Radiotherapy 2.0:: Stereotactic Treatments
Radiotherapy 2.0:: Stereotactic Treatments
Radiotherapy 2.0:: Stereotactic Treatments
Radiotherapy 2.0:
Robotics, Image Guidance, and Increased Precision
Stereotactic Treatments:
Notable Clinics Use Radiosurgical Approaches for Hard-to-Treat Tumors
A Commitment to Education:
Helping Customers Optimize Use of Varian Technology
ARIA 2011:
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CENTERLINE
Centerline magazine is published twice a year by Varian Medical Systems, http://www.varian.com. Centerline welcomes letters to the editor, contributions for point-of-view commentaries, and suggestions for articles. Reprinting of Centerline articles may take place with permission from the editor. Address comments, contributions, inquiries about reprints and permissions, subscription requests, and address changes to: Varian Medical Systems 3100 Hansen Way, M/S MGM Palo Alto, CA 94304-1038 Attn: Meryl Ginsberg +1 650.424.6444 meryl.ginsberg@varian.com
ON THE COVER
FEATURES
DEPARTMENTS
Point of View
In the Radiotherapy 2.0 era, robotics, image guidance, and increased precision are advancing the goal of saving more lives, says Varians Christopher Toth.
Stereotactic Treatments
Centerline looks at how four notable cancer centers are using advanced radiosurgical approaches for hardto-treat tumors.
News
European clinics introduce advanced TrueBeam capabilities European hospitals have been among the earliest adopters of the TrueBeam system for radiotherapy and radiosurgery.
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Varians Global Education and Training department helps customers develop successful oncology practices through the optimal use of Varian technology.
Brazilian hospital reaches RapidArc milestone Clinicians at the Hospital Israelita Albert Einstein have treated more than 100 patients with RapidArc technology. Study champions single-fraction HDR brachytherapy A UK study aims to determine the benets of singlefraction HDR brachytherapy boosts for prostate cancer. Florida center is first to use new brachytherapy applicator Doctors at Premiere Radiation Oncology are rst to perform HDR brachytherapy treatments using the Capri applicator. Proton therapy system gains 510(k) clearance Varian has received U.S. FDA 510(k) clearance for its proton therapy system, ProBeam.
In the era of Radiotherapy 2.0, there is little doubt that SBRT will be a key driver in expanding radiotherapy use in lung, liver, spine, and other disease sites. 2011 Varian Medical Systems, Inc. All rights reserved. ARIA, Clinac, On-Board Imager, RapidArc, Trilogy, Varian, Varian Medical Systems, and the Varian Medical Systems logo are registered trademarks, Capri, Eclipse, ProBeam, SmartConnect, Tx, and TrueBeam are trademarks, and MyVarian is a service mark of Varian Medical Systems, Inc. CyberKnife and MultiPlan are registered trademarks of Accuray, Inc. Novalis is a registered trademark of Brainlab AG. The names of other companies and products mentioned herein are used for identication purposes only and may be trademarks or registered trademarks of their respective owners.
Paperless Processes
Memorial Medical Center of Springeld, Illinois, is implementing paperless processes with Varians TrueBeam, ARIA, and Eclipse systems.
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UCSD Learning Center launches SBRT course The University of California San Diego is offering an online training course in Practical SBRT. TrueBeam wins R&D 100 Award for 2011 Varians TrueBeam system has been named one of the years 100 most technologically significant new products. ARIA certified for e-prescribing ARIA for radiation oncology has received e-prescribing certication for new prescriptions and rell requests. CyberKnife interface developed for ARIA A new interface connects the ARIA oncology information system to CyberKnife machines. ARIA receives ARRA HITECH certification The ARIA system has been certified for use in demonstrating stage 1 meaningful use of an EMR.
User-Centric Software
The user-friendly 2011 release of the ARIA oncology information system is designed to improve workow and offer personalized interfaces.
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Meaningful Use
U.S. ARIA customers should be well positioned to qualify for government nancial incentives based on the new meaningful use criteria.
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Point of View
Radiotherapy 2.0:
Robotics, Image Guidance, and Increased Precision
Varian Medical Systems mission is to explore and develop radiotherapy technologies that protect and save lives. Our goal is to help save 100,000 more lives per year, in partnership with clinicians who treat cancer and other lifethreatening conditions. Over the past three decades, radiotherapy has evolved significantly, with robotics, image guidance, and increased precision all opening new doors and advancing the goal of saving more lives. At Varian we have begun to refer to this new era using the term Radiotherapy 2.0to signify the fact that there has been an enormous sea change in the field. With the arrival of the Radiotherapy 2.0 era, we feel there is now a great opportunity for educating referring physicians, patients, and others in the medical community about all that radiotherapy can accomplish.
By Christopher Toth, Varian Senior Director of Oncology Marketing
A practical example of how Radiotherapy 2.0 has opened new doors is in the area of stereotactic body radiotherapy, or SBRT. Researchers are finding that SBRT is showing great promise in the treatment of tumors that would have been difficult or impossible to treat with radiotherapy prior to the advances outlined here. A fast-growing body of peer-reviewed studies is showing that SBRT, which some are now calling stereotactic ablative radiation therapy (SABR), is a feasible, noninvasive, well-tolerated therapeutic option for some patients with lung, liver, spine, and other tumors. Since these approaches are, by definition, delivered quickly over a short course of treatment, they may prove to be important for addressing unmet medical needs, such as the worldwide prevalence of lung cancer, which in 2010 was estimated at 1,608,055 new cases. Many innovations over the past three decades have powered the evolution to Radiotherapy 2.0. In the 1980s, the emergence of CT-based imaging and 3D conformal treatment planning brought about a new approach to delivering dose to tumors that was a major step forward from earlier methods that utilized only 2D data sets. During the 1990s, the multileaf collimator for shaping the radiotherapy beam and creating more conformal dose distributions opened new doors in treatment efficiency, giving rise to dose-sculpting techniques such as intensity-modulated radiotherapy (IMRT), which have helped us increase dose to the target while reducing exposure of healthy tissues and critical structures. In the early 2000s, robotic image guidance for image-guided radiotherapy (IGRT) emerged as a way to confirm a targets position prior to treatment based on images of internal anatomic structures or fiducials. This image
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Point of View
guidance movement evolved over the past decade to include the ability to acquire not only 2D, but also 3D conebeam CT and 4D fluorographic images prior to treatment. With the introduction of the TrueBeam system, Varian added real-time imaging during treatment as a motion management tool. Most recently, the growth and maturation of all of these technologies, including the introduction of RapidArc radiotherapy, have enabled new levels of precision and accuracy, and expanded the spectrum of treatment opportunities for many forms of cancer. As treatment technology advanced, the information management backbone underwent a commensurate evolution. Fully integrated software solutions emerged, with a focus on usability and efficiency. This has been crucial for enabling clinics to improve workflow and efficiency even while adopting these advanced new technologies. To this end Varian has invested heavily in software system development, and this year we are launching ARIA 2011, which will bring new efficiencies to the radiotherapy workflow process.
