6530--J&A Notice Fidelis Medical Ventilators
Request for Limited Sources Justification Format >SAT 36C247-23-AP-3069 Effective Date: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C... Request for Limited Sources Justification Format >SAT 36C247-23-AP-3069 Effective Date: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C247-23-AP-3069 (1) Contracting Activity: Department of Veterans Affairs, VISN 7, Network Contracting Office 7, on behalf of the Ralph H. Johnson VA Medical Center located at 109 Bee Street, Charleston, SC 29401. 2237: 534-23-4-783-0311 (2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). New Requirement. Order against: FSS Contract Number: 36F79719D0113 Name of Proposed Contractor: FIDELIS SUSTAINABILITY DISTRIBUTION Street Address: 204 WEST SPEAR ST., TE 3319 City, State, Zip: CARSON CITY, NV 89703 Phone: 877-929-0123 (3) Description of Supplies: The estimated value of the proposed action is [REDACTED]; no options included. QTY Eight (8) Servo-U Ventilators and Accessories. (4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service. FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; The Maquet Servo is the only FDA approved ventilator on the market that utilizes NAVA Technology. NAVA Technology delivers ventilator assist in proportion to and in synchrony with the patient s EDI signal. The EDI signal is the signal the brain sends to the diaphragm requesting a breath. Also, the ventilator is the only FDA approved ventilator on the US market that utilizes Non-Invasive NAVA technology. As a result, it is the only ventilator that is interface independent with improved leak compensation. This technology allows for increased patient tolerance, contributes towards decreasing the number of patients requiring intubation and decreases the likelihood of skin breakdown. Additionally, the O2 sensor operates off ultrasonic technology. The ultrasonic O2 sensor the servo utilizes is designed to last the life of the ventilator which reduces cost of ownership and therapist workload (eliminates the need to change ventilators should an O2 cell need replacement). This model also contains an integrated aerogen that eliminates the need for the therapist to look for a standalone unit and attach it to the ventilator; thereby, increasing ease of use and reducing operating costs. Stand-alone units can get lost forcing the hospital to purchase additional units for upwards of $1000 each. The servo offers the option to measure volumetric and end tidal CO2. Provides CO2 waveforms and trending as well. This can save costs associated with blood gases and improves patient comfort. This ventilator is the only model on the market that meet s the government s requirement. FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. (5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: The price of the ventilator has already been deemed fair and reasonable. Given that Fidelis is the only source for this product this is the best value and mitigates contractor failure. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Market Research was conducted. There is only one supplier for this requirement and no alternative sources. The VA rule of two cannot be met. I recommend a sole source award to Fidelis using FAR Part 8. (7) Any Other Facts Supporting the Justification: None. (8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: There is no other contract vehicle or mechanism that can meet the government s requirement. This is the sole acquisition strategy. (9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. //SIGNED// Regina Cahill Program Analyst (10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: a. Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. //SIGNED// Matthew Durden Contracting Officer NCO 7 b. 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. //SIGNED// Jason Compton Branch Chief NCO 7
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