U.S. Department of Transportation, Federal Railroad Administration, Office of Procurement (RAD-30), 400 7th Street, S.W., Rm 8222, Washington, D.C. 20590

Q -- POST-ACCIDENT TOXICOLOGICAL TESTING OF HUMAN SAMPLES AND RELATED SERVICES SOL DTFR53-95-R-00022 DUE 032195 POC Contact Point, Contract Specialist, Thomas Riddle, 202/366-0565/Contracting Officer, Robert Carpenter, 202/366-0564 The Federal Railroad Administration (FRA) intends to negotiate a one-year contract with 2 additional option years, for the forensically and scientifically sound toxicological analysis of primary urine and whole blood samples obtained from various railroad employees, subject to FRA's Post-Accident Toxicological Testing Program, as implemented pursuant to Title 49 Code of Federal Regulations (CFR) Part 219 -- Control of Alcohol and Drug Use. To be eligible for award, a prospective offeror must have, prior to award, Department of Health and Human Services/Substance Abuse and Mental Health Services Administration (DHHS/SAMHSA) certification for the laboratory proposed, and licensure under the Clinical Laboratory Improvement Act (CLIA). Since 1986, the FRA has required the special testing of rail crews to determine if drugs or alcohol were either a primary or contributing cause to a significant accident or incident. Following regulation-triggering events, samples are collected by carrier-selected medical facilities using FRA mandatory post-accident split-sample toxicology kits. Specimens include urine and blood for surviving crew members, and urine, blood, and tissue for deceased crew members. Samples are analyzed by utilizing specific cutoffs in urine and blood. Since 1986, post-accident testing has varied from high levels in 1987 (179 qualifying events, 770 crew members tested, 42 Medical Review Officer (MRO) verified positives), and 1988 (178 qualifying events, 682 crew members tested, 41 MRO verified positives); to low levels in 1993 (128 qualifying events, 403 crew members tested, 7 MRO verified positives), and 1994 (117 qualifying events, 287 crew members tested, 7 MRO verified positives). Analyses of approximately 300 specimens are projected for each year under the anticipated contract. The successful offeror's laboratory must be capable of the following: (A) Receiving and preserving specimen sets 24 hours a day, 7 days a week, either at its laboratory or through some other FRA-approved, forensically acceptable manner. (B) Accessioning specimens and implementing strict chain-of-custody procedures; full adulteration panels (at least specific gravity, pH, creatinine) are required to be run on each urine. (C) Analyzing specimen sets based on FRA-approved screening and confirmatory protocols. Urines are to be screened for the drugs of interest by an approved immunoassay (e.g., EIA, RIA, and FPIA). Presumptive drug positives are to be confirmed in urine by Gas Chromatography/Mass Spectrometry (GC/MS). The corresponding blood is to be evaluated by GC/MS for any confirmed urine positive drug group. Unless otherwise approved, GC/MS is the only FRA-approved confirmatory method. Where no acceptable urine sample exists, the laboratory must have the capability to directly screen the blood using an acceptable immunoassay procedure. For deceased crew members, the laboratory must also have the capability to screen and confirm for the presence of drugs and alcohol in various other body fluids and tissues, including vitreous, brain, liver, etc. Blood samples will always be evaluated by GC for the presence of ethyl alcohol. (D) Maintaining strict confidentiality provisions of 49 CFR Part 219, and 49 CFR Part 40 -- Procedures for Transportation Workplace Drug Testing Programs. The laboratory must also have the capability to respond to FRA request to (1) test for additional controlled substances/cutoffs where acceptable protocols are available and program requirements dictate, and (2) report any and all substances detected if anyone is confirmed above cutoff and other(s) are below. For negative drug screens (regardless of the alcohol results), reports are to be issued no later than three working days after receipt of samples of surviving crew members, and five working days where one or more fatalities are involved. For cases with presumptive positives on screening tests, reports are to be issued no later than ten working days after receipt of samples. Of special importance in this proposed contract, are the qualifications and expertise of the successful offeror's laboratory and assigned personnel relative to the interpretation of test findings. Among the areas of particular concern to FRA are the prospective offeror's capabilities to (1) provide expert testimony regarding the laboratory's analysis of urine, blood, and tissue; (2) advise FRA regarding the significance of analytical data in the determination of accident/incident cause; (3) provide expert testimony regarding the meaning of test findings with respect to human performance; (4) provide a statement of pharmacological significance related to positive determination, addressing drug characteristics and action, possible usage scenarios, and possible physiological effects; (5) properly interpret post-mortem findings in light of possible microbial generation of alcohol; and (6) provide information relating to drug pharmacokinetics and pharmacodynamics. The successful offeror will also be expected to have qualified personnel to regularly answer technical and operational questions from the FRA, and when requested, establish liaisons with rail carriers after major accidents and with medical examiners, coroners, and other custodians of potential specimens after a fatality. The successful offeror will also be responsible for the acquisition of standardized supplies and preparations for sale, and/or replacement and replenishment of 200-plus FRA post-accident, split-sample, toxicology shipping kits per year, to the railroads; and maintenance of the master mailing and distribution file. Stringent technical oversight of the successful offeror's laboratory will be provided by the FRA and its third-party, technical oversight contractor. The successful offeror/laboratory will be required to undergo quarterly inspections and evaluate open and blind proficiency specimens in both urine and blood. The solicitation alone (currently slated for issuance on or about February 17, 1995) shall establish and specify the due date for receipt of proposals (currently anticipated for March 21, 1995). The successful offeror must be capable of full-scale operation as of the anticipated start date for the proposed contract base period (June 1, 1995). Prospective offerors failing to meet the certification, licensure, and/or technical capability requirements identified herein will not be considered. Sources interested in fulfilling the stated requirement must request a copy of the solicitation in writing. Request for the solicitation, sent via facsimile transmission to FAX# 202/366-3055, ATTN: T. Riddle, SOL# DTFR53-95-R-00022, will be honored as a written request. This is an unrestricted competitive procurement. All responsible sources may submit a proposal which shall be considered by the Agency. This Notice is for Minority, Women-Owned and Disadvantaged Business Enterprises: The Department of Transportation (DOT), Office of Small and Disadvantaged Business Utilization (OSDBU) has a program to assist minority, women-owned and disadvantaged business enterprises to acquire short-term working capital assistance for transportation-related contracts. Loans are available under the DOT Short-Term Lending Program (STLP) at prime interest rates to provide accounts receivable financing. The maximum line of credit is $500,000. For further information and applicable forms concerning the STLP, call the OSDBU at (800) 532-1169. For information concerning the acquisition, contact the contracting official listed above. (0026)

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