intensive care unit more seamless. The team is eager to embark on more initiatives to improve patient care. The study limitations include the manner in which the initial charts were selected for review. Random data collection was not possible because of the lack of resources and the study team opted to collect data on the first 50 healthy babies born each month. This was generally the first 10 days of the month. Reviewing data on babies in only this time period may not reflect any changes in staffing or changes in patient volume or acuity over time. In addition, the results were reviewed in the beginning of each month. By doing so, the results may not represent an effect that would last all month long. However, clinical staff were blinded to the timing of the data collection.
Nemerofsky et al During the auditing phase, this limitation was corrected by selecting every fifth healthy baby admitted to the newborn nursery. One setback that was identified during the auditing phase occurred when the new electronic medical record system was implemented. The electronic records were implemented mid-month and the vaccine administration rate dropped within that month from 70% to 53%. Fortunately, the entire staff relearned the workflow in a timely fashion. Though this caused a slightly lower rate for the month, it remained within common cause variation. Within 2 months, the rate increased to 72% and 78%. Future steps for this project also include the expansion of the project to the other birthing facilities within the study medical system. Since the success of this QI initiative, 2 more QI projects have been started in the mother-baby unit. This project demonstrates that QI methods can rapidly improve adherence to NYSDOH recommendations. A successful multidisciplinary team approach to increase the birth dose of hepatitis B vaccine within 12 HOL and prior to discharge is possible. This project led to a successful and sustainable culture change. One year later, the vaccination rate within 12 HOL is greater than 60% and administration prior to discharge remains greater than 90%. Acknowledgment We are very appreciative of the delivery room team who helped initiate the ordering process. We want to thank the entire maternal-child health staff for their support with this initiative and their dedication to improving patient safety. Their enthusiasm helped make the project very successful. We also thank Munish Gupta, MD, MMSc, for his teaching and patience, and for making SPC charts easy; and the quality and performance team at Children’s Hospital at Montefiore, including Michael Rinke, MD, PhD, Elissa Faro, PhD, and Peterkaye Kelly.
Declaration of Conflicting Interests The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The authors received no financial support for the research, authorship, and/or publication of this article.
References 1. Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR Recomm Rep. 1991;40(RR-13):1-25.
7 2. Strikas RA; Centers for Disease Control and Prevention; Advisory Committee on Immunization Practices (ACIP); ACIP Child/Adolescent Immunization Work Group. Advisory committee on immunization practices recommended immunization schedules for persons aged 0 through 18 years—United States, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(4):93-94. 3. Centers for Disease Control and Prevention. Thimerosal in vaccines: a joint statement of the American Academy of Pediatrics and the Public Health Service. MMWR Morb Mortal Wkly Rep. 1999;48:563-565. 4. Centers for Disease Control and Prevention. Availability of hepatitis B vaccine that does not contain thimerosal as a preservative. MMWR Morb Mortal Wkly Rep. 1999;48: 780-782. 5. Mast EE, Margolis HS, Fiore AE, et al. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) part 1: immunization of infants, children, and adolescents. MMWR Recomm Rep. 2005;54(RR-16):1-31. 6. Robinson CL, Romero JR, Kempe A, Pellegrini C; Advisory Committee on Immunization Practices Child/Adolescent Immunization Work Group. Advisory Committee on Immunization Practices recommended immunization schedule for children and adolescents aged 18 years or younger—United States, 2017. MMWR Morb Mortal Wkly Rep. 2017;66(5):134-135. 7. Novello AC.Recently updated recommendations to improve the prevention of preinatal and early childhood hepatitis B virus (HBV) in the United States. https://www.health. ny.gov/professionals/hospital_administrator/letters/2006/ administrator/2006-04-18_recommentations_for_prevention_hepatitis_b_perinatal_early_childhood.pdf. Published April 2006. Accessed November 4, 2014. 8. Zhao Z, Murphy TV.Which newborns missed the hepatitis B birth dose vaccination among U.S. children? Prev Med. 2013;57:613-617. 