P09 Candelis Upgrade SOW.docx

STATEMENT OF WORK

SIEMENS CANDELIS HARDWARE, SOFTWARE, UPGRADE AND INSTALLATION

1. SCOPE: Contractor shall furnish and facilitate all labor, transportation, parts, test equipment, tools, reagents, and expertise necessary to install new Candelis hardware and the upgrade of the Candelis ImageGrid system including migration of DICOM studies from old the ImageGrid hardware to new ImageGrid hardware at the Iowa City VA Healthcare System.

2. QUALIFICATIONS: This requirement is being sole sourced to Siemens Medical Solutions USA, Licensed from Candelis, Inc as their hardware/software is connected to Siemens Syngo Dynamics and is proprietary and cannot be worked on by anyone else.

3. SERVICES TO BE PROVIDED:

A. General:

1. Contractor will provide the necessary manpower, supervision, and tools to properly execute the migration, of DICOM Studies.

2. Contractor will provide the necessary manpower, supervision, and tools to install the new hardware.

3. Upon completion of any work, thorough testing shall be completed, and a Field Service Report shall be provided within fifteen (15) working days of completed labor.

4. A “Field Service Report” (FSR) must be generated, and a copy given to the Iowa City VAHCS’s Contracting Officer’s Technical Representative (COTR) or designee after each episode of scheduled or unscheduled maintenance.

B. Work:

1. All work will be performed during normal VA business hours, 8:00am to 4:30pm, Monday through Friday, except Federal Holidays. If work must be performed outside of normal business hours (“over-time” work), the contractor must obtain prior approval from the COTR. If such work is at the cost of the Iowa City VA Health Care System, a purchase order number must be obtained by the contractor prior to performing any “over-time” work.

2. Contractor must furnish all tools and materials (e.g. service manuals, diagnostic software, reagents, etc.) required to complete work.

C. Documentation: A documentation package acceptable for Joint Commission purposes will be maintained by the contractor and made available to the Iowa City VA Healthcare System. Required features include, at a minimum:

1. Serial Number of equipment serviced

2. Hardware provided and associated part numbers

3. Testing of equipment and results

4. Any and all work performed on a particular date.

4. SPECIAL INSTRUCTIONS:

A. Contractor Check-In: The contractor’s representative will contact the Biomedical Engineering Department at (319) 338-0581, ext. 636881 to schedule the services at the Iowa City VA Healthcare System.

B. Electronic Patient Health Information (EPHI): The medical equipment covered by this contract may contain electronic patient health information (EPHI). The vendor shall not remove/copy/delete any of the EPHI. If a computer hard drive needs to be replaced, the old hard drive must be turned in to Biomedical Engineering for destruction. The vendor will not receive compensation for the hard drive. The contractor, their personnel, and their subcontractors shall be subject to the federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

C. Documentation: At the conclusion of each scheduled or unscheduled maintenance visit, the contractor will provide a written service report indicating the date of service, the model, serial number, and location of equipment serviced; the name of the representative, and the services

5. TERMS AND CONDITIONS:

A. User Responsibility: The contractor will not be held responsible under the terms of this contract for repairs to equipment necessitated by user abuse and/or misuse of the equipment.

B. Exclusions: Service does not include electrical work external to the equipment.

C. Inspection of Equipment: All bidders have the opportunity to make an appointment to inspect the equipment listed in Attachment 1 before submitting bids. Coordinate any visits beforehand with Biomedical Engineering, (319) 338-0581, ext. 3570.

Attachment 1: EQUIPMENT LIST

1. CANDELCUSTOM / Candelis Technology Bid

RECORDS MANAGEMENT OBLIGATIONS

A. 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.

B. 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:

1. includes Iowa City VAHCS records.

1. does not include personal materials.

1. applies to records created, received, or maintained by Contractors pursuant to their Iowa City VAHCS contract.

1. may include deliverables and documentation associated with deliverables.

C. Requirements

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.

1. 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.

1. 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.

1. Iowa City VA HCS 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 Iowa City VAHCS 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 Iowa City VAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

1. 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 Iowa City VA HCS 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).

1. 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 Iowa City VA HCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

1. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Iowa City VAHCS policy.

1. The Contractor shall not create or maintain any records containing any non-public Iowa City VAHCS information that are not specifically tied to or authorized by the contract.

1. 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.

1. The Iowa City VA HCS 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 Iowa City VA HCS 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.

1. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

D. Flowdown of requirements to subcontractors

1. 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.

1. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

E. Security A. 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.

B. Vendor must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6512, 6513, 6517 and 6550 (if applicable); and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations.

Business Associate Agreement Standard Language: It has been determined that protected health information (PHI) may be used, disclosed, accessed, transmitted, created, stored/maintained, and/or destroyed (providing appropriate proof of destruction in compliance with VA Directive 6371) by the Contractor, and a signed Business Associate Agreement (BAA) will be required. The Contractor will adhere to the requirements set forth within the BAA, referenced in the solicitation, and shall comply with all applicable VA/VHA Directives. Once awarded, Contractor and Contracting Officer will collaborate with the appropriate Facility Privacy Officer at vhaiowprivacyofficer@va.gov to implement the appropriate BAA.