-17011.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 08 Page 1 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:__36C252-19-AP-1395___

1. Contracting Activity:

Department of Veterans Affairs Great Lakes Acquisition Center, NCO-12 115 South 84th Street, Suite 101 Milwaukee, WI 53214-1476

Department of Veterans Affairs William S. Middleton Memorial Veterans Hospital 2500 Overlook Terrace, Madison, WI 53705

Identify purchase request number: 607-19-2-969-0051

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

The William S. Middleton VA Medical Center is requesting a new, initial, brand-name only procurement of a treatment planning system. This one-time, commercial procurement is in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6.

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

This procurement is for a treatment planning system, and is intended to be used in the Cancer Treatment Center at the Madison VA hospital. This equipment will be used in the process of developing patient specific radiation therapy-based treatment plans for oncology patients. This system will directly communicate with a new Linear Accelerator system and corresponding Oncology Information system (OIS), and a new CT Simulator imaging system. Installation and testing is required. This procurement is a key support piece to provide Radiation Oncology treatment options to the patients.

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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: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

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

The RayStation Treatment Planning System from RaySearch Americas, Inc. is the only brand capable of meeting the minimum needs of the facility. The RayStation Treatment Planning System is the primary treatment planning system (TPS) in use by the Madison VA’s key clinical partner, the UW Hospital and Clinics Human Medical Physics and Radiation Oncology Staff. The UW Madison Hospital and the Madison VA Hospital have a long-standing agreement of sharing products when possible. Experience and overall familiarity with the RayStation TPS provides a key level of confidence in the system daily clinical operation and quality assurance procedures. Because of the complicated nature of running the Cancer Treatment Center, there will be some anticipated down time for planned and unplanned maintenance events. During these times of machine down days, it creates a tremendous stress and anxiety for patients and staff. Having the same system and technology as our key clinical partners at the UW hospital greatly eliminates this risk with the ability to export treatment plan data from the VAMC to UW Hospital for continuity of care.

During the market research phase, the medical physician staff reviewed a number of integrated and third party treatment planning systems. The choices were narrowed down to the top three leading treatment planning systems (TPS) available on the market: the Varian Eclipse TPS, the Elekta Monaco TPS, and the RayStation TPS. There were several key features of the RayStation TPS that surpassed the capabilities of the other two Treatment Planning Systems.

The RayStation TPS offers a feature called License Migration, which allows the site to migrate their application licenses to various servers and client-side workstations as workflow changes in the future. This drastically reduces the cost of ownership to make changes to the system deployment model in the future. Both the Varian Eclipse TPS and the Elekta Monaco TPS do not offer the feature of license migration. Application licenses from Varian and Elekta are locked down to the servers of clients on which they are initially installed. Future changes would require the purchase of additional licenses at significant costs. Having additional license requirements would also increase the future cost of software and application upgrades.

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The RayStation TPS offers a feature called Multi Criteria Optimization, which allows the planner or physician to manipulate the treatment plan with simple sliders and visualize the changes in near real-time for selecting the best clinical trade-off. In other vendor TPS applications, the calculations and visualizations for these types of “what if we did x” changes take tens-of-minutes in time versus the near real-time visualizations with the RayStation TPS. The Varian Eclipse TPS and the Elekta Monaco TPS do not offer comparable features to the RayStation Multi Criteria Optimization. The work-around to this situation for both the Varian TPS and Elekta TPS is for the Dosimetry and Medical Physics staff to perform multiple iterations of simulation runs that take about 10 minutes per iteration to calculate. Per our Medical Physics contractor, the net result would likely be a general acceptance of the initial Patient Treatment Plan as “good enough”, which may result in more collateral tissue to be unnecessarily affected by the radiation therapy treatment.

The RayStation TPS offers a feature called Open Scripting Language, which provides access to their open scripting language for no additional cost. This would allow the Madison VAMC to characterize their systems for medical physicists using the QA scripts in place at their medical partner UW Madison Human Oncology department. The UW Madison hospital is using the same equipment and software packages, and the scripts which have already been developed by the partner would now be accessible to the Madison VAMC. This drastically reduces the time needed to establish the Radiation Oncology program as all the settings and protocols would not need to be established and input from scratch. Scripts are portable from site-to-site. The competitor products Varian TPS Eclipse and Elekta TPS Monaco do not offer access to this capability.

The RayStation TPS offers a feature called Machine Learning, which generates contours of organs in less than forty-five seconds. This short-time calculation is unheard of by other vendors. The Varian Eclipse TPS and the Elekta Monaco TPS do not offer this feature.

The last special feature that the RayStation TPS offers is operability, as it is compatible with all the major manufacturers for Linear Accelerator systems, including both Varian and Elekta. The Varian Eclipse TPS is only compatible with the Varian family of products, and the Elekta Monaco TPS is only compatible with the Elekta family of products.