9. HealthData. Hepatitis B birth dose vaccination rates: beginning 2012. https://www.healthdata.gov/dataset/hepatitisb-birth-dose-vaccination-rates-beginning-2012. Accessed November 21, 2016. 10. NYC Health. Hepatitis B in Pregnancy & Prevention of Perinatal Hepatitis B. http://www1.nyc.gov/site/doh/ providers/health-topics/hepatitis-b-and-pregnancy.page. Accessed November 21, 2016. 11. Wexler DL.Give the birth dose: hepatitis B vaccine at birth saves lives. www.immunize.org/protect-newborns/guide/ chapter2/give-birth-dose.pdf. Accessed August 30, 2017. 12. World Health Organization. Hepatitis B fact sheet. http:// www.who.int/mediacentre/factsheets/fs204/en/. Accessed November 19, 2016. 13. Society for Maternal-Fetal Medicine; Dionne-Odom J, Tita AT, Silverman NS. #38: Hepatitis B in pregnancy screening, treatment, and prevention of vertical transmission. Am J Obstet Gynecol. 2016;214:6-14. 14. Lin K, Vickery J. Screening for hepatitis B virus infection in pregnant women: evidence for the U.S. Preventive
8 Services Task Force reaffirmation recommendation statement. Ann Intern Med. 2009;150:874-876. 15. Immunization Action Coalition. Hepatitis B birth dose honor roll. http://www.immunize.org/honor-roll/birthdose/ honorees.asp#ny. Accessed March 7, 2017. 16. Yusuf HR, Daniels D, Smith P, Coronado V, Rodewald L. Association between administration of hepatitis B vaccine at birth and completion of the hepatitis B and 4:3:1:3 vaccine series. JAMA. 2000;284:978-983.
American Journal of Medical Quality 00(0) 17. Lauderdale DS, Oram RJ, Goldstein KP, Daum RS. Hepatitis B vaccination among children in innercity public housing, 1991-1997. JAMA. 1999;282: 1725-1730. 18. WNYC. Find your school’s vaccination rate. https://project.wnyc.org/vaccinations/. Accessed March 7, 2017. 19. Zhao Z, Murphy TV, Jacques-Carroll L. Progress in newborn hepatitis B vaccination by birth year cohorts-1998-2007, USA. Vaccine. 2011;30:14-20.
research-article2017
AJMXXX10.1177/1062860617732635American Journal of Medical QualityNemerofsky et al
Article
Sustained Improvement in Administration of the Hepatitis B Vaccine Birth Dose: A Quality Improvement Initiative
American Journal of Medical Quality 1–8 © The Author(s) 2017 Reprints and permissions: sagepub.com/journalsPermissions.nav https://doi.org/10.1177/1062860617732635 DOI: 10.1177/1062860617732635 ajmq.sagepub.com
Sheri L. Nemerofsky, MD1, Bolanle Akingboye, DO1, Claudia Ferguson, BS, MPH2, and Dawn Africa, BSN, MS2
Abstract The New York State Department of Health recommends the administration of the hepatitis B vaccine birth dose within 12 hours of life (HOL) for all full-term babies irrespective of maternal hepatitis B status. The primary and secondary aims of the project were to improve the timeliness of vaccine administration and increase the total number of infants vaccinated prior to discharge. Multiple Plan-Do-Study-Act cycles were performed. Statistical process charts of percentages of vaccination within 12 HOL and prior to discharge were constructed with 3-σ (data within 3 standard deviations from a mean) control limits. These control limits were adjusted after achieving significant improvements in performance over time. Administration within 12 HOL improved from 13% to ≥65% within 6 months, and has been sustained for >1 year. Vaccine administration prior to discharge increased from 94% to 98%. Quality improvement methods can rapidly improve adherence to newborn vaccine recommendations and these effects are sustainable. Keywords hepatitis B vaccine, quality improvement, vaccine, newborn Since 1990, the Centers for Disease Control and Prevention (CDC) has made numerous recommendations regarding the optimal time of administration of the hepatitis B vaccine birth dose.1-5 The current recommendations by the CDC are dependent on the maternal serologic status and birth weight of the infant. Infants born to hepatitis B–positive women should receive the vaccine and hepatitis B immunoglobulin (HBIG) within 12 hours of life (HOL) irrespective of their birth weight. Full-term infants born to mothers with unknown hepatitis B status should be given the vaccine within 12 HOL; depending on the birth weight—2000 grams—the HBIG should be administered within 12 HOL or by 7 days of life, respectively. The most recent guidelines endorsed by the CDC recommend administration of the hepatitis B vaccine birth dose within 24 HOL to infants born to hepatitis B–negative mothers.6 In 2006, the Commissioner of Health of the New York State Department of Health (NYSDOH) issued a statement that birthing hospitals should administer the hepatitis B vaccine within 12 HOL to all newborns in order to decrease the risk of hepatitis B infection and its long-term consequences, including cirrhosis, cancer, and death.7 Though this timing is earlier than the CDC recommendation, NYSDOH supports vaccination of all infants within 12 HOL as best practice.
