6515--WATCH PAT ONE DIRECT Home Sleep Apnea Test Device

This is a notice of intent to sole source a contract under the authority of FAR 13.106-1(b)(2), only one source being available to meet the Government s need. The contract will be to purchase 1,255 each WatchPATDirect #CS2116045/6 home sleep apnea test (HSAT) diagnostic devices. The North American Industrial Classification System (NAICS) code for this procurement is 334510 Electromedical diagnostic equipment manufacturing, with a small business size standard of 1,250 employees. The FSC/PSC is 6515 Medical and Surgical Instruments, Equipment, and Supplies. The Department of Veterans Affairs intends to solicit and award a sole source contract for the purchase of 1,255 each WatchPATDirect #CS2116045/6 home sleep apnea test (HSAT) diagnostic devices to Itamar Medical, Inc., 3290 Cumberland Club Drive, Suite 100, Atlanta, Georgia 30339-4914. There are no other sources of supply/service that will satisfy agency requirements. The Itamar home sleep apnea test diagnostic devices are to be used by: VA San Francisco Health Care System San Francisco VA Medical Center 4150 Clement Street San Francisco, CA 94121-1545 The WatchPATOne Direct HSAT is an FDA-cleared device that has been approved for use in apnea testing in the 2017 AASM HSAT Clinical Practice guidelines. The apnea testing will be performed to fulfill the sleep apnea testing requirement included in the study s eligibility screening process. The contractor must handle shipping and receiving of the device directly with the participant, educate and provide 24/7 support regarding the device that is to be used. The contractor must process and provide a comprehensive report of the scored study results from the data gathered during the at-home apnea test. No services such as installation training need to be performed. All the data transfer and processing of the anonymized data will be done by the contractor; therefore, software will not need to be downloaded or purchased. The vendor will use Somnoware which is VISN and Fedramp approved. Veteran data is uploaded here by clinician and product is mailed directly to veteran. The VA Northern California Healthcare System, San Francisco VAMC is seeking to purchase the following: Description Qty Itamar WatchPATDirect #CS2116045/6 home sleep apnea test devices (HSAT) 1,255 each These apnea test devices must monitor the following channels: PAT signal Body position Ability to differentiate sleep stages (wake vs REM vs non-REM) Respiratory effort cleared for central apnea and CSR detection Actigraphy Heart rate Snoring Oxygen saturation (ODI) Ability to generate an AHI and RDI based on true sleep time vs recording time Ability to adjust parameters Be simple to use and comfortable for participants There are no unusual requirements that will affect costs of contractor. The purchased devices shall remain with the contractor and the contractor shall mail/ship a device directly to each patient s home as and when directed by the VA. Any responsible source that feels it is capable in performing this requirement may submit a quote (monthly per scope) for the above listed items and describe and/or submit documentation to support your capabilities. The response will be considered by the agency. If you are not the Original Equipment Manufacturer (OEM), you must submit an authorized distributor letter signed by the OEM. If you are not the OEM and a small business, you must indicate in your response how you will comply with limitations on subcontracting and/or the non-manufacturer rule. Responses should be submitted to Brian K. Fritz at contact@example.gov no later than November 28, 2022 at 10:00 AM PST to be considered. If no responses are received, the Government will continue with its sole source procurement, and a sole source Request for Quote will be published to contract opportunities in accordance with FAR 5.102.