U.S. Department of Transportation, Federal Railroad Administration, Office of Acquisition and Grants Services, Mail Stop 50, 400 7th Street, S.W., Washington, DC 20590

Q -- POST-ACCIDENT TOXICOLOGICAL TESTING OF HUMAN SAMPLES AND RELATED SERVICES SOL DTFR53-98-R-00017 DUE 092598 POC Contracting Officer, Thomas Riddle, 202/493-6149 WEB: Click here for information about the FRA, Office Acquisition, http://www.fra.dot.gov/oagm.html. E-MAIL: Click here to contact the Contracting Officer via, tom.riddle@fra.dot.gov. The Federal Railroad Administration (FRA) intends to negotiate a 16-month base period contract with two (2) additional one-year option periods, for the toxicological analysis of samples obtained from various railroad employees subject to FRA's mandatory 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 rail accident or incident. Following regulation-triggering events, samples are collected by carrier-selected medical facilities using FRA mandatorypost-accident split-sample toxicology kits. Specimens include urine and whole blood for surviving crew members, and urine, whole blood, and tissue for deceased crew members. Samples are analyzed by utilizing FRA-established cutoffs in urine and whole blood, and results obtained must be scientifically sound and legally defensible. Analyses of specimens sets from approximately 250 employees after 80 -- 100 rule-triggering events are projected for each performance period (base & options) 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, seven 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. (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.,KIMS, EIA, RIA, or FPIA). Presumptive drug positives are to be confirmed in urine by Gas Chromatography/Mass Spectrometry (GC/MS). The corresponding whole blood is to be evaluated by GC/MS for any confirmed urine positive drug group. Where no acceptable urine sample exists, the laboratory must have the capability to directly screen the whole 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. Whole blood samples will always be directly evaluated by headspace GC (or equivalent) for the presence of ethyl alcohol. For negative drug screens (regardless of the alcohol results), reports are to be issued as a group, 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, whole blood, and tissue; (2) advise FRA regarding the significance of analytical data in the determination of accident/incident cause and the meaning of test findings with respect to human performance; (3) provide a statement of pharmacological significance related to positive determination, addressing drug pharmacokinetics and pharmacodynamics, possible usage scenarios, and possible physiological effects; and (4) properly interpret post-mortem findings in light of possible microbial generation of alcohol. The laboratory must also have the demonstrated capability to respond to FRA requests to test for additional controlled substances/cutoffs where acceptable protocols are available and program requirements dictate. The successful offeror will be expected to adhere to the provisions of 49 CFR Part 219, and 49 CFR Part 40 -- Procedures for Transportation Workplace Drug Testing Programs. The successful offeror will 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 whole blood. The solicitation alone (currently slated for issuance on or about August 24, 1998) shall establish and specify the due date for receipt of proposals (currently anticipated for closing on or about September 25, 1998). The successful offeror must be capable of full-scale operation as of the anticipated start date for the proposed contract base period (likely, December 1, 1998). Prospective offerors failing to meet the certification, licensure, and/or technical capability requirements identified herein will not be considered. The solicitation, DTFR53-98-R-00017, will be issued to all firms requesting a copy of the solicitation in writing. Request for the solicitation, sent via facsimile transmission to FAX# 202/493-6171, ATTN: T. Riddle, SOL# DTFR53-98-R-00017, 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. ATTENTION: Minority, Women-Owned and Disadvantaged Business Enterprises (DBEs)! The DOT, Short-Term Lending Program (STLP) offers working capital financing in the form of lines of credit to finance accounts receivable for transportation related contracts. Maximum line of credit is $500,000 with interest at the prime rate. For further information call (800) 532-1169. Internet address: http://osdbuweb.dot.gov. For information concerning the acquisition, contact the contracting official listed above.***** Posted 08/04/98 (W-SN232465). (0216)

Loren Data Corp. http://www.ld.com (SYN# 0076 19980806\Q-0004.SOL)