Especially for busy hospital emergency departments, avoiding blood culture contamination is a constant challenge for those tasked with collecting blood culture specimens
Better, faster diagnosis and treatment of sepsis continues to be a major
goal at hospitals, health networks, and other medical facilities throughout the
United States. Yet microbiologists
and clinical
laboratory managers continue to be frustrated with how frequently
contaminated blood culture specimens show up in the laboratory.
A recent poll of more than 200 healthcare professionals who
attended a
sponsored webinar hosted by Dark Daily, showed that nearly 10% of
those who responded reported an overall blood culture contamination rate in
their hospitals at above 4%.
However, the arrival of new technology may provide hospital
staff with a way to reduce contamination rates in blood culture specimens, in
ways that improve patient outcomes.
The effectiveness of a new tool, the Steripath Initial Specimen Diversion
Device (ISDD), is being demonstrated in a growing number of prominent
hospitals in different regions of the United States. What will be particularly
intriguing to clinical laboratory professionals is that the ISDD is capable of
collecting blood while minimizing the problems caused by human factors, micro-organisms,
and skin plugs or fragments. This device was developed by Magnolia Medical Technologies
of Seattle, Wash.
The ISDD isolates the initial 1.5
to 2.0 mL aliquot of the blood culture sample, which is most likely to be
contaminated with microscopic skin fragments colonized with bacteria. The device diverts this initial aliquot into a sequestration
chamber, mechanically isolating it from the rest of the sample, and then
automatically opens an independent sterile pathway into blood culture collection
bottles.
Such technology may be welcomed by medical laboratory
professionals based in hospitals and other healthcare facilities. That’s
because it is the lab staff that typically identifies a contaminated blood
culture specimen and must go back to the nurses, staffers, and physicians on
the wards to have them redraw an acceptable specimen that will produce an
accurate, reliable result. Patients under these circumstances generally
continue on unnecessary broad-spectrum antibiotics, and their length of stays
have been reported to increase by two days on average.
Problem of Decentralized Phlebotomy
One problem contributing to high blood culture rates is
that, in many hospitals and health networks, phlebotomy has been decentralized
and is no longer managed by the clinical laboratory.
“I’ve seen the havoc decentralized phlebotomy wreaks on contamination rates of blood culture rates,” stated Dennis Ernst, Director of the Center for Phlebotomy Education based in Mio, Mich. “That staffing model, which swept through the hospital industry in the late 1990s, may have looked good on paper, but I can count the number of facilities that have successfully decentralized on the fingers of one hand. And I don’t know of any decentralized setting that has an acceptable blood culture contamination rate.”
Dennis Ernst, MT(ASCP), NCPT(NCCT) (above), Director of the Center for Phlebotomy Education, shared his expertise during a recent webinar hosted by Dark Daily. Ernst considers blood culture contamination to be among the “low-hanging fruit” in every medical laboratory that can be easily and permanently corrected with the proper approach. (Photo copyright: Dennis Ernst.)
Ernst, a medical
technologist and educator, has seen the
difficulty in lowering contamination rates in a decentralized,
multidisciplinary workforce. He has worked for more than 20 years advocating
for best practices in the diagnostic blood collection industry and has helped clinical
laboratory facilities achieve a 90% reduction in their contamination rates. Ernst considers blood
culture contamination to be among the “low-hanging fruit” in every laboratory
that can be easily and permanently corrected with the proper approach.
“One statistic we’ve heard over and over again is that the American Society of Microbiology established the ‘threshold’ for blood culture contamination to be 3%,” Ernst said. “I believe strongly that a 1% contamination rate or less is what should be required and that it’s not only achievable, but sustainable.”
Regardless of
staffing mix, blood culture contamination is a common problem in the emergency
department, Ernst explained during his presentation, “Evidence-Based
Technology to Reduce Blood Culture Contamination, Improve Patient Care, and
Reduce Costs in Your Clinical Lab or Hospital,” which is available
free for streaming.
