TruScan Recertification - SOW - FY22.docx

TruScan RM Remote Performance Certification Statement of Work (SOW)

1.0 Background

The U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Criminal Investigations (OCI) is responsible for conducting and coordinating criminal investigations of violations of the Federal Food, Drug, and Cosmetic Act (FDCA), the Federal Anti-Tampering Act (FATA), other related acts, and applicable violations of Title 18 of the United States Code.

Due to the increasing concern of fentanyl and related compounds entering the United States, OCI has increased efforts for analyzing drug samples at the point of entry (e.g. International Mailing Facilities (IMFs) and Express Courier Hubs (ECHs). Analyzing samples at the point of entry allows for rapid detection of drug products. The TruScan RM Handheld Raman Analyzer instruments are used by OCI Import Operations Program (IOP) Special Agents to conduct the analysis and are effective in analyzing a wide variety of forensic samples such as counterfeit drugs, unknown materials, counter-terrorism related samples and suspected tampering samples.

The preliminary screening results obtained by OCI IOP Special Agents using the TruScan RM instruments are then used for rapid enforcement actions. Without the annual certification in place, all analyses conducted by these instruments would be considered uncertified and not useful in the enforcement process. The annual performance certification of the TruScan RM instruments will provide OCI with the ability to continue to utilize the TruScan RM instruments and provide the FDA/OCI with rapid field analysis capabilities which will help support the FDA’s mission in protecting the public from harmful counterfeit pharmaceuticals, illegal medicines and illicit drug substances.

It is critical to OCI’s mission to have the ability to conduct rapid field analysis. Furthermore, this analysis assists OCI Special Agents with the ability to perform intelligent sampling which is critical to the efficiency and effectiveness of the screening process. Annual certifications for all instruments was last conducted in February 2021.

1.1 Objective

The FDA OCI requires annual performance certification for sixteen (16) Thermo Fisher Scientific TruScan RM handheld Raman spectrometer systems, one (1) TruScan RM certification chemical kit and the required application that will enable OCI Special Agents to conduct rapid detection of drug products.

2.0 Requirements / Deliverables

The Contractor shall provide the Thermo Fisher Scientific TruScan RM instrument performance certification and related products and support as delineated in the table below for sixteen (16) instruments.

2.1 Deliverables:

2.2 Salient Characteristics

The salient functional characteristics for the Thermo Fisher Scientific TruScan RM instrument performance certification and related products and support are the following:

· The annual performance certification shall validate that the TruScan RM instruments are functioning properly,

· The annual performance certification shall still allow the instrument user the flexibility to develop methods using a third-party software program and transfer the methods to multiple TruScan RM hand held Raman instruments,

· The annual performance certification of the TruScan RM hand held Raman instruments shall allow the user to adjust the laser power and scan time during sample analysis,

· The annual performance certification shall allow the user to collect and store spectra and transfer spectra and results to a computer network or standalone computer,

· The annual performance certification shall allow for the transfer of Raman spectral data in a format that can be uploaded easily into the Eigenvector Solo+Model Exporter v8.1 software without any additional data manipulation.

· The annual performance certification shall be valid for 12-months from date of certification.

2.3 Compatibility

· The annual performance certification shall be compatible with the existing Thermo Scientific TruScan RM.

· The annual performance certification shall be compatible with the Eigenvector Solo+Model Exporter v8.1 software and shall not require any additional data manipulation.

· The annual performance certification shall be compatible with the FDA environment which consists of Microsoft Windows servers and Microsoft Exchange Servers.

3.0 Delivery Date / Period of Performance

Certifications shall be provided within 60 calendar days of contract award. Each certification shall be valid for 12 months. The anticipated period of performance is 1/1/2022 – 12/31/2022.

4.0 Delivery / Place of Performance

The Contractor shall deliver the required deliverables and provide the annual certifications (Section 2.1) within thirty (30) calendar days after award to the Contracting Officer’s Representative (COR) or Technical Point of Contact at:

TBD

FDA Forensic Chemistry Center (FCC) 6751 Steger Drive Cincinnati, OH 45237

5.0 Inspection and Acceptance

Pursuant to the inspection clause, all items specified in this Requirements Statement to be delivered under this order are subject to final inspection and acceptance by an authorized representative for the Government. The authorized representative of the Government is the Government’s COR or Technical POC, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

The Contractor shall remediate any problems with delivery within five (5) business days from the COR’s notification of a problem.

The performance criteria for this order shall be that all certifications and related products have been delivered to the COR within thirty (30) calendar days after award.

6.0 Contract Type

The contract type is firm-fixed price (FFP).

7.0 Government Points of Contacts

Contracting Officer (CO):

TBD

Contract Officer Representative (COR) / Technical POC:

TBD at time of Award

8.0 Section 508 Requirements

The following standards are applicable for this requirement:

· Must meet WCAG 2.0 A and AA

· E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

· E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

· E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

· E205 Electronic Content (Appendix A, Application and Scoping Requirements)

· E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

· Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

· 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

· Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.