Attachment 1 - SOW for Post-Accident Toxicological Laboratory Testing.pdf

STATEMENT OF WORK

Post-Accident Toxicological Testing of Human Samples and Related Services

1) INTRODUCTION/GENERAL

i. The purpose of this contract is to provide scientifically sound and legally defensible toxicological analyses of urine, whole blood, and tissue samples, obtained from railroad and railroad contractor employees in post- accident testing. The Federal Railroad Administration's (FRA) Post Accident Toxicological Testing Program (Program) was implemented in 1986 pursuant to 49 CFR Part 219 -- Control of Alcohol and Drug Use, Subpart C -- Post-Accident Toxicological Testing.

ii. Post-accident mandatory toxicological testing has been identified by FRA as a key element in our nationwide railroad safety program. The FRA requires the testing of safety-sensitive railroad and railroad contractor employees ("regulated employees") 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 at independent medical facilities using FRA mandatory post-accident toxicology kits (tox boxes). FRA- regulated employers are responsible for determining when incidents/accidents are within the scope of the Program and therefore require post-accident testing of their employees with guidance provided by FRA. Regulated employers are also responsible for training their personnel and service agents to comply with FRA rules, collect samples, complete documentation appropriate forms, and package and overnight ship specimens to the testing laboratory.

iii. Specimens should include urine and whole blood for surviving regulated employees, and urine, whole blood, vitreous humor, and tissue for deceased railroad employees.

Samples are analyzed by the Contractor utilizing specific cutoffs or limits of detection, with test findings that are in accordance with the highest scientific and technical standards.

2) SCOPE OF WORK

i. This requirement will have a 12-month base period with four (4) 12-month optional periods.

ii. The Contractor shall furnish and/or make available all technical and support personnel, equipment, supplies, and other material and services necessary for the timely analysis of up to 200 sets of urine and whole blood samples per year (and on occasion, where there has been a fatality(s), body fluid and tissue samples). There has been an average of 175 sample sets in the last few years of the program. These samples are obtained from regulated employees who are involved in train accidents meeting the thresholds in 49 CFR Part 219.201. The accuracy of this analysis is crucial to the credibility and integrity of the FRA Program in the eyes of the public, the railroad industry, the National Transportation Safety Board, and railroad employees and their representatives.

iii. The Contractor shall be responsible for providing a wide range of administrative and expert technical services that are integral to the proper forensic handling of FRA post-accident specimens, the toxicological testing of those specimens, and the reporting of the results of the testing.

iv. All administrative, technical, and scientific personnel assigned to this contract by the Contractor must be formally approved by FRA before they are permitted to start work on the requirements of this SOW. This approval will come after assessment of their education, experience, and knowledge relevant to their proposed job functions. It may include both an interview by FRA and their contract technical oversight contractor and a recommendation for specialized training on the requirements of this contract. Approved members of the FRA Team may be replaced at the discretion of the Contractor, but newly nominated FRA post-accident team members must undergo an equivalent approval process prior to performing work on this contract.

v. In addition to meeting the minimum qualification standards, senior scientific officers nominated to perform final review and sign off on test results must also be interviewed and approved by FRA (or its designee) before being permitted to perform those tasks under this contract.

vi. The Contractor may also be required to provide expert testimony regarding the analyses performed and/or the meaning of the findings with respect to human performance.

vii. Besides the assays/cutoffs required by this contract, the Contractor shall be prepared to expand analysis, at the request of the FRA per Part 219.211(a), to include additional assays and cutoffs in limited cases. FRA also reserves the right to require the Contractor to develop and perform assays for additional drugs, substances, or adulterants because of information gathered in the accident investigation. In some cases, these may include pills, powders, plant material, or suspected drug residue.

FRA and their technical oversight contractor will work with the Contractor in developing the additional assays and protocols using accepted scientific and technical standards. Any expansion of testing in this manner will first be approved by the FRA and the Contractor at a reasonable cost not to exceed an additional unit cost.

1. In some cases, the use of an FRA-designated laboratory other than the

Contractor's may be acceptable to fulfill this requirement.

viii. The Contractor shall also be responsible for the coordination and management of the FRA's Post-Accident Toxicology Box Program. This function can be accomplished through lab action or sub-contracted to outside providers.

ix. The Contractor acknowledges and accedes that as a condition of contract award, it shall be subject to comprehensive tri-annual on-site FRA examination of each FRA post-accident event/case, and on-site third- party Contractor oversight inspections and proficiency testing, through submission of open samples.

x. The Contractor's technical proposal, as negotiated, shall serve as the baseline approach by which the Contractor will accomplish the objectives and tasks under this contract.

