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§ 64809. Performance Evaluation Testing.

22 CA ADC § 64809BARCLAYS OFFICIAL CALIFORNIA CODE OF REGULATIONS

Barclays Official California Code of Regulations Currentness
Title 22. Social Security
Division 4. Environmental Health
Chapter 19. Certification of Environmental Laboratories
Article 5. Performance Evaluation Testing Process
22 CCR § 64809
§ 64809. Performance Evaluation Testing.
(a) No laboratory shall be certified to perform analyses in any Subgroup of any Field(s) of Testing as identified in Section 64823 unless the laboratory has submitted results for the analysis of performance evaluation sample study set(s) (where performance evaluation sample study set(s) exist) in each Subgroup within each Field of Testing for which certification is requested, and the results for the testing of the study set are in agreement with the criteria established below:
(1) within the 99% confidence limit of the mean computed by the Department for the collection of results received for the performance evaluation sample set for the following Subgroups: detection of total coliform or fecal coliform organisms in wastewater by Multiple Tube Fermentation technics; detection of total coliform or fecal coliform organisms in wastewater by Membrane Filter technics; Heterotrophic Plate Count technics; Fecal streptococci and Enterococci by Multiple Tube Fermentation technics; Fecal streptococci and Enterococci by Membrane Filter technics of Field of Testing 1; all Subgroups in Fields of Testing 6, 9, 10, 12, 13, 16, 17, 18, and 19;
(2) positive/negative, present/absent, above/below, or other similar discrete response when the only result possible from a test is a discrete response for the following Subgroups in Field of Testing 1: detection of total coliform, fecal coliform, or Escherichia coli (E. coli) organisms in drinking water by Multiple Tube Fermentation technics; detection of total coliform, fecal coliform, or Escherichia coli (E. coli) organisms in drinking water by Membrane Filter technics; detection of total coliform, fecal coliform, or Escherichia coli (E. coli) organisms in drinking water by use of Clark's Presence/Absence medium; detection of both total coliforms and Escherichia coli (E. coli) organisms in drinking water by the Minimal Medium ortho-nitrophenyl-beta-D-galactopyranoside - 4-methylumbelliferyl-beta-D-glucuronide (MMO-MUG) technics;
(3) for all Subgroups in Field of Testing 8: within the 99% confidence limit of the mean computed by the Department from the collection of results received for the performance evaluation sample set, or within the 95th percentile of a distribution of non-normal values. The choice determined by the Department through the application of standard tests that determine the normalcy of data;
(4) within the 95% confidence limit of the mean computed by the Department from the collection of results received for the performance evaluation sample set for the following Subgroups: alkalinity, calcium, chloride, corrosivity, hardness, magnesium, MBAS, sodium, sulfate, total filterable residue and conductivity, iron (colorimetric methods only), manganese (colorimetric methods only), and ortho phosphate in Field of Testing 2; asbestos in Field of Testing 3;
(5) within a given percentage of a known or true value for the following Subgroups: cyanide, fluoride, nitrate and nitrite in Field of Testing 2; all Subgroups in Field of Testing 3, except asbestos; all Subgroups in Fields of Testing 4, 5, 20, 21, and 22.
(b) Each performance evaluation sample study set shall state the method of evaluation that shall be utilized to score results for that performance evaluation sample study set, and which requirements identified in (a) above, or (c) below must be met by the laboratory.
(c) If a performance evaluation sample study set contains one or more analytes that may be analyzed by a single test method that the Department recognizes and certifies as a Subgroup of a Field of Testing, the results shall meet one of the following:
(1) when 6 or fewer analytes are in the performance evaluation sample study set, all analytes are within the stated acceptance limits; or
(2) when more than 6 analytes are in the performance evaluation sample study set, eighty-five point zero percent (85.0%) of the analytes are within the stated acceptance limits.
(d) If a laboratory fails to submit results for the analysis of performance evaluation sample study sets, which meet the above requirements, the laboratory may, within 30 days, request that it be given a second, successive attempt to submit such results. Failure of a laboratory to submit results for the analysis of performance evaluation sample study sets meeting the requirements of (a) or (c) within 6 months from the date of receipt by the Department of the laboratory's application for certification, or of its request for the addition of one or more Subgroups within a Field(s) of Testing shall result in the denial of the application or request.
(e) With the exception of Field of Testing 6, a certified laboratory shall, within 12 months from the date of certification, participate in at least one performance evaluation sample study set (where performance evaluation sample study set(s) exist) for each Subgroup within each Field of Testing as identified in Section 64823 for which certification is held. If the results from the study do not meet the requirements of (a) or (c), the laboratory shall be provided a second, successive attempt to submit such results. Irrespective of whether a second, successive attempt is provided, results meeting the requirements of (a) or (c) must be submitted by a certified laboratory to the Department at least 90 days prior to the expiration of its certificate or the laboratory's certificate may be restricted under Health and Safety Code, Section 1015(c).
(f) Laboratories holding certification in any Subgroup within Field of Testing 6 shall participate in all available performance evaluation test samples provided through the Environmental Protection Agency's Environmental Monitoring and Support Laboratory, Las Vegas inter-comparison cross check and performance evaluation studies. The laboratory must successfully complete a minimum of two inter-comparison cross check studies and one performance evaluation study each annual period from the date of certification. Failure to do so may be used by the Department as grounds for restricting the laboratory's certificate under Health and Safety Code, Section 1015(c).
(g) Laboratories seeking or holding certification in any Subgroup within Field of Testing 11 are exempt from compliance with the requirements of Health and Safety Code, Section 1015(b)(1).
Note: Authority cited: Sections 208, 1011 and 1012, Heath and Safety Code. Reference: Sections 1015, 1017 and 1019, Health and Safety Code.
HISTORY
1. New article 5 and section filed 12-2-94; operative 12-2-94 pursuant to Government Code section 11346.2(d) (Register 94, No. 48).
This database is current through 5/10/19 Register 2019, No. 19
22 CCR § 64809, 22 CA ADC § 64809
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