Improving Patient Care and Reducing Avoidable Costs
With unnecessary
antibiotic use, increased length of stay, and the cost of unnecessary
laboratory testing at issue, hospitals are tracking blood culture collection
results and exploring ways to reduce episodes of blood culture contamination. On these and other healthcare quality
improvement aims, providers are publishing study results on contamination
reduction and potential direct and indirect hospital cost savings. For example:
At the University of Nebraska, a
prospective, controlled, matched-pair clinical study showed an 88% reduction in
blood culture contamination with a 12-month sustained rate of 0.2% when
Steripath was used by phlebotomists in the ED. The author estimated the institution
would save approximately $1.8 million if the technology was adopted
hospitalwide, reported an article in Clinical
Infectious Diseases in July 2017.
Florida-based Lee
Health system’s microbiology laboratory reported an 83% reduction in
contamination rates comparing their standard method to ISDD for a seven-month
trial period. Their systemwide potential cost avoidance estimates ranged from
$4.35 million to nearly $11 million, reported an article in the Journal of Emergency
Nursing in November 2018.
Researchers from Massachusetts General reported that
ISDD is the single most effective intervention so far explored for reducing
costs related to false-positive blood cultures, potentially saving the typical
250- to 400-bed hospital $1.9 million or $186 per blood culture and preventing
34 hospital-acquired conditions (including three C.
difficile cases). The recent article “Model to Evaluate the Impact of
Hospital-based Interventions Targeting False-Positive Blood Cultures on
Economic and Clinical Outcomes” in the Journal
of Hospital Infection explains more.
Blood Facilities Should be Tracking Their Contamination
Rate
One of the biggest challenges faced during blood sample
collection is making sure an organism is not inadvertently introduced into the
blood. Therefore, importance has been placed on clinical laboratories and other healthcare providers
developing policies and procedures to limit the introduction of likely
contaminants.
“I believe most places monitor blood culture contamination,
but they are not doing much that is effective to reduce it,” Ernst said.
“That’s a real problem.”
To assist healthcare providers in blood culture quality
improvement, the free webinar, “Evidence-Based Technology to Reduce Blood
Culture Contamination, Improve Patient Care, and Reduce Costs in Your Clinical
Lab or Hospital,” available on-demand through Dark Daily, can be
downloaded by clicking here,
or by pasting the URL “https://darkintelligenceprogramsondemand.uscreen.io/programs/evidence-based-technology-to-reduce-blood-culture-contamination-improve-patient-care-and-reduce-costs-in-your-clinical-lab-or-hospital”
into a web browser.
This program, which polled more than 200 healthcare
professionals, explores the clinical and economic significance of blood culture
contamination, the downstream impact of false-positive blood cultures, and case-study
evidence of sustained reductions in contamination.
Using animal blood, the researchers hope to improve the accuracy of AI driven diagnostic technology
What does a cheetah, a tortoise, and a Humboldt penguin have
in common? They are zoo animals helping scientists at Saarland University in
Saarbrücken, Germany, find biomarkers that can help computer-assisted diagnoses
of diseases in humans at early stages. And they are not the only animals
lending a paw or claw.
In their initial research, the scientists used blood samples
that had been collected during routine examinations of 21 zoo animals between
2016 and 2018, said a news
release. The team of bioinformatics
and human genetics experts
worked with German zoos Saarbrücken and Neunkircher for the study. The project
progresses, and thus far, they’ve studied the blood of 40 zoo animals, the
release states.
This research work may eventually add useful biomarkers and
assays that clinical
laboratories can use to support physicians as they diagnose patients,
select appropriate therapies, and monitor the progress of their patients. As medical
laboratory scientists know, for many decades, the animal kingdom has been
the source of useful insights and biological materials that have been
incorporated into laboratory assays.
“Measuring the molecular blood profiles of animals has never
been done before this way,” said Andreas
Keller, PhD, Saarland University Bioinformatics Professor and Chair for
Clinical Bioinformatics, in the news release. The Saarland researchers published
their findings in Nucleic Acids
Research, an Oxford
Academic journal.
“Studies on sncRNAs [small non-coding RNAs] are often largely based on homology-based information, relying on genomic sequence similarity and excluding actual expression data. To obtain information on sncRNA expression (including miRNAs, snoRNAs, YRNAs and tRNAs), we performed low-input-volume next-generation sequencing of 500 pg of RNA from 21 animals at two German zoological gardens,” the article states.
