She has 20+ years experience managing pharma and commercial manufacturing plants
Albuquerque, NM Mar 31, 2014 – OsoBio has appointed Catherine R. Buck director of manufacturing.
In her capacity, Buck is responsible for ensuring that OsoBio’s operations comply with current Good Manufacturing Practices (cGMP) as they apply to the manufacturing of injectable sterile liquid, suspension and lyophilized pharmaceutical products. In addition, she ensures compliance with appropriate U.S. Food and Drug Administration and Drug Enforcement Administration regulations, and directs manufacturing activities to ensure timely, cost-effective and efficient production.
Buck brings to OsoBio more than 20 years of leadership and project management experience within the pharmaceutical, medical device and construction industries. She has managed multiple commercial and clinical pharmaceutical manufacturing plants that generated up to $2.5 billion annually.
“The same continuous improvement expectations that bear on just about every aspect of industrial productivity exist within pharmaceutical manufacturing as well,” said Milton Boyer, president of OsoBio. “We are fortunate to add someone with Catherine’s breadth of experience to lead a manufacturing team that keeps OsoBio competitive without sacrificing our commitment to quality and cGMP compliance.”
Her experience includes the start up, process, equipment and facility validation of a new Amgen manufacturing plant that produced Epogen®, that company’s highest revenue product. Her work included successfully obtaining FDA approval of automated equipment and software, and preparing for inspection and successfully obtaining FDA approval for commercial production. Buck also has managed manufacturing facility operations for Johnson & Johnson and Siemens.
Buck holds a bachelor’s of science degree in electrical engineering from Tufts University, and has completed the Emerging Leader Program at Columbia University.
Author: Julie Kaloides
Intralign develops surgical first assistants curriculum with HSS
This article appears in the online journal Orthopedics Today.
Mar 28, 2014
Intralign announced a partnership with Hospital for Special Surgery to develop a training curriculum for surgical first assistants, a clinical specialty comprised of surgeons, medical doctors, physician’s assistants and registered nurse first assists.
Operating as IntralignAcademy, the educational program will teach the latest technologies and methodologies in orthopedic care, as well as best practices for increasing operational efficiency in the surgical suite. According to a press release, leaders from Hospital for Special Surgery will provide insight and support to enhance Intralign’s existing academy programs. IntralignAcademy is the nation’s first professional academy to train surgical first assistants (SFAs) in both operational and clinical excellence with an emphasis on credentialing, clinical training, operating room (OR) management and continuing education. As part of the current program, IntralignAcademy offers clinical training in a variety of surgical specialties in addition to orthopedics, including surgical robotics. Professionals enrolled in IntralignAcademy are educated on OR behavior, communication and optimal methods for creating OR efficiencies, in addition to clinical best practices, which equip them with the broadest perspectives to assist any surgeon in any environment.
“Surgical first assistants help surgeons focus on the highest-value care activities, which can ultimately increase surgical throughout. Despite their pivotal role in the OR, there are few continuing education opportunities for SFAs today in which the curriculum goes beyond clinical techniques to also train on best operational practices to address the changing realities of healthcare,” Rick Ferreira, president and chief executive officer of Intralign, stated in the release. “By leveraging real-world insights from the most sought-after experts in orthopedic care, we can enrich Intralign’s educational offering and provide the strongest possible competencies for SFAs in orthopedic and total joint replacement training. These skills will further enhance Intralign SFAs’ ability to deliver high-quality, consistent and professional assistance that allows a surgeons to do more with fewer resources.”
NVQI™ launches module for Acute Ischemic Stroke
The NeuroVascular Quality Initiative™ (NVQI™) Launches First Procedure Module: Acute Ischemic Stroke
West Lebanon, NH Mar 25, 2013 – The Society of NeuroInterventional Surgery (SNIS) and M2S announce the launch of the NeuroVascular Quality Initiative™ (NVQI™), a multi-module registry system designed to track performance and outcomes data across a variety of neurovascular conditions. The launch debuts the Acute Ischemic Stroke (AIS) module, which will be used to track and benchmark clinical performance at the center level and nationally, providing valuable insight into the effectiveness of endovascular interventions and associated devices in treating a condition known to be the nation’s fourth leading cause of death. As of today, NVQI is officially enrolling hospitals and specialists in the AIS module.
