Justification and Approval for Outset Medical, Inc.
Awarded Limited / Sole Source Justification Posted
- Solicitation number
- 75A5012C00167
- Agency
- Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75A50120C00167 Federal contract award
- NAICS code
- 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing
- Place of performance
- San Jose CA 95112 USA
Notice details come from SAM.gov. Updated .
About this opportunity
This Limited/Sole Source Justification Notice from the Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response seeks to procure 50 portable hemodialysis machines from Outset Medical, Inc. as the only supplier with an FDA-approved, commercially available device that can produce dialysate from tap water as needed to provide round-the-clock hemodialysis and continuous renal replacement therapy to COVID-19 patients over a 24-month period. Market research identified no other potential suppliers meeting requirements. On August 17, 2020, contract 75A5012C00167 for an unknown amount was awarded under this justification to fulfill the sole source requirement estimated at $16,319,232.96.
Notice text
This acquisition is conducted under the authority of 41 United
States Code (U.S.C.) 253(c)(2) as set forth in Federal Acquisition
Regulation (FAR) 6.302-1. Only One Responsible Source.
ASPR objective has a need for 50 additional FDA-approved, commercial
dialysis platforms that can create their own dialysate from portable water
sources, using standard 15A or 20A outlets to carry out hemodialysis
treatments and include a support cache of systems and materials,
preventative maintenance support, and training for ASPR Teams to
deliver hemodialysis care for patients requiring resource-intensive
Hemodialysis and Continuous Renal Replacement Therapy (CRRT) 24
hours a day to address severe COVID 19 complications and other public
health emergencies. The portable hemodialysis machines will be
provided at up to 10 locations to ensure machines are operable and are
ready for initial use during a public health emergency. Outset is the only
vendor that has a portable, FDA approved and commercially
available device that makes its own dialysate from tap
water.
Awarded contract 75A50120C00167 to unknown vendor for unknown amount on 2020-08-17.
Attachments
| File | Type | Posted |
|---|---|---|
| J A Hemodialysis System Sole Source Justification.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Justification and Approval for Outset Medical, Inc. | Limited / Sole Source Justification | |
| 75A50120R00046 Notice of Award to Outset Medical, Inc. | Award Notice |
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