7A21--IDS (Investigational Drug System) Software

Description

{"description":" \n\n\nDISCLAIMER: THIS IS A SOURCE SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID.\nThis notice is not a solicitation as defined by FAR 2.101, therefore it shall not be construed as a commitment by the Government to enter into a contract, nor does it restrict the Government to an acquisition approach. All information contained in this RFI is preliminary as well as subject to modification and is in no way binding on the Government. Information submitted in response to this notice is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. The Government is requesting that restrictive or proprietary markings not be used in response to this notice. If a solicitation is released, it will be synopsized on the SAM.gov or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this RFI.\n\nSTATEMENT OF WORK: \nInvestigational Drug System (IDS); automation software to aid in the management of VAPSHCS s investigational drug service.\nVendor shall provide IDS, a secure, HIPAA and 21 CFR Part 11 compliant, web-based application that has the following features:\n\nMonitors Receive, Transfer, Dispense, Return to Supplier, Destroy, and Adjustment transactions\nManages a comprehensive drug catalog, protocols, patients, suppliers, documents, and pharmacies\nGenerates accountability logs exportable to NCI DARF, NCI ORAL DRAF, ACTG, De-Identified and other format, significantly facilitating the audit process\nGranular inventory tracking down to an individual Bottle, Vial, or Kit #\nPatient-specific drug tracking\nDouble signature verification\nBarcoded inventory labels\nPhysical inventory monitoring\nPar level management\nPharmacy billing\nOperates as a standalone system but has interfaces available to reduce data entry, including CTMS, EMR, and IRB systems for protocol, patient, and document management; inpatient or outpatient pharmacy systems for deducting inventory and logging dispenses; and carousels for inventory movement between locations\nComprehensive coverage of all inventory transactions performed with investigational drugs\nSimplifies preparation for monitor visits and audits\nEnsures dispensing accuracy by tracking a patient s dispensing history, treatment arms, expiration, and patient-specific inventory\nPrint patient labels and record inventory deduction on logs in a single dispense transaction\nSupports multi-site pharmacy systems and allows users to sign into specific dispensing locations\nMinimize workflow errors with role-based access\nHIPAA and 21 CFR Part 11 compliant (including audit trail logging)\n\nIDS will be accessible to staff at the Seattle and American Lake Divisions of VAPSHCS.\n\n\n"}