Revised Sources Sought - Implant Tracking Solutions 1-9-26.pdf

REVISED SOURCES SOUGHT 36C24126Q0029

1/9/2026

REVISIONS ARE IN BOLD TEXT. THIS IS NOT A REQUEST FOR PROPOSAL; THEREFORE, PLEASE DO NOT SUBMIT ANY PRICING INFORMATION AT THIS TIME. THE GOVERNMENT WILL NOT PAY ANY COSTS FOR

RESPONSES SUBMITTED TO THIS SOURCES SOUGHT NOTICE.

PROCUREMENT TITLE: SOFTWARE TRACKING SOLUTION FOR IMPLANT AND TISSUE BIOLOGICAL AND NON-

BIOLOGICAL ITEMS

SOURCES SOUGHT PURPOSE: The purpose of this REVISED SOURCES SOUGHT NOTICE is for market research purposes, to clarify salient characteristics for this upcoming Procurement, as described in the enclosed Revised Statement of Work.

WORK AND DELIVERY LOCATION:

The Department of Veterans Affairs, VA North Eastern Consortia (VANEC), VISNS 1, 2, 4, and 5 have a requirement for a Firm Fixed Price (FFP) Blanket Purchase Agreement (BPA) for a Total SaaS Solution comprised of a SaaS for Implant and Tissue Tracking Services, hardware and software described in the enclosed revised Statement of Work (SOW), and the Line Item List.

The existing Total SaaS Solution is currently being performed by the incumbent Contractor - LPIT Solutions Inc., under BPA Number 36C24121A0054, using their TrackCore SaaS Solution. The current BPA expires on August 31, 2026.

PERIOD OF PERFORMANCE: It is anticipated that the new BPA will consist of a Five Year Period of Performance, starting on September 1, 2026.

DESCRIPTION OF WORK:

The VANEC requires a web-based software solution to efficiently and accurately track and manage chain of custody for all biological and non-biological implantable items (also referred to as tissue and implants tracking and monitoring). This software solution must be a “Total Solution” from the same Contractor. The software solution must interface with the Cerner (Oracle) platform.

This Total SaaS Solution includes software, hardware and supplies, licensing, monitoring, training for tracking and managing inventory, reordering hardware and/or supplies at appropriate times and monitoring usage of products. However, refer to the enclosed SOW for full details of this requirement, and the attached current list for Line Items.

NAICS: The anticipated NAICS code for this Procurement will be: 513210 – Software. Size Standard $47M.

PRODUCT SERVICE CODE: DA10, IT and Telecom - Business Application/Application Development Software as a Service

RESPONSE TO SOURCES SOUGHT: The VA is requesting written Capability Statement (No Pricing) from interested Sources capable of fulfilling requirements described in the attached SOW, and Line Items.

WRITTEN CAPABILITY STATEMENT: If your company is interested in this requirement, please submit a brief written Capability Statement 2-5 pages, and include the following information in your written statement:

A. Submit a brief written capability statement confirming that your company can meet Software and hardware requirements in SOW. etc.

B. For all hardware and supplies, identify Country or Origin where items were manufactured (e.g., US, or another Country).

C. Submit OEM authorization letter, sole source letters and/or partnership agreement that authorizes your company to perform work in the SOW, including hardware and supplies.

D. Provide delivery lead time, in weeks, months, or calendar days.

E. Provide warranty information.

F. Identify if solution is provided are under FSS, NAC, BPA, etc.

G. Include your Company’s full Legal Name, Address, email for primary Point of Contact, Business type/size, and SAM.gov UEI number.

H. If your Company believes that another NAICS code besides 513210 is more suitable, please include the alternate NAICS code within your Company’s written response.

I. Interested Parties must be registered in the System for Award Management (SAM) by time of award, accessible at https://www.sam.gov/content/home

J. SDVOSB and VOSB firms must be certified by the center for Veteran Enterprise (CVE), accessible at https://veterans.certify.sba.gov/#search

DUE DATE FOR WRITTEN STATEMENTS: Please submit your Company’s written Capability Statement to the Contract Specialist and by the date shown below:

Submit Written Statements by: 1/19/2026, by 16:30 EST

Submit via email to: Pearl Wray, Contract Specialist at pearl.wray@va.gov.

