-13143.pdf

Chapter VI: Other Than Full and Open Competition (OFOC) SOP Attachment 3: Request for Sole Source Justification Format >$150K

OFOC SOP Revision 05 Page 1 of 4 Original Date: 03/22/11 Revision 05 Date: 05/02/2016

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>$150K)

Acquisition Plan Action ID: 523-18-1-7821-0008

1. Contracting Activity: Department of Veterans Affairs, VISN 01, VA Boston Medical Center

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

The endoscopy service at the VA Jamaica Plain Medical Center currently uses disparate, outdated, systems for manometry evaluation and diagnosis. These systems lack the advanced measurement tools, graphical reports, and speed of the latest systems. In addition the existing systems cannot cross-communicate and require different workflows in different systems, delaying a complete diagnosis. The Medtronic Manoscan system will help bring multiple manometry solutions under one umbrella, and make the workflow much smoother in regards to capturing, storing, and analyzing data. The latest hardware and software will allow clinicians to capture and visualize information that they previously couldn’t under the limitations of the legacy systems, and will therefore ultimately help facilitate better patient outcomes.

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

The purpose of this contract is to outfit the endoscopy service at VA Jamaica Plain Medical Center with the latest state of the art manometry system and pH monitoring system. Clinical engineering has worked with the endoscopy service to evaluate the technology market and has determined that the Medtronic ManoScan high resolution manometry best meet’s the VA’s needs in delivering a complete manometry hardware and software solution. Specifically the ManoScan ESO & 3D ESO provides a complete physiological mapping of esophageal motor function, from the pharynx to the stomach, with a single placement of a catheter. This advanced diagnostic technology will allow VA endoscopy to better diagnose disease states such as dysphagia, achalasia, and hiatal hernia in our veteran population.

The software specifications for the manometry and pH monitoring solution are as follows:

• Diagnostic system for display of high-resolution physiological data of multiple properties”

• Visualization of values of a physical property detected in an organism over time

• Method of measuring and displaying the position of radio-graphically contrasted material within luminal body organs The hardware specifications are as follows:

• Catheters with suspended pressure sensing arrays

• Full cart-hardware solution with computer, monitor, keyboard-video-mouse, printer, power cables

• Software discs for all applicable software required

• Quantity of two for all manuals

• Calibration hardware

• All applicable probes

The services required are:

• Installation and configuration of hardware and software

• Validation testing of all hardware and software

• Clinical application training for end users

• Technical services training with clinical engineering

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• 2 year warranty on all hardware

• 2 year software revision warranty

• Manometry catheter extended warranty for 2 years

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

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

FAR13.5 Simplified Procedures for Certain Commercial Items:

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

As elaborated in the attached source manufacturer’s letter, Medtronic (formerly Covidien) is the only vendor that can meet the specifications of the high resolution manometry system and pH monitoring system required by the VA Boston endoscopy department. The manufacturer’s advanced software acquisition and analytics including technologies associated with visualization of values of a physical property detected in an organism over time and diagnostic system for display of high resolution physiological data are patented. In addition Medtronic offers the complete manometry an pH monitoring solutions in one cart, which would minimize the need for multiple disparate systems.

ManoScan acquisition software incorporates unique capabilities including anatomical model data visualization of the esophagus with real time pressure profiles of Upper Esophageal Sphincter (UES), Esophageal Body and Lower Esophageal Sphincter, (LES). ManoView™ analysis software provides the eSleeve™ tool to measure sphincter barrier pressure, as well as graphical pointers to locate LES, UES, and Pressure Inversion Point (PIP) quickly and reliably. ManoScan catheters utilize a proprietary tactile-array pressure sensing technology that is unique to the ManoScan system. These catheters are designed, manufactured, serviced and supported by Medtronic.

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

Market research was conducted to evaluate potential alternative solutions, however none were found that had comparable measurement tools and data analysis capabilities. This is likely due to the proprietary patents held by Medtronic. Clinical engineering and endoscopy believe that the ManoScan system represents the best solution for the VA and our veteran population.

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

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Contracting along with Clinical engineering believe that the anticipated cost to the government is to be fair and reasonable. This determination was made based on other computer hardware/software legacy systems and their costs.

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 to evaluate potential alternative solutions, however none were found that had comparable measurement tools and data analysis capabilities. This is likely due to the proprietary patents held by Medtronic. Clinical engineering and endoscopy believe that the ManoScan system represents the best solution for the VA and our veteran population.

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

Based on the unique technical hardware and software requirements of the VA, no other information is available at this time that would support an open competition for this type of a system.

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

Due to proprietary patents, Medtronic was the only vendor that met the VA’s requirements.

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:

Based on the unique technical hardware and software requirements of the VA, no other information is available at this time that would support an open competition for this type of a system.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona

Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

X Jaspreet Mankoo Supervisory Clinical Engineer

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

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

Joyce Goodale Date Contracting Officer NCO1- Manchester VAMC

Date: _______ http://vaww.pclo.infoshare.va.gov/PMWeb/Vol6Chapter6.aspx vhabhsmankoj Typewritten Text 1/31/18

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b. Director of Contracting /Designee (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Linda Ward Date NCO1 Director of Contracting or Designee

Manchester VAMC