P03 - JEFO - Amarillo redacted.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

The following is pursuant to the authority of 41 U.S.C. 4106(c)(2) as implemented in Federal Acquisition Regulation (FAR) 16.505(b)(2)(i)(B) – Only One Capable Awardee

1) Identification of the agency and the contracting activity.

This Justification for an Exception to the Fair Opportunity process is being conducted on behalf of the Amarillo, TX Veterans Affairs Medical Center (VAMC). The Delivery Order will be executed by the Department of Veterans Affairs National Acquisition Center (NAC), High Tech Medical Equipment (HTME) Post Award, PACS & Laundry Division.

2) Nature and/or description of the action being approved.

Authorization to use an Exception to the Fair Opportunity process as Change Healthcare Technologies, LLC is the only one capable awardee of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. A Delivery Order will be issued under the terms and conditions of the Defense Logistics Agency (DLA) awarded contract SPE2D1-18-D-0006 to Change Healthcare Technologies, LLC

3) A description of the supplies or services required to meet the agency’s needs, including the estimated value.

The Delivery Order is for the Change Healthcare Technologies Nuclear Medicine (NucMed) Cardiology Picture and Archiving and Communication System (CPACS) which will be integrated into the existing VISN 17 Radiology PACS. This purchase includes system hardware, software, and services.

The purchase includes the following:

HARDWARE

• Change Healthcare Cardiology virtual App server – Requires customer supplied VMware ESX 4.x or higher server and SAN storage environment (1)

• BARCO Single 2 MegaPixel Color 24 display – incl 3y Hot Swap (4)

• 700W/1000VA Tower UPS – APC (2)

• NA Card Support Tools Workstation (2)

• 104-key USB Keyboard with Integrated CAC Reader HP (2)

• Change Healthcare Cardiology Web Station – HP – without display – Defective Media Retention (2)

• Barco Display controller for auxilliary displays – for Cardiology with or without Segami – incl 5y Hot Swap (2)

• NetApp AFF C30 HA System with SSD – ONTAP One Include Encryption – 65TiB Usable – 10GbE Copper – Advanced Deployment Government – Advisor SupportEdge Government Protect (1)

• NetApp AFF C30 HA System with SSD – ONTAP One Include Encryption – 118TiB Usable – 10GbE Copper – Advanced Deployment Government – Advisor SupportEdge Government Protect

(1)

SOFTWARE

• Change Healthcare Cardiology Stress Reporting Data Import Software License – per connected system (1)

• Change Healthcare Cardiology Nuclear Medicine Reporting Software License – per system (1)

• Change Healthcare Cardiology DICOM Gateway from Nuclear Camera Software License – per connected device (2)

• Segami Oasis CD Burning Software License – First concurrent user (2)

SERVICES

• Report Import from external applications interface services – per system and report type – Requires peer system to provide reciprocal file export interface in standard Word, Textual or PDF format to a network CIFS location (1)

• Change Healthcare Cardiology ECGLink to MUSE or Tracemaster interface services – per GE MUSE or Epiphany ECG system – Requires appropriate 3rd Party vendor supplied MUSE/Epiphany Web Client API (1)

• Reporting Interfaces Essentials (1)

• Stress report and data import interface services – from GE Case – Configure clinical measurements and final report import from a GE CASE version 6.0 or higher Stress/Treadmill system (1)

• Change Healthcare Cardiology NM Report implementation services – Reference Statement of work (1)

• Clinical Pilot training services - when adding Stress to Cardilogy Nuclear Medicine Report – For existing Change Healthcare Cardiology Nuclear Medicine Report adding stress measurements and fields in version 13.x – 3.5 days onsite Walkthrough/Pilot week (1)

• CPACS Interfaces Essentials (1)

• Change Healthcare Cardiology hourly remote implementation services

– Services to be scheduled during business hours – See Proposal Notes for details (20)

• Remote DICOM connectivity services – per modality – Configure and test receiving images from a new DICOM modality connection – Includes configuring DICOM Modality Worklist query service for new modality, if applicable (2)

• VMware Integration Services – Web or Application server – Services to prepare Change Healthcare Cardiology server applications as virtual machine templates according to quotation (1)

• Remote implementation services – each server (1)

• Change Healthcare Cardiology CPACS System Administration Course training course – per attendee – Travel and relate living expenses are not included in the tuition fee (2)

• CPACS training onsite (2)

• Segami Single session training services – One centralized Segami training session for all users at a single location. Includes approximate onsite for Segami Oasis application training (1)

• Segami Oasis Launcher (App-Hook) (2)

• Imaging Data Integration & Migration – Cardiology Online depository to online depository data move – Total data greater than 6TB (1)

• Imaging Data Integration & Migration – Radiology Cache to cache data move. 400K < Total Exams < 600K – DICOM Images, Scan Documents, Voice Clips and Event logs moved from legacy cache to new cache (1)

The total value is $427,369.17.