Delay in administration of the hepatitis B vaccine birth dose increases the risk of hepatitis B infection in infants and children and is associated with a decrease in overall vaccine compliance. A national survey, published in 2013, found that less than 40% of newborns received the hepatitis B vaccine birth dose.8 According to the NYSDOH, the percentage of hospitals that vaccinated more than 90% of newborns before discharge in New York City and New York State (NYS) were 60% and 63%, respectively.9,10 The hepatitis B virus is transmitted by blood and other bodily fluids containing blood. In newborns and children, exposure may occur during the perinatal period or by contact with an infected person. In addition, the virus may live outside the body for up to 7 days. Most of these infections are preventable with vaccine administration.11 Hepatitis B infections continue to be a significant 1
Albert Einstein College of Medicine, Children’s Hospital at Montefiore, Bronx, NY 2 Montefiore Medical Center, Bronx, NY Corresponding Author: Sheri L. Nemerofsky, MD, Children’s Hospital at Montefiore, Albert Einstein College of Medicine, 600 East 233rd Street, 3rd Floor, Bronx, NY 10466. Email: [email protected]
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American Journal of Medical Quality 00(0)
Figure 1. Fishbone diagram depicting factors affecting hepatitis B vaccine administration.
OB, obstetric providers; Peds, pediatric providers; FM, family medicine providers; IT, information technology.
worldwide public safety health issue. The prevalence of chronic hepatitis B carriers range from 0.1% to 0.5% in the United States to 5% to 10% in sub-Saharan Africa and East Asia.12 The recommendation for prenatal hepatitis B screening for all pregnant women was reaffirmed by the American College of Obstetrics and Gynecology in 2016 and is mandated by NYS public health law.13,14 In 2014, at one of the affiliated hospitals, the NYSDOH audited newborn charts to determine the incidence and timeliness of the hepatitis B birth dose vaccination. This event prompted the research team to investigate the hepatitis B vaccine practices at the Wakefield division; the team discovered that 13% of the patients were vaccinated within 12 HOL. This quality improvement (QI) work involved implementation of evidence-based practice to provide the hepatitis B vaccine in a timely fashion and comply with NYSDOH recommendations. There were no new interventions involved that affected the patients. Medical records were accessed by QI team members. No personal health information was shared outside of Montefiore Medical Center. This study was approved by the QI review board.
Methods Setting The Children’s Hospital at Montefiore (Wakefield Division) is located in the Bronx, New York, and provides treatment to more than 2200 live births annually. The hospital serves a diverse, urban, largely immigrant and socioeconomically disadvantaged population at extremely high risk for hepatitis B infection. In the last year at the study institution, the prevalence of obstetric patients who were known hepatitis B carriers at the time of delivery was 0.7%. In addition, approximately 10% of the population arrives without documented maternal serology and there is a 0.6% ambulant birth rate.
The Wakefield division’s mother-child health (MCH) department is staffed with trainees, nurse practitioners, physician assistants, and attending physicians from obstetrics, pediatrics, neonatal, and family medicine services. Additionally, medical students rotate through the department throughout the year. Patient flow after delivery is structured as dyadic mother-baby care. In this setting, the baby remains with the mother throughout the hospitalization and one nurse cares for both the mother and baby following delivery.
Aims A QI project was initiated in the newborn nursery with a goal of increasing administration of the hepatitis B vaccine birth dose within 12 HOL from 13% to 60%, and to 90% of all newborns prior to discharge every month. At one year, the study team reviewed the ongoing performance to assess sustainability.
