National Evaluation of Hospital Perinatal Hepatitis B Prevention Policies and Practices Bayo C. Willis, Lisa Jacques-Carroll, Susan Wang, Yuan Kong

Overview of Perinatal Hepatitis B Prevention

Successes in hepatitis B prevention in the United States New hepatitis B virus infections have declined from approximately 260,000 in the 1980s to an estimated 50,000 new infections in 2005 HBsAg screening of pregnant women is widely done, with data suggesting that 85% or more women get screened

Identification of HBsAg- positive pregnant women CDC expects ~23,000 hepatitis B surface antigen (HBsAg) positive women to deliver each year in the US In 2004, ~12,000 infants born to HBsAg-positive mothers were identified

Consequences of HBV Infection in Infants and Young Children ~90% of infants and 30% of children <5 yrs who acquire HBV infection become chronically infected ~25% of those with chronic infection are expected to die prematurely of liver cancer or cirrhosis

Perinatal Hepatitis B Prevention Without immunoprophylaxis, ~40% of infants born to HBsAg-positive mothers develop chronic HBV infection Immunoprophylaxis includes: hepatitis B vaccine & hepatitis B immune globulin (HBIG) at birth plus complete hepatitis B vaccine serieshepatitis B vaccine & hepatitis B immune globulin (HBIG) at birth plus complete hepatitis B vaccine series This is 85%-95% effective in preventing vertical (mother to infant) HBV transmission

Perinatal Hepatitis B Prevention cont’d Infants born to HBsAg-positive mothers should complete their hepatitis B vaccine series by 6 months (single antigen or Pediarix) or 15 months (Comvax) Post-vaccination serologic testing for anti-HBs and HBsAg should occur after the 3 rd hepatitis B vaccine

Chronology of Advisory Committee on Immunization Practices (ACIP) Perinatal Hepatitis B Prevention Recommendations 1984 – HBsAg screen pregnant women at high-risk; give HBIG and hepatitis B vaccine to infants born to HBsAg-positive women 1988 – HBsAg screen all pregnant women during the prenatal period 1991 – all infants should be given hepatitis B vaccination series 2002 – preference is to give first hepatitis B vaccine at birth but can be given up to 1 month of age 2005 – give hepatitis B vaccine at birth

2005 ACIP Statement: Perinatal Hepatitis B Prevention Summary Three things need to occur to prevent infection: 1. Prenatal care providers test all pregnant women for HBsAg during an early prenatal visit; hospitals test women upon admission to labor and delivery, as indicated

2005 ACIP Statement: Perinatal Hepatitis B Prevention Summary 2. Ensure all infants of HBsAg-positive and of HBsAg-unknown status mothers receive appropriate, timely post-exposure prophylaxis (PEP) in the hospital and infants complete follow-up (i.e., case management) 3.Vaccinate ALL newborns with hep B vaccine before hospital discharge

Gaps in Perinatal Hepatitis B Prevention HBsAg screening of pregnant women is not 100% (yet women w/o prenatal care have higher prevalence of HBsAg- positivity) Even with maternal screening, testing errors and lapses in reporting have resulted in missed post exposure prophylaxis for some infants born to HBsAg-positive women Hep B birth dose rates remain <50%* * Source: NIS, 2005 data

Gaps in Perinatal Hepatitis B Prevention cont’d Only ~50% of expected births to HBsAg-positive women are identified for case management Completion rate of case management to document HBIG and 3 vaccine doses by 8 months is 70% and completion rate to document infant serologic testing results is 52%

2006 National Evaluation of Hospital Perinatal Hepatitis B Policies and Practices

Objectives Baseline evaluation to be repeated in 3-5 years Evaluate maternal HBsAg screening and newborn hepatitis B vaccination policies and practices in US delivery hospitals Evaluate factors associated with lack of screening and vaccination

Evaluation Design Eligibility Criteria – 2003 AHA (American Hospital Association) birthing hospitals with >100 annual births (n=3,102) Stratified random sample – 51 strata (50 states + one stratum containing 5 territories + DC) Sample was proportional to stratum size

Methodology March 2006 hospital policy survey mailed to clinical nurse managers (n=242) Hospitals given abstraction form to review 25 paired maternal and infant medical records for infants born on or after Oct 1, perinatal hepatitis B coordinators volunteered to facilitate the evaluation in their jurisdictions

Data Collection & Analysis Response Rate: –Policy Survey: 186/242 = 77% –Medical Record: 191/242 = 79% 46/53 states/territories had >50% response rate –2 low responders were states with known high numbers of HBsAg positive pregnant women & historically low birth dose coverage Descriptive and weighted univariate analysis – SAS v9.1 & SUDAAN v9

PRELIMINARY RESULTS

Hospital Characteristics Annual live births (>100): mean=1336; min=80 max=9465; median=689 Highest Level of neonatal care: n (%) –Basic 88 (47) –Specialty56 (30) –Neonatal Intensive Care41 (22) Type of Attending Provider: –Obstetrician3536 (84) –Family practitioner778 (7) –Other/Unknown436 (10)

Hospital Policy Survey Results

Hospital Reported Policies & Standing Orders Question Denominator MissingYes nn% Policy to review prenatal HBsAg results at time of admission to L&D Standing Orders to review prenatal HBsAg results at time of admission to L&D Policy for HBsAg testing ASAP after admit for women without documented HBsAg result Standing Orders for HBsAg testing ASAP after admit for women without documented HBsAg result Policy for repeat testing for pregnant, HBsAg negative women at risk for HBV during pregnancy

