P09 SOW Stratton Ambulatory EEG.docx

Introduction The Stratton (Albany) VAMC is seeking equipment for the Neurology Department’s EEG Lab. This contract will ensure that Neurology can continue to conduct routine OP/IP, Ambulatory, and Continuous EEG monitoring for the facility’s veterans. This is a Brand Name or Equal solicitation for the line items listed below. The Natus Neuroworks system is the basis of design. ***Please be advised that vendors are only required to quote the line item(s) marked “optional” if they are not quoting the brand used as the basis of design; if the vendor’s quote is for the brand specified as the basis of design, the vendor does not need to quote the optional line item(s). See salient characteristics.

Table 1 – Package Items Summary

INC

INC

0009 **optional**

Additional Item Requirements The vendor will provide service manuals that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA HTM Department. Standard warranty is required.

Date of manufacture must not be greater than 2 years before the purchase order date. The equipment must not be used or refurbished and must have the latest manufacturer’s software/hardware updates installed. Any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.

General Conditions Site Address The address of the Stratton (Albany) VA Medical Center is provided below.

113 Holland Avenue Albany, NY 12208

Schedule and Order Management Post-award, the vendor will coordinate delivery identified in this document with the VA prior to beginning any work (See Section 2.4). A post-award meeting shall be conducted within 14 days (2 weeks) of award. Once the dates have been confirmed, modifications to the schedule are subject to written approval by the CO or POC and the vendor.

Delivery and Receiving Delivery and receipt of the proposed items is anticipated to be directed to the location identified below. Confirmation of delivery location will be provided post-award.

☒ Stratton (Albany) VA Medical Center (Direct Delivery to address detailed in paragraph 2.1) The vendor is required to define the need for a staging area to accommodate item delivery, if needed. Post-award, this information will be confirmed with the vendor.

The delivery of items identified in this document shall take place during normal loading dock business hours which are defined as: 8:00 AM to 3:30 PM Eastern Standard Time, Monday through Friday, and excluding Federal Holidays.

Labeling of delivered items shall include the VA facilities contract number and VA purchase order number for identification and reference upon receipt of product.

Upon delivery of the equipment, warehouse staff shall inspect equipment for any damages incurred during shipping / transit to the facility. Any equipment that is deemed as damaged shall be replaced by the vendor with the same OEM equipment within 5 business days.

Assembly, Installation, and Calibration Required (Yes ☒ No ☐) The vendor is required to manage and coordinate installation at the Stratton (Albany) VA Medical Center with the POC or his/her representative.

Upon completion of installation of equipment, the vendor shall verify and certify the system is fully functional. The system shall then be verified as fully functional and ready for clinical use by Biomedical staff. If any of the equipment is deemed as not fully functional, the vendor shall repair / replace the equipment to ensure it is fully functional. The vendor shall also provide an installation service report to Biomedical Engineering in order to add this information to the equipment record. Equipment shall not be considered verified until it has passed Biomedical incoming inspection.

Upon arrival to the facility, the vendor shall contact Biomedical Engineering. The vendor will be required to check in with the VA Police to obtain a visitors badge for the duration of their time on site. The vendor will also be required to allow Biomedical staff to scan any external media that shall be used on equipment connected to the VA network.

Training Required (Yes ☒ No ☐) Standard training is required.

2.7 Confidentiality, Non-Disclosure, and Records Management

1.1 Records Management Obligations 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.

Stratton VA Medical Center Albany, NY 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 Stratton VA Medical Center Albany, NY 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 the Samuel S. Stratton VAMC. 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 National contract/Statement of Work (SOW). 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 Samuel S. Stratton VAMC Albany, NY 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 National contract #HTC711-D-C003. 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 Samuel S. Stratton VAMC 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 Samuel S. Stratton VAMC policy.

The Contractor shall not create or maintain any records containing any non-public Samuel S. Stratton VAMC 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 Samuel S. Stratton VAMC 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 Samuel S. Stratton VAMC 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 Samuel S. Stratton VAMC-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.

The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract 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.

Records Management SOW 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), Freedom of Information Act (5 U.S.C. 552), 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.

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.

Salient Characteristics Description: The Department of Veterans Affairs (VA) is seeking vendors who can provide the Natus Neuroworks Ambulatory Monitoring package and associated equipment as listed in Table 1 or equal commodities which meet all of the following salient characteristics:

Statement of Work Page 1 of 8