The session will demonstrate the latest in blood collection technology designed to help enhance patient comfort, improve access to difficult veins, boost efficiency and reduce needlestick injuries

Learn how the new Thermo Scientific LabLink xL quality assurance solution turns routine QC into an exciting, automated, simple process with fast troubleshooting, peer comparison, sigma score, multiple lab management, Levey-Jennings charts, auto-QC data transfer and more.

Learning Objectives:

• Describe the various causative factors of ketosis and the physiological processes that lead to acidosis, a life threatening condition
• Summarize the biochemical differences of hepatic ketone bodies and the relative strengths and weaknesses of the different ‘ketone’ tests available to physicians who treat acute complications of diabetes and non-diabetic causes of acidosis

Alere™ i utilizes unique isothermal nucleic acid amplification technology which does not require temperature cycling or a sample purification step. It is significantly faster than other molecular methods and more accurate than conventional rapid testing giving you the confidence to make effective patient management decisions sooner.
 

Urinalysis is one the oldest, most established, and most frequently ordered laboratory tests.  However, there is wide variation in the methods, processes, quality checks, specifications, and diagnostic scope in clinical use today.  Dr. Skelton will describe his experience with a focused systematic effort to identify and implement best practices in all aspects of urinalysis testing at Lahey Health.  Decisions on best practice were made with the goal of optimizing clinical benefit to Lahey Health’s patient population and reducing the total healthcare cost attributable to the burden of diseases evaluated by urinalysis.  Changes to institutional policies combined with novel application of information technology were applied to overcome perceived regulatory obstacles to optimal evidence-based clinical practice.  Best practices for order design, result reporting, and data architecture and their impact on workflow efficiencies will be discussed.  Recent technical advances in instrumentation allow improved diagnostic abilities that enable a redesign of the laboratory process and clinical scope of urinalysis.  Data will demonstrate the impact that this type of redesign has had at Lahey Health. 
 
Learning Objectives:
After attending this session, participants will be able to:

• 1 Understand the variables that impact the clinical diagnostic performance of urinalysis testing
• 2 Identify key developments in instrumentation, information technology, and healthcare delivery that improve the value of urinalysis diagnostics

Ultra- Low (-80^oC) temperature freezers can use as much energy in a year, as a typical American house.  The -80^oC freezer is most often the highest energy intensive piece of laboratory equipment you use. Up until relatively recently, electrical energy in the United States was produces in abundance and used with little or no concern regarding its resulting effects on the environment. This lack of energy concern focused Ultra-Low freezer manufactures attention on improving operational performance like temperature recovery after door openings and BTU removal, rather than a focus on reducing energy consumption.

Today, our industry is changing. Our customers are requiring more sustainable solution for all laboratory equipment. Sustainability departments and initiatives are actively looking for partners to supply equipment that used less energy, without sacrificing performance, to help meet sustainability goals.

Manufactures of -80^oC freezers are now driving innovations that both improve operational performance while at the same time dramatically reducing energy consumption.

Please join Thermo Fisher Scientific as we review many of the innovation we have designed into our newest series of -80^oC freezers; the Thermo Scientific™ TSX. During this presentation, you will learn how to cut your ultra-low temperature freezer energy consumption by 50%, without sacrificing performance, and be well on your way to meeting your facilities energy reduction goals.
 

As the interface between the laboratory and the ward, POCCs perform much of their work while out in different hospital locations. This can be challenging when managing important tasks that require a PC, like performing remote troubleshooting tasks, arranging operator training, checking the status of a device or replacing an instrument. The new POC mobile app for cobas IT 1000 enables POCCs to complete all these tasks on a smartphone or tablet, no matter where they are – assisting them with saving time and increasing productivity while on-the-go.

The cobas IT 1000 application from Roche Diagnostics provides comprehensive Point-of-Care program management tools allowing for management of system configurations, test and QC materials, operators, and Point-of-Care instruments. The cobas IT 1000 application connects the full Roche POC portfolio including Accu-Chek^® Inform II, CoaguChek^® XS Plus, CoaguChek^® XS Pro, Urisys 1100^®, and cobas^® Liat as well as many instruments from other manufacturers. 

Until now, Point-of-Care management required a PC or laptop.  The Point-of-Care coordinator (POCC) had to remain in close proximity to their PC to effectively manage their Point-of-Care program. POC Mobile with cobas IT 1000 from Roche changes that and frees the POCC from their workstation to act while on-the-go.
 

The use of Liquid Chromatography Mass Spectrometry (LC-MS/MS) is becoming more prevalent in clinical research laboratories throughout the world. This technology brings an additional level of versatility with the ability for simultaneous quantitative and qualitative analysis.  This session will include an introduction to LC-MS/MS for the clinical lab, encompassing both the technology and advantages.
 
Learning Objectives:
1. Describe both the LC and MS/MS componentry that together make up an LC-MS/MS system.
2. Explain the theory of LC-MS/MS technology focusing on triple quadruple based systems.
3. Discuss how specificity and sensitivity is afforded by LC-MS/MS.
4. Summarize the laboratory requirements to implement LC-MS/MS technology.

Following attendance of this virtual event, participants should appreciate the changing epidemiology of trichomoniasis and clinician ordering patterns on the basis of improved laboratory diagnostics.  In addition, participants should be able to characterize the distribution of Mycoplasma genitalium infection in women and men on the basis of a new diagnostic option.  Finally, attendees will be able to describe the evolution of molecular screening for human papillomavirus and application to cervical cytology.

Learning Objectives:
I.Appreciate the changing epidemiology of trichomoniasis and clinician ordering patterns on the basis of improved laboratory diagnostics
II.Characterize the distribution of Mycoplasma genitalium infection in women and men on the basis of a new diagnostic option
III.Describe the evolution of molecular screening for human papillomavirus and application to cervical cytology

This presentation explores the changing role of pharmacy grade refrigerator and freezers in the refrigerated storage of vaccine and temperature critical products. The efficacy of stored vaccine is critically dependent on storage and handling practices, including the use of reliable temperature monitoring methods and properly controlled storage systems. The absence of those protections can result in substantial waste, diminished vaccine potency, and the need for revaccination.

Currently, vaccine providers and program administrators face significant challenges as they navigate the selection and purchase of effective vaccine storage equipment. Pharmaceutical and medical grade manufacturers also face significant challenges due to changing government environmental regulations. The presentation explores what end users should look for to ensure that vaccines and critical product efficacy and safety standards are maintained and to maximize their return on investment for the long term. 
 

Medicare is clearly moving to a pay for value paradigm, and commercial payers continue their own march away from traditional fee-for-service payment. How can you develop and articulate a persuasive value proposition for your specific product when the payers’ decisionmaking context is a much bigger picture? Successful diagnostic companies will clearly convey the impact of their test result on downstream patient outcomes. Payers expect to see evidence of patient benefit, and for diagnostic tests this means clinical utility.
 

The revolutionary ORTHO VISION® analyzer is a highly interactive, fully automated blood bank analyzer engineered for the specific needs of transfusion medicine.  Utilizing innovative ID-MTS^® gel technology,  the ORTHO VISION®  analyzer allows continuous access to load STAT and routine samples, reagents and consumables.
 
Join us for an interactive presentation on this revolutionary analyzer and learn about the first ever system that has the power to transform transfusion medicine through the benefits of responsive automation – namely:

• The efficiencies of dynamic workflow management
• The safety of secure monitoring technologies
• An interactive partnership with a committed team of experts

The Solana GAS Assay is a rapid in vitro diagnostic test for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat.

The Solana GAS Assay, when performed on the Solana instrument, allows for the rapid, accurate detection of Group A Strep without the need for culture confirmation.

The assay utilizes helicase-dependent amplification (HDA) of the DNase B (sdaB) sequence and fluorescent probe-based detection in the Solana instrument to determine assay results.

