patient safety A commitment to GE Healthcare

Transcription

1 GE Healthcare A commitment to patient safety GE Healthcare is committed to providing radiopharmaceuticals that are compounded and dispensed accurately. Quality assurance and patient safety are the cornerstones of our radiopharmaceutical business. We encourage your department staff, Quality Assurance group, and Regulatory or Risk Management group to visit our pharmacy to observe our high standards. GE Healthcare operates radiopharmaceutical compounding pharmacies in 18 states. Each one provides injectable, compounded sterile products for thousands of patients daily. Our quality systems include monitoring personnel, techniques, equipment, and the environment, while focusing on continuous improvement through ongoing personnel training and development opportunities. We endorse aseptic control as a patient safety priority and a professional responsibility. Quality assurance checks are built into our processes. Products are compounded from FDA-approved components and receive a radiochemical purity check prior to final release.

2 Dedicated to medical discovery and innovation GE Healthcare collaborates with university medical departments and hospitals around the globe in the pursuit of new treatment options and the development of nuclear medicines and imaging agents in: Cardiology Neurology Infectious Disease Oncology Urology/Nephrology

3 Changing patient care with innovative FDA-approved products GE Healthcare is focused on helping patients live longer and healthier lives by enabling the physician to make confident medical decisions. Each nuclear pharmacy in our vast network offers you a comprehensive portfolio of radiopharmaceuticals. Gain access to FDA-approved products unique to GE Healthcare DaTscan (Ioflupane I-123 Injection) C II AdreView (Iobenguane I 123 Injection) Myoview (Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection) Ceretec (Kit for the Preparation of Technetium Tc99m Exametazime Injection) Indium-111 Oxine (Indium In 111 Oxyquinoline Solution) DMSA (Kit for the Preparation of Technetium Tc99m Succimer Injection) Metastron (Strontium-89 Chloride Injection) Indium DTPA (Indium In-111 Pentetate Disodium) Choose from a variety of other products: Thallous Chloride Indium (In-111) Chloride Sodium Iodide (I-123) Capsules With a robust portfolio of products, GE Healthcare Nuclear Pharmacies provide you with a single location for all your radiopharmaceutical needs. (Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection) 30mL

4 GE Healthcare at your service GE Healthcare radiopharmaceuticals are backed by an experienced and professional staff, committed to servicing the diverse needs of our customers Experienced nuclear pharmacists and radiation safety officers are available to answer questions and offer in-service training at customer sites Staff pharmacists are available 24 hours a day, 7 days a week Highly trained couriers and a modern fleet of customized delivery vehicles ensure safe transport of radioactive materials Our professional couriers are extensively trained to be in full compliance with all applicable DOT, NRC, and state regulations regarding the packaging, handling, and transportation of radioactive materials For efficient, safe, and timely delivery of radiopharmaceuticals, a Web-based system tracks product deliveries in real time Same-day delivery of most isotopes enables maximum customer flexibility in scheduling patients and procedures

5 GE Healthcare Nuclear Pharmacies Maintaining high standards, from compound to consumer Start to finish, GE Healthcare Nuclear Pharmacies routinely meet or exceed all industry standards for safety, cleanliness, and quality, including those set by the United States Pharmacopeia Chapter 797 (USP<797>) standards. GE Healthcare Nuclear Pharmacies follow a uniform model, which features state-of-the-art equipment and USP<797>-compliant aseptic clean rooms Strict, established aseptic control procedures A proprietary and comprehensive white blood cell labeling process A detailed tracking system with bar code scanning

6 Improving quality and reducing risk GE Healthcare Nuclear Pharmacies have earned The Joint Commission Gold Seal of Approval for accreditation by demonstrating compliance with the Commission s national standards for healthcare quality and safety. The accreditation award recognizes GE Healthcare s dedication to continuous compliance with The Joint Commission s state-of-the-art standards. GE Healthcare s national network of 31 nuclear pharmacies is accredited as part of The Joint Commission s Home Care Accreditation program. This accreditation places GE Healthcare s Nuclear Pharmacies among a select group of accredited organizations offering pharmacy compounding services.

