Request for Information (RFI) for Post-Accident Toxicological Laboratory Testing of Human Samples and Related Services.

The Federal Railroad Administration (FRA) is releasing the attached draft Statement of Work (SOW) as part of a Request for Information (RFI) to solicit comments and improve the quality of the anticipated Request for Proposal for the 49 CFR Part 219 Control of Alcohol and Drug Use - Subpart C Post-Accident Toxicological Laboratory Testing of Human Samples and Related Services (NAICS 621511). FRA is contemplating a time and materials award. The FRA is interested in obtaining information from industry concerning their capabilities, experience, areas of expertise, knowledge in providing scientifically sound and legally defensible toxicological analyses of urine, whole blood, and tissue samples to fulfill the requirements. This RFI is for market research purposes only and is not part of a selection process. This RFI is issued solely to obtain information and for planning purposes and does not constitute as a Request for Proposal (RFP). No order will be awarded as a result of this announcement, and no payment will be made by the government for information provided in response to this announcement and any follow-up requests. There is no limitation of whether any potential laboratory vendor is a commercial laboratory or is affiliated with a Federal, state, or local agency. The current contract is 693JJ618C000021. The objective of the new contract is for the contractor to furnish all the necessary services, including but not limited to, qualified personnel, labor, material, equipment and services to conduct/perform the following: Analyze specimen results for between 80 and 100 qualifying railroad accidents annually. The schedule is indefinite as these accidents do not occur on a predictable schedule. Re-provision toxicological testing kits back to the field to refresh those received at the laboratory. Reprovisioning includes collection kits (with urine collection cup, split sample containers, blood tubes, and water bluing tablets), forms, and instructions. Refresh blood tubes for the approximately 5000 tox boxes (with ~30,000 blood tubes) nationwide every 24 months due to expiration and loss of vacuum. All in accordance with the SOW. The FRA has a requirement for the forensic toxicological analyses of urine, whole blood, and tissue samples obtained from railroad employees in mandatory post-accident testing. This requirement was implemented in 1986 pursuant to 49 CFR Part 219 -- Control of Alcohol and Drug Use, Subpart C -- Post-Accident Toxicological Testing. FRA's post-accident testing program is an essential part of FRA's investigation of major rail accidents and incidents. FRA's special emphasis is on determining whether drugs or alcohol were a cause or a contributing cause of an accident. The Contractor shall be responsible for analyzing specimens from approximately 80-100 major railroad accidents and other rule-triggering events involving up to 200 railroad employees per year. Urine and whole blood are collected from surviving regulated employees and urine, blood, and tissues are harvested from fatally injured employees. The contract is for testing and reporting only and does not require specimen collection or shipping of samples. Drug testing is performed for surviving employees by screening urine (when available) and confirmations in urine and blood. Drug testing is similarly performed for fatally injured employees by screening the best available matrix from urine, blood, or tissue. Acceptable methods for drug screening included an immunoassay or a chromatographic method (GC/MS or LC-MS/MS). Acceptable drug confirmation methods must be chromatographic. Alcohol screening and confirmation is by headspace GC. Expected drug categories include marijuana, cocaine, the amphetamines (including MDMA), the opioids, PCP, selected prescription sleep aids, selected prescription muscle relaxants, and the sedating antihistamines. Upon contract start, the Contractor shall maintain one or more of the following laboratory credentials: (a) Certification by the U.S. Department of Health and Human Services/Substance Abuse and Mental Health Services Administration (DHHS/SAMSHA) National Laboratory Certification Program (NLCP). (b) Accreditation as a forensic toxicology laboratory by the American Board of Forensic Toxicology (ABFT). (c) Accreditation as a forensic toxicology laboratory by the College of American Pathologists (CAP). It is understood that many qualified laboratories will not have active methods for tissue analysis. FRA does not consider the absence of active tissue methods as a disqualifier. It is acceptable for a laboratory to outsource tissue sample analyses if those capabilities aren't available in-house.[JJ(4] Laboratories are being permitted to outsource testing for samples other than urine, blood, or vitreous to an outside laboratory acceptable to FRA. In response to this RFI, the vendors are asked to provide the following information: Company information (Name/Primary Point of Contact/Phone Number/E-mail Address/ Business Size/ Unique Entity Identifier/Statement if SAM.gov registration is active or in process) Technical and Scientific capability statement describing experience and past performance for previous relevant Federal or commercial contracts Capability description of the ability of the laboratory to meet the requirements. No proprietary information is requested or required for this RFI Answer RFI questions Early industry involvement through comments, questions, and recommendations, is sought for refining the draft SOW and contributing to program success. FRA will also respond to appropriate questions from potential vendors on technical or scientific issues associated with the testing of samples and cutoffs, including technology requirements. Interested vendors shall submit comments, questions, recommendations, and responses to Christie Ong at christie.ong@dot.gov. All responses shall be received no later than December 22, 2022 at noon, 12:00 pm ET, local Washington, D.C. time. We will not read late submissions. Attachments: Attachment 1 - Draft Statement of Work (SOW) Attachment 2 - RFI Questions