A throat swab sample or an aliquot of liquid transport media is lysed by simple heat treatment, diluted, and added to a Reaction Tube containing the lyophilized HDA reagents including primers specific for the amplification of the DNAase B (sdaB) sequence as well as sequence specific probes. Competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or instrument failure.

Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s six USB ports. Solana GAS is supported by the power of Virena^. 
 

For the product overview/demonstration there will be an introduction to who Sekisui Diagnostic is, followed by a brief introduction to the point of care product line. The main focus will however be for one particular product the OSOM iFOBT assay. During this a PowerPoint presentation will run through the following: what is fecal occult blood, why is it important to test, what is fecal immunochemical testing, the benefits of immunochemical testing over other testing platforms, an overview over the OSOM iFOBT test, iFOB patient instruction video, OSOM training for the iFOB assay, support, and then conclusion. There will be two videos shown during this presentation on patient instruction and how the patient collects the sample and then the lab procedure video.
 

SeraCare partners with IVD researchers and manufacturers as well as clinical laboratories to bridge the gap between today’s diagnostic solutions and tomorrow’s emerging technologies for molecular diagnostics, next generation sequencing and companion diagnostics.   With a comprehensive portfolio of QC control and panel products, and with more than 25 years of diagnostic industry experience, SeraCare is uniquely positioned to ensure the highest level of consistency, confidence, and compliance as we jointly shape the future of medical diagnostics.

A meta-analysis published in the journal Vaccine, including studies published in more than 20 countries, estimated that 14% to 35% of vaccines are subjected to accidental freezing – the largest source of vaccine loss. Proper storage methods and effective control of the refrigeration systems in the vaccine refrigerators and critical in protecting vaccines from freezing and from excursions outside of the normal control range of 2C to 8C which can render vaccines ineffective. Vaccines providers currently face challenges in navigating the selection and purchase of vaccine equipment. Currently an NSF committee is charged with creating a new standard for vaccine storage to make the selection simpler. This presentation is aimed at explaining the challenges, proper storage equipment selection  and discussing the changes to come in the vaccine storage landscape.
 

PATHFAST is a small, benchtop cardiac marker analyzer with industry-leading precision designed for ED and stat labs. PATHFAST is the only point-of-care cardiac biomarker analyzer in the market with a 5.1% CV for Troponin I at the 99^th percentile cutoff. With the flexibility to run whole blood or plasma samples, PATHFAST allows for up to six simultaneous tests in under 17 minutes. The test menu includes Troponin, CK-MB, NTproBNP, D-Dimer, hsCRP and Myoglobin, and test results are unaffected by hemolysis^†, providing accurate, fast results – helping clinicians diagnose patients more effectively and efficiently.
 
Our goal is to not just to provide the best whole blood cardiac biomarker analyzer in the industry, but to improve the quality of patient care while simultaneously reducing costs.
 
PATHFAST is manufactured in Japan, from quality components, and under the strictest quality control standards.
 

The Cardinal Health^TM urEssential Award program is now in its third year and for the first time we are announcing the winner by live webcast! Please join us to meet your 2016 finalists, see the winner announcement, and find out which school will receive a $25,000 charitable contribution for the education of future clinical laboratory professionals. Stick around after the announcement for a live meet and greet with the Laboratory Professional of the Year!

The Centers for Medicare and Medicaid Services (CMS) is about to gather reimbursement data from laboratories to recalculate the clinical laboratory fee schedule.  The process and potential impact of this project, as well as  other new reimbursement models proposed by CMS will be discussed.  We will also update attendees on the FDA laboratory developed test guidance and controversy, describe the status of CLIA activities and analyze federal government policy developments pertaining to laboratory practice.
 

An emerging infectious disease or re-emerging infectious disease is defined by WHO as “one that has appeared in a population for the first time, or that may have existed previously but is rapidly increasing in incidence or geographic range.” A 2003 IOM report identified several factors that have contributed to the emergence and re-emergence of infectious diseases. Healthcare has seen many examples of emerging infectious in the past few decades and each outbreak has presented new lessons for dealing with future outbreaks.  In addition, the microbiology laboratory is challenged to serve as both sentinels for the disease activity as well as resources for testing and diagnostic information, and there are lessons to be learned here as well. This presentation will highlight several recent situations involving emerging infectious diseases, discuss the key contributing factors, identify lessons learned for the future, and describe the critical role of the laboratory in outbreak response.
 
