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SOURCES SOUGHT NOTICE: The Department of Veterans Affairs, Network Contracting Office 4 (NCO 04), is conducting a market survey to identify potential sources to provide full service maintenance for th... SOURCES SOUGHT NOTICE: The Department of Veterans Affairs, Network Contracting Office 4 (NCO 04), is conducting a market survey to identify potential sources to provide full service maintenance for the government owned CVX-300 Excimer Laser System located at the VA Pittsburgh Healthcare System (VAPHS) University Drive Campus, 4100 Allequippa St., Pittsburgh, PA 15240. This notice is issued for informational planning purposes only and is not a request for quote or announcement of a solicitation. Submitting information for this notice is voluntary and VA assumes no responsibility for any costs incurred associated with the preparation of responses submitted as a result of this notice. No solicitation is available at this time. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. The purpose of this market research is to identify capable sources that are both experienced and qualified to provide maintenance and repair of the CVX-300 Excimer Laser System. This equipment is utilized by VAPHS Cardiology for treatment of peripheral and coronary arterial disease. Due to the complexity of the system and classification of Class III medical device, it requires repair and maintenance by trained personnel using manufacturer approved parts and specifications. The reliable and accurate operation of this equipment at all times is considered critical to the health of patients. The North American Industry Classification System Code (NAICS) is 811219 Other Electronic and Precision Equipment Repair and Maintenance, and the small business size standard is $22.0 Million for this type of effort. Vendors must be registered in the System for Award Management (SAM https://www.sam.gov) and shall complete electronic annual representations and certifications in SAM prior to award of contract. If you are responding as a Service-Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses (SDVOSB s and VOSB s), your company must be registered in VETBIZ and maintain a current certification (https://www.vip.vetbiz.va.gov). CAPABILITY STATEMENT AND DOCUMENTATION: Companies are to provide a summary of your firm s capabilities, experience, and knowledge in providing these services. Sources are asked to provide the following information: 1. Company information: Company Name Company Address Company ueiSAM Company NAICS Code(s) Point of Contact Name Point of Contact Phone Number Point of Contact Email Address Company Website (if available) 2. The North American Industry Classification System Code (NAICS) is: 811219 Other Electronic and Precision Equipment Repair and Maintenance, SBA Size Standard - $22.0 Million Based on this information, please indicate whether your company is a: Service Disabled Veteran Owned Small Business (SDVOSB) Veteran Owned Small Business (VOSB) 8(a) HUB Zone Small Business Women Owned Small Business Small Disadvantaged Business (SDB) Small Business Concern Large Business 3. Provide a summary of your firm s Ability/ Capability to meet the services described in this notice (see attached SOW). In addition to a Capability Statement which provides the above, submissions can include specifications, brochures, and manuals as attachments. 4. Government contracts for these services in the last 3 years. Include: Government Agency Contract Number Dollar Value Period of Performance Government Point of Contact Information (name, email, phone number) Information regarding your company s capacity and capability to provide such services are to be submitted electronically on or before Monday, 05/30/20 addressed to Cynthia Grygier, Contracting Officer cynthia.grygier@va.gov. DRAFT Statement of Work A. GENERAL GUIDANCE Title: Full Service and Maintenance of VA Pittsburgh Medical Center owned CVX-300 Excimer Laser System Scope of Work: The Contractor shall provide full service and maintenance for government owned CVX-300 Excimer Laser System by the requirements stated herein. The facility is located at: VA Pittsburgh Healthcare System University Drive C Building 1 Pittsburgh, PA 15240 Background: This contract is issued to ensure the continuous reliability of the VA Pittsburgh owned CVX-300 Excimer Laser System in this SOW. The CVX-300 Excimer Laser System is utilized by VAPHS Cardiology, for treatment of peripheral and coronary arterial disease. Due to the complexity of the system and classification of Class III medical device, it requires repair and maintenance by trained personnel using manufacturer approved parts and specifications. The reliable and accurate operation of this equipment at all times is considered critical to the health of patients. Performance period: Base year plus options, see Schedule. Type of Contract: Firm-fixed-price. Biomedical Engineering: Lesley Lutao; Lesley.Lutao@va.gov (412-360-3760) Eric Ramsey; Eric.Ramsey@va.gov (412-495-4816) Assigned Biomedical Technician B. GENERAL REQUIREMENTS This agreement includes all preventive maintenance and corrective maintenance repairs to the following listed equipment for continuous reliability. Equipment to be Serviced: Each of the following items are to be serviced in