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IAHCSMM annual meeting report by MikeJenny


									July 23, 2011

New blood tests for 920 patients after six samples were mislabeled

A Bronx hospital has agreed to repeat blood tests for nearly 1,000 patients after an investigation found that some test results had been given
to the wrong patients, state health officials said Friday. State officials said that six patients being treated by outpatient clinics at Bronx-
Lebanon Hospital Center had received inaccurate test results last year because their blood samples had been mislabeled.

The state said that as many as 920 patients, including some children, who had been tested at Bronx-Lebanon clinics between April and
December 2008 would be retested. Errol C. Schneer, a hospital spokesman, said Friday that the hospital believed that the inaccurate tests
were “isolated incidents” affecting only six patients on six specific days, and that the hospital was “not aware of any adverse effects” on

But he said that in an effort to be prudent, the hospital had decided to retest every patient tested on those six days, plus all the patients
tested the day before and the day after. That added up to 920 patients on 18 days, he said.

Claire Pospisil, a spokeswoman for the State Health Department, said officials were not sure whether any patients had been given the wrong
diagnosis or the wrong medication as a result of the testing errors. But she said the state was investigating that possibility.

The hospital laboratory conducts blood tests for a broad range of conditions, including life-threatening diseases like H.I.V. and prostate
cancer and chronic conditions like diabetes and high cholesterol, hospital and state officials said. Officials said they could not say exactly
which tests had been given to those 920 patients, but could not rule out any of those tests.

Schneer said the hospital did not believe it was necessary to retest every patient tested from April 17 to Dec. 3, 2008, the eight-month period
when the mislabeling took place. The hospital has a network of about 70 clinics, and its laboratory performs two million tests a year for clinic
patients and 1.5 million tests for inpatients, Schneer said. Schneer said the hospital had sent out letters to the 920 patients over the last few
days, urging them to come in to be retested free and offering them free public transportation to cover the cost of the trip.

Schneer said the hospital’s quality review system had detected mislabeling in its laboratory in April 2008 and reported its finding to the New
York City health department, which passed the information to the state. But in a statement Friday, the State Health Department faulted the
hospital for failing to respond more quickly after it discovered problems with its testing. The hospital will be required to submit a formal plan of
correction, the state said. (NY Times)

Elkhart hospital accused of violating blood rules

Elkhart General Hospital (Indiana) violated federal rules by accepting blood from a donor who had tested positive for antibodies to the
hepatitis C virus and giving it to two patients, officials said. A hospital official said no one received infected blood.

But donors who test positive for hepatitis C antibodies must be permanently banned from donating, according to hospital procedures that are
patterned after federal regulations, a U.S. Food and Drug Administration official said in a warning letter to the northern Indiana hospital’s
president. A copy of the letter was obtained by the South Bend Tribune.

The FDA was not aware of anyone who received the blood becoming infected, agency spokeswoman Susan Cruzan said.

Gregory Losasso, the hospital’s vice president of operations, said no one received infected blood. He said the donor had tested positive for
the hepatitis C antibodies in November 2007, then donated last year in April and August. Losasso said the first test yielded a “false positive,”
meaning the donor no longer had the virus, and the blood was deemed safe for two transfusions. Losasso said the hospital’s only mistake
was allowing the donor to donate again five months after he tested positive in November. Federal regulations require a blood bank to wait six
months, he said.

The FDA inspection of the hospital’s blood center in December also found other violations, including that some donors who tested positive
for antibodies for AIDS and hepatitis B were not placed on a list of unsuitable donors. The persons with those antibodies had donated blood
for their own use.

Losasso said most of the violations involved documentation and had been corrected. The FDA letter said the agency had largely been
satisfied with the corrective measures. (Associated Press, Chicago Tribune)

Deep brain stimulation: Expanding its reach to new patients

Under the skin, a battery is surgically implanted – generally within the upper chest. From the battery, wires snake up to the head, to tickle
different targets deep inside the brain. Such is the hardware for deep brain stimulation – the equivalent of a cardiac pacemaker for the mind.

Until recently, deep brain stimulation was approved in the U.S. only to treat certain movement disorders, primarily those of Parkinson’s
disease, for which it diminishes tremors and rigidity and improves mobility. To date, more than 60,000 patients worldwide have had the
devices implanted. But now use of the technique seems set to mushroom.

