36C26119Q0373-004.doc

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C261-19-AP-1597

1. Contracting Activity: Department of Veterans Affairs, VISN 21 Network Contracting Office 21

3375 Koapaka Street, Suite F250

Honolulu, HI 96819

PR Number 612-19-1-271-0006

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The requirement is for a Champion Medical Technologies implant tracking system that tracks and effectively manages inventory of all types of implantable items/devices (biological and non-biological), as well as has the full capacity to extend to other tracked items e.g. hearing aids, dental implants, high cost items, critical need items, etc. The tracking system supports oversight of all devices across the VA Northern California Health Care System, which include Sacramento, Martinez, Mare Island, McClellan, and Redding VA sites. The estimated value is $130,187.00.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The system supplies access to a web based system to track devices from initiated request, use through to implant, delivery to patient and back (bi-directional) extending to warranty and supplier licensing/certification tracking. The tracking system integrates with Vista to automatically pass serial/lot numbers and expiration dates into appropriate Vista fields when an implant is used. All integrated features have retrievable supporting documentation with established analytics tools that drill by various fields and are exportable in various formats including, but not limited to, Excel & PDF. The implant tracking system includes all initial hardware (scanner & printer – full service for 5 locations), maintenance, licensing, unlimited storage capacity, and information retention for a minimum of 75 years from last date of entry, multi-level training. The system installation is for the most current version available.

Additional unique characteristics include:

· VA dedicated centralized remote server - Authorized by VA Central Office through national ISA/MOU

· Patient privacy & security - No patient names stored

· Tissue supplier certifications automatically updated, maintained & stored within program

· Tissue prep instructions automatically updated, maintained & stored within program

· Automated delivery of tissue implant record back to supplier

· Automatic recall matching for all tissue and non-tissue implants - Not reliant on 3rd-party recall notification provider (Notifications direct from the FDA)

· No on-site server at facility or VISN level

· Integration with VistA developed by DSS- including scanning of tissue/implants into patient record eliminating the need for nurses to manually enter data and automation of consult creation

· GS1/UDI barcode scanning ready - Label generation not required

· One-click entry of tissue shipments from LifeNet, Allosource, CTS, RTI, MTF, MiMedx directly into available inventory

· Ability to scan and parse out all UDI-certified bar code formats

· Integrated RFID storage with 24/7 remote monitoring - approved by VA Central Office through national ISA/MOU

· Data/Analytics for quick reconciliation including real-time cost per procedure per surgeon

· One scan check & certification of rep delivered inventory prior to use

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted in November 2018 via internet searches, VHA facilities surveys, software comparisons, and published pricing. Additional market research was conducted in February 2019 via internet searches and previous historical contract information. Market research of software comparisons and historical information showed that Champion Medical Technologies was the vendor capable of meeting all the requirements. Historical purchase order 36C24618P6362 was awarded on September 10, 2018 on a sole source basis to Champion Medical Technologies due to no responses to the sources sought. Additionally, historical contract VA262-16-P-0838 was also awarded to Champion Medical Technologies in August 2016 after it was determined that no other vendor could provide the supplies/services.

VHAPM Part 813.106

Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018