accordance with the specifications, terms and conditions of this contract. Line item Manufacturer Model Serial No. Location Hospital Asset # 1. Spectranetics CVX-300 80274 UD-Cath EE#324014 Corrective Maintenance: The Contractor and Biomedical Engineering shall maintain the equipment in accordance with Section D Conformance Standards. Service for corrective maintenance will be provided per hours of coverage defined in Section B.1f. Contractor shall provide unlimited telephone technical support, labor, travel and parts, required consumable parts, gases, reference catheters and footswitches and shipment charges, unless specifically excluded. Service calls to the Contractor requesting service are only authorized when they are received from the Biomedical Engineering, CO, or designated alternates. Unplanned repairs require remote troubleshooting session prior to Field Service Engineer dispatch. Outside of the Contract s hours of coverage, emergency on-site services require authorization by the Biomedical Engineer. The Biomedical Engineering Staff Member shall initiate these calls. If VA staff other than the Biomedical Engineering Staff Member place calls requesting services, the Contractor shall contact Biomedical Engineering services and verify the request. Service responses on calls from unauthorized personnel can result in nonpayment. The VA Administrative Officer of the Day is an authorized caller and can also be contacted for verification. Uncorrected deficiencies or unfavorable histories of downtime can result in the termination of this contract under the Termination for Default clauses of the Federal Acquisition Regulations. Preventive Maintenance: The Contractor shall perform preventive maintenance (PM) service to ensure that equipment listed in Section B.1a performs in accordance with Section D Conformance Standards. Any exceptions to the PM schedule shall be arranged and approved in advance with Biomedical Engineering and provided in writing to the CO. The Contractor shall provide complete and original documentation indicating PM work performed, referencing the procedures followed, actual tests and/or evaluation results obtained to Biomedical Engineering at the completion of the PM service. Parts (including required consumable parts, gases, reference catheters and footswitches as well as shipment charges), travel, and labor necessary for PM are provided by awarded contractor at no additional customer cost. Any charges for materials such as lubricants, fluids, cleaning supplies, services, manuals, or tools required for the Contractor to successfully complete scheduled PM shall be provided by the Contractor and are included within this contract, and its agreed upon price. Preventive maintenance will be provided at a scheduled time and must be scheduled at least one week in advance to minimize the impact to patient scheduling. All exceptions to the preventive maintenance schedule and procedure shall be addressed and approved in advance with Biomedical Engineering. A designated staff member will accompany the Contractor as an observer during the inspection. The inspection shall be thorough and shall conform to manufacturer and Industry Standards for the equipment. Sufficient time shall be allowed to permit a thorough inspection and test of each device comprising the overall system. Maintenance work and inspections may be combined at the approval of Biomedical Engineering or alternate designee if downtime is not considered significant. The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs. Parts and Software The contract shall include coverage for all parts unless specifically excluded by the contractor. All parts supplied shall be OEM and fully compatible with existing equipment. Used parts (or refurbished), those removed from another system, shall not be installed without approval by the COR. The determination of compatibility is at the discretion of the COR. All defective parts replaced become the property of the Contractor, unless otherwise specified by the CO, COR, or Alt COR. Software patches and quality updates are included under the terms of this contract and shall be applied in accordance with manufacturer specifications. Remote Service The contractor must be able to provide remote support as needed by phone for the equipment owned by VA Pittsburgh. Personnel with OEM equipment training will respond by phone. If situations are responded to by phone and do not resolve the service issue, OEM trained personnel will be required to provide on-site service call within one business day for an on-site visit after receipt of initial notification unless otherwise agreed upon, in writing, by the COR or Biomedical Engineering personnel. If the contractor cannot remediate the issues within this timeframe, the COR or Alt COR shall be notified immediately and provided an estimated time for resolution. Hours of Coverage: The contractor will provide all required services within the normal business hours (8:00 AM to 5:00 PM (EST) M-F), excluding holidays. All services shall be performed during these normal hours of coverage unless one of the following conditions exists: The contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the Government, the contractor submits a request to the COR prior to the proposed start of the work, and the request is approved