4) An identification of the exception to fair opportunity (See, FAR 16.505(b)(2)) and the supporting rationale, including a demonstration that the proposed contractor’s unique qualification or the nature of the acquisition requires use of the exception cited. If the contracting officer uses the logical follow-on exception, the rationale shall describe why the relationship between the initial order and the follow-on is logical (e.g., in terms of scope, period of performance, or value).

FAR 16.505(b)(2)(i)(B) – Only one capable awardee can provide the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

The PACS, for which these items are to be procured, was obtained from Change Healthcare Technologies, LLC and installation by third-parties would invalidate the warranty provided.

Change Healthcare Technologies, LLC is the only vendor who can perform the software maintenance and support; enabling the system to continue meeting the software build specifications, per Change Healthcare Technologies, LLC’s PACS U.S.

Food and Drug Administration (FDA) clearance. In addition, Change Healthcare Technologies, LLC is the only vendor for which these items are currently awarded to their DLA Indefinite-Delivery Indefinite-Quantity (IDIQ) contract. As these systems must be procured through one of the DLA’s IDIQ contracts, this vendor is the only capable awardee to provide these specific items.

Change Healthcare Technologies, LLC cannot guarantee compatibility of their software for any substituted maintenance and support. The maintenance and support include remote diagnostics, maintenance of the PACS software where Change Healthcare Technologies, LLC is the only contractor authorized to remotely access the Change Healthcare Technologies, LLC servers and workstations on which the PACS software is installed. Change Healthcare Technologies, LLC trained personnel deploy all software updates and upgrades. Software revisions, testing and support are all maintained in accordance with FDA regulations to which Change Healthcare Technologies, LLC adheres. Only personnel trained by Change Healthcare Technologies, LLC to support and maintain the PACS software may perform maintenance and support. Additionally, Change Healthcare Technologies, LLC and its affiliates abroad are the only entities capable of owning trade information about the PACS software.

5) A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Defense Logistics Agency (DLA) has negotiated fair and reasonable prices and determined the prices awarded under contract SPE2D1-18-D-0006 to be fair and reasonable; thus, a separate determination of fair and reasonable pricing is not required. The Contracting Officer has conducted a price evaluation to ensure that the quoted prices are equal to or less than the contract price. By placing an order against SPE2D1-18-D-0006 it is to be concluded that the Delivery Order represents best value in meeting the Government’s needs.

6) Any other facts supporting the justification.

The Veterans Health Administration (VHA) directive 1104 provides policy for establishing and maintaining VISN PACS to support storage for the display and interpretation of radiologic images.

PACS are computer-based medical systems dedicated to storage, retrieval, distribution, and presentation of images. The medical images are stored in an independent format.

The most common format for image storage is DICOM. Analytic and functional software for respective imaging modalities may be available from PACS vendors at an additional cost.

PACS have been acquired and implemented in various configurations within VHA. It is beneficial to establish VISN wide PACS with a common interface standard to facilitate the care of patients referred amongst facilities within a VISN, efficiently utilize radiologists by means of cross-facility interpretation agreements, reduce the costs of equipment and maintenance contracts, ensure interface compatibility with VISTA, share technical equipment expertise within a VISN, and ensure continuity of service in the event of a disaster. PACS achieve VISN wide interoperability for diagnostic imaging interpretation.

It is VHA policy that every facility within each VISN utilize the same PACS. All patient information in PACS is archived in VISTA Imaging at the respective VA medical facility.

PACS and voice recognition systems must be integrated to facilitate efficient workflow and mitigate wrong patient selections with two independent systems.

It is critical for this CPACS product to be integrated with the existing Radiology PACS as the testing, application of procedures, and interpretation of results are conducted by the facility’s Radiology Service.

7) A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

Every requirement is unique and costs/benefit assessment for competition will be made on a case-by-case basis.

8) The Contracting Officer’s certification that the justification is accurate and complete to the best of the Contracting Officer’s knowledge and belief.

By signing this justification, the Contracting Officer hereby certifies that the justification is accurate and complete to the best of their knowledge. The technical information contained in the quote was reviewed and certified by the facility Biomedical Engineer.

9) Evidence that any supporting data that is the responsibility of the technical or Requirement’s personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

By signing this justification, the Contracting Officer hereby certifies that the justification is accurate and complete to the best of their knowledge.

10) A written determination by the approving official that one of the circumstances in FAR 16.505(b)(2)(i)(A) through (E) and (G) of the section applies to the order.

Based on the information contained herein, a determination has been made that this requirement meets the exception at FAR 16.505(b)(2)(i)(B) – Only one capable awardee can provide the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

CERTIFICATION AND APPROVALS:

TECHNICAL/REQUIREMENTS CERTIFICATION

Pursuant to FAR 16.505(b)(2)(ii)(B)(9), I certify that the justification is complete and accurate to the best of my knowledge and belief.

Farid Attaran

PACS Program Manager BESS VISN 17: VA Heart of Texas Health Care Network

CONTRACTING OFFICER CERTIFICATION

Pursuant to FAR 16.505(b)(2)(ii)(B)(8), I certify that the justification is complete and accurate to the best of my knowledge and belief.

Joseph Levy

Contract Specialist

HTME Post Award, PACS & Laundry Division