Single Source Justification MPT to SAT_Redacted.pdf
PDF 174 KB Posted
- Attached to
- 6515--Sleep Implants
- Solicitation number
- 36C25525Q0532
About this file
This document is a Single Source Justification form for the Department of Veterans Affairs, specifically VISN 15 in Leavenworth, KS, supporting the Harry S. Truman Memorial Veterans' Hospital in Columbia, MO. The justification is for procuring 8 Inspire sleep implant systems, a unique FDA-approved treatment for obstructive sleep apnea (OSA). The device directly stimulates the hypoglossal nerve to stabilize the throat during sleep, offering an alternative to traditional CPAP machines with expected benefits of improved patient compliance, reduced sleep apnea events, and decreased snoring.
The acquisition plan (ID# 36C25526AP0069) requires the vendor to provide on-hand stock of Inspire sleep system sets, conduct quarterly inventory with the Contracting Officer's Representative, and offer comprehensive support including surgeon and sleep lab physician training, third-party data transmission support, and performance troubleshooting. Market research was conducted using NAICS 339113, confirming Inspire as the sole vendor for this specialized medical implant. The Contracting Officer, Denise Maynard, certified the justification, with price reasonableness determined through comparison with the Independent Government Cost Estimate, and the document is effective from 11/15/2024.
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| File | Type | Posted |
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| 36C25526P0002_2.docx | DOCX document |
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Text version
VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT
Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID# 36C25526AP0069
DEPARTMENT OF VETERANS AFFAIRS
Justification for Single Source Awards IAW FAR 13.106-1 For
Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)
Acquisition Plan Action ID: 36C25526AP0069
1. Contracting Activity: Department of Veterans Affairs, VISN 15, Leavenworth, KS in support of Harry S. Truman Memorial Veterans’ Hospital (HSTMVH), Columbia, MO
2237: 589-25-3-5418-2227
2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:
Requirements:
•Provide on hand stock of agreed upon consignment Inspire sleep system sets.
•Inventory on hand stock every quarter with COR and HSTMVH Implant Coordinatoror Inventory Management Specialist.
•Support and training will need to be provided for surgeon implanting the device and this determination will be on the surgeon’s need.
•Support for training after implantation of device for the sleep lab physicians monitoring the patient’s compliance and tolerance of device.
•Support of third-party programs used to transmit data from device to a third-party program for physician or sleep lab tech’s review.
•Support of any failure or deficiencies of the device’s performance outside the expected performance of the device.
Independent Government Cost Estimate:
One time buy for 8 sleep implant systems.
3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:
This Inspire implant is to provide an alternate method of treatment for sleep apnea.
The standard of treatment has been continuous positive airway pressure (CPAP).
However, patient compliance and meaningful treatment results have been an ongoing issue. Inspire is the only FDA approved implant therapy for the treatment of obstructive sleep apnea (OSA). The inspire implant directly stimulates the hypoglossal nerve stabilizing the throat during sleep to improve airflow and reduce obstructive sleep apnea events. This treatment is customizable to the patient and does not require masks or hoses traditionally associated with CPAP use. Due to this, patients will experience a significant reduction in sleep apnea events, OSA symptoms improvement and an overall reduction in snoring.
File details come from the government source that posted it. Updated .