J066--BacT/ALERT 3D Combo w Observa

The Department of Veterans Affairs, Network Contracting Office 2, is issuing this Notice of Intent to Sole Source in order to identify any potential sources that have the resources and capabilities to provide a comprehensive vehicle for all maintenance and repair of BacT/ALERT 3D Combo w Observa(FSA). SERVICES REQUIRED Contractor is to provide full service contract for the Northport VA Medical Center, during the approximate term of 1 Oct 2020 through 30 September 2021. INTERESTED & CAPABLE RESPONSES: NCO 2 is seeking responses from businesses that are interested in this procurement and consider themselves to have the resources, rights, and capabilities necessary to provide these services. Please respond with your: 1. Business name, business type, socio-economic status (e.g., Veteran-Owned, Woman-Owned, Disadvantaged Small Business, 8(a), etc.), person of contact (including telephone number & email address), GSA Contract number if applicable, and DUNS number. 2. Capability statement must provide detailed and specific information that would demonstrate a capability to perform the tasks as stated in the attached Statement of Work. Failure to tailor capability statement to this specific requirement may result in your company being determined non-responsive. Responses must be submitted by 5:00 PM EST September 25, 2020. Responses to the information requested above may be submitted via email to contact@example.gov. This Special Notice of Intent to sole source is for planning purposes ONLY. The results of this notice will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., small business set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses submitted as a result of this notice. Statement of Work Preventative Maintenance (PM) and Repair BacT/ALERT 3D Combo w Observa (FSA) 1. SCOPE: The Department of Veterans Affairs Medical Center wishes to contract for Repair and Preventative Maintenance Services of BacT/ALERT 3D Combo w Observa (FSA) located at 79 Middleville Road, Northport NY 11768. The Contractor shall furnish all necessary labor, equipment, tools, materials, repair service, software updates, parts, etc., for complete On-Site Maintenance and Repair Services. 2. PERIOD OF PERFORMANCE: Base year beginning at time of award, with four (4) one-year option periods. 3. SPECIFICATIONS OF WORK: Repair Services will be provided, at the request of the VA, to diagnose and correct equipment malfunctions on a routine basis. All repairs shall be performed solely by manufacturer trained staff, with current applicable certifications from the Original Equipment Manufacturer (OEM). Contractor will follow manufacturer s recommendation for preventative maintenance (PM), repairs, calibrations and modifications. Full service contract shall include all necessary labor, tools, equipment, transportation and parts required to perform repair and PM on listed equipment. All equipment shall be maintained in proper operating condition as specified by the manufacturer. Vendor shall have access to OEM s parts, manuals and schematics to perform the service. Vendors shall have their own schematics available on site at time of service. During scheduled service intervals, all parts including batteries and accessories shall be replaced. a. No work shall be performed outside the scope of this contract. Any justification must be pre-approved by the Contracting Officer, and a modification to the contract as well as a purchase order must be issued before any work can commence. Failure to obtain prior authorization shall result in NON-PAYMENT of charges incurred. 4. PREVENTATIVE MAINTENANCE: a. The contractor shall perform Preventive Maintenance services to ensure that equipment listed under Section 11 performs in accordance with Conformance Standards (Section 10). The contractor shall make thorough technical inspections of the equipment listed in Section 11 within ten (10) days after the award of the contract. The contractor shall submit a schedule of PM services and a PM checklist describing in detail the scheduled maintenance procedures for each piece of equipment listed. This checklist is subject to the approval of the COR. The contractor shall provide and utilize these procedures and checklists with worksheet originals indicating the work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM. b. PM Service shall be mutually scheduled within 10 days after submission and approval of the schedule of PM Services and PM Checklists as outlined above. Thereafter, PM Service shall be scheduled annually for each period of performance. c. PM procedures performed shall be in accordance with manufacturer s specifications, documented, and submitted in writing to biomedical engineering at inception of contract PM. The PM should also include testing and replacement of faulty parts and/or parts which are likely to fail. Upon completion of PM, the unit shall be clearly labeled with a sticker stating the date last PM was completed and the due date of next PM, as well as name of technician that performed said PM. d. The contractor shall be contacted by Biomedical Engineering when repair services are needed prior to, or after PM has been performed. Examples of repair services: calibration, cleaning, oiling, adjusting, and replacement of parts needed between regular PM services. e. Contractor shall perform all unscheduled services, including emergencies when needed. This includes on-site visits during normal business hours and repair, labor and travel costs relating to the services to be performed. In cases when technical support is required over the phone, the contractor shall provide 24/7 technical support to the government at no additional cost. All site visits must be scheduled, coordinated, and approved by Clinical Engineering and/or the COR before such site visits take place. f. The contractor assumes the risk of, and shall be responsible for, any loss, damage, destruction, or theft of Government furnished property as well as the equipment being serviced by the Contractor. g. Prior to commencement of work on this contract, contractor shall provide the VAMC with a copy of the current calibration certification on all test equipment which is to be used by the contractor on VAMC equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard. h. PM services shall include, but are not limited to the following (where applicable): i. Cleaning of equipment. ii. Reviewing operating system software diagnostics to ensure that the system is operating to the manufacturer's specifications. iii. Calibrating and lubricating the equipment. iv. Performing remedial maintenance of non-emergent nature. v. Testing and replacing faulty and worn parts and/or parts which are likely to become faulty, fail or become worn. vi. Measuring and adjusting and calibrating as necessary for optimal performance, output or image quality. vii. Inspecting electrical wiring and cables for wear and fraying. viii. Inspecting all mechanical components including, but not limited to: patient restraints and support devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance. viiii. Performing any Electrical Safety Inspections required by NFPA-99, 2012 as they may apply to this class of equipment and its application. x. Image quality assessment. xi. Returning the equipment to the operating condition defined in Section III, Conformance Standards. xii. Providing documentation of services performed. 