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from diagnosis,the seeds of better health
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Message from bioMérieux
September 2008 • vol 5 no 4C O N N E C T I O NbioMérieux
IN THIS ISSUEGlass vs. Plastic
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BORIS Project Posters Presented at the 108th ASM General Meeting
Surveys Show U.S. Clinicians Need New Tools to Combat Sepsis
bioMérieux Odyssey™: Photos from the Tour
Study Shows PNA FISH® Reduces ICU Mortality Rates
Welcome to the September 2008 issue of bioMérieux Connection. As of October 1, 2008, Centers for Medicare & Medicaid Services has stated that Medicare will no longer reimburse for the treatment of eight “hospital acquired conditions,” unless the condition was present when the hospital admitted the Medicare beneficiary.
These hospital-acquired conditions, such as surgical site and catheter-associated infections, are often referred to as “never events.” According to the national Quality Forum (nQF), “never events” are errors in medical care that are clearly identifiable, preventable, and serious in their consequences for patients, and indicate a real problem in the safety and credibility of a health care facility.1
The list of “never events” will grow in 2009, as ventilator-associated pneumonia, Staphylococcus aureus septicemia and deep vein thrombosis (DvT)/pulmonary embolism (PE) are considered for FY2009.
Hospitals will have to implement new diagnostic testing to both ensure greater patient safety and prevent denials. For instance, hospitals will need to screen patients for Urinary Tract Infections or Pulmonary Embolism/Deep venous Thrombosis before they are admitted. Additionally, in the case of tracking healthcare associated infections, a rapid method of strain typing is needed to uncover hidden reservoirs of infections to stop their further spread. z
1Centers for Medicare and Medicaid Services. (July 3) Medicare and Medicaid Move Aggressively to Encourage Greater Patient Safety in Hospitals and Reduce Never Events. Retrieved August 22, 2008 from the World Wide Web. http://www.cms.hhs.gov/apps/media/press_releases.asp
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2 Introducing bioZone:Online Ordering
TM
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NEW!
Welcome to the Zone! We’re pleased to introduce bioZone ( -o-zone) web ordering
to our valued customers. bioZone is the newly released, online ordering system that
is available to you 24 hours a day, seven days a week, 365 days a year – whenever
you’re working, we’re working right beside you.
Introducing bioZone: Online Ordering
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If you’re currently calling or faxing your reagent and disposable orders, bioZone is a viable ordering option for you. Why change your current process? Web ordering offers many advantages over your current method:
• Convenientaccesstoorderreagentsreal-time,anytime
• Weborderhistory,trackinginformation,andpricinghistoryavailable at all times
• Accurate,fastandsecuretransactions
• Abilitytocreateandsavedraftsandtemplatessavesyouvaluable time
We are very excited to premiere the web ordering system and look forward to your feedback. Based on your input, we will continuously enhance the web ordering experience to best meet your needs.
As part of 360°/365™ new Dimensions in Support, bioMérieux provides to you the ability to order via the worldwide web any time, anywhere, at your convenience. We’re putting you in the driver’s seat. This order fulfillment option is available to you now!
To request a web ordering account, please visit www.biomerieux-usa.com/biozone or e-mail [email protected] with “need Account” in the subject line. For more information, please call 800-682-2666, ext. 2. We’re waiting for you to join us in the Zone, and we look forward to seeing you there! z
• Electronicinvoicescanbeforwardedforreviewandapproval
• Timezonesarenolongeranissue–orderatyourleisure
• Nophonepromptstoforgethrough–loginandorder
• Notimewaitinginthequeueandnoworryaboutlostfaxes
• Alertstoyoure-mailaddresstonotifyyouwhendocumentsarrive in your web portal; e-mail alerts can be sent to multiple addresses
• Directlinktoshippingcarrierwebsitedisplaysup-to-datetracking information
• Orderpreviewscreenallowsconfirmationofitems,pricing,and quantity before submitting
Quickly and easily create new Purchase Orders. Save an order as a Draft to submit at a later date, or save as a template for future use.
Only know a portion of the product item number? Begin typing and a drop down menu appears.
