SECTION 252:307-9-60. Required records

  All required laboratory records must be written in a clear and unambiguous manner, be readily available for reference or inspection, and shall include:

(1)   Records of accreditation. The laboratory shall keep the following records on file at its main facility.

(A)   Scope of accreditation and the application on which it is based;

(B)   Copies of final reports and quality documents associated with reported data submitted to the DEQ or clients;

(C)   Internal audits and quality assurance plans; also

(D)   Each laboratory shall maintain on file the list of analytes for which it is accredited, and shall provide a copy of the list upon request.

(2)   Quality manual, which is addressed in 252:307-9-42;

(3)   Bench records. All raw data, whether hard copy or electronic data associated with testing, including analysts' worksheets and data output records (chromatograms, strip charts, and other instrument response readout records); date, time, analyst, method, amounts (volume and weights), clean up, separation protocols, incubation periods, calculations, sample matrix, and sample identification.

(4)   Calibration data. Calibration criteria, frequency and acceptance criteria including the curve or coefficient of the linear equation which describes the calibration curve; concentration/response data (or relative response data) for standards; percent recovery of all calibration checks (MRL, PSC initial) standard and the date it was analytically determined; percent recovery of the continuing calibration check standard; and laboratory sample identification of the samples run with the curve.

(5)   Sample history and associated data. All data is to be clearly and unambiguously documented so that all steps of the method are indicated. This shall include but is not limited to the following: Date, analyst, type of extraction or digestion for each sample, and laboratory sample identification.

(6)   Surrogate and tracer records. Surrogates or tracers, when required, are chosen to reflect the chemistries of the targeted components of the method and are added prior to sample preparation/extraction. The laboratory shall document the amount of surrogate or tracer spiked, percent recovery of each surrogate, date, analyst, and laboratory sample identification. The results are compared to the acceptance criteria as published in the method. If there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits.

(7)   Maintenance logs. Maintenance logs shall be kept for each instrument, to include dates and description of repairs, preventive maintenance, malfunctions, and other actions or events affecting performance. All instruments not in service must be tagged out of service. Maintenance logs shall also be kept for all devices that are necessary to support laboratory operations. These include, but are not limited to: balances, ovens, refrigerators, freezers, incubators, water baths, temperature measuring devices (including thermometers and thermistors), thermal/pressure sample preparation devices and volumetric dispensing devices (such as Eppendorf [Registered Trademark] or automatic dilutor/dispensing devices), if quantitative results are dependent on their accuracy, as in standard preparation and dispensing or dilution into a specified volume. Each balance shall be annually serviced and calibrated by a recognized accredited metrological service.

(8)   Corrective action procedures. Procedures for evaluating, documenting and reporting corrective action used for audits, PT failures, out-of-control situations and in response to enforcement actions.

(9)   Quality protocols. Procedures for monitoring the validity of the environmental testing and the resulting data shall be recorded in such a way that trends are detectable, and statistical techniques shall be applied to the reviewing of the results. All laboratories shall have documentation for positive and negative controls, variability, repeatability, and accuracy of the method.

(10)   Chain of custody and sample accession. Procedural plans for sample login, unique sample identification (all sample containers), date, time, source of sample (including name, location (location code) and sample matrix), preservative used, analysis required, name of collectors and any pertinent field data.

(11)   Spike duplicates and spike-duplicate data. The laboratory shall document procedures for determining the effect of the sample matrix on method performance. These procedures relate to the analyses of quality system matrix-specific quality control samples, and are designed as data quality indicators for a specific sample using the designated method. Information shall include but is not limited to: date, analyst, laboratory sample number, amount spiked, percent recovery, percent of difference, and makeup and concentration in the spiking solution.

(12)   Electronic data. All electronic data including security, software documentation and verification, software and hardware audits, backups, and records of any changes to automated data entries shall be preserved.

(13)   Sensitivity, LOD/LOQ. Procedures used for determining limits of detection and quantitation shall be documented. Documentation shall include the quality system matrix type. All supporting data shall be retained. LOQ shall be verified annually within the established control limits.

[Source: Added at 32 Ok Reg 961, eff 9-15-15]