Attachment 1 CTX Mobile PET CT SOW 36C25726Q0039 10 23.pdf

Attachment 1: SCOPE OF WORK- Mobile shielded PET/CT Scanner Solicitation Num.

36C25726Q0039

SCOPE OF WORK

Contractor shall provide a mobile shielded PET/CT Scanner for the Central Texas Veterans Health Care System (CTVHCS). The scanner will include supporting equipment and software to provide the CTVHCS Nuclear Medicine Service a like system which will provide the same level of care our patients are presently receiving. It is agreed upon and understood that the vendor will provide appropriate training for the Mobile Unit for all VA PET/CT CNMTs. All services shall be provided in accordance with the specifications, terms and conditions contained herein.

1. SERVICES:

Contractor shall provide a vendor owned mobile PET/CT scanner (minimum features seen below) in a mobile solution that meets regulatory requirements and specifications. The vendor will provide transportation to and from the pre-determined locations and PACS Network connectivity/hook up.

The entire offering of a PET/CT Mobile Trailer service shall meet all local, state, federal, industry, NHPP, NRC, Joint Commission NEC, NFPA, VA, OSHA, and other regulatory standards internal or external applicable to the CTVHCS The vendor shall provide initial medical physics compliance testing reports IAW JC. The vendor shall provide initial shielding requirements (based upon anticipated patient workload) and shielding verification reports IAW JC requirements.

The selected vendor is expected to provide specific services as follows:

• Mobile PET/CT must be operational after contract award, pending completion of site prep work by VA when applicable for each location.

• Mobile PET/CT unit on site for an estimated 1 year (with possible additional option years).

• System manufacturer of the PET/CT must meet the minimum specifications (PET/CT System Requirements below).

• VA Nuclear Medicine Physicians will interpret the mobile PET/CT images.

• The Vendor shall provide all VA technologist staff appropriate training on the equipment.

• The Vendor shall be responsible for transporting the unit to and from the determined locations.

• The Vendor shall be responsible for the maintenance of the unit by an OEM FSE, including all Preventative Maintenance (PM), and all Parts and Labor. After each service the OEM FSE must provide a vendor Engineering Service Report (ESR) to Biomed staff.

• The vendor shall perform the initial medical physics survey IAW Joint Commission requirements.

• The vendor shall also provide the shielding recommendation report IAW National Council of Radiation Protection 147.

• VA contracted medical physicist(s) also be given access to perform appropriate physics testing as necessary to maintain consistency with VA owned equipment or review appropriate documentation of completed testing to ensure adequacy. At a minimum ACR standards must be maintained for all imaging equipment.

• All equipment must be properly maintained and tested in accordance with JC/NRC/NHPP guidelines.

• Vendor shall have a Reciprocal Agreement between the State of Texas and the NRC to use radioactive materials under their State License on any Federal or Federally-leased property.

• Vendor shall be responsible for posting Radioactive Material signage in and on mobile unit and adding additional signage if requested from appropriate CTVHCS staff.

• System must be able to transfer image and data to multiple modalities including PACs, GE AW workstation, MIM, Cedars (when applicable) and VISTA Imaging. OEM FSE will establish network and printer connectivity at the site in coordination with local IT/PACs staff.

Verification of connectivity must be made prior to the start of patient procedures.

• System scan protocols must be verified and validated by CTVHCS Staff Nuclear Medicine Physicians.

• Vendor shall agree to cooperate with VA for quality control purposes.

• Upon removal of equipment from the VA custody, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

Section A:

PET/CT Mobile Unit

• Must provide a NEW build mobile unit at a minimum size of 12’ wide x 48’ long to accommodate full access inside mobile unit and around PET/CT scanner.

• Mobile unit must contain a minimum of two shielded/ ABA (Architectural Barriers Act) compliant Patient Injection Areas.

• Mobile unit must be Ground-Level, Flush-to-Surface Entry: Eliminates the need for wheelchair lifts or stairs, reducing fall risk, preventing lift malfunctions, and improving stretcher access.