Click on the tracking number to be redirected to a carrier site and obtain tracking details.
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Narelle Chenery, ONEgroup Research & Development Director, recently assessed the ecological impact of both glass and plastic packaging, using four environmental parameters:
1. Energy Consumption
2. Air Pollution
3. Environmental Release (Waste Production)
4. Global Warming Potential (Greenhouse Gases)
Energy Use per $1million Product ■ = Glass ■ = Plastic
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Electricity Coal NatGas LPG Petrol Diesel Kerosene Jetfuel Residual
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INDUSTRY TRENDS
Glass consumes nearly three times more energy to produce than plastic.
Source of graphs: The above information is summarized from the Economic Input-Output Life Cycle Assessment by Carnegie Mellon University Green Design Institute (2007). Available from www.eiolca.net
Glass vs. Plastic
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SO 2 CO Nox VOC PM<10um*
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*(Sulfur Dioxide, Carbon Monoxide, Nitrous Oxides, Volatile Organic Compounds, Particulate Matter <10um)
Air Pollutants $1million Product
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GWP CO2 CH 4 N2O CFCs
17001600150014001300120011001000900800700600500400300200100
(Global Warming Potential, Carbon Dioxide, Methane, Nitrous Oxide,
Greenhouse Pollutants $1million ProductKi
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Air Releases Water Releases Land Releases Underground Releases
Total Releases POTW transfers Offsite Transfers Total Release/Transfers
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Environmental Release $1million Product ■ = Glass ■ = Plastic
Glass produces nearly three times more air pollution than plastic.
Glass creates nearly three times more global warming gases than plastic.
Glass produces 40 percent more environmental waste release than plastic.
onEgroup found that even if no energy was involved in the transport and cleansing of returnable glass bottles, returnable bottles would have to be recycled about 20 times to compete with plastics. Instead of glass, onEgroup discovered the benefits of polypropylene bottles. Polypropylene:• Ismanufacturedfromcleantechnologies(non-toxic)• Doesnotleachharmfulchemicals(noBispenol-A,
noPVCplasticizers,noPhthalates)• Requires30percentfewerresourcesthan
other plastics• Isextremelystablewithexcellentbarrierproperties
(no leaching or outgassing)• Is100percentrecyclable• Islightweight(lessCO2 product during transit)• Hassuperiorimpactresistanceandresilience
(no product breakage during transit)
Polypropylene has none of the pitfalls of conventional plastic. It offers the strength and stability of glass without the weight and large carbon footprint. Airless (vacuum technology) packaging dispenses in any position (even upside down), is leak proof, has no metal parts (no corrosion, 100 percent recyclable), and has a pump with automatic self-closing valves that protect the product from oxidation and prevents dry-out. Polypropylene allows for no product oxidation, no contamination, no product wastage, and no leaking product. z
Source: Narelle Chenery, ONEgroup Research & Development Director
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Come aboard the Odyssey to gain
industry insights in a relaxed environment
with refreshments and our friendly staff
in your city.
The odyssey™ tour has visited over 30 cities since the launch at the end of May. over 475 guests have visited the odyssey truck to get product training, demonstration of newinstrumentsandobtainPACEcredits. The odyssey is headed to a city near you so be sure to visit www.biomerieux-usa.com/odyssey for more details!
Upcoming Tour Stops:New York City, NY • October 3Hartford, CT • October 6Danbury, CT • October 7Raleigh, NC • October 12-14 Richmond, VA • October 20Alexandria, VA • October 21Baltimore, MD • October 23
Be sure to visit the Odyssey to find out about special product coupon offers! z
Visit www.biomerieux-usa.com/odyssey to see the latest updates to the Odyssey schedule. Interested in hosting the Odyssey at your site? Call 919-620-2823.
