New Jersey Administrative Code
Title 7 - ENVIRONMENTAL PROTECTION
Chapter 18 - REGULATIONS GOVERNING THE CERTIFICATION OF LABORATORIES AND ENVIRONMENTAL MEASUREMENTS
Subchapter 5 - CHEMICAL TESTING
Section 7:18-5.5 - Requirements for quality assurance/quality control program

i. The change is made by the manager, supervisor or quality assurance officer of the laboratory; and

ii. The manager, supervisor or quality assurance officer makes the change in writing, signed and dated by the manager, supervisor or quality assurance officer.

i. When using new calibration standards or quarterly, the laboratory shall prepare new calibration curves consisting of at least one reagent blank and five standards. The calibration coefficient shall be [GREATER THAN] 0.995.

ii. The laboratory shall verify the calibration curve with the calibration check standard daily or after every 20 samples, whichever is more frequent. For analyses under the Drinking Water Program, the laboratory shall use a calibration check standard with a concentration at or near the maximum contaminant level (MCL). For analyses under other regulatory programs, the laboratory shall use a calibration check standard with a concentration at or near the middle of the concentration range of the calibration curve. If the applicable DSAM does not specify the permitted deviation, a verification is satisfactory only if the concentration as determined from the calibration curve is within a percent difference (PD) of 10 percent of the true concentration of the calibration check standard. If the PD is greater than 10 percent, the laboratory shall prepare a new calibration curve.

iii. The laboratory shall record all data used in determining the calibration curve, and have the record signed by the analyst. In the record, the laboratory shall include the date of calibration, identification and concentration standards;

i. If the laboratory analyzes 20 or more samples in a calendar month, it shall analyze one QC sample for every 20 samples analyzed during the month. If the laboratory analyzes fewer than 20 samples in a calendar month, it shall analyze one QC sample during the month;

ii. The laboratory shall calculate the percent recovery (% R) for each parameter in the QC sample. The % R shall be within the limits listed in the applicable DSAM. If the applicable DSAM does not list such limits, the laboratory shall calculate such limits from its experimental data, using the procedure in (c)9 below. If the % R is not within three standard deviations of the limits, the laboratory shall re-analyze the samples in question; and

iii. For categories AE01-AE04 and AE06, if a spiking solution is not available, a calibration solution, whose concentration approximates that of the samples, shall be included in each batch and with each lot of media. If a calibration solution must be used for the QC sample, the client will be notified prior to the start of analysis. The concentration of the QC sample shall be relevant to the intended use of the data and either at a regulatory limit or below it.

i. The laboratory shall verify the accuracy and precision of its analyses of parameters in the above categories. The laboratory shall maintain records of such verifications, signed by the analyst performing the verification. In the records, the laboratory shall include the date on which it performed the verification, the method of verification, and the results;

ii. If the laboratory analyzes 20 or more samples for any one parameter in a calendar month, it shall verify the accuracy and precision of such analyses on at least one of every 20 samples analyzed during the month. If the laboratory analyzes fewer than 20 samples for any one parameter in a calendar month, it shall verify the precision of the analysis once a month;

iii. The laboratory shall calculate the percent recovery (% R) for each matrix spike and the relative percent difference (RPD) between the matrix spike and matrix spike duplicate for each parameter. The % R and RPD shall meet requirements of the applicable DSAM. If the method does not list limits for % R and RPD values, the laboratory shall establish these limits from its experimental data, using the procedure in (c)9 below;

iv. For categories AE01-AE04, and AE06, matrix spikes and matrix spike duplicates are not required for those air samples that are introduced directly into an analytical instrument from SUMMA sampling canisters, sorbent tubes, or polyurethane foam (PUF) traps.

i. The laboratory shall calculate standard deviations for n-1 degrees of freedom (n samples - 1) for all % R and RPD measurements in (c)7 and 8 above. For this calculation in connection with (c)7 above, the laboratory shall use ongoing data collected from the analysis of 10 QC samples; for this calculation in connection with (c)8 above, the laboratory shall use ongoing data collected from the analysis of 10 matrix, matrix spike pairs. For parameters in Category DW03 and DW05-DW07, the laboratory shall use samples that have been prepared at the MCL. For other parameters, the laboratory shall use samples that have been prepared to approximate the middle of the concentration range normally encountered in the analysis. The laboratory shall record the theoretical or true value. The laboratory shall calculate and plot the mean value, the warning limits (two standard deviations), and the corrective action limits (three standard deviations); and

ii. The laboratory shall record subsequent quality control results for each parameter, and compare the results against its control limits. The control limits shall be updated after a batch of 20 new measurements.

i. For analyses in the Clean Air Program, the laboratory shall utilize a test method that provides a detection limit that is appropriate and relevant for the intended use of the data. Detection limits shall be determined by the protocol in the mandated test method or in accordance with 40 CFR Part 136, Appendix B. If the protocol for determining detection limits is not specified, the selection of the procedure shall reflect instrument limitations and the intended application of the test method. A detection limit study is not required for any component for which spiking solutions are not available. All procedures shall be documented. Documentation shall include the matrix type. All supporting data shall be retained. The laboratory shall have established procedures to tie detection limits with quantitation limits.

i. The date of instrument installation;

ii. The date and a description of repairs, modifications, and preventive maintenance;

iii. The signature of the person performing the maintenance; and

iv. Chromatographic column information and installation date.

i. The manufacturer's name and lot number of reagent, date received, percent purity, name of chemical, concentrations if a solution;

ii. The identification number of the concentrated stock standard solution, date of preparation, expiration date, signature of the analyst who prepared the solution, all chemical compounds in the solution, purity, gross weight, tare weight, net weight, adjusted net weight (corrected for purity of primary standard) (only net weight and adjusted net weight are required when using balances with automatic tare features), dilution volume, and concentration in specified units;

iii. The identification number of the intermediate concentration standard solution (if needed), date of preparation, expiration date, signature of the analyst who prepared the solution, all chemical compounds in the solution, identification number of the concentrated stock, strength of concentrated stock, aliquot of concentrated stock, dilution volume, and final concentration in specified units; and

iv. The identification number of the working standard solution, date of preparation, expiration date, signature of the analyst who prepared the solution, all chemical compounds in the solution, identification number of the intermediate concentration standards, concentration of intermediate standards, aliquot volumes, dilution volumes, and final concentrations in specified units.