Statement of Need/Statement of Work
Background
ORA’s Office of Regulatory Science (ORS) needs workstations to process data files generated from government-owned Sciex liquid chromatography-mass spectrometers (LC-MS) used in the analysis of human and animal food products for mycotoxins. All proprietary data files generated from highly complex scientific LC-MS instruments require processing to allow government scientists to evaluate and determine the level of mycotoxins in FDA collected samples, and to generate reports using government customized report templates. To facilitate the anticipated large volume of regulatory samples, ORS needs workstations capable of processing Sciex LC-MS data files and generating customized reports to support FDA’s regulatory and enforcement action.
Objectives
ORS is seeking to purchase data processing workstations to process data files from multiple government owned Sciex LC-MS instrument platforms at ORS laboratories located in Bothell, WA, Kansas City, KS and Atlanta, GA to utilize a new multi-mycotoxin analytical method to support the agency’s mission of protecting the public health from adulterated food products.
Scope
To purchase two data processing workstations including hardware and software at each of the 3 ORS laboratories to meet programmatic need of performing a new multi-mycotoxin analytical testing of human and animal food products.
Requirements
The contractor shall provide the minimum requirements under this contract:
- Computer hardware shall include the following:
- Appropriate computing processor with minimum 8-cores
- 2x2TB solid state hard drives in RAID configuration.
- 32 GB DDR4 RAM memory
- two (2) 100/1000 Mbps ethernet ports
- optical mouse and keyboard
- 24-inch LED monitor
- 64-bit Windows 10 Operating System
- The new computer and software must be adequately equipped with minimum computing requirements to access, read, and process data files generated from government-owned Sciex models 4500, 5500, 6500 and 6500+ LC-MS instruments running on Sciex OS version 3.x to the government’s satisfaction.
- Must transfer and successfully execute government customized instrument report template file(s) to successfully access, read, and process the instrument acquired data files and generate an acceptable instrument generated report of the desired mycotoxin analytes of interest. Minor modifications to the instrument generated report template are permitted with the government’s approval.
Trade and Service Specifications
- All hardware and software shall be newly manufactured units, not used or refurbished or previously used for demonstrations.
- All workstations shall be multi-user operable with unique user account login access.
- All software shall be standalone and single-use license for each workstation without any limitations.
- All issues or problems due to manufacturer defect shall be corrected to the government’s satisfaction.
- All cost of travel, lodging, and per diem of the contractor’s staff to meet all requirements of this statement of work shall solely be the contractor’s responsibility.
- All hardware, components, parts, software, etc. acquired through this contract shall include at a minimum 1-year warranty against any manufacturer defect.
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- INSPECTION/ACCEPTANCE CRITERIA
Upon arrival, the shipping container will be inspected for damage. If significant damage is observed, such as a hole going through the container and packing to reach the cabinet itself, it will be rejected. If there is damage that does not penetrate all the way through, it may warrant the receiver to open the container prior to acceptance. Installation is overseen and final acceptance will be by the on-site Technical Point of Contact (TPC). Final Acceptance is documented by the TPC signature on the Field Service R
CONTRACT TYPE
This is firm fixed price.
PERIOD OF PERFORMANCE
The period of performance (POP) is for 60 days after award.
Name and Location
Delivery Date
U.S. Food & Drug Administration
Atlanta Human and Animal Food Laboratory (ATLHAF)
60 8th Street Northeast
Atlanta, GA 30309
No later than 30-day after contract award date
U.S. Food & Drug Administration
Kansas City Human and Animal Food Laboratory (KCLHAF)
10749 West 84th Terrace
Lenexa, KS 66214
No later than 30-day after contract award date
U.S. Food & Drug Administration
Seattle Human and Animal Food Laboratory (SEAHAF)
22201 23rd Drive Southeast
Bothell, WA 98021
No later than 30-day after contract award date
PLACE OF DELIVERY AND PERFORMANCE
All hardware and software shall be delivered to the following government sites:
HOURS OF OPERATION
Work/Deliveries shall typically be performed/delivered during normal business hours (typically between 8AM and 5PM Eastern) Mondays through Fridays.
FEDERAL HOLIDAYS
The Government will not require support for the Federal Holidays listed below. Specific dates can be found on https://www.opm.gov/.
- New Year's Day
- Birthday of Martin Luther King, Jr.
- Washington’s Birthday
- Memorial Day
- Juneteenth National Independence Day
- Independence Day
- Labor Day
- Columbus Day
- Veterans Day
- Thanksgiving Day
- Christmas Day GOVERNMENT CLOSURES
Government operating statuses for offices nationwide can be found on https://www.opm.gov/.
Aside from Federal holidays, the contractor shall contact the COR or Contracting Officer to determine work status in the event of Government closures. If a contractor staff has been approved to work at an alternate work site, the Government anticipates that the contractor staff will continue to perform their tasks as assigned at the order level.
In the event of inclement weather, contractor staff that work on-site at a Federal facility shall be responsible for checking the operating status. If the facility is closed and the contractor staff is telework ready, the contractor staff may be required to work at the direction of the COR or CO.
DELIVERABLES AND DELIVERY SCHEDULE
The contractor shall deliver all items no later than the dates indicated with the deliverable below.
FDA Laboratory
Number of Workstations Needed
ATLHAF
2
KCLHAF
2
SEAHAF
2
Total Workstations
6
All shipments shall be made F.O.B. Destination.
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- GOVERNMENT POINTS OF CONTACT
Contract Specialist
Warren Jackson
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services 4041 Powder Mill Road, STE 400
Beltsville, MD 20705
Phone: 301-796-7376
Email: warren.jackson@fda.hhs.gov
Contracting Officer’s Representative/Technical Point of Contact (TPOC)
To be determine after award.