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A new study shows use of AdvanDx’s PnA FISH® test was associated with an 82 percent reduction in mortality rates from S. aureus bloodstream infections intheintensivecareunit(ICU),a53percentreductionin overall mortality from staphylococcal bloodstream infections, and a significant reduction in antibiotic use. The study, published in the latest issue of the Journal of Therapeutics and Clinical Risk Management, was undertaken by clinicians in the Section of Infectious DiseasesatWashingtonHospitalCenter(WHC)inWashington,D.C.1
Bloodstream infections due to Staphylococcus bacteria are a leading cause of hospital-acquired infection mortality. The infection is initially diagnosed when a culture of a patient’s blood turns positive with Grampositivecocciinclusters(GPCC),indicativeof staphylococci. Because conventional laboratory identification methods can take 48 hours or longer, treating clinicians can’t determine whether the blood
SPOTLIGHT
Study Shows Reduces ICU Mortality Rates from Staphylococcus aureus Bloodstream Infections by 82 Percent
culture was positive due to true infection, requiring aggressive antibiotic therapy, or due to blood culture contaminationwithCoagulaseNegativeStaphylococci(CoNS),agroupofcommonskinbacteria,thatdon’trequire antibiotic therapy. As a result, patients with true infections are at times undertreated, whereas patients with contaminated blood cultures are often unnecessarily treated with antibiotics.
PnA FISH provides rapid, molecular identification of S. aureusandCoNSdirectlyfrompositivebloodculturesin hours instead of days. The test enables laboratories to provide fast results and help clinicians guide early and effective therapy for patients with bloodstream infections.
DuringtheWHCstudyperiod,202patientswithpositivebloodculturescontainingGPCCwereenrolledand blindly randomized into a “notification” group or a“UsualCare”group.ForpatientsintheNotificationgroup, PnA FISH results and information on the
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identified bacteria were reported directly to the treating clinicians, whereas for patients in the Usual Caregroup,datawereenteredintothehospital’slaboratory information system as usual. Medical records of enrolled patients were analyzed for demographics, comorbid conditions, location within the hospital, antimicrobial use, length of hospitalization, mortality, and other factors to understand the impact of the rapid PnA FISH results on patient care and outcomes. Significant comparison results for the two groups are listed below.
ComparisonofDataforNotificationofPNAFISH(NPF)groupvs.UsualCare(UC)group:• Totalof202patientsenrolledinstudy;101inNPF
groupvs.101inUCgroup• 61patientswithS. aureus; 32 in nPF group vs. 29
inUCgroup
• 141patientswithCoNS;69inNPFvs.72inUCgroup• 44patientsinICUvs.158innon-ICU• 53percentreductioninoverallmortality;eight
deathsinNPFgroupvs.17deathsinUCgroup• 80percentreductioninmortalityrateforintensive
careunit(ICU)patients;10percent(twodeaths)forNPFgroupvs.48percent(11deaths)forUCgroup
• 82percentreductioninmortalityrateforICUpatients with S. aureus; 10 percent for nPF group vs. 56percentforUCgroup
• 67percentreductioninmedianantibioticuseafternotification of results; median of one day forNPFgroupvs.threedaysforUCgroup
• 100percentreductioninmedianantibioticuseforCoNSpatientsafternotificationof;zerodays forNPFgroupvs.2.5daysforUCgroup
• Trendtoward$19,441reductioninmedianhospitalcharges;$72,932medianchargesforNPFgroupvs.$92,373forUCgroup
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Every year, 350,000 patients contract bloodstream infections, causing over 90,000 unnecessary deaths and significant costs to the healthcare system. The infection is detected when a culture of the patient’s blood (i.e. a blood culture) turns positive with bacteria andyeast.Rapidandaccurateidentificationofthespecific infecting pathogen is crucial to ensure early and appropriate therapy and save patient lives.
PnA FISH is an easy-to-use and highly sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PnA (peptide nucleic acid) probes to target speciesspecificribosomalRNA(rRNA)inlivebacteriaand yeast. The unique properties of the non-charged, peptide backbone of PnA probes enable the use of FISH assays in exceedingly complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of very simple, yet very accurate tests that don’t require the extensive sample preparation necessary for other nucleic acid technologies. PnA FISH tests enable microbiology labs to provide rapid and accurate identification of bloodstream pathogens directly from positive blood cultures in hours instead of days.Clinicalstudiesshowthatrapididentificationofbloodstream pathogens using PnA FISH tests leads to more appropriate patient therapy that saves lives and reduces unnecessary antibiotic use, patient length of stay and hospital costs. z
Reference: 1 Ly et al. Impact upon clinical outcomes of translation of PNA FSH-generated laboratory data from the clinical microbiology bench to bedside in real time. Therapeutics and Clinical Risk Management 2008:4(3) 637-640.
