36C24120D0005-002.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (1&A)

For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-19-AP-3458

1. Contracting Activity: Department of Veterans Affairs, VISN 1, Providence VA Medical Center, NCO 1

Contracting. 2237 Number: 650-20-3-865-0001 FORCE Number: 36C241-19-AP-3458

2. Nature and/or Description of the Action Being Processed: Request a new Basic Ordering

Agreement-type contract be awarded to Blackrock Microsystems, LLC. Blackrock Microsystems LLC manufactures Neural Signal Processing equipment used in multiple studies with the Center for

Neuro restoration and Neurotechnology (CENN). This procurement is for an estimated $600,000.

3. 3Description of Supplies/Services Required to Meet the Agency's Needs: The Neural Signal

Processing System —and its components and accessories - receives and processes neural signals

CENN has several funded and ongoing studies which require repeated acquisition of Neural Signal Processing Systems and components. Establishing a Basic

Ordering Agreement with Blackrock Microsystems, LLC will facilitate the purchase of equipment, components and accessories already developed and allow CENN to leaverage any technological advances or upgrades. Equipment used for this cutting-edge research continually evolves which makes it difficult to purchase. Establishing the Basic Ordering Agreement will allow for the smooth acquisition of new and upgraded equipment without repeated and extensive contracting requirements.

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will

Satisfy Agency Requirements.

(x) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per FAR 6.302-1;

Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Blackrock Microsystems, LLC is the sole manufacturer and proprietary owner of the NeuroPort Neural Signal Processing System.

This is specific and unique research-based equipment that processes neural (brain) signals and transmits the signals to quipment. These systems are highly specialized for theirmnow investigative use and their use in research projects requiring compatibility with the current systems and in accordance with the requirements of the 4MOM. The main NeuroPort Neural Signal

Processing System are only compatible with components/accessories and from the original equipment manufacturer; the proprietary owner of the system.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: No attempt was made to solicit offers from other sources. The NeuroPort

Neural Signal Processing System and components are only available through Blackrock

Microsystems, LLC. An FBO notice stating the VA's intent to award this requirement on a sole-source basis will be posted in order to comply with regulatory requirements.

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

Reasonable: A comparative analysis of prices paid under the previous contract, prices for similar

(but NOT compatible systems) obtained through market research, as well as a best value review will be used to make a determination of fair and reasonable pricing.

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

Market Research Was Not Conducted: Market Research was conducted in a limited manner.

Blackrock Microsystems is unique (items are proprietary) in their offering of the Neural Signal

Processing System and it's associated compontents and this Basic Ordering Agreement is specifically for those systems with which only the manufacturer's equipment and accessories are compatible.

Market research located alternative systems, but again, these alterative sustem will not work with the current Blackrock Systems being used and are also not compatible with the "1" work being performed. Market research resulted in the following:

Ripple Neura (ht s _jpLL ro.com ) is a provider of intracronial neural recording systems. Their Grapevine Neural Interface Processor, Nano2, and Link-R 32 can all be used but the system provides only a limited number of recording channels (32 channels) per site in comparison to the number of recording channels with a single Blackrock implantable electrode array (96 channels) and the system is not compatible with the in-ploce Blackrock systems.

NeuroNexus (ht. _ _t.ps: neuronexi1s com) is a supplier of NeuroNexus Neural Probes, however their current offerings do not satisfy the specific needs of the program. The probes are not compatibile with the in-place ~~ elackrock Microsystem Systems, some are not currently avoilabl nd they also have a limited number of recording channels (up to 64 channels) in comparison to the number of recording channels with a single Blackrock implantable electrode array and NSP (96 channels).

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

Signal Processing System and the many components are unique research equipment items critical to th projects associated with the Providence VA Medical Center (Research and Development Service) and Brown University, our affiliate institution. Equipment components and accessories evolve and improve over time, yet are only compatible with the main system.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: An FBO notice stating the VA's intent to award this requirement on a sole-source basis will be posted in order to comply with regulatory requirements. Any responses will be handled on a case-by-case basis.

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:

This requirement is for items that are unique, highly specialized, and proprietary to the original equipment manufacturer, Blackrock Microsystems, LLC. At this time, there are no viable market alternatives and overcoming the necessary sole-source nature of this award is impossible.

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.

'AIMMOMM . 10/2/2019

Date

VA RR&D Center for Neu rorestoration and Neurotechnology (CENN)

Providence VAMC (650)

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.

Digitally signed by l 396533 Date: 2019.10.02 09:18:29 -04'00'

Date

Contracting Officer

SAO East, NCO 1

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $7000 1 certify the justification meets requirements for other than full and open competition.

Digitally signed X4610

Date: 2019.10.09 12:51:17 -04'00' 10/09/2019

Date

Branch Chief, Services Team North

NCO 1