36C24625Q0692.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

POINT OF CONTACT*

Contract Specialist Monique Cordero monique.cordero@va.gov

PLACE OF PERFORMANCE

401 Moye Blvd

Greenville NC

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

**This is a SOURCES SOUGHT NOTICE for market research purposes and not for solicitation.** In accordance with FAR 15.201 (e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Additionally, the Government reserves the right to revise the Performance Work Statement (PWS) before the release of any associated solicitation. This notice is not a Request for Proposal (RFP) or Request for Quote (RFQ). Information provided in this notice is subject to change prior to release of a solicitation. You will find the PWS which describes the requirement market research is being conducted for. If based upon the market research information the Government deems a solicitation is necessary a solicitation action will be posted in Contract opportunities on www.SAM.gov.

Small business requirements for market research purposes, all responses to this notice will be reviewed, regardless of small business/socioeconomic category, including those firms that are identified as large business. Review of response to this notice will support later determination of set-aside requirements, if a solicitation becomes available, where the rule of two is met regarding a set-aside, including set-asides under 38 U.S.C. 8127 and 8128 for Service-Disabled Veteran Owned Small Businesses (SDVOSBs) and/or Veteran Owned Small Businesses (VOSBs) firms registered in the SBA Dynamic Small Business Search (SBA, DSBS) database; https://dsbs.sba.gov , in accordance with priorities set by regulation.

NAICS code for this requirement is 513210, Software Publishers. Interested companies can respond, via email to Monique.Cordero@va.gov with the following information; (a) company point of Contact, including name, title, phone number, and email address, (b) Company name, SAM UEI number, small business/socioeconomic status of company, and address of the applicable office, (c) any relevant certifications and/or licenses to perform these services, (d) capabilities statement, and any additional information may be requested by the Contracting officer at a later time. The Point of Contract is Monique Cordero, Contract Specialist, Network Contracting Office (NCO) 6, Veterans Health Administration U.S. Department of Veterans Affairs at Monique.Cordero@va.gov. Dur Dates for Responses: This notice closes Wednesday, June 11, 2025, at 4:00pm Eastern Standard Time (EST).

CONTRACTOR RESPONSIBILITY: A potential source for the purpose of this notice, is considered to be any company meeting the following requirements. Some of the below requirements may be modified prior to the release of any solicitation. The potential source is registered in the System for Awards Mangement (SAM) database at https://www.sm.gov . The potential source is registered with the Small Business Administration, Dynamic Small Business Search (SBA, DSBS) at https://dsbs.sba.gov . The potential source has favorable (satisfactory) past peformance information for federal contracts, if applicable, as documented in the Contractor Assessment Reporting System (CPARS) or Government databases, including the Federal Awardee Performance and Integrity Retrieval System (FAPIIS), and Past Performance information Retrieval System (PPIRS), where applicable.

Below is an example of the Performance Work Statement that the market research is being conducted for.

I. GENERAL REQUIREMENTS

The Department of Veterans Affairs, Veterans Health Administration (VHA), Greenville VA Medical Center has a need InVita Champion Medical Technologies UDI Tracker Plus License.

Requirement Information:

Based on the determination of the Government if this requirement should be solicited with a contract to be awarded, the contract will have a one-year base year contract, no an additional options to be exercised.

1. INTRODUCTION

The Department of Veterans Affairs, Veterans Health Administration (VHA), Greenville VA Medical Center located at 401 Moye Blvd., Greenville, NC. The Durham VAHCS is in need of a contract for the UDI Tracker Plus License which is a web-based tracking product that was specifically developed for healthcare organizations that handle tissue and implants. The UDI Tracker Plus license is needed to streamline processes and eliminates time spent preparing for an audit.

2. SCOPE

The Department of Veterans Affaris, Greenville VAMC requires the contractor to be a qualified InVita Healthcare Technologist who will remotely install UDI Tracker license needed for implementing tissue tracking. The Contractor shall perform the services below as set forth in this Performance Work Statement (PWS) in compliance with all applicable federal, state and local laws, rules, and regulations.

3. UDI TRAKER LICENSE

The contractor shall provide the UDI Tracker License for the Greenville VA Medical Center to use with the UDI Tracker Plus system and ensure that the license allows to track and manage tissue and implantable medical devices in the hospital and surgery centers. The UDI Tracker software license shall provide access to the VA healthcare facility to manage and track medical devices in compliance with regulations and best practices.

Description of Licensing & License Services The UDI Tracker system license shall provide access to the UDI Tracker system that allows for use of web-based tracking for all tissue and implants. The contractor shall ensure that the licensing allows access to tracking components, alerts and notifications, inventory management, item movement, case management, temperature logs, Ad Hoc Queries, reports, implant item master management, settings and extra, and recall connect.

