SOW Sources Sought Software Tracking Solution 10-16-25.pdf

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 is seeking a 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.

Additionally, this solution shall include labor, materials, transportation, equipment, design, configuration, and training as detailed below, in compliance with federal, state, and local regulations.

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 (see attached SOW for full details of this requirement).

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 software solution shall interface with Cerner to be able to auto-populate the patient record in the electronic health record to include the implants specifics for compliance and tracing. This is needed to comply with the VHA policy as well as VHA Directive 1081.02 requires all biological and non-biological implants in a hospital to be tracked from manufacture to end user, as well as must be entered into the electronic health record for the patient.

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

http://www.newengland.va.gov/ http://www.newengland.va.gov/

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

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 12 months from the date of award with additional four 12-month option periods for a total of five years from the date of award. This BPA is to have firm fixed pricing per the price schedule in this solicitation. Please ensure pricing for the BPA is included in a responsive quote.

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).

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 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

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.

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 have cabinet, refrigerators, and freezer enclosures to be able to store implantables as needed.

Interface Requirements:

1. Solution shall integrate with Cerner 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 option years of support

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.

STATEMENT OF WORK: IMPLANT AND TISSUE SOFTWARE TRACKING SOLUTION