DOCUMENT
J -- Medrad Injection System Preventive Maintenance - Attachment
- Notice Date
- 3/23/2018
- Notice Type
- Attachment
- NAICS
- 811219
— Other Electronic and Precision Equipment Repair and Maintenance
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 2;James J. Peters VA Medical Center;130 West Kingsbridge Road;Bronx NY 10468-3904
- ZIP Code
- 10468-3904
- Solicitation Number
- 36C24218Q9108
- Archive Date
- 5/22/2018
- Point of Contact
- JAMES, EULANDA
- E-Mail Address
-
Eulanda.James@va.gov
(@va.gov)
- Small Business Set-Aside
- N/A
- Description
- Page 3 of 13 INTENT TO SOLE SOURCE The US Department of Veterans Affairs, Veterans Integrated Service Network (VISN 2), Hudson Valley Healthcare System, New York, intends to award a sole source contract under the authority of 41 U.S.C 253 (c) (1) (FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. For attached Statement of Work (SOW). BAYER Healthcare, LLC located 1 BAYER Drive Indianola, PA 15051, will furnish all labor, transportation, tools, and parts necessary to provide a full-service maintenance contract, and one (1) full service Preventive Maintenance (PM) per year. Certification and repair of the Medrad injectors equipment listed below for the base period of Date of Award, through March 26, 2019, plus four (4) twelve (12) months option. This action will result in a Firm-Fixed Price contract This notice of intent is not a request for competitive quotations. There will be no solicitation available for competitive quotes. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Responses to this notice will be used by the Government to make appropriate acquisition decisions. Respondents should reference 36C24218Q9108_1 Notice of Intent. Responses to this notice shall include company/individual name, a service capability statement, including examples of similar facilities for which services have been provided, proof of applicable OEM certifications to provide services on the equipment, DUNS number, address, point of contact and social-economic category (ex: SBVOSB, VOSB, 8(a), HUBZone, WOSB, EDWOSB, Small Business). Determination not to compete this proposed contract upon responses to this notice is solely within the discretion of the Government. Telephone inquiries or responses will not be accepted. If no viable responses have been received by the closing date of March 26, 2018 at 9:00am (EDT), the Government shall negotiate solely with Bayer Healthcare, LLC. The point of contact for this action is Eulanda James, Contract Specialist. STATEMENT OF WORK SERVICE/MAINTENANCE OF EQUIPMENT DESCRIPTION/SPECIFICATIONS GENERAL INFORMATION Title of Project: Medrad Injectors Maintenance service contract. Scope of Work: The contractor shall furnish all labor, transportation, tools, and parts necessary to provide a full-service maintenance contract, and one (1) full service Preventive Maintenance (PM) per year. Certification and repair of the Medrad injectors equipment listed below for the period Date of Award, 2018, through March 26, 2019, both dates inclusive, plus four (4) twelve (12) months option. Background and Conformance Standards: Medical equipment must be properly maintained in order to assure proper function and reduce equipment down-time. The listed equipment is used daily at the hospital to inject contrast (dye) for patient diagnostic procedures. 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. Type of Contract: The contract will be firm-fixed-price. CONTRACT AWARD MEETING The contractor shall not commence performance on the tasks in this SOW until the Contracting Officer (CO) has conducted a kick off meeting, or has advised the contractor that a kick off meeting is waived. GENERAL REQUIREMENTS Services to be provided: Repair and Hours of Coverage All repairs will be performed during normal VA business hours, 8:00 AM - 5:00 PM, Monday-Friday, except Federal Holidays, unless otherwise specified. Contractor may work outside normal business hours by arrangement with Contracting Officer s Representative (COR) if such services are provided without additional charge to the government. Any overtime charges must be approved by the COR or designee prior to the initiation of overtime work. Covered work performed outside the normal hours of coverage at the request of [COTR] will be billed at the price listed in Section B, item II. Billing will include service time, and exclude parts and travel time as they are included in Section B, item I. Work performed outside the normal hours of coverage at the request of FSE will be considered service during normal hours of coverage. A technical maintenance representative will respond by telephone to the VA within one (1) hour of the original service call. The contractor will arrive on-site for repair within two (2) hours of the original service call. Equipment will be returned to full operation within twenty-four (24) business hours of the original call. On-site visits will be authorized by COR only. The VA shall not provide service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE(s) all operational and technical documentation (e.g., operational and service manuals, schematics, and parts lists) 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. Any charges for parts, manuals, tools, or software required to successfully complete scheduled Preventive Maintenance (PM) are included within this contract and its agreed upon price unless specifically stated in writing otherwise. All removable media materials (laptop, DVD/CD, USB drive, etc.) will need to be scanned on site with approved anti-virus by OI&T or Biomedical staff and approved for use prior to the start of any work. Parts The contractor has ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contract shall INCLUDE all preventative maintenance parts. The contractor shall use OEM new or re-built parts. Used parts, those removed from another similar system shall not be installed without approval by the COTR. Scheduled Maintenance (PLANNED MAINTENANCE): The contractor shall perform Preventive Maintenance Inspection (PMI) services to ensure that equipment listed in the schedule performs in accordance with Section B, III, Conformance Standards. The contractor shall make thorough technical inspections of the equipment covered in the Schedule. Within ten (10) days after the award of the contract, the contractor shall submit a schedule of PMIs and a PMI checklist describing in detail the scheduled maintenance procedures for inspecting each piece of equipment listed. This checklist is subject to the approval of the COTR. 