Sole Source - PM&R Clinical - Analyzers | Abbot Molecular | Wilkes-Barre VA Medical Center

Statement of Work A. GENERAL GUIDANCE Title: Service Agreement for Government-owned Abbott Alinity m molecular diagnostics analyzer at Wilkes-Barre VAMC in Wilkes- Barre, Pennsylvania.

Scope of Work: The contractor shall provide a Standard Service Package for the Government-owned Abbott Alinity m molecular diagnostics analyzer mandatory by the requirements stated herein. The facility is located at: Wilkes-Barre Medical (VAMC)

1111 East End BLVD Wilkes-Barre, PA 18711 Background: This contract is issued to ensure the continuous reliability of the Abbott Alinity m molecular diagnostics analyzer in this Statement of Work (SOW). The equipment requires annual preventive maintenance and manufacturer-recommended operational and safety improvements to uphold availability and efficacy of the system. This equipment is critical for continuous operations of the laboratory at VA Wilkes-Barre.

The reliable and accurate operation of the system at all times is considered critical to the health of patients. Performance period: The period of performance is the duration of the service agreement for the base year, plus any exercised option years.

Type of Contract: Firm-fixed-price. B. GENERAL REQUIREMENTS This agreement includes software and equipment support for the continuous reliability of the Abbott Alinity m molecular diagnostics analyzer. The following item is to be serviced in accordance with the specifications, terms, and conditions of this contract. ABBOTT Alinity m, EE 57582, SN 1015 Service and support to be provided:

Standard Service Package: Single Point of Abbott Contact Parts, Labor & Travel AbbottLink Global Real-Time Support Centers AbbottLink Remote Diagnostics Regular Business Review Annual Manufacturer-Recommended Maintenance Manufacturer-Recommended Operational & Safety Improvements, including software and equipment upgrades Replacement parts On-Site Service and Support, including travel Three-Day Response time for onsite service Instrument & Assay training Hours of Coverage: On-site support: 8am 5pm EST, Mon Fri Phone support: 7am 7pm CST, Mon Fri Services shall be performed during these designated hours of coverage unless one of the following conditions exists: The contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the Government, the contractor submits a request to Biomed Engineering prior to the proposed start of the work, and the request is approved in writing before work is begun.

The technical point of contact in Biomed Engineering directs that the services be furnished at a time that is outside the normal hours of coverage and the additional cost is recommended authorized by the CO. Work performed outside the normal hours of coverage must be preapproved by the CO. The Contractor will provide a written estimate of the charges prior to approval of the work.

Work performed outside the normal hours of coverage at the request of the Field Service Engineer (FSE)/contractor shall be considered service performed during normal hours of coverage. There will be no additional charge for time spent waiting at the site during or after the normal hours of coverage for delivery of parts Federal Holidays Observed by the VA Medical Center: New Year s Day, Martin Luther King, Jr.

Day, President s Day (Washington s birthday), Memorial Day, Juneteenth National Independence Day Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated by the President of the United States.

Customer Notification: Contractor shall notify Biomedical Engineering when they arrive on site. Contractor will schedule all services with Biomedical Engineering. When the service(s) is/are completed, the FSE shall document the services rendered on a legible Engineering Service Report(s) per Section E. The FSE shall be required to check out with the Biomedical Engineering Department and submit the ESR(s).

All ESRs shall be submitted to the equipment user for an "acceptance signature" and to Biomed for an "authorization signature." If a signature is not available, a signed accepted copy of the ESR will be sent to the point of contact in Biomed within five 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.

D. 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.

E. 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.

ESR s must also be emailed to, VHAWBPBioMedEng@va.gov with the Vendor Name and contract Obligation Number listed in the Subject Line. In addition, each ESR must at a minimum document the following data legibly and in complete detail: Name of Contractor Name of FSE who performed services. Contractor Service ESR Number/Log Number. Date, Time (starting and ending), Hours-On-Site for service call. VA Purchase Obligation (PO) number covering the call, if outside normal working hours. Description of Problem Reported by COR/User. Identification of Equipment to be serviced to include the following:

Equipment ID # or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers. 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. Total price to be billed. Signatures from the following:

FSE performing services described. VA Employee who witnessed service described. Equipment downtime calculated in accordance with Conformance Standards.

Note: Any additional charges claimed must be approved by the CO before service is started. F. SCHEDULE FOR DELIVERABLES Draft copies of deliverables shall be provided to Biomedical Engineering staff before the contractor leaves the facility at each visit. If a final copy can be provided at that time then a draft copy is not necessary, final copies must be provided within 5 business days of the time of each deliverable.

G. CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

H. CONDITION OF EQUIPMENT: The contractor accepts responsibility for the equipment described in this scope of work, 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.