the On-Board Imager kV imaging systems. This groundbreaking system won a 2006 R&D 100 Award from R&D magazinean award that salutes the 100 most technologically significant products introduced into the marketplace in a given year. The fully automated On-Board Imager enables robotic control of the Varian treatment delivery system from outside the treatment vault. This technology paved the way for robotic radiotherapy and radiosurgery across Varians entire linear accelerator product line: the Clinac iX, Trilogy, Novalis Tx, and the TrueBeam and TrueBeam STx systems, which were just recognized with an R&D 100 Award for 2011. What was once a futuristic vision is now a reality: clinicians can use any of these systems to set up a patient, confirm internal tumor position prior to treatment, make minute adjustments, initiate treatment, and monitor the patient without having to enter the treatment vault. The Varian system has evolved into a highly precise, robotically guided solution. Whats more, treatments that took 30 to 45 minutes using earlier generations of technology can now be completed in just minutes a day.
Whats next?
As Radiotherapy 2.0 continues to evolve there is little doubt that SBRT will be a key driver in expanding radiotherapy use in lung, liver, spine, and other disease sites, as well as a key contributor to how these diseases are treated in emerging markets. Additionally, radiobiology and multidisciplinary care will emerge as important themes. We are already seeing teams of surgeons and radiation oncologists start to leverage the robotics, image guidance, and increased precision of the Radiotherapy 2.0 revolution. Varian is committed to helping facilitate this teamwork. We are convinced that these developments will open up even more opportunities for bringing the benefits of Radiotherapy 2.0 to new populations of patients worldwide and contribute further to our joint goal with clinicians to save an additional 100,000 lives per year. 5
The robotic CPT codes for reimbursement are as follows: G0339Image-guided robotic linear accelerator based stereotactic radiosurgery, complete course of therapy in one session, or first session of fractionated treatment. G0340Image-guided robotic linear accelerator based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five sessions per course of treatment. The Hospital Outpatient Prospective Payment System (HOPPS) provides assigned payment rates when a hospital submits these codes.
The Medicare Physician Fee Schedule, which provides reimbursement for freestanding centers, does not have published payment rates for codes. Only carriers in freestanding settings in 26 U.S. states and the District of Columbia currently reimburse the above robotic G codes. They are: Palmetto: HI, NV, CA, OH, SC, WV WI Physician Services: MN, IA, KS, NE, MO, IL, MI, WI Cahaba: TN First Coast: FL National Government Services (NGS): NY, CT National Heritage Insurance: ME, MA, NH, VT Highmark: DE, DC, MD, NJ, PA
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News
TrueBeam was selected for this project as we believe it to be the most advanced system of its kind, adds Richard Yacob, director of medical physics at HCA NHS Ventures. As well as being able to deliver higher doses faster than other systems, it is capable of advanced real-time imaging and gated RapidArc. It will be a big step forward in providing higher precision in treatment delivery. TrueBeam was designed from the ground up to treat tumors in a fast and precise manner, including tumors that move during treatment as the patient breathes in and out. Designed to advance the treatment of lung, breast, prostate, head and neck, and other types of cancer, TrueBeam features a multitude of technical innovations that dynamically synchronize imaging, patient positioning, motion management, and treatment delivery. With its High-Intensity Mode, TrueBeam can deliver very high doses quickly and accurately, more than twice as fast as earlier generations of technology. European clinical experience At Humanitas Institute in RozzanoMilan, Italy, TrueBeam is routinely used to treat 50 patients a day. Treatments focus on hypofractionated stereotactic body radiotherapy (SBRT), in particular for liver and pancreatic cancer, nonsmall cell lung cancer and lymph node metastases, along with total marrow irradiation. TrueBeam enables us to offer treatments for different kinds of pathologies than have previously been possible with radiosurgery here at Humanitas, says Marta Scorsetti, MD, head of radiation oncology and radiosurgery at the hospital. We are impressed by the greater precision and higher-quality imaging, the higher possible dose rate, the ability to deliver the total dose in fewer fractions, and the speed of the treatment, which allows for shorter
treatment sessions for patients. To date, Humanitas Institute has treated more than 420 patients using the TrueBeam device, with 25 new patients commencing treatment on the system each week. Two TrueBeam devices are treating up to 100 patients a day at VU University Medical Center in Amsterdam, Netherlands, and according to department head Ben Slotman, MD, PhD, the devices have become a vital part of their SBRT program. From a clinical perspective, he says, TrueBeam enables better integration between imaging and treatment delivery, much faster dose output using the flattening filter free mode, and a much shorter time is needed for pretreatment setup due to the user-friendly nature of the equipment. In Switzerland, Inselspital Bern and Kantonsspital Hospital Winterthur are treating cancer patients clinically with TrueBeam. TrueBeam enables us to deliver precise image-guided treatments quickly, which may potentially lead to a greater number of cancer patients who can benefit from these advanced radiotherapy treatments, says
Daniel Aebersold, MD, of Inselspital, the university hospital of Bern. To date we have used TrueBeam mainly for patients with large tumors, such as you often find with cervical cancer, anal cancer, and advanced head and neck cancer. Urs Meier, MD, head of radiation oncology at Winterthur, says, TrueBeam enables radio-oncology departments to perform fast and precise imageguided treatments, thereby allowing for shorter treatment sessions for patients and, potentially, a greater number of patients being treated. In recent months, routine clinical TrueBeam treatments have also commenced at Institut Catala dOncologia in Barcelona, Spain; Neolife Medical Center in Istanbul, Turkey; Davidoff Center in Petah Tikva, Israel; Casa di Cura San Rossore in Pisa, Italy; Radioonkologie Amsler in Liestal, Switzerland; Strahlentherapie-BonnRhein-Sieg/St. Josef Hospital in Troisdorf, Germany; and Azizia Royal Clinic/Azizia Royal Palace in Riyadh, Saudi Arabia. 5
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place of a fractionated schedule. To take this step, we require robust data to demonstrate that such a course of action does not result in increased toxicity for the patient while achieving good biochemical control of prostate cancer. With this study, we are developing a multicenter database registering patients treated with a common agreed protocol using external beam radiotherapy and a single-fraction HDR boost. In this way, we intend to provide the required evidence that single-fraction boosts are feasible, safe, and effective. Hoskin says early clinical results look promising, and he looks forward to reporting on the results of the study when it has been concluded. This is a broad-based study that will hopefully make HDR brachytherapy more convenient and accessible for prostate cancer patients and clinical staff, says Tim Clark, Varians brachytherapy product manager. We are happy to support this important and pioneering work. 5
radiotherapy and was not a candidate for surgery or chemotherapy, Zouain says. The procedure was done on an outpatient basis using only local anesthesia. The patient did not require any pain medication and was discharged to go home directly after the treatment was completed in a procedure that took about an hour. Designed with the intention of improving patient comfort, the Capri is a lightweight balloon applicator that is inflated upon insertion to adapt to the anatomy and hold it in place during treatment. Prior to the Capri applicators development, the principal brachytherapy option for endometrial cancer patients involved inserting rigid cylinders, which may require the fixation of the applicator to the treatment table. The Capri applicator is also compatible with CT imaging, which enables doctors to use it with 3D imaging to plan their treatments and determine exactly where they want to deposit the dose.
Nicholas Zouain, MD
I have used other applicators in the past, says Zouain. The Capri is very easy to use. Using its multiple channels, we can design a treatment plan that gives us a dose distribution with great tumor coverage, and the balloon allows for good fixation of normal tissues. The Capri applicator has FDA clearance for gynecological and rectal treatments in the United States and is awaiting CE approval in Europe. 5
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UCSD launches SBRT course Proton therapy system receives 510(k) clearance
Earlier this year, Varian received U.S. FDA 510(k) clearance for its proton therapy system, which delivers intensity-modulated proton therapy (IMPT) using pencil-beam scanning technology. The companys Eclipse treatment planning system also received FDA 510(k) clearance for use with Varians IMPT delivery systems in the United States. IMPT requires the integration of smart treatment planning and precise pencil-beam scanning delivery, says Moataz Karmalawy, head of Varians particle therapy group. Weve achieved that by teaming up our market-leading Eclipse treatment planning software with our ProBeam delivery system. The goal of IMPT is to shape the dose distribution so that it matches the shape of the targeted tumor in all three dimensions. An important feature of the latest Eclipse release is the ability to analyze the robustness of a treatment plan in terms of its ability to optimally cover the tumor and reduce dose to healthy tissues. IMPT is designed especially for complex tumor shapes, such as head and neck tumors, tumors of the lower abdomen that have a curved shape, and tumors wrapped around the spinal cord or brain stem, says Karmalawy. Varians ProBeam system incorporates pencil-beam scanning technology, which is designed to optimize the dose applied to every point within the area being treated. At this years annual Particle Therapy Cooperative Group (PTCOG) meeting, Varian exhibited a new user interface, a more compact robotic patient positioner, and advanced imaging capabilities for precise patient setup, verification, and correction, including planar imaging and 3D kV cone-beam CT. With the introduction of pencil-beam scanning, the workflow of proton therapy has already become significantly more efficient, says Karmalawy. The introduction of the new user interface, the patient positioner, and imaging enhancements make this system easier to use for clinicians, building on our workflow expertise in conventional radiotherapy. 5 The University of California San Diego (UCSD) Department of Radiation Oncology Learning Center is offering an online training course in stereotactic body radiation therapy. Practical SBRT provides up to 25 hours of lectures and course material targeted to the radiation oncologist. Created by Arno J. Mundt, MD, professor and department chair, and Joshua Lawson, MD, assistant professor, the practical online tutorial covers topics such as patient selection, dose prescription, target delineation, treatment planning, image-guided treatments, motion management strategies, toxicities, and outcome studies. Mundt and Lawson are also offering the material in the form of a weekend intensive on August 1213, 2011, at UCSD. Further information about the online tutorial is available at http://www .regonline.com/sbrt. To learn more about the weekend intensive, visit http://www.regonline.com/sbrtUCSD. For information on other online courses available through the UCSD Radiation Oncology Learning Center, such as Going Paperless and UCSD IGRT Protocols, contact Carol Shostak at cshostak@ucsd.edu. 5
TrueBeam was selected as a 2011 R&D 100 Award winner because of the technical innovations that were introduced to dynamically synchronize imaging, patient positioning, motion management, and treatment delivery. TrueBeam can deliver treatments with a dose delivery rate that is roughly twice the maximum output of conventional systems, making it possible to offer shorter treatment times for patients, potentially enabling clinics to treat more patients each day and improve precision by leaving less time for tumor motion during dose delivery. More than 220 TrueBeam systems have now been ordered by treatment centers around the world, and more than 65 installations are completed or in process. The R&D 100 Awards, widely known as the Oscars of innovation, identify and celebrate the top high-technology products of the year. Awards span industry, academia, and governmentsponsored research. To learn more, visit http://www.rdmag.com. 5
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ARIA is now in use at more than 2,500 treatment centers around the world. It has been rated among the top three oncology IT solutions every year since 2008, and was ranked number one in 2008 and 2009 by KLAS, an independent research firm that reports on the performance of healthcare vendors (http://www.klas.com). 5 With this new interface, treatment plan data can be imported into ARIA directly, in a form that is more useful when operating day-to-day and delivering treatments, he says. Now the staff members can bring up a plan and prepare for treatment, record the treatments delivered that day along with the quality assurance checks that are integral to our patient care process, record and verify, close the chart, and move on to the next patient. We have fewer manual steps and the integrity of the information is more secure. Kresl outlined several other important benefits to having an electronic interface between the two systems. Often you want to go back to a patients record for information about the treatment plan and about treatments that were delivered. This allows you to do that more easily, and to share that information with other medical providers or team physicians, he says. We live in a mobile society. People move and need to take information with them. We needed a John J. Kresl, MD, PhD better way to archive, retrieve, and use patient information. Now I can get CyberKnife and MultiPlan information from ARIA just as I can get information about treatments we planned using Eclipse.
