J065--Intent to Sole Source. Full-Service and Maintenance of Baxter Phoenix Dialysis equipment at the Philadelphia VAMC. New 5-year. This is NOT a Request for Quote.

Send a capability statement, no more than one page in length; to include Company Name, Duns Number, Socioeconomic Category, brief description of your business entities capability to handle this particular project in the Philadelphia, PA. area, website and GSA Contract number & or other VA Medical Center contract information. Email to David Santiago, [email protected] with 36C24421Q0661 in the email Subject line, no later than 4:00 pm (EST) Friday May 7, 2021. Draft Statement of Work A. GENERAL GUIDANCE Title: Full Service and Maintenance of the VA Philadelphia Medical Center owned Phoenix Dialysis equipment. Scope of Work: The contractor shall provide standard service and support for government owned Phoenix Dialysis system required by the requirements stated herein. The facility is located at: VA Philadelphia Medical Center 3900 Woodland Ave Philadelphia, PA 19104 Background: This contract is issued to ensure the continuous reliability of the Phoenix Dialysis equipment and associated hardware. This equipment requires repair and maintenance by trained personnel using manufacturer approved parts and specifications. This system is critical for Hemodialysis at the VA Philadelphia Medical Center, and the reliable and accurate operation of the equipment at all times is considered critical to the health of patients. Performance period: Base year plus option years, see Schedule. Type of Contract: Firm-fixed-price. B. GENERAL REQUIREMENTS This agreement includes all hardware and software support for the Phoenix Dialysis equipment for continuous reliability. Services included and to be provided under the standard service coverage include the following: Software licensing and support Computer hardware warranty and support Volume PRO co-processing board warranty and support Telephone and Remote Support Provide necessary operating system and applications software support, including telephone and online support 24x7. On-site emergency service Ongoing Software updates Remote Service: Personnel with OEM equipment training will respond directly by phone within 2 hours of the call for service. If situations are responded to by phone and do not resolve the service issue, OEM trained personnel will be required for an on-site visit within 1 business day after receipt of initial notification unless otherwise agreed upon, in writing, by Biomedical Engineering personnel. Full resolution is expected within 48 hours of initial call. If the contractor cannot remediate the issues within this timeframe, Biomedical Engineering personnel 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), but 24x7 service will be provided when necessary. Customer service shall respond to service request calls 24 hours a day, 7 days a week and all holidays. Parts: All parts supplied shall be OEM and fully compatible with existing equipment. No refurbished parts shall be used in the repairs of units covered in this contract. The contract shall include all parts with the exception of consumable or expendable items and specialty components. Used parts, those removed from another system, shall not be installed without approval by Biomedical Engineering. The contractor is required to install VA supplied parts when said parts are determined to be fully compatible. The determination of compatibility is at the discretion of Biomedical Engineering Staff. All defective parts replaced become the property of the Contractor, unless otherwise specified by the CO or Biomedical Engineering. Customer Notification: Contractor shall notify Biomedical Engineering and the Police service when they arrive on site (Biomedical Shop Room 33A152, building 2). Contractor will schedule all preventative maintenance with Biomedical Engineering. All vendor mobile media devices (USB drives, CDs, DVDs, etc.) must be scanned by Biomed before use. 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 designated personnel. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to Biomedical Engineering for an "authorization signature." A signed accepted copy of the ESR will be sent to Biomedical Engineering 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 (215) 823-5800 x5829 CO - Contracting Officer. 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 - VAPHI employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR. Authorization Signature Biomedical Engineering Staff signature; indicates Biomedical Engineering accepts work status as stated in ESR. NFPA - National Fire Protection Association. CDRH - Center for Devices and Radiological Health. VAPHI - Department of Veterans Affairs Philadelphia Medical Center. OEM - Original Equipment Manufacturer CEU Continuing Education Credit D. CONFORMANCE STANDARDS: Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, 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. ESR s must also be emailed to [email protected], with the Vendor Name and contract Obligation Number listed in the Subject Line. 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 Biomedical Engineering/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 Biomedical Engineering (through the CO) before service is started. F. SCHEDULE FOR DELIVERABLES Draft copies of deliverables shall be provided to Biomedical Engineering staff at VAPHI 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 VAPHI 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 VAPHI. 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 system identified in this SOW. The FSE(s) shall be authorized by the contractor and OEM 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. 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 VAPHI equipment. The CO and/or Biomedical Engineering specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAPHI equipment. If coming on-site, 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 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 Biomedical Engineering that all contract staff performing services at VA facilities are in compliance with the VHA Directive 1192. M. COVID-19: Upon entering VAPHI, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask. PPE will not be provided by VAPHI. 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 a replacement. 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 always wear visible identification while on the premises of VAPHI. 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. VAPHI 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 VAPHI. 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. 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. The following language from VA Handbook 6500.6 is required in this contract: Appendix B: All Appendix C: Paragraphs 1, 2, 3, 5, 6, 7, 9 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. Biomedical Engineering Staff 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 Ac3cess to or Use to VA Sensitive Information . Signed training documents must be submitted to Biomedical Engineering.