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STATEMENT OF NEED VA PITTSBURGH HEALTHCARE SYSTEM Title of Project: Purchase request for a BRAND NAME ONLY - Simbionix GI-BRONCH Mentor Simulator by 3D Systems. Background: The Simbionix GI-BRONCH Men... STATEMENT OF NEED VA PITTSBURGH HEALTHCARE SYSTEM Title of Project: Purchase request for a BRAND NAME ONLY - Simbionix GI-BRONCH Mentor Simulator by 3D Systems. Background: The Simbionix GI-BRONCH Mentor Simulator provides a focused instruction and the ability to provide unsupervised practice using a virtual bronchoscopy/endoscopy simulator for both novice and more experienced staff and healthcare trainees to attain a level of manual and technical skill at performing diagnostic bronchoscopic and endoscopic inspection like those of colleagues with several years of experience. These skills were readily reproducible in a conventional inanimate airway-training model, suggesting they would also be translatable to direct patient care to decrease the risk of patient injury. In recent years the use of flexible bronchoscopy has increased in critical care and anesthesia. It has become a standard of care for examining, diagnosing, and managing critical care patients and an important adjunct to anesthetic management of airway problems. Scope of Need: The Simbionix GI-BRONCH Mentor Simulator will be utilized to train CCM, GI, and Pulmonary VAPHS staff and healthcare professionals. The Simbionix GI-BRONCH Mentor Simulator flexible configuration supports real life options such as posterior and lateral working positions, oral or nasal scope introduction, various classification methods for bronchial segments, and team or solo practice. A variety of virtual patient cases exhibiting realistic all-inclusive patient behavior enable training and assessment of patient management during elective, ICU and emergency situations. Objectives: Using the Simbionix GI-BRONCH Mentor Simulator, VAPHS staff and healthcare trainees are provided with an educational and training opportunity covering the full extent of the bronchoscopic and endoscopic procedures, while allowing for gradual and controlled simultaneity thus optimizing the individual learning curve. Tasks: Realistic simulation environment, incorporating authentic scope with tactile feedback and simulated physics, flexible working setup, and a full screen mode in which display is restricted to displays available during a real procedure. True to life patient environment consisting of virtual patient cases modeled after real patients, with varying anatomies and diverse pathologies. Each patient environment exhibits simulated physiology including larynx contraction, breathing and coughing, and individual attributes such as difficult to sedate, being prone to bleeding etc. The highly reactive simulation incorporates reactive vital signs and consciousness level affected by virtual patient characteristics and user actions, as well as reactive complications, such as hypoxemia, bleeding, hypotension, hypertension arrhythmia and more. Comprehensive ongoing patient management including moderate sedation administration with varying effects on virtual patients, topical anesthesia administration and influence, oxygen supplement and complete patient monitoring. Educational aids enhancing 3D perception and anatomical knowledge such as external visualization, anatomy atlas, internal orientation aids, anatomy labels, etc. Educational environment promoting safe and efficient performance including real time guidance warnings and alerts, tutorials and video clips and comprehensive performance metrics. The instructor can conveniently monitor trainees individual progress. Elaborate performance metrics allow for retrospect and evaluation after each performance. Effective evaluation of various bronchoscopic skills, patient management and clinical performance is easily accessible at all times. Equipment Items: Simbionix GI-BRONCH Mentor Simulator Basic GI Package: Self-contained, haptic, GI-BRONCH Mentor Simulator configured with a Basic GI Package of training modules. Two Cyberscopy Training Modules Two Colonoscopy Training Modules Two Gastroscopy Training Modules MentorLearn Offline Training Management System GI Endoscopy Fundamental Skills (GI-EFS) Training Module Technical Specifications: The Combined GI-BRONCH Mentor Platform Offers a Comprehensive Training Environment for GI Endoscopy and Flexible Bronchoscopy Detailed System Description: System and Trolley: Stainless steel support 130 cm L X 57 cm W X 175 cm H Movable arm for screen Optional Height Adjustment: Min/max height (top of monitor) 69 /75 Monitor: 24" Flat LCD touch screen Mannequin: Mouth and buttocks for upper/lower GI Nose and mouth for Bronchoscopy Haptic The system is equipped with a reliable high end technological Haptic (force feedback) to provide realistic sensations that mimic the look and feel of an actual procedure Endoscopes per ordered modules Pentax ECS-3840F - Upper and Lower GI Pentax ED-3440T ERCP/EUS Pentax EB-1830T3 - Bronchoscopy Tools / Accessories per ordered modules One Master Tool device - Upper and Lower GI Two Guide-wire devices - ERCP One Master Tool device Bronchoscopy One 10cc Syringe Bronchoscopy One EBUS Needle Bronchoscopy Double Foot Switch Delivery: The company will deliver the equipment to VA Pittsburgh Healthcare System, University Drive Campus Warehouse, 4100 Allequippa St. (University Drive C), Pittsburgh PA 15240 within 30 days of contract award as listed above to include shipping, setup, calibration, installation, and training to VAPHS in appropriate shipping containers once it has been appropriately processed. Contractor shall coordinate with the COR to provide delivery according to the timeline. Please contact the Point of Contact to schedule delivery or with any questions or concerns. POC: Elias, Mary Ellen Phone: 412-360-6592 Email: maryellen.elias@va.gov Note: The POC has no authority to change the terms and conditions of the awarded contract. Hours of Operation Normal hours of operation are Monday through Friday from 8:00 am to 4:30 pm, excluding holidays All work must be scheduled in advance with the COR on a mutually agreed upon date and time. Emergency services required shall be coordinated through the COR. Contractor must be available to perform emergency services within 3 hours of notification. Federal Holidays observed by the VAMC are: New Years Day Labor Day Martin Luther King Day Columbus Day Presidents Day Veterans Day Memorial Day Thanksgiving Day Independence Day Christmas Day Government Furnished Property: None Place of Performance: VAPHS, UD, BLDG 29, 2M312 Period of Performance: The Simbionix GI-BRONCH Mentor Simulator will be used delivered and installed within 30 days of award with training occurring over the course of 12 months from award. Instructions The information identified above is intended to be descriptive, of the Brand Name Only Simbionix GI-BRONCH Mentor Simulator by 3D Systems, to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339112. Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (5) Describe how your small business takes ownership of the equipment in the manufacturing, assembly, or delivery process. (6) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (7) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job. (8) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. (9) If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (10) Please submit your capabilities regarding the brand name equipment. (11) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Responses must be received via email to david.santiago2@va.gov no later than, 4 PM Eastern Standard Time (EST) on Wednesday March 30, 2022. This notice will help the VA in determining available potential sources only. Reference 36C24422Q0547 in the subject of the email response. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, David Santiago. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. If a solicitation is issued, information will be posted on the beta.Sam web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for a set-aside. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by email to Contracting Specialist at david.santiago2@va.gov DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. 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 Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS. 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. COVID 19 Contractor shall provide evidence of vaccination records or a negative COVID testing result within 72 hours of planned onsite visitation. This is to include installation, training, maintenance and repairs. Emergency repairs will be evaluated on a case-by-case situation. 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.