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LEFT
| Samuel Ryu, MD, Indrin Chetty, PhD, and Benjamin Movsas, MD, with a new TrueBeam machine being installed at Henry Ford Hospital in Detroit. Image courtesy of the Henry Ford Health System.
RIGHT | Ben Slotman, MD, PhD, of the VU Medical Center in Amsterdam. FAR RIGHT
| Image from a treatment plan for trigeminal neuralgia. Image courtesy of the UCLA Medical Center.
In the last 11 years, doctors at the Henry Ford Health System of Detroit, Michigan, Ryu is the principal investigator of a nationtreated more than 2,000 radiosurgery wide phase 2 and 3 randomized clinical study cases, among the largest number anyof spine radiosurgery for spine metastases, Indrin Chetty, PhD, Henry Ford Health System where. In 2009, the Henry Ford installed RTOG 0631. It is potentially a landmark study the new Novalis Tx linac developed by encompassing 283 patients that will assess the effectiveness of a single, 16Varian Medical Systems and Brainlab. This new system utilizes multidimenGy fraction administered via radiosurgery versus a single, 8-Gy fraction adsional imaging to detect movement during treatment so targeting can be ministered via traditional external beam radiation therapy in relieving the precisely adjusted, as necessary, to limit damage to healthy tissues during back pain associated with spine metastases, which occur in 40 percent of cantreatment. cer cases. Collaborators include renowned SRS experts at the University of Much of Henry Fords groundbreaking work has been spearheaded by its Pittsburgh, Duke University, the University of Texas Southwestern, and elsedynamic radiosurgery director, Samuel Ryu, MD, who is also head of neurowhere. The studys primary goal is to achieve faster pain relief and related and spinal oncology in the Department of Radiation Oncology and Neurobenefits for patients. Indeed, results from multiple studies within the last surgery. Ryu has published numerous papers and speaks internationally on decade have suggested better overall pain control using higher radiation radiosurgery. He hopes eventually to launch a radiosurgery and radiotherapy doses. training center. Ryus research has shown that SRS treatment for spinal metastases can lead A trailblazing effort in spine radiosurgery at Henry Ford has been to study opto quick and durable pain relief, and can also be used to alleviate compression tions for reducing multiple, lower-dose fractions30 Gy in 10 fractions is the of the spinal cord caused by epidural tumors.2 He further makes the point current standardto a single, higher-dose treatment of 16 to 20 Gy or higher. that it preserves blood-producing bone marrow in the spine by treating only Single radiation sessions for the spine may relieve tumor pain more quickly the involved spine and, as a single-fraction treatment, neednt interfere with and durably than multiple fractions of smaller doses, and thus improve paa patients ongoing chemotherapy schedule.3 tients quality of life faster and longer.1 However, the higher radiation dose Although radiosurgery rather than surgery is now the primary treatment for and risk of collateral damage to the spinal cord make precise treatment planspine metastases at Henry Ford, the team occasionally uses radiosurgery ning and delivery absolutely essential. postoperatively, too, as a pain-relieving adjuvant or to treat the residual surgiSam has really defined what the volume-based tolerance doses for the cal bed itself. spinal cord are, says Indrin Chetty, PhD, director of Henry Fords physics division. Irradiating spine tumors that are located immediately next to the
Irradiating spine tumors that are located immediately next to the spinal cord is especially challenging. Our goal is to achieve <12 mm accuracy in every case.
spinal cord is especially challenging. Our goal is to achieve <12 mm accuracy in every case.
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A RapidArc SBRT treatment plan for adrenal metastases shown on a fused PET/CT image.
We follow all of the patients for years to come. There are patients Ive been following now for 20 years.
Antonio A.F. De Salles, MD, PhD, UCLA Medical Center
In treatment planning, computed tomography, magnetic resonance, and angiogram imaging scans provide a 3D profile of the tumor or lesion. Imageguidance technology has evolved to the point that bolted headframe immobilization of the patient is no longer necessary for some stereotactic radiosurgery procedures. UCLA also uses the Novalis Tx system for stereotactic body radiotherapy that is, to treat lung, liver, kidney, and other structures beyond the brain and spine. Nearly 400 patients come to the medical center each year for SBRT. When treating tumors in the body, rather than in the head, the problem of tumor motion during and between treatments becomes more challenging. These challenges are addressed at UCLA through the use of the three imaging systems on Novalis Tx that enable continuous imaging, motion detection, and robotic adjustments of the patients position in six dimensions during treatment to keep the radiation beams focused on the target. De Salles estimates that roughly 30 percent of his SRS cases involve metastatic tumors, 20 to 25 percent benign tumors, and 14 percent arteriovenous malformationsabnormal connections between veins and arteriesfollowed in fewer numbers by gliomas/glioblastomas and rare tumors like acoustic neuromas. After therapy, we follow all of the patients for years to come, De Salles says. There are patients Ive been following now for 20 years. Decades of experience, research, and technological development have paid off at UCLA, for both the radiosurgery staff and the patients who benefit from SRS.
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Inoperable S-1 NSCLC on the right side in a patient with a prior leftsided pneumonectomy, treated with RapidArc SBRT. Short-term (28 week) treatment response showed no decline in pulmonary function and minimal atelectasis/fibrosis. Twenty months later (bottom), there was no radiographic evidence of disease.
Case courtesy of Banner Good Samaritan Medical Center, Phoenix, Arizona.
