36C26023Q0725.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 20 (V4CONT) 1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

POINT OF CONTACT*

Contract Specialist Jeffrey Kelley jeffrey.kelley1@va.gov

PLACE OF PERFORMANCE

Puget Sound VA Healthcare Syatem

1660 South Columbian Way

Seattle Washington

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

DESCRIPTION

Sources Sought:

The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Small Business Manufacturers, and other Small Businesses interested and capable of providing items requested.

The intended contract is a Firm-Fixed price contract.

An SBA Non-Manufacturer Rule Waiver will not apply if this requirement is set-aside for small business. It does apply to all other socioeconomic small business categories.

The Department of Veterans Affairs, NCO20 is looking for an Investigational Drug System Software platform and installation in support of VA Puget Sound health Care system.

Salient Characteristics

This software must have the following features or requirements:

· Must be HIPAA and 21 CFR Part 11 compliant.

· Must have Records Receive, Transfer, Dispense, Return to Supplier, Destroy, and Adjustment transactions for investigational drugs.

· Must be able to generate investigational drug accountability logs exportable to NCI DARF, NCI ORAL DARF, ACTG, De-Identified and other formats

· Must provide granular inventory tracking down to an individual bottle, vial, or kit number.

· Must be able to supports patient-specific drug tracking.

· Must be able to provides physical inventory monitoring.

· Must be able operate as a standalone system (e.g., without electronic health record interface).

· Must provide support for at least 50 study protocols.

· Must allow for unlimited users, patients, and drugs.

· Must be able to allow for on-premises hosting (i.e., hosting on the local network rather than in the cloud).

Statement of Work

Investigational Drug System (IDS); automation software to aid in the management of VAPSHCS’s investigational drug service. Vendor will provide an Investigational Drug System Software platform (and install service), 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

· Minimizes workflow errors with role-based access

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

Investigational Drug System Software will be accessible to staff at the Seattle and American Lake Divisions of VAPSHCS.

Potential contractors shall provide, at a minimum, the following information to jeffrey.kelley1@va.gov:

1. Company name, address, and point of contact, phone number, e-mail address, and SAM UEI; whether services are presently offered on a current GSA Federal Supply Schedule contract.

2. Please identify your company’s size in comparison to the anticipated North American Industry Classification System (NAICS) code 339112 – SURGICAL AND MEDICAL INSTRUMENT MANUFACTURING. To be considered a small business your company must have size standard as fewer than 1,000 employees. This notice is to determine the marketplace for this specific requirement. Please check one of the following:

[ ] yes [ ] no Service-Disabled Veteran Owned Small Business (SDVOSB) [ ] yes [ ] no Veteran Owned Small Business (VOSB) [ ] yes [ ] no Small Business Manufacturers [ ] yes [ ] no All other Small Business (SB) [ ] yes [ ] no Other than Small Business

3. The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this Sources Sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). Any Offeror must complete their business Online Representations and Certifications Application in the System for Award Management (SAM) for consideration.

4. Any Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetCert Registry located at SBA.gov

5. Only authorized representatives/providers of the manufacturer will be considered. Equipment must be new, no used or refurbished equipment accepted. Please provide a proof of authorized dealer or reseller letter from manufacturer.

6. This is a “brand name or equal” requirement. As such, the salient characteristics reflect the physical, functional, or performance characteristics that “equal” products must meet to satisfy the Government’s needs. To be considered for any potential solicitation, offers of “equal” products, including “equal” products of the brand name manufacturer, must:

(a) Meet the salient physical, functional, or performance characteristic specified in this Sources Sought; clearly identify the item by Brand name, if any and make/model number.

(b) Include descriptive literature such as illustrations, drawings, or a clear reference to descriptive data or information available that identifies that the “equal” item meets or exceeds the salient characteristics required by the Government.

7. No gray market or remanufactured items will be acceptable. Vendor shall be an Original Equipment Manufacturer (OEM), authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM.

Responses are due by 06/20/2023 4:30 PM PST, to the Point of Contact.

Point of Contact:

Contract Specialist

Jeffrey Kelley jeffrey.kelley1@va.gov

Sources Sought Notice