7A21--IDS (Investigational Drug System) Software

DISCLAIMER: THIS IS A SOURCE SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID.

This 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.

STATEMENT OF WORK:

Investigational Drug System (IDS); automation software to aid in the management of VAPSHCS s investigational drug service.

Vendor shall provide IDS, a secure, HIPAA and 21 CFR Part 11 compliant, web-based application that has the following features:

Monitors Receive, Transfer, Dispense, Return to Supplier, Destroy, and Adjustment transactions

Manages a comprehensive drug catalog, protocols, patients, suppliers, documents, and pharmacies

Generates accountability logs exportable to NCI DARF, NCI ORAL DRAF, ACTG, De-Identified and other format, significantly facilitating the audit process

Granular inventory tracking down to an individual Bottle, Vial, or Kit #

Patient-specific drug tracking

Double signature verification

Barcoded inventory labels

Physical inventory monitoring

Par level management

Pharmacy billing

Operates 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

Comprehensive coverage of all inventory transactions performed with investigational drugs

Simplifies preparation for monitor visits and audits

Ensures dispensing accuracy by tracking a patient s dispensing history, treatment arms, expiration, and patient-specific inventory

Print patient labels and record inventory deduction on logs in a single dispense transaction

Supports multi-site pharmacy systems and allows users to sign into specific dispensing locations

Minimize workflow errors with role-based access

HIPAA and 21 CFR Part 11 compliant (including audit trail logging)

IDS will be accessible to staff at the Seattle and American Lake Divisions of VAPSHCS.