Table 5. Summary of QC requirements for Enterococci analysis by Enterolert QC Sample or Activity Minimum Frequency Acceptance Criteria Corrective Action Four (4) prepared samples Criteria for LCS recovery Capability demonstration analyzed prior to any Repeat until acceptable and duplicate precision customer sample analyses Investigate problem. Eliminate contaminations. Obtain new lot of Prior to use of new lot of Media sterility check No fluorescence Enterolert if necessary. Repeat Colilert18 and weekly until successful before using Enterolert lot. Investigate problem. Obtain new Media positive check with Prior to use of new lot of lot of Enterolert if necessary. Fluorescence control culture Enterolert and weekly Repeat until successful before using Enterolert lot. Investigate problem. Eliminate Media negative checks with contaminations. Obtain new lot of Prior to use of new lot of control cultures (gram+ and No fluorescence Enterolert if necessary. Repeat Enterolert gram-) until successful before using Enterolert lot. Clean analytical system and repeat At least weekly, Method blank < 20 CFU/100 mL MB analysis. Identify and prior to sample analysis eliminate source of contamination. RPD < 200% for <150 At least one (1) weekly, Investigate problem. If system CFU/100 mL Sample duplicate or matrix and one with all large precision is in control, qualify spike duplicate sample batches (~20 results. If system precision is out RPD < 100% for > 150 samples) of control, reanalyze entire batch. CFU/100 mL Samples and frequency Criteria for LCS recovery Investigate all unacceptable Internal PE sample determined by Lab QA and duplicate precision results. Officer Samples and frequency Determined by PE Investigate all unacceptable Blind PE sample determined by accrediting provider results. agencies and projects LCS = laboratory control sample QC = quality control MB = method blank %R = percent recovery MDL = method detection limit RL = reporting limit PE = performance evaluation RPD = relative percent difference
Table 5. Summary of QC requirements for Enterococci analysis by Enterolert QC Sample or Activity Minimum Frequency Acceptance Criteria Corrective Action Capability demonstration Four (4) prepared samples analyzed prior to any customer sample analyses Criteria for LCS recovery and duplicate precision Repeat until acceptable Media sterility check Prior to use of new lot of Colilert18 and weekly No fluorescence Investigate problem. Eliminate contaminations. Obtain new lot of Enterolert if necessary. Repeat until successful before using Enterolert lot. Media positive check with control culture Prior to use of new lot of Enterolert and weekly Fluorescence Investigate problem. Obtain new lot of Enterolert if necessary. Repeat until successful before using Enterolert lot. Media negative checks with control cultures (gram+ and gram-) Prior to use of new lot of Enterolert No fluorescence Investigate problem. Eliminate contaminations. Obtain new lot of Enterolert if necessary. Repeat until successful before using Enterolert lot. Method blank At least weekly, prior to sample analysis < 20 CFU/100 mL Clean analytical system and repeat MB analysis. Identify and eliminate source of contamination. Sample duplicate or matrix spike duplicate At least one (1) weekly, and one with all large sample batches (~20 samples) RPD < 200% for <150 CFU/100 mL RPD < 100% for > 150 CFU/100 mL Investigate problem. If system precision is in control, qualify results. If system precision is out of control, reanalyze entire batch. Internal PE sample Samples and frequency determined by Lab QA Officer Criteria for LCS recovery and duplicate precision Investigate all unacceptable results. Blind PE sample Samples and frequency determined by accrediting agencies and projects Determined by PE provider Investigate all unacceptable results. LCS = laboratory control sample QC = quality control MB = method blank %R = percent recovery MDL = method detection limit RL = reporting limit PE = performance evaluation RPD = relative percent difference
Withers%20MST%20QAPP%2001072013.docx