SOW.docx

CVM-OAS-25-C-1036 Attachment 3: SOW/Requirements Document

Background:

U.S. Food and Drug Administration (FDA) is a regulatory agency with responsibility for the safety of food for humans and animals and the safety and efficacy of drugs, devices, and other medical products. In support of this regulatory mission, the Division of One Health Monitoring (DOHM) at the US FDA Center for Veterinary Medicine, Office of Applied Science (CVM/OAS) and National Antimicrobial Resistance Monitoring System (NARMS) program investigates antimicrobial resistance in foodborne and zoonotic pathogens. In support of this effort, CVM/OAS owns and operates a Bruker MALDI Biotyper Commercial Module (CM) instrument system. This requirement is to procure a BASE year with four one-year option year, full-service maintenance agreement to cover all repairs of this instrument as well as an annual preventative maintenance (PM) service.

Objectives This requirement is to procure a BASE year with four one-year option year, full-service maintenance agreement for a Bruker MALDI Biotyper CM instrument system. This service agreement is to cover all repairs of this instrument as well as an annual preventative maintenance service.

Instrument information: Bruker MALDI Biotyper CM instrument system; serial number (860456204050). Operation status: The instrument has been maintained under a service agreement that expires on 1/15/2025. The last annual PM service was completed on (1/31/2024). The system, as of 10/28/2024, is operating normally.

Minimum Required Salient Characteristics:

The Contractor shall provide the following at the minimum:

· The Contractor shall provide all travel, labor, and parts required to complete both incidental repairs and annual preventative maintenance at no additional charge. Coverage shall include replacement of parts that fail before their specific warranty period. Upon completion of repairs, the Contractor shall ensure the instrument meets all performance specifications by the manufacturer.

· The Contractor shall include all software updates to the scientific instrument and system software and related installation of such instrument updates and system software during the Agreement Term.

· Coverage includes troubleshooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer.

· The Contractor shall ensure all necessary services are provided by service engineers who are trained by the original manufacturer of the instrument.

· The Contractor shall provide documentation of training as part of the proposal package. If the Contractor is not directly providing service, the Contractor shall provide documentation of prior experience providing service for the requested system through contract history with the OEM or other evidence of prior experience.

· The Contractor shall ensure their service providers have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

· The Contractor shall ensure the Technical Point of Contact (TPOC) or their designee has access to the manufacturer’s technical assistance call center during regular business hours (8am to 5pm EST). The service contract provider call center shall have accessible certified engineers via telephone or virtually to provide troubleshooting assistance. Response time shall be within 2 hours of initial phone call during regular business hours (8am-5pm).

· The Contractor shall ensure a service engineer is on site within five (5) business days of receiving a call from the TPOC. Upon the on-site visit, the Contractor shall assess the scientific equipment and determine if the repairs needed to the scientific equipment are covered under the current service maintenance agreement. If the repairs are not covered under the service maintenance agreement, the Contractor shall submit a quote to the TPOC for review, which shall include travel costs, parts costs and labor costs. The Contractor shall ensure the turnaround time for an emergency or non-emergency on-site visit to completion of repairs shall not exceed five (5) business days (120 hours).

· The Contractor shall not engage in repair work that is not covered by the Maintenance/Support Agreement unless the Contracting Officer has appropriately modified the contract to reflect the new work.

· The Contractor shall provide one preventative maintenance (PM) site visit per year to include all travel, labor, and parts. The Contractor shall ensure this inspection includes routine preventative maintenance of the instrument per OEM specifications, calibration, electrical safety testing and any other preventative maintenance measures required by the OEM.

Certificate of Maintainability:

At such time as the services of the Contractor are terminated, expire contractually or are otherwise not extended, or upon request by the Contracting Officer at any time, the Contractor shall issue, within five (5) working days, a "Certificate of Maintainability" for any or all equipment acquired and/or maintained under this contract. The certificate shall state that preventive maintenance in accordance with the specifications of the Original Equipment Manufacturer (OEM) has been performed and that the equipment is performing in accordance with the OEM's specifications such that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the equipment without billing any one-time charges (including but not limited to repair or inspection charges) if such maintenance were assumed effective the day after the Contractor's performance ceases. The Contractor is responsible for bearing all costs associated with obtaining such certification at no separate charge to the Government. Should the Contractor fail to issue the required Certificate of Maintainability in accordance with this clause, or should any equipment fail to perform in accordance with the certification, the Contractor shall be liable to the Government for any reasonable costs incurred by the Government for the purpose of bringing the equipment up to the required OEM maintenance level. If equipment is acquired under this contract, without maintenance of such equipment being concurrently acquired under the contract, the Contractor shall issue a Certificate of Maintainability for such equipment at the time of delivery for each piece of equipment. The certificate shall state that the equipment is in such condition that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the equipment without billing any charges to the Government. All charges required to, obtain the requisite performance of the equipment, up to the later of the time the equipment is accepted by the Government or the warranty expires shall be borne by the Contractor. The time the equipment is accepted by the Government is the date that the Government determines that the equipment has passed acceptance testing, not the effective date of acceptance. The fact that the equipment may have been acquired with a warranty does not relieve the Contractor of its obligations under this clause.

Period of Performance

· Base Year: 1/16/2025-1/15/2026

· Option Year 1: 1/16/2026-1/15/2027

· Option Year 2: 1/16/2027-1/15/2028

· Option Year 3: 1/16/2028-1/15/2029

· Option Year 4: 1/16/2029-1/15/2030

Place of Performance:

The items need to be delivered to the Technical Point of Contact, TBD AT AWARD at:

Bldg MOD2 8401 Muirkirk Rd Laurel, MD 20708 Note: Loading dock delivery is acceptable for any parts delivered.