• Must be a Stationary “No-Wheel” Modular-Like Build:

o Regular wheeled trailers have operational hazards including tire blowouts, axle wear, and instability when stationary for long periods, posing additional maintenance and safety risks. Our required unit avoids these vulnerabilities entirely.

• Hand washing sink.

• Must include HVAC system that meets manufacture requirements

• Mobile unit must provide separate temperature controls in the scanner room vs uptake/patient rooms to ensure optimal functionality and comfort for both clinical staff and patients, as these areas have different usage patterns and thermal loads that can impact equipment performance and patient well-being. It reduces the risk of humidity and excess heat impacting the scanner, cables, and other components.

o Scan rooms must be kept within manufacturer-specified temperature ranges to maximize uptime and protect sensitive electronics.

o Uptake areas are primarily for patient waiting or preparation, where comfort and a quiet, stable environment contribute to successful imaging procedures.

• Handicapped accessible meeting all ADA guidelines.

• The PET/CT mobile shall provide the space sufficient for the monitoring of injected patients and conducting CPR and code, if needed. Adequate radiation shielding and security measures are requisite.

• The Mobile unit shall also have an intercom system between the control room and scanning room

• The PET/CT mobile must include Integrated Restroom Facilities: Critical for oncology patients undergoing lengthy scan preparation or with urinary urgency related to care.

Eliminates unsafe patient transfer to external restrooms in inclement weather.

• Nuclear Medicine Information System (NMIS) must be included in the hot lab to manage radiopharmaceutical deliveries and patient administrations.

Section B:

PET/CT Scanner

With Minimum Features:

• Siemens Vision PET/CT, GE Discovery, or Digital PET/CT Scanner to best match current digital system(s) in use at CTVHCS Centra [specifications described below]

• Must have LYSO crystal-based technology and minimum 64 slice (128 slice preferred) CTAC. Time of flight scanning with a timing resolution less than 600ps is requisite.

• QSuite or equivalent package

• QClear iterative reconstruction or equivalent technology

• QCORE Power upgrade when applicable or equivalent upgrade

• 2M Scan Range preferred

• Most current software level per vendor

• Windows 10 or later version (Windows XP not acceptable)

• Metal Artifact Reduction preferred

• SnapShot imaging or equivalent package

• Q Static or equivalent package

• Motion Compensation Technology

• Advanced Scan tools for:

o Cardiac processing to include Myocardial blood flow and quantitation o Cardiac Ca++ scoring o Oncology o Neuro o PET Bone Imaging o Low Dose CT Lung Screening o Post-processing

• High Resolution LCD Monitor

• DICOM Workflow Management

• IHE Schedule Workflow

• Physiological Synchronization

• DVD read/write device

• DICOM Store/Query/Retrieve

• ACR Accredited system

• Patient table must meet or exceed 500lbs weight limit.

• Must also provide AW workstation or comparable reading station for NM physician.

Section C:

Service Locations

• The Mobile PET/CT unit’s base location will be at the CTVHCS in Temple, TX.

Olin E. Teague Veterans Center

1901 Veterans Memorial Drive

Temple, TX 76504

• Additional scanning site may include:

VA Austin Outpatient Clinic 7901 Metropolis Drive Austin, TX 78744

• Additional VA sites to be determined based on infrastructure availability and patient demand.

2. DEFINITIONS/ACRONYMS:

A. Biomedical Engineering - Supervisor or designee, Phone Number (210-617-5300 x15114).

B. CO - Contracting Officer.

C. COR - Contracting Officer's Representative.

D. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer’s latest established service procedures to ensure operation of equipment within manufacturer’s or VA’s performance specifications, whichever is the most rigorous.

PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM.

E. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Hospital premises.

F. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

G. Acceptance Signature - VA employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

H. Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR.

I. NFPA - National Fire Protection Association.

J. CDRH - Center for Devices and Radiological Health.

K. VA - Department of Veterans Affairs.

L. OEM - Original Equipment Manufacturer

3. GOVERNMENT FURNISHED UTILITIES/SERVICES:

a. The Government will provide the following utilities/services to the Contractor if required for the operation of the mobile PET/CT unit.

