Physicians office Resource 2019 Issue 6
™
Resources for You, Your Patients, & Your Practice
TOP 5 CRITERIA FOR CHOOSING THE RIGHT CHEMISTRY ANALYZER PLUS: Top Chemistry Analyzers
Pages 22 - 25
also in this issue Following Manufacturure’s Instructions Required for Certificate of Waiver Page 6 MDescapes: Luxurious Destinations and Special Discounts for Physicians Page 26 How In-House Testing Steers Income to Your Practice Page 36
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2019 Issue 6
Physicians office Resource™
PHYSICIANS office RESOURCE
Resources for You, Your Patients, & Your Practice Published by Medical Education Resources, LLC Publisher Aaron R. Medaris amedaris@physiciansofficeresource.com CEO Andrew C. Nimmo acnimmo@physiciansofficeresource.com President John D. Pasquale jpasquale@pharmaconnect.com Business Manager Marci J. Hills mhills@physiciansofficeresource.com
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Travel Editor Brandi L. Brower Editorial Board Michael Paquin, FHIMSS Barry Craig, MLT (NCA), CLC Staff Writer Dylan J. Chadwick Creative Director Production Manager Keith A. Katsikas Jr Copyright ©2019
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Thank you! 6/19/19 7:28 PM
How can something so small be so BIG? MIZE
 MIZE THE HASSLE OF ESR TESTING IN YOUR LAB
#6500
Fast, accurate, and reliable results in just 15 seconds directly from the primary EDTA tube.
ALCORSCIENTIFIC.COM
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2019 Issue 6
PHYSICIANS office RESOURCE
Physicians office Resource ™
table of contents
MDescapes Luxurious Getaways & Exclusive Deals for POR Magazine Readers
26
articles in this issue This enclave is a British Overseas Territory that lays 10 miles north of dual-sovereign Sint Maarten (Dutch) and Saint Martin (French). It’s known as the culinary capital of the Caribbean. For a strip of paradise, only 35 square miles, it’s dotted with delectable dining distinctions, but only one five-star resort that boldly asseverates “Arriving is belonging.” So, where is this magical place? Where can I find this best-kept secret? Recently named the #1 island in the Caribbean by readers of Travel + Leisure magazine, it may not be a secret for long. View this MDescapes special offer and others on page 26
also featured in this issue
Top 5 Criteria for Choosing the Right Chemistry Analyzer What would you consider the top 5 criteria for someone choosing a chemistry analyzer for a POL running tests for 5-10 family practice or internal medicine providers? In working on this process I’ve been comparing the CV’s for Proficiency testing for analytes on two systems. Read the article PLUS view related products on pages 22-25
Following Manufacturure’s Instructions Required for Certificate of Waiver
6
According to the CLIA regulations, “laboratories eligible for a certificate of waiver must follow manufacturers’ instructions for performing the test.” This is also a requirement for non-waived testing. Many people think...
How In-House Testing Steers Income to Your Practice
36
In a changing medical landscape, physicians willing to invest in their practices are the ones who’ll succeed. Though evolving technology and its subsequent improvements in patient care have brought substantial changes to the medical sector, an era of economic...
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Nail it with one swab. Syndromic respiratory infection testing now CLIA-waived The BioFire® FilmArray® Respiratory Panel (RP) EZ uses a molecular syndromic approach to accurately detect and identify a wide range of pathogens—not just Flu A and B. As a healthcare provider, this means your patients can receive the right treatment the first time, potentially leading to higher patient satisfaction and lower costs. And as the name implies, it’s easy and can be performed right in your office or clinic.1 1 test. 14 respiratory pathogens. All in about an hour.
#6501
biofiredx.com
CLIA
BioFire RP EZ Pathogens Viruses Adenovirus Coronavirus Human Metapneumovirus Human Rhinovirus/Enterovirus Influenza A
1
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WAIVED
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CLIA Certificate of Waiver required to perform testing.
For more information contact +1 801-736-6354 +1 888-844-7640ext. ext.1947 1947
BFDX-MKT-0234 2019 Issue 6.indd 5
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2019 Issue 6
PHYSICIANS office RESOURCE
FOLLOWING MANUFACTURER’S INSTRUCTIONS REQUIRED FOR CERTIFICATE OF WAIVER Teresa A. Scott, MT(ASCP) COLA Education Division Medical Technologist
According to the CLIA regulations, “laboratories eligible for a certificate of waiver must follow manufacturers’ instructions for performing the test.” This is also a requirement for nonwaived testing. Many people think that they are fulfilling this requirement if they follow the step-by-step procedure for the test process included in the instructions. However, there is much more involved than just following the procedural steps. Manufacturer’s instructions are found in instrument operator’s manuals and in package inserts; however, this article focuses on the instructions found in package inserts. In addition to the procedural steps, the package inserts include information and instructions for • specimen collection and handling; • reagent and test kit storage and expiration; • quality control; • expected results and interpretation of these results; • test limitations, precautions, and warnings; and • other pertinent information that affects the quality of test results. Inaccurate and unreliable test results may be obtained if the instructions are not followed. Also be aware that any modifications or changes may result in changing the test system from waived to high complexity. Then, the certificate of waiver no longer applies, and all of the high complexity requirements (including Personnel eligibility requirements and responsibilities, Proficiency Testing, and Quality Assessment, etc.) will have to be met.
Package Insert
To follow the manufacturer’s instructions, you should
understand every aspect of all package insert sections. Depending on the manufacturer, the sections will have different titles, but all of the following information should be available in the package insert. To be aware of all the information, it is imperative that you read the entire insert prior to performing patient testing. Throughout the rest of this article, each section includes a description of what you can expect to see in the package insert and at least one example of how that information may be presented.
Test Procedure
The test system package insert will contain a step-by-step procedure of how to complete the test. Depending on the manufacturer, specimen collection and other pre-analytic actions may be included. 1. Read all instructions prior to performing patient testing. 2. Assemble all necessary materials. 3. Insert test strip into meter, with the sample collection area facing to the left, away from meter. 4. Apply a single drop of whole blood to the test strip “sample collection” area. 5. Compare the “test reaction” area to the meter’s color chart exactly 60 seconds after blood drop is applied. Package inserts for reagents, cartridges, test strips, etc. may list only the steps that involve these products. Some may not state any procedural steps, opting instead to refer the user to the test system package insert or the instrument manual.
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Specimen Collection and Handling
Tests may be designed for one type of specimen (e.g. whole blood) or several different types (e.g. whole blood, urine, throat swab, etc.). The package insert will state this as well as how the specimen should be collected, handled, and stored. Conditions that would cause specimens to be unsuitable for testing and any timing constraints will also be listed. This test is performed on whole blood, collected in an EDTAanticoagulated tube (lavender top). Following collection, specimens should be stored at room temperature for no longer than 8 hours. If testing cannot be completed within 8 hours, refrigerate specimens at 2-8°C for up to 48 hours. Clotted specimens should not be used for testing.