in writing by the COR before work is begun. The COR directs that the services be furnished at a time that is outside the normal hours of coverage and the additional cost is recommended by the COR and authorized by the CO. Work performed outside the normal hours of coverage must be preapproved by the CO, COR or Alt COR. The Contractor will provide a written estimate of the charges prior to approval of the work. Work performed outside the normal hours of coverage at the request of FSE/contractor shall be considered service performed during normal hours of coverage. There will be no additional charge for time spent waiting at the site during or after the normal hours of coverage for delivery of parts Note: Any hardware/software update/upgrade installations shall be scheduled and performed during normal hours of coverage at no additional charge to the government. Federal Holidays Observed by the VA Medical Center New Year s Day, Martin Luther King, Jr. Day, President s Day (Washington s birthday), Memorial Day, Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated by the President of the United States. Customer Notification: Contractor shall notify Biomedical Engineering and the Police service when they arrive on site. Contractor will schedule all preventative maintenance with Biomedical Engineering. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s) per Section E. The FSE shall be required to check out with the Biomedical Engineering Department and submit the ESR(s) to the COR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature." If the COR is unavailable, a signed accepted copy of the ESR will be sent to the COR within five business days of work completion. FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR TERMINATION OF THE CONTRACT. C. DEFINITIONS/ACRONYMS: Biomedical Engineering - Supervisor or designee, Phone Number (412) 360-3780 CO - Contracting Officer. COR - Contracting Officer's Representative. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer s latest established service procedures to ensure operation of equipment within manufacturer s or VA s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting, lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Medical Center premises. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract. Acceptance Signature - VAPHS employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR. Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR. NFPA - National Fire Protection Association. CDRH - Center for Devices and Radiological Health. VAPHS - Department of Veterans Affairs Pittsburgh Healthcare System. OEM - Original Equipment Manufacturer D. CONFORMANCE STANDARDS: Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, JC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA. E. DOCUMENTATION/REPORTS: The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each ESR must at a minimum document the following data legibly and in complete detail: Name of Contractor Name of FSE who performed services. Contractor Service ESR Number/Log Number. Date, Time (starting and ending), Hours-On-Site for service call. VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours. Description of Problem Reported by COR/User. Identification of Equipment to be serviced to include the following: Equipment ID # or EE # from the bar-code, Manufacturer's Name, Device Name, Model #, Serial #, and any other Manufacturer's identification numbers. Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including: Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action. Total Cost to be billed. Signatures from the following: FSE performing services described. VA Employee who witnessed service described. Equipment downtime calculated in accordance with Conformance Standards. Note: Any additional charges claimed must be approved by the COR before service is started. F. SCHEDULE FOR DELIVERABLES Draft copies of deliverables shall be provided to Biomedical Engineering staff at VAPHS before the contractor leaves the facility at each visit. If a final copy can be provided at that time then a draft copy is not necessary, final copies must be provided within 5 business days of the time of each deliverable. G. CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor. H. SERVICE MANUALS/TOOLS/EQUIPMENT VAPHS shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation, (such as: operational and service manuals, schematics, and parts list), which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request. Prior to commencement of work on this contract, the contractor shall make available if requested a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by VAPHS. Test equipment calibration shall be traceable to a national standard. I. CONDITION OF EQUIPMENT: The contractor accepts responsibility for the equipment described in this scope of work, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract. J. CONTRACTOR EXPERIENCE REQUIREMENTS Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup. Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment or similar equipment identified in Section B.1a. The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at VAPHS. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VAPHS equipment. The CO and/or the COR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAPHS equipment. Any Contractor personnel must provide a copy of 1) Tuberculosis (Tb) vaccination documentation, 2) flu vaccination documentation and 3) copy of HIPAA compliance training certificate. K. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD: The contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The contractor shall: Have methods by which all employees are educated as to risks associated with bloodborne pathogens. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract. L. INFLUENZA PREVENTION PROGRAM: VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Healthcare 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. Those HCP 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 healthcare provider or pharmacy, or a copy of medical records documenting the vaccination. Completed Healthcare 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 to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities are in compliance with the VHA Directive 1192. M. COVID-19 PRECAUTIONS: Contractors scheduled to go onsite are required to provide COVID negative test not more than 72 hours prior to visitation or provide proof of COVID vaccination. Contractors reporting previous positive COVID test with clearance by medical professional are not required to undergo testing. Upon entering VAPHS, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask, to be worn correctly by covering the nose and mouth at all times. PPE will not be provided by VAPHS. All individuals are required to enter through the main entrance for temperature screening. If Contractor s temperature exceeds the designated threshold, they will be asked to leave. In the event of an FSE being forced to vacate the premises, they shall notify the necessary Biomedical Engineering staff and provide a contact for replacement. If you are within 6 of staff for greater than 15 minutes, you are additionally required to wear eye protection. i.e. clinical training etc. If you are required to work in patient care areas, you are additionally required to wear eye protection. N. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. O. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS: The contractor's FSE shall wear visible identification at all times while on the premises of VAPHS. Identification shall include, as a minimum, the employee s name, position, and the contractor s trade name. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. VAPHS will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings and on premise at VAPHS. This covers all smoking and tobacco products, including but not limited to: Cigarettes Cigars Pipes Any other combustion of tobacco Electronic nicotine delivery systems (ENDS), including but not limited to electronic or e-cigarettes, vape pens, or e-cigars. Chewing tobacco Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court. P. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS Contractor may not have access to the VA network or any VA sensitive information under this contract. If working on-site, contractor will be required to comply with security guidelines. Contractor is required to: Be registered on the vendor credentialing and visitor management system called Symplr - https://www.symplr.com/. Add VA PITTSBURGH HEALTHCARE SYSTEM UNIVERSITY DRIVE: PITTSBURGH, PA to their territory. Contractor must be greenlighted prior to working on site. Greenlight requires completed information and up to date documentation. Check in with the VA Police and Biomedical Engineering (Ground floor, Room AN305C) each time they come on-site to perform contracted services or by obtaining a VA Contractor ID badge from the VA Police. VA ID badge must be worn at all times while on VA premises. Check out with Biomedical Engineering and provide summary of work done see Customer Notification. Contractor owned computer equipment including laptops are not permitted to be connected to the VA network. Any removable storage device used in medical equipment must be scanned by Biomed or OIT. All Contractors must receive Privacy training annually using one of the following methods: Complete VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information training by using VA s TMS system (https://www.tms.va.gov/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The COR must ensure that all contractors are validated in the PIH domain. Complete the hard copy version of VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information . Signed training documents must be submitted to the COR. Training must be completed prior to the performance of the contract and annually thereafter. Proof of training completion must be verified and tracked by the COR. Q. VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors Contractor employees who work in or travel to VHA locations must comply with the following: Documentation requirements: If fully vaccinated, shall show proof of vaccination 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 and granted a medical or religious exception, 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. 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 following website: COVID-19 Screening Tool. Regularly check the website for updates. Contractor employees who work away from VA locations, but who will have direct patient 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.