Statement of Work.docx

PERFORMANCE WORK STATEMENT (PWS)

Imaging System De-installation and Disposal – GE INNOVA 4100-IQ Salt Lake City VA – George E Wahlen Veterans Affairs Medical Center

1.0 Scope

The contractor shall furnish all labor, tools, materials, equipment, and transportation necessary to fully de-install, remove, transport, and dispose of two (2) GE INNOVA 4100-IQ imaging systems and associated peripheral subcomponents from Radiology (1D44/1D42A in building 1) at the George E Wahlen Veterans Affairs Medical Center, Salt Lake City UT. Work shall be performed in accordance with Original Equipment Manufacturer (OEM) specifications and all applicable VA, federal, state, and local requirements.

2.0 Background

The GE INNOVA 4100-IQ imaging systems (Serial Numbers: 589832BU5 and 436339BU6, EEs: 57204 and 40402) are used to produce images during interventional procedures such as angiography, angioplasty and embolization. These systems have already been replaced, with the new systems being in a newly built IR space. The GE systems are not being used and need to be removed to make better use of the space in Radiology.

3.0 Performance Requirements

3.1 General Requirements

The contractor shall:

1. Provide all personnel, supervision, tools, materials, equipment, and transportation required to complete the work described in this PWS.

2. Perform all tasks in accordance with OEM specifications, applicable codes, VA policies, and infection control requirements.

3. Coordinate all on-site activities with the Contracting Officer’s Representative (COR) to minimize disruption to patient care and hospital operations.

3.2 De-installation and Removal Tasks

The contractor shall perform, at a minimum, the following tasks:

1. Pre-Removal Assessment

Perform necessary diagnostic checks and visual inspection of both GE INNOVA 4100-IQ systems and related subcomponents to identify any issues that may impact safe removal.

Confirm all utilities (e.g., power, data, grounding) are safely isolated or otherwise controlled in accordance with facility procedures prior to disassembly.

2. ICRA Level IV Area Setup

Establish and maintain an Infection Control Risk Assessment (ICRA) Level IV compliant work area surrounding the Radiology room, including dust barriers and any required protective measures as directed by the facility Infection Prevention and/or Safety offices.

Implement appropriate debris control, cleaning, and containment measures throughout de-installation and removal activities.

3. System Disassembly

Disassemble the GE INNOVA 4100-IQ imaging systems and its peripheral subcomponents in accordance with OEM specifications and good engineering practices.

Protect adjacent walls, floors, ceilings, and installed clinical equipment from damage during removal.

4. Component Removal and Transport

Remove all disassembled components from the Radiology room and transport them out of the facility using routes approved by the COR.

Load and secure all components for off-site transport in a safe and compliant manner.

5. Disposal

Dispose of all removed components in accordance with all applicable federal, state, local, and VA regulations and policies, including those governing electronic waste, metal scrap, and any hazardous materials, if present.

Provide documentation, if requested by the COR, verifying proper disposal (e.g., disposal receipt, recycling certificate).

6. Floor Restoration and Area Clean-Up

Remove all anchoring bolts or similar hardware from the floor related to the GE INNOVA 4100-IQ systems installation.

Restore the floor surface to a “flush” condition (e.g., filling or covering bolt holes) suitable for subsequent construction or installation activities as directed by the COR.

Remove all trash and debris generated by the removal activities and leave the area clean and free of dust and debris.

3.3 Optional Retention of Ceiling-Mounted Monitor Arm and Monitor

The default scope includes removal and disposal of the ceiling-mounted monitor arm and monitor associated with the GE INNOVA 4100-IQ systems. At the direction of the COR or Contracting Officer (CO), the contractor shall instead:

1. If Removal is Directed:

Disassemble and remove the ceiling-mounted monitor arm and monitor in accordance with OEM specifications and facility safety requirements; transport and dispose of them as part of the overall system disposal scope.

2. If Retention is Directed:

Disengage the ceiling-mounted monitor arm and monitor from the GE INNOVA 4100-IQ systems as needed while maintaining them safely in place, ensuring they are left in a secure, stable, and usable condition (or in a condition as directed by the COR).

The contractor shall be prepared to execute either option as directed by the COR prior to or during field operations.

