Cal. Code Regs. tit. 4 § 15730

Current through Register 2024 Notice Reg. No. 49, December 6, 2024

Section 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.

(a) The licensed laboratory shall analyze LQC samples in the same manner as the laboratory analyzes cannabis and cannabis products samples.

(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.

(c) If the result of the microbial analyses is outside the specified acceptance criteria in the following table, the licensed laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.

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.

(d) The licensed laboratory shall prepare and analyze at least one of each of the following LQC samples for each analytical batch:

(1) Method blank;

(2) Laboratory control sample (LCS); and

(3) Laboratory replicate sample or matrix spike sample.

(e) The laboratory shall analyze, at minimum, a continuing calibration verification (CCV) sample at the beginning of each analytical sequence and every 10 samples thereafter.

(f) If the result of the chemical analyses is outside the specified acceptance criteria in the following table, the laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.

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 [LESS THAN EQUAL TO]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.

(g) If any analyte is detected above any action level, as described in this chapter, the sample shall be re-prepped and reanalyzed in replicate within another analytical batch.

(1) For quantitative analyses, the re-prepped sample and its associated replicate must meet the acceptance criteria of RPD [LESS THAN EQUAL TO]30%.

(2) For qualitative analyses, the re-prepped sample and its associated replicate results must concur.

(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.

(i) If the licensed laboratory determines that the result is a false-positive or a false-negative, the Department may ask for the laboratory to re-sample or retest.

(j) The licensed laboratory shall compile and generate one LQC sample report for each analytical batch that includes LQC acceptance criteria, measurements, analysis date, and matrix.

Cal. Code Regs. Tit. 4, § 15730

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).

Note: Authority cited: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.

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).