PWS - Sorin LivaNova 3T Heater Cooler Maintenance.docx

1.0 BACKGROUND

1.1 The Eastern Colorado VA Health Care System requires the purchase of a service and maintenance contract for the LivaNova 3T Heater/Coolers employed at the Rocky Mountain Regional VA Medical Center.

1.2 This system is proprietary, highly specialized, and essential for operations at the Rocky Mountain Regional VA Medical Center. A service contract will lead to improved reliability, decreased downtime, and improved patient care.

2.0 REQUIRED SERVICES

2.1 The contractor shall furnish labor, parts, supplies and equipment necessary to provide scheduled and unscheduled maintenance, and periodic preventive maintenance inspections for the equipment listed below. Equipment is located at the Rocky Mountain Regional VA Medical Center, 1700 N Wheeling Street, Aurora, CO 80045.

2.2 The contractor shall furnish all spare and replacement parts needed to service the equipment. The price of all parts used to perform all scheduled preventive and unscheduled maintenance shall be included in the coverage. The Government will not pay for any parts provided (during either scheduled or unscheduled maintenance), by the contractor during the period of the medical equipment being covered. Only new standard parts (manufactured by the maker of the equipment, or equal) shall be furnished to maintain the equipment.

2.3 The contractor shall provide tools, (test) equipment, service manuals or service diagnostic software. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation (such as; operational and service manuals, schematics, and parts list) necessary to meet the performance requirements and repair of the medical equipment. A reference list of applicable service manuals and their respective locations shall be provided to the Biomedical Engineer upon request.

2.4 The Contractor shall perform PM Service to ensure that the equipment listed performs in accordance with the original manufacturer’s specifications. Annual PM Service must be completed by December 31st of each year. An outline of the PM schedule and procedures shall be provided to the Biomedical Engineer. PM services shall include, but need not be limited to, the following:

2.4.1 Cleaning of equipment.

2.4.2 Reviewing operating system software diagnostics to ensure that the system is operating in accordance with the manufacturer's specifications.

2.4.3 Calibrating and lubricating the equipment.

2.4.4 Performing remedial, non-emergent maintenance.

2.4.5 Testing and replacing faulty and worn parts and/or parts likely to fail or become faulty or worn.

2.4.6 Inspection and replacement of worn or frayed electrical wiring and cables.

2.4.7 Returning the equipment to the operating condition and mode

2.4.8 Providing documentation of services performed.

2.5 All service/repairs shall be performed during normal hours of coverage unless requested or approved by the Biomedical Engineer. The only exception is hardware/software update/upgrade installations which shall be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the Biomedical Engineer).

2.6 The contractor shall provide any applicable system updates and enhancements at the discretion of the contractor at no additional cost.

2.7 All exceptions to the PM schedule shall be arranged and approved in advance with the Point of Contact, or Biomedical Engineer. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to the Point of Contact at the completion of the PM.

2.8 Work performed outside the normal hours of coverage, at the request of FSE, shall be considered service during normal hours of coverage and shall be exempt from an extra labor hour charge.

2.9 The contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, to include all intervening service calls performed between scheduled services and calibrations. All required parts shall be furnished by the contractor to the VA at no cost. The contractor shall repair the equipment to functional level equivalent to the original manufacturer’s specifications.

2.10 Only the Biomedical Engineer, Point of Contact, or Contracting Office Representative designated by the CO has the authority to approve/request an unscheduled maintenance service call to the contractor.

2.11 The contractor's FSE shall respond on site within four (4) hours after receipt of request for service. The contractor shall provide parts, if required to effect repair, within 24 hours of diagnosing the problem.

2.12 There shall be no hourly charge to the Government for unscheduled, in-person, maintenance performed within the normal hours of coverage, 8:00am MST to 5:00pm MST. Work performed outside the normal hours of coverage, at the request of the Biomedical Engineer, Point of Contact, or Contracting Office Representative, shall be invoiced separately and shall not have service rendered until Purchase Order is obtained. In the event of a Government caused delay, the VA will pay hourly labor charges for unscheduled service the inadvertently extends beyond the specified normal hours of coverage.

2.13 SPECIFIC SERVICE FOR

2.13.1 LivaNova/Sorin 3T Heater/Cooler

2.13.2 Serial Number: 16S17484

2.13.3 VA Equipment Entry (EE) Number: 554 MX1053749

2.13.4 LivaNova/Sorin 3T Heater/Cooler

2.13.5 Serial Number: 16S17811

2.13.6 VA Equipment Entry (EE) Number: 554 MX1287995

2.14 The contract shall provide 24/7 remote, technical support for the LivaNova/Sorin 3T Heater/Cooler systems employed at the Rocky Mountain Regional VA Medical Center.

