§141.40. Monitoring requirements for unregulated contaminants.
40 C.F.R. § 141.40
(1) All laboratories performing analysis under UCMR must demonstrate that they are capable of meeting data quality objectives at or below the MRL listed in Table 1, column 4, in paragraph (a)(3) of this section.
(2) The MRL, or any concentration below the MRL, at which performance is being evaluated, must be contained within the range of calibration. The calibration curve regression model and the range of calibration levels that are used in these performance validation steps must be used in all routine sample analyses used to comply with this regulation. Only straight line or quadratic regression models are allowed. The use of either weighted or unweighted models is permitted. The use of cubic regression models is not permitted.
(3) Replicate analyses of at least seven (7) fortified samples in reagent water must be performed at or below the MRL for each analyte, and must be processed through the entire method procedure (i.e., including extraction, where applicable, and with all preservatives).
(4) A prediction interval of results (PIR), which is based on the estimated arithmetic mean of analytical results and the estimated sample standard deviation of measurement results, must be determined by Equation 1:
(5) The values needed to calculate the PIR using Equation 1 are: Number of replicates (n); Student's t value with a two-sided 99% confidence level for n number of replicates; the average (mean) of at least seven replicates; and the sample standard deviation. Factor 1 is referred to as the Half Range PIR (HRPIR).
(6) The HRPIR is calculated by Equation 2:
(7) The PIR is calculated by Equation 3:
(8) The lower and upper result limits of the PIR must be converted to percent recovery of the concentration being tested. To pass criteria at a certain level, the PIR lower recovery limits cannot be lower than the lower recovery limits of the QC interval (50%), and the PIR upper recovery limits cannot be greater than the upper recovery limits of the QC interval (150%). When either of the PIR recovery limits falls outside of either bound of the QC interval of recovery (higher than 150% or less than 50%), laboratory performance is not validated at the concentration evaluated. If the PIR limits are contained within both bounds of the QC interval, laboratory performance is validated for that analyte.
(2) You must ensure, once your laboratory has performed an IDC as specified in each analytical method (demonstrating that DQOs are met at or below an MRL), that a daily performance check is performed for each analyte and method. A single laboratory blank, fortified at or below the MRL for each analyte, must be processed through the entire method procedure. The measured concentration for each analyte must be converted to a percent recovery, and if the recovery is within 50%-150% (inclusive), the daily performance of the laboratory has been validated. The results for any analyte for which 50%-150% recovery cannot be demonstrated during the daily check are not valid. Laboratories may elect to re-run the daily performance check sample if the performance for any analyte or analytes cannot be validated. If performance is validated for these analytes, the laboratory performance is considered validated. Alternatively, the laboratory may re-calibrate and repeat the performance validation process for all analytes.
Notes, amendments, and revision history
Amendments
[72 FR 393, Jan. 4, 2007; 72 FR 3916, Jan. 26, 2007, as amended at 77 FR 26098, May 2, 2012; 81 FR 92688, Dec. 20, 2016; 86 FR 73155, Dec. 27, 2021; 87 FR 3679, Jan. 25, 2022]
Authority
Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.
Source
Source: 40 FR 59570, Dec. 24, 1975, unless otherwise noted.
Amendments
[72 FR 393, Jan. 4, 2007; 72 FR 3916, Jan. 26, 2007, as amended at 77 FR 26098, May 2, 2012; 81 FR 92688, Dec. 20, 2016; 86 FR 73155, Dec. 27, 2021; 87 FR 3679, Jan. 25, 2022]