36L79726F0006 - Temple -- CPACS Upgrade Delivery Order -- JEFO Redaction.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 Temple 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 Philips Healthcare Informatics, Inc. 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 SPE2D1-19-D-0036 to Philips Healthcare Informatics, Inc.

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 Philips IntelliSpace CardioVascular (ISCV) Cardiology Picture and Archiving and Communication System (CPACS) which will replace the existing ISCV which has reached end of life and operates in conjunction with the Philips Interventional Cardiology Workspace (Xper). This purchase includes system hardware, software, and services.

The purchase includes the following:

HARDWARE

• HP Workstation (17)

• Barco 22" Clinical Display (17)

• Barco 24" Clinical Display (5)

• HP NAS 32TB (4)

SOFTWARE

• Upgr. Xc/ISCV non-ASU Customer (1)

• IntelliSpace CV 3.X (1)

• Upgrade ISCV to ISCV 6 (1)

• Upg Production CU to ISCV 4 (16)

• Existing Vascular US Module (1)

• IntelliBridge Enterprise (1)

• Exist. CV Solutions Conn Lic (1)

• Extend current IBE for ISCV (1)

• IBE to IBE Upgrade(1)

• ISCV 6.0 (1)

SERVICES

• OnSite Training Professional Services (24)

• Remote Training Professional Services (62)

• OnSite Implementation Professional Svs (176)

• Remote Implementation Professional Svs (468)

• ISCV Weekend Upgrade (1)

• ISCV Web Reporting PS Hours (1)

The total value is $350,089.20.

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 CPACS, for which these items are to be procured, was obtained from Philips Healthcare Informatics, Inc. and installation by third-parties would invalidate the warranty provided.

Philips Healthcare Informatics, Inc. is the only vendor who can perform the software maintenance and support; enabling the system to continue meeting the software build specifications, per Philips Healthcare Informatics, Inc.’s CPACS U.S. Food and Drug Administration (FDA) clearance. In addition, Philips Healthcare Informatics, Inc. 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.

Philips Healthcare Informatics, Inc. 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 Philips Healthcare Informatics, Inc. is the only contractor authorized to remotely access the Philips Healthcare Informatics, Inc. servers and workstations on which the PACS software is installed. Philips Healthcare Informatics, Inc. trained personnel deploy all software updates and upgrades. Software revisions, testing and support are all maintained in accordance with FDA regulations to which Philips Healthcare Informatics, Inc. adheres.

Only personnel trained by Philips Healthcare Informatics, Inc. to support and maintain the CPACS software may perform maintenance and support. Additionally, Philips Healthcare Informatics, Inc. and its affiliates abroad are the only entities capable of owning trade information about the CPACS 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 SPE2D1-19-D-0036 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 SPE2D1-19-D-0036 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.

CPACS 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 CPACS vendors at an additional cost.

The Healthcare Technology Management (HTM) Service has emphasized that if ISCV becomes unavailable, providers would be restricted to viewing images only within the procedure control room. Images stored on the Philips Xper system remain accessible for approximately 30 days; after that, they are permanently deleted. Without ISCV functionality, these images cannot be accessed from clinician workstations, reviewed for follow-up, or transferred to the Community Care Network (CCN). This interruption creates a “hard stop” in workflow, preventing providers from comparing current and historical studies and delaying patient care decisions.

ISCV has been experiencing intermittent connectivity issues with the central server.

These disruptions result in delayed access to patient cardiac imaging studies, incomplete data retrieval, and occasional loss of system functionality during critical workflows.

Despite multiple troubleshooting efforts and temporary network adjustments, the issue persists and continues to recur unpredictably.

ISCV operates in conjunction with the Philips Xper system, which is currently being upgraded. Currently, ISCV is operating on an unsupported version and its close integration with Xper means that the ongoing Xper updates will create incompatibility issues. This integration risk increases the likelihood of data transmission failures, loss of archived images, and workflow interruptions. Synchronizing the ISCV upgrade with the Xper upgrade ensures uninterrupted interoperability.

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