If in the event of an alleged or actual discrepancy between the requirements in this document, elsewhere in the contract, or 49 CFR Part 219, and the Contractor's proposal specifications, methodology, or approach, then the former (i.e., the contract or the regulation, as appropriate) shall take precedence.

xi. All work under the contract shall be conducted consistent with applicable portions of

49 CFR Part 219 Subpart C, as amended; FRA Post-Accident Toxicological Testing Instructions; and other written guidelines or findings and recommendations determined by FRA to be necessary or integral components to better assure the quality of performance under the contract, or the integrity of the Program (e.g., guidance from the Department of Health and Human Services’ SAMSHA or NLCP).

1. 49 CFR Part 219 may be accessed electronically at the FRA, Office of

Railroad Safety at the following link: https://www.ecfr.gov/current/title- 49/subtitle-B/chapter-II/part-219

3) SPECIMEN ACCESSIONING AND INTERNAL CHAIN OF CUSTODY

PROCEDURES AND DOCUMENTATION

i. In consultation with FRA, the Contractor shall develop and implement a detailed written set of Standard Operating Procedures (SOPs) for the receipt, accessioning, and internal laboratory chain-of-custody of FRA post-accident specimens, using the most rigorous forensic standards. Specimens should arrive in standardized FRA-mandated shipping boxes (with each box containing three kits, one or more of which should contain samples). Samples should be packaged in accordance with 49 CFR Part 219 and FRA post- accident kit instructions. All written SOPs, and any subsequent changes, must be reviewed and approved by the FRA Drug & Alcohol Program Manager/Subject Matter Expert (SME) and the Contracting Officer's Representative (COR) before their implementation for the intake, processing, testing, and reporting of FRA specimens. The SOPs must also address all documentation aspects of the accessioning process, including shipping package log-in, specimen log-in, accession number assignment, and initiation of the internal laboratory chain-of-custody document.

ii. The procedures must also incorporate all expected evaluative and forensic aspects of the receiving and accessioning process. This includes but is not limited to, inspection of shipping papers and packaging; specimen container evaluation;

specimen identification and verification; and inspection and assessment of FRA collection documents (including FRA Form 6180.73, Accident Information Required for Post-Accident Toxicological Testing, and FRA Form 6180.74 (for surviving employees) and FRA Form 6180.75 (for deceased employees), Post- Accident Testing Blood/Urine Custody and Control Forms). These forms are static currently and FRA does not anticipate any future changes. The Contractor must document and electronically notify FRA (by secure email and encrypted server access) of any deviations in procedural requirements relative to the above areas for each case.

1. The Contractor is not responsible for resolving collection or collection documentation discrepancies. The decision and order to proceed with testing (and https://www.ecfr.gov/current/title-49/subtitle-B/chapter-II/part-219 https://www.ecfr.gov/current/title-49/subtitle-B/chapter-II/part-219 the resolution of any documentation issues) rests with FRA. Only FRA has the authority to proceed with or cancel a test.

4) ANALYSIS OF SPECIMENS-PROCEDURES AND DOCUMENTATION

i. The Contractor shall be responsible for analyzing specimens from approximately 80-100 accident events involving up to 200 railroad employees per year, most of which will be blood, and urine sets from surviving employees. However, specimens from approximately 10 fatalities per year will be received as part of the overall total.

ii. As a general approach to drug testing, urine will be screened for the FRA drugs of interest. Presumptive non-negative screening tests will result in confirmation testing in both urine and blood. If urine is not available or is not judged to be credible by the Contractor or meets one or more of the criteria found in C.4.1(c), blood will be screened, and presumptive positives will result in confirmation testing in blood and urine (if possible).

1. As a general approach to ethyl alcohol testing, blood must always be screened for alcohol in the “head room” of the sample. Presumptive positives must be confirmed in blood and urine. In the absence of testable urine and blood (such as some fatalities), the Contractor will contact FRA for guidance on which additional specimens (i.e., vitreous, liver, brain, etc.) should be analyzed.

iii. In some fatality cases, analysis of other types of specimens (gastric contents, brain, liver, kidney, vitreous fluid, etc.) may also be required. In some fatalities, urine samples may not be provided or may be unsuitable for analysis, thereby requiring the reliance on whole blood, vitreous humor, or tissue as a screening medium. The screening and confirmatory tests for the above-mentioned specimen types shall be conducted at a single laboratory location unless authorized by FRA in advance.

iv. All methods and procedures used for the analysis of FRA post-accident specimens must be approved in advance of implementation by FRA. FRA reserves the right to disqualify proposed methods, procedures, or processes if they do not meet FRA standards for scientific or forensic laboratory practices, appear vulnerable to challenge by outside forensic experts or inspecting toxicologists, or could fail to be scientifically sound and legally defensible.

