Department of Transportation, Federal Railroad Administration (FRA), Office of Acquisition and Grants Services, 1120 Vermont Avenue, NW, Mail Stop 50, Washington, DC, 20590

Q -- ADVISORY AND ASSISTANCE OVERSIGHT OF POST-ACCIDENT TOXICOLOGICAL SOL DTFR53-99-R-00009 DUE 060499 POC Thomas Riddle, Contracting Officer, Phone (202) 493-6149, Fax (202) 493-6171, Email tom.riddle@fra.dot.gov -- Linda Dearing, Contracting Officer, Phone (202)493-6154, Fax (202)493-6171, Email linda.dearing@fra.dot.gov WEB: Visit this URL for the latest information about this, http://www.eps.gov/cgi-bin/WebObjects/EPS?ACode=P&;ProjID=DTFR53-99-R-0 0009&LocID=1042. E-MAIL: Thomas Riddle, tom.riddle@fra.dot.gov. The Federal Railroad Administration (FRA) intends to negotiate on a sole source basis with Greystone Health Sciences to oversee and promote the reliability, quality control and caliber of laboratory services provided under a separate FRA contract for 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; and to provide specialized, expert advice and assistance to FRA in accomplishing its objectives and mandates under 49 CFR Part 219 and 49 CFR Part 40 -- Procedures for Transportation Workplace Drug Testing Programs. The proposed contract will include a one-year base period contract with two (2) additional one-year option periods. 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 mandatory post-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. The third party oversight contractor must be capable of assesssing and attesting to the reliability of the Department of Health and Human Services/Substance Abuse and Mental Health Services Administration (DHHS/SAMHSA) certified, Clinical Laboratory Improvement Act (CLIA) licenced laboratory's capabilities for (1) Receiving and preserving specimen sets. (2) Accessioning specimens and implementing strict chain-of-custody procedures. (3) Analyzing specimen sets based on FRA-approved screening and confirmatory protocols using approved immunoassays ranging from KIMS, EIA, RIA, or FPIA to GC/MS. (4) The assessment on qualifications and expertise of the laboratory and assigned personnel relative to the interpretation of test findings and their capabilities to (a) provide expert testimony regarding the laboratory's analysis of urine, whole blood, and tissue; (b) 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; (c) provide a statement of pharmacological significance related to positive determination, addressing drug pharmacokinetics and pharmacodynamics, possible usage scenarios, and possible physiological effects; and (d) properly interpret post-mortem findings in light of possible microbial generation of alcohol. The FRA third party technical oversight contractor is utilized by the FRA to help ensure, though scheduled quarterly inspections using DHHS certified/licensed inspectors and forensic toxicology experts, that the contracted laboratory's procedures and analysis of FRA samples are scientifically sound and legally defensible, and that its operations otherwise fully satisfy the FRA's Post-Accident Toxicological Testing Program scientific, technical, and administrative goals. The contractor subjects the laboratory to both open and blind proficiency testing in whole blood and urine. Samples are constructed by the third party technical oversight contractor to challenge the laboratory's ability to analyze specimens in accordance with approved FRA protocols at established cutoffs. Following inspections, the contractor drafts (for FRA-approval) reports of findings, recommendations, and/or required changes to operating procedures for implementation by the contracted laboratory. Under parallel responsibilities, the contractor is responsible for providing expert advice on the Medical Review Officer (MRO) Guidebook previously prepared in part by the contractor, under the Department of Transportation (DOT), Drug Enforcement and Program Compliance drug and alcohol testing rule. The contractor is responsible for developing or assisting in the preparation of materials and the conduct of technical training for Office of Safety Operating Practices (OP) inspectors (Federal and state). The contractor must be prepared to individually instruct or co-instruct classes in urine specimen collection, laboratory analysis, MRO functions, Substance Abuse Professional (SAP) functions, breath specimen collection, mandatory post-accident specimen collection for both surviving and deceased crew members, and other topics as assigned. The contractor is responsible for providing FRA with one or more technical experts for Part 219 compliance audits of both rail carriers and their service providers at various designated locations throughout the country. Contractor technical experts must be prepared to act as senior adjunct members of a team of FRA inspectors auditing all drug and alcohol requirements of the applicable federal rules (both Part 219 and Part 40). Specialexpertise is required in urine, blood, and breath specimen collection; collection