8.1.2023 PATT Laboratory Performance Requirements Summary.docx
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- Solicitation number
- FRA23PATTLaboratory
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This performance requirements summary outlines the key deliverables required for Post-Accident Toxicological Testing and related laboratory services. The contractor must analyze up to 200 urine and blood specimen sets per year within 7-10 days of receipt and report timely, comprehensive, and error-free results to the Federal Railroad Administration and involved medical review officers. Additional requirements include re-provisioning toxicology testing kits for railroads within 30 days, replacing expired blood collection tubes in all test boxes every 24 months, and maintaining specimen records for five years. The contractor must receive and preserve specimens 24/7 and submit accurate monthly status reports within 10 days of each month. Thorough transition in and out plans are due within 10 business days of award and 90 days before expiration, respectively, to ensure continuity of services. The Federal Railroad Administration's solicitation for these services is identified.
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Other files
| File | Type | Posted |
|---|---|---|
| 8.1.2023 PATT Laboratory Questions and Answers.docx | DOCX document | |
| 8.1.2023 Combined Synopsis and Solicitation.docx | DOCX document | |
| 8.1.2023 PATT Laboratory PWS.docx | DOCX document | |
| PATT Laboratory Performance Requirements Summary.pdf | ||
| PATT Laboratory PWS.pdf | ||
| PATT Laboratory - Combined Synopsis and Solicitation.pdf | ||
| PATT Lab Pricing Reference.xlsx | XLSX spreadsheet |
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PERFORMANCE REQUIREMENTS SUMMARY
Post-Accident Toxicological Testing (PATT) of Human Samples and Related Laboratory Services The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success. Note: Government surveillance of contractor performance is not limited to the Performance Objectives as outlined in this PRS. The Government reserves the right to conduct compliance surveillance of any contractual requirement of this acquisition.
| Performance Objective/Task |
| Performance Standard |
| Acceptable Quality Level (AQL) |
| Incentive/Remedy |
Timely analysis of up to 200 sets of urine and whole blood specimens per year (and on occasion, where there has been a fatality(s), body fluid and tissue specimens).
Test findings shall be in accordance with the highest scientific and technical standards, also 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). Results shall determine if drugs or alcohol were either a primary or contributing cause to a significant accident or incident.
| AQL: Timely, comprehensive, detailed, accurate and error-free communications and analyzed results should be completed within 7 to 10 days of receipt at the laboratory. |
| 100% or approximately 200 out of 200 specimen sets analyzed in a timely manner |
| Performance levels documented in CPARS, with particular attention paid to performance that |
failed or exceeded the standard.
When there are issues with the testing results and analysis, the contractor is required to correct them and resubmit at no additional cost to the Government.
| Report results of testing |
| AQL: Once the analysis of the received specimens has been completed, the contractor should ensure that FRA and the Medical Review Officer (MRO) of the railroad(s) involved receive the confirmed testing results in a timely manner. |
In the event of a positive result, the contractor must receive FRA authorization before releasing results to the MRO.
100% of the time
| 100% or the results for approximately 200 out of 200 analyzed specimen sets. |
| Performance levels documented in CPARS, with particular attention paid to performance that failed or exceeded the standard. |
Aside from when there are positive results, the contractor must be able to explain to FRA any delays in reporting the results of the analyzed specimens.
| Re-provisioning and fielding of Toxicological Testing Kits after testing incident to the railroad involved |
| AQL: Ensure these kits are re-provisioned and fielded within 30 days of receipt at the laboratory, and shipped to the railroad involved |
| 98%- the contractor must make every effort to re-provision and field the kits, so that there is no lapse in the ability of the railroads to perform required testing. |
| Performance levels documented in CPARS, with particular attention paid to performance that failed or exceeded the standard. |
When kits are not acceptable, the contractor is required to correct them, and re-provision and field at no additional cost to the government.