5) Sample Integrity

i. The Contractor shall make reasonable efforts to ascertain the quality and integrity of each urine specimen submitted. Such efforts shall include conducting an adulteration/sample substitution panel on all urine specimens for at least specific gravity, pH, creatinine, and any other specific integrity analytes required by FRA. On an ongoing basis, FRA may direct the Contractor to routinely perform specific integrity checks based on the Contractor's own experience, that of its technical oversight contractor or that of the U.S. Department of Health and Human Services/Substance Abuse and Mental Health Services Administration

(DHHS/SAMHSA) as part of their national laboratory certification program (NLCP).

ii. The following urine specimen integrity checks will also be required at a minimum:

a. Visual inspection of the specimen to ascertain unusual sediment, color, or other factors which may indicate the possibility of adulteration or dilution.

b. Cursory olfactory inspection of the specimen to determine any obvious unusual odor or lack of odor which may indicate the possibility of adulteration or substitution.

iii. If the integrity of the urine specimen is in question, the Contractor shall automatically screen the blood for the drugs of interest. This must occur in the following circumstances:

a. The specimen at the collection site has a temperature outside FRA's acceptable range (less than 90° or greater than 100°F.) or there is no temperature annotated on the FRA post-accident collection form, or

b. The urine sample has a creatinine and a specific gravity reading less than FRA-specified levels (less than 20 mg/dl of creatinine and less than 1.0030 specific gravity), or

c. The specimen has an abnormal pH (The pH is equal to or greater than 3 and less than 4.5 or equal to or greater than 9 and less than 11), or

d. The Contractor's visual and/or olfactory examinations indicate possible adulteration or substitution, or

e. The specimen is tested and found to be adulterated, substituted, or invalid (the Contractor cannot achieve an acceptable test result).

f. For any other scientific or technical reason, the Contractor questions the integrity or credibility of the urine (e.g., inconsistent, or mismatched creatinine and specific gravity concentrations, etc.) and FRA approves.

iv. When the credibility or integrity of a urine specimen is suspected, the Contractor shall consult with the FRA to determine what further action should be taken with that specimen. Such further action shall typically include one or more of the following:

a. Testing of dilute urine specimens for drugs of abuse down to the sensitivity of the assay; and/or

b. Attempting further laboratory tests at the Contractor laboratory if directed, or at another laboratory designated by FRA, to determine the source of the possible adulteration or specimen contamination; and/or

c. Omitting analysis of the specimen for drugs of abuse and reporting the laboratory data regarding the quality and integrity of the specimen, and/or screening the blood sample for drugs.

6) Screening and Confirmatory Protocols

i. The Contractor shall evaluate blood and urine specimens for drugs, drug metabolites, and ethyl alcohol at the administrative cutoffs listed in the Summary of Analysis.

The drugs, metabolites, and alcohol, and respective cutoffs provided in the Summary of Analysis, are base substances/levels which will be tested for as a matter of course.

However, the FRA Drug & Alcohol Program Manager/Subject Matter Expert (SME) and COR may add or delete drugs and/or modify cutoffs, only within accepted toxicological standards, to meet Program needs as per Part 219.211(a). The Contractor will be expected to update or modify its methods and strategies to meet FRA requirements.

ii. Within 45 days of contract award, the Contractor will be expected to have in place, written comprehensive standardized analytical protocols and other SOPs applicable to the analysis of FRA specimens. All written protocols must be reviewed and approved by the FRA SME and COR before their implementation and use for FRA post-accident specimens. Once the analytical protocols are formally approved by the SME and COR, the Contractor shall give notice of any proposed change in analytical procedures which modifies a previously approved method or technique.

Any such change shall be subject to the written approval of the SME and COR before they may be implemented.

iii. Occasionally, the Contractor may be required to test specimens for additional controlled substances and with different cutoffs, prescription medications, and over-the-counter products (also including dietary supplements and herbal remedies), where accepted protocols are available and Program requirements dictate. In addition, FRA may require the Contractor to report all analytes detected if any are confirmed above cutoff and other(s) are below. Such additional testing shall be done only upon written request from FRA and may involve development of additional screening and confirmatory methods.

7) Specimen Evaluation Overview For Surviving Employees

a. Where an acceptable urine and blood or chromatographic/mass spectrometric sample set exists, the urine will be initially screened for the drugs of interest by an approved immunoassay technique.

i. Currently, FRA requires an FDA-approved immunoassay or an FRA-approved chromatographic/mass spectrometric method to screen urine or blood samples for its standard drug classes. These are the cannabinoids, cocaine, phencyclidine, the opiates, the amphetamines, the barbiturates, the benzodiazepines, the sedating antihistamines, and the synthetic/semi-synthetic opioids. Additional drug classes including the prescription sleep aids and muscle relaxers, may be added by FRA.

ii. The specific screening technology for drugs offered by the Contractor in both urine and blood, whether by immunoassay or chromatographic separation, must be approved by FRA.

iii. For each presumptive urine or blood positive, the sample must be confirmed positive for those analytes of interest by Gas Chromatography Mass Spectrometry (GC/MS), by liquid chromatography/tandem mass spectrometry (LC-MS/MS), or another method acceptable to FRA which employs chromatographic separation and mass spectrometric identification.