Reagents
Package inserts for test kits will list the reagents included in the kit. They may also list other materials needed to perform the test, dividing them into two categories: materials supplied in the kit and materials needed but not provided. Storage conditions, special handling requirements, and expiration dates for the test kits and the individual reagents will also be listed. This package contains only reagent test strips. A test strip reading meter, alcohol wipes, gauze pads, and skin-lancing devices will be needed to perform testing, but are not included in this package. Test strips must be stored in their original container, with the lid tightly closed, to protect them from moisture. Store at 22-30°C and protect from humidity and temperatures beyond the stated range. When proper storage conditions are maintained, the test strips are stable until the expiration date stamped on the container label.
by an alternate method, which may include sending the specimens to another laboratory for testing. The ABC test system automatically runs a comprehensive set of quality checks of analyzer and cartridge performance each time a sample is tested. This internal quality system will suppress results if the analyzer or cartridge does not meet certain internal specifications. If the analyzer or cartridges have been compromised, results may be persistently “Also be aware that any modifications suppressed and one or the or changes may result in changing other must be replaced to the test system from waived to high restore normal operating complexity. Then, the certificate of conditions. waiver no longer applies, and all of Since storage and the high complexity requirements shipping conditions (including Personnel eligibility vary, external controls requirements and responsibilities, (normal, high, and Proficiency Testing, and Quality low) must be run on each new cartridge Assessment, etc.) will have to be met.” shipment and each Teresa A. Scott new cartridge lot number.
Expected Results and Interpretation of Results
Qualitative tests verify the presence or absence of the analyte. Quantitative tests will produce numeric values that have to be compared to a reference range to determine if the result is normal or abnormal. When applicable, the package insert will list reference ranges for different types of patients. For example, the reference range for men may be different than that of women, or the range for adult patients may be different than that of pediatric patients. If the test system has been approved for different types of specimens, expected values for each specimen type would be listed as well.
Quality Control
Pay special attention to this area of the package insert since it is the section that is most often overlooked. Many testing devices have internal controls built-in as part of the test. However, just as many require some sort of external quality control to be run at specific intervals: once each day, once each shift, with each new shipment, the first run of a new lot number, etc. The package insert will list the type(s) of controls to test as well as when to test these controls. Controls must be performed as required by the manufacturer. Prior to reporting patient results, you must • Perform all required QC; • Review QC results to ensure they are acceptable; • Document that QC has been run, reviewed, and is acceptable. Do NOT report patient results if QC results are not acceptable. Instead, investigate the cause of the QC failure, perform the necessary corrective actions, re-run the controls, and document everything. Do not report patient results until the problem is identified and corrected, and QC results are acceptable. If the problem cannot be identified and/or corrected, perform testing
In some instances, the reported result is in a different format than the value obtained through testing; that is, the test result has to be interpreted before it is reported. The information in these sections of the package insert will help you determine what to report and how to report it. The XYZ test system is very sensitive to technique; thus each laboratory should establish its own normal range based upon its own techniques, controls, equipment, and patient population. The sample can then be classified as negative, weak positive, or strong positive. The following can be used as a general guideline.
Read the rest of this and other articles at www.PhysiciansOfficeNews.com 7 2019 Issue 6.indd 7
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2019 Issue 6
PRODUCTFOCUS #6502
TURN SMALL PLACES INTO SMART SPACES From Abbott
PHYSICIANS office RESOURCE
With reduced budgets, shrinking laboratory space and staffing challenges, many laboratories need a solution that lets them work smarter with less. The CELL-DYN Emerald 22 AL is a full performance, automated optical 5-part differential analyzer that delivers smarter results for small to midsize clinical laboratories. • Compact Design • Walkaway Functionality • Ease Of Use • Smart Safety Features
View Brochures, Videos & Mores at POR.io Enter Number 6502 in the Search Area
#6503
“ mInIIMIZE THE HASSLE OF ESR TESTING IN YOUR LAB
From ALCOR
miniiSED™ is the newest of the iSED® family of ESR analyzers from ALCOR Scientific. The miniiSED™ measurement of ESR is accurate and unaffected by variables associated with traditional methodologies, such as hematocrit. This single position, fully automated ESR analyzer works directly from primary EDTA tubes, requires 100 μL of sample, has an internal barcode reader, and produces results in 15 seconds! miniiSED™ is the ideal solution to ESR testing for small laboratories, POL’s, and emergency clinics. Proudly manufactured in the USA.
View Brochures, Videos & Mores at POR.io Enter Number 6503 in the Search Area
#6504
PENTRA 60 C+ HEMATOLOGY ANALYZER WITH 5-PART DIFFERENTIAL From HORIBA
Now you can have the same results hospitals and reference labs provide in a small, benchtop analyzer. The Pentra 60 C+ hematology analyzer provides a CBC with 5-part differential result using proprietary technology that ensures an accurate count and differential on the first run. Reduce repeats and reflex to the microscope with Pentra hematology technology.
View Brochures, Videos & Mores at POR.io Enter Number 6504 in the Search Area
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The interpretation could be nothing more than verifying that the test result falls within the instrument’s reportable range. If it does not, the result would be reported as “less than” or “greater than” the range limit. Since most instruments suppress or flag values for results that fall outside of this range, the interpretation is relatively simple. Tests that rely on color change can be more difficult to interpret, especially if it is left to the human eye to determine the amount of change. The timing of the color comparison can also greatly affect result interpretation. Some colors may diminish quickly after the reaction occurs, while others may be enhanced over time; either will cause inaccuracies in result interpretation. In most cases, automated systems are available to simplify this interpretation. Research studies performed to determine this data may be included as additional information in this section.
Test Limitations, Precautions, and Warnings The information included here varies greatly and may include: • Hazardous reagent ingredients Sodium Azide, used as a preservative, is a poison and may be toxic if ingested or absorbed through the skin. • Safety precautions Always wear gloves when handling reagents. If skin comes in contact with reagent, flush exposed area by holding under cold running water for 10 minutes. • Substances that interfere with testing Reagent bubbles may interfere with proper detection of reagent level in the cartridge. If present, remove air bubbles with a clean applicator stick. To minimize volume depletion, do not use a transfer pipette to remove the bubbles. • Patient conditions that may interfere with testing Patients receiving peritoneal dialysis using solutions that contain
icodextrin should not use the KLM test system, since the dialysis solutions may falsely raise blood glucose results. • Limitations on test performance Performance characteristics have not been established for specimens other than whole blood. Reference ranges have not been established for neonates, infants younger than 2 years of age, or pregnant women. This is by no means a comprehensive list and further serves to stress the importance of reading the entire package insert.
Other Pertinent Information
The information included in this area also varies. What is considered “pertinent” depends upon what is in the package. Test kits will have different information than control materials. Reagents, test strips, and test cartridges will have different information than hand held meters. Possible package insert section titles include: • Intended use • Explanation of the test • Principles of the procedure • Instrument calibration • Performance characteristics (reference range, specificity and sensitivity, accuracy and precision) • Method comparison • Important information • Technical information As with the last section, this is by no means a comprehensive list. Again, it only serves to stress the importance of reading the entire package insert. Manufacturer’s instructions must be followed whether the test is waived or non-waived. Waived tests, by definition, “employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible.” However, this is only true if all of the manufacturer’s instructions are followed.
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Read the rest of this and other articles at www.PhysiciansOfficeNews.com 9 2019 Issue 6.indd 9
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#6506
FIRST EVER CLIA WAIVED HEMATOLOGY ANALYZER
PHYSICIANS office RESOURCE
2019 Issue 6
PRODUCTFOCUS
From Sysmex
Faster test results, clinical decisions and greater practice efficiency are coming to physicians’ offices with the first CLIA-waived CBC analyzer. Hematology diagnostics leader Sysmex is bringing more lab testing to the point of care. One of the most common blood tests can be conducted reliably and accurately on-site, in as few as three minutes. The device’s ease of use and innovative technology means in-house staff can operate it in just a few easy steps, without lengthy certification and training. The new Sysmex XW100 will improve health care efficiency and patient care.
