Attachment B Statement of Need (Microprobes).pdf

Attachment B

36C24822Q1408

Statement of Need

Background.

This North Florida/South Georgia VA Healthcare System has a requirement for: Microprobes.

Developing a novel stimulus paradigm and interface of vagus nerve stimulation (VNS) to treat obesity.”

These devices are customized specifically to work with the neural target.

Scope.

This work will be performed at the Malcom Randall VA Medical Center. These electrodes will allow stimulation of the vagus nerve that conveys information between the brain and the stomach. The intent is to stimulate this nerve using different stimulation patterns to determine which pattern is most effective at reducing food consumption.

Performance Monitoring

The electrodes are required to serve as an interface for the stimulator, which will deliver electrical current to the nerve. Rodent behavior, eating, and weight, and brain activity will be monitored over a multi-month study following implant. These electrodes are intended for permanent implant. They could be used in other studies using the same animal to assess the effect of electrical nerve stimulation on other targets. This might include observing changes in blood pressure, heart rate, circulating hormones, behavior, and responses to environmental variables.

Place of Performance.

Malcom Randall VA Medical Center, 1601 SW Archer Road, Gainesville, FL.

Warranty of Equipment: Contractor must provide manufacturer(s) warranty on all provided equipment/supplies.

Salient Features & Characteristics

The Microprobes shall meet the following qualities and characteristics:

Low impedance, specifically “ribbons” or sheets instead of exposed wires to maximize surface area, arranged with a tripolar circumferential orientation with specified distances between electrodes and from the electrodes to the edges of the cuff, within a highly flexible silicone cuff; fit around the nerve (0.3 mm) with a small amount of space to allow for nerve swelling (total internal diameter of 0.5 mm);

coiled lead wires in sealed tubes for safe percutaneous exist; biocompatible; sterilizable; able to mate with specified Plastics 1 mini-pedestals. 350 mm lead length.

VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the

COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID- 19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

https://www.va.gov/covid19screen/ https://www.va.gov/covid19screen/ https://www.va.gov/covid19screen/

4. For indefinite delivery contracts: Contractor agrees to comply with VHA

Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.