REVISED STATEMENT OF WORK

IMPLANT AND TISSUE SOFTWARE TRACKING SOLUTION

BACKGROUND AND GENERAL DESCRIPTION:

VA North Eastern Consortia (VANEC) including VISN 1, 2 ,4, and 5 are seeking a total software solution to efficiently and accurately track all biological and non-biological implantable items. This will include all software, licensing, training, hardware peripheral devices and supplies used to manage the par levels of inventory, reorder at appropriate times and monitor usage of products.

The software solution also includes a hardware and supplies solution, all hardware and supplies must be compatible with the software solution (see SOW for required hardware and supplies).

Additionally, this solution shall include labor, materials, transportation, equipment, design, https://www.sam.gov/content/home https://veterans.certify.sba.gov/#search mailto:pearl.wray@va.gov configuration, and training as detailed below, in compliance with federal, state, and local regulations.

The software solution shall interface with Cerner (Oracle) platform in order to auto-populate the patient record in the electronic health record to include the implants specifics for compliance and tracing. Cerner interface must be read to launch at time of BPA award. The solution must comply with the VHA policy as well as VHA Directive 1081.02 which requires all biological and non-biological implants in a VA hospital to be tracked from manufacture to end user, as well as must be entered into the electronic health record for the patient.

The tracking solution and accompanying RFID devices shall be used to monitor implants and tissue specimens. Solution must include all software, licensing, training, hardware peripheral devices and supplies necessary to manage inventory control tracking, reordering, and monitoring product usage. The solution shall meet all FDA guidelines, regulations, and laws. The certification and accreditation (C&A) requirements do not apply, and a Security Accreditation package is not required.

The scope of this requirement includes all facilities within the VANEC including VISN 1, 2, 4, and 5 as outlined below, as well as any respective Community Based Outpatient Centers (CBOCs) associated with the main medical centers. The scope of this requirement includes all 11 VISN 1 Facilities as outlined below as well as any respective Community Based Outpatient Centers (CBOCs) associated with the main medical centers.

Veterans Health Administration: VISN 1: VA New England Healthcare System

Station ID Facility Address State Phone

VISN

10N1 VISN 1: VA New England

Healthcare System

200 Springs Rd, Bldg. 61 Bedford, MA 01730

MA 781-687-4821

Veterans Health Administration: VISN 2:

Station # Facility Address State Phone# 10N2 VISN 2: New York/New Jersey VA

Health Care Network

130 W. Kingsbridge Road, Building 16 Bronx, NY 10468

NY 718-741-

Mailing Address: 130 W. Kingsbridge Road, Building 16 Bronx, NY 10468

Veterans Health Administration: VISN Offices StationID Facility Address State Phone

VISN

10N4 VISN 4: VA Healthcare -

VISN 4

1010 Delafield Road Pittsburgh, PA 15215

PA 412-822-3316

http://www.newengland.va.gov/ http://www.newengland.va.gov/ http://www.visn2.va.gov/ http://www.visn2.va.gov/ https://vaww.va.gov/directory/guide/facility.asp?id=1004&r=1 https://vaww.va.gov/directory/guide/facility.asp?id=1004&r=1

Veterans Health Administration: VISN Offices StationID Facility Address State Phone

VISN

10N5 VISN 5: VA Capitol Health

Care Network

849 International Drive, Suite 275 Linthicum, MD 21090

MD 410-691-1131

Veterans Health Administration: VISN 5: VA Healthcare-VISN 5 StationID Facility Address State Phone 512 VA Maryland Health Care

System

10 North Greene Street Baltimore, MD 21201

MD 410-605-7000

Period of Performance:

The intent of the Government is to establish a Blanket Purchase Agreement (BPA) with a period of performance of five (5) years from the date of award.

Contractor and Solution Requirements:

Application Requirements

The contractor shall provide a solution for tracking all implants and supply items tracked within the system, which will provide, at a minimum, tracking from the point of receipt by a Veterans Affairs (VA) facility through patient use. The solution shall have a complete chain of custody for every item entered into the system, with a unique identifier for every entry. The Contractor shall ensure that manufacturer, manufacturer item number, expiration date, and lot number for each item is tracked and traceable.

1. Solution shall use both a unique item identifier and a unique patient identifier that does not compromise

Protected Health Information (PHI) or Personally Identifiable Information (PII).

2. Solution shall include a perpetual license with the ability to install the software application on unlimited VA provided workstations

3. Solution shall read inputs from manufacturer barcodes.

4. Solution shall distinguish between VA owned and consigned items.

5. Solution shall provide for customizable views, which shall include individual clinician tracking needs through enterprise-wide visibility at the VISN level. Customization options will include the ability to assign individual users the ability to view, log out, and track items located only in specific areas of the hospital.

