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1. STATEMENT OF NEED

Background: The Department of Veterans Affairs, James A. Haley Veterans Hospital Sun Nuclear equipment, and QA. The equipment is currently being used for patient-specific and end-to-end stereotactic Quality Assurance (QA). SunCHECK QA fully integrates machines and high expectations for overall treatment quality to support patient safety. SunCHECK provides flexible workflow automation for fully integrated and independent QA.

Scope of Work: The contractor shall provide (to include license, deployment, installation, and training) for the SunCHECK Platform, SunCHECK Machine, SunCHECK Machine Non-Linac, PlanCHECK, SunDEPLOYS Remote Installation, SunDEPLOYS, Remote Project Management, and SUnDEPLOYS Education Units. The Government already owns the below equipment. This is the annual support for the equipment and associated licenses.

INCLUDED OR

COMMENTS

Contractor shall provide premium on-site & remote radiation therapy customer support for all SunCHECK Platform, SunCHECK Machine, SunCHECK Machine Non-Linac, and SunCHECK medical device products. Remote applications support Monday — Friday 8am — 5pm EST.

1. 24x7 website access for customer download of information

2. 15- 30-minute initial response Monday — Friday 8am — 5pm EST

3. Firm ware Updates as upon new releases of software

4. Maintenance and repair to include parts and labor (not including negligence)

5. 24/48 Loaner at no additional charge (subject to availability of stock)

6. One (1) annual onsite manufacturer preventative maintenance schedule

Government Responsibilities: Government is responsible for completing deployment and education training provided by the Contractor.

Contractor Responsibilities: The Contractor is responsible for furnishing the SunCHECK QA licenses and medical device support and service for base plus four option years. The Contractor is responsible for all deployment, installation, troubleshooting and training requirements.

2. SPECIAL WORK REQUIREMENTS:

· Hours: Services shall be performed according to specifications of Government point of contact and COR. The regular work hours four this facility is Monday through Friday 0800am to 5:00pm (EST).

· Special Instruction: The contractor's representative will schedule all work with the Bio Medical Engineering Department. Contractor shall drop off all service reports to the Bio Medical Engineering Department detailing the work performed. Failure to drop off service reports may delay contractor payment. All contractor personnel (without exception) must report to the Engineering Department, MSDU (Room GC-003), to sign in and receive a contractor identification badge before any work is performed and return to the same location to sign out and turn-in said badge along with the documented. service report for the service performed. Noncontract Charges: The contractor shall not perform any service that will result in additional charges without prior approval from the Contracting Officer.

· Property Damage: The contractor shall take all necessary precautions to prevent damage to any government property and will notify the Contracting Officer immediately if damages occur. The Contracting Officer will authorize the contractor to remedy the situation in one of the following ways: be assessed current replacement costs for damaged property, replace damaged property in a timely manner, or correct the damages with like materials at no additional cost.

· Identification, Parking, Smoking, and VA Regulations:

The contractor will need to acquire a badge for each worker and ensure that the badge be always worn in a visible location on the worker while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police. The VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VA. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States District Court.

· Documentation: All service documentation must contain:

a. Date and time of the contractors' arrival on station

b. Type, model, and serial number(s) of all equipment on which service was performed

c. Total time of performance period, excluding travel time

d. Detailed narrative description of reason for service performed to include reported problem and cause of problem (When applicable)

e. Complete list of parts replaced (When applicable)

f. Date and time equipment was returned to serviceability.

· Infection Control: There is a potential for exposure to blood borne or other infectious material with equipment throughout the hospital. All contractor personnel are cautioned and must use "Universal Precautions" (i.e., hand washing, wearing protective gloves, aprons, and goggles, etc.) as appropriate during the performance of this contract.

· Personnel Qualifications: Contractor personnel performing under this contract will be fully qualified and competent for the equipment to be performed. Service Quality: All services provided in this contract must meet manufacturers' performance and technical specifications, Federal Regulations, VA Regulations, and meet the requirements of The Joint Commission and Life safety Code. The contractor shall document all maintenance and provide said documentation to the COR upon completion of each service action.

PERIOD OF PERFORMANCE: This purchase of the SunCheck QA solution will require a base plus four option years for the maintenance and service agreement.

3. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

With No Sensitive Data but Requires Training

VA INFORMATION CUSTODIAL LANGUAGE:

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. 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.

c. 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.

d. 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:

a. 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.

b. 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.

c. 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.

d. 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:

a. 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.

b. 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 COMPLIANCE TESTING:

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:

a. 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.

(1) 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.

b. 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.

c. 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.

All Contractor, Pharmaceutical Company Representative (PCR), and Healthcare Industry Representatives (HIR) will coordinate with Contracting Officer Representative for instructions so they are in compliance with James A. Haley Veterans’ Hospital policies listed on the JAHMC Document Management Center share point site:

HPM NO. 90-25; HEALTHCARE VENDOR ACCESS AND COMPETENCY

HPM NO. 132-04; SECURITY MANAGEMENT PROGRAM

HPM NO. 132‑05; HOSPITAL IDENTIFICATION PROGRAM

HPM NO. 11-91; PHARMACEUTICAL COMPANY REPRESENTATIVES

HIR are required to report to MSDU (Room GC-003), immediately after entering the facility. HIR will be required to sign into the monitoring system and print a badge for proper identification. . The Healthcare Industry Representatives for Nutrition and Food Services, Office of Information and Technology, and Social Work Services are in included in this policy; vendors (HIR) for Pharmacy Services are to follow (HPM 11-91) policy. HIR must be sponsored by a physician, a Service Chief, or their designee, for a specified date and a specified case. HIR are not permitted in patient care areas or clinics unless a prior appointment has been made.

Pharmaceutical Company Representative (PCR) refers to anyone acting on behalf of a pharmaceutical company or its business partners for the purpose of promoting the use of items managed under the VA formulary process. These items primarily include drugs, but to a lesser extent also include any medical supplies, nutritional supplements, and similar commodities managed under the VA formulary process.

a. Sign-In: PCRs may visit VA Medical care facilities no earlier than 8:00 a.m. and stay no later than 3:30 p.m., Monday through Friday, unless they receive prior approval from both the Chief of the Service that they will be visiting and the Chief of Pharmacy. Representatives visiting the JAHVH must sign in at the Pharmacy Administrative Office (Located in Trailer 78) and wear a visitor’s badge as well as their company’s personal name badge while in the hospital.

Vendors: Reference Hospital Memorandum Policy Number 90-25 Healthcare Vendor Access and Competency.

Contractors and/or project managers: Will be issued a PIV/ID badge in accordance with the facility PIV Policy. Contactors will contact their assigned VA Contracting Officer Representative (COR) for coordination.

Contract Personnel/Sub-Contractors: Contractors are responsible for the daily accountability and identification of all personnel assigned to their respective contract including sub-contractors. Contractors will identify personnel using the following procedures as appropriate.

Construction Project contract personnel will report to the contractor for issuance of a temporary self-adhesive identification badge. This badge will be issued on a daily basis and must include the following information: Company name, project number, date and name of individual. Contractor will maintain a daily log of all personnel.

Contract personnel not involved in an actual construction project will report to police dispatch for issuance of a numbered badge. A driver’s license or photo ID will be required each day upon entering the facility, in exchange for the badge, and will be given back once the badge is returned to police dispatch. The contractor will provide Police Service with a list of names for all sub-contract personnel requiring access to the facility. It is the responsibility of the contractor to update the list as necessary.

NPR OPC; CBOCs and Off-site Lease facilities with VA Police staffing: As above with check-in with VA Police.

Off-site Lease facilities w/o VA Police staffing: Coordinate with COR, Administrative Officer, or Service Point of Contact.

8. RECORDS MANAGEMENT CONTRACT LANGUAGE

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. chess. 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 while 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. James A Haley Veterans’ Hospital and Clinics 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 James A. Haley Veterans’ Hospital and Clinics 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 James A. Haley Veterans’ Hospital and Clinics. 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 James A. Haley Veterans’ Hospital and Clinics 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 James A. Haley Veterans’ Hospital and Clinics 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 James A. Haley Veterans’ Hospital and Clinics policy.

8. The Contractor shall not create or maintain any records containing any non-public James A. Haley Veterans’ Hospital and Clinics 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 James A. Haley Veterans’ Hospital and Clinics 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 James A Haley Veterans’ Hospital and Clinics 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, Talent Management System (TMS) Item #3873736, Records Management for Records Officers, and Liaisons. 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.]

D. Flow down 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.

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