The following comments refer to a letter posted on the Silicon Investor Board
which has created some questions regarding CCSI,and I thought I might try and
answer them.
To: +C.K. Houston (181 )
From: +John T. Harbaugh Aug 14 1997 11:42AM EST
Reply #185 of 229
#1
At the hospital where I am on staff, a total bilirubin test is included in
our Chem 23 panel. The hospital charge for this test is $48.25. Usually,
infants are monitored once a day for five days or until they leave the
hospital. (No additional charge and no less charge if the bili was eliminated
from the panel-- it's part of a package).
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#1response:The cost to the patient for a bilirubin test ranges from $22.25 to
$37.75.
#2
If a baby develops a bilirubin over 20, then an infant could be monitored by
blood testing as often as every 4 hours.
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#2 Response:"TREATMENT:For the treatment of the 25-48 hour old
infant,phototherapy is recommended when the TSB(Total Serum Bilirubin) level
is greater than 12 mg/dl.Phototherapy should be implemented when the TSB
level is greater than 15 mg/dl. If intensive phototherpay fails to lower a TSB level of 20
mg/dl,exchange transfusion is recommended".
Note: "Term infants who are clinically jaundiced at approximately 24 hours
old are not considered healthy and require further extensive evaluation".
#3_
So, for the great majority of infants, the total bilirubin test is part of
the Chem 23, and thus is a throw in at no additional charge.
#4
Most babies at home, do well and there would be little need for this test
unless there was illness, or jaundice noticed by the mother. This would be
rare once a child leaves the hospital.
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#4Response:According to the American Academy of Pediatrics "MANAGEMENT OF
HYPERBILIRUBINEMIA IN THE HEALTHY TERM NEWBORN" "each year approximately 60%
of the newborn babies in the United States become clinically jaundiced and
recieve various forms of evaluation and treatment".
Also,according to an August 4,1997 HEALTH article in Newsweek magazine,"bilirubin infant jaundice is responsible for 40% of newborns readmitted to the hospital during the first month of life.The next highest cause for readmission to the hospital was suspected infection of pneumonia,unexplained fevers,etc. at 25%".
#5
In adults, jaundice can be caused by liver disease, and hemolytic anemia. We
use a direct and indirect bilirubin to help with this diagnosis. Ordered
separately, this fractionation cost is $19.06 (indirect)and $15.44 (direct).
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#5 Response:Not applicable to this discussion.
#6
I assume the instument in question measures jaundice, the breakdown products
of hemoglobin that can be seen staining the skin. The color varies from
yellowish-orange-greenish. I would doubt that the instrument would be useful
for descrimination between indirect and direct hemoglobin.
#7
It is possible that the instrument that CCSI proposes could reflect changes
in skin color, and color density that could relate to actual serum levels of
bilirubin.
#8
Until there are controlled studies, clinical trials side by side with the
current methodology, and more information provided by the company about this
medical use, a lot of what I've read seems speculative.
________________________________________________________________________#8 Response:There have been controlled clinical trials for the FDA since 1990 on over 6000 babies in which results tracked in all cases.And in 3 independent studies the correlative coefficient showed a range of 91%-94%
#9
Keep in mind that the routine screening test for bilirubin is done as part of
a general screening test, and thus, even if the CCSI instrument could replace
the bilirubin, there would be no fewer blood draws anyway, and the cost
savings in this specific instance, would be zero. (Actually, there would be
extra costs to a hospital for capitalization, and possibly the cost of
nursing time spent performing the test).
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#9 Response:To start with there are two populations of infants requiring different monitoring standards of bilirubin infant jaundice-.Full term and premature. According to World Health Organization_published figures approximatley 4,000,000 babies are born per year and approximately 10% of babies are born premature.This equals 3,600,000 full term,and 400,000 premature.
"There are no simple solutions to the management of jaundiced neonates. Continuing uncertainties about the relationship between serum bilirubin levels(TSB) and brain damage as well as differences in patient population and practice settings contribute to variations in the management of hyperbilirubinemia.Additionally early postpartum discharge from the hospital further complicates the management of jaundiced newborns,because it places additional responsibilities on parents or guardians to recognize and quickly respond to developing jaundice or clinical symptoms".
'"RECOMMENDATIONS: The following recommendations were developed by the American Academy of Pediatrics to aid in the evaluation and treatment of the healthy term infant for hyperbilirubinemia.(1) When family history,ethnic,geographic origin or the appearance of jaundice occurs TSB laboratory assessment on the infant should be performed.A TSB level needs to de determined in infants noted to be jaundiced in the first 24 hours of life and followup should be provided to all neonates discharged less than 48 hours after birth by a health care professional in an office,clinic or at home".
10
In cases of more serious hyperbilirubinemia, it is possible that this method
could be useful when blood tests are not being done. However, when bilirubin
is elevated enough to be considered serious, more frequent blood test to
monitor liver, and kidney function would be done anyway.
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#10 Response:"Eighteen percent of full term healthy infants are treated by phototherapy.As current discharge is occuring within 24 hours after birth,the majority of this phototherapy occurs in the home".In early hours after birth TSB tests may be done as part of a panel from cord blood. Followup tests are specifically requested for monitoring TSB and are not usually part of panels.
Nearly all premature infants are monitored extensively for hyperbilirubinemia.According to MEDICAL SYSTEMS DATA STUDY "the average length of monitoring in the hospital is 11 days and the average number of TSB tests is 3 per day.The recommended treatment of phototherapy for premature infants is well under 12 mg/dl of TSB."
According to American Journal for Diseases in Children,December 1992.LABORATORY EVALUATION OF JAUNDICE IN NEWBORNS,FREQUENCY,COST,"the average "hyperbilirubinemia workup" cost $125.00 per workup."
Additionally,all the above are statistics related to the United States only.Other countries
have the same or higher incidence as an example,the World Health Organization reports that the Asian race has a 70% incidence of bilirubin infant jaundice in all births.
11.
In summary, the CCSI instrument does not seem to be needed on a routine
basis, but in rare, more serious cases in infants, it might be useful once
the specificity and sensitivity of the machine are better known.
Response to #11.It is obvious you left some things out in your post.Perhaps,you are not as familiar with bilirubin as one might have thought.
I hope that helps.
John
The following are comments and literature that I have come across in the last couple of months.I thought it might really help.
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