MODIFICATION
J -- Outset Tablo Hemodialysis
- Notice Date
- 5/27/2022 5:33:56 AM
- Notice Type
- Justification
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
- ZIP Code
- 45428
- Solicitation Number
- 36C25022C0119
- Archive Date
- 06/26/2022
- Point of Contact
- Roman Savino, Contracting Officer, Phone: 216-447-8300 x3788
- E-Mail Address
-
Roman.Savino@va.gov
(Roman.Savino@va.gov)
- Award Number
- 36C25022C0119
- Award Date
- 05/26/2022
- Awardee
- SDV OFFICE SYSTEMS, LLC ASHEVILLE 28805
- Award Amount
- 210000.00000000
- Description
- Part 806.3 Other Than Full and Open Competition (OFOC) Attachment 7: Request for Sole Source Justification Format >SAT Rev: 13 Effective Date: 02/01/22 Page 1 of 6 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C250-22-AP-3616 Contracting Activity: Department of Veterans Affairs, VISN10, Network Contracting Office (NCO) 10. The 2237 for this procurement is 541-22-3-5163-0213. Nature and/or Description of the Action Being Approved: This activity proposes to procure a Firm Fixed contract with SDV Office Solutions, a verified Service-Disabled Veteran Owned Small Business (SDVOSB) business for maintenance of the 10 Outset Tablo Hemodialysis Systems located at the Cleveland VA Medical Center (VAMC) and the Outpatient Midtown Dialysis Center. This will be a Base Year contract with Four One-Year Option Periods. The estimated value of the proposed action is $ 350,000.00 (for five years.) Description of Supplies/Services Required to Meet the Agency s Needs: The maintenance & service contract will be used to ensure that these 10 systems are operating properly for the treatment of patients who require hemodialysis services. The Outset Tablo devices were purchased as part of the VA Medical Centers response to the Covid-19 pandemic as they are used for the acute bedside hemodialysis treatment of Covid-19 positive patients in our ICU s and isolation rooms. The service and maintenance of these devices is critically important to ensure that veterans with Covid-19 can receive their regularly scheduled life sustaining hemodialysis treatments. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S. Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below: ( X ) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business; or ( ) 819.7008 Sole source awards to a verified veteran-owned small business Demonstration that the Contractor s Unique Qualifications and/or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Cleveland VA Medical Center has been working with SDV Medical on the implementation of these new hemodialysis systems for the past year and over this time SDV Medical have provided exceptional service to meet the needs of the medical center staff and the Veterans they serve. The authority in VAAR 819.7007 allows sole source awards to SDVOSB/VOSB based on 38 U.S.C. 8127(c) and SDV Office Solutions has been determined to be a responsible source with respect to performance. Additionally, SDV Solutions meet the eligibility requirements in 819.7003. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies: Outset Medical, the proprietor of the Outset Tablo Hemodialysis Systems uses SDV Office Solutions as its sole authorized government distributor. The requested services must be provided by a certified Outset personnel which limit the sources who can furnish the requirements for this agreement. Therefore, no other sources can provide this service. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Determination of cost was conducted through a review of past service for this requirement, which had been determined to be fair and reasonable. The current pricing is consistent with the past pricing. Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format >SAT Rev: 13 L Effective Date: 02/01/22 Page 1 of 6 Page 3 of 4 Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: VIP was queried by the Contracting Officer using NAICS Code 811211 and keywords SDV which identified SDV Office Solutions as a SDVOSB Contractor. Proprietary software and OEM-certified field service engineers must be used on this system to meet specific capabilities and specifications of the above stated system and SDV Office Solutions is the sole authorized government distributor of Outset Medical. The requested services must be provided by certified Outset Medical personnel which limit the sources who can furnish the requirements for this agreement. Therefore, other third-party vendors do not have access to the OEM software and would void manufacturers coverage if utilized. Therefore, the VA Rule of Two Cannot be met. Any Other Facts Supporting the Use of Other than Full and Open Competition: None under authority 38 USC 8127(c). Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: SDV Office Solutions. 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: The Service will continue to monitor the marketplace for changes. Paul W. Marshall W. Marshall 220308 Digitally signed by Paul 220308 Date: 2022.04.12 09:55:05 -04'00' 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. Paul W. Marshall, MBA Date Health Systems Specialist -Director s Office 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. Name: Harvey J. McGowan Date Contracting Officer Facility: NCO 10 Independence, OH One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. John Mike Ryan Date Branch Chief: Services Team #1 & #2 Network Contracting Office 10 (Indiana, Ohio & Michigan)
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