iv. For any sample set involving a confirmed urine positive (or a presumptive urine positive, when dictated by the Contractor or FRA experience with the drug of interest), the Contractor shall analyze the whole blood sample for the parent drug and/or metabolites equivalent to those detected in the urine (or analytes necessary for a complete analysis), as indicated in or as directed in writing by FRA.

v. In some specific instances, the Contractor may propose for FRA approval, separate confirmatory testing, or quantitative testing in either blood and/or urine by another reliable, substantially equivalent method or technique.

vi. Confirmatory analyses in urine for amphetamines must always include a d/l isomer evaluation. Confirmatory analyses in whole blood and urine for opioids must always include a 6- acetylmorphine (6-AM) evaluation for the organic opiate marker.

vii. Where no acceptable urine sample exists as determined by the expertise of the

Contractor or does not meet FRA standards for specimen integrity, the Contractor shall screen the whole blood using an analytical procedure accepted by FRA.

Confirmation procedures for presumptive whole blood positives shall follow routine whole blood confirmatory protocols. Where evidence of interfering substances or adulteration exists in the urine specimen, the Contractor will make every technical and scientific effort to determine the presence of drugs in the blood sample.

8) Specimen Evaluation For Surviving Employees -- Ethyl Alcohol

i. Whole blood samples shall be analyzed for ethyl alcohol (and other volatiles upon special request) by gas chromatography with an internal standard, and presumptive positives may be confirmed either on a separate instrument or on a separate column using the same instrument.

ii. The Contractor may propose for FRA approval, an alternate approach to whole blood alcohol analysis, so long as it meets the highest standards generally accepted in the forensic science community. Where the whole blood is confirmed positive for alcohol, the urine shall be analyzed for alcohol by a similar method.

9) Specimen Evaluation Overview For Fatalities

i. Where a fatality has occurred, qualified Contractor personnel may be required to establish liaison with medical examiners, coroners, other custodians of potential specimens, and FRA investigators participating with the railroads in sample gathering or harvesting. It is understood that such liaisons may sometimes be required outside normal business hours to identify samples of choice from cases involving exsanguination and/or contamination of primary sample material.

ii. Where acceptable whole blood and/or urine specimens are available, the protocols for analysis will parallel those outlined above. When the analysis of tissue and/or other fluids is required, the Contractor shall employ screening techniques generally accepted in the forensic science community to presumptively identify the analytes of interest in limited specimens, and perform appropriate confirmations, including ultimate chromatographic separation and mass spectrometric identification confirming positive findings. All methods for the analysis of tissues and/or other fluids must be approved by FRA.

iii. It is understood that most laboratories do not maintain active assays for the analysis of tissues. Given the limited number of FRA post-accident cases that ultimately require tissue analysis, FRA would consider the use of a similarly qualified laboratory other than the Contractor for these occasional requirements.

iv. The Contractor shall take all reasonable precautions to minimize problems with interpreting post-mortem specimens as positive for ingested alcohol, where microbial generation of alcohol may have occurred. Where sample material permits, more than one type of specimen (e.g., whole blood, urine, and vitreous, etc.) shall be analyzed where a particular specimen-type tests positive for alcohol.

10) Ongoing Communication

i. Because of the sensitivity and visibility of the FRA's Post-Accident Testing Program, the Contractor shall hold ongoing real-time discussions with the SME and COR with respect to the receipt of specimens, the qualification of triggering events, and the status of testing in process. Such communication will permit the FRA to track the progress of specific analyses as needed.

ii. The Contractor will maintain a system of both verbal and secure electronic communications (email “tickler” for encrypted FRA post-accident email site) to keep FRA updated on case status, to receive authorizations, and to exchange information on deficiencies found in the receiving/accessioning process. The Contractor must provide FRA with a single point of contact within the Contractor's FRA team, along with one or more alternates, to facilitate these discussions. Discussions and contacts will most often occur during business hours, but not always. Contractor emergency contact information would also be required in the rare case that after-hours contact was needed.

iii. Ongoing communication shall also include the Contractor's submission of monthly progress reports to FRA, and when required by the COTR, submission of specific case reports/documentation. When formally approved by FRA, on a case-by-case basis the Contractor shall also provide basic explanatory information to carrier Medical Review Officers (MRO's) or specific railroad and employee representatives who may contact the FRA concerning the proper interpretation of the test results. However, such communication shall not compromise the integrity of the Program or unduly infringe upon the rights to confidentiality or privacy of tested individuals.

