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Statement of Work - Saint Louis, Missouri VA Medical Center OBJECTIVE The VA Saint Louis Health Care System intends to procure a COPAN Walkaway Specimen Processor (WASP) at John Cochran to replace the... Statement of Work - Saint Louis, Missouri VA Medical Center OBJECTIVE The VA Saint Louis Health Care System intends to procure a COPAN Walkaway Specimen Processor (WASP) at John Cochran to replace the EOL unit already at the facility. This document highlights the technical specifications and services being requested by the facility for consideration towards purchase of the units. Vendors under this proposal shall provide all equipment and accessories, installation services, and project management support. EQUIPMENT SPECIFICATIONS Requirements: COPAN Walkaway Specimen Processor System weight < 1600 lbs. Includes peripherals of touch screen monitor, external barcode reader, and label printer Custom streaking patterns Accept multiple media types/containers Accept multiple specimen types/containers Inoculate and spread calibrate volume of specimen at 1 uL and 30 uL Full sample traceability using uniquely barcoded disposable culture plates Remove & replace specimen lids/tops Include module to prepare slides for gram staining Shall not require cleaning material or decontamination beyond periodic maintenance Can be serviced/calibrated remotely Automatable tasks as needed by microbiology staff Attach to existing WASP Lab track system to move from specimen processor to incubators System footprint fits within current lab layout and not require lab remodeling SYSTEM FUNCTIONALITY The WASP must have the ability to connect to VISTA via Data Innovations and meet VA security requirements to remotely connect and service instrumentation. Instrumentation must include all upgrades, databases, etc. included in initial purchase, and be capable of adding future advancements and additions to the lab system. Onsite vendor led training must be provided and include system operations as well as basic troubleshooting and repair. Unpacking and installation of the equipment by a technical expert (white-glove installation) is required. The contractor shall also provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and state-of-the-art technology at no additional charge after initial installation of the system. These must be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, including database upgrades, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc. SOFTWARE 1. Vendor shall ensure all software operating on the device provided is supported by the original manufacturer at time of delivery. For example, vendor shall not provide VA Saint Louis a device utilizing the Windows XP or Windows 7 operating system as they are no longer Microsoft supported. 2. Proprietary software systems are acceptable so long as vendor supports the version provided to VA Saint Louis and it is the newest version at time of delivery. 3. Access to all software shall be provided to VA Saint Louis in situations where re-installation is necessary. 4. Software shall be provided to VA Saint Louis with unlimited perpetual licensing for the supported life of the device. 5. In cases where vendor insists on utilizing a licensing fee model this should be noted in the bid provided for VA Saint Louis consideration. NETWORK SECURITY The vendor is required to fill out the attached VA Security Forms if their equipment can be connected to the VA network. If these forms are not completed and submitted with the bid package the vendor can be disqualified from the bidding process. CERNER CAPABILITY 1. All vendors providing a bid to this requirement shall provide a Cerner compatibility statement from the OEM of the equipment that they are proposing to the VA Saint Louis Health Care System. 2. This statement will include an OEM attestation that the product proposed is Cerner verified and provide a list of healthcare organizations that have deployed the project with the Cerner EHR. 3. The statement will also include any relevant information as to what data can be transmitted to Cerner. 4. This statement will be dated within 60 days of the quote being provided to ensure it is recent and accurate. 5. The statement will provide an OEM point of contact who can be reached to further discuss any questions or concerns over Cerner compatibility. 6. If the device/system being proposed does not connect to the network or medical record the vendor shall note this in their proposal. 7. Vendor bids that do not include a Cerner compatibility statement directly from the OEM will be discarded from consideration. INSTALLATION AND ASSEMBLY 1. Vendor shall be responsible for assembly and installation of systems after notification from VA Saint Louis Biomedical Engineering that it has been delivered to station. 2. Installation shall include implementation and testing of all purchased interfaces to VA electronic systems in coordination with Clinical Staff, Biomedical Engineering staff, O&IT staff, and others identified as needed. 3. Install shall include unboxing and transportation of equipment to final use location. 4. Assembly and install shall occur within 30 days of delivery to station. 5. Vendor shall provide all necessary accessories, cables, adaptors, etc. to deliver a fully functional clinical device. TRAINING 1.Vendor shall provide on-site clinical/applications training for relevant VA Saint Louis staff members. 2. Vendor shall provide introductory system/maintenance training to VA Saint Louis Biomedical Engineering staff during installation. 3. Vendor shall include all costs for travel to provide this training in their proposal. 4. Vendor shall coordinate all installation and training dates with VA Saint Louis specified Biomedical Engineering POC who will communicate internally with clinical staff. WARRANTY AND SERVICE 1. Service and Operator Manuals – The vendor shall provide the following documentation for the proposed system: 2. Two (2) copies of operator's instruction manuals per unit purchased 3. Two (2) copies of complete technical service manuals including detailed troubleshooting guides, necessary diagnostic software, service keys, schematic diagrams, parts lists, and any other resources available to the manufacturer’s service technicians. 4. Two (2) copies of a system manager’s manual outlining back-up procedures, managing privilege group limits, routine tasks, etc. 5. Warranty – The system, all accessories, and all software shall be covered under the manufacturer’s warranty 6. A manufacturer’s factory-trained Field Service Engineer shall perform installation and maintenance during the warranty period. 7. The warranty period shall not begin until after the VA Saint Louis Biomedical Engineering POC has accepted the products delivery, installation, and functionality. 8. The warranty shall include all manufacturer recommended Preventive Maintenance procedures for its duration. 9. All available software updates and security patches will be made available to the VA Saint Louis during the warranty period. 10. Vendor shall provide response to applications and technical calls within 8 hours. 