Glaxo Agrees to Pay $3 Billion in Fraud Settlement By nd The New York Times -- Published: July 2, 2012 In the largest settlement involving a pharmaceutical company, the British drugmaker greed to plead guiltyto criminal charges and pay $3 bil ion in fines for promoting its best-sel ing antidepressants for unapproved uses and failingto report safety data about a top diabetes drug, federal
Microsoft word - outreach laboratory update june 2010 _2_.doc
TEST CHANGES – CLOSTRIDIUM DIFFICILE (C.DIFF)
Effective July 7, 2010 Bellin Health Laboratory will begin testing stool specimens for C. difficile
toxin using a real-time, on-demand, PCR (DNA), method. This is a rapid and highly accurate
method that uses PCR (polymerase chain reaction) to detect gene sequences that are associated
with the toxin producing C. difficile.
The change in method provides a much more sensitive (>94%) and specific (> 95%) assay than
the current methods available and multiple specimen collection is not recommended or
necessary. Repeat specimens collected within a 24-hour time frame is considered an
A negative result has been reported to be 98% sensitive for C. difficile, therefore such a result
should indicate the need to investigate other causes for patient symptoms.
A positive result indicates infection and a repeat specimen within 14 days is not considered
acceptable due to the continued presence of the gene sequences from the organism. For this
same reason, a repeat specimen within that time frame should not be submitted as a test of cure.
All testing for C. difficile will be tested upon receipt into our laboratory. Please allow a
minimum of one hour after receipt for analysis. All positive results will be considered a
significant finding and will be communicated as an automatic call back up to the next business
Although this testing is more expensive to perform, a savings will be realized due to the
discontinued collection of repeat specimens.
The base client price will be $49.00 and the cpt code will change to 87493.
Specimen Collection / Transport
Please collect an unformed stool specimen into a clean container. The specimen should be
labeled and sent to the laboratory at refrigerated temperature. A specimen at room temperature is
acceptable for up to 24 hours.
Completely formed specimens are considered an unacceptable specimen and will be rejected. A
stool specimen is acceptable when it is liquid or soft enough to conform to the shape of the
TEST CHANGES – OVA AND PARASITE EXAM
Effective July 9, 2010 Bellin Health Laboratory will be performing Cryptosporidium and Giardia
Antigen testing in place of the routinely ordered Ova and Parasite Exam.
The new antigen assay is currently the preferred method used in our area to detect the most
commonly seen parasites of Cryptosporidium and Giardia. The current Ova and Parasite Exam
has sensitivity for detection of these parasites of 50 – 80 %, while the new antigen assays have a
sensitivity of 88 –98%.
Any stool specimens submitted with an order for Ova and Parasite Exam will be reported with
the Cryptosporidium and Giardia Antigen Screen. This screen will also replace the older IFA
methods we currently perform for Cryptosporidium and Giardia.
All results will be reported out with a comment that states certain conditions when further
specialized testing may be required. This includes a patient who is a resident or visitor to a
developing country; a patient that has suspected roundworms or tapeworms, and a patient whose
diarrhea persists. In this case, a separate specimen should be collected and placed into a special
Eco-fix vial from Mayo Medical for a Parasitic Exam. Please contact our laboratory for these
There will be no change in the specimen collection and transportation. Please continue to submit
a stool specimen in the yellow-capped Para-Pak SAF vial. The specimen must be placed into the
vial within one hour of collection with transportation to the laboratory within the 96 hours.
The CPT codes will change to 87328 for Cryptosporidium and 87329 for Giardia. The test will
be performed daily and all positive results will be considered an automatic callback. Base client
fee will be $30.00.
In the last Outreach Update, there was an error in the notation regarding the shipping temperature
for Keppra/Levetiracetam. The specimen should be sent at refrigerated temperature instead of
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