As neurointerventional procedures (minimally invasive techniques designed to treat endovascular conditions of the brain and spine), have changed the treatment landscape over the past two decades and offered thousands of patients quality treatment alternatives to traditional medical approaches, NVQI is designed to track the success of these procedures, as well as demonstrate areas for improvement. Specifically, NVQI will collect detailed data on:
Patient demographics including age, weight/height, and co-morbidities
Patient history including pre-op medications, pre-stroke status and key time metrics associated to patient arrival and imaging
Procedure details including treatments and devices used and medications given
Follow-up including 14 day, 30 day, month and 1 year follow up
NVQI will be governed by the SNIS Patient Safety Organization (SNIS PSO), which oversees the data sharing arrangements and patient safety initiatives conducted within the NVQI. The importance of the PSO structure is that it protects all comparative analyses generated within the PSO from legal discovery in state and federal court. Furthermore, it permits the collection of patient identified data for quality improvement purposes without requiring consent from individual patients or prior approval from an Institutional Review Board.
“By encouraging the collection, aggregation, benchmarking, and analysis of clinical data, NVQI will assist SNIS members in understanding and improving patient outcomes in a safe environment. NVQI will also permit tracking of new devices and device efficacy in a real world setting which is a critical need within this evolving field,” said Peter Rasmussen, MD, Medical Director of SNIS PSO.
Gregory Lange, CEO of M2S, adds, “The NVQI Registry, supported by the M2S PATHWAYS platform, can provide, for the first time, both the breadth and depth of real time clinical data to assist hospitals and quality departments, as well as physicians, improve care for stroke patients.
Looking forward, the SNIS PSO is already planning its next-stage launch of two modules dedicated to cerebral aneurysms and cerebral arteriovenous malformations, scheduled for later this year. Additional considerations for modules include diagnostic angiography and spinal disease.
SNIS PSO has chosen M2S as the technology vendor to host the NVQI. All data will be securely stored within the M2S PATHWAYS quality improvement data platform. M2S specializes in cloud-based quality improvement registries for data collection and reporting, offering several unique features designed to maximize reporting as well as ease of use by specialists enrolled in registries hosted on M2S PATHWAYS.
Precyse University Partners with athenahealth to Provide Comprehensive ICD-10 Education to Physician Practices, Clinics and Ambulatory Settings
Wayne, PA and Alpharetta, GA Mar 26, 2014 — Precyse University, the most innovative, complete and widely adopted on-site, online and mobile ICD-10 education solution, available exclusively through HealthStream, today announced a partnership with athenahealth, Inc. as part of athenahealth’s More Disruption Please (MDP) program. Together, the companies will work to link athenahealth’s growing network of more than 50,000 health care providers with the capabilities of Precyse University so they can more efficiently prepare their staffs for the transition to ICD-10 in October 2014. The Precyse/HealthStream solution for ICD-10 education is now used by approximately 1.2 million learners in health care organizations.
“Precyse University delivers a powerful tool for physician practices,” said Thomas Ormondroyd, Vice President and General Manager of Precyse Learning Solutions. “Although ICD-10 seems daunting and burdensome, it actually offers tremendous opportunity to optimize reimbursement, minimize denials and appeals and improve clinical care through more valuable and detailed data. Our solutions are designed to ease the change to ICD-10 and have physicians and their staffs ready for its arrival.”
athenahealth is a cloud-based services company on a mission to build an information backbone to help make health care work as it should. Through the MDP program, athenahealth is accelerating the introduction of high-value innovation via the cloud, providing new services to help providers thrive in the face of industry change and pressure. MDP partners with innovators, entrepreneurs, companies, investors, and individuals—those who are passionate about overthrowing established approaches in health care that simply aren’t working, aren’t good enough, or aren’t advancing the industry. Unlike other health care startup incubators, MDP invites qualified companies like Precyse to gain access to the more than 50,000 providers that are already plugged into athenahealth’s cloud-based network.
NVQI™ launches module for Acute Ischemic Stroke
The NeuroVascular Quality Initiative™ (NVQI™) Launches First Procedure Module: Acute Ischemic Stroke
West Lebanon, NH MAR 26, 2013 – The Society of NeuroInterventional Surgery (SNIS) and M2S announce the launch of the NeuroVascular Quality Initiative™ (NVQI™), a multi-module registry system designed to track performance and outcomes data across a variety of neurovascular conditions. The launch debuts the Acute Ischemic Stroke (AIS) module, which will be used to track and benchmark clinical performance at the center level and nationally, providing valuable insight into the effectiveness of endovascular interventions and associated devices in treating a condition known to be the nation’s fourth leading cause of death. As of today, NVQI is officially enrolling hospitals and specialists in the AIS module.
