Attach 01-SOW.docx

Statement of Need for Zeiss Tivato 700 ENT Comfort Package Corporal Michael J. Crescenz Department of Veterans Affairs Philadelphia VA Medical Center 3900 Woodland Ave Philadelphia, PA 19104-4551

1. Background

1.1. The Corporal Michael J. Crescenz Philadelphia VA Medical Center Otolaryngology Department has a new requirement for the Zeiss Tivato 700 ENT Comfort Package. The current Zeiss microscope is old and limited by outdated technology and is developing maintenance issues. Due to the obsolescence of numerous parts, the manufacturer can no longer support the service needs of this legacy unit and it has also exceeded its service life. The current microscope patient safety is significantly compromised with severe lack of depth perception, poor visualization of critical detail, and differing views between supervisory and resident surgeon.

1.2. The microscope would be shared among four (4) board-certified ENT physicians as well as mid-level and a senior ENT resident in the performance of cases performed in the operating room. To effectively operate on ENT patients with small microscopic structures, the providers must be able to visualize these structures with a magnification microscope. Without this piece of equipment, the VA would have to utilize Community Care to perform delicate ENT procedures at a considerable cost to the VA for patient care and hospitalization.

2. Scope

2.1. The Zeiss Tivato 700 ENT Comfort Package is used for performing ENT surgical procedures of all types. The surgical microscope allows for optimized workflow through the automatic inversion of the microscope and video images. The system allows for safe instruction of resident surgeons where it is important for the assistant to see the surgical field with the same stereopsis as the main surgeon.

3. Requirement

3.1. Zeiss Tivato 700 ENT Comfort Package (Brand name Only)

3.1.1. Active vibration dampening strengthened by robotic movements

3.1.2. Large working distance of 200-625 mm

3.1.3. Intuitive graphical user-interface

3.1.4. Ready for digital operating rooms with the ability to digitally manage surgical data with Zeiss Apps

3.2. Salient Characteristics

3.2.1. Main Tubes Straight

3.2.1.1. Binocular Tube

3.2.1.2. 180° tiltable Tube

3.2.1.3. Foldable Tube f170/f260

3.2.2. Eyepieces

3.2.2.1. 10x wide-field eyepieces

3.2.2.2. 12,5x wide-field eyepieces

3.2.2.3. Focus SpeedFokus

3.2.3. Illumination

3.2.3.1. Xenon

3.2.3.1.1. Fully integrated Xenon light source with automatic lamp exchange

3.2.3.1.2. TriLED

3.2.3.1.3. Fully integrated LED light source

3.2.3.2. Co-Observation

3.2.3.2.1. Face-to-face with StereoBridge

3.2.3.2.2. Left/Right with Stereo Co-observer

3.2.3.3. XY-Movement

3.2.3.3.1. Angular movement with joystick or foot pedal

3.2.3.4. Video System

3.2.3.4.1. Standard HD Video Package

3.2.3.4.1.1. Fully integrated 1-chip HD camera, 1080p

3.2.3.4.2. Premium HD Video Package

3.2.3.4.2.1. Fully integrated 3 chip HD camera, 1080p

3.2.3.4.3. 4K Video Package

3.2.3.4.3.1. Fully integrated 3-chip 4K camera, 2160p

3.2.3.5. Video Options

3.2.3.5.1. Videorecording

3.2.3.5.2. HD Video-In

3.2.3.6. Fluorescence

3.2.3.6.1. Zeiss YELLOW 560 Preparation

3.2.3.6.2. Zeiss INFRARED 800 Preparation

3.2.3.7. Visualization

3.2.3.7.1. Additional Depth of Field

3.2.3.8. Networking & Storage

3.2.3.8.1. Integrated 1TB Hard drive

3.2.3.8.2. Wireless Network Package

3.2.3.8.2.1. Enables WLAN and Wi-Fi Hot Spot functionality

3.2.3.8.3. Shared Network Package

3.2.3.8.3.1. Storage on shared network directories

3.2.3.8.4. DICOM Package

3.2.3.8.4.1. Patient data exchange with PACS system via DICOM

3.2.3.9. Zeiss Smart Services Package

3.2.3.9.1. Connectivity for ZEISS Smart Services

3.3. Table

4. Specific Tasks

4.1. Vendor must arrange for a mutually agreeable time to install and train end users on new equipment

4.2. Vendor must also arrange with Biomedical Engineering a mutually agreeable time to review specifics of microscope operation and preventative maintenance

4.3. Vendor must provide at least one (1) hardcopy maintenance manual to Biomedical Engineering

5. Delivery

5.1. Hours of operation are 0800-16:30 ET, Monday-Friday excluding Holidays.

5.2. The warehouse must receive all equipment prior to Biomedical Engineering inspecting the equipment. Biomedical Engineering must inspect the equipment prior to deployment in the operating room. Biomedical Engineering must notify the Contracting Officer of any disputes with equipment deliverables.

5.3. Address

Philadelphia VA Medical Center Attn: RCV, PO # 3900 Woodland Ave Philadelphia, PA 19104

Mark for: Government Contact

6. Place of Performance

6.1. Corporal Michael J. Crescenz

Department of Veterans Affairs Philadelphia VA Medical Center 3900 Woodland Ave Philadelphia, PA 19104

7. Period of Performance

7.1. 30 DAYS ARO

8. VHA Supplemental Contract Requirements for Combatting COVID-19

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

8.1.1. Documentation requirements:

8.1.1.1. If fully vaccinated, contractors shall show proof of vaccination.

8.1.1.1.1. 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.

8.1.1.2. 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.

8.1.1.3. 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.

8.1.1.4. 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.

8.1.2. 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.

8.1.2.1. 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.

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

8.1.4. 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.