Learning Objectives:

1. Describe factors that contribute to emerging infectious diseases, and provide examples of infections related to those factors.
2. Describe the role of the microbiology laboratory in recognition and diagnosis of emerging infectious diseases.

This presentation covers the "Individualized Quality Control Plan” (IQCP) implemented by The Centers for Medicare & Medicaid Services (CMS) on January 1, 2016. The guidance and concepts for IQCP are a formal representation and compilation of many of the activities currently undertaken in laboratories to ensure quality test results for patients.  The three main parts of IQCP are Risk Assessment, Quality Control Plan, and Quality Assessment.  IQCP permits the laboratory to customize its QC plan according to test method, environment, patient population, and personnel competency. 
Upon completion of this presentation, participants should be able to:

• Identify eligible test for IQCP
• Identify the three sections of an IQCP
• Prepare a plan for implementation of IQCP

Medical providers now have a number of new technologies available for the rapid diagnosis of strep pharyngitis. Dr. Schuman will present an overview of strep pharyngitis, signs and symptoms and complications with an emphasis on expediting diagnosis in the medical office.   The role of the strep score with be reviewed and discussed regarding its clinical utility.  Recommendations will be made for improving your current diagnostic technology.

Patient Blood Management (PBM) is an emerging clinical concept designed to reduce unnecessary, excessive and avoidable blood transfusions.  Interest in PBM has grown rapidly throughout the world as new evidence demonstrates a strong association between transfusion and a variety of healthcare care complications (infections, pulmonary injury, and mortality).  Reducing transfusion exposure in hospitals has the dual benefit of significantly reducing costs while improving safety and outcomes.  PBM Programs often utilize a variety of resources and technologies to optimize blood management, including point-of-care testing. Point-of-care Hemoglobin testing has been widely used in hospitals and published in the literature as an evidence based strategy to support transfusion management.  This presentation will focus on practical applications of POCT Hgb to improve the recognition and management of anemia, support the paradigm shift of RBC transfusion as single units with reassessment, and optimize transfusion decision making in the anemic or bleeding patient.
 
Learning objectives

1. Describe how optimal transfusion practice and patient blood management can result in reduced health care costs and improved patient outcomes
2. Define how point-of-care Hemoglobin testing can improve recognition/management of anemia and transfusion decision making in the bleeding patient

This presentation will outline activities from pre-inspection through the post inspection process as it relates to QC throughout your laboratory. You will be provided you a strategy on what information to have available for your unannounced inspection as well as details on the most common QC related inspection deficiencies. Come join the session so you can sail through your next inspection as it relates to QC.

Learning Objectives:

1. Learn how to prepare and develop strategies for your next laboratory inspection related to QC.
2. Obtain a list of the most common inspection deficiency from The Joint Commission, CAP and COLA.

 

I will be discussing the following subjects in my presentation:

• Update from 2015
• PAMA Proposed (or Final Rule)
• FDA Regulation of LDTs
• Change to Physician Payment and impact on diagnostic testing
• Cancer Moonshot

Big data has been with us for a long time, and tools to explore it continue to improve.  Where are these data resources, how are we using them, and what are we finding as we explore them? Laboratory information systems accumulate billions of results, healthcare organizations collapse them into billions of charges for laboratory services, and healthcare management databases aggregate laboratory activity into millions of items related to labor and other expense of operating laboratories.  These sources feed into gaining insight into provider ordering practices, patient safety outcomes, and operational efficiencies.  Examples include CMS reimbursement incentives and Choosing Wisely campaigns to reduce waste in provider practices, both of which incorporate laboratory data in their measures.  While there are almost infinite opportunities to advance patient safety and organizational efficiency, there are also risks associated with availability, use, and interpretation of big data.  These and other topics will be explored in this presentation.