Can Animals Improve the Accuracy of AI to Detect Disease
in Humans?
However, the researchers perceived an inability for AI and machine learning to
discern real biomarker patterns from those that just seemed to fit.
“The machine learning methods recognize the typical
patterns, for example for a lung tumor or Alzheimer’s disease. However, it is
difficult for artificial intelligence to learn which biomarker patterns are
real and which only seem to fit the respective clinical picture. This is where
the blood samples of the animals come into play,” Keller states in the news
release.
“If a biomarker is evolutionarily conserved, i.e. also
occurs in other species in similar form and function, it is much more likely
that it is a resilient biomarker,” Keller explained. “The new findings are now
being incorporated into our computer models and will help us to identify the
correct biomarkers even more precisely in the future.”
Andreas Keller, PhD (left), and zoo director Richard Francke (right), hold a pair of radiated tortoises that participated in the Saarland University study. (Photo copyright: Oliver Dietze/Saarland University.)
“Because blood can be obtained in a standardized manner and
miRNA expression patterns are technically very stable, it is easy to accurately
compare expression between different animal species. In particular, dried blood
spots or microsampling devices appear to be well suited as containers for
miRNAs,” the researchers wrote in Nucleic Acids Research.
Animal species that participated in the study include:
Additionally, human volunteers contributed blood specimens
for a total of 19 species studied. The scientists reported success in capturing
data from all of the species. They are integrating the information into their
computer models and have developed a public database of their
findings for future research.
“With our study, we provide a large collection of small RNA
NGS expression data of species that have not been analyzed before in great
detail. We created a comprehensive publicly available online resource for
researchers in the field to facilitate the assessment of evolutionarily
conserved small RNA sequences,” the researchers wrote in their paper.
Clinical Laboratory Research and Zoos: A Future
Partnership?
This novel involvement of zoo animals in research aimed at improving
the ability of AI driven diagnostics to isolate and identify human disease is
notable and worth watching. It is obviously pioneering work and needs much
additional research. At the same time, these findings give evidence that there
is useful information to be extracted from a wide range of unlikely sources—in
this case, zoo animals.
Also, the use of artificial intelligence to search for
useful patterns in the data is a notable part of what these researchers
discovered. It is also notable that this research is focused on sequencing DNA
and RNA of the animals involved with the goal of identifying sequences that are
common across several species, thus demonstrating the common, important
functions they serve.
In coming years, those clinical laboratories doing genetic
testing in support of patient care may be incorporating some of this research
group’s findings into their interpretation of certain gene sequences.
Kaiser
Health News (KHN) recently
reported on investigations by the OIG into hospitals allegedly offering
unusually high salaries and other perks to specialists because they attract highly
profitable business.
Wheeling, KHN reported, paid one anesthesiologist $1.2
million per year, which, Rau notes, is higher than the salaries of 90% of the
pain management specialists around the country. Rau went on to describe how
Wheeling also paid one obstetrician-gynecologist $1.3 million per year, and a
cardiothoracic surgeon $770,000 per year along with 12 weeks of vacation time.
In each of those cases, the whistleblower who prompted the qui tam investigation reported
that the specialists’ various departments were frequently in the red, reported KHN.
“The problem, according to the government, is that the
efforts run counter to federal self-referral bans and anti-kickback laws that
are designed to prevent financial considerations from warping physicians’
clinical decisions,” wrote Rau.
Wheeling not only contests the lawsuits brought against it,
but also has filed a countersuit against the whistleblower. KHN said the
hospital claims “its generous salaries were not kickbacks but the only way it
could provide specialized care to local residents who otherwise would have to
travel to other cities for services such as labor and delivery that are best
provided near home.”
“We are confident that, if this case goes to a trial, there will be no evidence of wrongdoing—only proof that Wheeling Hospital offers the Northern Panhandle Community access to superior care, [and] world class physicians and services,” KHN reported Gregg Warren (above), Vice President of Marketing and Public Relations at Wheeling Hospital, saying in a statement. (Photo copyright: LinkedIn.)