5. RESPONSE TIME: Contractor shall provide a phone call back by a qualified technician within 2 hours of a service request and an onsite response by a qualified technician within 6 hours. The Contractor shall proceed progressively without undue delay to correct the misfunction or mechanical breakdown. Equipment shall be returned to fully functionality, to manufacturer specifications within 16 business hours of initial service call. 6. HOURS OF COVERAGE: 8:00am to 4:30pm, Monday-Friday (excluding Federal Holidays). Overtime shall only be paid for emergencies and pre-approved situations as determined and approved by the Contracting Officer. Federal Holidays observed by the VAMC are: New Year s Day Labor Day Martin Luther King Day Columbus Day President's Day Veterans Day Memorial Day Thanksgiving Day Independence Day Christmas Day And any other day specifically declared by the President of the United States to be a national holiday. 7. DOCUMENTATION REQUIREMENTS: At the completion of each service call/PM, the contractor shall provide a written service report to Biomedical Engineering. This report shall clearly show the date of service, type of service performed, model and serial numbers, name of field technician(s), a description of the work performed (including time spent for labor and travel) and a list of any parts replaced. The contractor shall leave the service report with Biomedical Engineering Administrative Office, building 11, room 1 after servicing equipment. Certification of invoices is clearly dependent upon receipt of service reports as proof of services rendered. Payment shall be declined if proper documentation is not provided. a. If work is not completed prior to leaving the premises, a service report shall be left, as per the above procedures, indicating the equipment status. b. No payments shall be made if the above procedures are not complied with. 8. QUALIFICATION OF VENDOR: To be eligible for consideration, offerors shall have acquired certification in servicing the equipment listed for a period of no less than two (2) years prior to award. The contractor s representative shall have received service training from the equipment manufacturer specifically on the model(s) listed and shall be capable of presenting certification of such training. No allowance will be made for the contractor not having qualified personnel available to respond as specified in this contract at all times within the contract period. 9. SECURITY AND REPORTING: a. All vendors/contractors will sign-in at the Biomedical Engineering Administrative Office building 11 room 1, before reporting to their respective work site. Each vendor/contractor will be issued a temporary identification badge that must be worn at all times above the waist, in front, with the face of the card visible. b. Upon completion of the scheduled work, the vendor/contractor will return to the Biomedical Engineering Administrative Office building 11 room 1, to sign-out, return the temporary identification badge, and leave any Service Reports. c. Outside of Normal Business Hours, the Service Report(s) may be left in the Biomedical lock-box located at the entrance to Biomedical Engineering (Building 11, Basement Level, Room 1). Detailed Service Report(s) must be received within five (5) business days after completion of work, electronically e-mailed to the COR. d. The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the CO and COR in writing, of the existence or the development of any defects 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. 10. STANDARD BIOMEDICAL PROCEDURE: For the sake of this contract, equipment capabilities and diagnostic analysis of equipment as they relate to storage of and access to patient sensitive information will be determined by the separate completion of the Information Security 6500.6 Checklist. Contractors shall be expected to comply with Department protocol regarding removable media (i.e. USB or DVD/CD Device), hard drives, optical disks, remote system diagnosis, and compliance with applicable Federal and VA information confidentiality and security laws, regulations and policies. 11. CONFORMANCE STANDARDS: The contractor shall ensure that the equipment (hardware and software) functions in conformance with the latest FDA (medical device regulations (including but not limited to Class I, Class II, Class III and MDDS), validation, quality assurance and compliance), latest published edition of NFPA-99, TJC, OSHA, CDRH, and any other performance standards and specifications used when the equipment was procured by VA and any upgrades/updates. 12. LIST OF EQUIPMENT: Equipment Description Serial # VA Entry # PM FREQ. BacT/ALERT 3D Combo w Observa (FSA) 205CL3345 33161 ANNUAL 13. SERVICE MANUALS The VAMC shall not provide service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its Service Technicians 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. 14. PAYMENTS: Payments will be made QUARTERLY in arrears upon receipt of properly prepared, certified invoices at the VA Financial Services Center which must show reference to the contract s purchase order number issued upon the award of this contract. INVOICES: Invoices shall be submitted in arrears: a. Quarterly [X] b. Semi-Annually [] c. Other [] Quarterly Reports: All reports and invoices must be filed electronically: 1. Records of all scheduled PM Inspections performed under this contract as per manufacturer specifications. 2. PM checklist and frequency of calibration for each system model, serial number. 3. Repairs and parts replaced by model and serial number. 15. NATIONAL ARCHIVES and RECORDS ADMINISTRATION (NARA) RECORDS MANAGEMENT 1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 4. The Department of Veterans Affairs Northport Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of The Department of Veterans Affairs Northport Medical Center or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [FACILITY]. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to The Department of Veterans Affairs Northport Medical Center control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). 6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and The Department of Veterans Affairs Northport Medical Center guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. 7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with The Department of Veterans Affairs Northport Medical Center policy. 8. The Contractor shall not create or maintain any records containing any non-public The Department of Veterans Affairs Northport Medical Center information that are not specifically tied to or authorized by the contract. 9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. 10. The Department of Veterans Affairs Northport Medical Center owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which The Department of Veterans Affairs Northport Medical Center shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. 11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.