Attachment B Statement of Need- SRA.pdf

Attachment B

36C24823Q0771

Statement of Need

Background:

The Malcom Randall VA Medical Center have a requirement for; one (1) Surgical Robotic Arm System for Total Knee//Partial Knee//Total Hip; One (1) for Orthopedics OR.

Salient Characteristic:

The offerors equipment shall meet or exceed the following:

Indications for Use

• The Surgical Robotic Arm System (SRAS) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

• Operating Dimensions: (LxWxH) 24”x35”x56”

• RF Emissions: Class A

• Radiated RF: 3 V/m

• Power Frequenc7: (60 Hz) Magnetic field 3 A/m

• Line Surge: +/- 1 kV differential: +/- 2 kV common mode

• Conducted RF: 3 Volts

• Voltage Dip Immunity: Operated on 5%, 5%, 40%, and 70% of AC main power for 250 cycles, 0.5 cycles, 5 cycles, and 25 cycles, respectively

• Weight: No more than 870 pounds.

• Power requirement: Minimum 100 /120 / 23 V, 1150 W, -50-60Hz

• Foot Print: 24” x 35”

Cable Length:

• Foot Switch: 12 ft

• Arm Power: 20 ft

• Handpiece: 12 ft

• The SRAS is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy.

o These procedures include unicondylar knee replacement and/or patellofemoral knee replacement (PKA); Total knee arthroplasty (TKA); and Total Hip

Arthroplasty (THA).

Delivery:

• Vendor shall deliver equipment to the warehouse no later than 30-days from the date of award to the place of performance indicated below.

• Monday – Friday (Excluding National Holidays), 8am – 4:30pm:

PLACE OF PERFORMANCE: Malcom Randall VA Medical Center, 1601 SW Archer Rd, Gainesville Florida 32608.

WARRANTY OF EQUIPMENT: Contractor must provide manufacturer(s) warranty and any extended warranties on all provided equipment and accessories.

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.

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.

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