6. Solution shall provide real time inventory tracking of all implants and designated supply items to include “on the shelf”, “missing”, “implanted”, “wasted without patient contact”, “wasted with patient contact”, “explanted”, and “transferred”.

7. Solution shall provide a portal for access to supplier regulatory status information for all implants tracked, as well as Joint Commission and regulatory requirements information as they relate to implant and clinical supply tracking.

8. Solution shall upload and store documents in formats that are easily retrievable. Documents to be stored are manufacturer/regulatory storage requirements, tissue preparation instructions, and other critical instructions.

9. Solution shall include a master vendor list for all implants and supply items tracked.

10. Solution shall include bi-directional communication with the National Recall Alert Center (NRAC).

11. Solution shall allow for Active Directory access to the software.

12. Solution shall provide references of installation in use.

https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.va.gov%2Fvisn5&data=05%7C02%7C%7C5e8f22b6467745ee47e208dd66e42c4a%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638779852370657458%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=haWNlRFzIlZpX28mXreTE0F0D2syWfA3I6WFtb9id5o%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.va.gov%2Fvisn5&data=05%7C02%7C%7C5e8f22b6467745ee47e208dd66e42c4a%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638779852370657458%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=haWNlRFzIlZpX28mXreTE0F0D2syWfA3I6WFtb9id5o%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.maryland.va.gov%2F&data=05%7C02%7C%7C5e8f22b6467745ee47e208dd66e42c4a%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638779852370679795%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ciWR7zGeOSX%2FoFYaLm8ERil4Dnw5XBgF1IGNVIQWDBg%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.maryland.va.gov%2F&data=05%7C02%7C%7C5e8f22b6467745ee47e208dd66e42c4a%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638779852370679795%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ciWR7zGeOSX%2FoFYaLm8ERil4Dnw5XBgF1IGNVIQWDBg%3D&reserved=0

13. Solution shall be able to use 1D and 2D custom bar code label capabilities. This barcode system is inherent to the system and no separate barcode system is needed.

14. Security Requirements: The Contractor shall follow all Government rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations, and shall adhere to all VA Privacy & Security, the Privacy Act and HIPAA requirements when obtaining and reviewing information.

Reports Requirements

1. Solution shall have a reporting tool that allows for integration of external reporting tools.

2. Solution shall provide commonly used “canned” reports, as well as allow for customizable reports and provide fully open data access to VA users.

3. Solution shall include a report generator to document at minimum:

a) Change of custody occurrences

b) Receiving reports

c) Joint Commission’s tracer methodology information

Hardware Requirements

1. Solution shall include RDIF enclosures, cabinet, refrigerators, and freezer enclosures to be able to store implantable as needed.

Interface Requirements:

1. Solution shall integrate with Cerner (Oracle) platform as the future Electronic Health Record scoped for all

VHA

Training Requirements:

1. Contractor will provide technical training to ensure Biomed staff at each facility can service and support the equipment for first pass as trained service technicians. This includes providing any user and technical manuals as available.

2. The Contractor shall provide Training Material and Schedules for each training event and complete those events in accordance with the approved Facility Training Plan. The Contractor shall submit a Training Plan for each VISN 1 Facility for review and approval by the COR. The Training Plan shall include, at a minimum:

a. Training locations, training dates, and training times

b. Format, method and / or delivery of training (e.g. onsite, web based)

c. Training audience (e.g. technical repair, system user, system administrator)

d. Instructor profile and content information

3. Certified instructors must provide user training for staff on day, evening, and night shifts at times to be determined by each facility.

a. Day shift (0730-1600)

b. Evening Shift (1530-MN)

c. Night Shift (2330-0800)

4. Training needs to be flexible based on day, evening, night, and weekend shifts. All times will be determined by each facility.

5. Go-live

a. Applications training for system users be provided onsite during go-live support for user interface, application, and its features.

b. The vendor shall include at minimum two trainers.

c. Training shall provide super-users and end-users with the capability of being self-sufficient in operating the system by the end of the training session

6. On-going

a. Phone and email support for warranty period and during life of POP, Configuration Requirements:

1. Including Project Management

2. Software/site Configuration Support

3. Server Configuration Support

Government Responsibilities:

1. Each VA Site is responsible for inventorying materials prior to acceptance of order

2. Each VA Site shall identify and provide limited daily storage of vendor parts/supplies at the time of delivery and reject items that do not conform to this requirement.

END OF REVISED NOTICE AND SOW