OIG’s Fraud and Abuse Laws: A Roadmap for Physicians
The KHN article mentions
five laws the OIG lists on
its website that are particularly important for physicians to be aware of. They
include the:
False Claims Act: states that it’s illegal to file false Medicare or Medicaid claims.
Anti-Kickback Statute: states that paying for referrals is illegal, that physicians can’t provide free or discounted services to uninsured people, and that money and gifts from drug and device makers to physicians are prohibited.
Stark Law(physician self-referral): says that referrals to entities with whom the physician has a familial or financial relationship are off-limits.
Exclusion Statue: describes who cannot participate in federal programs, such as Medicare.
Civil Monetary Penalties Law: authorizes the Secretary of Health and Human Services, which operates the OIG, to impose penalties in cases of fraud and abuse that involve Medicare or Medicaid.
“Together, these rules are intended to remove financial
incentives that can lead doctors to order up extraneous tests and treatments
that increase costs to Medicare and other insurers and expose patients to
unnecessary risks,” KHN said.
Other Hospitals Under Investigation
Wheeling Hospital is not the only healthcare institution
facing investigation. The Dallas
Morning News (DMN) reported on a case involving Forest
Park Medical Center (FPMC) in Dallas that resulted in the conviction of
seven defendants, including four doctors. Prosecutors outlined the scheme in
court, saying that FPMC illegally paid for surgeries.
“Prosecutors said the surgeons agreed to refer patients to
the Dallas hospital in exchange for money to market their practices,” DMN
reported, adding “Patients were a valuable commodity sold to the highest
bidder, according to the government.”
One of the convicted physicians, Michael Rimlawi, MD,
told DMN, “I’m in disbelief. I thought we had a good system, a fair
system.” His statement may indicate the level to which some healthcare
providers at FPMC did not clearly understand how anti-kickback laws work.
“The verdict in the Forest Park case is a reminder to
healthcare practitioners across the district that patients—not payments—should
guide decisions about how and where doctors administer treatment,” US Attorney Erin Nealy Cox told DMN.
Know What Is and Is Not a Kickback
Both the Wheeling Hospital investigation and the Forest Park
Medical Center case make it clear that kickbacks don’t always look like
kickbacks. Becker’s Hospital Review
published an article titled “Four
Biggest Anti-Kickback Settlements Involving Hospitals in 2018” that details
cases in which hospitals chose to settle.
These four incidents involved hospitals in Tennessee,
Montana, Pennsylvania, and New York. This demonstrates that kickback schemes
take place nationwide. And they show that violations of the Stark Law, the
False Claims Act, and the Anti-Kickback Statute can happen in numerous ways.
Whether in a clinical laboratory or an enterprisewide health
network, violating laws written to prevent money—rather than appropriate
patient care—from being the primary motivator in hiring decisions, may result
in investigation, charges, fines, and even conviction.
“If we’re going to solve the healthcare pricing problem,
these kinds of practices are going to have to go away,” Vikas Saini, MD, President
of the Lown Institute, a Massachusetts
nonprofit that advocates for affordable care, told KHN.
Though these recent OIG investigations target hospitals,
clinical laboratory leaders know from past experience that they also must be
vigilant and ensure their hiring practices do not run afoul of anti-kickback
legislation.
Based on clinical trials of the medical laboratory test, pregnant women can expect a reduced risk for experiencing complications associated with the dangerous blood disorder
Clinical pathology laboratories and obstetricians in the UK may soon have a new blood test that can help provide earlier diagnoses of pre-eclampsia, a hypertensive disorder of pregnancy that can cause liver and kidney disfunctions and, if untreated, can lead to eclampsia and deadly seizures.
Following a clinical trial conducted by scientists at King’s College London (King’s College), the National Health Service (NHS) in the United
Kingdom (UK) announced it would be making the new test widely available.
The researchers published their findings in The
Lancet medical journal. Their paper explains that the clinical trial
took place in 11 maternity units in the UK from June 2016 through October 2017.
And that 1,023 women were divided into two groups:
576 (56%) were in the “intervention group,”
meaning they had PGF test results made available to their maternity teams;
447 (44%) did not have PGF test results made
available.
