PATT Laboratory PWS.pdf

Performance Work Statement Post-Accident Toxicological Testing of Human Samples and Related Services

1. General Information

The Federal Railroad Administration’s (FRA), Office of Railroad Safety, Drug and Alcohol Division, require contractor laboratory support services for the Post-Accident Toxicological Testing (PATT) Program 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 PATT Program was implemented in 1986 pursuant to 49 CFR 219 – Control of Alcohol and Drug Use, Subpart C – Post-Accident Toxicological Testing.

This requirement will have a 12-month base period with two (2) 12-month optional periods.

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.

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. Government-Furnished Property (GFP) and Services

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 for direct contractor access.

b) 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.

c) FRA shall be responsible for notifying the contractor of new testing events and when the collected specimens will arrive at the contractor’s facility.

d) FRA shall evaluate the Contractor’s performance under this contract in accordance with a Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards as listed under the Performance Requirements Summary (PRS).

3. Contractor-Furnished Items and Services

a) 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(ies), body fluid and tissue samples). There has been an average of 175 sample sets in the last five complete years of the program 2017 to 2021. 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.

b) 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.

c) 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 PWS. 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.

d) In addition to meeting the minimum qualification standards described in Section 5 of this document, 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.

e) 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.

f) 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.

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

Contractor's may be acceptable to fulfill this requirement.

g) 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.

h) 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.]

i) 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.

j) 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.

k) 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.

l) 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.

m) In those performance periods in which a blood tube replacement/switch out is to occur, the reconciliation should be completed not less 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.]

n) 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.

o) 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 PWS, or 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.

p) 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. 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.

q) 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

i. shipping package log-in, specimen log-in, accession number assignment, and initiation of the internal laboratory chain-of-custody document.

r) 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 at this time 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.

s) The Contractor is not responsible for resolving collection or collection documentation discrepancies. The decision and order to proceed with testing (and the resolution of any documentation issues) rests with FRA. Only FRA has the authority to proceed with or cancel a test.

t) 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).

a. 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

u) Quality Control - The Contractor shall develop and maintain an effective quality control program (QCP) to ensure services are performed in accordance with this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor’s quality control program should provide the framework to ensure that the Contractor work complies with the requirement of the contract. The QCP shall be delivered to the Contracting Officer (CO) and COR within 30 days after contract award. After acceptance of the QCP, the Contractor shall receive the CO’s acceptance in writing of any proposed change to the QCP.

4. Specific Tasks

a) 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.

b) 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 below, blood will be screened, and presumptive positives will result in confirmation testing in blood and urine (if possible).

c) 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:

i. 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

ii. 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

iii. The specimen has an abnormal pH (The pH is equal to or greater than 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

3 and less than 4.5 or equal to or greater than 9 and less than 11), or

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

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

vi. 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.

d) 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:

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

ii. 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

iii. Omitting analysis of the specimen for drugs of abuse and reporting the laboratory data regarding the quality and integrity of the specimen, and/or.

iv. Screening the blood sample for drugs.

e) 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.

f) 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.

g) Toxicological Testing kits must be re-provisioned back to the field to refresh those received at the laboratory. Reprovisioning includes collection kits (with urine collection cup, split sample containers, blood tubes, and water bluing tablets), forms, and instructions. These kits need to be re-provisioned and fielded within 30 days of receipt at the laboratory. This can be checked by verifying receipt by the railroads that have had the accidents.

h) Blood tubes need to be refreshed in approximately 5000 tox boxes (with ~30,000 blood tubes) nationwide every 24 months due to expiration and loss of vacuum. This task needs to be accomplished before expiration of the current blood tubes. FRA approves this requirement in consultation with the contracted laboratory

i) 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.

j) The Contractor shall arrange formal procedures for the receipt and preservation of specimen sets on a 24 hours a day/7 days a week basis either at its laboratory or in some other FRA-approved, forensically acceptable manner. The Contractor shall provide 24 hours a day/7 days a week answering service or equivalent arrangement accessible to the railroads to handle questions, receive information on the shipment of samples, and trigger the Contractor being prepared to take physical possession of specimens personally or through an agent during other than normal business hours.

k) The Contractor shall provide expert witnesses, as requested by the FRA

(approximately 2-5 days annually), in litigation and Federal administrative proceedings growing out of the accidents/incidents covered by the Post-Accident Testing Program and, in exceptional cases, other accidents/incidents of significant public interest. Expert testimony may be required with respect to the laboratory analysis of specimens and/or the toxicological or pharmacological significance of the test results.

i. [Note: Expert witness testimony has not been required since the initiation of FRA post-accident testing in 1986.]

l) The Contractor may be required to occasionally assemble a comprehensive, standard "litigation package" containing complete screening and confirmatory support data at the request of a railroad or other party. Such material will be assembled only with the written permission of the SME and COR using specific forms and/or formats as provided by FRA. The package must be reviewed and approved for release by FRA prior to delivery to any party. The Contractor shall provide these packages to FRA, and bill for their preparation. FRA will in turn furnish the package(s) to the railroad or other requesting party at no cost to the requester.

m) Monthly Status Report - The Contractor shall develop a monthly status report to be delivered to the Government every month. All documents will be considered drafts until formally accepted in writing by the designated Project Manager (PM). The Contractor shall address all comments provided by the PM on the draft deliverable within 2 weeks of receipt.

5. Qualifications

Laboratory

The Contractor shall comply 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:

• 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)

• 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 (at this time it is the ANSI National Accreditation Board (ANAB) with an additional ABFT checklist)

• Accreditation as a forensic toxicology laboratory by the College of American Pathologists

(CAP)

Key Personnel

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:

• 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).

• 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).

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.

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.

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.

6. Applicable Regulations

a) 49 CFR Part 40 is the base regulation controlling the procedures used in the

"normal" transportation industry drug and alcohol testing program for most types of testing (i.e., pre-employment, random, reasonable cause, etc.).

Although the FRA Post-Accident Testing Program is exempt from the requirements of Part 40 (see §40.1(c)), FRA has and will continue to employ Part 40 requirements when it is in the best interests of the Program.

b) 49 CFR Part 219 is specifically geared towards FRA and provides the framework for the FRA Post-Accident Toxicological Testing Program.