§ 15730. Laboratory Quality Control (LQC) Samples.
4 CA ADC § 15730Barclays Official California Code of RegulationsEffective: November 7, 2022
Effective: November 7, 2022
4 CCR § 15730
§ 15730. Laboratory Quality Control (LQC) Samples.
The licensed laboratory shall use LQC samples and adhere to good laboratory practice (GLP) in the performance of each analysis according to the following specifications.
(b) The licensed laboratory shall use at least one negative control, one positive control, and one laboratory replicate sample in each analytical batch for each target organism during microbial testing. If one of the controls produces unexpected results, the samples shall be re-prepped and reanalyzed with a new set of controls.
Laboratory Quality Control Sample | Acceptance Criteria | Corrective Action |
---|
Positive control | Produces expected result, positive result | Re-prep and reanalyze the entire analytical batch, once. If problem persists, locate and remedy the source of unexpected result, then re-prep samples and reanalyze with a new set of controls. |
Negative control | Produces expected result, negative result | Re-prep and reanalyze the entire analytical batch, once. If problem persists, locate and remedy the source of unexpected result, then re-prep samples and reanalyze with a new set of controls. |
Laboratory replicate sample | Sample results must concur | Reanalyze sample and associated replicate sample once. If problem persists, re-prep samples and reanalyze. |
Laboratory Quality Control Sample | Acceptance Criteria | Corrective Action |
---|
Method blank sample | Not to exceed LOQ | Reanalyze entire analytical batch once. If method blank is still greater than the LOQ for any analyte, locate the source of contamination then re-prep samples and reanalyze. |
LCS | Percent recovery 70% to 130% | Reanalyze the entire analytical batch, once. If problem persists, re-prep samples and reanalyze or re-run the initial calibration curve. |
Laboratory replicate sample | RPD ≤30% | Reanalyze sample and associated replicate sample once. If problem persists, re-prep samples and reanalyze. |
Matrix spike sample | Percent recovery between 70% to 130% | Reanalyze sample and associated matrix spike sample once. If problem persists, re-prep samples and reanalyze. |
CCV | Percent recovery between 70% to 130% | Reanalyze all samples that followed the last CCV that met the acceptance criteria. If CCV still fails, re-run the initial calibration curve and all samples in the analytical sequence. |
(h) If any LQC sample produces a result outside of the acceptance criteria, the laboratory cannot report the result and the entire batch cannot be released for retail sale. The laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.
Credits
Note: Authority cited: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
History
1. Change without regulatory effect renumbering and amending former title 16, section 5730 to new title 4, section 15730 filed 7-14-2021 pursuant to section 100, title 1, California Code of Regulations (Register 2021, No. 29). For prior history of title 16, division 42, see Register 2019, No. 3.
2. Amendment filed 9-27-2021 as an emergency; operative 9-27-2021 (Register 2021, No. 40). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 3-28-2022 or emergency language will be repealed by operation of law on the following day.
3. Amendment refiled 3-28-2022 as an emergency; operative 3-28-2022 (Register 2022, No. 13). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 9-26-2022 or emergency language will be repealed by operation of law on the following day.
4. Certificate of Compliance as to 3-28-2022 order, including amendment of subsection (i), transmitted to OAL 9-26-2022 and filed 11-7-2022; amendments effective 11-7-2022 pursuant to Government Code section 11343.4(b)(3) (Register 2022, No. 45).
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 4, § 15730, 4 CA ADC § 15730
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