GPCC GPCPC Yeast
PNA FISH® tests enable microbiology labs to provide rapid and accurate identification of bloodstream pathogens directly from positive blood cultures in hours instead of days.
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ASPERGILLUSFUMIGATUS
BACILLUSANTHRACIS
BORRELIABURGDORFERI
CAMPYLOBACTERJEJUNI
CANDIDAALBICANS
CLOSTRIDIUMBOTULINUM
CLOSTRIDIUMDIFFICILE
ENTEROCOCCUSFAECALIS
ESCHERICHIACOLI
HELICOBACTERPYLORI
HUMANIMMUNODEFECIENCYVIRUS
HUMANPAPILLOMAVIRUS
LISTERIAMONOCYTOGENES
METHICILLINRESISTANTSTAPHYLOCOCCUSAUREUS
MYCOBACTERIUMTUBERCULOSIS
NEISSERIAMENINGITIDIS
PSEUDOMONASAERUGINOSA
SALMONELLAENTERITIDIS
STAPHYLOCOCCUSAUREUS
STREPTOCOCCUSPNEUMONIAE
STREPTOCOCCUSPYOGENES
VANCOMYCINRESISTANTENTEROCOCCUS
YERSINIAPESTIS
Identify the Superbugs!
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bioMérieux recently conducted two surveys at the American Thoracic Society and Society of Hospital Medicine conferences. The survey results show that hospitalists, pulmonary and critical care physicians and researchers are unanimous in their
view that new methods and technologies are needed to quickly diagnose and combat severe bacterial sepsis in U.S. hospitals.
Sepsis, a usually fatal medical condition generally caused by the body’s response to a severe infection of the blood and/or tissues, affects between five and 10 percent of all hospital patients, leading to an increase ofabout$5billioninU.S.healthcarecostsannually.
bioMérieux’s 20-minute test to detect levels of procalcitonin(PCT)—atelltalesignofsystemicbacterialinfection—recentlyreceived510(k)clearancefrom the U.S. Food and Drug Administration to aid in the risk assessment of critically ill patients, on their first dayofICUadmission,forprogressiontoseveresepsisandsepticshock.PCTtestshavebeenusedinEuropefor years. nearly all survey respondents said such a test would represent a “dramatic improvement” to the current methods of diagnosis and care for sepsis and suspected sepsis.
Because symptoms of sepsis can be vague and overlap with other diseases, there is no
goldstandardfordiagnosis—currentmethods of detection are slow and
inaccurate. of the pulmonary and critical care specialists surveyed, 69 percent viewed overlapping symptoms as the most difficult
aspect of diagnosing sepsis. In fact, most clinicians reported starting empiric therapy – prescribing an antibiotic treatment immediately before an accurate and firm diagnosis is determined – because the risk of not treating suspected bacterial sepsis is too dangerous. However, according to the surveys, nearly all participating hospitalists and pulmonary and critical care specialists indicated that antibiotic resistance stemming from antibiotic misuse is a primary concern as it may have an increasing effect on the development of Superbugs.
Marking a significant shift in the care of sepsis patients, 73 percent of hospitalists indicated that they now play the primary role in managing patients with suspected sepsis, while 83 percent of pulmonary and critical care specialists indicated the same. of those surveyed, all were nearly unanimous in their desire for a rapid test that would help confirm the cause of suspected sepsis.
