6515--Brand Name Only - STRYKER MAKO 3-App Robotic Arm System and Applications. Unrestricted

DEPARTMENT OF VETERAN AFFAIRS STATEMENT OF NEED MAKO ROBOTIC ARM SYSTEM AND APPLICATIONS Introduction: The Wilkes-Barre VA Medical Center, located at 1111 East End Blvd., Wilkes-Barre, Pa, 18711, has a brand name only requirement for one (1) STRYKER - MAKO Robotic Arm System and Applications. History/Background/Purpose: As a Level II Intermediate Facility Wilkes-Barre VA Medical Center has a new brand name only requirement to procure one (1) STRYKER - MAKO Robotic Arm System and Applications to perform surgical procedures in the operating room. This advanced technology is a remarkable tool in the battle against knee and hip pain and will extend and enhance the quality, precision, and safety of total knee and total hip replacement procedures presently being completed at our facility for the Veterans we serve. WBVAMC has four (4) full time Orthopedic Surgeons, and the procurement of this system and application would allow for expansion of the current surgery program to include thoracic or vascular surgery services, transplant surgery, cardiac surgery, bariatric surgery, neurosurgery, or total joint replacement and initiation or expansion of advanced technology applications to already approved procedures, i.e., radiofrequency ablation, cryotherapy, robotic surgery, and sentinel node evaluations (pathology and nuclear medicine). The addition of this system in WB VAMC would increase the volume of surgical procedures possible, provide better surgical outcomes, improve patient satisfaction, strengthen the Choose VA conversation for Referral Coordination Initiatives, and VHA DIRECTIVE 1043 APPENDIX A A-4 reduce Wilkes Barre s reliance on the community and VISN partner sites. Wilkes-Barre VA Medical Center Case Load Data Wilkes-Barre FY2021 # of VA Medical Procedures Center Case Load Data Specialty Orthopedic Surgery FY2022 # of Procedures FY2023 (to-date) # of Procedures FY2024 Projection Total Knee 45 Replacement 50 37 65 Total Hip 29 27 14 Replacement Value to our Veteran Community: The WB VAMC Surgical Service would like to offer the same competitive orthopedic services to our Veterans that is currently being offered in within our catchment location and in facilities outside of VISN 4. 111619 SILICONE RETRACTOR CORD 40 110135 MICS, 6MM BALL BUR 40 116239 MICS IRRIGATION CLIP-STERILE 40 111613 RIO® SYSTEM IRRIGATION TUBE 40 Delivery Requirement: Delivery accepted at the Wilkes Barre VA Medical Center, Attn: Warehouse, 1111 East End Blvd, Wilkes Barre, PA 18711 Weekdays 8:00am 4:00pm, excluding any government holidays. Attention: Operating Room. The C&A requirements do not apply, and that a Security Accreditation Package is not required.//WCL. General Requirements The contractor shall provide all labor, equipment, tools, materials, and other items necessary to deliver and install the equipment and materials listed in the Statement of Need. All equipment shall be installed without modifications to the existing structure or utilities. TEST AND ACCEPTANCE: Contractor shall test all equipment after installation to confirm proper operation. The VA shall accept equipment once installation and successful testing has been completed and approved. Installation Dates and Delivery Installation of all equipment shall be coordinated with the VA and shall take place within 30 days of contract award. No equipment shall be delivered or will be accepted before award and must be coordinated with the COR/POC. All items must be delivered to the following location: Wilkes-Barre VA Medical Center 1111 East End Blvd. Wilkes-Barre, PA 18711 Warehouse Supervisor: Kaitlyn Varneke Phone: +1 (555) 000-0000 X 27178 Email: contact@example.gov Monday Friday from 8:00am 4:30pm GOVERNMENT FURNISHED INFORMATION OR MATERIAL: This acquisition does not include Government-furnished property (GFP), identify in the Statement of Work all available information on GFP to be provided, including the make, model, bar code number and serial number, if available, of all accountable assets with an acquisition cost of $500 or more. This acquisition does not include Contractor-acquired property (CAP). REPORTS/DELIVERABLES: Delivery confirmation of equipment and commodities will be made through the Logistics Department of the VAMC Wilkes-Barre (693). This will include documentation of receipt and assignment of a facility based EE number for identification and tracking purposes. Delivery confirmation of non-equipment/ commodities acquisitions is the responsibility of the receiving Facility and/ or Service. PERIOD OF SERVICE: Delivery must be made no later than 30 days After Receipt of Order. VHA Supplemental Contract Requirements for Combatting COVID-19 1) Contractor employees who work in or travel to VHA locations must comply with the following: 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. 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. 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. 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. 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 COVID19 Screening Tool. Check regularly for updates. 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. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities. 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. Influenza Vaccination VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical, and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractors. Personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VA. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation: - Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination. - Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine. The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities is in compliance with VHA Directive 1192. Tuberculosis Prevention Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually. HIPAA Training Certificates If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract. Smoking All VA Pittsburgh property is smoke-free. Contractor personnel will comply with VA Pittsburgh smoking policies. Violations will result in a warning and possible citation