| Replace blood collection tubes in all toxicology boxes due to expiration, loss of vacuum, or any other reason (e.g., broken). Schedule, coordinate, facilitate, and communicate all logistics of the replacement of these tubes. Blood collection tubes shall be ready to use. Historically, there are approximately 5,000 tox boxes (with ~30,000 blood collection tubes) nationwide. Also, replacement occurs before the expiration of the current blood collection tubes due to expiration and loss of vacuum. |
| AQL: Blood collection tubes are refreshed/replaced before expiration and loss of vacuum. These blood collection tubes are clean and distributed nationwide in all tox boxes timely and accurate and error-free 98% of the time. |
| 98% or approximately 29,400 out of 30,000 blood collection tubes replaced in a timely manner, every 24 months. |
| Performance levels documented in CPARS, with particular attention paid to performance that failed or exceeded the standard. |
When blood collection tubes are not acceptable, the contractor is required to correct and them and replace at no additional cost to the Government.
| 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. |
| AQL: To preserve the integrity of the results produced by the analysis, in case of investigation or litigation; the contractor must maintain copious and complete records of all analyses performed. |
Additionally complete records allow for accurate accounting and timely payment
| 100%- All records related to the approximately 200 specimen sets analyzed each year must be maintained by the contractor. |
| Performance levels documented in CPARS, with particular attention paid to performance that failed or exceeded the standard. |
The contractor should maintain complete records related to the analysis performed and must be able to explain any lapses in recordkeeping to FRA.
| Establish, implement, and maintain formal procedures for the receipt and preservation of specimen sets on a 24- hours a day/7-days a week basis at its laboratory or in some other FRA-approved, forensically acceptable manner |
| AQL: Due to the uncertain frequency of when incidents occur, and to preserve the integrity of the results produced by the analysis, in case of investigation or litigation; the contractor must be able to receive and preserve specimen sets whenever they are delivered to the laboratory. |
| 100% - The contractor must be able to receive and preserve all specimen sets delivered to their facility at any time of the day, or day of the week. |
| Performance levels documented in CPARS, with particular attention paid to performance that failed or exceeded the standard. |
The contractor should make FRA aware of any issues with receiving and preserving the specimen sets, to maintain the integrity of the testing.
| Monthly Status Report |
| AQL: Comprehensive, accurate, and submitted to FRA within 10 days of the first of the month. The report should be detailed and address both the activities performed by the contractor and any issues they had in performing the duties outlined in the PWS. |
| 100%- A report must be received by FRA for every months of the life of the contract; approximately 36 in total. |
| Performance levels documented in CPARS, with particular attention paid to performance that failed or exceeded the standard. |
The reports will also allow FRA to be aware of any issues, so that they can be resolved, and work completed successfully.
| Transition In Plan |
| AQL: The Contractor shall provide a transition in plan to the Contracting Officer and COR. This plan shall address the contractor’s plan for minimizing impact such that continuity of services will be maintained without disruption. The contractor shall describe how it will achieve full staff support levels with 60 days of award. This report is due 10 business days after award of contract. |
| 100%- A comprehensive plan is essential for the smooth transition from one contractor to another. It is important that as soon as the new contractor is awarded the contract, they begin to plan how they will fulfill the job duties laid out in the PWS, without any issues. |
| Performance levels documented in CPARS, with particular attention paid to performance that failed or exceeded the standard. |
An incomplete or missing plan could cause delays and issues with the execution of the vitally important duties related to the contract. If the contractor runs into any issues with the plan or starting work, they should be reported to FRA as soon as possible.
| Transition Out Plan |
| AQL: The Contractor shall provide a transition out plan to the Contracting Officer and COR. This plan shall address the contractor’s plan for minimizing impact such that continuity of services will be maintained with disruption. The contractor shall describe how it will transition work to the new contractor. This report is due 90 days before the expiration of the contract. |
| 100%- A comprehensive plan is essential for the smooth transition from one contractor to another. If there are issues with the contractor transitioning out, there may be delays or lapses in the services , which could impact the successful completion of FRA’s vitally important work. |
An incomplete transition out plan could also impact the onboarding contractor, leading to extended issues as the handover of duties is completed.
Performance levels documented in CPARS, with particular attention paid to performance that failed or exceeded the standard.
An incomplete or missing plan could cause delays and issues with the execution of the vitally important duties related to the contract. If the contractor has any issues in the process of transitioning off of the contract, or if there are any issues which could cause a lapse in service, they should inform FRA as soon as they can.
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