VISN__JEFO_Agfa_DINPACs_redacted_Redacted.pdf

JUSTIFICATION FOR EXCEPTION TO FAIR OPPORTUNITY

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment Division, is the contracting activity.

2. This justification is for the purchase of DIN-PACS Maintenance Service and Support for the Radiology voice dictation system, including software and hardware, on a sole source basis, for the eight medical centers in the Veterans Integrated Service Network (VISN) 16. The period of performance is from December 1, 2016 through November 30, 2017.

3. The VISN has ongoing requirements for maintenance services for installed Agfa Healthcare (Agfa) TalkStation, a speech recognition, dictation and reporting system, which is part of the DIN-PACS systems currently in place. TalkStation annual maintenance is available from the Agfa DIN-PACS IV contract, SPE2D1-16-D-0013 valid through July 12, 2021. Maintenance services must be purchased for TalkStation after expiration of the first year of warranty on an annual basis as needed by the customer. The estimated total maximum dollar value of this acquisition is $188,000.

4. The authority waiving competition requirements is FAR 16.505(b)(2)(i)(b), only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. Agfa is the only vendor who is able to perform maintenance services on its Agfa TalkStation to ensure the installed systems’ performance is in accordance with the terms and conditions of the contract.

TalkStation systems include proprietary hardware and software. Proprietary clinical software that is used requires licenses. Only the manufacturer providing that software can provide licenses for the software. Upgrades to system software can only be provided by the manufacturer as these are FDA approved medical devices.

The manufacturer of the system is responsible for all system information security certifications, testing and on-going Information Assurance (IA) and security updates and patches or fixes. Accordingly, only the manufacturer of the system can maintain the critical security status of the system on an on-going basis under yearly maintenance programs. Since the system is a Food and Drug Administration (FDA) approved medical device, updates and patches must be thoroughly tested by the manufacturer prior to being applied to a medical system.

5. The Agfa DIN-PACS IV contract includes fixed prices for yearly maintenance service programs. These prices were determined fair and reasonable by the Contracting Officer at time of contract award based on the discount from their commercial pricing and sales to similarly situated commercial customers. Based on the above facts, the pricing of the maintenance service order to be issued under this contract represents the best value to the Government and will result in the lowest overall cost alternative to best meet the Government’s needs.

6. Market research has been conducted for DIN-PACS acquisitions from January 2010 through the present. It has revealed that no other DIN-PACS vendor is capable of performing maintenance service on Agfa TalkStation.

JUSTIFICATION FOR EXCEPTION TO FAIR OPPORTUNITY

7. There are no other facts supporting this justification.

8. DIN-PACS vendors have the opportunity to add products that fall within the scope of the DIN-PACS contract at any time; however, currently there are no other known DIN- PACS vendors that would be able to offer a maintenance, service and support program for an existing Agfa TalkStation system.

9. As the Contracting Officer, I hereby certify that this justification is accurate and complete to the best of my knowledge and belief.

DATE KATIE HUGHES

Contracting Officer FSDB

I hereby certify that the requirements which form the basis of this justification are accurate, that these supplies meet the Government’s needs in accordance with applicable specification and that this justification is accurate and complete to the best of my knowledge and belief.

DATE

Biomedical Engineer DLA Troop Support, FSDB

HUGHES.KATI

E.1284072096

Digitally signed by

HUGHES.KATIE.1284072096

Date: 2016.11.23 10:43:07 -05'00'