Statement of Work (Draft).pdf

36C25625Q0732 Attachment

STATEMENT OF WORK

Ion GeneStudio S5 Plus Next-Generation Sequencer (S/N 2772919030143)

Annual Preventive Maintenance & Repair Service

1. SCOPE OF WORK:

a. The contractor shall furnish all labor, transportation, parts, test equipment, tools, and expertise necessary to maintain the Ion GeneStudio S5 Plus Next-Generation Sequencer located at the Central Arkansas Veterans Health Care System. The Pharmacogenomics Analysis Laboratory is located at the John L.

McClellan Veterans Hospital, 4300 West 7th Street, Little Rock, AR 72205.

b. The contractor shall provide Applied Biosystems (AB) Assurance plan/ annual service agreement service in accordance with the terms and conditions stated within this Statement of Work (SOW). The contractor shall provide the following coverages on the system: Corrective Maintenance, Planned Maintenance, and Software Maintenance. The selected vendor shall have the ability to connect to the system remotely through an approved VA VPN connection for troubleshooting purposes. The vendor shall have the ability to apply all Thermo Fisher Field Change Orders to ensure the system is maintained to manufacturer’s standards to include software and quality updates. The vendor shall provide all coverages and benefits normally given in their commercial service and support agreements. The contractor shall provide priority telephone and email access to instrument technical support and application Technical support.

c. The performance period shall be effective for 1 year upon date of award plus 4 one-year options that may be exercised by the government.

d. The medical equipment covered by this contract does not contain electronic patient health information (EPHI) but shall contain de-identified genomic sequencing information. The vendor shall not remove/copy/delete any of the de-identified genomic sequencing information. If a computer hard drive needs to be replaced, the old hard drive must be turned-in to biomedical engineering for destruction. The contractor shall not receive compensation for the hard drive. 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.

e. Normal service requirements under this contract consist of scheduled preventive maintenance inspections, adjustments and repairs, as specified herein, along with scheduled contractor maintenance in response to service calls made by VA Pharmacogenomics Analysis Laboratory, Research Service, Central Arkansas Veterans Healthcare System to the contractor due to a partial or complete system or subsystem failure which requires the contractor to respond within a specified time frame to make needed repairs/adjustments to the system.

2. EQUIPMENT:

The equipment to be serviced/maintained includes:

Ion GeneStudio S5 Plus System, Product # A38195, S/N 2772919030143 on EIL 401

Located in GC135, Research Service, Little Rock VA Hospital

3. CONFORMANCE STANDARDS:

a. Contract service shall ensure that the equipment/system functions in conformance with the latest published edition of NFPA-99, Occupational Safety and Health Administration (OSHA), manufacturer’s Network Equipment/System.

b. Upgrades/updates shall be installed in strict accordance with manufacturer’s specifications and must operate within manufacturer’s specifications and must operate within manufacturer’s specified parameters.

4. HOURS OF COVERAGE:

a. The contractor shall respond by phone at no additional charge, within the normal business hours (8:00 AM to 5:00 PM (CST) M-F).

b. All scheduled service/repairs shall be performed during these normal hours of coverage unless one of the following conditions exist:

1) The contractor wishes to perform such maintenance at a time that is outside of the normal hours of coverage, at no additional cost to the Government, and the contractor submits a request to the Contracting Officer’s Representative (COR) prior to the proposed start of the maintenance and the request is approved by the COR before work is begun.

2) The COR directs that the scheduled maintenance be performed at a time that is outside the normal hours of coverage and the additional cost is recommended by the COR and authorized by the Contracting Officer.

c. Scheduled maintenance shall be performed in accordance at the manufacturer’s recommended intervals and should be scheduled/completed during the month the VA requests. Changes in this periodicity shall occur only when approval is granted by the COR and CO.

d. Scheduling for unscheduled maintenance requirements outside of normal hours shall be coordinated with and require the approval of the COR.

e. Federal holidays observed:

New Years Day Martin Luther King Day President's Day Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day and any other day specifically designated by the President of the United States.

5. UNSCHEDULED MAINTENANCE:

a. Contractor shall maintain the equipment in accordance with manufacturer’s standards.

b. The contractor shall provide repair service, which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and installing parts.

c. All parts shall be covered in this agreement.

d. The Contracting Officer, COR and designated Alternate have the authority to approve/request a service call from the contractor.

e. Response time:

1) Contractor’s Field Service Engineer (FSE) shall respond by phone during normal business hours or within (30) minutes after normal business hours.

2) If the problem cannot be corrected by phone or by remote diagnostics the contractor shall dispatch a technician to arrive not more than 2 business days after receipt of a service call.

6. SCHEDULED MAINTENANCE:

a. Contractor shall perform Preventive Maintenance (PM) service to ensure that equipment listed in the schedule performs in accordance with the manufacturer's recommendations as published in the Manufacturer’s Maintenance Manuals for the system.

b. Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM.

c. PM services shall include, but need not be limited to, the following:

1). Cleaning of equipment to include filters, gearing, and other parts.