4.0 Deliverables

The contractor shall provide the following deliverables to the COR:

1. ICRA Setup Confirmation

Confirmation (verbal and noted on the service report) that an ICRA Level IV compliant area was established and maintained for the duration of work.

2. Field Service Report

A detailed field service report upon completion of work, including at a minimum:

Equipment identification (e.g., device name, model, serial number, VA EE number if applicable).

Date(s) and time(s) on site.

Description of tasks performed (disassembly, removal, transport, disposal, floor restoration, clean-up, etc.).

Confirmation of whether the ceiling-mounted monitor arm and monitor were removed or retained and their final disposition.

Any issues encountered and corrective actions taken.

The report shall be submitted to Biomedical Engineering and the COR.

3. Disposal Documentation (if requested)

Documentation evidencing compliant disposal of equipment (e.g., manifests, certificates) when requested by the COR.

5.0 Hours of Work

5.1 Normal hours of coverage are Monday through Friday, 8:00 AM to 6:00 PM local time, excluding federal holidays.

5.2 All on-site work shall be performed during normal hours unless otherwise requested or approved in advance by the COR.

5.3 Any off-hours work, if authorized, shall be coordinated with the COR in advance to minimize impact to patient care.

6.0 Contractor Personnel Qualifications

6.1 All Field Service Engineers (FSEs) performing work under this PWS shall be fully qualified and authorized by the contractor to perform de-installation and removal of the GE INNOVA 4100-IQ systems or similar imaging systems.

6.2 “Fully qualified” FSEs shall:

Have successfully completed formal OEM or equivalent training for imaging system de-installation and related tasks; and

Have at least two (2) years of field experience with scheduled and unscheduled maintenance or de-installation of comparable imaging systems (except for equipment newly introduced to the market).

6.3 Documentation of training and qualifications shall be provided to the COR upon request.

6.4 The COR reserves the right to reject any contractor personnel deemed not qualified or not in compliance with facility requirements.

7.0 Coordination and Check-In/Out

7.1 Upon arrival on site, the FSE(s) shall report to Biomedical Engineering to:

Obtain a VA identification badge;

Sign in and undergo any required screening (e.g., virus scan of mobile media devices).

7.2 Upon completion of work, the FSE(s) shall:

Brief Biomedical Engineering staff or the designated supervisor on work performed;

Return the VA badge;

Sign out with Biomedical Engineering.

7.3 All scheduling and coordination shall be made through the COR or designee.

8.0 Safety and Infection Control

8.1 The contractor shall comply with all applicable federal, state, local, and VA safety requirements, including but not limited to OSHA regulations and facility safety policies.

8.2 The contractor shall comply with the OSHA Bloodborne Pathogens Standard, including:

Educating employees on risks;

Implementing policies and procedures to reduce exposure;

Providing mechanisms for counseling and treatment following potential exposure;

Providing and enforcing use of personal protective equipment (PPE).

8.3 The contractor shall implement and maintain an ICRA Level IV work area as described in Section 3.2, including dust control, barrier installation, and housekeeping.

8.4 At the direction of the facility, the contractor shall immediately correct any identified safety issues. Failure to do so may result in work stoppage at no additional cost to the Government.

9.0 Security, Identification, and Parking

9.1 All contractor personnel shall obtain and prominently display a VA-issued identification badge while on VA property.

9.2 Contractor personnel shall comply with all VA regulations regarding parking, smoking, weapons, and access.

9.3 Toolboxes and enclosed containers may be subject to search by VA Police.

9.4 No VA sensitive information shall be accessed, stored, or transmitted as part of this effort, and no system connectivity is required for this removal service.

10.0 Place of Performance

Department of Veterans Affairs George E Wahlen Veterans Affairs Medical Center 500 Foothill Dr.

Salt Lake City, UT 84148

11.0 Records Management

The contractor shall comply with VA and federal records management requirements as applicable to any records created or handled in performance of this PWS. Records management obligations are as stated in the VA records management clause incorporated in the contract, including but not limited to preservation, protection against unauthorized destruction, and restrictions on disclosure and retention of non-public information.

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 Department of Veterans Affairs (VA) records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VA contract.

4. 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.

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 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.

4. VA 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 VA 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 VA. 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 VA 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 VA 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 VA policy.

8. The Contractor shall not create or maintain any records containing any non-public VA 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 VA 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 VA 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 VA-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.

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.

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