Preventative Maintenance and Qualification Services for the Stacked Generator

Request for Quotation: 75F401-23-Q- 1263930

Response Date: Date: April 26, 2023, 3:00 p.m. Eastern Time.

NOTE: Please indicate company’s SAM.gov Unique Entity ID on the quote. The subject line shall read: 75F401-23-Q-1263930 – Preventative Maintenance and Qualification Services for the Stacked Generator.

This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures. This solicitation is issued as a Request for Quote (RFQ).

NAICS Code: 541990

Line Item Structure: The following is a contract line item numbers, (including options):

Line Item 0001 – Base Year - Preventative Maintenance and Qualification Services for the Stacked Generator.

Line Item 0002 – Option Year 1 - Preventative Maintenance and Qualification Services for the Stacked Generator.

Line Item 0003 – Option Year 2 - Preventative Maintenance and Qualification Services for the Stacked Generator.

Background

The Food and Drug Administration (FDA) Center for Tobacco Products (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. This law gives CTP the authority to regulate the manufacturing, distribution, and marketing of tobacco products.

Objective

The Southeast Tobacco Laboratory (STL) of Center for Tobacco Product (CTP) has a requirement for a preventative maintenance repair and operation qualification service agreement for an Agilent Liquid Chromatographic System with an AB Sciex 6500+ QTrap Tandem Mass Spectrometer Detection System. The instrument is currently under contract (HHSF223201810199G) and expires on 08/05/2023.

Requirements

The Contractor shall provide both the Preventative Maintenance and Qualification Services for the Stacked Generator.

The contractor shall meet the following minimum requirements for a Preventative Maintenance (PM) and Repair:

• The Contractor shall provide One (1) Preventative Maintenance Inspection (PMI) service visit during each 12-month period of performance for the instruments and its components.
• The Preventative Maintenance Service shall be performed in accordance with the specifications contained in the original equipment manufacturer’s service manual.
• The service representative shall be manufacturer-certified and trained to perform maintenance and repairs for each instrument covered under the service agreement
• The PMI shall include all parts, labor and travel for remedial repair.
• The Turbo Pumps replacement shall be included under the service contract.
• The contractor shall obtain all new parts required for all repairs and maintenance which meet the original equipment manufacturer’s specifications at no additional cost to the Government.

• The Contractor shall repair or replace any part or parts which prove to be defective at no additional charge to the Government.
• The Contractor shall make arrangement for the fastest delivery and will resume work upon receipt of parts.
• The COR designee shall contact the Contractor to schedule a mutually acceptable date and time for all preventative maintenance visits. All visits must be scheduled at least 72 hours in advance with the COR/COR designee.
• The Contractor shall provide documentation of preventative maintenance duties performed. (See Records and Reports section).

The contractor shall meet the following minimum requirements for Qualification Service (QS):

• The Contractor shall provide Qualification Service after the planned PM and after any other repairs of the system. The Qualification Service shall include Operation Qualification/Instrument Performance Verification (OQ/IPV).
• The Contractor shall perform one (1) annual OQ/IPV verification for the systems that is equal to or exceeds the qualification requirements of the original equipment manufacturer.
• The OQ/IPV service shall be performed by a qualified engineer. The Contractor shall provide documentation that the system is functioning according to the original equipment manufacturer’s specifications.
• The OQ/IPV shall include all supplies needed to perform the service. Both the OQ and IPV shall be scheduled at a date approved by the TPOC or Alternate TPOC.

• The Contractor shall provide the TPOC documentation for temperature verification, calibrations, and an instrument performance run.
• If at any point during the Qualification Service, the system fails a test, the Contractor shall provide onsite service to remedy the failure and re-execute the Qualification Service to demonstrate to the TPOC that the system passed all the Functional Requirements Specification and the system is operating in accordance with OEM specifications.
• If parts are needed to re-execute the OQ, the Contractor shall schedule delivery of the necessary parts and perform a return service visit within 48 hours.

Service Calls

• The Contractor shall respond within Two (2) business days after receipt of a service call from the COR designee.
• The Contractor shall provide unlimited telephone and email access to instrument technical support Monday – Friday between the hours of 9-5 p.m. EST.
• All repairs shall result in the system serviced meeting the original equipment manufacturer specifications. All repairs shall use factory, new replacement parts.
• The Contractor shall perform a diagnostic test and document results and provide a narrative summary demonstrating that the system is meeting the original equipment manufacturer’s specifications
• Any parts or components removed for replacement shall be returned to the FDA unless the TPOC approves in writing for the parts or components to be disposed.  The Contractor shall remove the parts from the site at the time of the service call or provide shipping instructions and return shipping information so that the FDA may return the parts to the Contractor at no additional cost to the Government, no later than three (3) business days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments.

Service Conditions

• To the maximum extent practicable, service shall be rendered on-site at the FDA.
• The Contractor is responsible for cleanup and removal of all shipping/packing materials at the time of service. Some shipping and packing material cannot be placed in the facility dumpster (e.g. pallets and/or crates) and shall be removed by the contractor and at no additional cost to the Government.
• In the event a part needs to be repaired off-site, the Contractor shall be responsible for all packaging, shipping, and transportation costs as well as liability for the shipment to and from the FDA, 60 8th ST.NE, Atlanta, GA. The Contractor shall be responsible for providing a “Return Authorization Number” or other information authorizing return of the shipment to their facility prior to the shipment. The Contractor shall also provide a shipping account number to pay for the shipment.
• The Contractor shall only employ tools, parts, instruments, test apparatus, methodologies, techniques, and practices approved for use by Shimadzu with the instruments specified in the SOW.

Warranty

The Contractor shall provide warranty on all labor, replacement parts and components (excluding consumables) of the system for at least a 12-month period.

Records and Reports

• The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.

PLEASE SEE ATTCHED RFQ FOR FULL DETAILS