Medical errors put infants at risk for chronic hepatitis B virus infection

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Medical errors put infants at risk for chronic
hepatitis B virus infection six case reports
Debra Blog, MD, MPH, Elizabeth Herlihy, RN, BSN,
MS,
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Consequences of HBV Infection in Infants and
Young Children

• 90 of infants and 30 of children lt5 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

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Chronic Liver Disease Caused by HBV Infection
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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

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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!

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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!!

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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!

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NYS Perinatal Hepatitis B Public Health Law

• Its 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

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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

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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
• infants insurance status or
• physician preference

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NYS Birth Dose InitiativeEnrollment as of Feb
2006
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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!

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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

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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/communicab
  le/hepatitis/infants_hepb.htm

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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 1st dose of vaccine at 1 month of age

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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 toldnot 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

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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

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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.

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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
  mothers positive HBsAg status is known.

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Case Study 5 cont

• 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 childs follow up pediatrician, who is not
  aware of the mothers 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.

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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.

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Case Study 6 cont

• 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 mothers HBsAg-
  positive status, came back a week after hospital
  discharge. It was too late to administer HBIG.

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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
  mothers 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 hospitals 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 wasnt
  given until discharge, over 48 hours after birth,
  when the error was discovered. Its not clear why
  HBIG wasnt given at that time.
• The parents are outraged and pursuing legal
  action.

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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.
• .

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Perinatal Hepatitis B in NYSOur Goal - Healthy
Babies