SOW for Spectral Flow Cytometer.pdf

SOW

Spectral Flow Cytometer

RFQ-NIAID-24-2227600

Statement of Work (SOW)

A. Background The mission of the Laboratory of Immunogenetics (LIG) of the National Institute of Allergy and Infectious Diseases (NIAID) is to advance our knowledge of the mechanisms underlying the activation and regulation of human immune cells and the biology and structure of the pathogens to which the immune system responds. Flow cytometry is an imperative technology for the research conducted in every section within our department. The LIG is supported by a dedicated flow cytometry core facility with multiple analyzers and a cell sorter.

B. Purpose and Objectives To sustain and advance our immunological research, the LIG needs to acquire its own spectral flow cytometer. This advanced instrument will equip LIG researchers with the necessary tools to explore and understand the genetic basis of the immune system, thereby enhancing our scientific capabilities and contributions.

The primary objective of the LIG is to gain a deep understanding of the mechanisms underlying the activation and regulation human immune cells, as well as the biology and structure of the pathogens that elicit immune responses. Acquiring a spectral flow cytometer will enable us to perform high-parameter flow cytometry, allowing for the exploration of expression profiles for over 35 markers in various experimental systems.

This advance technology will significantly enhance our research capabilities and is uniquely suited to meet these high demands, making it an indispensable tool for our investigations.

The intent of this purchase is to acquire a spectral flow cytometer, which is now the gold standard for performing panels that exceed 20 different fluorescently labeled markers.

This technology is essential for a core facility that serves laboratories heavily dependent on flow cytometry for their research. By employing specialized detectors that register the spectral output of specific fluorophores, modern flow cytometers greatly expand the repertoire of markers that can be used in a single labeling experiment, thereby more accurately defining cell types.

C. Scope The scope of this project is to acquire and integrate a spectral flow cytometer into the LIG at the NIAID. This encompasses the procurement of the instrument, coordination of its delivery and installation, and ensuring proper setup and calibration. Comprehensive training for LIG researchers and staff will be provided, along with familiarization with the manufacturer-provided user manuals and standard operating procedures (SOPs).

D. Technical Requirements The system must meet the following requirements:

1. The system must be equipped with these five lasers: 355 nm, 405 nm, 488 nm, 561 nm, and 637 nm.

2. The power output of each laser is adjustable by the user.

3. The user has the option of operating with any of these lasers turned off: 355 nm, 405 nm, 561 nm, and 637 nm.

4. All lasers are spatially separated (time delayed).

5. Each laser is coupled to a fluorescence detection array that is dedicated to that laser only.

6. Provides a user-operated system that automatically optimizes the optical alignment.

7. Detection arrays have a minimum average of 29 fluorescence detectors per laser.

8. Supports simultaneous detection of at least of forty-two (42) individual fluorescent parameters.

9. A spatially separated 320 nm laser, coupled to a fluorescence detection array dedicated to that laser only, may be added to the system by a field upgrade.

10. Uses fluorescent calibration/QC beads to monitor instrument function and performance. QC results can be tracked over time within the cytometry software or exported in .csv format.

11. Has a Standardization Mode of operation, in which, the signal output of each detector array is adjusted daily to meet the criteria set by a fluorescent calibration bead. Standardization Mode maintains consistent data output from each cytometer over time and provides uniform data output from multiple units.

12. Has a fluidic system that automatically supplies sheath fluid from a 10-liter tank.

13. Includes an automated sampling system that supports 5 mL tubes, 96-well plates

(flat-bottom, v-bottom, and u-bottom), 96-well plates (mid-depth), 96-well plates (deep-well), and 384-well plates.

14. Is equipped with an integrated thermoelectric sample cooling that works with 5 mL tubes, 96-well plates, and 384-well plates.

15. Provides automated cleaning from a dedicated cleaning fluid station that holds 5 mL tubes.

16. Provides the option to automatically clean and shutdown after acquiring data from a rack of 5 mL tubes, a 96-well plate, or a 384-well plate.

17. Provides individual sample agitation with these three options: 1) once, 2) periodic, or 3) continuous sample agitation during data acquisition.

18. Provides a low dead volume mode that leaves less than 5 µL of sample in the tube or well.

19. Provides automatic clog detection and remediation during data acquisition.

20. Applies spectral unmixing in real-time during data acquisition.

21. The software has tools with which the user can manually adjust the spectral unmixing settings to correct discrepancies between the spectral references and the stained multi-color samples.

22. The software has a tool with which the user can dissect the autofluorescence of unstained cell samples, identify multiple autofluorescence sources, and calculate a spectral reference for each source.

23. The software supports functions relevant to 21 CFR Part 11. These features include user-defined templates that provide an electronic and human readable audit trail that tracks all changes made during data acquisition and analysis.

E. Contractor Requirements The contractor shall provide:

1. Installation: a. The contractor will be responsible for the complete installation of the spectral flow cytometer, ensuring it is fully operational and integrated with existing laboratory infrastructure. b. The installation process must include initial calibration and validation to confirm the system's accuracy and reliability. c.

Installation will take place at: [5625 Fishers Lane, Rockville, MD 20852].

2. Training: a. The contractor will provide one (1) comprehensive, on-site training for multiple (6-8) users on the operation, maintenance, and troubleshooting of the spectral flow cytometer. b. Training sessions should cover the use of manufacturer-provided user manuals and standard operating procedures (SOPs).

3. Support and Maintenance: a. The contractor will offer full support for the device throughout the warranty period, including technical assistance and troubleshooting. b. Regular maintenance checks and software updates must be provided to ensure optimal performance. c. The contractor will supply a detailed maintenance schedule and documentation of all performed maintenance activities.

4. Warranty and Service: a. The contractor will honor all warranty terms, including repair or replacement of any defective parts or components. b. A clear process for reporting issues and requesting service must be established, with guaranteed response times.

5. Documentation: a. The contractor will provide all necessary documentation, including installation reports, training materials, maintenance logs, and any updates to user manuals or SOPs.

F. Government Responsibilities The government will be responsible for providing an appropriate room that meets all necessary environmental and space requirements for the spectral flow cytometer.

Additionally, the government will ensure that the room is equipped with the necessary power supply and electrical infrastructure to support the operation of the microscope system.

G. Reporting Requirements and Deliverables Payment will be processed once the spectral flow cytometer is successfully installed and verified as fully operational. The contractor must provide a detailed installation report, including calibration and validation results, which will be reviewed and approved by the government before receiving and payment are finalized.

H. Delivery Schedule

1. Procurement and Delivery:

The spectral flow cytometer must be delivered to the specified location within 60 days of contract award.

2. Installation and Setup:

Installation and initial setup must be completed within 30 days of delivery.

3. Calibration and Validation:

Calibration and validation must be performed immediately following installation and completed within 30 days.

4. Training:

Comprehensive training for LIG researchers and staff must be conducted within 30 days of installation and validation.

I. Inspection and Acceptance Criteria The flow cytometry facility will vet the performance of the system after installation. The spectral flow cytometer will undergo a thorough inspection and acceptance process to ensure it meets all specified requirements. Upon delivery, the system will be inspected for any physical damage and verified against the purchase order specifications.

Installation and setup will be closely monitored to ensure proper integration with existing laboratory infrastructure. Following installation, the system must undergo initial calibration and validation to confirm its accuracy and reliability.

Comprehensive training for LIG researchers and staff must be completed, and the contractor must provide a detailed installation report, including calibration and validation results. The system will be deemed acceptable only after the successful completion of these steps, and once the government has reviewed and approved all documentation.

Final acceptance will be contingent upon the system's full operational functionality and compliance with all specified technical requirements.