The most challenging tumor location for Such findings are part of the learning SBRT is in the lung, because you have a curve for medical professionals as moving target, says Feigenberg, explaining they refine and improve SBRT techthat tumors move differently from patient niques. According to Feigenberg, SBRT to patient and can also vary from day to is currently being compared to surday. He says one advance in particular4D gery in three large prospective clinical Steven Feigenberg, MD, University of Maryland CT imaging for use in treatment planning trials, challenging the paradigm of Greenebaum Cancer Center for various extracranial tumors that move surgery being the standard of care for related to respirationmakes therapy even more precise because it enables patients with select small tumors. Theres a lot of buzz about this treatment the clinical team to tailor the radiation beam to the specific tumors motion, modality, which is now being investigated in the liver, pancreas, spine, and maximizing tumor coverage and minimizing injury to surrounding normal prostate. 5 structures. In the past, clinicians often used population-based margins, which were either an over- or underestimate. Last year Feigenberg and coinvestigators at Fox Chase Cancer Center and Henry Ford Hospital in Detroit published a study involving 18 patients that delivered higher radiation doses in fewer treatments via SBRT for medically inoperable patients with early-stage, nonsmall cell lung cancer. The total dose was escalated from 40 Gy to 48 Gy, then to 56 Gy, in four equal fractions two to three times a week. Target volumes were based on 4D CT or breathhold scans. Seventy-two percent of the patients didnt experience any adverse side effects during or after treatment. There was only one grade 3 pulmonary event, which was attributed to heavy pretreatment with chemotherapy, radiation, and surgery. According to the authors, among those that did experience side effects, the morbidity was relatively low. Although clinical trials in the United States are still under way, research abroad suggests that, for smaller tumors, 12 Gy in four fractions for a total of 48 Gy appears to be effective and minimize side effects, while 20 Gy in three fractions for a total of 60 Gy appears to be more advantageous for treating larger tumors.5, 6
References 1. Ryu S. et al. Patterns of failure after single-dose radiosurgery for spinal metastasis. J Neurosurg. 2004;101(S3):402405. doi: 10.3171/sup.2004.101.supplement3.0402. 2. Ryu S. et al. Image-guided and intensity-modulated radiosurgery for patients with spinal metastasis. Cancer. 2003;97:20132018. doi: 10.1002/cncr.11296. 3. Ryu S. et al. Pain control by image-guided radiosurgery for solitary spinal metastasis. J Pain Symptom Manage. 2008;35(3):292298. doi:10.1016/j.jpainsymman.2007.04.020. 4. Palma et al. Impact of introducing stereotactic lung radiotherapy for elderly patients with stage I nonsmall cell lung cancer: a population-based time-trend analysis. J Clin Oncol. 2010;28:51535159. 5. Onishi H. et al. Stereotactic hypofractionated high-dose irradiation for stage I nonsmall cell lung carcinoma: clinical outcomes in 245 subjects in a Japanese multi-institutional study. Cancer. 2004;101(7):16231631. 6. Nagata Y. Clinical outcomes of a phase 12 study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame. Int J Radiat Oncol Biol Phys. 2005;63(5):14271431.
SBRT is currently being compared to surgery in three large prospective clinical trials, challenging the paradigm of surgery being the standard of care for patients with select small tumors.
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Global Education and Training: Supporting Clinical Teams in the Safe and Effective Use of Varian Technology
Varians Global Education and Training, a department within the Customer Support Services organization, is made up of dedicated professionals working around the globe, helping customers to develop successful oncology practices through the optimal use of Varian technology.
At Varian, we are well aware that many of our customers are being asked to practice in more challenging clinical environments, and to do more with less. In addition, increasingly sophisticated treatment techniques are being developed techniques like image-guided SBRT with motion managementthat require adept and skillful use of technology, says Kolleen Kennedy, vice president of Varian Customer Support Services. Consequently, we have evolved our strategy to include greater attention to high-risk elements and have incorporated this focus into our training and education programs so that clinical teams can deliver high-quality, safe, and effective treatments. Varian takes a blended learning approach to education, offering classroom training at centers around the world, on-site clinical support, and remote learning options such as webinars with prominent clinical experts. Combined with roundthe-clock access to help desk personnel who can even launch an impromptu SmartConnect remote training session if needed, the Varian resources for customer education and training are focused on one goal: enabling clinicians to use Varian technology safely and effectively.
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Clinicians complete an Eclipse software class at Hospital Israelita Albert Einstein, one of Varians regional training partners, in So Paulo, Brazil.
Buc, France, and in Crawley, United Kingdom. Finally, the European training team organizes numerous clinical schools that take place at hospitals and treatment centers across Europe that have been equipped with the latest Varian technology. These schools cover IMRT, RapidArc, respiratory gating, and IGRT, using both lectures and hands-on training. To serve customers in South America, Varian partners with a site in So Paulo, Brazil, so customers can receive classroom education and hands-on training delivered in Portuguese. A new education center is on the drawing board for Tokyo, Japan, slated to open in 2012. Worldwide, 34 full-time educators are providing Varian product classroom-based education programs for nearly 3,700 oncology professionals each year. According to Sue Merritt, senior manager of clinical training for the Americas (including North, South, and Central America), Varian course instructors are themselves all radiotherapy professionals, including RTTs, dosimetrists, and physicists. We have over 1,500 years of combined clinical experience, says Merritt. Worldwide, we hire training professionals who all have clinical experience in radiotherapy and maintain their professional qualifications.
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A class in progress at the Varian Education Center in Beijing, China, where training is offered in Mandarin.