7 All GE Healthcare Nuclear Pharmacies have an Aseptic Control Program that includes: Adherence to USP<797>, which provides comprehensive standards and procedures for facility and personnel in order to maintain an aseptic clean room environment Third-party monitoring to ensure compliance with established USP<797>-required particle and microbial testing Use of FDA-approved product ONLY for all compounded sterile products (CSP) dispensed In adhering to USP<797> standards, all GE Healthcare Nuclear Pharmacies have been engineered to meet the specifications of the ISO standard for clean room and controlled environments Each clean room in a GE Nuclear Pharmacy is equipped with the necessary features that help assure the quality of its products Clean room ante areas that are reserved for gowning and garbing by nuclear pharmacy personnel, each with a floor that is divided and color coded to provide visual demarcation between the outside environment and the buffer areas Clean room buffer rooms, which contain the primary engineering controls (PEC) and the laminar flow hoods (LFHs), where the actual compounding and dispensing activities take place Clean room direct compounding area with LFHs that pass previously filtered buffer room air through an additional set of HEPA filters Clean room temperature, humidity, pressure differentials, and airflow rates that are monitored daily to ensure the air system is functioning normally throughout the clean room, including the ante and buffer areas Clean room air handling system with HEPA filtration, that exchanges the room air 30 times per day to remove airborne particulates and maintain the appropriate ISO classification

8 Clean room Cart Pass-Through with Interlocked Doors Table Buffer Room PEC PEC Cart Pass-Through Observation Window with Interlocked Doors Mo99/Tc99m Generator Table Buffer Room Anteroom HEPA Pass-Through Anteroom Anteroom Line of Demarcation Gowning PEC Anteroom Observation Window Observation Window Observation Window Cart Pass-Through with Interlocked Doors

9 Dedicated to the future of nuclear medicine GE Healthcare provides ongoing educational support to help you maximize your performance. For more details regarding the following educational services, please contact your local GE Healthcare Sales Representative. EdGE Seminars Our informative seminars, focused on today s nuclear medicine, offer you the latest on imaging protocols and keep you up to date on important issues, such as operational efficiency or the approved applications for our products GE Healthcare-sponsored speakers and educational programs keep technologists and physicians informed of the latest medical developments GE Healthcare continues to be a powerful voice in both government and industry affairs as a supporter of the following organizations: The Society of Nuclear Medicine and Molecular Imaging (SNMMI), an international scientific and professional organization that promotes the science, technology, and practical application of nuclear medicine The American Society of Nuclear Cardiology (ASNC), a professional society that promotes nuclear cardiology services through education, leadership, and the establishment of standards and guidelines

10 Access the support you need Our business is about helping our customers help their patients. By partnering with GE Healthcare, healthcare providers gain access to several valuable resources: Reimbursement Hotline ( ) GE Healthcare employs a reimbursement team able to answer your reimbursement questions GE Healthcare Pharmacy ( ) Your local GE Healthcare Pharmacy Manager is a key resource, from answering your day-to-day tactical questions to helping create customized strategies for your facility Medical and Professional Services ( ) Our expert Medical and Professional Services department is available to answer all of your questions regarding GE Healthcare products Online Resource For all product information and the latest industry updates, please visit our website at:

11 About GE Healthcare GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement, and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems. Recognized for innovation and commitment to molecular imaging : National Safety Council s Occupational Excellence Achievement Award 2008: Frost & Sullivan Growth Excellence Award 2008: FDA approval of AdreView (Iobenguane I 123 Injection) 2011: FDA approval of DaTscan (Ioflupane I-123 Injection) C II 2013: FDA approval of AdreView (Iobenguane I 123 Injection) label expansion 2013: FDA approval of Vizamyl (Flutemetamol F18 Injection) 2013: The Joint Commission Gold Seal of Approval for all 31 GE Healthcare Nuclear Pharmacies Customer Service Reimbursement Hotline General Electric Company All rights reserved. GE, the GE Monogram, and imagination at work are trademarks of General Electric Company. All products are trademarks of General Electric Company or one of its subsidiaries. The Gold Seal of Approval is a registered trademark of The Joint Commission. February 2014 JB16084USc