JA_Linear_Accelerator_Travis_AFB_Redacted.pdf

Justification and Approval (J&A) for Other Than Full and Open Competition

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)14 Nov 2017

NOTE: If a Justification and Approval was approved for the preceding acquisition, a copy of the approved J&A for the predecessor action must be included in the staff package for approval of the instant J&A. This applies to J&A staff packages that are submitted for review and approval at a level above the contracting officer. The predecessor J&A will be used as a reference document by the approving official.

Is this a new or amended J&A Document? New Amended ( Prior to Award Only! )

Funding level for this acquisition: < $700K > $700K and < $13.5M > $13.5M and < $93M > $93M

Contracting Activity: 60th Contracting Squadron

Purchase Request / Local ID Number:

Program / Project (and PE, if applicable): Linear Accelerator Maintenance Contract

Program Type (PEO or Other Contracting): Other Contracting

Authority: 6.302-1 – 10 USC 2304(c)(1), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

Estimated Contract Cost (including options): J&A Type: Class Individual

COORDINATION (AFFARS 5306.304(a) )

Date

29 Jan 2018

Contracting Officer

Signature

Date

Project Lead / Program Mgr / Requiring Activity

Local Legal Reviewer

30 Jan 2018

Chief, Acquisition Flight

31 Jan 2018

Activity Competition Advocate

31 Jan 2018

Chief of the Contracting Office (COCO)

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)14 Nov 2017

APPROVAL (AFFARS 5306.304(a) )

Date

02 Feb 2018

Approving Official / Competition Advocate

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)14 Nov 2017

I. Contracting Activity.

Department of the Air Force, 60th Contracting Squadron, Travis AFB, CA 94535-2632

II. Nature and/or description of the action being processed.

Request is for a new sole source award to Varian for a full coverage maintenance agreement for the Linear Accelerator at the DGMC at Travis AFB.

Period of Performance:

Base Period: 01 Apr 2018 - 30 Sept 2018 with four (4) one-year options.

Firm Fixed Price Contract

III. Description of supplies/services required to meet agency needs.

Varian linear accelerators and radiation therapy systems hardware and software maintenance agreement.

Base Period (1 APR 18 - 30 Sep 18)(6-Months) CLIN 0001 Clinac HE H294303 - Essentials CLIN 0002 Clinac Trilogy H294626 - Essentials CLIN 0003 Aria - Essentials - CLIN 0004 Eclipse Essentials - CLIN 0005 Eclipse Anti - Obsolescence Protection - CLIN 0006 Aria - Anti Obsolescence Protection - Total

Option #1 (1 Oct 18 - 30 Sep 19) CLIN 1001 Clinac HE H294303 - Essentials CLIN 1002 Clinac Trilogy H294626 - Essentials CLIN 1003 Aria - Essentials - CLIN 1004 Eclipse Essentials - CLIN 1005 Eclipse Anti - Obsolescence Protection - CLIN 1006 Aria - Anti Obsolescence Protection - Total

Option #2 (1 Oct 19 - 30 Sep 20) CLIN 2001 Clinac HE H294303 - Essentials CLIN 2002 Clinac Trilogy H294626 - Essentials CLIN 2003 Aria - Essentials - CLIN 2004 Eclipse Essentials - CLIN 2005 Eclipse Anti - Obsolescence Protection - CLIN 2006 Aria - Anti Obsolescence Protection - Total

Option #3 (1 Oct 20 - 30 Sep 21) CLIN 3001 Clinac HE H294303 - Essentials CLIN 3002 Clinac Trilogy H294626 - Essentials CLIN 3003 Aria - Essentials - CLIN 3004 Eclipse Essentials - CLIN 3005 Eclipse Anti - Obsolescence Protection - CLIN 3006 Aria - Anti Obsolescence Protection - Total

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)14 Nov 2017

Option #4 (1 Oct 21 - 30 Sep 22) CLIN 4001 Clinac HE H294303 - Essentials CLIN 4002 Clinac Trilogy H294626 - Essentials CLIN 4003 Aria - Essentials - CLIN 4004 Eclipse Essentials - CLIN 4005 Eclipse Anti - Obsolescence Protection - CLIN 4006 Aria - Anti Obsolescence Protection - Total

Total Clinac HE H294303 - Essentials Clinac Trilogy H294626 - Essentials Aria - Essentials - Eclipse Essentials - Eclipse Anti - Obsolescence Protection - 0 Aria - Anti Obsolescence Protection - Total

IV. Statutory authority permitting other than full and open competition.

Title 10 USC 2304(c)(1), as implemented by FAR 6.302-1. Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements

V. Demonstration that the contractor's unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority).

The linear accelerators and radiation therapy treatment planning systems are complex FDA-certified medical devices that produce and deliver targeted radiation into oncology patients. Varian, the original equipment manufacturer (OEM) is the only source for both hardware and software support of the existing equipment and has no other authorized vendors certified to perform the services requested. Varian has proprietary rights to the equipment and software. Without the most up to date hardware and software support to maintain the equipment in working condition, it could result in catastrophic failure inhibiting Radiation Oncology from treating cancer patients.