SmartConnect Now is an on-demand remote information system. For a site deploying the customers have many opportunities support feature that enables a Varian service or Eclipse treatment planning system, we have to continue building their skills help desk representative to provide real-time our Eclipse Administration and Physics class through e-learning. desktop sharing. We can securely dial into a geared to physicists and our Eclipse Operations customers system and walk them through a class for dosimetrists. Once those classes have process, Hollon says. We see this as part of the training arc that starts with been completed, we offer two days of on-site support that is complementary coming to a training center for classes, having access to on-site applications to the didactic classroom training and allows us to help customers employ support during go live, and then finishing up with real-time remote support, the newly acquired skills in their own clinical settings. This exemplifies our either over the phone from the help desk or online via SmartConnect. In our commitment to the blended learning strategy. experience, each role in the training and education team is leveraged to faciliIn the United States, education regional managers oversee Varians on-site tate customers achieving the confidence to successfully implement technoltraining operations. We used to have one big national applications team in ogy that is new to them. the United States, says Hollon. We changed that to put the on-site training program managers within the service regions. Once a sale is concluded, a Varian project manager coordinates a sequence of activities, including site preparation, installation, training, and an agreedupon launch date for going clinical with the new product. The on-site applications trainers are scheduled to arrive as soon as the technology is installed so that training takes place on time. Often, the classroom education is completed by the customer while the product is being installed. By regionalizing these teams weve been able to achieve a much closer relationship with customers as they move through the learning curve, says Hollon. This relationship over time allows us to be more effective when structuring a customers training plan, since we are more familiar with their individual areas of need. On-site support doesnt end when the formal on-site training is over, however. The applications training people write up a trip report, and we make sure we provide appropriate after care, Hollon says. This is where we rely on our help desk team, the local service personnel, and often, our SmartConnect Now technology. In 2010, clinical help desks were launched in Beijing, Hong Kong, and Tokyo, says Harry Tao, Varians senior manager of training and education for the Asia Pacific region. During 2011 we implemented a strategy to network our global clinical support centers so that agents in the United States can join or answer calls for customers in the Asia Pacific region, implementing a true follow the sun strategy for customer support.
Remote learning
After classroom and on-site training, customers have many opportunities to continue building their skills through e-learning. Varian produces a robust schedule of webinars covering a wide range of topics, from brachytherapy techniques to RapidArc planning, from updates on the ARRA HITECH Act to establishing paperless processes. These webinars are promoted and archived on the MyVarian customer support website (see sidebar, next page).
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In addition, the Varian Learning Center offers self-paced, on-demand, online courses that include didactic instruction, demonstrations, and hands-on practice. Via the Learning Center, customers can train on Varian system upgrades and learn about new features and options without traveling. These are also accessed via the MyVarian customer support website.
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The Varian Education Center in Mumbai, India, opened in 2010 with state-of-the-art classrooms. Courses are conducted in Hindi.
CME programs
Varians Continuing Medical Education (CME) program is another vital component of the companys global education offerings. The CME programs are approved by the American Society of Radiologic Technologists (ASRT) or the Medical Dosimetrist Certification Board (MDCB), and are open to interested MDs and RNs as well as physicists, medical dosimetrists, and therapists. Varian partners with the Institute for Medical Education (IME), based in UCLA, to deliver these programs. In 2011, 15 CME events will have been held in different U.S. cities, says Barbara Hird, manager of educational programs for Varian. Clinicians can also earn credits by accessing accredited web-based educational resources such as video and slide sets from these in-person CME programs.
The MyVarian customer support environment offers personalized assistance to Varian customers as well as access to education resources and product information. Redesigned in April 2011, MyVarian requires users to register and obtain a unique log-in and password. This provides access to a wide spectrum of materials, including extensive product documentation, presentations, marketing materials for promoting Varian technology, interactive user groups, webinars, and updates on relevant legislation.
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CE-credit management: With Varians Certificate Manager, customers can view and print documents for ASRTor MDCB-approved continuing education (CE) credits that were provided at Varian-hosted events. The customer submits this documentation to the accrediting organizations to receive CE credits. Personalized accounts can be accessed anytime, making it easy to track credits. Varian Learning Center: The Varian Learning Center allows customers to log in and complete self-paced, on-demand courses on their own schedules. Self-directed tutorials include didactic instruction, demonstrations, and hands-on practice. Through the Learning Center, customers can train on Varian system upgrades, new features, and new options without ever leaving their departments. Peer-to-peer training: Varian provides world-class product training and support through Varian Education Centers, applications training teams, and help desk teams. To provide an even broader spectrum of learning options useful when adopting new technology, Varian has developed a peer-topeer training program. This program connects clinicians who have adopted technologies and protocols to fellow clinicians who are beginning to adopt those same technologies and protocols. An interactive map helps users pinpoint a peer-to-peer training location that is convenient for them and suits their needs. To learn more about MyVarian or register for an account, visit http://www.MyVarian.com.
Below is a sampling of key education resources available through MyVarian: Product documentation: MyVarian was launched in 2007 to provide a self-service portal offering customers immediate access to documentation that would support them in properly using their in-house equipment and software. Today, customers still have 24/7 access to this important product information. Webinars: Varians webinar library includes recordings of presentations that were delivered live to international audiences. These recordings can be accessed anytime. Examples of recent webinars include Early Clinical Experience with TrueBeam, by John Fiveash, MD, and Richard Popple, PhD, from the University of Alabama in Birmingham, and Expanding the Clinical Use of RapidArc, by John Niemkiewicz, PhD, of Lehigh Valley Health Network. New webinars are added frequently, and the library now numbers more than 80.
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ARIA affects every aspect of the radiation oncology experience, so you need a team that has members from all the sections of the department, says Ray Capestrain, director of diagnostic medical physics at Memorial Medical Center. Its especially important to have physicians and staff willing to work through some of the difficulties of transitioning to an electronic medical record. In certain situations, doing something that benefits one section may make it more difficult for another section. But you need to look for overall efficiency. Throughout this process we greatly valued the contributions of our Varian clinical consultant. Kristen Lee, clinical systems analyst for information services at Memorial, says there was a bit of anxiety over changing patient record systems, but the staff felt we had gone as far as we could with the Impac application. Everyone in the department understood the reason we needed to implement a new solution and that our ultimate goal was to have an electronic medical record for patients in the cancer center, Lee continues. We were all engaged from the beginning because we could see the value of what moving to ARIA and TrueBeam would bring.
much initiative, we havent needed her back. She has provided critical support via email and telephone, and weve been able to make substantial progress, she says. ARIA is intuitive and very user friendly, Jones adds. We have some work left to do in the area of interfacing with the larger hospital so we can send documents and data back and forth. But for the most part, our workflow is now electronic. Our goal is to finish that process by late summer or early fall 2011.