11) Technical Oversight

i. The FRA will utilize a third-party technical oversight contractor to help ensure, through scheduled triannual inspections, that the Contractor's procedures and analysis of all 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.

ii. Each inspection will be conducted by the SME and COR, or designee, and a team of forensic toxicologists and other experts assigned by the oversight contractor, Each inspection will normally last three days. The inspection team will examine records, SOPs, and supporting documentation covering FRA specimen receiving accessioning, screening, extraction, and confirmation, data review, quality assurance and quality control, equipment, turnaround time, security, safety, personnel and staffing, training, and other elements which determine the scientific soundness and legal defensibility of FRA test results. The oversight contractor will assess the laboratory's procedures and protocols based on DHHS and other widely recognized scientific or authoritative standards of practice. The content of each individual inspection may be modified by the SME and COR depending on the needs of FRA.

iii. Following the inspection and a detailed verbal out-briefing, an FRA-approved report of findings, recommendations, and/or required changes will be released by the third-party technical oversight contractor. Unless the SME and COR furnishes specific instructions to the contrary, the Contractor shall expeditiously carry out or implement all appropriate recommendations and/or required changes. Only when the recommendations and/or required changes affect the substantive elements of this contract (i.e., price, quantity, quality, or delivery) would a modification to the contract and/or task order (initiated at the request of either party) need to be considered and negotiated.

iv. The SME and COR may require the Contractor to undergo occasional additional inspections or technical assistance visits as dictated by the needs of the Program and/or because of scientific or technical issues that arise during the Contractor's performance of this SOW.

v. The Contractor shall grant the FRA's third party technical oversight contractor access to all FRA Program records and facilities during inspections and for discussions on specific issues or cases.

vi. The Contractor will be subject to open proficiency testing in whole blood and urine.

Samples will be constructed by the third-party technical oversight contractor to challenge the Contractor's ability to analyze specimens (including validity testing) in accordance with approved FRA protocols at established cutoffs.

vii. Affirmative, cooperative, and professional communications between the Contractor and the third-party technical oversight contractor are essential to ensure the scope and services of this contract are fully realized and met.

12) INTERPRETATION OF RESULTS AND REPORTING

a. Prior to the reporting of FRA test results, at least one qualified senior scientific officer approved by FRA shall review all data available to the laboratory, including accessioning information, the internal chain-of-custody, raw data on validity evaluation, screening, and confirmation data, and associated quality control data.

i. The senior scientific officer must be prepared to affirm that the analyses for each tested employee were conducted in accordance with this contract and FRA-approved protocols, and that the test results were accurate, complete, internally consistent, fully documented, scientifically sound, legally defensible, and compatible with other available scientific information.

a. This review shall be performed by the same FRA-approved officer certifying the test results, and his/her signature on the form and/or report shall be deemed to attest to satisfactory completion of said review.

b. This review does not limit the Contractor from performing additional layers of review in advance of this action. Contractor personnel performing these types of roles do not have to be qualified in accordance with the requirements listed below.

b. Individuals proposed by the Contractor for FRA approval to conduct final review and certification of non-negative results (positive, adulterated, substituted, or invalid) must at a minimum hold one or more of the following credentials:

i. A Ph.D. in a relevant scientific field and at least three years of equivalent full-time

FRA-acceptable experience as a forensic toxicologist, and/or Hold current Fellow or Diplomate status from the American Board of Forensic Toxicology (F-ABFT or D-

ABFT).

ii. Be currently certified as a Laboratory Responsible Person (RP or Co-RP) by the U.S.

Department of Health and Human Services/Substance Abuse and Mental Health Services Administration's (DHHS/SAMHSA's) National Laboratory Certification Program (NLCP).

c. Individuals proposed by the Contractor for FRA approval to conduct final review and certification of negative results must hold at a minimum one of the credentials described above or hold a master's degree in an applicable scientific field and have the equivalent of at least three years of FRA-acceptable experience in forensic toxicology.

d. FRA retains the right to not accept Contractor-nominated personnel for either level of the scientific officer positions described above even if they meet the minimum qualifications for the position. FRA may choose to withhold approval if the candidate's education, experience, background, communication skills, or knowledge of forensic toxicology does not meet the expectations or standards established by FRA for these critical roles in the Post-Accident Testing Program.

e. Of special interest to the FRA is the capability of the Contractor to interpret the toxicological data to the extent scientifically possible to help determine, when coupled with specific behavioral data obtained elsewhere, the possibility of employee impairment contributing to the cause or severity of an accident/incident. When requested, the Contractor shall provide a statement of pharmacological and toxicological significance related to any report showing a positive test result on post-mortem or antemortem samples. FRA may request a written summary of available information regarding the drug's characteristics and action, possible usage scenarios, and possible physiological and psychological effects, as appropriate. The Contractor shall provide other information related to pharmacodynamics and pharmacokinetics of particular drugs as may be requested by FRA.

f. The Contractor shall be responsible for the timely release of final test results to interested parties as follows:

1. Unless otherwise directed by FRA, both positive and negative results shall be forwarded to the FRA during the Contractor's regular business hours via a suitable encrypted email account when the case is completed by the Contractor.

Written report hard copy originals shall be forwarded to the FRA COR or designee the same day via overnight delivery.

2. When approval is given by FRA, written reports of both positive and negative results shall be forwarded via overnight delivery to the railroad's Medical Review Officer (MRO). The MRO will then share their result determination and any related safety concerns with FRA after interviewing the employee.

