1. Medical errors put infants at risk for chronic hepatitis B virus infection – six case reports Debra Blog, MD, MPH, Elizabeth Herlihy, RN, BSN, MS,

2. 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 Without immunoprophylaxis, ~40% of infants of Hepatitis B Surface Antigen (HBsAg) positive mothers develop chronic HBV infection ~25% of those with chronic infection die prematurely of liver cancer or cirrhosis

3. Chronic Liver Disease Caused by HBV Infection

4. Modes of HBV Transmission in Early Childhood Vertical transmission from mother to infant Horizontal transmission from infected household contact to child  Both modes of transmission can be prevented by vaccination of newborns

5. Vaccine Efficacy in Preventing Vertical HBV Transmission Immunoprophylaxis includes: –Hepatitis B vaccine & Hepatitis B Immune Globulin (HBIG) within 12 hours of birth This is 85%-95% effective in preventing vertical HBV transmission; hepatitis B vaccine alone at birth prevents transmission in 70-95% of infants!

6. Vaccine Efficacy in Preventing Horizontal HBV Transmission Before implementation of perinatal hepatitis B prevention programs, studies show: –61%-66% of children with chronic HBV infection were born to HBsAg-negative mothers –Children likely were infected by household contacts* *Birth dose of hepatitis B vaccine will prevent these early childhood infections!!

7. Further Benefits of Hepatitis B Birth Dose Ensures that infants born to mothers with unknown HBsAg status at delivery receive timely prophylaxis An opportunity to immunize during one of the few dependable medical encounters (at delivery in a hospital) Places the importance of immunization as an early and visible priority for parents – studies show greater chance that hepatitis B series and overall immunization series will be completed on time  Hepatitis B is the only vaccine that is reliably immunogenic in the newborn period!

8. NYS Perinatal Hepatitis B Public Health Law It’s the law in NYS! –In 1989, New York State passed a Public Health Law 2500-e mandating maternal HBsAg testing, reporting of results, and treatment of infants born to HBsAg- positive women

9. Hospital record review: The cornerstone of quality assurance for perinatal hepatitis B prevention in NYS Delivery hospital site visits are routinely conducted to ensure compliance with PHL and ACIP recommendations: –Maternal/infant records are reviewed –Hospital staff are updated

10. NYS Birth Dose Initiative Initiated in 2003, this program provides free hepatitis B vaccine to all NYS birthing hospitals (including NYC) that implement standing orders for all infants to receive a birth dose regardless of: –maternal HBsAg status; –infant’s insurance status; or –physician preference

11. NYS Birth Dose Initiative Enrollment as of Feb 2006

12. Gaps in Prevention of Perinatal and Early Childhood Hepatitis B Virus Infections in NYS Despite PHL 2500-e and close monitoring of hospitals, medical errors continue to occur placing infants at risk of infection! Despite providing free vaccine to birthing hospitals, only ~ 60 % of all infants in NY currently receive the first dose at birth!

13. Medical Errors in Prevention of Perinatal HBV Transmission During July 1999-October 2002, public health reported more than 500 medical errors to the Immunization Action Coalition Examples: Infants born to HBsAg-positive mothers did not receive hepatitis B vaccine and HBIG within 12 hrs of birth Infants of mothers with unknown HBsAg status did not receive hepatitis B vaccine within 12 hrs of birth HBsAg screening test results were misordered, misinterpreted, mistranscribed, or miscommunicated Incorrect hepatitis B screening tests ordered

14. Underscoring the Importance of the Birth Dose in NYS Six cases that recently occurred in upstate NY underscore the importance of the birth dose! “Medical Errors put infants at risk for chronic hepatitis B virus infection – 6 case reports in NYS” http://www.immunize.org/catg.d/p2128.pdf AND http://www.health.state.ny.us/diseases/communicable/hepatitis/infants_hepb.htm

15. Case Study #1 Known positive HBsAg mother gives birth to third child Two prior children had received appropriate prophylaxis at birth This time, her HBsAg status is incorrectly recorded as negative in the hospital record Hospital does not have a universal birth dose policy so infant received no prophylaxis The error found during public health follow up to ensure the infant had appointment for second dose Infant got 1 st dose of vaccine at 1 month of age

