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

2. Overview of Perinatal Hepatitis B Prevention

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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%

13. 2006 National Evaluation of Hospital Perinatal Hepatitis B Policies and Practices

14. 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

15. 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

16. 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, 2005 43 perinatal hepatitis B coordinators volunteered to facilitate the evaluation in their jurisdictions

17. 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

18. PRELIMINARY RESULTS

19. 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)

20. Hospital Policy Survey Results

21. Hospital Reported Policies & Standing Orders Question Denominator MissingYes nn% Policy to review prenatal HBsAg results at time of admission to L&D 183 313070 Standing Orders to review prenatal HBsAg results at time of admission to L&D 154 327750 Policy for HBsAg testing ASAP after admit for women without documented HBsAg result 185 111662 Standing Orders for HBsAg testing ASAP after admit for women without documented HBsAg result 139 477755 Policy for repeat testing for pregnant, HBsAg negative women at risk for HBV during pregnancy 179 72011

22. 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 184 214880 Standing Orders for administration of HepB within 12 hrs of birth for infants born to HBsAg + mothers 170 1611869 Policy to routinely administer HepB to all newborns before hospital discharge 185 112165 Standing Orders to routinely administer HepB to all newborns before hospital discharge 156 3012681 Hospital receives HepB at no cost from state or local health department for infants born to HBsAg + mothers 157 298244

23. 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 100 84 69% 56% 0.9 Policy for repeat testing for pregnant, HBsAg negative women at risk for HBV during pregnancy (%) Screening laws Yes No 99 79 18% 4% 0.0035* * p<0.05 **totals vary due to missing data * 24 states have prenatal HBsAg screening laws

24. 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 99 83 77% 65% 0.07 Policy to routinely administer HepB to all newborns before discharge (%) Screening laws Yes No 100 84 66% 64% 0.80 **totals vary due to missing data

25. 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 81 74 74% 54% 0.0078* Standing orders to routinely administer HepB to all newborns before discharge (%) HepB at no cost Yes No 73 59 86% 77% 0.18 * p<0.05 **totals vary due to missing data

26. Maternal Medical Record Review Results

27. 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 3265 610 138 88 18 734 679 2747 1427 60.8 16.0 3.9 1.1 0.1 18.2 18.4 51.2 30.4

28. Maternal Insurance Status, n=4,853 Mothers (n)%, weighted Private Medicaid Other or Unknown Missing 2332 2085 333 103 52.3 38.4 9.3

29. 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 4495 194 118 18 4492 60 *93.0 4.5 2.5 0.6 98.1 1.3 * Of these, 98% of mothers were tested within 9 months of admission

30. Documentation of Prenatal HBsAg Test Result Mothers (n) %, weighted Copy of lab report Clinical transcription Other* Missing 639 3126 593 152 10.7 77.4 11.9 * progress notes, copies of prenatal record without hardcopies of lab report

31. Infant Medical Record Review Results

32. 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 398 4406 3 4000 740 46 18 3961 8.1 91.7 0.1 91.0 8.3 0.7 99.4 **totals vary due to missing data

33. 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 3459 1255 139 3065/3459 427/3459 99/1255 71.2 28.8 88.8 11.2 7.9

34. Factors associated with HBsAg Screening Rate Prior to Admission **n % screened prior to admission (± 95%CI ) State Screening laws Yes No 2428 2103 96.1 (1.0) 94.6 (1.7) Policy to review prenatal HBsAg results on admission Yes No 3140 1341 95.0 (1.2) 96.2 (1.6) Std orders to review prenatal HBsAg results on admission Yes No 1869 1839 94.9 (1.6) 95.3 (1.5) **totals vary due to missing data

35. Factors associated with Rate of HepB Administration **n % HepB Birth dose (± 95%CI ) Maternal HBsAg result in neonatal medical record Yes No 4000 740 70.9 (1.4) 67.3 (5.5) HepB vaccine at no cost Yes No 2096 1767 *84.5 (1.9) 54.4 (1.9) Policy to routinely administer HepB to all newborns before discharge Yes No 2992 1534 *89.2 (1.4) 41.9 (2.5) * p<0.05 **totals vary due to missing data

36. 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 3124 685 *88.3 (1.5) 51.6 (2.7) The highest level of neonatal care Basic Specialty Neonatal intensive care None 2158 1423 944 24 74.4 (1.1) *66.9 (1.7) 71.9 (2.4) 100 * p<0.05 **totals vary due to missing data

37. Factors associated with Rate of HepB Administration cont’d **n% HepB Birth dose (± 95%CI ) Number of live births <350 350-699 700-2000 ≥2000 1148 1184 1075 1142 *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

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

39. 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

40. 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

41. 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