The researchers, the Independent
reported, wanted to determine the impact, if any, the new test’s results would
have on diagnoses.
Significantly Reduced Time to Diagnosis
Trial results indicated that measuring the placental growth factor (PGF) in women who are suspected of having pre-eclampsia can increase speed to diagnosis. “PGF testing was shown to reduce the average time to pre-eclampsia diagnosis from 4.1 days to 1.9 days, and serious complications before birth (such as eclampsia, stroke, and maternal death) [dropped] from 5% to 4%,” a King’s College press release stated.
“Complications like stroke, seizures and maternal death fell
by 20% when doctors had access to PGF testing,” the Independent
reported.
The researchers stated in their study, “Our trial has shown
that, in women presenting with suspected pre-eclampsia, PGF measurement,
incorporated into a management algorithm based on national guidelines,
significantly reduces the time taken for treating clinicians to diagnose
pre-eclampsia. This improvement was associated with a significant reduction in
maternal adverse outcomes, with no detected difference in gestational age at
delivery or adverse perinatal outcomes.”
The King’s College press release states, “Pre-eclampsia is
suspected in around 10% of UK pregnancies, affecting approximately 80,000 women
annually. If untreated, it can progress to cause complications in the woman,
including damage to vital organs, fits, and can be fatal for the woman and
baby. Globally, 100 women die as a result of the condition every day.”
The release also noted that “doctors were able to diagnose
pre-eclampsia on average two days sooner. This was associated with significant
improvements in outcomes for women without causing health problems for babies.”
Tony Young, PhD (above), National Clinical Lead for Innovation at NHS, stated in the King’s College press release that “This innovative blood test helps determine the risks of pre-eclampsia in pregnancy, enabling women to be directed to appropriate care or reduce unnecessary worry more quickly.” (Photo copyright: LinkedIn.)
Measuring PGF in Clinical Laboratory Study
PGF is a molecular marker for inflammation associated mostly
with the mother’s placenta.
The King’s College researchers wanted to find out if a quicker diagnosis of
pre-eclampsia was possible. And, if so, could it reduce adverse outcomes in the
mother and baby?
“For the last hundred years, we have diagnosed pre-eclampsia
through measuring blood pressure and checking for protein in a woman’s urine.
These are relatively imprecise and often quite subjective,” said Lucy Chappell, PhD,
NIHR Research Professor in Obstetrics at King’s College, and lead author of the
study, in the news release.
“We knew that monitoring PGF was an accurate way to help
detect the condition, but [we] were unsure whether making this tool available
to clinicians would lead to better care for women. Now we know that it does,” she
concluded.
Pre-eclampsia can lead to stroke, seizures, and even death
of expectant mothers and unborn children. It is usually diagnosed after 20
weeks of gestation through blood pressure tests and urine tests that show
hypertension and elevated protein levels.
“We found that the availability of PGF test results
substantially reduced the time to clinical confirmation of pre-eclampsia. Where
PGF was implemented, we found a lower incidence of maternal adverse outcomes,”
the researchers wrote in their study.
Similar Study in the US
In the UK, pre-eclampsia affects about one in 20 pregnancies
or 80,000 women each year, New
Scientist explained. While in the US, data compiled from the Centers for Disease Control
and Prevention (CDC) indicate that pre-eclampsia affects one in 25
pregnancies or about 154,220 women annually.
Researchers in Ohio also recently reported on a test and a piloted
clinical study for rapid diagnosis of pre-eclampsia.
“This is the first clinical study using the point-of-care,
paper-based Congo Red Dot (CRD) diagnostic test, and the mechanism proved
superior in establishing or ruling out a diagnosis of pre-eclampsia,” Kara Rood, MD, a maternal-fetal
medicine physician at Wexner Medical Center and first author of the study said
in the Wexner press release. “Our findings will have a huge impact on the
health of women and children.”
The researchers published their findings in EClinicalMedicine,
a Lancet Journal.
“Pre-eclampsia is often described as ‘mysterious’ because
it’s difficult to diagnose. Our researchers show that there’s an easy,
non-invasive test that will help diagnose this condition and maintain the
health of pregnant women and their babies,” K. Craig
Kent, MD, OSU Dean of the College of Medicine, said in the press release.
