D--*Intent to Sole Source* Simplifi 797 Software

Coatesville VAMC has a requirement for installation and access to Simplifi 797/800, a web-based quality assurance tool to be utilized by pharmacy staff members. Simplifi will allow staff to conduct training to maintain accredited compliance with The U.S. Pharmacopeial Convention (USP) regulations 797 and 800. The Simplifi 797 software helps staff stay in compliance with IV compounding regulations 797 and 800 in dealing with hazardous drugs. In addition to offering unlimited access to 42 hours of Accreditation Council for Pharmacy Education (ACPE) continuing education credits, the software records: sterile compound temperatures, cleanings, maintenance and other required measurements for USP 797 and 800 compliance. The Simplifi software also has a policy creation tool, that allows users to create new procedures for staff t follow when there are changes to the 797 and 800 regulations. The Simplifi software is also regularly updated with policy flashes to allow users to adapt and create new procedures. Lastly, the Simplifi software covers and records information that OIG/JHACO look for in inspections and it will allow inspectors to have easy access to required data. This requirement will include a Base Period and four Option Years. This is a sole source requirement of Pharmacy OneSource, an entity/subsidiary of Wolters Kluwer. Pharmacy OneSource is a Large Business. A sole source letter has been provided and there are no other authorized sources for the Simplifi software. Simplifi is the only web-based tool that combines the service of recording USP 797/800 required data with the service of online, accredited, continuing education units.