2024 Justification_form SSM R2.pdf

UNCLASSIFIED

17 June 2024

1. Agency and contracting activity

The U.S. Department of Justice, Federal Bureau of Investigation (FBI), Scientific Response and Analysis Unit (SRAU), has prepared this justification for other than full and open competition for ANALYTICAL SERVICES – RADIOBIOASSAY on behalf of the Laboratory Division (LD).

2. Action to be approved

The LD requests a sole-source award to the contractor shown below.

GEL LABORATORIES, LLC., Charleston, SC 29407-4731 SAM Unique Entity ID JAKYVDNNUJP9

This is a Blanket Purchase Agreement (BPA) with a base year plus four (4) option years – the base occurring in Fiscal Year (FY) 2024.

This will be a continuation of the current agreement with the vendor, where FY2023 is the fourth and last option year on the existing BPA, as detailed below. The original base year award was effective 09/29/2019.

Requisition: DJF-23-0700-PR-0000229 Contract number: 15F06719A0004456 Purchase Order: 15F067200002197 Period of Performance: 09/30/2023 through 09/29/2024

3. Services required

Radiobioassay detects and/or measures radioactive materials (radionuclides) in biological specimens, such as blood, urine, feces, and organ tissue. This type of analysis supports investigations involving Chemical, Biological, Radiological, and Nuclear (CBRN) materials and Weapons of Mass Destruction (WMD). The LD does not have the capability to perform radiobioassay in-house.

The LD establishes agreements with private and government laboratories to conduct analysis on evidence when the type of analysis needed is not available at the FBI Laboratory. However, all specimens and items submitted are evidence to support investigations of criminal offenses, acts of terrorism against the United States, and other matters involving national security. Therefore, the LD has stringent requirements to ensure evidence is handled correctly, a chain of custody established, records maintained, and analysis is of sufficient pedigree to be admitted to trial in a court of law.

Services that involve the handling and analysis of such evidence must be reviewed and deemed reliable, as mishandling or improperly conducted analysis could destroy evidence and significantly impact an investigation or court case. Due to the gravity of the circumstances, the LD needs to have proven and reliable services providers to conduct the services described above.

Specific requirements are further detailed in the Statement of Work (SOW).

4. Statutory authority

In accordance with 41 U.S.C. 3304(a)(1) “…the property or services needed by the executive agency are available from only one responsible source and no other type of property or services will satisfy the needs of the executive agency…”

The LD requests a sole source procurement for services as described in this document. As a result of the market research performed, to the best of our knowledge, no other private entity is known that can satisfactorily meet requirements.

5. Contractor qualifications

The text below paraphrases the contractor’s capabilities.

GEL is certified by over 41 states and federal agencies including Department of Energy (DOE), Department of Defense (DoD), the National Environmental Laboratory Accreditation Program (NELAP) and ISO17025:2005 accreditation. Additionally, GEL is approved to receive foreign soil from the Department of Agriculture. GEL’s advanced, networked Laboratory Information Management System (LIMS) automates all aspects of sample management and tracking, capacity forecasting for the laboratory, data collection, quality control, and customized data packages and electronic deliverables. GEL’s radiobioassay laboratory is experienced in providing analyses for a variety of matrices, including but not limited to, urine, feces, blood, nasal swabs, tissue, bone, and hair. GEL participates in the U.S. EPA and Department of Energy (DOE) nationwide audit programs and inter‐comparison studies. GEL is also accredited by A2LA to the ISO 17025:2005, Department of Defense Environmental Laboratory Accreditation Program (DoD ELAP), and Clinical Laboratory Improvement Amendments (CLIA). GEL also maintains a radioactive materials license.

After an internal review of GEL’s processes, procedures, and capabilities, the FBI determined that it was in the best interest of the US Government to use GEL’s services for radiobioassay of specimens collected as evidence. The contractor met or exceeded FBI requirements. In addition to

GEL’s technical capabilities, the FBI found GEL’s quality assurance system and records processes to be compatible with FBI Laboratory standards for evidence and reporting of analysis.

6. Effort to ensure that offers are solicited No RFI was posted.

In a general comparison to other radioanalytical analysis performed by national laboratories, the FBI feels that the contractor provides services at a reasonable cost. The contractor also makes fee schedules available for various services and will provide itemized cost estimates as requested.

Direct one-for-one cost comparisons is not readily available since there were no other known private contractors available with the same pedigree of service.

7. Market research conducted

These services are highly specialized and the requirements for handling FBI evidence also adds additional rigor. To the best of our knowledge, the FBI is not aware of other private service providers within the United States that can satisfy requirements. The LD is regularly engaged in radioanalytical matters, in both domestic and foreign circles and is generally aware of capabilities and technologies available on an ongoing basis.

8. Additional supporting information

No additional justification other than what has been provided above.

9. Sources that expressed interest

No RFI was posted during this round of market research; therefore, no specific interest was received.

10. Barriers to competition

The services required are not common and require specialized facilities and uniquely trained professionals. There are some options through government-funded laboratories and facilities;

however, the LD is trying to be careful to not put government-funded and private service providers in competition and use qualified private providers where possible.