chain-of-custody and documentation; laboratory procedures, analysis, and test result documentation; MRO procedures and documentation; SAP procedures and documentation; and other elements and requirements of said rules. The contractor is responsible for development or updating of the Part 219 Compliance Manual for FRA OP Inspectors that provides detailed protocol on how to properly evaluate all Part 219 and Part 40 elements, and the Part 219 Compliance Manual for FRA the Railroad Industry that provides regulated carriers with specific guidelines on how to comply with all Part 219 requirements, including service provider and carrier responsibilities and record keeping. The contractor is also responsible for developing and presenting seminars specifically designed to show regulated carriers how to properly comply with Part 219 drug and alcohol regulations, and seminars/training modules for OP inspectors to certify them as Part 219compliance field experts. This effort is a follow-on contract to services previously provided by the incumbent, Greystone Health Sciences. The capability of Greystone to perform the task is unique. Greystone is the incumbent and only contractor that has provided these substantially same services to FRA for over ten years. As the author of the review standards and the inspection protocols as well as the reporting and remedy protocols, the incumbent has a unique understanding of the FRA requirements and Program standards and protocols. The incumbent's expertise is singular in that unlike other sources that have the resources to inspect and report on compliance of DHHS certified laboratories which only review testing using urine as the specimen, it also is equally qualified to inspect and audit laboratory services on the other specimens which are unique to this contract -- blood and tissue. In addition to its expertise in post mortem and ante mortem forensic toxicology, the incumbent has the requisite consulting expertise in drug and alcohol procedures and documentation necessary for this contract. The incumbent's familiarity with the rail industry's employees' jobs and functions makes it arguably the foremost expert in determinations concerning the detrimental effects of the identified drugs and alcohol on the performance of the donor employees. The demonstrated uniqueness of the incumbent contractor with respect to the highly specialized nature of the services to be acquired, support the agency's conclusion and determination that only one responsible source and no other supplies or services will satisfy the agency's requirements, and to contract on a sole source basis. The applicable authority for this announced intention is that under 41 U.S.C. 253 (c)(1) as implemented by FAR 6.302-1, "Only One Responsible Source." Any parties that maintain they can satisfy the requirements of this acquisition as outlined above, must indicate their interest in writing and furnish, not later than 4:30 p.m. local time, June 4, 1999, written statements evidencing their scientific and technical qualifications and capabilities both in forensic toxicology consultation in the analysis of urine, blood and tissue, and in drug and alcohol abuse management. Any such response must include documentation in sufficient detail for evaluation of qualification and capabilities, without the need for further discussion; and the competencies asserted must be specific to the requirements of this proposed contract action and reflective of knowledge and experience with the Programs under 49 CFR, Parts 219 and 40 (i.e., a resume or curriculum vitae would not in and of itself be sufficient.) All responsible sources may submit a response which will be considered by the agency. Qualification/capability statements may be sent by regular mail to T. Riddle, Federal Railroad Administration, Office of Acquisition and Grants Services, 1120 Vermont Ave., N.W., Mail Stop 50, Washington, DC 20590; or by express delivery to the same addressee at 1120 Vermont Ave., Room 6138, Washington, DC 20005. Neither electronic nor facsimile transmitted responses will be accepted. Responses received after the time specified will not be considered. This is not a competitive Request for Proposals (RFP) and a competitive RFP is not available. Only in the event of the Contracting Officer determining that other sources are capable of fulfilling the requirements and needs of the agency would issuance of a competitive solicitation be considered. The determination to contract on a full and open competitive basis or on other than full and open competition when justified, based on responses received and information otherwise available to the Government, is solely within the discretion of the Government. No other announcement of this proposed contracting action will be issued. See Note 22. 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 accountsreceivable 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. Posted 05/21/99 (D-SN334492). (0141)

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