Clinical laboratory tests such as these being developed in
the US and abroad could help pregnant women worldwide experience happy
pregnancies and give birth to healthy babies. Medical laboratory leaders in
this country may want to stay abreast of the development of these simple blood
and urine tests.
Following the raid, the company’s co-founders resigned
from the board of directors
Microbiome testing company, uBiome, a biotechnology developer that offers at-home direct-to-consumer (DTC) test kits to health-conscious individuals who wish to learn more about the bacteria in their gut, or who want to have their microbiome genetically sequenced, has recently come under investigation by insurance companies and state regulators that are looking into the company’s business practices.
CNBC
reported that the Federal Bureau of
Investigation (FBI) raided the company’s San Francisco headquarters in
April following allegations of insurance fraud and questionable billing
practices. The alleged offenses, according to CNBC, included claims that
uBiome routinely billed patients for tests multiple times without consent.
Becker’s
Hospital Review wrote that, “Billing documents obtained by The Wall Street
Journal and described in a June 24 report further illustrate uBiome’s
allegedly improper billing and prescribing practices. For example, the
documents reportedly show that the startup would bill insurers for a lab test
of 12 to 25 gastrointestinal pathogens, despite the fact that its tests only
included information for about five pathogens.”
Company Insider Allegations Trigger FBI Raid
In its article, CNBC stated that “company insiders”
alleged it was “common practice” for uBiome to bill patients’ insurance
companies multiple times for the same test.
“The company also pressured its doctors to approve tests
with minimal oversight, according to insiders and internal documents seen by CNBC.
The practices were in service of an aggressive growth plan that focused on
increasing the number of billable tests served,” CNBC wrote.
FierceBiotech reported that, “According to previous
reports, the large insurers Anthem, Aetna, and Regence BlueCross BlueShield
have been examining the company’s billing practices for its physician-ordered
tests—as has the California Department of Insurance—with probes focusing on
possible financial connections between uBiome and the doctors ordering the
tests, as well as rumors of double-billing for tests using the same sample.”
Becker’s Hospital Review revealed that when the FBI
raided uBiome they seized employee computers. And that, following the raid,
uBiome had announced it would temporarily suspend clinical operations and not
release reports, process samples, or bill health insurance for their services.
The company also announced layoffs and that it would stop
selling SmartJane and SmartGut test kits, Becker’s reported.
uBiome Assumes New Leadership
Following the FBI raid, uBiome placed its co-founders Jessica
Richman (CEO) and Zac
Apte (CTO) on administrative leave while conducting an internal
investigation (both have since resigned from the company’s board of directors).
The company’s board of directors then named general counsel, John Rakow, to be interim CEO,
FierceBiotech
reported.
John Rakow (center) is shown above with uBiome co-founders Jessica Richman (lower left) and Zac Apte (lower right). In a company statement, Rakow stressed that he believed in the company’s products and ability to survive the scandal. His belief may be based on evidence. Researchers have been developing tests based on the human microbiome for everything from weight loss to predicting age to diagnosing cancer. Such tests are becoming increasingly popular. Dark Daily has reported on this trend in multiple e-briefings. (Photo copyrights: LinkedIn/uBiome.)
After serving two months as the interim CEO, Rakow resigned
from the position. The interim leadership of uBiome was then handed over to
three directors from Goldin
Associates, a New York City-based consulting firm, FierceBiotech
reported. They include:
SmartFlu: a nasal microbiome swab that detects bacteria and viruses associated with the flu, the common cold, and bacterial infections.
What Went Wrong?
Richman and Apte founded uBiome in 2012 with the intent of
marketing a new test that would prove a link between peoples’ microbiome and their
overall health. The two founders initially raised more than $100 million from
venture capitalists, and, according to PitchBook,
uBiome was last valued at around $600 million, Forbes
reported.
Nevertheless, as a company, uBiome’s future is uncertain. Of
greater concern to clinical laboratory leaders is whether at-home microbiology
self-test kits will become a viable, safe alternative to tests traditionally performed
by qualified personnel in controlled laboratory environments.
