SOLICITATION NOTICE
Q -- Technical Oversight of Post-Accident Toxicological Testing, Advisory & Assistance Services for Scientific and Technical Substance Abatement Issues
- Notice Date
- 3/19/2007
- Notice Type
- Solicitation Notice
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Transportation, Federal Railroad Administration (FRA), Office of Acquisition and Grants Services, 1120 Vermont Avenue, NW Mail Stop 50, Washington, DC, 20590, UNITED STATES
- ZIP Code
- 20590
- Solicitation Number
- Reference-Number-07R00005
- Response Due
- 3/30/2007
- Point of Contact
- Gerald Rhymes, Contract Specialist, Phone 202-493-6419, Fax 202-493-6171, - Illona Williams, Contracting Officer, Phone (202) 493-6130, Fax (202) 493-6171,
- E-Mail Address
-
Gerald.Rhymes@fra.dot.gov, illona.williams@fra.dot.gov
- Description
- The Federal Railroad Administration (FRA) intends to negotiate a one-year base period contract with four (4) additional one-year option periods to acquire the services of a third-party contractor to provide technical oversight of laboratory services (provided under separate contract to FRA) 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. 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 technical oversight contractor (contractor) must be capable of assessing and attesting to the reliability of the Department of Health and Human Services/Substance Abuse and Mental Health Services Administration (DHHS/SAMHSA) certified 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. Additionally, the contractor must provide FRA with ongoing assessments on the 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 contractor will be utilized by the FRA to help ensure, through 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, that the laboratory maintains high levels of quality and reliability in its product and service offerings to FRA, and that the laboratory’s operations otherwise fully satisfy 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 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. The contractor is responsible for providing expert advice on Department of Transportation (DOT), Drug Enforcement and Program Compliance guidance documents, and developing or assisting in the preparation of materials and conducting technical training for FRA, 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). Special expertise 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 and the railroad industry, which provides detailed protocol on how to properly evaluate all Part 219 and Part 40 elements, and 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 219 compliance field experts. Additionally, the scope of the Post-Accident laboratory contract is subject to change due to scientific and technical innovations; consequently, this scope requirement may be subject to change. As of the release/posting of this notice, it is anticipated that on or about March 30, 2007, the subject solicitation will be issued (i.e., made available) in electronic media and posted to the Federal Business Opportunities (FedBizOpps) website (formerly known as the Electronic Posting System (EPS)). Once posted, the solicitation may be downloaded or printed from the following Internet address: http://www.fedbizopps gov/. The FRA does not intend to make the solicitation available in hard copy. (Note: The anticipated solicitation release date cited above is a target date and is provided for information purposes only. The actual date of posting of the solicitation at FedBizOpps may be before, on, or after that date.) As of the release/posting of this notice, it is anticipated that the closing date for receipt of offers for the subject solicitation will be on or about April 30, 2007. (Note: The anticipated solicitation closing date cited above is a target date and is provided for information purposes only. The solicitation, and the solicitation alone, shall establish and specify the closing or due date for receipt of offers.) Materials or other submission that will be due on the closing date established in the Request for Proposal (RFP) will be specified, in full, in the RFP. The FRA intends to state in the solicitation that the Government intends to evaluate proposals and make award without discussions. At the conclusion of the FRA’s evaluations of offers (and any negotiations or discussions if such are conducted with offerors in the competitive range), as determined necessary by the Contracting Officer/Source Selection Authority (SSA), and the submission and evaluation of any final proposal revisions, if such are requested by the Contracting Officer/SSA, the SSA will make a determination as to which offer is of the best value to the Government, in accordance with the evaluation factors and subfactors set forth in the solicitation, and make contract award to that single, responsible source/offeror. This is an unrestricted, competitive procurement. All eligible, responsible sources may submit a proposal, which shall be considered by the Agency. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (19-MAR-2007). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 18-APR-2007, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/DOT/FRA/OAGS/Reference-Number-07R00005/listing.html)
- Record
- SN01276464-F 20070420/070418223500 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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