STATEMENT OF WORK.docx

STATEMENT OF WORK

Background The Influenza research team in the Allergy and Clinical Immunology Branch will utilize Flexmap3D instrument. This instrument will be used for measuring multiple proteins such as cytokines, chemokines, various signaling pathway proteins from a very small amount of blood, BAL, urine or culture media. Instead of running individual ELISA. The FLEXMAP 3D system combines differentially dyed fluorescent microsphere sets with an innovative instrument design to allow multiplexing of up to 500 unique assays within a single sample, both rapidly and precisely. FLEXMAP 3D has a flexible and easy to use multiplexing platform capable of performing a variety of protein and nucleic acid applications. There are various groups within ACIB and members from other branches also could use this instrument for their sample analysis. This instrument is critical to the work conducted in the laboratory, which includes influenza, and COVID related studies.

I. Project Objectives The primary objective of the proposed procurement is to acquire a new Luminex Flexmap3D multiplexing instrument that will replace the 10-year-old Luminex 200, that is heavily used by different teams within ACIB and other team members of HELD. Influenza research team use aerosol generating procedures and molecular biology techniques to understand the functional role of influenza and other viruses in an occupational setting. We collect clinical samples from patients and use the serum to run for the chemokines and cytokines in addition to the mRNA and miRNA levels. We also generate a lot of samples from cell culture and animal model studies. As there are many ongoing studies in the laboratory that require quantification of genes or proteins the multiplexing using Flexmap 3D assures us to accomplish the goals of the research project in a timely fashion. We are also planning to collaborate with RHD division in analyzing their clinical samples for cytokines and different proteins.

II. Scope of Work Flexmap3D is inevitable in our research to accomplish the goals of the research project in a timely fashion. Moreover, Flexmap 3D provides consistency to maximize accuracy and efficiency with results.

Detailed Technical Requirements Summary of Tasks or Phases

Instrument unpacking and installation by a certified Luminex service engineer.

Description of Specific Tasks or Phases

2- day training with a specialist, including assay and instrument training as well as troubleshooting guidelines. Support- Assay specific technical support as well as Luminex instrumentation support.

Description of End Products/Deliverables

The FLEXMAP 3D instrument with xPONENT 4.3 Software.

The instrument may distinguish a minimum of 1 to a maximum of 500 unique, preset bead spectral addresses within a single sample. The reader is driven by the RUO xPONENT 4.3 acquisition software.

Included Equipment

• FM3D Unit (includes Analyzer, XYP plate handler)

• PC bearing xPONENT 4.3 and Windows 10

• Flat Screen monitor

• Dimensions including PC, 110x62x63cm, Weight 77.1kg (170lbs).

Ancillary Equipment

• Keyboard and mouse

• Power cables USB Communication cables

• Off plate reagent area

• Automated Maintenance Plate (AMP)

• 96 & 384 well heater block

• 3 sample probes

• Sample probe alignment kit

• Sheath fluid intake line

• Waste fluid out take line

• Empty cubitainer for waste

• Monitor arm.

• Barcode reader (optional) Consumables

• FM3D Calibration Kit (Replacement reference F3D-CAL-K25)

- Microspheres to calibrate the FM3D. The convenient calibration kit contains xMAP® calibrators for the FM3D classification and reporter channels. A lot of specific CD is included for importing target values. The kit is intended to be used with the AMP Plate. Strip wells are included with each kit.

Each kit provides 25 calibrations.

• FM3D Performance Verification Kit (Replacement reference F3D-PVER-K25) - Microspheres to verify optics, fluidics, classification channels and reporter channel. The kit is intended to be used with the AMP Plate. Strip wells are included with each kit. Each kit provides 25 verifications.

• 1 box containing 20L of Sheath Fluid (Replacement reference 40-50015).

12 Month Warranty Custodial Account #: 00393 1 Each

Handheld Magnetic Separator Block for 96 Well Flat Bottom Plates or 96 Well Conical Well Plates

1 Each

Freight Charge

1 Each

III. Reporting Schedule:

White glove inside delivery and installation by Luminex Field Service Engineer Side by side training from Vendor Field Application Scientist, First year warranty Unlimited scheduled Vendor Field Application Scientist trainings on Vendor assays and FM3D system.

Support- One-year full-service warranty provided with the purchase.

IV. Special Considerations

V. References

Section 508 and Accessibility Requirements Part A – Provision Reference HHSAR 352.239-73[8] Electronic Information and [Communication] Technology Accessibility Notice.

[(Deviation)] Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies, products, platforms, information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions. The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

(c) If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the Template are available at https://www.section508.gov/.

(e) Additionally, offerors must provide enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(f) Respondents to this solicitation must identify any inability to conform to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(g) Items delivered as electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative.

(End of provision)] Part B - Clause 352.239-74[9] Electronic, Information, and Communication Technology Accessibility. [(Deviation)]

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services, or support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order are identified as follows:

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 402 Closed Functionality 403 Biometrics 404 Preservation of Information Provided for Accessibility 405 Privacy 406 Standard Connections 407 Operable Parts 408 Display Screens 409 Status Indicators 410 Color Coding 411 Audible Signals 502 Inoperability with Assistive Technology 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements for review by the agency Section 508 Program.