This year, the Food and Drug Administration granted a so-called humanitarian device exemption for the treatment to be used in severe cases
of obsessive-compulsive disorder – the first approval of deep brain stimulation therapy for any psychiatric condition. Large clinical trials are
also in the works for use of deep brain stimulation for epilepsy and depression, and experimental studies in the U.S. and elsewhere – still in
their early stages – are exploring the treatment for obesity, traumatic brain injury, severe chronic pain, Alzheimer’s disease, anorexia, tinnitus
and addiction. There are discussions too on the possible use of deep brain stimulation to treat hypertension.

In studies with a total of 26 patients with severe obsessive-compulsive disorder, 60% of those whose device was turned on demonstrated
“very much improved” symptoms after months of deep brain stimulation as measured by interviews and questionnaires, said Dr. Benjamin
Greenberg, an associate professor at Brown University Medical School and Butler Hospital in Providence, RI, who was one of the study
researchers. The patients had previously failed on medicines as well as behavioral cognitive therapy.

Patients were stimulated in an area called ventral capsule/ventral striatum, chosen, in part, because removal of nerve fibers in that area is
known to cause improvement in obsessive-compulsive symptoms. Based largely on these findings, the FDA recently granted a limited
humanitarian device exemption that permits the device to be used in as many as 4,000 of the country’s most severe cases of obsessive
compulsive disorder per year.

To get this kind of exemption, Medtronic – makers of the only deep brain stimulation device that is FDA-approved – needed only to show its
safety and probable benefit. Greenberg is now doing a randomized, double-blinded trial with 30 patients, some of whom have devices turned
on right away and some who have them turned on after a delay. No one will know whose device is turned on for the first several months of
the trial.

Medtronic has conducted a large-scale randomized trial for deep brain stimulation on epilepsy. Data will be submitted to the FDA this year,
said Paul Stypulkowski, senior director of therapy research of Medtronic. The device was turned on, for three months, in half of the 110
volunteers, stimulating – and thereby, paradoxically, inhibiting – an area called the anterior nucleus of the thalamus. That area is believed to
influence a circuit involved in seizures. The data, presented in December at a meeting in Seattle, show that deep brain stimulation reduced
the number of seizures by 38% compared with what was seen before implanting the device. That is slightly better than improvement seen
with vagus nerve stimulation, another FDA-approved electrical stimulation treatment, which reduces seizures by about 25%.

The control group whose device was kept turned off, also improved, by 14.5%. That could be due to a placebo effect. Or it might be because
people who join trials are usually at their worst – and often tend to improve somewhat on their own, said trial researcher Dr. Douglas Labar,
of the Weill Cornell Medical College in New York. If deep brain stimulation is approved, Labar said, patients will have the choice between a
more efficient but also more risky treatment and the slightly less efficient but also less risky vagus nerve stimulation.

Medtronic’s depression trial will follow about 200 patients stimulated in an area called the anterior limb of the internal capsule for at least one
year. This brain target for depression was identified by accident: When obsessive-compulsive disorder patients who also had depression
were stimulated in this area, their depression also improved. In one case, a patient produced a one-sided smile when stimulated on one side
of the brain and also expressed feelings of happiness, said study researcher Dr. Wayne Goodman of the National Institute of Mental Health.
With deep brain stimulation now being tried in at least three brain areas for depression, the question is, which target is the best? All agree
that it’s too early to tell. (LA Times),0,1520191.story
New blood test greatly reduces false-positives in prostate cancer screening

A new blood test used in combination with a conventional prostate-specific antigen (PSA) screening sharply increases the accuracy of
prostate cancer diagnosis, and could eliminate tens of thousands of unneeded, painful, and costly prostate biopsies annually, according to a
study led by researchers at Dana-Farber Cancer Institute.

At the annual meeting of the American Society of Clinical Oncology in Orlando, FL, William K. Oh, M.D., and Robert W. Ross, M.D., reportrf
that the six-gene molecular diagnostic test, when combined with a PSA test, accurately detected prostate cancer more than 90 percent of the
time. Earlier studies suggest that the conventional PSA test is 60-70 percent accurate in detecting cancer.

Men who are found to have elevated levels of PSA in routine screening tests are often referred for a biopsy of the gland to check for tumors.
Nearly two-thirds of biopsies performed – a painful procedure with some risk of complications – do not find any cancerous cells. This high
rate of “false positive” PSA test results underscores the need for a more accurate method for detecting prostate cancer, said Oh, who is the
clinical director of the Lank Center for Genitourinary Oncology at Dana-Farber.