View Brochures, Videos & Mores at POR.io Enter Number 6506 in the Search Area
#6507
COST-EFFECTIVE AI MEDICAL SCRIBE From Phraze
Are you frustrated with spending more time writing notes than seeing patients? Has the EHR become a “screen between” you and your patients? Are you interested in having a medical scribe, but find that the cost is prohibitive? Phraze’s is a cost-effective AI Medical Scribe software that analyzes the conversation between you and your patient. It then automatically produces a clinical note that is as beautiful as it is intelligent: saving you time and improving your connection to patients.
View Brochures, Videos & Mores at POR.io Enter Number 6507 in the Search Area
CLIA-WAIVED FOR RAPID DETECTION OF FLU A+B #6508
From BD Veritor
The CLIA-Waved BD Veritor™ Plus System for rapid detection of Flu A+B, combines speed and accuracy. It provides clear digital results in under 11 minutes and has demonstrated performance compared to molecular tests.[1] It is easy to use and has a low cost of ownership. The BD Veritor ™ Plus System is CLIA-Waved for Flu, RSV and Group A Strep. [1] (BD Veritor System for Rapid Detection of Flu A+B, CLIA-waved kit package insert, 8087667 (14) 2018-06. BD Veritor System for Rapid Detection of Flu A+B, laboratory kit package insert, 8087666 (11) 2017-10., 2018-06.)
View Brochures, Videos & Mores at POR.io Enter Number 6508 in the Search Area 10
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NEW
#6499
TURN SMALL PLACES INTO SMART SPACES With reduced budgets, shrinking laboratory space and staffing challenges, many laboratories need a solution that lets them work smarter with less. The CELL-DYN Emerald 22 AL is a full performance, automated, optical 5-part differential analyzer that delivers smarter results for small to mid-size clinical laboratories with: • Compact design maximizes valuable laboratory space • Ease of use and walkaway functionality optimizes staff time • Smart open tube sample device ensures user safety
41 cm
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CELL-DYN Emerald 22 AL is a Class 1 laser. For in vitro diagnostic only. Refer to the Operator’s Manual for operational precautions, limitations, and hazards. CELL-DYN Emerald and CHOOSE TRANSFORMATION are trademarks of Abbott Laboratories in various jurisdictions. CAUTION: United States Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory. © 2019 Abbott Laboratories. ADD-00064842.
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Jacob’s birthday party No, my migraine wants me to lie down in the dark Yes, I will attend
Š 2019 Teva Pharmaceuticals USA, Inc.
2019 Issue 6.indd 12
FRE-41678
March 2019
6/19/19 7:28 PM
Less migraine. More moments.
TM
Help patients say yes to more moments AJOVY® (fremanezumab-vfrm) injection is the only anti-CGRP treatment for the prevention of migraine with quarterly and monthly dosing options1 More migraine-free days with AJOVY in clinical trials1
INDICATION
AJOVY is indicated for the preventive treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy. Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions. Please see Brief Summary of full Prescribing Information on the following page.
To learn more, visit AJOVYhcp.com CGRP: calcitonin gene-related peptide. Reference: 1. AJOVY® (fremanezumab-vfrm) injection Current Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.
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BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR AJOVY® (fremanezumab-vfrm) injection, for subcutaneous use SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE AJOVY is indicated for the preventive treatment of migraine in adults. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage Two subcutaneous dosing options of AJOVY are available to administer the recommended dosage: • 225 mg monthly, or • 675 mg every 3 months (quarterly), which is administered as three consecutive subcutaneous injections of 225 mg each. When switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration. If a dose of AJOVY is missed, administer as soon as possible. Thereafter, AJOVY can be scheduled from the date of the last dose. 2.2 Important Administration Instructions AJOVY is for subcutaneous use only. AJOVY may be administered by healthcare professionals, patients, and/or caregivers. Prior to use, provide proper training to patients and/or caregivers on the preparation and administration of AJOVY prefilled syringe, including aseptic technique [see Instructions for Use in full Prescribing Information]: • Remove AJOVY from the refrigerator. Prior to use, allow AJOVY to sit at room temperature for 30 minutes protected from direct sunlight. Do not warm by using a heat source such as hot water or a microwave. Do not use AJOVY if it has been at room temperature for 24 hours or longer. • Follow aseptic injection technique every time AJOVY is administered. • Inspect AJOVY for particles or discoloration prior to administration. Do not use if the solution is cloudy, discolored, or contains particles. • Administer AJOVY by subcutaneous injection into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. For multiple injections, you may use the same body site, but not the exact location of the previous injection. • Do not co-administer AJOVY with other injectable drugs at the same injection site. 4 CONTRAINDICATIONS AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumabvfrm or to any of the excipients [see Warnings and Precautions (5.1)]. 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria, were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY, and institute appropriate therapy. 6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in clinical practice. The safety of AJOVY was evaluated in 2512 patients with migraine who received at least 1 dose of AJOVY, representing 1279 patient-years of exposure. Of these, 1730 patients were exposed to AJOVY 225 mg monthly or AJOVY 675 mg quarterly for at least 6 months, 775 patients for at least 12 months, and 138 patients for at least 15 months. In placebo-controlled clinical trials (Studies 1 and 2), 662 patients received AJOVY 225 mg monthly for 12 weeks (with or without a loading dose of 675 mg), and 663 patients received AJOVY 675 mg quarterly for 12 weeks. In the controlled trials, 87% of patients were female, 80% were White, and the mean age was 41 years. The most common adverse reactions in the clinical trials for the preventive treatment of migraine (incidence at least 5% and greater than placebo) were injection site reactions. The adverse reactions that most commonly led to discontinuations were injection site reactions (1%). Table 1 summarizes adverse reactions reported in the 3-month placebo-controlled studies (Study 1 and Study 2), and the 1-month follow-up period after those studies. Table 1: Adverse Reactions Occurring with an Incidence of At Least 2% for Either Dosing Regimen of AJOVY and At Least 2% Greater Than Placebo in Studies 1 and 2 Placebo AJOVY AJOVY Monthly 225 mg Monthly 675 mg Quarterly (n= 668) (n= 667) (n= 290) % % % Injection site reactionsa 43 45 38 a Injection site reactions include multiple related adverse event terms, such as injection site pain, induration, and erythema. Adverse Reaction
2019 Issue 6.indd 14
AJOVY® (fremanezumab-vfrm) injection 6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to fremanezumab-vfrm in the studies described below with the incidence of antibodies in other studies to other products may be misleading. Clinical immunogenicity of AJOVY was monitored by analyzing anti-drug antibodies (ADA) and neutralizing antibodies in drug-treated patients. The data reflect the percentage of patients whose test results were positive for antibodies to AJOVY in specific assays. In 3-month placebo-controlled studies, treatment-emergent ADA responses were observed in 6 out of 1701 (0.4%) AJOVY-treated patients. One of the 6 patients developed anti-AJOVY neutralizing antibodies at Day 84. In the ongoing long-term open-label study, ADA were detected in 1.6% of patients (30 out of 1888). Out of 30 ADA-positive patients, 17 had a neutralizing activity in their post-dose samples. Although these data do not demonstrate an impact of antifremanezumab-vfrm antibody development on the efficacy or safety of AJOVY in these patients, the available data are too limited to make definitive conclusions. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant women. AJOVY has a long half-life. This should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY. Administration of fremanezumab-vfrm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at doses resulting in plasma levels greater than those expected clinically did not result in adverse effects on development [see Animal Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated rate of major birth defects (2.2-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. Data Animal Data When fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) was administered to male and female rats by weekly subcutaneous injection prior to and during mating and continuing in females throughout organogenesis, no adverse embryofetal effects were observed. The highest dose tested was associated with plasma exposures (AUC) approximately 2 times that in humans at a dose of 675 mg. Administration of fremanezumab-vfrm (0, 10, 50, or 100 mg/kg) weekly by subcutaneous injection to pregnant rabbits throughout the period of organogenesis produced no adverse effects on embryofetal development. The highest dose tested was associated with plasma AUC approximately 3 times that in humans (675 mg). Administration of fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) weekly by subcutaneous injection to female rats throughout pregnancy and lactation resulted in no adverse effects on pre- and postnatal development. The highest dose tested was associated with plasma AUC approximately 2 times that in humans (675 mg). 8.2 Lactation Risk Summary There are no data on the presence of fremanezumab-vfrm in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AJOVY and any potential adverse effects on the breastfed infant from AJOVY or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of AJOVY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 US License No. 2016 ©2019 Teva Pharmaceuticals USA, Inc. This Brief Summary is based on the full Prescribing Information for AJOVY AJO-002.
