FDA-FY22-SS-1256484.pdf

FDA-FY22-SS-1256484

Notice of Intent to Issue a Sole Source Purchase Order for Services to move three (3) ACQUITY LC-MS Systems services to be performed by a certified an original equipment manufacturers engineer/technician.

The Food and Drug Administration intends to issue a sole-source purchase order to Waters Technologies Corporation located at 34 Maple Street, Milford, MA 01757. The anticipated purchase order is for services to move three (3) ACQUITY LC-MS Systems, services to be performed by a certified an original equipment manufacturers engineer/technician. An Award will be made in accordance with Federal Acquisition Regulation (FAR) Part 6.302-1, only one responsible source and no other supplies or services will satisfy the agency requirements using Simplified Acquisition Procedures per FAR Part 13.5. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within seven (7) days after the publication of this synopsis, which will be considered by the agency. Responses received after seven (7) days or without the required information may not be considered. A determination by the Government not to compete as a result, of information received is solely within the discretion of the Government. Information received will be considered solely for determining whether to conduct a competitive procurement. For information concerning this acquisition, contact Linda Troutman, Contract Specialist at Linda.Troutman@fda.hhs.gov

Scope of Work

The LC-MS systems modules that will be moved and to have post-move PM and IQ/OQ are listed in Table 1 below. The destination for this system will be in the same building where they are currently housed and will be one floor below their current location. The moving distance between the original location and the destination is approximately 200 feet.

Table 1. LC-MS Systems Needing Services

Module OEM* Model

Mass Spectrometer Waters Bioaccord ACQUITY RDa Mass Spec Detector

Solvent Manager Waters ACQUITY I Solvent Manager Autosampler Waters ACQUITY I Sample Manager Column Thermostat Waters 1290 Infinity II Multicolumn Thermostat G7116B LC Detector Waters ACQUITY I TUV Detector Fluorescence Detector Waters ACQUITY FLR Detector

*OEM: original equipment manufacturer.

Requirements

1) Contractor Requirements:

The contractor shall be certified by the original equipment manufacturers (OEM) to perform maintenance, installation, and qualification of the LC-MS systems listed in Table 1.

2) Project Requirements:

• The contractor shall organize the project with the following steps and perform the tasks.

FDA-FY22-SS-1256484

a. The contractor shall verify the performance of the LC-MS systems before the move and save the results as a reference to be compared with the post-move results for performance verification.

b. The contractor shall be responsible for powering off the LC-MS systems, deinstalling, and packaging the systems as needed for the preparation of the move.

c. The contractor shall move the LC-MS systems to the locations determined by OTR.

d. The contractor shall reinstall the LC-MS systems after the move, power them on and verify their performance.

e. The contractor shall perform preventative maintenances (PM) and installation and operational qualification (IQ/OQ) for the LC-MS systems after the move.

f. The contractor shall provide all documentation and reports for PM and IQ/OQ

• All pricing shall be inclusive of labor, travel, and PM replacement parts.

• The maintenance activities shall be performed following the original equipment manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, and subassemblies. No other brands of supplies are allowed unless they are approved by OEM.

Deliverables

• Relocation of the three LC-MS systems to their new locations and evidence of comparable before-and after-move performance of the systems.

• Post-move preventative maintenance (PM) for the LC-MS systems and appropriate documentation

• Post-move IQ/OQ for the LC-MS systems and appropriate documentation

Place of Performance/Delivery Location Services will be rendered by the contractor at the following location:

FDA/CDER/OPQ/OTR

645 Newstead Ave., St Louis, MO 63110

Inspection and Acceptance Criteria

• The move shall not cause any damage or harm to the LC-MS systems.

• Before- and after-move performance of the LC-MS systems are comparable.

• IQ/OQ are successfully performed.

Period of Performance

• Within 10 business days after the contract is awarded, the contractor shall contact OTR to schedule the services. The services will need to be staggered to accommodate OTR’s laboratory duties.

• The services for each LC-MS system shall be completed within 10 business days after the starting date of services for this system.

• All services shall be completed within 90 days of the awarded contract.