# Presentation: 047918

## Universal Birth Dose Hepatitis B: A Safety Net

- Pat Fineis
- Michigan Department of Community Health

**Notes:**
Hi, my name is Pat Fineis.  I am the Perinatal Hepatitis B Coordinator for Michigan.  

## Overview

- History of Michigan’s Universal Hepatitis B Vaccination Program
- Case example and responses to tragedy
- Process of adding hepatitis B (hep B) administration information to birth certificate and immunization registry
- Evaluation tools and methods to increase hep B birth dose coverage levels
- Barriers to implement birth dose
- Hospital enrollment process

**Notes:**
Today, I will be discussing the history of Michigan’s Universal Hepatitis B Vaccination Program; I will provide a case example and responses to a tragedy that occurred in Michigan; I will discuss the process of adding hepatitis B administration information to our birth certificate and to our immunization registry; I will share evaluation tools and methods we used to increase hepatitis B birth dose coverage levels; I will discuss barriers to implementing the birth dose of hepatitis B vaccine; and I will discuss our universal hepatitis B hospital enrollment process.  

## Michigan’s History

- 1991 Universal Hepatitis B Vaccination Program began
- Goal: offer hep B vaccine to all birthing hospitals for all infants
- Michigan’s birth cohort
- 132,000 (1991)
- 128,000 (2007)
- Visited and provided education to all birthing hospitals  (102)

**Notes:**
In 1991, Michigan’s Universal Hepatitis B Vaccination Program began.  The goal of this program is to offer hepatitis B vaccine to all birthing hospitals so that they can provide hepatitis B vaccine to all of the infants born in their facility.  When we first began our program, our birth cohort was 132,000 and has since decreased to approximately 128,000, however we found it feasible to be able to offer this program.  When we first rolled out the Universal Hepatitis B Vaccination Program we visited all 102 birthing hospitals, we provided education on the current recommendations to offer hepatitis B vaccine to all babies, how to order hepatitis B vaccine from their local health department (LHD) and made sure that we had the most current contact information for each hospital.    

## Hepatitis B Birth Dose is Postponed

- July – September 1999
- Thimerosal statement released
- Recommendation:
- Postpone birth dose until 2 - 6 months of age if infant born to hepatitis B surface antigen (HBsAg)-negative woman
- Give birth dose to infants born to HBsAg-positive and unknown HBsAg status women

**Notes:**
Between July and September of 1999 as many of you may recall there was concern that our babies were receiving too much thimerosal in the recommended childhood immunization series.  Since hepatitis B vaccine contained thimerosal at this time, Centers for Disease Control and Prevention (CDC) released a statement to postpone the birth dose of hepatitis B vaccine until 2-6 months of age if the infant was born to a hepatitis B surface antigen (HBsAg) negative woman.  The statement also recommended continuing to give the birth dose of hepatitis B vaccine to the infants born to women who were HBsAg-positive or whose HBsAg status was unknown.  Unfortunately, due to this statement there was a loss in momentum for birthing hospitals to give the birth dose of hepatitis B vaccine.  And unfortunately many errors occurred in documentation of mom’s HBsAg status which led to some errors in providing appropriate prophylaxis to our newborns. These errors caused a serious tragedy in Michigan. 

## Case Example

- Mother
- 15 y.o. HBsAg-positive Laotian female
- 10 prenatal visits
- Lab and prenatal care provider (PCP) did not report HBsAg-positive result to local health department (LHD)
- PCP reported HBsAg result as negative on prenatal record sent to delivery hospital
- Infant
- Healthy baby girl born (38 wks gestation)
- Mom’s HBsAg status also noted as HBsAg-negative in baby’s chart
- Due to recommendation to delay birth dose, no hep B vaccine was given

**Notes:**
A 15 year old Laotian female tested HBsAg-positive during one of her 10 prenatal visits.  The lab performing the HBsAg test and the prenatal care provider ordering the HBsAg test did not report the HBsAg-positive result to the LHD even though Michigan has a testing and reporting law that requires labs and ordering physicians to report all HBsAg positive results to their LHD.  The prenatal care provider did report mom’s HBsAg result to the delivery hospital, but due to a transcription error it was hand written as HBsAg-negative.  Mom delivered a healthy baby girl.  However, mom’s HBsAg status was also noted as HBsAg-negative in the baby’s chart and due to the latest recommendation to delay the birth dose to infants born to HBsAg-negative mother, no hepatitis B vaccine was given. 

