36C24621Q0826.docx

Contract Opportunity Special Notice

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OPTOS MONACO

23667 36C24621Q0826 N 339112 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 Contract Specialist Ruth Morris ruth.morris@va.gov 757-315-2985 ruth.morris@va.gov ruth.morris@va.gov Notice of Intent to Sole Source

The Department of Veterans Affairs, NCO 6 intends to award a sole source, FFP, Purchase Order to MELLING MEDICAL, LLC. for the procurement/purchase of OPTOS MONACO to be used at Asheville VAMC, 1100 Tunnel Road Asheville NC 28805. The North American Industry Classification System (NAICS) for this requirement is 339112 with a small business size standard of 1000 employees.

Authorized product distributors of OPTOS MONACO may provide a capability statement as instructed below.

This proposed contract action is for the purchase of OPTOS Monaco instrument an ultra-widefield retinal imaging device with integrated spectral domain OCT, Monaco produces a 200° single-capture optomap® image in less than ½ second and provides cross-sectional 40° OCT views of retinal structures.

The government intends to solicit from only one source under the authority of FAR 13.106-1(b), Soliciting from a Single Source. This notice of intent is not a request for competitive quotes; however, interested parties may identify their skill and ability by sending capability statements in reference to this requirement no later than 11:00a.m. EST; June 21, 2021; to ruth.morris@va.gov.

Interested firms must indicate whether they are a large, small, small-disadvantaged, 8(a) or woman owned business. If your firm is a Service-Disabled Veteran Owned or Veteran Owned Small Business, you must be CERTIFIED in VetBiz (see internet site: http://vip.vetbiz.gov). Also indicate whether the vendor is U.S. or foreign owned (in compliance with the Buy American Act).

Respondents who submit proprietary data shall clearly mark the data with appropriate markings. The Government will not pay for any information submitted as a result of this notice. This notice shall not be construed as an obligation on the part of the Government to acquire any products or services.

A determination by the Government not to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Email is the preferred method of communication, please reference #36C24621Q0826 in ALL correspondence pertaining to this requirement.

Product Service Code: 6515 – Medical and Surgical Instruments, Equipment, and Supplies NAICS Code: 339112 – Surgical and Medical Instrument Manufacturing point of contact - Ruth Morris ruth.morris@va.gov Phone Number 757-315-2985

DEPARTMENT OF VETERANS AFFAIRS

Justification for Brand Name IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID:36C246-21-AP-3678

1. Contracting Activity: Department of Veterans Affairs, VISN 06, Asheville VA Medical Center, 1100 Tunnel Road, Asheville NC 28805 Purchase Request Number:637-21-3-996-0180

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The OPTOS Monaco instrument an ultra-widefield retinal imaging device with integrated spectral domain OCT, Monaco produces a 200° single-capture optomap® image in less than ½ second and provides cross-sectional 40° OCT views of retinal structures.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Asheville VA Medical Center Ophthalmology Department Hickory - CBOC eye clinic has a requirement to procure Brand Name item OPTOS Monaco. The Optos takes a wide field image of the retina with multiple filters and scans without dilation, thereby reducing clinic time, reducing wait area traffic while allowing medical staff to maintain (and improve) clinical care to vets. Also, the Optos Monaco has the capability to provide wide angle fundus autoflourescent images along with combined OCT allowing for detection, diagnosing and monitoring of earlier stages of retinal disease unlike other wide-angle imaging modules.

Minimum requirement:

· Combined ultrawide field (200°) fundus imaging, fundus autofluorescence and OCT

· Single image captures at least 80% (927 mm2) of the retina,

· Image capture efficiency: Ultra-widefield (200°) image capture in less than ½ second

· Images viewable in a consistent geometry that accurately represents anatomical features across the retina and allows for accurate measurements across the retina

· Color imaging with red/green lasers to minimize exposure to blue light

· All functions (color photo, red-free photo, choroidal imaging, autofluorescence imaging, OCT) are included in one instrument

· DICOM compatible

The Optos Monaco will allow optometrist to provide and improve patient care by providing images of internal ocular structures, improving disease monitoring and diagnosis, and eConsult capabilities to reduce both in-house and community care referrals when appropriate and would be instrumental at improving quality of care and increasing clinic capacity during and post-covid restrictions. This procurement is in direct support of the Medical Services continuity of care. Based on facility need and existing conditions, like or similar items will not suffice.

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted by querying the VIP search conducted on 06/10/2021 utilizing NAICS 339112 and Key Words “OPTO Monaco” revealed 03 vendors: 03 SDVOSBs and no VOSBs. A Source Sought Notice was issued on Contract Opportunities (36C24621Q0763) on 05/28/2021 to 06/04/2021. The following response received (1) SDVOSB: Melling Medical (DUN: 078774013) provided a capability statement and a letter of authorization as reseller/distributor from OPTO, Inc. NAC searched using keyword “OPTO Monaco” revealed no results. SAC searched using keyword “OPTO Monaco” revealed no results. FPDS searched using keyword “OPTO Monaco” under department of Veteran Affairs revealed no results, additional search “OPTOs” revealed 128 vendor contracts and 8 contracts for vendor (Melling Medical) was used for information purposes only. GSA eLibrary search using keyword “OPTO Monaco” revealed no results. GSA Advantage: searched using keyword “OPTO Monaco” revealed no results. SBA Dynamic Small Business Search (SBDS) search using NAICS 339112 and Keywords “OPTOS Monaco” revealed no potential vendor; additional search using keyword “OPTO” revealed 2 possible vendors. SBA.gov was used to verify 339112 size standards as 1000 employees.

The Contracting Officer does not have a reasonable expectation of receiving 2 or more quotes from SB if we were to set this requirement aside as 100% SB. The CO is electing to Sole Source and award to the authorized reseller/distributor Melling Medical, LLC. IAW FAR Part 13.106-1 (b).

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

VHAPM Part 813.106 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020