FRE-41620
March 2019
6/19/19 7:28 PM
THIS HEART HEALTH MONTH, PREVENT HEART DISEASE IN YOUR OFFICE
HEART DISEASE AFFECTS EVERYONE
Heart disease can happen to anyone – not just aging adults. To be heart healthy, patients must be in the know. The Alere Cholestech LDX® System provides lab accurate results in five minutes that can lead to coachable moments for improved heart health. Identifying CVD risk is quick and easy with fingerstick sampling from a CLIA-waived instrument With in-visit test results, you can get your patient on the road to a healthier heart faster Know your patients’ numbers with a complete lipid profile with glucose on the same test cassette
THE ALERE CHOLESTECH LDX ® IS AVAILABLE FROM ABBOTT. TO LEARN MORE, VISIT LDX.POR.IO.
#6510
© 2019 Abbott. All Rights Reserved. All other trademarks referenced are trademarks of their respective owners. CVD177640 10004525-01 1/19
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#6511
MICROS ES 60 HEMATOLOGY ANALYZER WITH 3-PART DIFFERENTIAL
PHYSICIANS office RESOURCE
2019 Issue 6
PRODUCTFOCUS
From HORIBA
Simple to use and easy to maintain with a zero maintenance concept, the Micros ES 60 is a small tabletop hematology analyzer with an integrated data management system. The analyzer provides a CBC with 3-part differential result in less than 60 seconds using only 10 µL of sample. Connect to the LiteDM Patient Data Management System for an affordable way to consolidate patient results to one report.
View Brochures, Videos & Mores at POR.io Enter Number 6511 in the Search Area
#6512
MICROS HEMATOLOGY ANALYZER WITH 3-PART DIFFERENTIAL PLUS THE LITEDM From HORIBA
Is it viral or bacterial? A CBC with 3-part differential can provide the clues to help distinguish between viral and bacterial infections before you decide to treat. The Micros 60 Hematology analyzer provides a CBC with 3-part Diff result in less than 60 seconds using only 10 µL of sample. Connect to the LiteDM Patient Data Management System for an affordable way to consolidate patient results to one report.
View Brochures, Videos & Mores at POR.io Enter Number 6512 in the Search Area
#6513
BREWER’S FLEX™ ACCESS EXAM TABLE From Brewer
Step up to power table performance for less with Brewer’s Flex™ Access Exam Table. Industry-leading 700-lb. patient weight capacity, unique safety features and unmatched ergonomic patient access maximize your clinical efficiency and ROI. A streamlined footprint and optional upgrades like safety grab bars, stirrups, and pass-through work surface provide ultimate flexibility for your practice.
View Brochures, Videos & Mores at POR.io Enter Number 6513 in the Search Area
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The Adview 2 is still the only truly modular diagnostic station that grows with your needs. Start with blood pressure and choose temperature or pulse oximetry option at the time of purchase.
Bionet CardioCare 2000: $1,255.00 Schiller AT-2 Plus: $2,275.00* *add Spirometry: $1,000.00 Burdick ELI 250c: $3,188.00 Welch Allyn CP150 w/ Interp: $3,258.00
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#6521 #6522
#6523
Coaxial Ophth, Fiber Optic Oto, Speucla Dispenser, Aneroid BP, Wall Transformer and Wall Board without Thermometer: $904.04 with Thermometer: $1,275.88
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#6525
#6526
#6527
#6528
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#6529
SELF-CONTAINED DIAGNOSTIC WORKSTATION From Vitalograph
Vitalograph introduces the Compact Expert diagnostic workstation. The device is a full touch-screen based medical workstation, which comes equipped with Vitalograph’s flagship Pneumotrac spirometer. This accurate, robust and linear Fleisch pneumotach produces over 50 spirometry parameters, automatically stores all test data, calibration data and clinical audit trail data in a secure network capable SQL Server database. An intuitive user interface enhances the routine workflow in most practices, allowing quick patient throughput. Beyond spirometry, it is a desktop testing station for ECG, Pulse Oximetry, Weight , COPD assessment, and Blood Pressure measurements.
PHYSICIANS office RESOURCE
2019 Issue 6
PRODUCTFOCUS
View Brochures, Videos & Mores at POR.io Enter Number 6529 in the Search Area
#6530
SINGLE, INTEGRATED POC TESTING SOLUTION From Abbott Point of Care
The fully automated i-STAT System offers a broad menu of tests for diagnostic and treatment indicators related to disease state management and clinical practice guidelines. Using just 2 or 3 drops of blood, the system provides timesensitive tests at the patient’s side in just minutes.
View Brochures, Videos & Mores at POR.io Enter Number 6530 in the Search Area
#6531
THE RX IMOLA From Randox
A fully automated, random access analyzer with STAT sampling functionality; boosting productivity and saving time when it matters most. Developed for medium-high throughput laboratories, the RX imola provides comprehensive testing with the world-class RX series test menu, including specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing. The RX imola: A cost-effective system that delivers consistent high quality results with a small footprint.
View Brochures, Videos & Mores at POR.io Enter Number 6531 in the Search Area 18
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WORRIED ABOUT CREATING ANTIBIOTIC-RESISTANT SUPERBUGS? A CBC with 3-part or 5-part differential can provide clues to help distinguish between viral and bacterial infections before you decide to treat.
Why invest in laboratory testing? Horiba’s analyzers: • Provide fast and accurate results, allowing you to deliver more decisive patient care. • Increase office efficiency by reducing call-backs to patients with test results • Increase patient satisfaction by eliminating wait time for results and repeat office visits
Micro ES 60 Hematology System 3-part diff
Pentra 60C+ Hematology System 5-part diff
Fast, accurate results in a small footprint
Advanced technology comparable to hospital analyzers
HORIBA Part #5360600241 HS Item # (129-7842) ea.
#6532
HORIBA Part #5300001398 HS Item #(111-3703) ea.
Pentra C400 Chemistry Analyzer Routine to specialty testing in a benchtop analyzer
#6533
HORIBA Part #5300001388 HS Item #(887-0033) ea.
