J A Hemodialysis System Sole Source Justification.pdf

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

Health & Human Services Assistant Secretary for Preparedness and Response Office of Resource Management Contracts & Grants Division Strategic National Stockpile (SNS) Contracts Branch

b. Sponsoring organization.

Health & Human Services Assistant Secretary for Preparedness and Response Immediate Office (IO)

c. Project Officer Information.

Colton Maddox Strategic National Stockpile (SNS) Office of the Assistant Secretary for Preparedness and Response (ASPR) US Department of Health and Human Services

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

• 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.

b. Project background.

• The Coronavirus Disease 2019 (COVID-19) is a respiratory disease caused by infection with a new form of coronavirus (SARS-COV-2) has been detected in multiple locations around the world, including US COVID-19 has been declared a public health emergency both within the United States and worldwide. As many as 30% of patients in the ICU being treated for COVID19 experience Acute Kidney Injury requiring life-maintaining dialysis for 14-21 days. The majority require resource-intensive Hemodialysis and Continuous Renal Replacement Therapy (CRRT) 24 hours a day to address COVID severe complications.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title

• Hemodialysis System Lease, Maintenance and Training

b. Project description

• This procurement is for 50 additional FDA approved portable dialysis platforms including routine and field maintenance and training for up to 10 USG defined sites.

c. Requirement type.

☐R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

• Type of action.

X New requirement Follow-on Other (specify): ______________________

• Proposed contract/order type.

☒ Firm-fixed-price

Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________

Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

• Acquisition identification number.

d. Total estimated dollar value and performance/delivery period.

Total estimated dollar value is $16,319,232.96. Period of performance is 24 months from date of award.

4. Identification of the statutory authority permitting other than full and open competition.

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.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Outset Medical 1830 Bering Drive San Jose, CA 95112

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Outset is the only vendor that has a portable, FDA approved and commercially available device that makes its own dialysate from tap water.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A Fedbizopps notice will be publicized as required under FAR Subpart 5.2. Market research was unable to locate any other potential vendors.

7. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

A Full and Open RFP was posted on Fedbizopps under RFP 75A5011R00038 for Hemodialysisportable machines on July 6, 2019 for Office of the Principal Deputy Assistant Secretary (OPDAS). Two vendors responded. Of the two vendors, Outset Medical, Inc. is FDA approved and determined to be the only vendor capable of providing commercial dialysis platforms that can create its own dialysate from potable sources, using standard 15A or 20A outlets to carry out hemodialysis treatments in temporary outpatient care facilities. On September 27, 2019, Outset Medical, Inc. was awarded a contract providing portable hemodialysis services for up to 5 locations.

8. Any other facts supporting the use of other than full and open competition.

These services are not located on any Federal Supply Schedule or Government Contracting Vehicle. In addition, Medical Outlet, Inc. has provided a letter to affirm that it is currently the only FDA approved vendor capable of meeting the government's requirement to provide an additional 50 FDA approved hemodialysis unit for the COVID19 response and other public health emergencies. Based on this information Outset Medical, Inc. remains the only known FDA approved vendor that has the technology to make dialysate from tap water and requires minimal power for use.

9. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

N/A

10. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The Office of the Assistant Secretary for Preparedness and Response continually researches and conducts discussions with industry partners to fulfill the requirements of the Strategic National Stockpile. Reviews of Federal Supply Schedules, Government Wide Contracting Vehicles and coordination with other Federal Agencies (FEMA, Air Force, FDA, etc.) is on-going. If additional potential vendors are identified in the future, the Government will compete this requirement.

11. Program Office Certification This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition are accurate and complete.