The two-year study involved 484 participants. The group comprised 204 men with known prostate cancer, 110 men with benign prostatic
hypertrophy (BPH), and 170 healthy men in a control group. (BPH can elevate PSA levels in the blood, which often leads to a biopsy to rule
out prostate cancer.) The researchers sought to measure the accuracy of a six-gene whole blood RNA transcript-based diagnostic test
developed by Source MDx in Boulder, CO, both in terms of its sensitivity (the ability to detect prostate cancer) and specificity (the ability to
identify people who don't have prostate cancer).

Source MDx researchers developed the test after initially working with a set of 174 candidate genes whose activity was compared in the
different study groups. They narrowed the pool down to just six genes that, as a group, were highly sensitive in predicting which patients had
prostate cancer and which were normal.

The study found that “the six-gene model was more accurate than PSA alone at predicting cancer if you had it and no cancer if you didn’t,”
said Oh. The test’s accuracy improved even more when PSA measurements were added. Combined, the two tests achieved a diagnostic
accuracy of more than 90 percent in specificity and sensitivity and eliminated most of the false-positives yielded by the PSA test.

Based on these findings, the researchers are planning to conduct a larger, multicenter clinical trial involving approximately 1,000 men to
determine if the findings remain valid. “These findings are very encouraging and suggest that this new test could spare tens of thousands of
men from undergoing an unnecessary biopsy,” Oh said. “However, until we can verify our findings, it is important to recognize that the PSA
test, despite its limitations, is still the best test available for diagnosing prostate cancer at this time.”

Maryland ICU patients connected to remote critical care staff, improving quality and safety; First Maryland eCare Hospital goes

Maryland intensive care patients will now be connected by voice, video and data lines to specialized physicians and nurses at a tertiary care
referral center 130 miles away. A year after announcing that six independent Maryland hospitals, with a $3 million grant from CareFirst
BlueCross BlueShield, were joining together to provide state-of-the-art critical care to their patients, the first hospital, Calvert Memorial
Hospital in Prince Frederick, MD, is fully online with the sophisticated care system.

Studies have shown improved patient outcomes and decreased lengths of stay for patients in intensive care units (ICU) managed by
physicians who specialize in critical care. Yet, due to a current shortage in the specialty, it’s difficult for many hospitals to keep these
physicians on-site 24 hours a day. eCare virtually connects physicians, nurses and patients via voice, camera and data, enabling hospitals to
provide the highest level of specialized care around the clock. Calvert Memorial will work most closely with eCare on nights, weekends and
holidays, times typically difficult for local specialists to remain on-site.

Working with a remote monitoring center at Christiana Care in Wilmington, DE, eCare supplements local ICU staff with experienced critical
care physicians and nurses. Christiana Care was the first health system in the country to adopt the eICU Program to monitor critically ill
patients in its emergency departments and post-anesthesia care units and currently uses the technology in four of its ICUs.

With eCare, patients benefit from receiving timely, critical care when they need it and where they are most comfortable – close to home.
Moment-by-moment monitoring quickly detects changes in patient condition, watching trends in crucial indicators such as blood pressure,
heart rate, oxygen levels and respiratory rates, allowing remote staff to alert and work cohesively with on-site staff to improve patient status.
eCare does not take the place of bedside staff. It provides an extra set of eyes and ears ensuring an added layer of safety and enabling a
patient’s care plan to prevent a medical crisis instead of responding to one. For on-site caregivers, in-room help is available at the push of a

Since the 2008 Maryland eCare announcement, eCare hospitals have been coordinating staff, securing data lines and working closely with
the team at Christiana Care to ready their facilities for seamless inclusion of remote monitoring. Later this year, Peninsula Regional Medical
Center in Salisbury and St. Mary’s Hospital in Leonardtown will also come online. By 2011, almost 80 ICU beds will be connected through
Maryland eCare. eICU is a registered trademark of Philips-VISICU Inc. For more information

Olympus broadens portfolio with new biliary metallic stent

Olympus America Inc. has expanded its medical portfolio by introducing the X-Suit NIR, a biliary metallic stent designed with exceptional
anatomic conformability and superior radial support. The X-Suit NIR’s proprietary NIRflex cell design provides a physician support and
flexibility; both critical to help relieve the symptoms associated with pancreatic, liver and bile duct cancers.

The NIRflex advanced cell design biliary metallic stent provides flexible construction to fit the shape of any biliary duct. Constructed of Nitinol,
the stent is water-jet cut and electro-polished for much greater durability. Each strut is also rounded, helping to reduce stress to the tissue
and prevent damage to the bile duct and duodenal walls.