Finally, the use of an independent vendor’s treatment planning system provides a level of investment protection from vendor development and planned replacement cycles. RaySearch Americas, Inc. does not produce or market any radiation therapy delivery systems or CT imaging systems. The RayStation TPS is capable of integration with nearly all commercial products for radiation therapy and CT imaging systems, now and in the future. So, in the future, if the Madison VA hospital chooses to install a PET/CT or Proton Therapy System from a different vendor than the current linear accelerator(s), it will not require a completely new system for Treatment Planning.

Because of the aforementioned reasons, the RayStation Treatment Planning System from RaySearch Americas, Inc. is found to be the only source to meet the needs of the requirement.

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Revision 08 Date: 04/18/2018

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

The RayStation by RaySearch Americas, Inc. is determined to be the only brand that meets the needs of the facility.

On March 5th, 2019 the contracting officer emailed the manufacturer RaySearch Americas, Inc., a large business, and requested a list of authorized distributors for the United States of America.

RaySearch stated that they sell direct and have one authorized distributor, the small business

Because the Non-Manufacture Rule applies, this procurement cannot be set-aside for small businesses that are not the manufacturer. Therefore, this procurement will be solicited unrestricted on the open market, to solicit from as many potential sources as possible.

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

The Contracting Officer anticipates the cost to the Government will be Fair and Reasonable based on competition IAW the Simplified Acquisition Procedures set forth in FAR 13.106-3(a)(1). Quotations will be compared with the Independent Government Cost Estimate provided by the facility IAW the Simplified Acquisition Procedures set forth in FAR 13.106-3(a)(2)(vi). Quotations will also be compared to offered prices paid on past procurement for similar items IAW the Simplified Acquisition Procedures set forth in FAR 13.106-3(a)(2)(ii).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

A FPDS-NG query was performed on Thursday, February 28th, 2019. The keyword “Raystation” revealed that the Department of Veteran Affairs has purchased similar equipment in the past.

Purchase Order 36C24919P0309 for $148,274.00 to the Small Business vendor

An Ability One query was performed on Thursday, February 28th, 2019. The keyword “RayStation” was searched with no results.

A GSA Advantage query performed on Thursday, February 28th, 2019, using keyword “RayStation” gave no results. A second search was done using the keyword “treatment planning system”, which gave many results, none of which met the minimum needs of the facility. No SDVOSB or VOSB companies presented themselves on GSA.

A National Acquisition Center (NAC) MedSurg Catalog search performed on Thursday, February 28th, 2019, using keyword “RayStation” gave no results. A second search was done using the keyword “treatment planning system”, which gave many results, none of which met the minimum needs of the facility. No SDVOSB or VOSB companies presented themselves on the NAC.

VHAMIWHedmaJ2 Cross-Out

VHAMIWHedmaJ2 Typewritten Text 36C25719P0309

OFOC SOP Revision 08 Page 5 of 6

Revision 08 Date: 04/18/2018

On March 5th, 2019 the contracting officer emailed the manufacturer RaySearch Americas Inc., a large business, and requested a list of authorized distributors for the United States of America.

RaySearch stated that they sell direct and have one authorized distributor, the small business

The requirement package received from the Madison VA hospital on Friday, December 28th, 2018 included a quotation from the company . The company is listed in SBA as a Business. This quote was utilized by the Madison VA as the IGCE.

The NAICS code for this requirement is 339112 (Surgical and Medical Instrument Manufacturing).

The Federal Supply Code (FSC) is 6515 (Medical and Surgical Instruments, Equipment and Supplies).

A treatment planning system, model name RayStation, is known to meet the facility’s needs.

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

N/A

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

The Business company provided the government a quotation as market research for the facility.

The Business company expressed interest via email in providing a quotation for a future solicitation for the procurement.

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:

It has been determined that the RayStation Treatment Planning System from RaySearch Americas, Inc. is the only brand capable of meeting the needs of the facility for this procurement. However, by procuring the RayStation TPS which is compatable with all the major manufacturers for Linear Accelerator systems, the Government is ensuring fair competition for future acquisitions related to the Treatment Planning System and Linear Accelerator systems.

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.

Mark Heritage Date Chief BioMed Madison VA Hospital

03-25-2019

MARK

HERITAGE

1123140

Digitally signed by MARK

HERITAGE 1123140

Date: 2019.03.25 16:50:28 -05'00'

OFOC SOP Revision 08 Page 6 of 6

13. Approvals in accordance with the VHAPM Part 806.3 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.

Stephanie Sack Date Contract Officer Great Lakes Acquisition Center

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Daniel Rasmussen Date Supervisory Contract Officer Great Lakes Acquisition Center

03/26/2019stephanie e sack 435532

Digitally signed by stephanie e sack 435532 Date: 2019.03.26 07:09:05 -05'00'

Daniel R. Rasmussen 457897

Digitally signed by Daniel R.

Rasmussen 457897 Date: 2019.03.29 10:33:00 -05'00'