As neurointerventional procedures (minimally invasive techniques designed to treat endovascular conditions of the brain and spine), have changed the treatment landscape over the past two decades and offered thousands of patients quality treatment alternatives to traditional medical approaches, NVQI is designed to track the success of these procedures, as well as demonstrate areas for improvement. Specifically, NVQI will collect detailed data on:
Patient demographics including age, weight/height, and co-morbidities
Patient history including pre-op medications, pre-stroke status and key time metrics associated to patient arrival and imaging
Procedure details including treatments and devices used and medications given
Follow-up including 14 day, 30 day, month and 1 year follow up
NVQI will be governed by the SNIS Patient Safety Organization (SNIS PSO), which oversees the data sharing arrangements and patient safety initiatives conducted within the NVQI. The importance of the PSO structure is that it protects all comparative analyses generated within the PSO from legal discovery in state and federal court. Furthermore, it permits the collection of patient identified data for quality improvement purposes without requiring consent from individual patients or prior approval from an Institutional Review Board.
“By encouraging the collection, aggregation, benchmarking, and analysis of clinical data, NVQI will assist SNIS members in understanding and improving patient outcomes in a safe environment. NVQI will also permit tracking of new devices and device efficacy in a real world setting which is a critical need within this evolving field,” said Peter Rasmussen, MD, Medical Director of SNIS PSO.
Gregory Lange, CEO of M2S, adds, “The NVQI Registry, supported by the M2S PATHWAYS platform, can provide, for the first time, both the breadth and depth of real time clinical data to assist hospitals and quality departments, as well as physicians, improve care for stroke patients.
Looking forward, the SNIS PSO is already planning its next-stage launch of two modules dedicated to cerebral aneurysms and cerebral arteriovenous malformations, scheduled for later this year. Additional considerations for modules include diagnostic angiography and spinal disease.
SNIS PSO has chosen M2S as the technology vendor to host the NVQI. All data will be securely stored within the M2S PATHWAYS quality improvement data platform. M2S specializes in cloud-based quality improvement registries for data collection and reporting, offering several unique features designed to maximize reporting as well as ease of use by specialists enrolled in registries hosted on M2S PATHWAYS.
Revenue Cycle Software Company, GAFFEY Healthcare, Announces Release of Document Genie
Plano, TX Mar 25, 2014 – GAFFEY Healthcare, a leading provider of next generation, cloud-based revenue cycle management software & business office outsourcing services, has announced the release of its latest product, a document management and file organization system called Document Genie.
Document Genie is a powerful cloud-based file management system that is used to associate files with claims. Designed to help healthcare organizations manage their documents, it transforms the piles of EOB’s, revenue cycle paperwork, contracts and other documents into digital file catalogues that can be accessed from anywhere. Document Genie seamlessly integrates with GAFFEY Healthcare’s workflow automation & business intelligence platform, AlphaCollector, to provide the ability to tag or associate any document with a field in AlphaCollector – enhancing education, scripting and document reference. The system accepts all scanned documents and is fully encrypted to remain HIPAA compliant.
“The GAFFEY Healthcare team is extremely excited at the release of Document Genie. The efficient management of documents, files and images is a critical component of almost any healthcare process today,” said GAFFEY Healthcare CEO, Derek Morkel. “Document Genie adds significant capabilities to our next generation cloud based RCM platform – especially in terms of automation, efficiency and, equally as important, safety. A safe and secure document management workflow platform is a critical component of an efficient process.”
Health Information Professionals Week Focuses on “Transforming Healthcare with Information” During 25th Annual Celebration
HIP Week Set for March 16‒22, 2014
Wayne, PA and Alpharetta, GA Mar 20, 2014 — Precyse, a leader in health information management (HIM) Performance Management and Technology, joins the American Health Information Management Association (AHIMA) in honoring and celebrating health information professionals during the 25th annual Health Information Professionals (HIP) Week, March 16‒22, 2014. This year’s theme is “Transforming Healthcare with Information.”
“The work health information management (HIM) professionals do to ensure the integrity of health information is imperative to clinical and administrative decision making. Access to accurate information helps all of us make important decisions and leads to a healthy society,” said AHIMA CEO Lynne Thomas Gordon, MBA, RHIA, CAE, FACHE, FAHIMA. “AHIMA’s Health Information Professionals Week spotlights the important role HIM professionals play in our healthcare system.”
HIP Week 2014 will coincide with AHIMA’s Hill Day, an event where AHIMA members visit Capitol Hill and share the importance of advancing HIM. Information governance, privacy and security, and fraud and abuse concerns continue to be key issues for HIM professionals, and AHIMA is ready to provide guidance to the healthcare industry and government leaders seeking counsel.
Precyse is proud to continue its support in this effort and in the progression of healthcare information services and technology as a Diamond Corporate Partner with the American Health Information Management Association (AHIMA), whose main mission is to advance the HIM profession through educational programs, research, and funding for grants and scholarships for the next generation of Health Information Management (HIM) leaders.
“Our participation in Health Information Professionals Week, underscores our commitment to ensuring a healthy organization to promote a healthy population,” said Pamela Goans, SVP and Chief Client Officer, Precyse. “Today more than ever, the role of technology in healthcare information is vital. By working together, Precyse’s people, processes and technology create solutions that drive healthcare actions that help providers capture, organize and better utilize their structured and unstructured data, improve financial performance, maintain regulatory compliance and ultimately deliver better patient care.”
“AHIMA’s vision is a world in which healthcare decisions are informed by instant access to intelligence,” said Thomas Gordon. “In this vision, data is a critical asset. This year’s theme, ‘Transforming Healthcare with Information,’ describes the future we want to see and reminds us that HIM professionals’ work is supporting quality of care and population health today.”
As the focus in healthcare shifts from the ability to collect data to using information effectively, healthcare organizations will continue to depend on HIM professionals as leaders in this area. With their expertise in management of information, as well as data integrity and analytics, health information professionals are well positioned to move the healthcare industry into a transformed future.
Classic Industries Establishes Third-Party Logistics Center in Juarez, Mexico
Latrobe, PA Mar 19, 2014 — Classic Industries, a full-service contract manufacturer of injection-molded components used in medical devices and regulated healthcare products, has opened a third-party logistics facility in Ciudad Juarez, MX, across the Rio Grande from its El Paso, TX plant. The company constructed the 125,000 square-foot facility to meet a Fortune 100 customer’s requirements for assembly, inventory management, kitting and packaging services.
“As customers have asked us increasingly to manage the components we manufacture for them, third-party logistics has become a growing segment of our business,” says Robert P. Subasic, Jr., Classic Industries’ CEO. “By complementing our superior design and manufacturing capabilities with efficient systems for organizing components and moving them to their destinations, we are adding value to customers’ businesses while creating new revenue streams for our company.”
To maximize the efficiency and cost-effectiveness of its operations, Classic Industries employs state-of-the-art equipment to assemble and package medical components. Its packaging services include sterile packaging (form, fill and seal), sterile pouching, bar code labeling and bulk packaging. In addition to inventory management, kitting, packaging and transportation, the company’s logistics capabilities include crossdocking, and customs management and compliance services.
ZirMed Partners with Precyse for Physician Office ICD-10 Education
Premier health information connectivity and management solutions company offers providers comprehensive ICD-10 training
Wayne, PA and Alpharetta, GA Mar 13, 2014 — Zirmed®, a leading health information connectivity and management solutions company, has partnered with Precyse/HealthStream to offer its clients a powerful and unique ICD-10 education program for the physician office/ambulatory market. Precyse and HealthStream have teamed together to offer a unique and comprehensive ICD-10 education solution that is delivered exclusively through HealthStream’s workforce development platform. ZirMed’s more than 195,000 providers at over 25,000 locations will be offered access to the following revolutionary benefits and features of the Precyse University Physician Office ICD-10 Education Solution:
• A single solution for all ICD-10 education needs within a practice or clinic;
• Diversified education providing each impacted population with the specific tools and training needed to be successful in ICD-10;
• Myriad of advanced courseware, applications and tools to make education more practical, accessible and relevant to physicians’ concerns, needs and time constraints; and
• Exclusive access to Precyse University’s expansive, one-of-a-kind ICD-10 education program.