#6534
Get Connected!
Lite
Easy • Patient Data Management
#6535
The LiteDM Patient Data Management System: • Provides an affordable way to connect up to four analyzers • Eliminates transcription errors by consolidating results to one report • Streamlines operations by connecting directly to EMR systems
Contact us at 888-280-1401 mail us at: medical-marketing.US@horiba.com Contact your Horiba Medical Representative for more information • www.horiba.com/us/en/medical
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2019 Issue 6
PRODUCTFOCUS
PHYSICIANS office RESOURCE
#6536
THE BREWER BASIC EXAM TABLE From Brewer
Full featured, entry-level exam table design. The Brewer Basic Exam Table features a pneumatic cylinder, seamless upholstery, and the largest storage capacity available. We invite you to compare features, price, warranty and you will find the Brewer Basic Exam Table is clearly the best entry level exam table available.
View Brochures, Videos & Mores at POR.io Enter Number 6536 in the Search Area
#6537
THE BREWER CENTURY SERIES STOOL From Brewer
Has a pneumatic height adjustment, 16” wide, 4” thick poly-foam seat cushion, and five-leg 23” brushed aluminum accent base. Optional adjustable 18” chrome footing. Optional adjustable contoured backrest with black plastic shroud.
View Brochures, Videos & Mores at POR.io Enter Number 6537 in the Search Area
#6538
ULTRA HCG COMBO TEST From Sekisui Diagnostics
The OSOM® Ultra hCG Combo test is a simple immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Internal studies have confirmed that the OSOM® Ultra hCG Combo test does not have a false negative result from hCG variants providing physicians with a higher level of confidence.
View Brochures, Videos & Mores at POR.io Enter Number 6538 in the Search Area
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2019 Issue 6
PHYSICIANS office RESOURCE
TOP 5 CRITERIA FOR CHOOSING THE RIGHT CHEMISTRY ANALYZER Barry Craig, Ask the Expert Laboratory Consulting, LLC. Regulatory compliance consulting for CLIA, COLA and CAP laboratories. Specializing in urine drug testing laboratories
Q: What would you consider the top 5 criteria for someone choosing a chemistry analyzer for a POL running tests for 5-10 family practice or internal medicine providers? In working on this process I’ve been comparing the CV’s for Proficiency testing for analytes on two systems. One is a system that has hundreds of sites; the other has fewer than 20 in their peer group. Do CV values become more significant with bigger peer groups? A: My top five criteria for choosing an analyzer may not be everyone’s view, but here goes. 1. Service – How good is their 1-800 service? Do they answer promptly? Do they guarantee a service or repair call within 24 hours of notification? Are the repair people employees and factory trained or are they “contracted” repair people with no affiliation to the company that makes the instrument. Are parts readily available or do you sit for weeks waiting on a part from China? 2. Cost – How does the instrument, reagents, 22
calibrators and controls cost compare to others in the market? The cheapest may be cheap for a reason. How much will the service contract cost once the warranty runs out? 3. Performance – As the question suggest, look at the performance of your proposed instrument by examining its performance on PT testing. How well does it score to comparable instruments? Does it have only a few units in use or hundreds. The more units in use, the better it should score on the PT events. Even if only a few units are listed, look at the performance first. Fewer units doesn’t mean it is not a well-made instrument, it may just be newer to the market. Ask for references for sites already using the instrument. Try to find units in use independently and not who the sales guy suggests you call. 4. Ease of use – Does it have a multitude of maintenance steps daily? Does it require constant replacement of tubing, filters, etc.? Does the instrument program easily or do the operational steps take a lot of time? How thorough is the training for the instrument?
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5. Reliability – Check with as many sources as possible to determine the “downtime” factor. It does not matter how pretty it is, or how cheap it is, if the machine is not working. Not running means not billing. Check with the sales guy, the company that makes the machine, anyone who can help you find units that have been in operation for a while.
A: You should always look at your current test volume. If you are only running a small volume now, or sending out a small volume to a reference lab, you may not have “TOP 5 Criteria for Choosing the enough testing Right Chemistry Analyzer” to warrant 1. Service purchasing a 2. Cost larger unit or 3. Performance adding testing 4. Ease of Use such as CBCs. 5. Reliability
Q: We have been using small chemistry analyzers for several months but due to the cost of cartridges and small profit margins we are looking to expand our lab to a larger analyzer and add hematology to our lab.
Barry Craig
I am gathering information on what my best options are. If you have any suggestions, please let me know.
Figure out your break-even point on cost and then look at how many tests you actually send out or perform. Remember, you cannot suddenly increase your number of test. The send out history will tell the tale of whether you need to move up, stay pat, or fold.
Read this and other articles at www.PhysiciansOfficeNews.com 2019 Issue 6.indd 23
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From Carolina Liquid Chemistries
PHYSICIANS office RESOURCE
2019 Issue 6
DRUGS OF ABUSE TESTING AND ROUTINE CHEMISTRY PANELS ON A SINGLE ANALYZER
#6544
Carolina Liquid Chemistries Corp. announces the successful launch of Medica Corporation’s high-speed benchtop analyzer, the EasyRA®. The updated analyzer now operates at a photometric rate of up to 240 tests per hour or up to 480 tests per hour with ISE. The EasyRA urine drug screening and general chemistry reagents are CLIA categorized as moderately complex. This all-in-one system allows clinical laboratories to screen for drugs of abuse in urine while also allowing healthcare providers to assess routine chemistry panels on a single analyzer.
View Brochures, Videos & Mores at POR.io Enter Number 6544 in the Search Area
IDEAL SYSTEM FOR LOW-TO-MODERATE VOLUME LABORATORIES
#6545
From Sekisui Diagnostics
The SK™500 chemistry instrument and SEKURE Reagents offer an ideal system for low-to-moderate volume laboratories seeking exceptional throughput with minimal use of space and water. The SK500 is a compact and efficient instrument with a full menu of reagents specifically designed for and packaged for the system
View Brochures, Videos & Mores at POR.io Enter Number 6545 in the Search Area
#6546
CLIA-WAIVED COMPREHENSIVE METABOLIC PANEL From Abbott Point of Care
The Piccolo Xpress™ point-of-care chemistry analyzer delivers comprehensive CLIA waived diagnostics to Physician Offices. In 3 easy steps, the Piccolo provides lab-accurate results in minutes from a menu of 29 general chemistry tests, including lipids, liver, kidney, metabolic and other specialty functions. By using only 100 microliters of whole blood, serum or plasma - physicians can make confident treatment decisions faster, thereby increasing the efficiency, throughput and capacity of their practice, while also increasing revenue and ensuring patient satisfaction.
View Brochures, Videos & Mores at POR.io Enter Number 6546 in the Search Area
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FOCUSONCHEMISTRY #6547
THE RX DAYTONA+ From Randox
A bench-top, fully automated, random-access chemistry analyzer, providing routine and specialized testing with emergency STAT sampling functionality. Demonstrating unparalleled versatility, the RX daytona+ combines robust hardware and intuitive software with the world-class RX series test menu, including specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing. The RX daytona+ ensures unrivalled precision, reliability and accuracy for results you can trust.