Varian is the OEM with proprietary rights and can provide all necessary maintenance, technical/operator support, proprietary OEM upgrades for software platforms and hardware, and guarantees a 98.5% uptime of the equipment.

DGMC requires their linear accelerator to provide Stereotactic Radiosurgery services on Travis AFB. This service delivers precisely targeted radiation at significantly higher doses than normal radiation therapy. This allows DGMC to treat a malignancy in a one day session, although most of the cases consist of four (4) treatments. On average we have one or two of these cases per month. This focused beam therapy must be performed with a highly calibrated linear accelerator.

If the technical maintenance package is not fully qualified to identify and resolve any issues associated with the treatment platform with minimum downtime, it poses significant risks to operations at DGMC.

Prior to commencement of a treatment plan, patients in need of radiation therapy undergo a consultation and simulation before any treatment begins. This consultation and simulation workup takes weeks to prepare. If the linear accelerator is inoperable for an extended period of time a patients cancer treatment must be started from the beginning again resulting in unnecessary pain, suffering, and possibly death. The Government would pay significantly higher costs through repeated one-time service requests for like support in the civilian sector. The DGMC Radiation Oncology Center treats an estimated 20 patients each day, from Intensity Modulated Radiation Therapy (IMRT), to simpler 3D Conformal cases. The American College of Radiology (ACR) rule of thumb to scale from patients per day to patients per year is a factor of 10, so we arrived at 200 patients per year. Failure of this equipment would require disengagement of the patient to a private center. The IMRT cases are typically billed in the civilian sector at per patient, and the 3D Conformal cases at about . However, because of the higher utilization of IMRT at DGMC and because IMRT is a

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)14 Nov 2017 more optimal treatment, we estimated the cost per patient on the higher side, that is per patient. Therefore, the total cost per year of civilian sector care is .

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

A Sources Sought was posted to FBO for the period of 13 Apr 17 - 26 Apr 17 with no responses received. A second sources sought was posted to FBO for the period of 24 Aug 17 - 25 Aug 17 with one response received from the Remi Group, LLC.

A memo dated 4 Jan 18, from the District Service Manager for Varian Medical Systems, Inc. states, "Varian Medical Systems, Original Equipment Manufacturer (OEM), is the only certified company to perform work on our Hardware and Software products; as we own the proprietary rights for all our software and hardware products. As well, Varian is not a subcontractor or partner, nor does Varian sub-contract any product or service related activity to any outside independent company."

VII. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

Based on historical and current pricing as well as the independent government estimate it can be determined that the pricing is fair and reasonable.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

For the linear accelerator the end users must be able to make regular contact with the OEM regarding the treatment planning software portion of the linear accelerator systems. Varian Inc was contacted to verify whether or not they authorize and certify any non-OEM sources to provide services for their Clinac IX and Trilogy linear accelerators, work stations, and/or the Aria and Eclipse software systems. Reference statement from Varian Medical Systems in Section VI.

Siemens was contacted, and they do not offer coverage. GE and Philips offer limited contracts for linear accelerator maintenance but subcontract all work back to Varian.

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)

FOR OFFICIAL USE ONLY (Linear Accelerator, Travis AFB, CA)14 Nov 2017

IX. Any other facts supporting the use of Other Than Full and Open Competition.

Acquisition is sole source. No action is planned as no other company has entered the market that can provide the support to Varian linear accelerators. If this service is needed after the contract expires new market research will be completed to identify if any other contractors have entered the market and are capable of providing linear accelerator support services.

X. List of any sources that expressed, in writing, an interest in the acquisition.

A total of three (3) interested parties responded to verbal questioning notice for this requirement: GE, Phillips and The Remi Group. Further information is listed above in Sections VI and VIII.

XI. 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.

Acquisition is sole source. No action is planned as no other company has entered the market that can provide the support to Varian linear accelerators. If this service is needed after the contract expires new market research will be completed to identify if any other contractors have entered the market and are capable of providing linear accelerator support services. The Government will proceed with a J&A for other than full and open competition.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my signature above, I certify that any supporting data contained herein, which is my responsibility, is both accurate and complete.