## Case Example (cont’d)

- 2 months of age
- 1st dose of hep B vaccine
- 3 months of age
- Ill with fever, diarrhea, jaundice
- 5 days after onset of symptoms
- Diagnosed with HBV infection and acute liver failure
- 8 days after becoming ill
- Infant dies

**Notes:**
At two months of age the baby girl received the first dose of hepatitis B vaccine, but it was too late. By three months of age the baby became ill with a fever, diarrhea and jaundice.  Five days after the onset of these symptoms mom took the baby to the emergency room and the baby was diagnosed with having hepatitis B virus infection with acute liver failure.  Three days later the baby died due to fulminant hepatitis B infection.    

## Response to Situation

- Presented case study in newsletters and conferences
- Visited 102 birthing hospitals
- Provided new CDC recommendations
- Reinforced state law
- Recommended original lab report with prenatal record to birthing hospital

**Notes:**
A response to this tragedy was presented in newsletters and at conferences.  We visited all of our birthing hospitals and provided the new CDC recommendations to reinstate or implement giving the birth dose of hepatitis B vaccine to all newborns.  We reinforced our state laws to test all pregnant women and to report all HBsAg-positive test results to the LHD and we recommended sending a copy of the original lab report with the prenatal records to the birthing hospital so that we could prevent a tragedy like this from ever occurring again.     

## Method to Assess Efforts

- Conducted hospital surveys
- 1999
- 82 of 102 (80%) had written policies and standing orders to give hep B birth dose
- 2001
- 92 of 102 (90%) had written polices and standing orders
- Identified need for an assessment tool to measure hep B birth dose

**Notes:**
In 1999, we conducted a hospital survey; 80% of our birthing hospitals had written policies and standing orders to give the birth dose of hepatitis B vaccine to all babies.  After the thimerosal scare and the unfortunate death of the baby girl, only 90% of the birthing hospitals surveyed in 2001 had written policies and standing orders in place. After all this we identified the need for an assessment tool to measure the hepatitis B birth dose coverage levels.  We wanted to make sure that even if we had a missed opportunity or if we had a transcription error we would still be able to offer a “safety net” of protection by providing the hepatitis B birth dose.  

## Adding Hepatitis B to Electronic Birth Certificate (EBC), 1999-2000

- Meetings with records manager and data entry staff
- Goal:
- Documentation of hep B vaccine dose on EBC
- Box created to include hep B vaccine administration
- Yes or No field
- Date vaccine given (month/day/year)

**Notes:**
In 1999, Michigan met with the manager from our vital records department and their data entry staff.  Our goal was to have documentation of the hepatitis B vaccine dose included on the electronic birth certificate record.  After discussion with the group they were able to create a box which included a yes or no field to indicate if hepatitis B vaccine was administered and a date field to record the date the vaccine was given.  

## EBC - Hepatitis B Birth Dose

**Notes:**
This is a snapshot of the actual electronic birth certificate record and the box that includes the hepatitis B vaccine administration fields. 

## Adding Hepatitis B Birth Dose to Immunization Registry, 2000-2001

- Identified need to capture hep B birth dose through the immunization registry
- Meetings with immunization registry coordinator and technology staff - Michigan Care Improvement Registry (MCIR)
- Goal:
- Create a process to obtain the birth dose data
- Develop process to download EBC birth dose data into MCIR

**Notes:**
In 2000, we identified a need to be able to capture the hepatitis B birth dose information that was being recorded on the electronic birth certificate records through the immunization registry.  We met with the immunization registry coordinator and the technology staff.  Michigan’s immunization registry is the Michigan Care Improvement Registry or MCIR.  The goal of this meeting was to create a process to obtain the hepatitis B birth dose data and to develop a process to download the hepatitis B birth dose data from the electronic birth certificate record to our immunization registry.  

## Monitoring Hep B Birth Dose, 2002

- Began monitoring the birth dose coverage levels
- Developed reports based on the information entered into Michigan Care Improvement Registry (MCIR)
- County
- Birthing hospital
- Number of births
- Number of doses given within 4 days of life
- Percentages of births/number of doses
- Discovered only 72% of Michigan’s babies were receiving hep B birth dose

**Notes:**
By 2002, Michigan began monitoring the hepatitis B birth dose coverage levels.  We developed reports based on the information that was entered into our immunization registry from the electronic birth certificate records.  The reports include hepatitis B birth dose coverage levels by county, birthing hospital, and included the number of births, number of doses given within 4 days of life and the percentages of babies receiving the birth dose of hepatitis B vaccine.  We discovered in 2002, only 72% of Michigan’s babies were receiving the birth dose of hepatitis B vaccine based on our immunization registry data.