We were clear: if we buy a product like TrueBeam, we want to be able to make full use of it. Linda Jones, Memorial Medical Center
A seamless transition
Memorials TBX team effected a seamless transition to TrueBeam, ARIA, and Eclipse. Martha was here several weeks before we went live to help us with the ARIA implementation. Our goal was not to replicate our paper processes or existing workflow. We really wanted to create optimal workflow and processes using the electronic medical record, recalls Jones. Martha gave us each work assignments based on our roles within the department, along with tasks that involved integrating processes with other disciplines. That got us all working together and communicating via the medical recorda big change from how we worked before, communicating on sticky notes or on notes in the written medical record. We were all learning to communicate through ARIA. When our go-live day arrived, we were ready to go. Martha was there just in case, but everything went smoothly. From an RTT perspective, one of our biggest anxieties was being prepared and comfortable with the equipment and new software prior to treating our first patient, says Lea Manuel, lead radiation therapist. The transition going from Siemens equipment to the Varian technology was quite seamless, especially with the training available through Varian. According to Jones, there were several major champions on the TBX team who really liked the new processes and showed a great interest and aptitude for coming up with electronic solutions using the ARIA system. Every week, we were building new documents, refining our work processes, and it just naturally seemed to happen over time. In fact, we had originally planned for Martha to come back a second time postlaunch, but the staff here showed so
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The ARIA oncology information system has long provided cancer treatment cenRoman Wicha, Varian product manager ters with powerful tools for managing the full spectrum of clinical, administrative, and financial activities in multidisciplinary settings. It incorporates a comprehensive oncology-specific electronic medical record (EMR) that enables clinicians to design a personalized care plan for each patient, from initial diagnosis through follow-up.
With the 2011 release, the ARIA system is certified for use in demonstrating stage 1 meaningful use of an EMR. It is also more tightly integrated with Eclipse treatment planning than ever before, allowing clinicians to access either system seamlessly from their home screens and task lists. Whats changed the most, with this new release of ARIA, is how tasks are accomplished, says Corey Zankowski, senior director of product management. ARIA has been completely redesigned for release in 2011, based on careful observation of how different users interact with the program.
The focus in this release was on patientcentric processesmaking it easier and more intuitive for the people who work with patients and with patient information.
For customers using Eclipse with ARIA, the 2011 release changes the paradigm from having a separate oncology information management system and treatment planning system into having a unified dashboard that accesses a complete clinical management system, says Chris Toth, senior director of marketing for Varians Oncology Systems business. In an era of more complex treatments and greater demands on clinicians time, this enhanced workflow expedites processes. If youre a physician, you may want to start with a look at all the tasks that youll need to complete today, including your schedule with a list of all the patients youll be seeing, explains Roman Wicha, a manager of treatment management products at Varian. If youre a dosimetrist, youll want a different viewperhaps all the tasks assigned to you and to physics/dosimetry on that day. ARIA 2011 can be customized to show you the data you need to see as soon as you need to see it, and to remind you of your tasks and appointments. The patient summary is available quickly from anywhere within the ARIA system, with no need to launch another module. Customized views of the patients EMR can be defined in accordance with a users role for quick access to specifically relevant information, be it the diagnosis, medications, any issues reported in the last visit, contact or insurance information, treatment progress, or other data from the electronic patient record.
Zankowski is referring to a new user-centric design approach that has been applied to the ways users access and utilize ARIA. The graphical user interface has been redesigned so that all the diverse professionals, including doctors, nurses, radiation therapists, physicists, dosimetrists, and administrators, can easily get what they need, when they need it, at the level of detail necessary for the task at hand. In addition to support for ARRA HITECH, the main changes to ARIA for 2011 can be grouped into three general areas: personalization to the user, expedited workflow, and enhanced automation for greater ease of use. ARIA 2011 incorporates powerful new workflow management features that make the system more role specific and user friendly than ever before. It also employs an icon-oriented, graphical look, so that navigation is guided by pictures rather than words, making it easier to learn and to use.
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A users home page with task pad, patient list, and schedule.
For example, the system can be configured Treatment planning with the Eclipse sysso that whenever new images are genertem is tightly integrated into ARIA, with ated, an image review task is automatically seamless access to all functions. One of created and assigned to the relevant doctor. the most complex areas in radiation oncolWhen he or she selects the image review ogy is the treatment planning process and Phil Koken, PhD, VU University Medical Center task, the system will launch Offline Review workflow, says Charmaine Lawrence, ARIA and load the relevant patients images. All product manager. It can be cumbersome tasks in a care path can be managed in this way, Wicha points out. This alto create and approve a treatment plan when different people are responsilows clinical professionals to focus on the patient and the clinical path rather ble for different parts of the process. With ARIA 2011, the treatment planning than worry about which application to launch. In fact, even the names of the steps are managed through a task-driven process that maps out actions and tasks in a care path are configurable by the users, and can be translated into responsibilities. other languages for use outside the United States. Other features enable reassignment of tasks, or task escalation. If a dosimetrist responsible for creating a treatment plan by noon on a given day falls ill, ARIA can inform a back-up person the moment the task becomes overdue, Wicha says. That way, the appropriate person is notified whenever an incomplete task could cause problems if not reassigned. The system can be further configured with rules that are unique to a treatment centers processesfor example, an image must be reviewed within 24 hours or prior to the next treatment. With such a rule in place, if the review is not completed, the next step in the care path cannot proceed without an intervention. ARIA 2011 enables treatment centers to define checklists and attach them to any task, as a QA/safety measure. Systems can be configured to require that these checklists be completed during time-outs that would occur at key points during the radiotherapy processa safety measure that Varian supports and has pledged to facilitate through changes in the ARIA information system. For example, in order to configure a treatment approval task, the user can specify: as part of this, there must be a double check of the plan against the prescription, says Wicha. Or the system can require a time-out session with a longer set of checklist items pegged to the institutions established QA procedures. Once configured, the system will require that checklist items are completed prior to the next step in the care path. Also, users can build in approval mechanisms, and have data be locked once approvals have been logged so that no one can make inadvertent changes to the treatment plan without override permissions.
