Attachment B Statement of Need.pdf

Attachment B

36C24823Q0698

Statement of Need

GENERAL: The operating room at the Malcom Randall VA Medical Center, located at:

1601 SW Archer Rd, Gainesville Florida 32608, has a requirement to replace 12 end-of-life

Surgical Tables.

BACKGROUND:

Malcom Randall VA Medical Center Operating Room surgical tables reached end-of-life and are due for replacement. Gainesville currently has 11 OR suites to support over 15 surgical services so the surgical tables shall be able to support various accessories and attachments to support the numerous positions and surgical procedures performed in our facility. Our department has 1968 infrastructure and very limited storage space. For this reason, the surgical table shall have “auto-drive” feature so that a single staff member can “drive” the surgical tables to storage or O.R. suite without injuring themselves pushing/pulling heavy surgical tables.

1. General Surgery

• Supine position with single or split leg plate

• Lateral position for nephrectomy procedures

• Genucubital position with rectal positioning device

• Standing positioning for bariatric surgery

• Sitting position for bariatric surgery with seat plate and leg

• Sitting position for surgery with split leg plates

2. Gynecology and Urology

• Lithotomy position with leg holder

• Lithotomy position with seat plate extension and leg holder

• Lithotomy position with leg holder and TUR set

• Lithotomy position with leg holder and vacuum mattress

3. Ophthalmology, ENT, Oral and Facial Surgery

• Supine position with horseshoe head rest

• Supine position with head rest and head ring

• Supine position with motorized head rest adjustment

4. Neurosurgery

• Supine position with carbon fiber skull clamp

• Supine position with steel skull clamp

• Park-bench positioning

5. Orthopedics and traumatology

• Prone position

• Prone position with long carbon fiber plate

• Lower arm surgery with hand operating table in supine position

• Lower arm, vascular surgery in supine position with hand operating table and long carbon fiber plate, reverse orientation

• Cervical spine surgery in supine position with carbon fiber back plate

• Elbow surgery in prone position

• Genucubital position with kneeling frame and buttocks support

• Beach chair position with short back plate for shoulder operations

• Beach chair position with long back plate for shoulder operations, reverse orientation

• Knee arthroscopy in supine position

• Lower leg fracture with carbon fiber pair of leg plates

• Femur surgery in supine position, traction on the extended leg

• Femur surgery in supine position, traction on the extended leg, nonoperative leg on leg holder

• Femur surgery in supine position, transcondylar traction, nonoperative leg on leg holder

• Femur surgery in lateral position with femur countertraction post

• Tibia surgery in supine position with countertraction post for tibia and fibula and joint supporting arm

• Tibia surgery in supine position with countertraction post for tibia and fibula, nonoperative leg on leg holder

• Tibia surgery in supine position with countertraction post for tibia and fibula, nonoperative leg on universal support

SPECIFIC NEED & SALIENT CHARACTERISTICS:

Clinical

• Multi-disciplinary surgical table shall be able to support all listed procedures listed above.

• Surgical Table shall have a height range of 23.6” – 41.3”

• Shall have range for Trendelenburg/Reverse Trendelenburg of 25 degrees / 35 degrees.

• Shall have Lateral tilt range up to 20 degrees.

• Lower Back plate shall have movement range of +70 degrees/-40 degrees.

• Leg Plate shall have movement range of +80 degrees / -90 degrees.

• Length of operating tabletop with standard back plate, head rest, and leg plate must be minimum of 80” in length.

• Width of surgical table shall be a minimum of 21” without side rails and minimum of 23” with rails.

• Surgical Table shall have a Maximum Radiolucent area must be a minimum of 64”.

• Surgical table shall have a maximum overall load of 1,000 lbs. in normal orientation.

• Surgical table shall have the ability to support a minimum of 550 lbs. in reverse orientation.

• Surgical table shall be able to support multi-disciplinary services and procedures. Must be able to support a minimum of 45 patient positions.

• Surgical table shall have the ability to store up to 10 positioning options to meet surgeon needs.

• Surgical table shall include enhanced safety feature, three-point stance for locking the table and keeping it stable throughout procedure. (Reduces risk of patient injury during surgery by preventing table movement).

• Surgical table shall have the ability to offer consistent radiolucency at a minimum of 64”.

• Surgical table shall include auto-drive feature. (Patient and staff safety feature). Allows 1 operator to safely “drive” the surgical table from OR suite to storage room. This prevents work injuries having to move extremely heavy surgical tables y multiple staff members. (Auto-drive feature assists in reducing workplace injuries).

• Surgical table shall include override panel that has a smooth surface made of glass fiber reinforced composite plastic, resistant to impact, breakage, and disinfectants. (Safety feature—easy access to table controls in the case of an emergency). (Maintains operation of the surgical table in the event of a hand control failure, resulting in reduced downtime).

• Surgical table shall include safety feature—headrest safety latch. (Safety latch ensures the headrest remains inserted into the table in the event the clinical tame does not secure the headrest locking screw).

• Surgical table shall include the option(s) to use a wired or cordless pendant control for table. (This allows surgeon / anesthesia provider unrestricted access to position table even when sterile field setup).

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 extended warranties on all provided supplies and equipment.

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.

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

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.