2) Reviewing operating system software diagnostics to ensure that the system is operating as specified by the manufacturer’s specifications.

3) Calibrating and lubricating the equipment.

4) Performing remedial maintenance of non-emergent nature.

5) Performing electrical safety inspection IAW NFPA 99.

7. PARTS:

a. The Contractor shall provide all replacement parts needed to keep the system in operating condition as originally designed by the manufacturer.

b. Parts may be repaired or replaced, as the contractor deems appropriate. No used parts shall be used to repair this equipment.

c. Parts shall be shipped for arrival the next day by 1030 A.M central station time.

8. SERVICE MANUALS:

a. VA shall not provide service manuals of service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSEs 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.

b. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request.

9. DOCUMENTATION/REPORTS:

a. Documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices required to maintain the equipment in accordance with manufacturer specifications. Test equipment used for calibration shall be listed on the service report by manufacturer, model number, serial number and date due calibration.

b. Any additional charges claimed shall be approved by the CO via the COR before service is completed.

10. REPORTING REQUIREMENTS:

a. Upon arrival at VA Little Rock the contractor shall be required to log in with Biomed in room GD109 (office) or GD114D (Biomed Staff Laboratory) in John L. McClellan VA Hospital, Little Rock, AR. This log-in is mandatory as well as wearing the contractor badge issued upon log-in. Contractor’s FSE(s) shall wear visible identification at all times while on the premises of the VA. Identification shall include, at a minimum, the employee’s name, position, and the contractor’s trade name. In addition, the contractor shall submit fingerprints through the VA police for issuance of a VA identification badge that shall be worn at all time while working at a VA facility.

b. When service is completed, the FSE shall document services rendered on a legible ESR(s) and submit to the Biomedical Equipment Support Specialist (BESS) who set-up the service. The ESR can be submitted when logging out with Biomed, via an internet web site or e-mail. ESRs should be submitted not later than 5 business days after service is complete. Preferred method of delivery is via email to VHALIT Biomedical Engineering@va.gov

c. In those cases when the Biomed office is closed, contractor personnel shall log in and/or out via the VA police and after-hours service shall be prearranged with the BESS.

11. SERVICES BEYOND THE CONTRACT SCOPE:

a. Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence of 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.

b. Contactor shall furnish the COR with a written estimate of the cost to make necessary repairs.

12. CONDITION OF EQUIPMENT:

a. The contractor accepts responsibility for the equipment described in “as is” condition.

b. Failure to inspect the equipment prior to contract award shall not relieve the contractor from performance of the requirements of this contract.

13. TEST EQUIPMENT:

Test equipment calibration shall be traceable to National Institutes of Standard Technology standards. Each service report shall list test equipment used and date calibration to NIST is due. Test equipment out of calibration shall not be used.

14. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

a. Contractor’s FSE(s) shall wear visible identification at all times while on the premises of the VA.

Identification shall include, at a minimum, the employee’s name, position, and the contractor’s trade name.

b. It is the responsibility of the contractor to park in the appropriate designated parking areas.

Information on parking is available from VA Police Service. VA shall not invalidate or make reimbursement for parking violations of the contractor under any conditions.

c. Smoking is prohibited inside all VA buildings.

d. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search.

e. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state or municipal court.

15. CONTRACTOR QUALIFICATIONS:

a. “Fully qualified” is based upon training and experience in the field. For training, the FSE(s) has successfully completed a formalized training program for the equipment identified in this solicitation as required by the Original Equipment Manufacturer (OEM) and equal to what the manufacturer provides their own field service personnel.

b. Contractor must provide, upon request, evidence of appropriate training of any FSE(s) providing services under terms of the contract. Subcontracting of any ensuing award of this solicitation shall not be allowed without written permission of the Contracting Officer.

c. Contractor must have access to all OEM proprietary information due to the critical nature of these services. Examples of this information would be software updates and factory service bulletins that describe updates/modifications needed to make the equipment under this contract safe for use.

16. RECORDS MANAGER:

a. 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.

b. 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.

c. 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.

d. Central Arkansas Veterans Healthcare system 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 Central Arkansas Veterans Healthcare system 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. e. Shallful 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 Central Arkansas Veterans Healthcare system. The agency must report promptly to NARA in accordance with 36

CFR 1230.

f. 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 Central Arkansas Veterans Healthcare system 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).

g. 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 Central Arkansas Veterans Healthcare system guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

h. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Central Arkansas Veterans Healthcare system policy.

i. The Contractor shall not create or maintain any records containing any non-public Central Arkansas Veterans Healthcare system information that are not specifically tied to or authorized by the contract.

j. 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.

k. The Central Arkansas Veterans Healthcare system 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 Central Arkansas Veterans Healthcare 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.

l. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take Central Arkansas Veterans Healthcare system 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.