You dont have to know what application you need; you just have to know what task you are doing next... When youre ready to complete a task, you click on it and the correct application launches. Its like a project management dashboard.
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ABOVE LEFT
| Visual Care Path displays all patient-related activities and status information.
| In RT Summary, the user can drill down to details with a single click.
Varian recognizes the importance of continuing to find ways of enhancing the safety of radiation therapy, says Zankowski. These new features in ARIA 2011 improve and simplify clinical workflow, and we expect them to contribute to a more consistent process following established workflows and defined QA measures, which could result in improved patient care.
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GEARING UP FOR
The race is on! The starting gun was the release of meaningful use criteria from the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) defining what would constitute the meaningful use of electronic medical records (EMRs) as mandated by the HITECH Act, part of the American Recovery and Reinvestment Act (ARRA).
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arian customers in the United States should be well positioned in the race to qualify for the financial incentives CMS is offering to medical centers and oncologists for deployingand showing meaningful use ofEMRs. The final rule requires that organizations demonstrate meaningful use of their EMR for at least three consecutive months in their first calendar year of participation in the program. To qualify for the full US$44,000 per provider in incentive payments, they need to begin meaningful use reporting by September 30, 2012. With our ARIA system and existing practices, I think we will have a fair amount of the meaningful use requirements already satisfied with very little additional effort, says John W. Ridley, executive director of oncology services at Decatur Memorial Hospital of Central Illinois. The new ARIA 2011 to be released later this year will help us accomplish the remainder. During 2011, Varian will release a new version of its ARIA oncology information system, which will be compliant with ARRA HITECH stage 1 requirements. Varian was already updating ARIA to be compliant prior to the final rule release, and has now received certification for use by customers to demonstrate stage 1 meaningful use of an EMR, to qualify for U.S. federal funding under the ARRA HITECH Act. Varian executives, who had partnered with other oncology EMR vendors to provide CMS with input regarding the specific needs of the oncology community during the rule-making process, were pleased to see that the final rule incorporated a number of their suggestions. The final rule focuses primarily on requirements for stage 1 of the new multiyear EMR program. Rules that cover the more stringent parameters for compliance with stages 2 and 3 of the program will be announced sometime in the future.
With our ARIA system and existing practices, I think we will have a fair amount of the meaningful use requirements already satisfied with very little additional effort. The new ARIA 2011... will help us accomplish the remainder.
John W. Ridley, Decatur Memorial Hospital
15 core capabilities, and through requirements for adoption of an additional five options that can be selected from a menu of ten. All webinars were recorded and are available, along with a wealth of other resources, on http:// www.MyVarian.com.
Ridley recently tuned into a webinar presented by Rob Thibault, manager of clinical implementation consulting at Varian. Decatur Memorial is a completely integrated Varian site with three linear accelerators, multiple Eclipse treatment planning workstations, and a large network of ARIA workstations, Ridley says. So we have a keen interest in keeping up with Varians work, particularly with respect to ARRA HITECH. While he was aware of many of the things Thibault spoke of, Ridley was anxious to hear insights to clarify some of the ambiguity with the new regulations. Theres a lot of interest in this, and the Varian webinars have been well attended, Ridley says. The webinars I tuned into this week each had well over 200 people participating. Additionally, Decaturs Kim Wolpert, radiation oncology director, had just traveled to a Varian training center to work with a prerelease version of ARIA 2011. Im confident that the new release of ARIA will enhance our workflow, as part of meeting our meaningful use needs, Wolpert reports. It is obvious that a lot of work and resources have gone into making that happen. At this point Ridleys main concern with implementing meaningful use is in determining how best to provide patients with access to their EMR. The technology isnt a problem. Decatur will do this through a password-protected patient portal into ARIA data. His concern is with being sensitive to the patient.
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Electronic access to scheduling information and into a wealth of survivorship programs and resources will be great, Ridley says. But at the same time a patients anxiety levels might go up if he or she were able to read a physicians dictated notes, or look at images without clinical guidance. Meaningful use doesnt require this depth of access, but these are questions that will need to be considered.
Here are some tips from a recent webinar presented by Thibault: Assign an internal champion. Appoint one person who needs to understand the complexities of the ARRA HITECH initiative. As part of his or her role, this person should set up a cross-functional core team to assist with the implementation. Understand the guidelines. It is important to understand the 15 core capabilities and the 10 menu options, which are covered by the recent Ken Hotz webinar available at http://www.MyVarian.com. Dont procrastinate. Many of the guidelines can be met with current functionality. So use the functionality you already have to make meaningful use part of your operational procedures. Review current processes and amend as needed. Identify what is currently being done and optimize how this may have to change in order to capture the required data. If a nurse needs to enter vital signs, does he or she have immediate access to a computer to do so? Are you capturing mandated demographic data? One requirement is to simply ask about smoking and record the response. Identify educational resources for patients. Search now for electronic resources you will be able to point patients to. Create IF/THEN scenarios. Decide now which clinical decision support rules to implement. For example, if white blood cells drop below X, then the course of action is Y. Formulate patient reminders. Work now on defining reminders to be sent to patients regarding preventative practices and follow-up care. Perform security and privacy audits. Policies and procedures need to be in place for password management, workstation security, emergency access to your systems, and other factors such as the deactivation of accounts of departing staff members. 5
ARIA for Medical Oncology and ARIA for Radiation Oncology Receive ARRA HITECH Certification
ARIA for medical oncology (version 10 MR2) and ARIA for radiation oncology (version 11) have been certified for use in demonstrating stage 1 meaningful use of an EMR to qualify for U.S. federal funding under the HITECH Act. Both versions of ARIA have now received complete EMR certification for ambulatory environments from the Drummond Group. Tested under the Drummond Groups Electronic Health Records Office of the National Coordinator Authorized Testing and Certification Body (ONC-ATCB) program, the ARIA systems were certified as 20112012 compliant in accordance with the criteria adopted by the U.S. Secretary of Health and Human Services. 5
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Presort Standard US Postage PAID San Jose, CA. Permit No. 2196