JUSTIFICATION_AND_APPROVAL_-_High_Density_Stimulator_Redacted.pdf

LOG# 15‐10190

TDP 15-121/PR N6264515RCP3254 Page 1 of 4 1 Nov 12

JUSTIFICATION AND APPROVAL

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 (NMLC), Fort Detrick, MD, on behalf of the Naval Medical Center (NMC) San Diego to meet the NMC San Diego’s requirements.

2. Nature and/or description of the action.

The requirement is for one (1) stimulator, electromagnetic, high-intensity, brain/spinal cord. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Brain Research and Development Service LTD, 19 Hartom St, POB 45169, Jerusalem, Israel 9777518.

3. Description of Supplies or Services:

The requirement is for a Transcranial Magnetic Stimulation (TMS) System for Naval Medical Center San Diego. The system shall be capable of delivering non-invasive supra-threshold TMS to deep brain regions (Deep TMS). The system shall be indicated for the treatment of a variety of conditions including but not limited to Major Depressive Disorder (MDD), Bipolar Depression, Schizophrenia, Parkinson’s Disease, and Chronic Pain. The system shall include user training for up to five (5) individuals upon installation. Installation and training shall take place on dates to be coordinated in advance. The power requirement is multiple 110VAC, 60 Hz, 20Amp outlets on separate circuits.

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 system 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.

TDP 15-121/PR N6264515RCP3254 Page 2 of 4 1 Nov 12

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1) and FAR 13.501(a) sole source (including brand name) acquisitions soliciting from a single source.

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

The Brainsway Transcranial Magnetic Stimulation (TMS) System offered by Brain Research and Development Service LTD is the only product which can meet the minimum requirements of the government. The Brainsway system is the only commercially available product which is capable of delivering Deep TMS treatment and is FDA approved. Other commercial systems are only capable of delivering TMS treatment to superficial brain tissue and are thus limited in their clinical application and do not meet the minimum requirements of the government. No other vendor besides Brain Research and Development Service LTD is capable of meeting the minimum requirements.

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.

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 Brain Research and Development Service LTD’s commercial price list and will be determined fair and reasonable.

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

Market research was conducted in March 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. Vendors which can provide TMS systems capable of treating Major Depressive Disorder include Brain Research and Development Service LTD, Neuronetics, and Nexstim. The TMS system offered by Nexstim is not currently FDA approved. The TMS systems offered by both Neuronetics and Nexstim are not capable of delivering Deep TMS treatment and thus do not meet the minimum requirements.

Only the TMS system offered by Brain Research and Development Service LTD is capable of delivering Deep TMS treatment and is FDA approved. Brain Research and Development Service LTD is the only vendor which can meet the minimum requirements of the government.

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

TDP 15-121/PR N6264515RCP3254 Page 3 of 4 1 Nov 12

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. 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, NMLC has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, NMLC 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.

The Government expects to obtain a technical data package that will support competition for future acquisitions of the same or similar items.

12. Point of Contact.

The point of contact at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD, regarding the contents of the sole source justification is

TDP 15-121/PR N6264515RCP3254 Page 4 of 4 1 Nov 12

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

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

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.

Office of Counsel Phone Date