BACKGROUND
The FDA (Food and Drug Administration) Seattle Human and Animal Food Laboratory (SEAHAF) Chemistry Branch analyzes a wide variety of regulatory samples across numerous program areas. Additionally, the laboratory often requires the development and verification of methodology to detect contaminates in a wide variety of regulated commodities. PNL is seeking to bring the Association of Official Analytical Chemists (AOAC) paralytic shellfish poisoning (PSP) method online, which requires a post-column derivatization system capable of integration into an existing government-owned high-performance liquid chromatography (HPLC) instrument.
REQUIREMENTS
The contractor shall meet the following requirements for the HPLC Post-Column Derivatization System:
- Shall have the approximate dimensions: depth: 42 cm; height 45 cm; width: 22 cm
- Shall have a heater reactor that controls at + 0.4°C from 10°C above ambient to 130°C
- Shall have a reaction coil that can withstand 600 psi
- Shall have a reagent pump adjustable from 0.05 mL to 2.00 mL/minute
- Shall have a flow accuracy ~3%
- Shall have a flow precision ~0.5%
- Shall have weight: 10 to .12 kg
- Shall have at a minimum one-liter capacity pressurized reagent reservoir.
- Shall uses inert gas to maintain inert conditions
- The system shall be compatible with all HPLC instruments. The contractor shall provide HPLC post-column derivatization system to bring the AOAC PSP method online that meet the following requirements.
The contractors should ensure the following:
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- The system shall be a newly manufactured unit, not used and refurbished or previously used for demonstration.
- FOB Point destination to include delivery, installation, and clean-up of area after installation.
- All defects or deficiencies found during the installation and qualification of the equipment shall be corrected to meet OEM specifications.
- The entire system shall be warranted for parts and labor for 12 months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an original equipment manufacturer (OEM)-trained service engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, and OEM quality parts.
- Instrument operators shall have access to a technical representative call center at no additional charge during the warranty period, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise supported by documented experience, skill and training for troubleshooting the instrument.
- Any necessary Preventative Maintenance (PM) or Repair Services shall be included during the warranty period. This visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers which perform this service shall be trained by the OEM.
- Sufficient familiarization training for 3-5 users per delivery onsite location will be provided at time of installation or shortly thereafter (within 30 days), such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training.
- The Contractor shall provide upon request installation qualification with an employee who can provide proof of the necessary education, experience, and training to perform installation qualification/operation qualification (IQ/OQ).
Records and Reports
The Contractor shall provide a report within 14-days of the installation identifying the equipment name, manufacturer, model number, and serial number of the equipment installed and detailing the work performed, results of any qualification measurements, and indication whether the equipment meets qualification specifications.
The Contractor shall provide the end-user of the equipment with a copy of the field corrective service report identifying the equipment name, manufacturer, model number, and serial number of the equipment being repaired and detailing the reason for the warranty call, a detailed description of the work performed. The parts and the test equipment used to repair the system shall be on the report. This will include the name(s) and contact information of the engineer who performed the repair, and for information purposes, the on-site hours expended, and parts/components replaced.
Security and Privacy Requirements
Section 2 of FDA Security and Privacy Language does not apply to procurements for only hardware and software licenses.
1. The Contractor (and/or any subcontractor) shall ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.
2. The Contractor (and/or any subcontractor) shall follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.
3. The Contractor (and/or any subcontractor) shall ensure that computer software developed on behalf of HHS/FDA or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The contractor shall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the HHS/FDA environment. No sensitive data shall be used during software testing.
4. The Contractor (and/or any subcontractor) shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations, or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS/FDA shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.
Section 508 Compliance
The Contractor shall be familiar with Section 508 requirements as described at
http://www.section508.gov/ to ensure that documents generated as part of the
tasks are fully Section 508-accessible using the available COTS tools. Each order will
identify the standards applicable to that order.
PERIOD OF PERFORMANCE
The anticipated dates are: 09/17/2024 – 09/16/2025
The system shall be delivered NLT 60 days post award.
SHIPPING LOCATION:
U. S. FDA/SEAHAF
22201 23rd Drive SE
Bothell, WA 98021-4421
Attn: POC to be identified at time of award
Contractor must call the Government POC at least 48 hours prior to delivery. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above.
GOVERNMENT POINTS OF CONTACT
Contract Specialist
Elena Tatarov
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
Email: elena.tatarov@fda.hhs.gov
**PLEASE SEE ATTACHED Solicitation FDA-24-1275435 FOR ALL REQUIREMENTS**