View Brochures, Videos & Mores at POR.io Enter Number 6547 in the Search Area
#6548
PENTRA C400 CHEMISTRY ANALYZER From HORIBA Medical
One benchtop, not a whole lab! No water system, drain or special electrical connected required to operate the Pentra C400 chemistry analyzer. Now you can have the power of a floor model analyzer on the benchtop! The Pentra C400 chemistry system processes up to 420 tests/hr including ISEs and offers routine metabolic assays, TDMs, DAUs and Adulterants, HbA1c and Vitamin D tests. With 40 open channels, you can add much more for a complete menu to meet your practice needs.
View Brochures, Videos & Mores at POR.io Enter Number 6548 in the Search Area
SPOTCHEM™ EZ CHEMISTRY ANALYZER #6549
From Jant Pharmacal
SPOTCHEM™ EZ chemistry analyzer is a small bench top chemistry analyzer that utilizes dry chemistry technology to test whole blood. Results are available on the SPOTCHEM™ printer or downloaded via LIS. SPOTCHEM™ is ideally suited for small laboratories and physician offices that desire an easy-to-use analyzer with a small footprint. Maximum throughput is 48 tests per hour. Test menu includes 21 tests and 3 panels. Tests whole blood, serum or plasma with rapid results within 4 – 15 minutes. Extensive CLIA-waived menu, includes lipid panel, creatinine, AST, ALT, glucose, and 2 chemistry panels. Automatic calibration.
View Brochures, Videos & Mores at POR.io Enter Number 6549 in the Search Area 25 2019 Issue 6.indd 25
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June 2019
FOUR SEASONS ANGUILLA
MDescapes
Sun-seeking vacationers eager to learn more about Caribbean island culture while unwinding on the property’s luxurious white sand beaches and tranquil blue waters will find plenty of reason to celebrate on Anguilla this summer.
The Experience Anguilla package provides extra value with a fifth night free plus all the following: • • • •
Complimentary daily breakfast in Coba for 2 (per bedroom) Complimentary Kids For All Seasons activities Children under 12 eat free with each paying adult Rates starting at USD 550 for a Resort View
Additional Details at MyMDescapes.com
FOUR SEASONS ORLANDO Within the gates of Walt Disney World ® Resort, discover Central Florida’s only resort to receive the coveted AAA Five Diamond Award. A perfect blend of Four Seasons experiences and Disney offerings––for family time, for romance, or special events. Create a Four Seasons-only getaway in Orlando, with golf, spa, dining and a fun-filled island for kids, or make the Resort your base for a Disney adventure. No one brings dreams to life quite like Four Seasons and the magic of Disney. Additional Details at MyMDescapes.com
$50 Daily Resort Activities Credit!
FOUR SEASONS COSTA RICA Nestled on a Pacific coast hillside and overlooking golden sand beaches, Four Seasons Resort Costa Rica at Peninsula Papagayo is your premier eco-adventure destination. This year, join us to experience Costa Rica’s renowned “pura vida” lifestyle and our exciting renovation. The Resort’s 181 guest rooms, suites and residences capture the exotic character of Costa Rica, with comfortable rattan and bamboo furnishings, local artwork and indigenous wood and stone finishes. Additional Details at MyMDescapes.com
Reserve 5 Nights in Luxurious Accommodations and Receive 2 Additional Nights On Us!
FOUR SEASONS PUNTA MITA Sunshine and perfect temperatures year round, a secret landscape of astonishing beauty and the Pacific Coast’s most scenic beach. This and much more awaits you at Four Seasons Resort Punta Mita. With 173 rooms including 32 suites (all suites with private plunge pools), an option for everybody is available. In addition, Four Seasons private 4 and 5 bedroom Villas offer the true home away from home experience. Additional Details at MyMDescapes.com
Receive a Third Night in Luxurious Accommodations FREE with Every Two Consecutive Paid Nights! 26
Luxurious Getaways & Exclusive Discounts
2019 Issue 6.indd 26
All offers on this page are subject to availability at the time of reservation. Limited Time Only. Offers may not be combined with any other promotions/program benefits/offers/savings. Subject to change without notice.
6/19/19 7:28 PM
YOU BELONG AT FOUR SEASONS ANGUILLA OWNERSHIP AS EASY AS THE ISLAND ITSELF Here on the welcoming island of Anguilla, the turquoise water and azure blue sky meet in harmonious accord. You anticipate the peace of Anguilla before you ever get on the plane, and upon arrival your remaining cares simply roll away with the Caribbean tide. World-renowned Four Seasons service and carefree luxury are yours to enjoy. We welcome you home. You belong.
DELUXE STUDIOS TO 5 BEDROOM VILLAS FROM $825,000 TO OVER $10 MILLION TO FIND OUT MORE OR PLAN A DISCOVERY WEEKEND, CALL +1 800 901 7079 OR EMAIL US AT INFO@ANGUILLAPRIVATERESIDENCES.COM
AnguillaPrivateResidences.com
This offer is not directed to residents in any state in which a registration is required but in which registration requirements have not yet been met, including, but not limited to, New Jersey. Recreational features and amenities described herein are subject to change periodically. Warning: the California Department of Real Estate has not examined this offering, including, but not limited to, the condition of title, the status of blanket liens on the project (if any), arrangements to assure project completion, escrow practices, control over project management, racially discriminatory practices (if any), terms, conditions, and price of the offer, control over annual assessments (if any), or the availability of water, services, utilities, or improvements. It may be advisable for you to consult an attorney or other knowledgeable professional who is familiar with real estate and a law in the country where this subdivision is situated. In New York, the complete offering terms are in an offering plan available from sponsor. File no. CD11-1029 (Resort Residences) and fi le no. H11-0007 (Villas). Four Seasons Private Residences Anguilla are not owned, developed or sold by Four Seasons Hotels limited or its affi liates (Four Seasons). The developer, an affi liate of Starwood Capital Group, uses the Four Seasons trademarks and tradenames under a license from Four Seasons Hotels limited. The marks “FOUR SEASONS,” “FOUR SEASONS HOTELS AND RESORTS,” any combination thereof and the Tree Design are registered trademarks of Four Seasons Hotels Limited in Canada and U.S.A. and of Four Seasons Hotels (Barbados) Ltd. elsewhere. © 2019
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#6550
CLIA-WAIVED BIOFIRE® FILMARRAY® RESPIRATORY PANEL (RP) EZ
PHYSICIANS office RESOURCE
2019 Issue 6
PRODUCTFOCUS
From BioFire
The BioFire RP EZ accurately detects and identifies 14 viral and bacterial pathogens—not just Flu A and Flu B— so you can provide your patients with the right treatment, the first time. The test is easy and can be performed right in your office or clinic, with results in about an hour. The BioFire RP EZ is designed to run on a single computer/ instrument configuration (EZ Configuration) of the BioFire® FilmArray® 2.0 System.
View Brochures, Videos & Mores at POR.io Enter Number 6550 in the Search Area
#6551
BIOFIRE® FILMARRAY® TORCH From BioFire
The BioFire® FilmArray® Torch is a fully integrated, random, and continuous access system designed to meet your laboratory’s syndromic infectious disease testing needs. The BioFire Torch offers a radically reduced benchtop footprint, saving precious space in the lab, and its scalability meets high throughput demands. BioFire® FilmArray® Link Software automatically uploads patient results. Fully compatible with all CLIA Moderate BioFire® FilmArray® Panels, the BioFire Torch helps you maximize efficiency and productivity.