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 COTR at the completion of the PM. PMI services shall include, but need not be limited to, the following: Cleaning of equipment. Reviewing operating system software diagnostics to ensure that the system is operating to the manufacturer's specifications. Calibrating and lubricating the equipment. Performing remedial maintenance of non-emergent nature. Testing and replacing faulty and worn parts and/or parts which are likely to become faulty, fail or become worn. Measuring and adjusting and calibrating as necessary for optimal performance, output or image quality. Inspecting electrical wiring and cables for wear and fraying. 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. Performing any Electrical Safety Inspections required by NFPA-99 as they may apply to this class of equipment and its application. Returning the equipment to the operating condition defined in Section B, III, Conformance Standards. Providing documentation of services performed. All exceptions to the PMI schedule shall be arranged and approved in advance with the COTR. All parts, services, manuals, tools, or software required to successfully complete scheduled PMI are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise. Upon completion of the preventive maintenance and any required electrical safety inspection, the FSE must tag the equipment with an inspection tag, label or sticker which provides the following information: date inspected, date of expiration of inspection, and initials of FSE. VA Biomedical Engineering Labels will be provided to the FSE upon request when reporting (signing-in) to Biomedical Engineering. Inspection of Equipment - Any site visits will be coordinated in advance with COR, Biomedical Engineering, 845-831-2000 ext. 5737. MISCELLANEOUS SERVICES, COVERAGE AND TERMS: VA shall notify contractor immediately of any equipment failure which may require corrective action to resolve in order to schedule repairs and provide Purchase Card information or Purchase Order Number. Contractor shall be responsible for all preventative (planned) maintenance service-related travel expenses including overnight living expenses. VA shall notify contractor 24 hours in advance of a scheduled service visit if equipment will be unavailable for PM. Telephone Technical Support and any applicable remote diagnostics shall be available from the contractor on a 24-hour by seven days- per-week basis. Software Updates ARE INCLUDED and shall consist of any modification, update, improvement or error corrections and shall be performed during normal business hours. Updates do not include separately licensed software modules which provide additional functionality relating to an application or feature for the hardware or software. Software Upgrades that consist of separately licensed software modules providing additional functionality relating to an application or feature for the hardware or software are NOT INCLUDED and shall require a separate Purchase Order. Clinical Applications Support by telephone shall be available M-F, 8AM 5PM Eastern Standard Time to contractor-trained VA personnel who use the covered equipment and the COTR. 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 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. DOCUMENTATION/REPORTS: The documentation will include legible detailed descriptions of the scheduled 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 Section. 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), and Hours-On-Site for service call. VA Purchase Order (PO) #(s) covering the call, if outside normal working hours. Description of Problem reported by COTR/User. Identification of Equipment to be serviced: VA Inventory Entry # (if available), manufacturer, model#, serial#, and any other manufacturer's ID# s. Itemized Description of Service Performed (including Costs associated with after normal working hour services), including: Labor and travel hours, parts replaced (with part #s), location of problem (equipment assembly, circuit, etc.) and corrective Action. Signatures: FSE performing services described. VA Employee who is notified and accepts that repair /service has been completed. A Log Book to be left with the supervisor at the equipment site for entering arrival and departure times and maintaining a PM and Repair records. REPORTING REQUIREMENTS: The contractor shall be required to report to Engineering, Building 9, Room 101 to log in during Normal Business Hours. Outside of Normal Business hours, FSE may report directly to area Supervisor at equipment site. When the service is completed, the FSE shall document services rendered on a legible ESR(s). All ESRs require an acceptance signature from the Area Supervisor. The FSE shall be required to log out either by contacting/meeting the COTR to provide him with the ESR(s) or at Biomedical Engineering. Outside of Normal Business Hours, FSR(s) may be left in the Biomedical Engineering Office. Detailed FSR(s) must be received within five (5) business days after completion of work electronically (e-mailed to COTR jeremy.redisch@va.gov) by fax to (845) 838-5259, or by mail VA Hudson Valley HCS Attention D. Hurst 41 Castle Point Road, Castle Point NY 12590. 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. GOVERNMENT RESPONSIBILITIES The government will make the equipment available in accordance with the established schedule for the work. EQUIPMENT COVERED Medrad Stellant, SN10295 Medrad Spectris Solaris, SN 45835 Gray Market Prevention Language Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufacturers or gray market items will be acceptable. Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents form the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item (s) delivered to a VA Medical Facility upon discovery of such items. With No Sensitive Data but Requires Training VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE VA INFORMATION CUSTODIAL LANGUAGE: Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. SECURITY INCIDENT INVESTIGATION: The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. LIQUIDATED DAMAGES FOR DATA BREACH: Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non- Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. SECURITY CONTROLS AND COMPLIANCE TESTING: All vendors/contractors will sign-in at the Engineering Administrative Office building 9 room 101, 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. If removable media (i.e. USB or DVD/CD Device) is required to service, troubleshoot or install/update software, then it must be scanned with an anti-virus program. The removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device at the scanning workstation located in Biomedical Engineering. Any vendor/contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility. All items covered by the manufacturer's warranty, contractor service of any devices, systems, or other equipment containing media (hard drives, optical disks, etc.) with VA sensitive information must not be removed / returned to the vendor at the end of life, for trade-in, or other purposes. Upon completion of the scheduled work, the vendor/contractor will return to the Engineering Administrative Office building 9 room 101, to sign-out, return the temporary identification badge, and leave any Field Service Reports if necessary. All medical device workstations and servers must be in compliance with MDIA (Medical Device Infrastructure Architecture) as well as comply with all FDA regulations. On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. TRAINING: All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training before being granted access to VA information and its systems. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Rules of Behavior before being granted access to VA information and its systems. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. The Certification and Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required for this SOW. Records Management Contract Language The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. 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 by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. 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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE: The Contractor shall immediately, but not later than 24 consecutive hours after discovery notify the CO and COTR, (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. QUALIFICATIONS: Offers will be considered only from offerors who are established in the business called for and whom in the judgment of the Contracting Officer (CO) are financially responsible and able to show evidence of their reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service. CONDITION OF EQUIPMENT: The contractor accepts responsibility for the equipment described in Section B, I, 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. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT: 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) has successfully completed a formalized training program, for the equipment comparable to that identified in the Section B schedule. For field experience, the FSE(s) has a minimum of one year of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on covered equipment. The FSEs shall be authorized by the contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSEs who are authorized and certified by the OEM. The contractor shall be able to furnish upon request written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model of equipment the contractor services at the VAMC. The CO may authenticate the training requirements, request training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VAMC equipment. The CO and/or the COTR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAMC equipment. If subcontractor(s) are used, they must be approved by the CO; the contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval. TEST EQUIPMENT: Contractor is required to utilize testing equipment for calibration which has been certified to be accurate, with accuracy traceable to a national standard. Certification certificates shall be made available to COTR upon demand. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: The contractor's FSE's shall wear visible company identification at all times while on the premises of the VAMC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Smoking is prohibited inside any buildings at the VAMC or near entranceways. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to police search. Violations of VA regulations may result in citations answerable in the United States (Federal) District Court. PAYMENT: A. Purchase Order Payment Procedures: Payments will be made upon receipt of properly prepared, certified invoices which must show reference to the purchase order number and contract number issued upon the award of this contract. Each invoice must be provided in [triplicate] and must include the Service Reports (ESR's) for work performed during that quarter. ADDITIONAL CHARGES: There will be no additional charge to the Government for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts. INSURANCE Worker compensation and employer's liability. Contractors are required to comply with applicable Federal and State Worker Compensation and occupational disease statutes. General Liability. Contractors are required to have Bodily injury liability insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence. Property Damage Liability. Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.
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