Interventions A multidisciplinary team was formed to identify, evaluate, and implement Plan-Do-Study-Act (PDSA) cycles to correct factors contributing to suboptimal rates of hepatitis B vaccine administration within 12 HOL and prior to nursery discharge. The team included pediatricians, neonatologists, MCH nurses, family medicine and obstetrical trainees, attending physicians, information technology (IT) staff, and pharmacists. A fishbone diagram was created depicting all the potential areas that affect and may cause delay in vaccine administration (Figure 1). After developing the fishbone diagram, the team developed key drivers (Figure 2) with potential interventions to address the drivers identified. The first PDSA cycle included educational sessions and discussions with postpartum nurses and physician staff on the importance of early vaccination and how to discuss
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Figure 2. Driver diagram defining key points to improve timeliness of vaccine administration.
NYSDOH, New York State Department of Health; IT, information technology; OB, obstetricians; HOL, hours of life.
vaccine recommendations with parents. This included empowering the nursing staff with instructions on how to obtain consent for the vaccination. This process includes the distribution of the mandated vaccination information sheet, discussing the risks and benefits of the vaccine, and documenting the verbal consent from the mother. If parents refused after the initial nursing discussion, a physician would then address the families’ concerns and encourage vaccination. Additionally, the staff was educated on the NYS public health law and the complications of hepatitis B infection for newborns. After discovering that the timely administration rate remained low, it was discussed that often the newborns arrived to the postpartum unit after 12 HOL. Though the education was valuable, it was clear it did not affect timeliness, and it was felt that the wrong group may have been targeted for education. The team quickly recognized the plan needed an adjustment that would involve including providers from other services to discuss the vaccine beginning at the time of the maternal admission onto the labor floor. This second PDSA involved a discussion between nurses and families in the labor room regarding the importance of timely vaccine administration. The nursing team voiced their concerns regarding the inability to give the vaccine without an order. The newborn nursery is not staffed by in-house pediatric providers overnight for routine care, which caused a significant gap for timely order entry of the vaccine. The third PDSA cycle focused on educating the family
medicine physicians and obstetricians about the NYS requirements and importance of the hepatitis B vaccine birth dose in order for these physicians to place the hepatitis B vaccine order right after delivery. There still was no significant change in the vaccination rate following this educational intervention. Although the obstetrical staff had the right intentions, remembering to place the order and finding the correct order within the computerized order entry system remained a challenge. The fourth PDSA cycle involved the IT department. The team believed it would increase compliance if the system was more automated. The obstetric department agreed to amend the obstetrical post-delivery newborn order set to include the order for the hepatitis B vaccine for all newborns. Regular didactic sessions were conducted with the day and night staff to reinforce the reason for the change and inform them about the necessity of a timely vaccination. Additionally, monthly meetings were held with the team to share the results of these interventions.
Measures and Data Collection The intervention was monitored on a monthly basis by determining the percentage of administration of the hepatitis B vaccine within 12 HOL. The statistical process chart was utilized using 3-σ (data within 3 standard deviations) control limits to identify special cause variation.
4 Baseline data for hepatitis B vaccine administration within 12 HOL and prior to discharge was collected from January through November 2014. Excel spreadsheets were utilized to determine time of birth, HOL when the vaccine was ordered, whether or not the vaccine was administered, and, if so, the HOL it was given. This intervention began in December 2014. Approximately 200 infants are born each month. During the baseline and intervention phases, the first 50 healthy infants born each month were audited. Because data were manually extracted, this method was chosen. Data were collected on about 25% of all healthy newborns. Newborn infants admitted to the neonatal intensive care unit were excluded. The average time of order placement was determined on a monthly basis. The incidence of timely administration and administration prior to discharge during the baseline and intervention phases was determined by dividing the number who received the vaccine by 50. At the conclusion of the intervention phase, audits were conducted for 12 months. During this period, every fifth chart was reviewed. Statistical process control (SPC) charts were used for further analysis.