11.Vendor shall ship replacement parts within 48 hours of identifying necessity by VA Saint Louis Biomedical Engineering staff. OTHER FEATURES 1. Value added features in the vendor’s proposal that will be considered include but are not limited to: 2. Service and Biomedical training options shall be outlined in bid package 3. Options for this training should include all registration, travel, and lodging costs when possible HOURS OF OPERATION 1. Normal hours of coverage are Monday through Friday, 7:00 AM to 3:30 PM Central Standard Time excluding national holidays. 2. Vendor on-site visits will be coordinated with the VA Saint Louis Biomedical Engineering POC before being scheduled or conducted. 3. Vendor representatives will check in with the VA Saint Louis Biomedical Engineering POC when they arrive on-site and check out upon completion of work each day. 4. All services shall be performed during normal hours unless otherwise scheduled with the VA Saint Louis Biomedical Engineering POC. 5. Vendor staff shall always be professional and shall take all necessary precautions to maintain a safe environment for the occupants. This includes, as necessary, coordinating access and closures for sensitive areas of the Medical Center 6. Vendor shall be responsible for cleaning all work areas after completion of tasks. This includes removal of packaging, and a clean sweep/mop of the area as required by work type. 7. Vendor staff shall minimize noise as much as possible while working in all buildings. 8. Vendor is responsible for providing all PPE necessary for their work. Note: Hardware/software update/upgrade installations, where applicable, may be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the VA Saint Louis Biomedical Engineering POC). DELIVERY 1. Vendor shall deliver purchased equipment within 120 business days of receiving completed Contracting package from the VISN 15 Contracting Officer. If delivery delays occur vendor shall notify the Contracting Officer and the VA Saint Louis Biomedical Engineering POC. 2. Delivery will be to the VA Saint Louis Health Care System main campuses. Vendor shall coordinate exact delivery location with the Contracting Officer and VA Saint Louis Biomedical Engineering POC at the time of the purchase. 3. Vendor will ensure that equipment is sent to the Attention of Biomedical Engineering and will include the VA Saint Louis PO Number on the shipping label. 4. Delivery of oversized, palletized orders or orders that contain a large number of components will be coordinated with VA Saint Louis Biomedical Engineering POC who will communicate internally with Warehouse Staff. VA Saint Louis Health Care System Delivery Locations: Department of Veterans Affairs St. Louis VA Medical Center John Cochran Division 915 North Grand Blvd. St. Louis, MO 63106-1621 RECORDS MANAGEMENT OBLIGATIONS Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. The term Federal record: includes VASTLHCS records. does not include personal materials. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract. may include deliverables and documentation associated with deliverables. Requirements 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. 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. 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. [Agency] 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 [Agency] 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 [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230. 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 [Agency] 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). 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 [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy. The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract. 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. The [Agency] 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 [Agency] 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. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-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. [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] Flow down of requirements to subcontractors The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor. CONTRACT ADMINISTRATION DATA All contract administration functions will be retained by the Department of Veterans Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such Change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. CONTRACTING OFFICER’S REPRESENTATIVE Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer, the designated representative for this contract will be determined at award. ACRONYMS AND DEFINITIONS CDR: Contract Discrepancy Report. Report issued by the Government to the contractor to document a supply or service found to be unacceptable during contract performance. CLIN: Contract Line-Item Number. Unit of work (or service) to be performed (or delivered) by the contractor as a pay item. CO: Contracting Officer. A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings. COR: Contracting Officer’s Representative. An individual, including a Contracting Officer’s Representative (COR), designated and authorized in writing by the contracting officer to perform specific technical or administrative functions. QA: Quality Assurance. Actions taken by the government to assure contracted services meet PWS requirements. PERSONNEL Non-Personal Services This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service s performing services herein. Such contract service s shall be accountable solely to the Contractor who, in turn, is responsible to the Government. Contractor Compliance with the Immigration and Nationality Act of 1952 The Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals. HOURS OF OPERATIONS Business hours for the VAMC follow: A. Administrative hours: Monday through Friday, 8:00 a.m. - 4:30 p.m. B. National Holidays: The 11 holidays observed by the Federal Government are: New Year’s Day; Martin Luther King’s Birthday; Presidents Day; Memorial Day; Juneteenth Independence Day Independence Day; Labor Day; Columbus Day; Veterans Day; Thanksgiving; Christmas; and any other day specifically declared by the President of the United States to be a national holiday. C. Off-Duty hours: Friday through Monday, 4:30 p.m. - 8:00 a.m.; Monday through Thursday, 4:30 pm – 8:00 am. QUALITY CONTROL CONTRACT PERFORMANCE MONITORING. The COR may perform surveillance of services by any of the methods listed below: A. Observing actual performance; B. Inspecting the services to determine whether or not the performance meets the performance standards; and C. Review of any other appropriate records. When unacceptable performance occurs, the COR shall inform the Contractor and the Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file. When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor program manager. The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor has to present this corrective action plan to the COR. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer. Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer Representative(s); The Government shall periodically evaluate the Contractor performance by appointing a Contracting Officers Representative (COR) to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The Government Contracting Officer shall make final determination of the validity of customer complaint(s). If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government. CONTRACT SECURITY “The C&A requirements do not apply and a Security Accreditation Package is not required”.