P03 - FAR13.5_JA_OVER_SAT.pdf

Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 3 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 695-21-2-969-0099 /36C252-21-AP-2292

1. Contracting Activity: Department of Veterans Affairs, VISN 12, the Milwaukee Zablocki Medical Center has submitted 695-21-2-969-0099 for an AlignRT unit to be utilized for Surface Guided Radiation Therapy to the Great Lakes Acquisition Center (NCO12). Tiffany Vanpetersom from the Logistics will be the Milwaukee contact point & Matthew Hohl from NCO12 will be responsible for the Contracting Action.

2. Nature and/or Description of the Action Being Processed: This justification and approval is for a Brand Name AlignRT procurement which will be Sole Source to the original equipment manufacturer Vision RT and awarded as a firm-fixed-priced purchase order. This item is utilized to monitor the patient’s positioning while receiving Radition Therapy.

This order is estimated at $370,510.00.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This Requirement is for an AlignRT unit that will help monitor the patients positioning to ensure radiation is only received in the required area. The system must be able to perform the following therapies and examinations: Deep Insiration Breath Hold. General Breast - SRS (Stereotactic Radiosurgery), SBRT (Stereotactic Body Radiation Therapy), Head and Neck, Breath Hold SBRT, Sarcoma, Prostate and Pediatrics. The system also must be compatible with Milwaukee’s Elekra Brand Linear Accelerators, this includes being able to interface with Elektra’s Gating “Response” Feature. This feature allows the coordination between the patient (Holding Breath), staff (confirming) & machine (Confirming than Activating Radiation) that will immobilze the targeted anatomy. This system improves the accuracy of Radiation as the target anatomy will only receive the radiation. If patient moves or fails to meet one of the requirements Radiation will not be applied.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified

Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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 AlignRT system is directly manufacturered by Vision RT. Vision RT does not have any Authroized Distributor. This system is highly specialized and VISION RT is the inventor of the Surface Guided Radiation Therapy (SGRT) and

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3

Revision 03 Date: 02/11/2021 regularly develops solutions using Computer vision and Artificial Intelligence to help ensure Cancer Patients Radiation therapy is delivered Safely.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: In an effort to identify potential sources or alternative products a Sources Sought notice (36C25221Q0572) was completed on April 12nd, 2021. The results of the sources sought were negative as no interested parties responded. An intent to Sole Source (36C25221Q0572_1) was posted 4-29-2021 to allow any vendors a second chance to identify alternative products; No responses were received.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The steps to be taken to find that the price will be determined fair and reasonable will be based on historical data from AlignRT from Federal Procurement Data System – Next Generation (FPDS-NG).

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Several Vendor Information Page (VIP) were completed to identify other sources which resulted in zero results. Original Equipment Manufacturer (OEM) for this requirement is Vision RT who is considered a Other Than Small Business (OTSB). An inquiry was sent to the OEM to identify any Authorized Distirbutors in which the OEM stated there is no Authorized Distributors of their Product. Therefore, there is not an expectation of two or more SDVOSB, VOSB, or other small business that will submit offers.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

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

A review of Vision RT’s Patents shows Align RT is fully patented. See P02 – Vision RT Patent of AlignRT.pdf Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Craig Lundberg Vision RT (078365077)

580 HOWARD AVE STE A

Somerset, NJ 08873-1136 310-745-4126

7. 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: To ensure no other suitable products are on the market a Sources Sought Posting (36C25221Q0572) was posted to ensure any interested parties has another chance to come forward. A second opportunity was completed by an Intent to Sole Source (36C25221Q0572) which was posted 4-29-2021. The results of this posting resulted in zero (0) other interested parties or products able to meet this acquisition.

8. 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.

Aleksandar Ljubic Date Biomedical Engineer Milwaukee VAMC

Aleksandar Ljubic 5/10/2021

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 3

Revision 03 Date: 02/11/2021

9. 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.

Matthew Hohl Date Contracting Specialist NCO12 Equipment

Great Lakes Acquisition Center (GLAC)

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Jim Hedman Date Contracting Officer NCO12 Equipment

c. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Parris Weidenbach Date NCO12 Equipment Branch Chief https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx VHAMIWHedmaJ2 Typewritten Text 5/10/2021