3. For research purposes, FRA may require the Contractor to report results on certain drug categories only to FRA. This includes medications such as sedating antihistamines which are over the counter and not controlled substances. This may also occur when FRA is considering adding additional drug classes to its post-accident testing panel and the Contractor has developed approved methods for their analysis.

g. Reports made on an accident or incident shall be reported as a group and not released individually, unless specifically authorized by FRA. The format of all formal or official reports shall be as specified and/or approved by the FRA.

h. The results of drug and alcohol testing activities shall be reported to FRA in accordance with the following schedule:

i. For accidents/incidents involving negative drug screens and either positive or negative whole blood alcohols, reports shall be issued as a group for FRA approval, as soon as practicable, but no later than ten (10) working days after receipt of samples.

ii. For all accidents/incidents involving presumptive drug positives on the screening tests, or when one or more fatalities are involved, reports shall be presented to the FRA as a group for approval of issuance as soon

iii. as practicable, but not later than fifteen (15) working days after receipt of samples.

13) RELEASE OF INFORMATION/CONFIDENTIALITY AND RECORDS

a. Unless otherwise directed by the COR, all reports for a particular accident/incident shall be released concurrently after approval by the FRA COR or his/her designee. Contact concerning the status of testing and the test results (prior to reporting) shall be made exclusively with the FRA COR or designee. Unless specifically granted by written authorization by FRA, the Contractor is prohibited from releasing information on the status of specific specimens, results of any toxicological testing performed, or interpretation of test results to regulated employers, tested employees, other governmental bodies, the media, or other outside parties. All contact with such parties shall be through and in a manner specifically directed in writing by the FRA.

b. The Contractor's documentation of railroad employee tests, together with medical facility or employee-provided information relating to use of medications, etc., shall be held in the strictest confidence, except as disclosure is specifically authorized or required in writing by the FRA.

c. Documentation of railroad employee tests and related records shall be maintained in secure storage except when subject to the continuous supervision of authorized laboratory personnel. Except as otherwise directed by the SME and COR, access to this data shall be limited to (1) authorized laboratory personnel approved by FRA, and (2) recognized outside inspection bodies or agencies specifically granted access by FRA; and then only on a need-to-know basis. Without the written permission of the COR, no records relating to identified individual employees shall be removed or copied by any such inspector except under a binding nondisclosure agreement or other pre-approved arrangement acceptable to the Chief Counsel of the FRA (which agreement will ordinarily contain provision's that require the removal of personal identifying information). The FRA oversight contractor is exempt from these provisions.

d. The Contractor shall maintain all records and working notes regarding accessioning, chain-of-custody, specimen analysis, results or findings, interpretation, and reports on FRA specimens under strict forensic and confidentiality standards for a period of not less than five years, except as described in C.13, hereinafter. The Contractor shall obtain instructions from the SME and COR for further retention or destruction on all records maintained for a period of not less than five years. Participation of individual laboratory personnel in all stages of sample handling, preparation, analysis, reporting, and storage shall also be specifically documented in accordance with strict forensic standards.

e. Extensive data paperwork shall be maintained on the accessioning process, including, but not limited to, incoming shipping and messenger delivery papers, FRA shipping box receipt logs (with all signatures), accessioning logs (with all signatures), and notes on such elements as the condition of the arriving shipping kit, the inventory of samples received, the condition of the samples, and copies of the FRA forms.

f. All data and analytical notes relating to internal specimen processing, testing, and reporting shall be retained including, but not limited to, internal chain-of-custody documents, raw screening data, work lists and work sheets, data on the calibration of the instruments and the controls used, raw confirmatory data on the testing of the unknowns (including all chromatograms and mass spectra), data review and result certification forms, other quality control and quality assurance data, equipment maintenance logs, and copies of all memoranda for the record, correspondence, and reports relevant to the testing of FRA specimens.

g. All documentation described above should be considered the property of the FRA.

The FRA retains the right to inspect all the documentation described including but not limited to notes, work products, memoranda, paperwork, data sheets, documents, etc. The Contractor must be prepared to produce for inspection and/or provide copies of all such documentation when requested by the SME and COR.

h. The originals of the FRA official forms and any other accident/incident paperwork received in the shipping box are the property of the FRA but shall be retained with the case file by the Contractor.

