570-25-2-555-0014 Lasers SOW.docx

LUMENIS SURGICAL LASER SERVICE CONTRACT

SCOPE OF WORK

Contractor shall provide a service agreement for Preventive Maintenance (PM), Corrective Maintenance (CM), and Parts for four (4) Surgical Lasers as described in the table below. Services shall be provided for the Department of Veterans Affairs Central California Health Care System – Fresno VA Medical Center. All services shall be provided in accordance with the specifications, terms and conditions contained herein.

The following equipment located at VACCHCS, Fresno, CA.

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

1. SERVICES: The C&A requirements do not apply, and that a Security Accreditation Package is not required. Refer to handbook 6500.6 Appendix A for additional information.

Contractor shall furnish the following:

· Routine Preventive Maintenance as required by the Original Equipment Manufacturer

· Priority on-site Corrective Maintenance which includes all remediations and repairs during normal operating hours excluding Federal Holidays.

· 2 Business Day response time.

· Parts & Labor necessary for PM or CM are provided by the Contractor at no additional customer cost.

· Support Telephone Consultation is provided 24 hours per day 7 days a week by the Contractor at no additional customer cost.

2. DEFINITIONS/ACRONYMS:

A. Biomedical Engineering - Supervisor or designee.

B. CO - Contracting Officer.

C. COR - Contracting Officer's Representative.

D. COTR - Contracting Officer's Technical Representative.

E. 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 manufacturers 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.

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

G. 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.

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

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

J. NFPA - National Fire Protection Association.

K. CDRH - Center for Devices and Radiological Health.

L. VAOPC - Department of Veterans Affairs Outpatient Clinic.

M. OEM - Original Equipment Manufacturer

3. CONFORMANCE STANDARDS:

Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

4. PREVENTIVE MAINTENANCE (PM):

A. Contractor shall perform Preventive Maintenance inspections as per contract.

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.

5. CORRECTIVE MAINTENANCE (CM):

A. All required parts shall be furnished, except for expendable and consumable parts. Consumable and expendable parts are defined as items that require replacement on a greater than one-month frequency. Any exceptions shall be noted by the contractor in writing prior to the initiation of the contract.

B. The CO, COR or designated alternate has the authority to approve/request a service call from the contractor.

C. On-site response within 2 business days.

6. Software Support A. The contractor shall provide technical support for all of the system’s software which includes but limited to: Software updates and patches.

7. HOURS OF COVERAGE:

Normal hours of coverage are (Monday through Friday) from 8:00am to 5:00pm, excluding Federal holidays. Work performed outside the normal hours of coverage at the request of the customer will be billed at the government rate. After-hour service calls will be funded separately from this contract and will require a distinct purchase order to cover the associated costs.

8. PARTS:

The contractor shall furnish and replace parts at no cost with next day delivery by 10:30a. The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be OEM or equivalent and fully compatible with existing equipment. The contract shall include all parts except for 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 the COTR. The contractor is required to install VA supplied parts when said parts are determined to be fully compatible. The determination of compatibility is at the discretion of the COTR.

9. SERVICE MANUALS:

VACCHCS shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. 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), which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request.

10. DOCUMENTATION/REPORTS:

The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

A. Name of Contractor B. Name of FSE who performed services.

C. Contractor Service ESR Number/Log Number.

D. Date, Time (starting and ending), Hours-On-Site for service call.

E. VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours.

F. Description of Problem Reported by COTR/User.

G. Identification of Equipment to be serviced to include the following: Equipment ID #

a. or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

H. Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action.

I. Total Cost to be billed.

J. Signatures from the following:

a. FSE performing services described.

b. VA Employee who witnessed service described.

K. Equipment downtime calculated in accordance with Conformance Standards.

NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE CO BEFORE SERVICE IS COMPLETED!

11. REPORTING REQUIREMENTS:

The contractor shall report to Biomedical Engineering to "check-in" upon arrival and 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). The FSE shall be required to check out with the Biomedical Engineering Department (location to be specified at time of contract award) and submit the ESR(s) to the COTR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COTR for an "authorization signature." If the COTR is unavailable, a signed accepted copy of the ESR will be sent to the COTR within 5 business days of work completion.

FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON- COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR TERMINATION OF THE CONTRACT.

12. 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.

13. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COTR, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The contractor shall furnish the CO and COTR with a written estimate of the cost to make necessary repairs.

14. CONDITION OF EQUIPMENT:

The contractor accepts responsibility for the equipment described in Section B, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

15. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

A. Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

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 two years 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 each make and model the contractor services at the VAOPC. 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 VAOPC equipment. The CO and/or the COTR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAOPC equipment.

16. TEST EQUIPMENT:

Prior to commencement of work on this contract, the contractor shall make available if requested t 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 VAOPC. Test equipment calibration shall be traceable to a national standard.

17. 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 VAOPC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VAOPC will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VAOPC. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. 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 (Federal) District Court, not a local district state, or municipal court.

18. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

The contractor shall comply with the Federal/California 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.

19. RECORDS MANAGEMENT OBLIGATIONS

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.

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:

includes [Agency] records.

does not include personal materials.

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

may include deliverables and documentation associated with deliverables.

Requirements 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.

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.

[Fresno VA Medical Center] 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 [Fresno VA Medical Center] 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 [Fresno VA Medical Center]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

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 [Fresno VA Medical Center] 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).

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 [Fresno VA Medical Center] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Fresno VA Medical Center] policy.

The Contractor shall not create or maintain any records containing any non-public [Fresno VA Medical Center] information that are not specifically tied to or authorized by the contract.

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.

The [Fresno VA Medical Center] 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 [Fresno VA Health Care System] 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.

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 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.

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