Results The baseline year showed a stable process with common cause variation and an average rate of vaccination within 12 HOL of 13%. The relationship of various interventions to 12-hour administration of hepatitis B vaccine is shown on the annotated SPC chart (Figure 3). During the first 3 months of the project, there was no significant improvement in timeliness of the vaccination. Over this time period, the team continued to grow as they realized the extent of workflow that would be affected by what initially seemed to be a simple change in practice. The average time to order entry of the vaccine was 10 HOL. The most significant process change was the implementation of the vaccine on the obstetric post-delivery newborn order set in mid-April 2015. This decreased the average time of order entry after birth to 30 minutes. This step led to special cause variation and an increase from an average of 13% to 65% within 12 HOL (Figure 3). Vaccination prior to discharge increased to 98% by mid-March 2015 (Figure 4). However, in August 2015 there was a decrease in timeliness of vaccine administration to 38% that created special cause variation (Figure 3). By one year, 79% of newborns received the vaccine within 12 HOL. There were no incident reports filed for duplicate vaccinations or vaccination administration without assent. Overall, 3% to 6% of newborns did not receive the vaccination prior to discharge because of parental refusal.
American Journal of Medical Quality 00(0) During the auditing year, the vaccine rate within 12 HOL ranged from 59% to 79%. The lowest rate was in June 2016. The hospital’s new electronic medical record was implemented at this time, though there was no special cause variation at this time. The vaccination rate prior to discharge remained ≥90% throughout the year.
Discussion This QI initiative addresses a significant need with the study institution’s high-risk obstetric population. At this time, babies are discharged only after the staff have confirmed negative serology during the current pregnancy or the baby received the vaccine and HBIG. None of the patients are discharged before 24 HOL. In the last year, 1.5% of the newborn population received HBIG either because of positive maternal serology or an unknown status at the time of discharge. This is higher than the national average and is a significant problem in this patient population. The study team successfully designed and implemented a QI project to improve the timeliness and overall vaccination rate to newborns. Within 6 months, and after extensive planning and support by obstetrics colleagues, the obstetric post-delivery newborn order set was amended by adding the order for the hepatitis B vaccine birth dose to be placed at the time of delivery. This joint effort immediately remedied delays in order entry by more than 9 hours. This also eased the process for the nurses significantly. For hospitals without 24-hour inhouse pediatric coverage, this will improve timeliness of vaccination significantly. The study team identified a drop in timely administration during the eighth month of the intervention phase, though the rate was still significantly higher than the baseline phase. The following month, while reviewing the data, the team realized that patient volume in August was higher than previous months and the nurse manager of that department along with a significant number of other nursing staff were on vacation the first 2 weeks of the month when charts were being audited. The time invested and team approach to this initiative led to the achievement of the primary and secondary aims by 6 months. This collaborative effort led to recognition of the hospital for 2 consecutive years by the Immunization Action Coalition, a nonprofit organization, as one of the 14 named birth hospitals in NYC to receive honor roll recognition for successful vaccination of more than 90% of newborns annually prior to discharge.15 The biggest improvement occurred after the implementation of adding the vaccine to the obstetric post-delivery newborn admission order set. This indicates that streamlining the ordering process is a high-yield intervention, particularly when primary pediatric providers are not readily
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Figure 3. Statistical process chart for hepatitis B vaccine administration within 12 hours of life. The baseline and one year intervention period included 50 patients per month causing constant control limits. The following year every fifth chart was audited each month. The denominator over these months ranged between 29 and 40 patients. Abbreviation: IT, information technologist; LCL, lower control limit. 1. Inform postpartum nurses and pediatric providers. 2. Inform labor and delivery room nurses and families. 3. Inform family medicine physicians and obstetricians. 4. Work with IT and amend the post-delivery newborn order set. 5. Educate the nursing staff. 6. Educate the nursing staff. *High patient volume and high staff vacation. **New electronic medical record introduced. This did not cause special cause variation; it maintained within the control limits.