## Issues and Barriers

- Lag time of 2 – 3 weeks to get birth dose data into MCIR
- Downloading problems
- Electronic systems not compatible
- Billing data conflicts
- Some hospitals batching data
- Documentation problems
- EBC didn’t include hep B
- Neonatal Intensive Care Unit (NICU) not documenting
- Education and training were needed

**Notes:**
We identified issues and barriers with the hepatitis B birth dose data that was being reported to our immunization registry.  Sometimes there was a lag time of two to three weeks to get the birth dose of hepatitis B data from the birthing hospital electronic birth certificate into MCIR.  We experienced problems with downloading data because some of the existing hospital electronic reporting systems were not compatible with our immunization registry.  Sometimes hospitals used billing data and the dates that were recorded in the billing data were not necessarily the hepatitis B administration dates. Some hospitals, especially those with a smaller number of births, were batching their data causing a lag time of 2-3 weeks or longer before the data was actually sent to the state.  This would cause problems with the follow-up providers accessing the birth dose information in the registry.  Additional time would be spent to make calls to the delivery hospital medical records department to verify if vaccine was given, or this could cause the child to receive an additional dose that they didn’t need.  Documentation issues also became a problem.  Some hospitals had trouble recording the birth dose of hepatitis B vaccine on the electronic birth certificate prior to sending the data to the state.  If the vaccine was not documented on the electronic birth certificate prior to submission to the state, the birth dose information would have to be hand entered.  This seemed to be a reoccurring problem for our neonatal intensive care unit NICU babies.  Most of the babies who went to the NICU were not necessarily eligible for the birth dose of hepatitis B vaccine, but if they were to receive a birth dose or even a dose at a later date but prior to discharge, these doses were not being entered into the immunization registry.  We identified that additional education and training were needed.  

##     Publicizing Hepatitis B Birth Dose, 2000

- Published results in Immunization Newsletter by hospital name (>10,000 readers)
- Reinstating/implementing written policies and standing orders to OFFER birth dose to all infants (based on survey results)
- 82 of 102 (80%) hospitals had policies in place to offer hep B to all newborns
- Generated many calls
- Discussed hospital process
- Reporting birth dose information to state
- Documenting birth dose on EBC (yes and date)
- Continued to update and publish list quarterly

**Notes:**
In 2000, we published hepatitis B birth dose results in our Immunization Newsletter which was distributed to over 10,000 readers. These results included the names of the hospitals that reinstated or implemented written policies and standing orders to OFFER hepatitis B birth dose to all infants.  Based on the 2000 survey, only 80% of Michigan’s birthing hospitals had policies in place to offer hepatitis B vaccine to all newborns. As you can imagine, this generated many calls.  Through these calls we were able to discuss the hospital’s process of documenting the hepatitis B birth dose on the electronic birth certificate to the state.  In order for the vaccine administration information to download to our immunization registry the hospital staff had to mark the box “yes” and include the date of administration.  If one or both fields were not completed the information would not post to the immunization registry. We continued to update and publish the list of birthing hospital names quarterly.  

## Publicizing Hepatitis B Birth Dose, 2002

- Published article that listed hospitals by name
- Written policies and standing orders to offer hep B vaccine to ALL newborns
**AND**
- Birth dose coverage levels _> _90% (based on MCIR data)
- 32 of 102 hospitals named (31%)
- Caused concern among hospitals and prompted
- More calls
- Hospitals to re-evaluate their systems
- State to verify birth data

**Notes:**
In 2002, we continued to publish articles that listed the hospitals by name that had written policies and standing orders to offer hepatitis B vaccine to 100% of their newborns, and those who also had documentation of hepatitis B birth dose coverage levels of 90% or greater based on our immunization registry (MCIR) data.  There were only 32 hospitals who met these criteria.  This caused great concern among hospital staff and prompted more calls. It allowed additional discussion about how hospitals were documenting the birth dose information and the need to re-evaluate their reporting systems.  It also prompted the state to verify our hepatitis B birth dose data.

## Ongoing Activities

- Presentations
- Created and distributed program manual
- Conduct hospital surveys
- Identify/update contacts
- Listserv for hospital and LHD contacts
- Provide updates on policy/procedure information
- Provide program manual updates annually
- Distribute hep B birth dose coverage level reports semi-annually
- Direct contact (phone call, e-mail or site visit)

**Notes:**
We continue to conduct presentations about birth dose data with birthing facilities.  We created and distributed the Perinatal Hepatitis B Program manual and distributed it to all of our birthing hospitals, local health departments, obgyn offices, laboratories, pediatricians and our family practitioners.  There were approximately 3000 manuals distributed.  It is now available on line and all updates are made directly on line.  We try to conduct hospital surveys at least every other year and continue to identify and update our contacts at each facility.  With staff turnover we try to ask for updates every time we make a call to a hospital.  We created a listserv for both our hospitals and our local health department contacts.  With a quick e-mail, we are able to provide updates regarding program policy and procedural information, disperse annual program manual updates and distribute and discuss hepatitis B birth dose coverage level reports at least semi-annually. We find that it is still very important to have as much direct contact with the hospitals and local health departments to continue to form and establish relationships.  Most of our contact is done through telephone conversations or periodic e-mails due to time and travel constraints.  But it is still very important to be able to conduct chart reviews at the hospitals and have site visits when needed. 

