Attachment 1- Statement of Requirement (SOR).pdf

STATEMENT OF REQUIREMENTS

TITLE: Procurement of the MALDI TOF system for microbial identification

I. BACKGROUND INFORMATION

The Material Measurement Laboratory’s Biosystems and Biomaterials Division within the

National Institute of Standards and Technology (NIST) develops and provides methods, reference materials, and reference data for characterizing biological systems. To fulfill this mission, robust characterization of microorganisms is required. The acquisition of an instrument to identify microorganism accurately and rapidly is needed. The measurement capability is critical to ongoing and future work in the division.

Accurately identifying Microorganisms is challenging and the acquisition of the MALDI TOF system will increase confidence in identify pure and complex microorganisms in various samples.

This instrument will enable NIST to acquire a vast library of pure and known organisms at a faster rate, saving the group and the division time and money and promoting research.

II. SPECIFICATIONS

The Contractor shall provide one (1) MALDI-TOF system that meets the following minimum technical requirements. The Contractor shall install the system and provide training and warranty as described below.

Hardware Requirements:

1. The system must be new equipment and not a refurbished equipment.

2. The system must be compatible with North American 110V/60Hz power supply.

3. The system must include any uninterruptable power supply or power conditioning equipment deemed necessary for normal operation by the original equipment manufacturer (OEM).

4. The system must include any mobile cart deemed necessary for normal operation by the original equipment manufacturer (OEM).

5. The system must be a matrix assisted laser desorption and ionization – time-of-flight

(MALDI TOF) mass spectrometer system including hardware and/or software specific to microbial strain identification applications.

6. The system must have a benchtop form factor. Dimensions of instrument must not exceed

710 x 1100 x 720 mm (width by height by depth)

7. The system must be provided with a Windows PC-based computer or integrated controller for controlling the system and analyzing instrument data.

8. The system must be compatible with use of a commercially available E. coli or E. coli peptide as a calibration standard.

9. The Contractor shall provide copies of all manuals for user operation and user maintenance in either electronic or hardcopy format.

10. The system must be compatible with single-use sample target plates.

11. The system must be able to run a minimum of 1 sample.

12. The system must be compatible with loading at least 48 samples in the instrument at a time for serial data acquisition from all loaded samples.

Software Requirements

13. The system must include a software-based reference library database containing reference spectra for at least 1000 unique microbial strains.

14. The system must include software for system control and data analysis that includes pre-defined workflows for recording spectra and performing microbial organism identification using recorded spectra. Identification capabilities must include:

a. Bacterial identification

b. Filamentous fungus identification

c. Mycobacteria identification

15. The system must include software for adding new reference spectra to the reference library database and/or the creation of user-defined library databases.

16. The system must include capabilities for user to export spectra in one or more non-proprietary data formats such as XML/JSON, CSV, HDF5, etc.

17. The system must include capability for statistical analysis of recorded spectra.

Installation:

The Contractor shall install the instrument the National Institute of Standards and Technology, 100 Bureau Drive, in Building 227, Room A262, Gaithersburg, MD 20899. Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and hook-up of all equipment, start-up, demonstration of specifications, and removal of all trash. Instrument shall operate to manufacturer’s specifications upon installation. Installation shall take place during normal business hours, between 8:30 am and 5:00 pm Eastern Time, Monday through Friday except Federal Holidays, and shall be coordinated with the NIST Contract Officer Representative

(COR). Installation shall occur within 30 calendar days of delivery.

Warranty:

The Contractor shall provide, at a minimum, a one-year warranty for the system. The warranty shall cover all parts, labor and travel. The warranty shall commence upon formal acceptance by the Government.

Training:

The Contractor shall provide an on-site MALDI TOF MS application training at NIST, Gaithersburg, MD for up to 3 NIST personnel. The training shall cover basic instrument operating theory; normal instrument operation, troubleshooting, and routine maintenance; and demonstration of sample measurement and data analysis workflows using OEM standard materials and/or user-provided samples Training shall be provided during normal business hours, between 8:30am and 5:00pm Eastern Time, Monday through Friday, except Federal Holidays, and shall be coordinated with the NIST COR to ensure maximum availability of NIST personnel.

Training shall occur within 10 calendar days of installation. The training may be completed on-site at NIST immediately after installation and demonstration of specifications.

III. Delivery

Delivery shall be F.O.B Destination and shall occur within 120 calendar days of award.

FOB Destination means: The contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for any loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery.

Delivery shall occur during normal business hours, between 8:30am and 5:00pm Eastern Time, Monday through Friday, except Federal Holidays and shall be made to:

National Institute of Standards and Technology

100 Bureau Drive

MS 8311

Gaithersburg, MD 20899

ATTN: Monique Hunter

IV. DELIVERABLES

Description Quantity Due Date

MALDI-TOF system One (1) 120 calendar days after award of this requirement.

Operations and maintenance manual One (1) set

120 calendar days after award of this requirement Installation of the analytical instrument Once 30 calendar days after delivery.

Training of NIST personnel at NIST, Gaithersburg, MD

Once 10 calendar days after installation.

V. ACCEPTANCE CRITERIA

Formal acceptance of the system shall be given at the time the Contractor successfully demonstrates that all performance specifications in this Statement of Requirement have been met including installation and training. The NIST COR shall review all deliverables and determine if these criteria are met.

VI. GENERAL INFORMATION

Safety: The Contractor employee shall be responsible for knowing and complying with commercial installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

Security: NIST is a restricted campus. An identification badge is required for access for entry into buildings and also is shown to the armed Security Police when entering the campus.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. The Contractor shall provide the name and citizenship information of employees for on-site visits to the NIST COR prior to arrival. The COR will submit the name(s) and citizenship information to the NIST Office of Security in order for a given Contractor employee to enter the NIST campus. The Contractor employee is responsible for absences due to missing or expired identification and access documents. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office.

Vehicle Registration: All Contractor employees must register their vehicles with the NIST

Security Office to gain access to the campus. A valid driver’s license, Government-furnished civilian ID (which in most cases can be a valid driver's license), proof of insurance and current registration must be presented to the NIST Security Office.