Chapter 6. TESTING LABORATORIES Article 1. Chapter Definitions: § 5700. Definitions In addition to the definitions in section 5000 of this division, the following definitions apply to this chapter. (a) “Acceptance criteria” means the specified limits placed on the characteristics of an item or method that are used to determine data quality. (b) “Accredited college or university” means a college or university accredited by a regional or national accrediting agency that is an accreditor recognized by the Secretary of the US Department of Education. (c) “Accreditation body” means an impartial non-profit organization that operates in conformance with the International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) standard 17011 and is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) for Testing. (d) “Action level” means the threshold value that provides the criterion for determining whether a sample passes or fails an analytical test. (e) “Analyte” means a chemical, compound, element, bacteria, yeast, fungus, or toxin to be identified or measured. (f) “Analytical batch” means a group of samples that is prepared together for the same analysis and analyzed sequentially using the same instrument calibration curve and that have common analytical quality control checks. (g) “Analytical method” means a technique used qualitatively or quantitatively to determine the composition of a sample or a microbial contamination of a sample. (h) “Cannabinoid” means a (y) “ISO/IEC 17025” means the general requirements specified by the ISO/IEC for the competence of testing and calibration laboratories. (z) “ISO/IEC 17034” means the general requirements established by the ISO/IEC for the competence of reference material producers. (aa) “ISO/IEC 17043” means the general requirements established by the ISO/IEC for proficiency testing. (bb) “Laboratory” means “testing laboratory” as defined at Business and Professions Code section 26001(as). (cc) “Laboratory replicate sample” means a duplicate sample of the representative sample used for quality control purposes to demonstrate reproducibility. It is prepared in the identical manner as the representative sample and analyzed separately from the representative sample. (dd) “Laboratory quality assurance” means the set of operating principles that enable laboratories to produce defensible data of known accuracy and precision and includes employee training, equipment preventative maintenance procedures, calibration procedures, and quality control testing, among other things. (ee) “Limit of detection” means the lowest quantity of a substance or analyte that can be distinguished from the absence of that substance within a stated confidence limit. (ff) “Limit of quantitation” means the minimum concentration of an analyte in a specific matrix that can be reliably quantified while also meeting predefined goals for bias and imprecision. (gg) “Matrix” means the substances that are present in a sample except for the analyte(s) of interest. (hh) “Matrix spike duplicate” means the duplicate sample of the matrix spike sample that is prepared by adding a known quantity of a target analyte to a sample matrix or to a matrix that is as closely representative of the matrix being analyzed as possible. (ii) “Matrix spike sample” means a sample prepared by adding a known quantity of the target analyte to a sample matrix or to a matrix that is as closely representative of the matrix being analyzed as possible. (jj) “Method blank” means an analyte free matrix to which all reagents are added in the same volumes or proportions as used in the sample preparation. (kk) “Moisture content” means the percentage of water in a sample, by weight. (ll) “Non-target organism” means an organism that the test method or analytical procedure is not testing for and can be used in evaluating the specificity of a test method. (mm) “Percent recovery” means the percentage of a measured concentration relative to the added (spiked) concentration in a reference material, matrix spike sample, or matrix spike duplicate. A laboratory shall calculate the percent recovery by dividing the sample result by the expected result then multiplying the quotient by 100. (nn) “Practical experience” means experience performing scientific analytical tests in a laboratory setting using equipment, instruments, kits, and materials routinely found in a laboratory. Practical experience includes experience in any type of laboratory setting and is not limited to cannabis-specific laboratories. (oo) “Proficiency test” means an evaluation of a laboratory’s performance against preestablished criteria by means of interlaboratory comparisons of test measurements. (pp) “Proficiency test sample” means a sample that is prepared by a party independent of the testing laboratory with the ISO/IEC 17043 accreditation, where the concentration and identity of an analyte that is known to the independent party, but is unknown to the testing laboratory and testing laboratory employees. (qq) “Quality control” means the set of measures implemented within an analytical procedure to ensure that the measurement system is operating in a state of statistical control for which errors have been reduced to acceptable levels. (rr) “Quality control sample” means a sample that is produced and used by a laboratory for the purpose of assuring the quality of the data and results. Quality control samples include blank samples, matrix spike samples, field duplicate samples, replicate samples, and reference material samples. (ss) “Reagent” means a compound or mixture added to a system to cause a chemical reaction or test if a reaction occurs. A reagent may be used to tell whether a specific chemical substance is present by causing a reaction to occur with the chemical substance. (tt) “Reference material” means material containing a known concentration of an analyte of interest that is in solution or in a homogeneous matrix. (uu) “Reference method” means the method by which the performance of an alternate method is measured or evaluated. (vv) “Relative percent difference” means the comparative statistic that is used to calculate precision or random error. RPD is calculated using the following equation: RPD = │ (representative sample measurement – duplicate sample measurement) │ / ([representative sample measurement + duplicate sample measurement] / 2) × 100% (ww) “Relative standard deviation” means the standard deviation expressed as a percentage of the means recovery. RSD is calculated using the following equation: RSD = (s / x) × 100%; where s = standard deviation and x = mean (xx) “Representative” means a small quantity of the batch whose characteristics represent, as accurately as possible, the entire batch, thus allowing the results to be generalized. (yy) “Requester” means the person who submits a request to the laboratory for testing of cannabis or cannabis product from an entity licensed under this division. (zz) “Sample” means a representative part of, or a single item from, a batch which is comprised of several sample increments. (aaa) “Sampler” means the laboratory employee responsible for obtaining samples of cannabis or cannabis product from a distributor. (bbb) “Sanitize” means to sterilize, disinfect, or make hygienic. (ccc) “Scope of accreditation” means the tests or types of tests performed, materials or products tested, and the methods used for testing cannabis or cannabis products for which the accreditation has been granted. (ddd) “Tamper-evident” means a one-time-use security tape or seal that is affixed to the opening of a package, allowing a person to recognize whether the package has been opened. (eee) “Target organism” means an organism that is being tested for in an analytical procedure or test method. (fff) “THC” and “delta-9 THC” means tetrahydrocannabinol, CAS number 1972-08-3. (ggg) “THCA” means tetrahydrocannabinolic acid, CAS number 23978-85-0. (hhh) “Validation” means the confirmation by examination and objective evidence that the requirements for a specific intended use or analytical method are fulfilled. (iii) “Water activity” means the measure of the quantity of water in a product that is available and therefore capable of supporting bacteria, yeasts, and fungi and which is reported in units Aw. Authority: Section 26013, Business and Professions Code. Reference: Sections 26013 and 26100, Business and Professions Code