of the hospitalists surveyed, the vast majority was unawarethatcirculatingPCTlevelsareverysensitivetothe severity of bacterial infection and closely track with the severity of that infection.1PCT,theprohormoneofcalcitonin, can be produced by numerous cell types and organs after proinflammatory stimulation, especially whencausedbybacterialinfection.ThismakesPCTan ideal indicator of systemic bacterial infection and sepsis. When provided information about procalcitonin, over half of hospitalists said a 20-minute biomarker test that could help with the diagnosis of a clinically relevant bacterial infection and/or sepsis would make a dramatic improvement in patient care and improve antibiotic stewardship. z
Surveys Show U.S. Clinicians Need New Tools to Combat Sepsis
1 Müller B, Becker KL, Schächinger H, Rickenbacher, PR, Huber PR, Zimmerli W, Ritz R. Calcitonin precursers are reliable markers of sepsis in a medical intensive care unit. Crit Care Med 2000;28:977-983.
INDUSTRY TRENDS
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C O N N E C T I O NbioMérieux
bioMérieux ConnectionispublishedbybioMérieux,Inc.,100RodolpheStreet,Durham,NC27712.Pleasesendaddresscorrectionsandmailinglistadditionsto [email protected]. For customer service, call toll free 800-682-2666. Please visit our web site at www.biomerieux-usa.com. Please share your comments and suggestions with us through your local account manager or by emailing us at the address above. As always, we thank you for being a bioMérieux customer.
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Southwest Association Clinical Microbiology (SWACM)September10-13•St.Louis,MO
Inter. Mountain StateSeptember 17-20
Southern California Symposium (SOCAL)September24•HuntingtonBeach,CA
Lab Supply Company (LABSCO)September29-October1•Louisville,KY
Northwest Medical Lab SymposiumOctober15-18•Portland,OR
Healthcare Industry Distributors Association (HIDA)October16-18•Chicago,IL
Northeast Lab ConferenceOctober22-24•Portland,MEBooth #s 66 & 67
American College of Chest Physicians (CHEST)October25-28•Philadelphia,PA
Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC/IDSA) – 47th Annual October25-28•Washington,DCBooth #1516
American College of Emergency PhysiciansOctober27-30•Chicago,IL
Association for Molecular Pathology October30-November2•Grapevine,TXBooth #903
Southeast Association of Clinical Microbiology (SEACM)November5-8•MyrtleBeach,SCUsers Meeting November 58:00 a.m.-12:00 p.m.
Southern California American Society of Clinical Microbiology (SCASM)November13-15•LaJolla,CA
2008 SHOwS ANd CONFeReNCeS
ThebioMérieuxOrganismResistanceSurveillanceNetwork(BORIS)was established as a means for bioMérieux to actively participate in the epidemiologic surveillance of microorganisms exhibiting unusual patterns of resistance.BORISworkswithseveralclinicallaboratorieslocatedthroughoutthe U.S. to collect target organisms. These isolates are sent to our St. louis location for ID and AST confirmation and additional testing for antibiotic resistance traits. As a result of this testing, we can determine trends in antibiotic resistance as well as detect any regional differences in antibiotic resistance expression. These isolates are then available for subsequent research and development activity. The bioMérieux team worked with several of our network laboratories within the microbiology community to complete the following studies presented as posters at the 108th ASM General Meeting held in early June of this year:
Prevalence of Metallo-ß-lactamases in Acinetobacter baumannii clinical isolates: a report from the BORIS project and
Characterization of multi-drug resistant Pseudomonas aeruginosa clinical isolates: a report from the BORIS project
BORIS Project Posters Presented at the 108th ASM General Meeting in Boston
While both Acinetobacter baumannii and Pseudomonas aeruginosa are commonly encountered and discussed within the laboratory/hospital setting, they are actually now being discussed in our communities due to their increasing levels of resistance. As an industry leader in the field of diagnostic microbiology, bioMérieux will continuetosupporttheBORISproject.Ourparticipationallowsustheabilityto work with fresh clinical isolates to challenge and enhance our current products and develop future products based upon the needs presented within the community. The field of microbiology is a world of organisms that adapt and change almost as quickly as they are introduced to the antibiotics. OurcommitmenttoConsultationandResearchisanimportantpartofour360°/365™ new Dimensions in Support. Through the education of technologists, better products and better customer service, we will have better patient care. z
To view these posters online, visit www.biomerieux-usa.com/education.