6650--Microscope for PTSD

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 5: Request for Sole Source Justification Format >SAT OFOC SOP Revision 11 Page 1 of 9 Original Date: 03/22/11 Revision 11 Date: 02/11/2021 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID:___36C241-21-AP-2191________________________________________ Contracting Activity: Network Contracting Office 1 is processing the procurement action for Department of Veterans Affairs, VISN 1, VA Boston Healthcare System (VABHS) Jamaica Plain Campus. The 2237 number is 523-21-4-1866-0033. Nature and/or Description of the Action Being Processed: The National Center for PTSD Brain Bain seeks to acquire a ClearScope light sheet theta microscope and associated administrative software to store the images generated by the system. This is a new firm-fixed-price contract. The anticipated value of this contract is $519,189.00. The equipment is determined to be a commercial item and the procedures in FAR Part 12 and Part 13 will be followed. Description of Supplies/Services Required to Meet the Agency s Needs: The PTSD Brain Bank requires a ClearScope light sheet theta microscope for imaging of cleared tissue specimens. The system is composed of a light sheet theta microscope which uses intersecting light sheets that are projected deeply into cleared tissue specimens and observed with a third objective placed above the sample. The system is fitted with an extended stage that can accommodate coronal tissue specimens. The system also includes a computer workstation and software that has an authority to operated within the VA. This is a research system that will be deployed on a VLAN that is behind the VA firewall. The software licence will allow computers connected to the VLAN to access the software. Delivery is 180 calendar days after receipt of order. Statutory Authority Permitting Other than Full and Open Competition: (X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3; ( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5; ( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6; ( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority: The MBF ClearScope light-sheet theta microscope is a highly specialized microscope capable of scanning large tissue specimens measuring up to 6 x 4 inches. The system's geometry allows any large section of cleared tissue up to 12 mm thick to be scanned using up to 7-different wavelengths of light. The light sheet theta microscope is a patented light-sheet geometry and not available from any other vendor. The system also has a 7 wavelength laser system which is also not available in any other commercial light-sheet system. The features of this system make it the only microscope that fits the needs of the brain bank. Accordingly, MBF Biosystems is the only firm capable of providing the supplies and services described in Section III above without the Veteran's Health Administration experiencing substantial duplication of the cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Several other vendors that make light-sheet microscopes were considered, including Leica, LifeCanvas, Bruker, and Miltenyi. None of these vendors make a light sheet theta microscope, and none of these vendors can scan specimens that are larger than a couple of centimeters. Also, all of these systems require a light sheet that is perpendicular to the objective, which is not possible with large tissue specimens. Moreover, none of these vendors offer 7-wavelengths of excitation energy. For these reasons, none of the other vendors can provide the system required by the Brain Bank. A notice of intent to sole source to MicroBrightField LLC DBA MBF Bioscience, the small business manufacturer of the ClearScope200 Light Sheet Theta Microscope, was published to Contract Opportunities on 06/28/2021 with a response date of July 9, 2021 (copy of notice attached). There were no responses received to the notice. On 06/29/2021, the Contracting Officer spoke with Heaven Collins, from MicroBrightField LLC DBA MBF Bioscience regarding ClearScope200 Light Sheet Theta Microscope to confirm that they were the manufacturer of the equipment and question if there were any socio-economic categories as authorized distributors. Ms. Collins confirmed that MBF Bioscience is the manufacturer and stated that they were the only company to sell it and there were no authorized dealers. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: A review of contract opportunities published award documentation has identified several specialized microscopes purchased throughout the Government in the past three years. This requirement is new technology also considered a specialized microscope. Based on this research, the contracting officer determines the anticipated cost will be fair and reaonsable. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. The vendor is the manufacturer of the equipment and is not an SDVOSB/VOSB. They are a small business concern. There are no authorized distributors. A 2268 will be submitted for approval prior to award. There are no exceptions to the Buy American Act as the equipment is manufacturered in the US. Any Other Facts Supporting the Use of Other than Full and Open Competition: The MBF ClearScope light-sheet theta microscope is a patented design that allows large tissue specimens to be imaged. There is no other light-sheet microscope that can image specimens of the size required by the brain bank. Because the technology is patented and there are no other vendors that sell a comparable instrument, this is the only system that meets the brain bank's needs. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: We have examined systems from Leica, LifeCanvas, Bruker, and Miltenyi. None of these systems meet the needs of the brain bank. There were no responses received to the notice of intent to sole source this procurement, which was published on contract opportunities. 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 procurement is a one time purchase, therefore subsequent acqusiitions are not anticipated. However, the images that the system generates are in a common file format and are compatible with software in our laboratory, so we are not locked into using the software from the vendor. The consumables that are used to clear tissue are purchased from other vendors and therefore not purchased from MBF. 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. _____________________________ ________________________ Name Date Title Facility Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: 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. _____________________________ ________________________ Judith Ruggiero Date Contracting Officer Network Contracting Office 1 One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ David Gabrysiak Date Supervisory Contract Specialist Network Contracting Office 1