14) MANAGEMENT OF THE FRA POST-ACCIDENT TOXICOLOGY TESTING INFORMATION

SYSTEM

a. The FRA maintains the Post-Accident Toxicology Testing Information System (commonly referred to as PATTS). The original PATTS system was a proprietary database of historical and current post-accident information which documents summary information on each rule-triggering testing event. The database program was constructed to capture pertinent information and documents related to each testing event (and subsequent testing and analysis) since the inception of the Program. The program archives were used to create a new system. The current system (known as PATTS 2.0) does not allow direct contractor access.

b. Scans and documentation of Forms 6180.73-75, Orders/Taskers, and results will still be required from the Contractor to be uploaded to the Secure Large File Transfer Solution (SLFTS) to allow for FRA personnel to retrieve these documents and populate PATTS 2.0. No additional equipment or data entry is required to support the PATTS 2.0 system from the Contractor.

a. All sample material is the property of the FRA, and such material may not be employed for any purpose other than FRA testing, unless expressly authorized by the FRA. Continuously from receipt of the FRA shipping box through analysis and long-term storage, the Contractor shall maintain original sample containers in an area secure from undetected intrusion by unauthorized personnel, and in accordance with national standards of forensic laboratory practice, and consistent with the requirements of the National Laboratory Certification Program of the U.S. Department of Health and Human Services/Substance Abuse and Mental Health Services Administration (DHHS/SAMHSA).

15) SPECIMEN STORAGE AND SECURITY PROTOCOLS

b. When not under continuous supervision of responsible laboratory personnel, specimens shall be maintained in a secure refrigerator (short-term storage) or a secure freezer (long-term storage) to which only authorized laboratory personnel have access. Appropriate records shall be maintained reflecting which laboratory personnel have been issued keys/combinations or are otherwise authorized access.

c. The Contractor shall retain unused portions of specimens in their original sample containers in frozen form (secured as set forth above) after completion of analysis. Specimens from sample sets for which all tests were negative shall be retained for not less than six (6) months, as required by current FRA regulation. Specimens from sample sets confirmed non-negative (positive, adulterated, substituted, or invalid) for one or more substances shall be retained for not less than two (2) years. Longer retention of an identified specimen may be required where the specimen is relevant to pending litigation, an administrative proceeding, or an FRA priority accident.

d. If requested by FRA, the Contractor shall facilitate retesting of any specimen by an FRA-selected referee laboratory in a timely manner and consistent with strict forensic protocols. In addition, periodically (on average four times a year), the National Transportation Safety Board (NTSB) requests FRA to provide specimens from fatally injured employees for other testing specific to that organization's mission at the NTSB contract laboratory. The NTSB will be expected to subpoena the Contractor directly for these aliquots; however, the Contractor must notify the FRA immediately upon receiving a subpoena and receive written permission before complying. The NTSB laboratory testing, for the purposes of this contract, is neither a referee laboratory nor a re-tester, and its testing is outside the scope of this contract. The Contractor shall arrange for forensic shipment of an aliquot or split by secure overnight carrier service in response to either of these needs/requests from FRA for additional/other testing. The Contractor will always be permitted by FRA to retain sufficient sample to ensure that they can defend challenges from outside parties.

16) QUALIFICATIONS OF THE LABORATORY

a. The Contractor shall be in compliance with all relevant requirements of any organization, agency, or jurisdiction, state or Federal, with respect to licensing or certification for work to be performed under this contract. To qualify for this contract and throughout performance of this contract, the Contractor shall maintain one or more of the following laboratory credentials:

i. 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)

ii. Accreditation as a forensic toxicology laboratory by the American Board of Forensic

Toxicology (ABFT), or whomever ABFT employs as a credentialling body for its accreditation (currently it is the ANSI National Accreditation Board (ANAB) with an additional ABFT checklist).

iii. Accreditation as a forensic toxicology laboratory by the College of American

Pathologists (CAP)

b. Integral to the qualifications of the laboratory and the credibility of the FRA's Post-Accident Program are the qualifications of key contract personnel proposed by the Contractor. At a minimum, personnel performing or nominated to perform senior scientific and/or interpretive duties as outlined in C.5 above, must be identified as key personnel for the purposes of this contract. Replacement of such key personnel must be with experienced individuals who are determined by FRA to possess both equivalent credentials and reputation among the forensic toxicology and scientific communities, as those individuals they are replacing. FRA reserves the right of approval or replacement of all key personnel and further reserves the right to seek whatever relief or remedies are available under the terms and conditions of the contract, if individuals proposed for replacing key personnel positions are not determined to be acceptable, or if such right of approval is not forthcoming.

17) SPECIAL ASSAYS

a. In extremely rare cases, the Contractor shall, as requested by FRA on an as-needed basis, be prepared to analyze blood, urine, or tissue samples for the presence of analytes which are not in the FRA's standard testing panel as per 49 CFR Part 219.211(a). Such analyses could include several possibilities, including but not limited to, detecting the presence of hallucinogens; the phenethylamines; non-Federally controlled substances;

federally controlled substances not in the standard FRA testing panel including synthetic marijuana, anabolic steroids, and related compounds; and selected adulterants. History has required this action only several times since the inception of the program in 1986.

