Please see the attached solicitation for full details. 

Background

The FDA (Food and Drug Administration) Northeast Medical Products Laboratory (NMPL), microbiological sciences laboratory has been involved in the testing of Sterile Drug Products as part of survey work and various illness injury type samples.  The types of samples analyzed utilizing the Steritest Filtration System has resulted in several recalls and criminal action. There is presently a preventive maintenance agreement in place for these systems through June 22, 2020.  The last preventive maintenance visit was conducted on December 18, 2019.  The systems are in good working condition and none are known to have any existing issues.

Purpose

The Steritest Equinox LFH Pumps are used in the analysis of sterile drug products.  These pumps require calibration on a yearly basis to ensure that these units provide accurate volumes during testing procedures.  The Preventive Maintenance Agreement shall cover onsite calibration and the changing of pump seals which are critical for accuracy in testing the drug products.  These units are state of the art and the re-calibration will ensure that peak efficiency is attained during testing. 

Requirements

Northeast Medical Products Laboratory requires services from an OEM-trained technician capable of providing service for routine maintenance, calibration and any potential repair of the four (4) Steritest Equinox LFH Pumps located at NMPL: 

                                                                                  Serial Number     

                Equinox Pump   TQNXLFH01                         824                       

                Equinox Pump   TQNXLFH01                         812                      

                Equinox Pump   TQNXLFH01                         1441                  

                Equinox Pump   TQNXLFH01                         1429                       

Offerors are afforded the opportunity to inspect the system by contacting the Contract Specialist identified in the solicitation to schedule an appointment. Failure to inspect the system will not relieve the successful offeror from fully meeting the requirements of the resulting contract at the price offered.

Technical Specifications:

At a minimum, the support plan shall cover engineer labor and travel, at least one (1) annual scheduled Preventative Maintenance visit per year, unlimited repairs as needed on the pumps during the coverage period, factory-certified replacement parts, and technical support.

Through the service agreement, the Contractor shall provide the necessary personnel to execute on-site preventative maintenance and repair and other services as identified below:

• Providing the Northeast Medical Products Laboratory/Sterility Laboratory with direct telephone and/or Internet technical support from Original Equipment Manufacturer (OEM)-trained individuals.
  • The Contractor shall provide at least one (1) annual Preventative Maintenance visit per year per instrument and on-site repair calls when necessary.
  • The service contract must provide unlimited on-site visits with a maximum 72-hour on-site response time (for issues that cannot be resolved remotely via telephone or Internet).
• All maintenance and repair activities (including warranty work) shall be accomplished in accordance with Original Equipment Manufacturer (OEM) specifications using new OEM parts.
• All PM or repair services shall be performed by OEM-trained technicians
• Contractor shall have access to the most current OEM factory training for hardware
• Contractor shall have access to the most current OEM factory parts – not build to order parts
• Contractor shall not use salvaged parts from other instruments for performing maintenance and repair
• All parts used in the PM and repairs must be guaranteed, factory-tested, OEM quality parts.
• PM visit includes replacing parts subject to wear as defined by OEM specific PM checklist with OEM factory parts
• Parts, labor and travel/per-diem costs for PM and repairs shall be included in the price of the service agreement.

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.