Hospital Reported Policies & Standing Orders cont’d Question Denominator MissingYes nn% Policy for administration of HepB within 12 hrs of birth for infants born to HBsAg + mothers Standing Orders for administration of HepB within 12 hrs of birth for infants born to HBsAg + mothers Policy to routinely administer HepB to all newborns before hospital discharge Standing Orders to routinely administer HepB to all newborns before hospital discharge Hospital receives HepB at no cost from state or local health department for infants born to HBsAg + mothers

Relationship of State HBsAg Screening Laws to Hospital Policy **n Policy for HBsAg testing ASAP after admit for women without documented HBsAg result (%) p-value Screening laws Yes No % 56% 0.9 Policy for repeat testing for pregnant, HBsAg negative women at risk for HBV during pregnancy (%) Screening laws Yes No % 4% * * p<0.05 **totals vary due to missing data * 24 states have prenatal HBsAg screening laws

Relationship of State HBsAg Screening Laws to Hospital Policy cont’d **n Policy to review prenatal HBsAg results at time of admission to L&D (%) p-value Screening laws Yes No % 65% 0.07 Policy to routinely administer HepB to all newborns before discharge (%) Screening laws Yes No % 64% 0.80 **totals vary due to missing data

Relationship of Receipt of HepB at No Cost to Hospital Policy **n Policy to routinely administer hepatitis B to all newborns before discharge (%) p-value HepB at no cost Yes No % 54% * Standing orders to routinely administer HepB to all newborns before discharge (%) HepB at no cost Yes No % 77% 0.18 * p<0.05 **totals vary due to missing data

Maternal Medical Record Review Results

Maternal Race/Ethnicity, n=4,853 Mothers (n)%, weighted Race White African American Asian AI/AN Native Hawaiian or other PI Other or Unknown Ethnicity Hispanic or Latino Not Hispanic or Latino Unknown

Maternal Insurance Status, n=4,853 Mothers (n)%, weighted Private Medicaid Other or Unknown Missing

Prenatal HBsAg Testing, n=4,853 Mothers (n) %, weighted Prenatal HBsAg testing before admit for delivery Yes No Not documented Prenatal HBsAg tests results Positive Negative Not documented * * Of these, 98% of mothers were tested within 9 months of admission

Documentation of Prenatal HBsAg Test Result Mothers (n) %, weighted Copy of lab report Clinical transcription Other* Missing * progress notes, copies of prenatal record without hardcopies of lab report

Infant Medical Record Review Results

Infant Medical Record Characteristics, n=4,853 Infant Characteristics**Infants (n)%, weighted Infant <2000 grams at birth Yes No Not documented Recorded maternal HBsAg test result in infant record Yes No Not documented Maternal HBsAg test result Positive Negative **totals vary due to missing data

Infant Vaccination, n=4,853 # of Infants%, weighted Hepatitis B vaccine given to infant Yes No Missing Hep B given: By standing orders By specific MD order If Hep B not given: Specific order not to vaccinate / / /

Factors associated with HBsAg Screening Rate Prior to Admission **n % screened prior to admission (± 95%CI ) State Screening laws Yes No (1.0) 94.6 (1.7) Policy to review prenatal HBsAg results on admission Yes No (1.2) 96.2 (1.6) Std orders to review prenatal HBsAg results on admission Yes No (1.6) 95.3 (1.5) **totals vary due to missing data

Factors associated with Rate of HepB Administration **n % HepB Birth dose (± 95%CI ) Maternal HBsAg result in neonatal medical record Yes No (1.4) 67.3 (5.5) HepB vaccine at no cost Yes No *84.5 (1.9) 54.4 (1.9) Policy to routinely administer HepB to all newborns before discharge Yes No *89.2 (1.4) 41.9 (2.5) * p<0.05 **totals vary due to missing data

Factors associated with Rate of HepB Administration cont’d **n % HepB Birth dose (± 95%CI ) Standing orders to routinely administer HepB to all newborns before discharge Yes No *88.3 (1.5) 51.6 (2.7) The highest level of neonatal care Basic Specialty Neonatal intensive care None (1.1) *66.9 (1.7) 71.9 (2.4) 100 * p<0.05 **totals vary due to missing data

Factors associated with Rate of HepB Administration cont’d **n% HepB Birth dose (± 95%CI ) Number of live births < ≥ *77.4 (1.6) *75.9 (1.7) *79.2 (1.5) 66.1 (2.0) * p<0.05 **totals vary due to missing data

Limitations Respondent bias Record review bias – health dept vs. hospital personnel Data quality issues Skip patterns caused erroneous responses

Summary of Preliminary Analysis High rate of HBsAg prenatal testing indicates integration into prenatal care Substantial gaps in policies related to identification of susceptible infants 71% of infants received hepatitis B vaccine birth dose Factors associated with hepatitis B vaccine administration in univariate analysis: –Receipt of hepatitis B vaccine at no cost; policies & std orders in place to routinely vaccinate infants prior to discharge; hospital size

Next Steps Compare policy survey results with medical record reviews Resolve discrepancies with medical record data (e.g. HBsAg screening test results) Conduct multivariate analyses Hospital Feedback & recommendations

Acknowledgments Perinatal Hepatitis B Coordinators Yuan Kong, HSREB Edith Gary, HSREB Laverne Graham, HSREB John Stevenson, HSREB Pascale Wortley, HSREB Ed Brink, POB Abby Shefer, ISD Lance Rodewald, ISD Division of Viral Hepatitis DHQP