License shall cover and provide the ability to conduct audits of implant and tissue inventory, provide a bi-directional tracking method that can track inventory from shipment to arrivals and document key information, manage recalls and regulatory compliance.

The License shall provide the following components;

1. Alerts & Notifications

2. Inventory Management

3. Item Movement 4.Case Management 5.Temperature Log

6. Exportable Ad Hoc Queries

7. Reports 8 .Implant Item Master Management

9. Settings & Extras

10. Recall Connect

Alerts and Notifications The License shall have an Alerts and Notifications Module where all the information of the other modules comes together in one clear and concise view. Alerts and notifications and alerts should be easily viewed and presented in the order of safety and compliance and allow for detailed viewing. Notifications should allow VA employees to be able to see any and all expiring inventory, pending transfers, shipments pending receipt, and expiring tissue supplier registrations.

The Alerts and Notifications module shall allow the healthcare organization to view the following:

a. Expiring Inventory

b. Recall Connect

c. Temperature Log

d. Adverse Events

e. Overdue Reserved Inventory

f. Overdue Issued Inventory

g. Transfers Pending Receipt

h. Shipments Pending Receipt

i. Expiring Tissue Supplier Registrations

Inventory Management The License shall provide an Inventory Management module that allows the healthcare organization to fully track and manage tissue and implant items upon receipt at the hospital and while being stored until clinical use. The Inventory Management module shall provide information such as the product code/description, lot number, serial number, expiration date, quantity, location, RFID tag and inventory type (Owned, Consigned or Brought-in/Bill-only) that can be easily accessed and managed.

The module shall provide accessibility for looking up received shipments, create inventory items, view current tissue & implant inventory, reserve inventory items for an upcoming case and manage part and re-order levels. Inventory Management module shall provide the following options:

a. Receive Shipments b .Shipments Receipt

c. .Inventory List d .Reserve Inventory

e. Manage Par and Re-order Levels

f. Add Items Direct to Inventory

Item Movement The UDI Tracker® Plus Item Movement module shall provide a platform to document the chain of custody for inventory, fulfilling Joint Commission’s regulatory handling requirements. The module shall allow the healthcare organization to transfer items between departments, view issued items and return inventory back to the supplier and document this activity. Within the Item Movement module, the following options shall be available;

a. Transfer Inventory

b. Internal Transfer

c. Transfer Requests

d. Supplier Returns

e. Issue / Issued Inventory

Case Management The Case Management module shall allow the healthcare organization to create and edit procedures/cases when inventory items are used. The module shall also allow the hospital to be able to document associated tissue preparation solutions and automatically return the tissue card to the supplier. Within the Case Management module, the following options shall be available:

a. Create Case

b. Completed Cases

c. Implant/Tissue Card - Auto Return

Temperature Log The Temperature Log module shall allow the hospital to add manual temperatures for equipment that house inventory or sync with RFID equipment to automatically log temperature ranges. These temperature ranges shall be customized from 4, 12, and 24 hrs.

Exportable Ad Hoc Queries The License shall have an Exportable Ad Hoc Queries option that allows employees to create and generate queries by Location, by Product Type, by RFID Tag ID, by Supplier, etc. These queries shall provide an option to downloaded into industry-standard formats (e.g., .axles, .pdf, etc.).

Reports The Reports module shall provide the ability to help with inventory management. Within the Reports module the healthcare organization shall be able to run and schedule the following reports:

a. Reconciliation

b. Consumed Items

c. Expired and Expiring Products

d. Implant Cards Sent

e. Inventory Level

f. Charge Capture

g. Inventory / Shipment

Implant Item Master Management The Implant Item Master Management module shall allow the healthcare organization to manage the implant items. This module shall include the ability to add items to their implant master, manage suppliers, staff, procedures, and locations. This module shall be able to pull information automatically and additional fields from the FDA (i.e., a supplier’s name and product description), further automating the process of adding products to the UDI Tracker system.

Settings & Extras The Settings & Extra module shall allow for client customization, view activity logs, and user management. This module shall all the healthcare organization to view adverse events and document issues received by both supplier, patient, and document down to the product level for regulatory compliance.

Recall Connect The License shall include the RecallConnect module which matches FDA reported recalls with the hospital’s inventory and items used in previous patient procedures for all implants.

4. QUALIFICATIONS

The Department of Veterans Affaris, Greenville VAMC requires the contractor to be a qualified InVita Healthcare Technologist who will remotely install UDI Tracker license needed for implementing tissue tracking. The Contractor shall perform the services below as set forth in this Performance Work Statement (PWS)in compliance with all applicable federal, state and local laws, rules, and regulations.

Sources Sought Notice