available to place admitting orders for infants around the clock. This is a common occurrence throughout the country, and standing orders for nurses to implement or for the obstetric team to assist in the absence of 24-hour pediatric in-house coverage are keys to its success. There were several key stakeholders, particularly MCH nurses, who led this initiative to achieve vaccine administration within 12 HOL. They took on the role to help educate other nurses and provide vaccinations to newborns upon admission to their unit. Educating families prenatally on the benefits of early hepatitis B vaccine administration will also yield higher compliance during the birth hospitalization. One of the reasons families
declined the vaccine was the preference of receiving it in their pediatrician’s office. This is one factor to tackle with the community physicians. The aims of this project are achievable and sustainable, and the value is immeasurable. As a public health initiative, there is an association between overall vaccine compliance and the timing of the hepatitis B vaccine birth dose.16,17 According to WNYC public radio, which provides vaccination rates among school-age children, the immunization rate in the Bronx is higher than 95%.18 However, on a national level, hepatitis B birth dose vaccine compliance remains a significant problem.19 Future investigations as to how this project affects long-term
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Figure 4. Statistical process chart for hepatitis B vaccine administration prior to discharge. The process during the auditing year remained stable while reducing variation within the system.
vaccine compliance have not yet been conducted, but the study team hopes the association found by Yusuf and Lauderdale persists and this project aids in promoting a culture of vaccine acceptance.16,17 Though the refusal rate is low, the team will continue to strive to do more for these patients. This initiative led to new innovations among the nursing and physician staff regarding QI work and specifically the effects of the hepatitis B virus on the study community. This project highlighted the importance of perinatal hepatitis B prevention. Additionally, some of the staff were unaware of the high incidence of hepatitis B infection in the institution’s population and unfamiliar with the consequences of acquired perinatal infection. They also are now aware of the current New York Public Health Law that includes maternal testing within the current pregnancy and that the date and serology results should be in the maternal and neonatal chart. Some members of the team were new to the QI process. Many understood the idea of being part of a team, but learned much more on how to implement system and
behavior changes. This also included determining which changes made an impact on the system. The group learned about auditing a system and, in particular, special cause variation. This project increased the collaborative work effort among the nursing staff of the 3 separate units and helped make the transition of transferring patients from the labor and delivery unit to the newborn nursery and neonatal intensive care unit more seamless. The team is eager to embark on more initiatives to improve patient care. The study limitations include the manner in which the initial charts were selected for review. Random data collection was not possible because of the lack of resources and the study team opted to collect data on the first 50 healthy babies born each month. This was generally the first 10 days of the month. Reviewing data on babies in only this time period may not reflect any changes in staffing or changes in patient volume or acuity over time. In addition, the results were reviewed in the beginning of each month. By doing so, the results may not represent an effect that would last all month long. However, clinical staff were blinded to the timing of the data collection.
Nemerofsky et al During the auditing phase, this limitation was corrected by selecting every fifth healthy baby admitted to the newborn nursery. One setback that was identified during the auditing phase occurred when the new electronic medical record system was implemented. The electronic records were implemented mid-month and the vaccine administration rate dropped within that month from 70% to 53%. Fortunately, the entire staff relearned the workflow in a timely fashion. Though this caused a slightly lower rate for the month, it remained within common cause variation. Within 2 months, the rate increased to 72% and 78%. Future steps for this project also include the expansion of the project to the other birthing facilities within the study medical system. Since the success of this QI initiative, 2 more QI projects have been started in the mother-baby unit. This project demonstrates that QI methods can rapidly improve adherence to NYSDOH recommendations. A successful multidisciplinary team approach to increase the birth dose of hepatitis B vaccine within 12 HOL and prior to discharge is possible. This project led to a successful and sustainable culture change. One year later, the vaccination rate within 12 HOL is greater than 60% and administration prior to discharge remains greater than 90%. Acknowledgment We are very appreciative of the delivery room team who helped initiate the ordering process. We want to thank the entire maternal-child health staff for their support with this initiative and their dedication to improving patient safety. Their enthusiasm helped make the project very successful. We also thank Munish Gupta, MD, MMSc, for his teaching and patience, and for making SPC charts easy; and the quality and performance team at Children’s Hospital at Montefiore, including Michael Rinke, MD, PhD, Elissa Faro, PhD, and Peterkaye Kelly.
Declaration of Conflicting Interests The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The authors received no financial support for the research, authorship, and/or publication of this article.
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