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Procedures for Detection and Quantitation

WORKING DRAFT FOR DISCUSSION

Summary of Technical Work Group Questions

  1. Evaluation Characteristics
    • Should the Characteristics and measures presented be used in the Matrix? If not, what changes should be made so that they can be used in the Matrix?
    • Should any Procedures be dropped from the Matrix?
  2. Pilot Study Purpose and Objectives
    • Should the proposed pilot purpose and objectives be changed/approved by the FACDQ?
  3. Multi-lab Pilot Study Design
    • For LCMRL - In considering the DL/QL uses where it is determined that an inter-laboratory DL or QL would be most appropriate, should this be implemented through a multi-laboratory design (e.g. pooling or otherwise utilizing single laboratory data) or through a true inter-laboratory (see glossary) design?
    • Should the TWG continue the design of the pilot study incorporating and detailing how a stepwise approach would be utilized with the understanding that the plan would be initially approved by the FACDQ but thereafter, implementation would not require FACDQ approval, but rather be tracked by the TWG?
  4. Single-lab Pilot Study Design
    • Are Procedures intended to identify the absolute detection and quantitation limits achievable by a laboratory (Descriptive approach where each laboratory shows to what level they can measure); or Are the Procedure(s) intended to provide a demonstration that the detection and quantitation limits claimed by the laboratory are as high or higher than the absolute detection limits (Prescriptive, where a level would be set considering measurement objectives and a laboratory would need to show they can meet that level); or Should Procedures do both?
    • Should any Procedures be modified depending on the answer to the first question?
    • Should the TWG continue to examine candidate statistical procedures for LD and LC that require the use of blank subtraction?
  5. Blank Subtraction
    • Should the Technical Work Group continue to examine candidate statistical procedures for LD and LC that require the use of blank subtraction?
    • Does the FACDQ want to consider a detection limit procedure that would require the complete revision of some or all 40 CFR 136 analytical methods?

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