1. Electricity*

2. Telephone Line(s) **

3. Data Port

4. Water and sewage

* In accordance to the Original Equipment Manufacturers’ (OEM) electrical specifications.

** Use of telephone extension while mobile unit is on site to permit the unit to make and receive telephone call and to facilitate the movement of patients to and from the unit.

b. The professional component of the PET/CT exams will be provided by VA Nuclear Medicine

Physicians.

c. VA staff will be responsible for scheduling and imaging the patients for the mobile unit.

4. PREVENTIVE MAINTENANCE (PM)/ REPAIRS:

A. Contractor shall ensure that the system has current PMs performed by the OEM and is meeting the manufacturer’s specifications.

B. The contractor shall furnish documentation, including all measurement and calibration data to certify that the system is performing in accordance with the performance specifications. All required repairs shall be completed within 5 business days of identification of any deficiency.

5. EMERGENCY MAINTENANCE:

The contractor will maintain that a greater than 95% uptime of the system is met and that there are provisions for emergency service during normal business hours. All maintenance will be performed by a contract agreement with the OEM.

6. PARTS:

The contractor shall furnish and replace all parts at no cost to the Government. The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be OEM and fully compatible with existing equipment. The contract shall include all parts with the exception of consumable or expendable items. The contractor shall use new or rebuilt parts. Used parts, those removed from another system, shall not be installed without approval by Biomedical Engineering and/or CTVHCS Medical Physicist.

7. REPORTING REQUIREMENTS:

The contractor shall contact Biomedical Engineering prior to performance of work under this contract. This check-in is mandatory and can be accomplished in person or by phone contact.

When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s).

9. ADDITIONAL CHARGES:

There will be no additional charge 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.

10. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify CTVHCS of the existence or the development of any defects in, or repairs required to be scheduled. Documentation of repair and physics evaluation is required.

11. CONDITION OF EQUIPMENT:

The vendor shall provide equipment that at a minimum meets ACR standards and requirements.

12. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

A. The contractor must have a “Fully Qualified” FSE who is familiar with the equipment identified in Section B.

B. “Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment identified in Section B. For field experience, the FSE(s) shall have a minimum of one year of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on equipment identified in Section B.

C. The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for the make and model of the equipment leased to the CTVHCS s. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any CTVHCS equipment. The CO and/or the COR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the CTVHCS leased equipment.

13. TEST EQUIPMENT:

Prior to commencement of work on this contract, the contractor shall make available, if requested, a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by the CTVHCS. Test equipment calibration shall be traceable to a national standard.

14. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA

REGULATIONS:

The contractor's FSE shall wear visible identification at all times while on the premises of the VACTHCS. It is the responsibility of the contractor to park the mobile unit in the appropriate designated parking areas. Designated parking areas will be determined in advance of mobile unit delivery. Additionally, information on parking will be available from the VA Police-Security Service.

The CTVHCS will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the CTVHCS. Possession of weapons is also 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 (Federal) District Court, not a local district state, or municipal court.

15. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

The contractor shall comply with the Federal/Texas OSHA Bloodborne Pathogens Standard. The contractor shall:

a. Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

b. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

c. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

d. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

16. 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-day’s 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.

17. TRAINING

a. If necessary, all contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

i. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

ii. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

iii. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

iv. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor 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.

PRIVACY OFFICER LANGUAGE

The Contractor will have limited access to protected Patient Health Information (PHI) only for the purposes of providing clinical care. If removal of equipment from the VA is required, any memory storage device with patient information will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified.

Information System Officer, Information Protection

The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government.

RECORDS MANAGEMENT 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:

1. 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.

2. 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.

3. 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.

4. 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.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns all components containing and used to store patient data and has the right to retrieve such components upon termination of contract. At the end of the contract, any hard drive containing patient information will be relinquished to the VA.

8. 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.

9. 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.].

10. 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.

11. 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.

VA INFORMATION CUSTODIAL LANGUAGE

Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements.

VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

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.

If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

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.

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.