Remote IV Compounding Validation

Transcription

1 Remote IV Compounding Validation

2 The correct preparation and administration of compounded sterile preparations (CSPs) is a complex process that must be conducted by highly skilled professionals in a specialized environment. Grifols is a global healthcare company with more than 75 years of experience and a record of maintaining the highest quality and safety standards in all of its manufacturing processes. Grifols is therefore uniquely qualified to help make compounding safer. Grifols i.v.tools is the set of products, technologies, processes, management tools, and related services designed to enhance quality, safety, and efficiency in compounding. i.v.tools products are designed to improve institutional compliance with guidelines and regulations. In addition, we provide customized services and consultation on all aspects of compounding, including environmental design and monitoring, operational analysis and workflow, process implementation, and regulatory compliance. Grifols high standards of quality and excellent service make a decisive contribution to minimizing the risks associated with sterile compounding.

3 Phocus Rx is a noninvasive IV workflow management system that provides a safe, reliable, and easy-to-use solution for remote validation and documentation of the compounding processes. Phocus Rx facilitates regulatory compliance by helping to ensure medications are correctly prepared, reducing the risk of contamination and occupational exposure, and maintaining a detailed database for drug traceability, retrospective review, and reports. As a result, workflow efficiencies are optimized while staff safety and product quality are enhanced.

4 Main benefits Reduced Environmental Risk Noninvasive system prevents risk of contamination in the direct compounding area no wires or devices are inside the ISO 5 area Adaptability to any type of hood, glove box, or open compounding environment. Embedded solution available Foot pedal and voice recognition available for hands-free operation Enhanced Patient Safety High resolution imaging with zoom-in capability provides clear details of names, numbers, labels, drugs, and syringes Lot traceability and expiration control Drug identification process ensures that the components used in the preparation are correct Improved Pharmacy Management Real-time tracking of compounded preparations Remote verification access from different platforms: PC, laptop, and tablet Image capture and management allows documentation of the compounding process for quality management and analysis Text messaging for pharmacist/pharmacy technician communication Integrates with pharmacy information system (PIS) via label print stream, label scanning, or HL7 interface Detailed documentation in searchable history and PDF reports Multi-facility configuration allows multiple sites on one server. Information and orders can be filtered by site Drug Identification Process Regulatory Compliance Reduces risks of contamination Enhances staff safety Provides photographic documentation of compounding procedures Maintains a detailed database for traceability, reviewing processes and information, and reporting

5 Workflow Compound Info PC Phocus Rx Database General Pharmacy OK OK OK Drug Identification Check Check Check Physical Inspection Compound Order Cleanroom Flexible configuration options allow the user to customize the number of in-process orders, perform drug identification processes, and enter lot numbers and expiration dates Adapts easily to existing workflows Customizations available at many levels: ingredients, users, workstations and facilities Delivery to Patient

6 Equipment Camera Articulated arm Medical grade touchscreen computer Workstation (Cleanroom) Medical grade fanless touchscreen computer running Phocus Rx client software Ultra-compact, high resolution camera installed inside fully cleanable enclosure on the hood or ceiling Articulated arm attached to ceiling or adjacent wall Pharmacy Optional label scanner for order entry without interface IT Department Virtual or dedicated server (contains the Phocus Rx server) Medical grade fully cleanable wireless 2D barcode reader and vial holder Optional hands-free accessories: Bluetooth headset and double foot pedal Pedal Barcode reader Headset Scanner

7 Software Phocus Rx Server (Pharmacist side) Phocus Rx Server provides pharmacy workflow management using a web-based software application, enabling the pharmacist to: Check the compounding status dashboard and the status of the orders received from the pharmacy information system Review full-detail, high resolution images with zoom-in capabilities and approve, reject, or send messages during each phase of the compounding process (dilution check, drug check, final check, and visual check) Check historical database Pharmacist administrator can configure system parameters (users, number of checks, drug database, etc) Main dashboard Phocus Rx Client (Technician side) From Phocus Rx Client, the technician can start different compounding orders at the same time, perform the drug identification process, and take and submit pictures for all orders as determined by the internal policy of the pharmacy. High resolution review Phocus Rx Client provides technicians with a dashboard screen from which to navigate from one compounding order to another and check the current status of the compounding orders in process. Image capture Instant message

8 Grifols sterile manufacturing expertise applied to the compounding pharmacy HN/HP/1216/0001 GRIFOLS USA, LLC 2410 Lillyvale Avenue Los Angeles, CA USA Tel. (34)