## Hepatitis B Birth Dose Coverage Levels - MCIR

- MCIR hep B birth dose coverage levels (within 4 days of life)
- 76% in 2004
- 78% in 2005
- 80% in 2006
- 81% in 2007

**Notes:**
Since 2002, we have been analyzing our hepatitis B birth dose data through our state immunization registry (MCIR) for all doses given within 4 days of life.  Based on the information from our registry in 2004, we identified that 76% of our babies were receiving the birth dose of hepatitis B vaccine within 4 days of life.  Annually we have increased our hepatitis B birth dose coverage by 2% in 2005 and 2006 and 1% in 2007.  We continue to work with our birthing hospitals to correct downloading and documentation issues to ensure a “safety net” of providing the birth dose of hepatitis B vaccine is in place in all of our birthing hospitals.  

## Hepatitis B Birth Dose Coverage Levels - NIS

- Hep B birth dose coverage levels from the National Immunization Survey (NIS) are within 2 days of life
- 2006 Michigan ranks 3rd highest in nation
- National:  48.8% _+_ 1.1
- Michigan: 78.3% _+_ 5.0
- Detroit, MI:  81.7% _+_ 5.6

**Notes:**
Nationally, the birth dose coverage levels are evaluated through the National Immunization Survey for doses given within the first two days of life.  With this survey, the nation was at a 49% hepatitis B birth dose coverage level.  Michigan was ranked 3rd highest in the nation at 78% with one of our largest cities, Detroit at 82%.  Michigan has worked very hard to increase the hepatitis B birth dose coverage levels but still has a long way to go. Per a CDC presentation, “For every 15 infants born to HBsAg-positive mothers who are identified and given post-exposure prophylaxis one death is prevented.” Our greatest concern is since the Perinatal Hepatitis B Prevention Programs identify less than 50% of all births to HBsAg-positive pregnant women in the United States we have to strive harder as a nation to provide the “safety net” that the birth dose of hepatitis B vaccine can offer. 

## New EBC - Hepatitis B Birth Dose and HBIG Reporting, 2007

- Created new web based electronic birth certificate (EBC) worksheet
- HBIG was added
- New EBC now includes:
- Hep B vaccine
- HBIG

**Notes:**
In 2007, Michigan created and started using a new web based electronic birth certificate worksheet.  This new worksheet allowed us to have an HBIG field added.  Our electronic birth certificate now has fields which include both the hepatitis B vaccine and HBIG administration.  

## New EBC Fields

**Notes:**
This is a snapshot of the hepatitis B immunization and the HBIG fields as they appear on our new electronic birth certificate.  

## Universal Hepatitis B Vaccination Program, 2003

- Continuous need to evaluate and improve methods
- Developed Enrollment Form with MI’s Vaccines for Children (VFC) Program which requires hospitals:
- Minimal paperwork
- Complete profile table
- Total annual number of births who were:
- Enrolled in Medicaid
- Uninsured
- American Indian/Alaska Native
- Underinsured/Fully insured/Private Pay

**Notes:**
Back in 2003, we identified the need to evaluate and improve our Universal Hepatitis B Vaccination Program.  In collaboration with our Vaccines for Children (VFC) Program staff we developed Universal Hepatitis B Vaccination Program enrollment forms.  These forms required our hospitals to enroll annually to receive the hepatitis B vaccine for all of their newborns.  It involves minimal paperwork but does require the hospital to complete a profile table.  This profile table provides the total annual births for those who were enrolled in Medicaid, uninsured, American Indian, Alaska Native, or who were underinsured, fully insured or had private pay.  

