JA_Linear_Accelerator_(FBO)_Redacted.pdf

Log #15-10195

Form 02.4G.AB/N6264515RCP3504 1 Nov 2012

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD to meet the requirements of Naval Medical Center Portsmouth.

2. Nature and/or description of the action.

The requirement is for Linear Accelerator Test Equipment. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Sun Nuclear Corporation, 3275

Suntree Blvd, Melbourne, FL 32940-7514.

3. Description of the supplies/services required.

The requirement is for linear accelerator test equipment for Naval Medical Center Portsmouth.

The equipment shall be capable of performing Quality Assurance assessments for the newly acquired Stereotactic Radiosurgery equipment at Naval Medical Center Portsmouth in accordance with American Association of Physicists in Medicine (AAPM), American College of

Radiology (ACR), and American Society of Therapeutic Radiology and Oncology (ASTRO) guidelines. The equipment shall be capable of testing patient dose quality assurance (QA) and characterizing and adjusting the treatment beam profile. The patient QA test equipment shall include a cylindrical detector array with sub-millimeter resolution. The patient QA equipment and beam characterization equipment shall be gantry mountable. The equipment shall include water equivalent buildup phantoms with a cross section of 35.3cm x 36.7cm and various thicknesses ranging from 0.3cm to 5.0cm. All required hardware, software, and licenses shall be included. The equipment shall be capable of managing and analyzing data, managing user access, and logging data for audit. The required equipment shall be from a single manufacturer.

The equipment shall be capable of interfacing with the Stereotactic Radiosurgery equipment awarded for Naval Medical Center Portsmouth.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/systems such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The systems shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10

USC 2304(c)(1) and FAR 13.501(a), sole source (including brand name) acquisitions.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The linear accelerator test equipment offered by Sun Nuclear is the only equipment which can meet the minimum requirements of the government. Sun Nuclear is the only vendor that can provide a cylindrical detector array for patient QA testing. No other vendor can provide a cylindrical detector array for patient QA testing. Sun Nuclear is the only vendor that can provide test equipment capable of interfacing with the Stereotactic Radiosurgery equipment awarded for

Naval Medical Center Portsmouth.

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

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to NECO and/or FedBizOpps in accordance with FAR 5.202. The government will evaluate any responses received.

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

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted in April 2015. The market research conducted included research conducted by the internet, and review of product literature. The internet search was done using

Google, Bing, GSA Advantage, and the ECRI Sourcebook. Other vendors which can provide linear accelerator test equipment include Mobius Medical Systems, Modus Medical Devices, Fluke Biomedical, and CIRS Inc. None of these vendors is capable of providing a cylindrical detector array for radiation therapy patient QA testing. Additionally, none of these vendors can provide equipment capable of interfacing with the Stereotactic Radiosurgery equipment awarded for Naval Medical Center Portsmouth. Sun Nuclear is the only vendor which can provide a cylindrical detector array and which can interface with the Stereotactic Radiosurgery equipment awarded for NMC Portsmouth. Sun Nuclear is the only vendor which can meet the minimum requirements.

9. Other facts supporting the use of other than full and open competition.

None

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on

FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command has no plans at this time to compete future contracts for the types of supplies/services covered by this document. If another potential source emerges, Naval Medical Logistics Command will assess whether competition for future requirements is feasible. However, there is constant attention to the market to insure that shall technology change, the source selection is reconsidered. U.S. Navy Subject Matter Experts are required to take into consideration the impact on the installed base of equipment when source selection occurs. All necessary components of integrated logistics support are taken into consideration.

12. Point of Contact

The point of contact at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD, regarding the contents of the Justification and Approval is Adam Belanger, who may be reached at (301) 619-8271.

TECHNICAL AND REQUIREMENTS CERTIFICATION

REQUIRED BY FAR 13.501

I CERTIFY THAT THE FACTS AND REPRESENTATIONS UNDER MY COGNIZANCE

WHICH ARE INCLUDED IN THIS JUSTIFICATION AND APPROVAL AND WHICH

FORM A BASIS FOR THIS JUSTIFICATION ARE COMPLETE AND ACCURATE.

Technical Cognizance

Clinical Engineer

Code 03

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and found to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

____N/A______________________________________________________________________

Name Phone Date

Competition Advocate