2.15 Period of Performance

Base: August 1st, 2026, to July 31st, 2027 Option 1: August 1st, 2027 to July 31st, 2028

3.0 HOURS OF COVERAGE

3.1 Normal hours of coverage are Monday through Friday from 7:30 a.m. to 5:00 p.m., excluding the federal holidays listed as follows:

Federal Holidays:

Any other day specifically declared a National Holiday by the President of the United States These hours of coverage only apply for on-site and in-person support. Remote, technical support is required 24/7.

3.2 When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by US Government Agencies.

4.0 DOCUMENTATION/REPORTS

4.1 Field Service Reports shall be provided to the Agency within two weeks of service for all service activities and shall contain, at a minimum, the following information:

a. Name of contractor and contract number

b. Name of technician who performed services

c. Contractor service job number/log number

d. Date, time (starting and ending), and equipment downtime

e. Description of problems reported by the POC/user (if applicable).

f. Itemized Description of Service Performed

4.2 All field service reports for equipment located at the Eastern Colorado VA Health Care System shall be emailed to VHADENBiomedGroup@med.va.gov. Failure to carry out the above procedures shall be considered as a failure to document and shall constitute a failure to perform.

5.0 SERVICES BEYOND SCOPE OF CONTRACT

5.1 The contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the COR or POC, in writing, of the existence or development of any defects in provided parts/equipment, delays to installation or implementation, or additional required repairs. The contractor shall furnish the Government with a written estimate of the cost to make the necessary repairs.

5.2 For any additional equipment or labor that is over and above the Statement of Work, if quote pricing is within the Contracting Officer’s Representative’s (COR)’s Government Purchase Card (GPC) threshold, the COR will decide to approve and authorize payment. For emergency costs over the COR’s GPC threshold, only the Contracting Officer (CO) is authorized to approve contract modifications.

5.3 Additional services not covered under the scope of this contract shall be approved by the Contracting Officer prior to the contractor initiating any work.

5.4 Once an emergency modification has been issued to the contractor, the FSE shall respond within 48 hours of modification emergency notification.

6.0 SECURITY

6.1 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.

6.2 Services provided under this contract do not require the connection of one or more contractor-owned IT devices (such as a laptop computer or remote connection from a contractor system) to a VA internal trusted (i.e., non-public) network. Therefore, Certification and Accreditation (C&A) requirements do not apply and a security accreditation is not required for this contract.

6.3 Services provided under this contract do not involve equipment that stores, generates, transmits, or exchanges sensitive data.

6.4 The contractor is required to obtain the Contracting Officer’s approval prior to engaging in any contractual relationship in support of this contract requiring the disclosure of information, documentary material, and/or records generated under or relating to this contract. The contractor is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

7.0 PERFORMANCE MONITORING

7.1 The Agency shall oversee work done by the contractor and accept the quality of work as appropriate.

8.0 PLACES OF PERFORMANCE

8.1 Delivery of services shall be coordinated through the Biomedical Engineering located at:

Rocky Mountain Regional VA Medical Center 1700 N Wheeling St.

Aurora, CO 80045

9.0 ACRONYMS

9.1 CO - Contracting Officer. The Federal employee who is warranted by the Government to enter into contracts on behalf of the Government and is the only person authorized to make changes to those contracts

9.2 COR - Contracting Officer's Representative. Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract

9.3 FSE - Field Service Engineer

9.4 OEM - Original Equipment Manufacturer

9.5 PWS - Performance Work Statement

9.6 SME - Subject Matter Expert

9.7 SOW - Statement of Work

9.8 VAMC - Department of Veterans Affairs Medical Center

DEPARTMENT OF VETERANS AFFAIRS Records Management Language for Contracts VA Eastern Colorado Health Care System Aurora, CO 80045

RECORDS MANAGEMENT OBLIGATIONS

This clause applies to all contractors whose employees create, work with, or otherwise handle Federal records, as defined below:

“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 information value of data in them.

The term Federal Record:

1. Includes (Agency) records

2. Does not include personal materials

3. Applies to records created, received, or maintained by Contractors to the (Agency) contract

4. May include deliverables and documentation as associated with deliverables

The following items should be added to the Statement of Work (SOW) for contracts:

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 transportation, 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 (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. Eastern Colorado Health Care System (ECHCS) 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 ECHCS 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 ECHCS. 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. 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 ECHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the Contract. 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 co, contracts. The Contractor (and any sub-contractor) is required to abide by Government and ECHCS 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 contractor and in accordance with ECHCS policy.

8. The Contractor shall not create or maintain any records containing any non-public ECHCS 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. ECHCS owns the rights to all data and records produced as part of the contract. All deliverables under the contract are property of the U.S. Government for which ECHCS 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. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

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, and require written subcontractor acknowledgement of same.

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