PATT Laboratory Performance Requirements Summary.pdf

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

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.

primary or contributing cause to a significant accident or incident.

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

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 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.

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.