Statement of Requirements.docx

STATEMENT OF REQUIREMENTS

Cell Counter Instrument Based on Electrical Impedance

I. BACKGROUND

The Material Measurement Laboratory’s Biosystems and Biomaterials Division, Biomaterials Group provides measurement assurance to support the development of innovative applications in regenerative medicine and public health. The group is developing microbial and mammalian reference materials and analytical methods to facilitate high quality cell material development for the regenerative medicine and biotechnology community. To quantify the concentration and size distribution of biological samples the division requires a cell counting instrument.

II. SPECIFIC REQUIREMENTS

The Contractor shall provide one (1) cell counter instrument with accompanying components that meet the following specifications:

· The instrument must count cells and cells aggregates (referred to as particles heron) based on electrical impedance.

· The instrument must provide concentration and volumetric size distribution of particles suspended in a liquid using fluid flow and measure the sample volume to determine the concentration of particles (e.g., number of particles per volume) in the sample.

· The instrument must measure the volume of each particle to provide the full distribution of particle volumes for a given sample.

· The instrument must be able to measure particles from 0.15 µm3 to over 1.5x106 µm3 in particle volume.

· Particle properties, such as color, shape, composition, and refractive index, must not affect the particle concentration and volume results. Examples of properties that may vary for samples include particle aspect ratio, particle chemistry, cell viability, etc. In summary, the instrument must count the cells as particles and not biological entities.

· The measurement must not require modification (i.e., fluorescent labeling) of the particles.

· The instrument must include one 100 µm aperture tube and must be able to accommodate other aperture tubes including 10 µm, 20 µm, 30 µm, 50 µm. These tubes are required to measure various cell types and their aggregates.

· The instrument must include a set of beads with standardized size (i.e., polymer beads of a certified size) to be used for size calibration.

· The instrument must have the capability of mixing the sample during measurement to avoid the settling of particles.

· The instrument package must include a computer (i.e., monitor, hardware, and mouse) and software to collect and analyze data. The computer must also be compliant with NIST Special Publication 800-147, BIOS Protection Guidelines (which include the requirement of a protected and signed BIOS).

· The instrument must operate on 115 V/ 60 Hz electrical power.

· The instrument must include a user guide containing directions for its operation.

III. DELIVERY

Delivery shall occur within sixty (60) calendar days of award. Delivery 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 Contracting Officers Representative (COR). Delivery will be to NISTs campus at 100 Bureau Drive, Gaithersburg, MD, 20899, USA.

IV. INSTALLATION

The Contractor shall install the instrument at NIST, Gaithersburg, MD Building 224 room B139 to occur within 30 calendar days of the delivery date. Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and necessary connections for operation, hardware and software installation, basic functionality, instrument start-up, demonstration of instrument performance with the specifications and removal of any trash.

V. TRAINING

In-person training for up to two (2) personnel shall be completed within 30 calendar days of installation. Training shall include a thorough demonstration of the instrument/solution functions, maintenance, data administration, basic troubleshooting and the basic use of the hardware and software, VI. WARRANTY

The Contractor shall provide, at minimum, a one (1) year warranty to include all parts, materials, labor, and travel for the instrument to keep the instrument operating to manufacturer's specifications. The warranty shall commence upon Government acceptance of the requirements. `

VII. ACCEPTANCE

Acceptance shall occur one Government requirements are met, and the instrument is tested using NIST cell samples for compliance with the parameters of Section II. SPECIFICATIONS. Acceptance will occur within 7 calendar days of installation.

VIII. OPTIONAL SERVICE AGREEMENT

Upon expiration of the warranty, the Contractor shall provide a service agreement for maintenance and repair for four (4) one year option periods.

· Preventative Maintenance: Annual service shall include one scheduled preventive maintenance (PM) visit to ensure long-term performance and reliability of the system.

· Email/Telephone Support: The Contractor shall provide unlimited remote (email, telephone, or teleconference) support when issues arise with operation of the system.

· Repair: The Contractor shall provide repair visits within 72 hours of a down instrument. The contractor shall cover labor, travel and parts required for all repairs and maintenance. All repairs must result in the instrument meeting Original Equipment Manufacturer (OEM) specifications.

IX. DELIVERABLES