## Funding of Universal Program

- Develop annual population estimates to determine annual allocation of federal funds
- Michigan’s birth cohort x $9.50 = ($1,200,000)
- Estimate 46% are VFC eligible (enrolled in Medicaid, uninsured, American Indian, Alaska Native, and those underinsured served at FQHC/RHC)
- 54% served by 317/state funding (insured, underinsured) = ($648,000)

**Notes:**
With these profiles the VFC program staff are able to develop annual population estimates to determine annual allocations of federal funds to provide the universal hepatitis B vaccine to hospitals for all babies born in Michigan.  With these population estimates, based on our birth cohort times approximately $10 per dose for the hepatitis B vaccine, with 46% of our births being served under the VFC program, and approximately 54% of all babies who would need to be served by our 317 and state funding, it would only cost $648,000.  In the scheme of our annual immunization budget, it is feasible for Michigan as it would be for most of you, to be able to provide the birth dose of hepatitis B vaccine to those who are uninsured or are underinsured.      

## Hospital Enrollment Process

- Hospital eligibility information based on:
- Registry data (preferred)
- Billing data
- Tally Sheets
- Prior year’s ordering data
- Doses administered report
- Shipping information (site days/hours of operation)
- Forms due to state by February 15th

**Notes:**
The enrollment form requires hospital eligibility information.  This can be based on immunization registry data which is the preferred method of obtaining this information, through tally sheets, the prior year’s ordering data or a doses administered report.  The enrollment form also includes shipping information which should include the correct mailing address and the days and hours the facility is in operation so that they can receive vaccine shipments.  These forms are due to the state by February 15th of each year.  

## Recruiting Hospitals to Program

- VFC provides a list of hospitals not enrolled
- Call LHD to determine if there are specific issues/corrective action plans
- Contact hospital pharmacy manager/director to discuss:
- Barriers
- Universal Program
- Recommendations
- Ease of obtaining hep B vaccine
- Cost savings

**Notes:**
After the February 15th deadline it takes the VFC clerk a few weeks to a month to enter all of the data.  Once this is completed, she provides the Perinatal Hepatitis B Coordinator with a list of the hospitals not enrolled in the program.  The coordinator calls the local health department for each hospital to determine if there are any specific issues or corrective action plans that may prohibit a hospital from enrolling in the Universal Hepatitis B Vaccination Program.  If there are issues, then we work to get them corrected.  If not, I work with the local health department and contact the hospital pharmacy manager or pharmacy director to find out what barriers exist that are keeping them from enrolling in the program.  I discuss what the Universal Hepatitis B Vaccination Program entails, the current recommendations to offer hepatitis B vaccine to all infants prior to hospital discharge, how easy it is to obtain the hepatitis B vaccine and how much of a cost savings this program has for the hospital.  

## 	Assessing Enrollment Process

- 2004
- 54 of 95 birthing hospitals enrolled (57%)
- 2005
- Identified barriers
- Too much paperwork
- Didn’t know about process or program
- Purchased their own vaccine
- Worked to increase participation
- 2005:  86 of 95 (91%) enrolled
- 2006:  88 of 95 (93%) enrolled
- 2007:  92 of 94 (98%) enrolled

**Notes:**
There has been a reduction in the number of birthing hospitals in Michigan.  A reduction in birthing services offered and many birthing hospital consolidations account for the decrease in the number of our birthing hospitals. We went from 102 birthing hospitals in 2002 to 94 in 2007. In 2004, we started assessing the Universal Hepatitis B Vaccination Program by the number of hospital enrollment forms that we received.  Only 57% of our birthing hospitals submitted a hospital enrollment form.  In 2005, we identified barriers and determined that the hospital pharmacy managers thought there was too much paperwork.  Our document is a three paged document and has minimal paperwork.  Our enrollment form will be posted on CDC’s website along with this presentation after the web cast for you to view.  Many pharmacy managers said they didn’t know about the process or the program and many purchased their own vaccine.  After we worked to increase participation and offered education about the process and the program, we increased from 57% of our hospitals being enrolled to 91% in 2005, 93% in 2006, 98% in 2007 and currently 95% for 2008.  We have five hospitals that we are still working with to get enrolled in the program.     

## Summary

- Ensure hospitals have written policies and standing orders
- Consider establishing a Universal Program and enroll hospitals
- Encourage hospitals to give hep B birth dose to all infants
- Provide feedback to counties and hospitals on birth dose coverage levels
- Continue to provide education and materials

**Notes:**
In summary, we all need to ensure our birthing hospitals have written policies and standing orders.  We need to establish Universal Hepatitis B Vaccination Programs and enroll the hospitals.  We need to continue encouraging all of our birthing hospitals to give the hepatitis B birth dose to all infants before hospital discharge so that we can provide a “safety net” especially for those whose mothers were infected, but were not reported properly.  We need to provide feedback to our counties and hospital on the birth dose coverage levels and continue to improve these rates.  And as all of you know we need to continue to provide education and educational materials to all of our hospitals about the Perinatal Hepatitis B Prevention Program.