Attachment_5_-_Reporting_Requirements_and_Deliverables.pdf
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Department of the Army Medical Command
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ATTACHMENT 5
REPORTING REQUIREMENTS AND DELIVERABLES
The contractor shall provide reports and other electronic data deliverables as part of its reporting/data package. Contractor data packages shall include the following documentation:
A. Complete/Final Data Package (Submitted via PDF), to include the following
1. Invoice for Services Rendered – Contractor shall submit original invoice, in a separate PDF from the analytical data package PDF. The invoice should reflect any penalties accrued for late reporting or missed hold times as outlined in the PWS of the contract.
2. All of the analytical report/data package items specified in the DoD QSM version the Contractor is currently accredited to.
3. On the analytical results pages (see Appendix A, DoD QSM v5.0, paragraph 4.0), the samples are to be identified by the APHC Lab ID and the corresponding field ID.
4. In addition to the items listed in Appendix A, DoD QSM v5.0, paragraph
5.0 (Sample Management Records), the data package shall include a copy of the appropriate pickup order form.
5. In the quality control data summary (DoD QSM v5.0, Appendix A paragraph 6.0), ICV and CCV spike concentrations and recoveries are also desired (but not required if not in the laboratory’s standard reporting format).
6. Stage 4 (previously, and equivalent to, Level IV) raw data elements are required in all data packages (see Appendix A, DoD QSM v5.0, paragraph 7.0). Raw calibration data and standards traceability data/information are required in all data packages.
7. Calculations sheets (that show all calculations and factors involved in calculating the final result) and method detection limit (MDL, or detection limit (DL)) summaries (showing individual results and calculated MDLs) must be provided (either in each data package, or in separate files, with updates provided as the information changes).
8. Concentration results are to be reported to 2 significant figures. Please identify any proposed exceptions, with justification, in the proposal.
9. The laboratory must have the capability to report (pdf and EDD) J-flagged estimates for confirmed detections between the method detection limit (MDL, = detection limit, DL) and the LOQ, unless not applicable to the method (e.g., pH). Reporting of J-flagged estimates is required for organic methods (all GC, GC/MS, LC, and LC/MS methods); metals methods (all ICP, ICP-MS, CVAA methods), perchlorate methods (LC/MS and/or IC- MS); and all IC methods. The J-flags will be applied for any positive detection (that meets method requirements for target analyte identification) between the MDL/DL and the LOQ (which is equal to or greater than the lowest calibration standard). J-flag will be defined as an estimated value.
10. For J-flagged detections between the MDL/DL and LOQ to be reported, all method target analyte identification criteria must be met. Examples are 1) the evaluation of the mass spectrum using the same criteria as with a detection at or above the LOQ; and 2) second column confirmation for GC methods, using the same criteria as with the confirmation of a detection at or above the LOQ. Discussions may take place between APHC and the contract lab regarding the usefulness of reporting J-flagged estimates for a particular method.
11. Non-detects are to be reported as “not detected” at the DoD QSM defined limit of detection (LOD), with a “U” flag, if the DoD QSM reporting format is being used for a particular method (will be most methods in this PWS). If LODs are not being used for reporting for a particular method/project, non-detects are to be reported as “not detected” at the LOQ, with a “U” flag.
This reporting and flagging approach will be discussed between APHC and the contract lab(s) to ensure agreement on the definitions of reporting terms, and on the reporting and flagging approach.
Note: All Final Reports shall be archived at least five years after approval of the data package by the APHC COR/Technical Representative.
A. PDF Instructions for the Complete “FINAL” Data Package – This PDF document will include the entire data package as described above, minus the invoice. Please provide the invoice via PDF as a separate file from Final report. Final package PDF and invoice PDF are emailed to the following address:
usarmy.apg.medcom-phc.mbx.dls-contract-hardcopies@mail.mil .
These will be due no later than 2:00 PM Eastern Standard Time on the due date specified on the Pick-up Order. Naming convention of hard copy file and invoice should at least include the lab queue (acronym) and the PHC Pick up Order number, both of which will be provided on the documentation.
B. Preliminary Sample Analysis Results (pdf file) – Due one day before Complete Hard Copy Data Package PDF, for High and Top Priority Turn Around Time requests. These prelim PDFs will contain final, numerical results in appropriate units, for the requested parameters. Sample data shall be identified by APHC lab ID and field ID.
C. ELECTRONIC DATA DELIVERABLE (EDD) - The electronic data deliverable
(EDD) and Final PDF report are REQUIRED to be derived from the same source.
Information (sample ID, field ID, etc) and data (analytical results, units) must match. The process that generates the final report and EDD is REQUIRED to be validated to demonstrate that the process provides identical information and data.
mailto:usarmy.apg.medcom-phc.mbx.dls-contract-hardcopies@mail.mil
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