View Brochures, Videos & Mores at POR.io Enter Number 6551 in the Search Area
#6552
LAB-ACCURATE RESULTS FOR ACR AND HBA1C From Abbott
With its compact size and panel of tests, the Afinion 2 system is ideal for point-of-care testing in physician offices, clinics, community health centers and hospital out-patient clinics. From just a small urine or fingerstick whole blood sample, lab-accurate results for ACR and HbA1c are made available during the consultation.
View Brochures, Videos & Mores at POR.io Enter Number 6552 in the Search Area
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A better way.
They’re Here Flu, RSV, Strep. Be Ready.
With confirmatory molecular results,
Cepheid’s CLIA Waived test menu delivers peace of mind to you and your patients.
#6553
#6554
#6555
Xpert Xpress Flu/RSV
Xpert Xpress Flu
Xpert Xpress Strep A
• One sample. One Cartridge. Three results
• Qualitative, molecular detection and differentiation of influenza A and B
• Accurate, real-time PCR molecular testing for Group A Strep
• Qualitative, molecular detection and differentiation of influenza A, influenza B and RSV
• Sample types include nasal swab and nasopharyngeal swab
• Internal QC in each cartridge
®
®
• Room Temperature reagent storage
®
• No confirmation required for negative results*
• Sample types include Nasal swab and Nasopharyngeal swab
For more information, call (888) 256-6990 For in vitro diagnostic use. * No culture confirmation required for negative results unless clinical symptoms persist, or there is an outbreak of acute rheumatic fever (ARF). 904 Caribbean Drive | Sunnyvale, CA 94089 USA | TOLL FREE +1.888.336.2743 | PHONE +1.408.541.4191 | FAX +1.408.541.4192 | www.cepheid.com
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2019 Issue 6
PRODUCTFOCUS #6556
DEFINING MOBILE TELEDIAGNOSTICS
PHYSICIANS office RESOURCE
From MedPod
With the ability to deploy into a medical office in less than 2 minutes, MobileDoc is the ultimate portable practice. Revolutionary in its compact and mobile design, MobileDoc integrates best-in-class professional medical-grade devices with state-of-theart HD video and EHR connectivity. Physicians can provide care remotely that is on par or better than a face-to-face visit, including conducting basic exams, checking vitals, and performing specialty testing— shattering the boundaries of traditional care.
View Brochures, Videos & Mores at POR.io Enter Number 6556 in the Search Area
OPTIMIZE PRODUCTIVITY AND EXPAND YOUR PRACTICE
#6557
From MedPod
The Medpod Medical Cart optimizes productivity and load balancing by enabling access to remote physicians during high volume periods or to reach low-density populations. Medpod’s proprietary software integrates with a wide range of professional medical devices and gives the remote provider control of the devices to conduct an examination that is on par with a face-to-face visit. Patient images, audio and data can be captured, annotated, tagged and uploaded in real-time or stored and forwarded into the EHR by either remote or local provider.
View Brochures, Videos & Mores at POR.io Enter Number 6557 in the Search Area
#6558
ACCURATE, ACTIONABLE RESULTS FROM THE LEADER IN POINT-OF-CARE LIPID TESTING From Abbott
The CLIA-waived Alere Cholestech LDX™ Analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in point-of-care lipid profile, cholesterol, and glucose testing. Results are easy to obtain. Fingerstick sampling and a small sample size (40μL) makes results less painful and time consuming.
View Brochures, Videos & Mores at POR.io Enter Number 6558 in the Search Area
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#6561
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2019 Issue 6.indd 31
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6/19/19 7:28 PM
#6579
MEMORY LOSS BIOMARKERS TO AID IN DIAGNOSIS IN PRIMARY CARE PRACTICES From Evoke Neuroscience
PHYSICIANS office RESOURCE
2019 Issue 6
PRODUCTFOCUS
The eVox® System is an FDA 510(k) cleared medical device to aid primary and specialty care physicians in diagnosis of memory loss and other cognitive disorders. eVox® measures memory loss biomarkers that may aid in detecting memory loss sooner, identifying the root cause of memory loss, and performing a differential diagnosis. eVox® procedures are performed in-office and are reimbursable by Medicare and commercial payers.
View Brochures, Videos & Mores at POR.io Enter Number 6579 in the Search Area
ACCUTEST PH® PHENAPHTHAZINE PAPER From Jant Pharmacal
#6580
Test papers give instant, easy-to-read results, with clear, bright matches at 0.5 intervals from pH 4.5 to 7.5. Color charts are lab-tested for precision accuracy. Made in the U.S.A. with state-of-the-art materials. An FDA-listed medical test product, used in hospitals and doctor’s offices around the world. Economical – approximately 100 tests/roll. Widely used in hospitals and doctors’ offices to detect the presence of amniotic fluid in vaginal secretions during late-term pregnancy, a sign of premature amniotic sac rupture.
View Brochures, Videos & Mores at POR.io Enter Number 6580 in the Search Area
#6581
SILARIS™ INFLUENZA A&B TEST From Sekisui Diagnostics
A molecular test utilizing polymerase chain reaction (PCR) technology providing accurate results for early diagnosis and proper management of influenza. Accurate √ Molecular Results √ State-of-the art microfluidic cassette technology √ PCR test using proprietary OscAR™ Technology Affordable √ Single Test Diagnosis √ Controls in every kit √ Molecular reimbursement (CPT Code 87502) Simple √ Easy to Use √ Compact portable dock with no calibration required √ Room temperature storage
View Brochures, Videos & Mores at POR.io Enter Number 6581 in the Search Area 32
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#6583
#6582
#5316
Call 888-522-9939 or Visit medpod.por.io for More Information
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2019 Issue 6
PRODUCTFOCUS #6584
FIRE YOUR FINANCIAL ADVISOR
PHYSICIANS office RESOURCE
From White Coat Investor
Fire Your Financial Advisor is the course that should’ve been taught to you in college, medical school, or residency but never was. For 1/10th the price and half the time of hiring a professional financial planner, this course will take you from feeling anxious and having no plan to having a written financial plan you can follow the rest of your investing career as a professional and a retiree. Topics covered include insurance, investing, retirement planning, and much more. Learn more at whitecoatinvestor.com.
View Brochures, Videos & Mores at POR.io Enter Number 6584 in the Search Area
#6585
PENTRA XLR HEMATOLOGY ANALYZER WITH 5-PART DIFFERENTIAL From HORIBA Medical
The Pentra XLR hematology analyzer with autoloader provides a CBC with 5-part Diff result using proprietary technology that ensures an accurate count and differential on the first run. The Pentra XLR also provides a complete menu of Retic parameters for treating oncology and anemia patients. The autoloader processes 80 samples an hour and provides random continuous access for mediumto high-volume clinics and rural or community hospitals.
View Brochures, Videos & Mores at POR.io Enter Number 6585 in the Search Area
#6586
PAD TESTING SYSTEMS IDEAL FOR PRIMARY CARE TO VASCULAR SPECIALISTS From Newman Medical
Your patients Trust You to find their PAD • You have many high risk patients, including anyone over 65 or diabetics or smokers • Even if they are unaware of their PAD, 25% will have a heart attack or stroke within 5 years if not managed • Patients often mistake symptoms of PAD for arthritis. simpleABI Cuff-Link systems are easy to learn and use • Push button remote, automatic calculations/waveforms • PC based – reports are easy to save and share Excellent Value and Reimbursements • One test per week pays off system in less than one year • Medicare reimbursements range from $80 to $220 depending on location and test
View Brochures, Videos & Mores at POR.io Enter Number 6586 in the Search Area 34
www.PhysiciansOfficeResource.com
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Win a FREE iPad Mini!