16. Case Study #2 Woman presents in labor with unknown HBsAg results Family practice physician did not test this pregnancy because the mother was negative two years ago and she was told“not to worry about it” Hospital ordered a test but did not ask for a STAT test Infant not given vaccine or HBIG, and mother discharged 2 days later, before results were known Results came back HBsAg positive 3 days after birth Public health was able to immediately track down the family and the infant received HBIG and vaccine dose # 1 at 3 days of age

17. Case Study #3 Infant born in a hospital to a known positive HBsAg woman receives HBIG, but not hepatitis B vaccine Hospital did not have a birth dose standing order in effect and the physician forgot to write an order for the vaccine The error was found during routine public health follow up at two weeks of age The infant was immediately vaccinated with dose #1

18. Case Study #4 NYSDOH staff conducted a follow up hospital record review; the hospital had deficiencies during a prior visit so it was recommended that they include a copy of the HBsAg lab results on the maternal record. On three out of 35 records examined, it was discovered that the wrong test had been ordered; (Anti-HBs, rather than HBsAg) Furthermore, the error had been made by three different OBs! Clarification memo immediately went to all medical staff that HBsAg test must be ordered on all pregnant women.

19. Case Study #5 A known chronically infected woman is pregnant with her second child. The first child was successfully prophylaxed. During this pregnancy, she is referred to a gastroenterologist who orders further hepatitis testing including HBeAg, which is non-reactive, and viral load which is low. This is often the case in persons chronically infected with hepatitis B! The infant is born 5 weeks premature and transferred to the NICU. The neonatologist in the NICU consults with the gastroenterologist and the two decide the infant dose not need prophylaxis, even though the mother’s positive HBsAg status is known.

20. Case Study #5 con’t Neither vaccine nor HBIG is administered to the infant The hospital does not have a universal birth dose policy so the infant is not routinely given vaccine upon hospital discharge The error is discovered during public health follow up to ensure the child received a second dose of vaccine The child’s follow up pediatrician, who is not aware of the mother’s positive status, is very disturbed to learn of this error and immediately administers the first dose of vaccine, but the child is two months old.

21. Case Study #6 A multipara woman seeks late prenatal care She was known to be chronically infected during her prior pregnancies An HBsAg test is done and the result is negative; it is suspected this is a false negative result. A second specimen is drawn and sent to the state lab, but before results are known, the woman delivers. The delivery hospital was sent prenatal records marked “HBsAg negative”, with no mention of a second test being done, or suspicion of this being a false negative.

22. Case Study #6 con’t Since the mother was incorrectly identified as HBsAg - negative, the infant did not receive HBIG Fortunately, the hospital recently adopted a universal birth dose policy, so the infant was administered a routine birth dose of hepatitis B vaccine! The second test, confirming the mother’s HBsAg- positive status, came back a week after hospital discharge. It was too late to administer HBIG.

23. Another Recent Case Recently, a 9 month old child infected with Hepatitis B was reported to the state health department. The birth occurred at a large downstate NY teaching hospital. Upon investigation, it was learned that the mother’s positive HBsAg status was well documented on the medical record. Furthermore, she reminded hospital staff of her positive hepatitis status several times during her admission. The hospital’s perinatal hepatitis B policies and procedures were found to be consistent with recommended treatment protocols. Since this is an urban hospital, serving a large Asian population, several HBsAg positive women give birth there annually. Everyone thought treatment was ordered, but it was not! HBIG was never administered, and vaccine wasn’t given until discharge, over 48 hours after birth, when the error was discovered. It’s not clear why HBIG wasn’t given at that time. The parents are outraged and pursuing legal action.

24. Summary Despite state laws for perinatal hepatitis B prevention and close monitoring of hospital practice, medical errors continue to occur in NYS, putting infants at risk of chronic hepatitis B viral infection. Documentation of these medical errors serves to underscore the importance of the hepatitis B birth dose as an important “safety net” for missed prophylaxis of high risk infants, and to prevent early childhood transmission..

25. Perinatal Hepatitis B in NYS Our Goal - Healthy Babies