To ensure precise placement of the stent during a therapeutic procedure, the X-Suit NIR has virtually no foreshortening. In addition, each
end of the stent features five radiopaque markers that allow physicians to determine the position of the stent under an X-ray prior to
deployment. A black marker is positioned at the proximal end of the stent facilitating endoscopic confirmation of the stent during deployment.
The ease of deployment combined with superior radial support makes the X-Suit NIR ideal for re-establishing biliary flow. For more
information, visit

VA hospitals face tough questions by panel

Officials from the Department of Veteran Affairs will be facing some tough questions next month from a congressional panel regarding
shoddy medical practices at several VA hospitals that have put thousands of former soldiers at risk of possible exposure to HIV and other
infectious diseases.

In recent months, VA officials have been forced to recommend that more than 10,000 former VA patients in Miami, Murfreesboro, TN, and
Augusta, GA, go for blood tests to screen for possible infections. According to a statement on the VA’s official website, five veterans have
tested positive for HIV and another 43 have tested positive for hepatitis.

The VA’s June 16 hearing before the U.S. House Committee on Veteran’s Affairs oversight and investigations subcommittee will focus on
probing the causes of the apparent negligence as well as what measures have and will be taken to rectify them. The VA’s inspector general
is currently under investigation.

In a phone interview on Thursday, U.S. Rep. Harry Mitchell of Arizona, the subcommittee chairman, stated that the VA has a responsibility to
care for patients who have tested positive for HIV and hepatitis, regardless of whether they contracted it from a VA hospital or not.

A leading physician for the VA has stated that there is no way to ever know definitively whether the veterans were infected with the diseases
due to exposure to improperly cleaned equipment at the hospitals. VA officials, however, have not denied the possibility.

In December of last year, the VA’s initial discovery of improper equipment use prompted a nationwide safety “step-up” across its 153
healthcare centers. The VA says it has since taken steps to reeducate staff on equipment use and has also been in close contact with the
equipment’s manufacturers.

In the Murfreesboro hospital, VA officials explained that an incorrect valve on a device used in colonoscopies may have allowed residual
body fluid to be transferred between patients, though they have yet been unable to determine whether this was a one-time incident or if it had
been occurring for the five years since the equipment had been installed in 2003.

At the Miami clinic, VA investigators found that between May 2004 and March 2009, a section of equipment tubing that ought to have been
cleaned between consecutive uses with each patient was only being cleaned once at the end of the day.
The story was similar for the Augusta hospital, where scopes used in ear-nose-throat check-ups were also being improperly cleaned,
affecting patients from January 2008 to November 2008.

As of May 18, the VA said that roughly 8,000 of the 10,483 potentially affected patients had been notified of the results of their blood tests,
while the remaining tests are still underway. (redOrbit)

Wristband monitors sunscreen needs

It has happened to most of us: You get lost in the warmth of a summer day – at the beach, playing softball, biking or even just working in the
garden – and before you know it you have a bad sunburn.

A new device, the UVSunSense wristband, should eliminate the problem. The wristband, used in conjunction with a reliable sunscreen, lets
the wearer know when that sunscreen is no longer doing its job. The wristband stands up to water - fresh, salt or chlorinated - and helps the
wearer gauge how much UV radiation he or she has soaked up.

The technology behind the wristband is similar to that used in the monitoring devices that nuclear plant workers wear to measure levels of
radiation exposure. Fresh from the package, the wristbands are orange. When you apply your sunscreen (SPF 15 or higher), you also apply
some to the band and it changes to blue/purple. When the blue/purple disappears and it turns brown, it’s time for another application of
sunscreen. And should it turn a yellow/orange/salmon, it’s time to get out of the sun.

A fair-skinned volunteer who had been using sunblock for about 30 years recently tried out the wristbands. “The first one was on a day that
promptly turned cloudy and the band barely turned blue,” said the tester. “The second time was on a partly cloudy day of yard work. I
snugged it on my wrist and put on an even coat of SPF50. Within 10 minutes the band was a smeary, then a more solid, blue - indicating it
was activated. The sun came and went, I shoveled soil and mulch for seven hours and the band finally faded to its original peach color. I kept
an eye out for the dangerous yellow-orange color, but it stopped at peach. The band was a good reminder to apply another coat, and I’d buy
a pack for the days when I spend most of the day in the sun.”

The bands are manufactured by a New Jersey company, UVSunSense. They’re available online at, and (prices range from $5.87 to $7.89 for a package of seven). (Baltimore Sun)

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