Join POR as we conduct our first in a series of brief surveys, designed to give a voice to providers. With your help we can better understand what’s trending in physician offices, laboratories, and healthcare facilities across America, and help improve office and laboratory proficiency, profitability, and patient care.
As a Thank You, we’ll report the results from this and future surveys in Physicians Office Resource magazine. Moreover, we will enter you in our periodic drawing for a FREE Apple iPad, which you may gift to someone or keep for yourself. The more surveys completed, and the more questions you answer in each, the more chances you will have to win.
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2019 Issue 6
PHYSICIANS office RESOURCE
HOW IN-HOUSE TESTING STEERS INCOME TO YOUR PRACTICE Dylan J. Chadwick, Staff Writer Physicians Office Resource – www.PhysiciansOfficeResource.com
In a changing medical landscape, physicians willing to invest in their practices are the ones who’ll succeed. Though evolving technology and its subsequent improvements in patient care have brought substantial changes to the medical sector, an era of economic uncertainty and fiscal instability may wring just as prescient an effect. According to an article by Ben Brown, MD, reductions in Medicare contract payments (some as much as 21.3%) and physician reimbursements from insurers might result in critical decreases in physician salaries, medical profits and general revenue for a practice. What proves even more concerning for physicians and patients alike, is a present medical landscape of high healthcare costs, an ever-increasing need for healthcare options and diminishing resources. Furthermore, caring physicians want to be effective providers for their patients, but they also want the appreciation and financial compensation for their profession demands. In this regard, many physicians, Urologists, Oncologists, Gastroenterologists and Dermatologists for example, have made conscious efforts to optimize their practices in an effort to generate other streams of ancillary income. One specializing measure has been opening in-office testing labs (POL’s) directly at their office location. These labs, carefully stocked and equipped to run routine (but important) procedural tests, provide real life “one stop shop” scenarios for patients with busy schedules and limited funds, and can quickly develop into thriving profit centers for small practices...but before opening up a lab, let’s talk some basics. Physicians have a number of options when it comes to medical testing. The first, and least efficient, is for them to refer patients to a hospital or an off-site lab for their tests. This method, though convenient for practices with a high volume 36
of appointments, generally proves inconvenient for the patient, who has to make additional trips for a singular medical problem. Additionally, it yields a low (virtually non-existent) financial return for the physician. Another “off-site testing” option for physicians is to take the samples in the office, and then send them to an off-site lab for analysis. Commercial Reference Labs (CRL), like Quest Diagnostics, Laboratory Corporation of America Holdings and Bio-Reference Medical Labs, have carved a space in physician circles as adept facilities that aid practices by doing the testing work for them. Still, the method is not without its downsides as it creates another process “step” for physicians who must take the test samples in-house, and then send them off-site before a further diagnosis can be made. Turn-around times increase as patients and physicians wait for their samples, shipping expenses must be considered and again, since Commercial Reference Labs are compensated for their lab work, financial returns for the actual physician are low. In the immediate sphere, these off-site methods may take stones from practices’ proverbial backpack as they’re “freed up” to see more patients, but in more pressing ways they’re potentially yanking dollars from a practice’s proverbial wallet. Bringing testing in-house increases a practice’s potential to make more money, and per a hightable article by Ken Powell, the Physician’s office lab is a sector forecasted to grow 10-15% in the following decade. A viable route for physicians is to run the testing themselves using products that have been specifically waived by the Clinical Laboratory Improvement Amendments (CLIA). Established in 1988, the CLIA sets standards and issues certifications for
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clinical laboratory testing, with an emphasis on ensuring office lab.” He contends that a practice can save anywhere from accuracy, reliability and timeliness. Using CLIA waived $100,000 to $1 million (depending on the size) simply by the cut products keeps the testing in-house, and can generate muchexpenses that an in-house lab espouses. needed revenue for a physician by steering testing and That’s not to say that establishing an in-house Physician’s procedural fees directly to the practice. However, testing done Office Lab doesn’t have its own set of costs that a practice must on CLIA waived products isn’t always the most extensive and take into account. For one, it will require a CLIA certification can be limited in scope. (approximately $1,200). Depending on the type of practice, it In an effort to generate additional income for their practice, will also require specialized equipment and a space in which to and to create an efficient and allhouse it. Physicians encompassing experience for their must make their own “These labs, carefully stocked patients, physicians may be better decision whether to and equipped to run routine advised not to stop simply at CLIA purchase equipment products, but to establish an entire or to lease it, but (but important) procedural CLIA certified lab in their office. Dumas insists that tests, provide real life “one In his article Oncologists leasing it is cheap stop shop” scenarios for paAdvised to Build Their Own and cost effective. tients with busy schedules and In-Office Clinical Labs Michael Finally, a well-oiled limited funds, and can quickMcBride cites an anecdote by Physician’s office lab ly develop into thriving profit Tim Dumas, a lab scientist and requires a competent POL consultant, when he says staff of specially centers for small practices.” “someone’s going to run and trained individuals Dylan J. Chadwick get paid for these tests. It might (the number depends as well be you.” In the article, on the size of the Dumas references a three doctor lab) and a competent Oncology practice in Raleigh North Carolina that generates medical lab manager (approximate salary of $75,000 a year) to an additional $400,000 annually with their own Physician oversee the testing. office lab. He even predicts that a ten to twelve doctor practice Though hefty, they’re necessary expenses and serve can look at $7-800,000 a year in additional revenue if they multiple worthwhile purposes. For one, specialized staff ensures implement such a facility. accuracy and efficiency in testing, and a CLIA certification Besides the extra cash flow, in-house Physician Office Labs will protect practices from any legal red tape. Additionally, by usher in various benefits for small and mid-level practices. For one, putting concentrated amounts of time, effort and resources waiting games and turnaround time between specimen collection, into their Physician’s Office Lab, practices make their lab more analysis and patient follow up are diminished. Since tests don’t attractive to managed care organizations (MCOs) and insurance need to be sent out, appointment is maximized and the practice companies. Subsequently, these organizations are far more likely becomes more beneficial both to the patient and to the physician. to give generous reimbursements when they’re assured that a POL promotes customer satisfaction, emphasizes quality and generally has effectiveness and efficiency in their top priority. While many physicians might seek to avoid what Michael Sanders MD calls the “headache” of dealing with CLIA, MCOs and the insurance companies, a top notch Physician’s office lab has far more advantages than it does hindrances, and the financial benefits far outweigh the expenses. For example, a standard CBC test for an oncology practice usually costs around $1 to run, but the insurance reimbursement is around $10. After deducting the fixed costs of the lab, profits become substantial, even more so for tests like CEA, CA 125 and CA 27-29 which cost between $3-4 to run and receive insurance reimbursements of $20-30 each. From simplifying the overall patient experience to whipping together an ancillary stream of income for a practice, it’s win-win on all counts. “A practice is at its most efficient, when it’s generating revenue,” says Tim Dumas. Though it will take effort to get Besides adopting the role of a practice’s lucrative profit started, the returns will come quickly and practices will come center, Physician’s office labs will help practices save money. upon their destination, be it financial success, an increase in Tim Dumas goes as far as to accuse practices of “wasting disposable revenue or a better patient experience, much quicker revenue” when they “decide not to install their own physician’s and more seamlessly with one than without. Read this and other articles at www.PhysiciansOfficeNews.com 2019 Issue 6.indd 37
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