P09_SOW_LivaNova Heart Lung Full Service and PM.docx

STATEMENT OF WORK – LivaNova Heart and Lung Maintenance

1.0 BACKGROUND

1.1 The Eastern Colorado VA Healthcare System requires a maintenance and service contract with LivaNova USA, Inc. to maintain functionality of the Sorin heart and lung bypass machines.

SPECIFIC SERVICE FOR

1.2 Equipment to be covered.

1.2.1 Heart-Lung Bypass Unit Serial Number: 48E05694

1.2.2 Heart-Lung Bypass Unit Serial Number: 48E00986

2.0 REQUIRED SERVICES

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 above (1.2.1). Only preventive maintenance inspections will be completed on asset 48E00986 (1.2.2). Equipment is located at the Rocky Mountain Regional VA Medical Center, 1700 N Wheeling Street, Aurora, CO 80045.

2.1 PREVENTIVE MAINTENANCE

2.1.1 The contractor shall provide preventive maintenance by a LivaNova certified technician.

2.1.2 The contractor shall provide travel and accommodation of the technician.

2.1.3 The contractor shall exchange all predefined preventive maintenance spare parts according to preventive maintenance report.

2.1.4 The contractor shall perform manufacturer specified safety checks.

2.1.5 The contractor shall provide the latest software and firmware version updates (bugfixes). NOTE: Hardware upgrades can be purchased at an additional charge in the case of non-compatibility between software and hardware.

2.1.6 The contractor shall provide technical support via telephone 24/7.

2.1.7 The contractor shall perform preventive maintenance according to the manufacturer specified interval.

2.1.8 The contractor shall schedule visits at a mutually convenient time during the PPM.

2.1.9 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 maintenance shall be included in the coverage. The government will not pay for any parts provided during preventive maintenance. Only new standard parts (manufactured by the maker of the equipment, or equal) shall be furnished to maintain the equipment.

2.2 CORRECTIVE MAINTENANCE

2.2.1 The contractor shall have a LivaNova certified technician visit for needed corrective maintenance according to corrective maintenance report.

2.2.2 The contractor shall pay for the travel and accommodation costs of the technician.

2.2.3 The contractor shall provide remote support to local technicians over the phone.

2.2.4 The contractor shall make commercially reasonable efforts to provide on-site response within forty-eight (48) hours from receipt of a service request, unless delayed by causes outside its reasonable control.

1.1 SPARE PARTS

1.1.1 The contractor shall replace worn out or defective spare parts.

1.2 ANNUAL INSPECTION

1.2.1 The contractor shall perform annual functional and electrical safety tests according to IEC62353 by a LivaNova certified technician according to inspection report.

1.2.2 The contractor shall provide travel and accommodation for the technician.

1.2.3 The contractor shall perform annual inspection that follows manufacturer recommendation. The inspection can be executed during a corrective maintenance visit.

2.0 HOURS OF COVERAGE

2.1 Normal hours of coverage are Monday through Friday from 8:00 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.

2.2 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.

2.3 Coverage will be for one (1) twelve (12) month term, with four (4) possible option years to be exercised by the government.

2.4 There will be no additional charge for time spent at the site (during or after the normal coverage areas) awaiting the arrival of additional FSE and/or delivery of parts.

3.0 DOCUMENTATION/REPORTS

3.1 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), equipment downtime and hours on-site for service call

e. VA purchase order number(s) covering the call if outside normal working hours

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

g. Itemized Description of Service Performed (including, if applicable, costs associated with after normal working hour services) including:

· Labor and Travel,

· Parts (with part numbers),

· Materials and Circuit Location of problem/corrective action.

· Total Cost to be billed (if applicable - i.e., part(s) not covered or service rendered after normal hours of coverage)

h. Signatures:

· Technicians performing services described

· Authorized VA Employee who witnessed service described

3.2 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.

4.0 SERVICE MANUALS/TOOLS/EQUIPMENT

4.1 The contractor shall provide tools, (test) equipment, service manuals or service diagnostic software. The contractor shall obtain, have on file, and make available to their field service engineer (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.

5.0 SERVICES BEYOND SCOPE OF CONTRACT

5.1 The contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the POC, in writing, of the existence or development of any defects in provided parts/equipment, delays to installation or implementation, or additional required labor/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 Government Purchase Card (GPC) threshold, the POC will decide to approve and authorize payment. For emergency costs over the 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 be on site within 48 hours of modification emergency notification.

5.5 The contractor shall guarantee workmanship and all parts furnished by the contractor for a period of not less than 2 years from the date of install.

5.6 Any additional charges claimed must be approved by the CO before service is completed.

6.0 COMPETENCY AND CERTIFICATION OF PERSONNEL SERVICING EQUIPMENT

6.1 Each respondent must have an established business, with an office and full-time staff. The staff shall include a fully qualified technicians and/or electricians, and/or other certified field service engineers.

6.2 “Fully Qualified” is based on successful completion of training and experience in the field. For training, the service provides shall have successfully completed a formalized training program for the equipment identified in the schedule.

6.3 The technician and/or electricians shall be authorized by the contractor to perform the services. All work shall be performed by fully qualified competent technicians and/or electricians or other field service engineers. The contractor shall provide copies of all certificates for technicians, electricians, and/or field service engineers if necessary. When deemed appropriate, the POC or CO reserves the right to prohibit contractor personnel from working on VAMC equipment.

6.4 Any electrician and/or certified engineer shall provide licenses upon request of the VA.

7.0 SECURITY

7.1 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.

7.2 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.

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

7.4 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.

8.0 PERFORMANCE MONITORING

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

9.0 PLACES OF PERFORMANCE

9.1 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

10.0 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 [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] 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. [Agency] 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 [Agency] 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 [Agency]. 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 [Agency] 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 [Agency] 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 [Agency] policy.

8. The Contractor shall not create or maintain any records containing any non-public [Agency] 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 [Agency] 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 [Agency] 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 [Agency]-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.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

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.