-17506.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For Other Than Full and Open Competition

Acquisition Plan Action ID: 36C249-19-AP-2237

1. Contracting Activity:

Department of Veterans Affairs, VISN 09, Memphis Medical Center [Facility], NCO-9, Purchase Requisition 614-19-4-560-0198.

2. Nature and/or Description of the Action Being Processed:

This will be a Firm-Fixed Price contract, for new upgraded and replacement of Bayer Healthcare’s Medrad brand-name equipment for magnetic resonance (MR) contrast media injectors for the Facility and purchase of software licenses for proper integration of a recently-purchased Medrad Stellant computed tomography (CT) dose injector to the Facility’s radiology department automation scheme.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

This requirement is for the following items peculiar to one manufacture- Bayer/Medrad:

• Two Medrad MRXperion MR Injectors including all software, connecting software licenses, accessories, manuals, and service support.

• One set of Software licenses for recently procured Medrad Stellant CT injector to ensure connectivity with VISN Radiametrics server and establish an automated workflow process between the CT injector, CT scanner, and operator in the CT room.

The estimated cost of this procurement is $156,671.76 with trade-in credit for the two Medrad Spectris Solaris EP MR Injectors currently used at the Facility. Replacement of the current devices helps the facility to progress from manual processes in the radiology department to a more efficient automated one. No options were considered.

The MEDRAD® MRXperion MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.

Bayer’s proprietary software, Certegra, digitally communicates and synchronizes injection timing processes with Medrad MRXperion MR or Stellant CT injectors, the MRI/CT Scanner, and the operator workstation(s). Both, Medrad’s MRXperion MR and Stellant CT injectors, use Bayer’s Contrast Dose Management (CDM) software to manage contrast media dosage and support management oversight of radiology CT and MR room practices and The Joint Commission standards.

4. Statutory Authority Permitting Other than Full and Open Competition:

41 USC §3304(a)(1), as implemented by FAR 6.302-1. Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

This procurement is a logical follow-on contract for continued development of automated processes VISN-wide for each Facility’s Radiological Department’s MRI and computed tomography (CT) rooms.

CT and MRI imaging devices are commonly known to be highly specialized pieces of medical equipment. These scanners use contrast media injectors to help develop clear images to facilitate the medical practitioner’s development of a proper patient diagnosis and treatment plan.

The current injectors in both CT and MRI rooms are Medrad products. The Medrad injectors support the CT and MRI scanners currently used at the Facility. The CT injectors and scanners, with the exception of one injector recently bought, are the only equipment currently integrated with the VISN’s Radimetric Servers, providing a fully-digitized process to the CT workflow area. The MR injectors and scanners are the next phase of digital synchronization and integration to support a fully automated CT & MR workflow solution. Both CT and MR scanners and injectors use proprietary Bayer software – Certegra, CDM, and Radimetrics. The foundation for the management of these digital processes into a simple single digital solution is already established and maintained by the Department of Veteran Affairs Integrated Service Network (VISN) associated with the Facility. The VISN’s digital solution uses McKesson picture archiving and communication system (PACS) software designed for use only with Radimetrics’ Dose Management program processed via dedicated Radimetrics Enterprise Software servers. All Facilities in the affected VISN are connected to the Radimetrics servers for compliance with Joint Commission standards that follow NHPP Radiology guidelines and Agency standardization policy.

If a different injector is purchased, then additional software will have to be implemented on the CT and MRI operator’s workstation, increasing the Facility’s risk of operator input error. Between 2013 and 2018, the facility spent $889,349.95 for a CT Scanner System that includes the Medrad Stellant CT injector; however, the system did not include the necessary software licenses for the device to interact with all systems in the Radiology department’s information technology infrastructure. The use of multiple software applications incurs duplication of costs in the form of money, equipment management, and personnel training. Additional dollars would be required to purchase another company’s dose management software along with a separate database server, licenses, etc. in order to remain within compliance. This would require the Facility to set aside valuable patient treatment time for medical staff and maintenance staff to be trained on the additional equipment. Finally, mixing different equipment brands and models in the CT and MR workflow process creates adverse risks to patient safety and medical staff with no positive benefit found for the Government.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Vetbiz/VIP search gave zero results. A Sources Sought Notice – 36C24919Q0358, was posted for seven days on FBO.gov.

An initial search of VA Federal Supply Schedule holders selling MR Injectors identified only one company – K-Art X-ray Supply Company [K-Art], a Woman-Owned Small Business (WOSB). K-Art was selling Bracco’s Empower MR Injector System. A further email to Bracco’s Technical support confirmed that the Empower MR Injector System is only compatible with Bracco’s NEXO platform.

7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable:

Price provided is fair and reasonable based on a comparison with a previous FPDS purchase over a year ago for nearly exact sought items and prices.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research was conducted in accordance with FAR Part I0 and VAAR part 810. These items are not available from mandatory sources.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

1st American Medical Supply Distributors, LLC – VIP-certified SDVOSB ASE Direct, Inc. – VIP-certified SDVOSB

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: None.

12. Approvals in accordance with the VHAPM, Volume 6, Chapter VI: OFOC SOP.

Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER