Newborn at 39 weeks gestation with IUGR failed hearing test, so urine sample ordered to check for CMV. Sample NEVER SENT to lab. Eighteen days later another sample proved positive for CMV. The hospital sent mother a letter of apology admitting the error. Child has brain damage confirmed by MRI.
Babies with congenital CMV are usually treated with Valganciclovir. Can you say that because CMV test was not sent the child was deprived of its best chance to avoid more serious injury?
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Do you believe there might have been medical error?
If there was congenital CMV infection treatment with Valganciclovir would not have made a difference.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Once congenital CMV infection occurs chances of improvement are minimal. Also there are no recommendations and no data to support Valganciclovir treatment in this situation.
What makes you a good expert for this case?
I have 33 years of experience as an infectious diseases specialist and 30 year experience as Hospital Epidemiologist and Chair of Infection Prevention and Control Committee. I have been a clinical investigator funded by NIH, CDC and HRA and have published 100s of articles on infectious diseases. I have been part of leadership of professional organizations and part of teams making national recommendations. I have been an educator training medical students, residents and Fellows. I have served on examining bodies for infectious diseases physicians.. I have served as a medical expert both for plaintiffs and defendants. I have given depositions and testimony. I developed the algorithm for CMV testing in newborns at our institution that has been adopted statewide.
How often do you encounter cases similar to this one in your practice?
All the time. We are regularly consulted for newborns who test positive for CMV with or without clinical manifestations
Do you believe there might have been medical error?
An infant with IUGR and a failed hearing screen should, as a matter of standard of care, be evaluated for congenital CMV (cCMV). You have up until a month of age to start treatment so while there was an error in delaying sending the specimen, it isn't clear from the info above whether that delay had an impact on the patient.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
As above, you have a month after birth to determine the degree to which cCMV is symptomatic, and initiate treatment. The only data supporting Ganciclovir or Valganciclovir use is in infants with symptomatic disease at birth. It sounds likely, if there was later MRI evidence of brain damage, that the baby was indeed symptomatic at birth, with IUGr and a failed hearing screen. However the baby would have required further workup--labs, imaging, evaluation from ophthalmology and audiology--to determine for sure if the baby met criteria for treatment. Certainly, delaying the dx until 18 days or life will delay the time for that workup to occur and could result (have resulted) in delayed treatment. But I would need to know more about the specifics of the case. If the infant had clear signs of symptomatic congenital CMV and the diagnosis was delayed leading to treatment delay, that could absolutely have had an outcome on the baby's long-term hearing and neurological function; prompt treatment in symptomatic infants with the meds mentioned above does help prevent further progression of the disease.
What makes you a good expert for this case?
I have cared for numerous infants with cCMV and am currently one of the site PI's for a NY state long-term CMV outcome study. I have also done numerous medicolegal reviews (>10 cases) with some depositions and one testimony at trial, so I am experienced.
How often do you encounter cases similar to this one in your practice?
We see a handful of congenital CMV patients each year. In my 11.5 years of practice as an attending I have seen more than I can count.
Do you believe there might have been medical error?
If clinical signs of possible CMV infection in a newborn are detected the baby should be evaluated with a diagnostic test. The test should be sent within 21 days of birth to confirm the diagnosis if congenital CMV disease. It seems that the second test was sent within this time frame. There is no clear evidence that delaying treatment by 2-3 weeks has an adverse effect on the outcome of the patient given that CMV is a latent virus requiring many months of treatment. Other issues to review for this scenaro include other causes of IUGR and CNS damage that may have been present. Also, a neonate born with IUGR appears to have alread had a significant effect of infection or some other process in utero; damage to the brain may have already occured.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
As stated above it is recommended to diagnose congenital CMV within 21 days of birth. There is no evidence that a delay of 2-3 weeks has an effect on outcome.
What makes you a good expert for this case?
As Chief of Pediatric ID at SUNY Downstate Health Sciences University I routinely manage patients with congenital CMV. I am also part of a national congenital CMV working group and have performed studies and quality improvement projects in the area of screening and diagnostic testing for congenital CMV.
How often do you encounter cases similar to this one in your practice?
I see 2-3 cases of congenital CMV every year. I have been in practice since 2002.
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