b. In many of these cases, it is expected that analytical protocols must be developed from scratch, but in doing so, the Contractor must embrace leading-edge scientific and technological approaches for the detection of these analytes. In some cases, the Contractor may be unable or is in some way hampered (through no fault of its own) in its efforts to develop a suitable special assay in a timely manner. Examples would include a requirement for specialized equipment that is not normally needed to fulfill the core contract requirements, and it would be unduly cost prohibitive to acquire such equipment, or when other prohibitive factors, or extraordinary or atypical situations exist, and time is of the essence. In such circumstances, the FRA may consider a case-by-case one-time action in which the Contractor would be allowed to subcontract to another laboratory for the single assay/analysis only. The Contractor shall obtain FRA approval on the proposed subcontractor prior to award of a subcontract for the assay/analysis.

c. The Contractor shall, as requested by the FRA on an as needed basis, analyze other body fluid samples provided by railroad employees responsible for duties directly affecting rail safety (e.g., confirmation as a referee laboratory of a disputed positive test under other Federal drug testing provisions, such as 49 CFR Parts 40 and 219). The FRA will provide evidence of implied or actual consent with respect to the re- analysis of any such body fluid sample.

18) FRA POST-ACCIDENT TOXICOLOGY BOXES

a. The Contractor shall be responsible for the manufacture, distribution, tracking, repackaging, replacement, and shipment of standardized FRA post-accident toxicology boxes containing three collection kits each, and replenishment of kits and internal expiring components (e.g., blood tubes), to the railroad carriers. [Note: This requirement is not directed at and does not cover the cost of shipment of collected post-accident samples from the employer/railroad to the laboratory. Such costs are not reimbursed under this contract and should be the responsibility of the employer/railroad.]

b. Services to accomplish these requirements may be acquired by the Contractor, through subcontract, from a qualified responsible source (hereinafter referred to as the "box subcontractor"). The Contractor shall be responsible for the conduct of the contract/contract requirements, coordination of efforts, and performance of the box subcontractor (if applicable).

Except as it may adversely affect or impact the FRA Post-Accident Program, selection and/or replacement of a box subcontractor shall be the responsibility and prerogative of the Contractor.

i. Task requirements under this subsection shall include the following:

a. The Contractor shall be responsible for ensuring that all shipping containers, toxicological kits, and component supplies tendered, meet OSHA safety standards for Occupational Exposure to Blood borne Pathogens (29 CFR Part 1910.1030), and are otherwise materially acceptable.

b. The Contractor shall be responsible for ensuring that each FRA post-accident toxicology box meets the minimum content and specification requirements as outlined in the Post-Accident Toxicological Box Specifications.

c. FRA's computer-based tracking program for FRA post-accident toxicology boxes and a master mailing and distribution file list identifying the distribution of approximately 5,000 toxicology boxes already in the field or in inventory will initially be provided to the Contractor by FRA as Government Furnished Material (GFRA). At present, the FRA Toxicology Box Management Inventory is on an MS Excel spreadsheet.

d. FRA shall be responsible for implementation, operation, and maintenance of the FRA post-accident toxicology boxes inventory during the contract and will be shared with the Contractor. FRA will retain unlimited rights to use, copy, and distribute its inventory at the contract's completion or termination.

e. At any given time, through use of the inventory, the Contractor shall be able to verify to FRA, in total and by individual regulated employers, and location, the number of boxes distributed, and the unique identification number assigned to each box. The Contractor must also be capable of verifying to FRA the dates of box distribution, the blood tube expiration/replacement schedule dates and any other pertinent information for tracking box/kit distribution, and inventory levels of existing stock. Performance includes both on-going input and upkeep, and periodic reconciliation as follows:

a. Ongoing Input/Upkeep. Based on FRA notifications, the Contractor shall be responsible for adding to or deleting from the master file list regulated employers not previously identified and/or regulated employers new to the post-accident program, as they are identified or come into or go out of existence or merge with other regulated employers, or other changes as they occur or are identified. Also, to be accounted for are standing inventories maintained at the Contractor laboratory or elsewhere.

b. Periodic Reconciliation. The Contractor shall be responsible for conducting an annual reconciliation to verify the accuracy of the master file/distribution list with the FRA who will coordinate with the regulated employers.

The Contractor shall be responsible for coordinating with FRA to verify the status and location of boxes assigned to each regulated employer and for making corrections and updates to the database as necessary.

f. In those performance periods in which a blood tube replacement/switch out is to occur, the reconciliation should be completed not less than 30 days before the scheduled replacement/switch out commences.

[Note: Each box must be assigned to a specific site somewhere on the railroad or with the railroad contractor.]

c. The Contractor shall be responsible for ensuring that the railroads have been issued the correct, self-imposed number/apportionment level of toxicology boxes in coordination with FRA. The Contractor is also responsible for replacing, at no cost to the carrier, boxes used in post-accident testing events, or damaged boxes and kits on a one-for-one basis. Shipping costs for both initial and replacement boxes sent to the railroads will be borne by FRA and the Contractor will be reimbursed through this contract.

[Note: The total number of boxes/kits initially requested by each individual railroad when placed on the master mailing and distribution file list shall serve as the self-imposed number/apportionment level of toxicology boxes that the railroad is authorized to have replaced at no cost.