Sources Sought Notice.pdf

Sources Sought Notice

SUBJECT* SLEEP IMPLANTS

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 66048

SOLICITATION NUMBER* 36C25524Q0308

RESPONSE DATE/TIME/ZONE 04-19-2024 10:00am CENTRAL TIME, CHICAGO, USA

ARCHIVE 45 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* 6515

NAICS CODE* 339113

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

POINT OF CONTACT*

Denise Maynard denise.maynard@va.gov

PLACE OF PERFORMANCE

ADDRESS Harry S. Truman Memorial Veterans' Hospital 800 Hospital Drive Columbia, MO 65201-5275

This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does no obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified businesses.

Responses to this notice shall include:

1. Company Name

2. Address

3. Point of Contact

4. Phone, Fax, and Email

5. DUNS number

6. Must provide a capability statement that addresses the organizations qualifications and ability to perform the work in the Statement of Requirements.

See Attached:

1. Statement of Work

Please respond if you can provide.

All responses due by 10:00 am CST, Friday, April 19, 2024 Denise Maynard Contract Specialist denise.maynard@va.gov 913-946-1978 Network Contracting Office 15

See attached document: Statement of Work mailto:denise.maynard@va.gov

Statement of Work (SOW)

INSPIRE SLEEP IMPLANT

Harry S. Truman Memorial Veterans’ Hospital (HSTMVH)

*ALL ITEMS HEREIN THAT MENTION BRAND NAME PRODUCTS

MAY BE SUBSTITUTED FOR A LIKE OR SIMILAR ITEM*

GENERAL INFORMATION

1.0 Scope of Work:

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.

Having the contractor supply a consigned inventory to have as on hand stock. Then requiring the contracted company to ensure the manufacturer (INSPIRE) PROVIDE TRAINING AND SUPPORT FOR ALL THIRD-PARTY WEBSITE ACCESS. Since the device itself transmits compliance data to a third-party website the sleep lab physicians and ENT physicians will NEED administrative roles and support in evaluating the data and troubleshoot any issues with corrupted data or failure of device to communicate. Any new or change in protocols due to changes of the device or the device accessories will be provided through the manufacture of the device and will be brought to the local physician, Contracting Officer and Contracting representatives’ attention as soon as possible.

Training, if necessary, will be provided in a timely manner to the end user of such changes.

2.0 Background:

Historically, once eligibility requirements were met patient was then referred to the community for drug induced sleep endoscopy (DISE), device implantation, and follow-up management. This method of treatment has resulted in lengthy patient wait times and significant costs to the VA.

Recent requirement changes by the FDA have significantly increased the number of patients eligible for the Inspire implant. This has been noted in the HSTMVH ENT clinic by a significant increase in the number of referrals from sleep medicine and primary care providers requesting evaluation of veterans diagnosed with OSA who have failed CPAP.

HSTMVH ENT and Sleep Medicine have put in a substantial amount of work to bring this treatment option to our facility and local veteran population as demand continues to increase.

ENT physicians have all attended necessary Inspire training to perform appropriate evaluation to determine patient eligibility and perform device implantation. Post-operative follow-up and device management will then be managed by HSTMVH Sleep Medicine. In doing so, this will greatly reduce/eliminate the need for community care consults for Inspire, increase OSA treatment options available to our veterans, and significantly decrease costs to our facility and the Department of Veterans Affairs.

CONTRACTOR REQUIREMENTS

3.0 Technical Requirements/Tasks:

1. Provide on hand stock of agreed upon consignment Inspire sleep system sets.

2. Inventory on hand stock every quarter with COR and HSTMVH Implant Coordinator or Inventory Management Specialist.

3. Support and training will need to be provided for surgeon implanting the device and this determination will be on the surgeon’s need.

4. Support for training after implantation of device for the sleep lab physicians monitoring the patient’s compliance and tolerance of device.

5. Support of third-party programs used to transmit data from device to a third-party program for physician or sleep lab tech’s review.

6. Support of any failure or deficiencies of the device’s performance outside the expected performance of the device.

4.0 Government Furnished: The only Government Furnished data would be the data sent from the device to the third-party program for the physician’s review. NO Approval is needed as this data is not being submitted for approval just monitored.

5.0 Deliverables / Schedule:

The deliverables will be the implant systems themselves. After initial stock is brought on board replacement stock purchased through Prosthetics will need to be delivered within 14 business days from the day the contractor receives the purchase order.

Schedule of training and technical support should be done through the end user and the manufacture Inspire. Lovell shall coordinate this within a reasonable amount of time that is satisfactory to the end user.

6.0 Security Requirements: security of all PII will be kept according to VHA standards and safeguarded according to ISO.