65--A00002 Pulmonary Cryosurgical System

Amendment 36C25618Q0241 A00002 CLOSING DATE EXTENSION: January 16, 2018 12:00pm Questions and Answers Question - 6.2: The Pulmonary Cryosurgical System must permit maintenance professionals the ability to perform diagnostics, troubleshooting, and maintenance as required. Our standard policy for this equipment is that the VA Medical Center Maintenance professionals will have limited abilities until they attend the manufacturers training session. Upon successful completion of training, the attendee will be provided an authorization Memo stating exactly what he/she is authorized to perform, which reflects the position of the manufacturer and the manufacturer s parent company. As a result, can this section be removed or a line item added should the VA wish to send maintenance professionals to the manufacturers facility for this training? Answer - I have used the system before on the patients - we can set up in-service training once the equipment arrives to the facility Question - 6.4.1: The Contractor shall provide, for the duration of the warranty period, all computer software, access keys or codes, or external devices required for the operation, calibration, or repair of the equipment purchased. - Any such items not listed on the price proposal and required for maintenance of the system, shall be taken as included with the purchase of the system. - Our standard policy for this equipment is that for liability reasons the Calibration Procedures and Passwords for the VIO / APC2 devices are Not Authorized for release to Customers. Also, Maintenance / Diagnostic / Calibration software is not authorized for customer release as determined by the manufacturer s parent company. As a result, can this requirement be removed? Answer - yes. 6.4.1. is removed. Question - 6.4.2 Any minor upgrades or changes to the maintenance software, hardware, or access keys or codes shall be provided at no charge to the medical center during the time the equipment is operational at this facility. - Our standard policy for this equipment is that updates as defined by the manufacturer will be completed only as being necessary and per directive from the manufacturer s parent company. Insignificant updates (i.e. Chinese language character changes) are not included in this definition. Changes that affect functionality or device performance will be available for Ascension per guidelines as stated below. SPECIFICALLY - Whenever Software Updates are released, (Revision Changes) the manufacturer s parent company will: Determine the impact per regulatory requirements. Direct the applicability /guidelines for any required change as it applies to the manufacturers devices. - Manufacturer by law will /must comply with the manufacturer s parent company directives. Software revision structure and change guidelines are controlled by the manufacturer s parent company and take precedence over entities definitions/requirements for updating units. - Manufacturer will determine related costs associated with updating devices and at their discretion determine their applicability. - Per Manufacturer s parent company, all software updates will be provided only at the direction of manufacturer s parent company. As a result, can this requirement please be clarified to be consistent with our standard policy? Answer Yes. 6.4.2. is removed. Question - 6.5.1 The Contractor shall provide support services for a period of one year, and option of additional four years. Support services may be in the form of telephone/teleconference and/or face-to-face when deemed necessary by the Government. - Contractor shall provide list of contact options for non-face-to-face visits. Contractor support shall be available to the Government Monday through Friday, including weekends. Our standard policy for this equipment is that all service is provided by our manufacturers Technical Support staff in Marietta, GA. We, nor our manufacturer, at this time, has on-site service support. All repairs and warranty work is completed at our manufacturers DEPOT repair facility. Technical support is available 24 / 7 via a Toll-Free Number which will be provided should an Award be made to us. As a result, can this requirement please be removed or updated to reflect our standard policy? Answer - yes. VA Medical Center, New Orleans agrees to the 24/7 Technical support. Question - 6.5.5 Response time for CM repairs during normal VA working hours will be Monday through Friday, 8:00 am to 4:30 p.m. Responses time are required at a minimum of Sixty (60) minutes call back, three (3) hours on site in an emergency and twenty-four (24) hours regular, excluding holidays. Our standard policy for this equipment is that all service is provided by our manufacturers Technical Support staff in Marietta, GA. We, nor our manufacturer, at this time, have on-site service support. All repairs and warranty work is completed at our manufacturers DEPOT repair facility. Technical support is available 24 / 7 via a Toll-Free Number which will be provided should an Award be made to us. As a result, can this requirement please be removed or updated to reflect our standard policy? Answer - yes. VA Medical Center, New Orleans agrees to the 24/7 Technical support. Question - 6.4.6 Preventative Maintenance (PM) inspections shall be provided at a minimum of once a year. It shall include, but not limited to, running system diagnostics (hardware and software), calibrating, adjusting and lubricating per OEM specifications, checking for leakage current and ground wire resistance. - Our standard policy for this equipment is that all Service is provided by our manufacturers Technical Support staff in Marietta, GA. We, nor our manufacturer, at this time, have on-site service support. All Preventive Maintenance requests will be the responsibility of the VA Medical Center, New Orleans to contact us or the manufacturer for such services. As a result, can this requirement please be clarified to be consistent with what our standard policy is? Answer - Yes. VA Medical Center, New Orleans will contact the company for services as described above. Question - 6.5.6 The contractor is responsible for incorporating all manufacturers' recommended hardware and software updates, which ensure performance to current product specifications at no additional cost to the VA. Our standard policy for this equipment is that per the manufacturer, all software updates will be provided only at the direction of the manufacturer s parent company. As a result, can this requirement please be clarified to be consistent with what our standard policy is? Answer -- Yes. VA Medical Center New Orleans agrees to the standard policy. Question - 6.5.7 Contractor must have the capability to provide remote support via VPN access. VA will provide authorized personnel limited access for remote connectivity to the system. We, nor the manufacturer, have the ability to provide remote support via VPN access. As a result, can this requirement please be removed? As a result, can this requirement be removed? Answer - Yes. 6.5.7 is removed. Question - 7.2 The contractor shall provide a training program to the Biomedical Engineering technicians and in-house clinical personnel. Our standard policy for this equipment is that all technical training is provide only at the manufacturers facility in Marietta, GA, per schedule. As a result, can this requirement please be removed? Answer - Yes. 7.2 is removed. Question - 7.3 Technical training must provide Biomedical Engineering with the tools and knowledge to fully operate and maintain the system. Tools - Are the procedures and specific technical training for our manufacturers devices. It does not imply testing equipment, software or associated items that are not authorized for customer release/usage. As a result, can this requirement please be clarified to be consistent with what our standard policy is? Answer Yes. VA Medical Center New Orleans agrees to this standard policy.