“With the ICD-10 transition just months away, we’ve heard that many providers are still concerned about being prepared to make the switch,” said Betty Gomez, director of regulatory strategy, ZirMed. “Through our partnership with Precyse/HealthStream, our clients will receive a comprehensive solution for successful migration to ICD-10 in their coding and clinical care workflows while realizing the benefits of sustained reimbursement levels, improved outcome indicators and fewer claims denials.”
Precyse and HealthStream have partnered to offer a one-stop solution for all of the ICD-10 education needs within physician practices, clinics, and other ambulatory settings. With Precyse’s innovative ICD-10 education programs and HealthStream’s market leading platform for workforce development, healthcare providers have made the ICD-10 solution from Precyse and HealthStream the healthcare industry’s top choice.
“The Precyse University ICD-10 Physician Office Solution is built to fully prepare physicians and all members of their offices and/or clinics for the new world of ICD-10,” explains Thomas Ormondroyd, vice president and general manager of Precyse Learning Solutions. “Although ICD-10 seems daunting and burdensome, it actually offers tremendous opportunity to optimize reimbursement, minimize denials and appeals and improve clinical care through more valuable and detailed data. Our solution is designed to ease the change to ICD-10 and have physicians and their staffs ready for its arrival.”
Unlike its competitors, the Precyse University solution is fully built and tested with more than 200 courses, applications and tools specifically for physicians’ needs. In addition, most courses are mobile-ready for use on a computer, iPad® or mobile device to make education available anywhere and at any time. Innovative tools and resources such as video games, labs, simulators and animations are available as well.
Intralign, HSS Partner for Training
This article appears in the online journal Orthopedics This Week.
Mar 7, 2014
by Elizabeth Hofheinz, M.P.H., M.Ed.
Intralign, a specialty healthcare services provider, has announced it will partner with one of the world’s most respected orthopedic care providers, Hospital for Special Surgery (HSS), to develop a first-of-its-kind training curriculum for surgical first assistants (SFAs)—a clinical specialty comprised of surgeons, medical doctors, physician’s assistants and registered nurse first assists, that is in high demand to help provide better patient care. The educational program, operating as Intralign Academy, will teach the latest technologies and methodologies in orthopedic care, as well as best practices for increasing operational efficiency in the surgical suite.
“Surgical first assistants help surgeons focus on the highest-value care activities, which can ultimately increase surgical throughput. Despite their pivotal role in the OR, there are few continuing education opportunities for SFAs today in which the curriculum goes beyond clinical techniques to also train on best operational practices to address the changing realities of healthcare,” said Rick Ferreira, president and CEO of Intralign. “By leveraging real-world insights from the most sought-after experts in orthopedic care, we can enrich Intralign’s educational offering and provide the strongest possible competencies for SFAs in orthopedic and total joint replacement training. These skills will further enhance Intralign SFAs’ ability to deliver high-quality, consistent and professional assistance that allows a surgeon to do more with fewer resources.”
Intralign’s Intra-Operative Support service makes highly trained SFAs available to the hospital to function as a “surgeon extender,” a specially trained healthcare worker who performs tasks that might otherwise be performed by a surgeon. The advanced support SFAs provide help optimize the surgeon’s efficiency throughout the case, which reduces procedure time and enhances patient throughput.
As part of the current program, Intralign Academy offers clinical training in a variety of surgical specialties in addition to orthopedics, including surgical robotics. Professionals enrolled in Intralign Academy are educated on OR behavior, communication and optimal methods for creating OR efficiencies, in addition to clinical best practices, which equip them with the broadest perspectives to assist any surgeon in any environment.
Rick Ferreira told OTW, “Our curriculum development team will work with Hospital for Special Surgery leadership to identify new and evolving orthopedic surgery best practices to enhance the training that is already available for surgical first assistants through Intralign Academy,” said Ferreira. “This intelligence sharing will be an ongoing process to keep the training program grounded on the latest orthopedic care methodologies and surgical efficiency standards.”
Asked about how quality/success will be measured, Ferreira commented, “Success of our training program will ultimately be measured by increasing the number of healthcare facilities and providers that embrace the valuable role highly skilled surgeon extenders play in increasing surgical efficiency and bridging the pending surgeon shortage gap.”
Louis Shapiro, president and CEO of Hospital for Special Surgery, told OTW, “From a provider’s perspective, we believe the Intralign Academy will help elevate the level of clinical and operational support delivered to surgical teams to set new standards for surgical efficiency.”