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§ 64814.00. Notification, Reporting, and Control of Records.

22 CA ADC § 64814.00BARCLAYS 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 6. Notification, Reporting, Records Retention, Change of Technical Manager or Ownership, and Trade Secrets
22 CCR § 64814.00
§ 64814.00. Notification, Reporting, and Control of Records.
(a) State Regulatory Agencies and federal agencies to whom data is reported may have notification, reporting, and record retention requirements that are in addition to requirements here, and it is the responsibility of the laboratories to know those additional regulatory requirements.
(b) If an analytical result warrants a Client notification, the notification shall occur after the Technical Manager or designee, set forth in the laboratory's Quality Manual, has approved of the result.
(c) A laboratory accredited to perform analyses on drinking water samples shall notify a water supplier's designated contact person:
(1) Immediately within 24 hours, when the following results are confirmed:
(A) The presence of total coliforms, fecal coliforms, or Escherichia coli (E. coli);
(B) A bacterial sample result is invalidated due to an interference as defined in Title 22, California Code of Regulations, Section 64425(b);
(C) A nitrate sample result exceeds the maximum contaminant level; or
(D) A chlorite sample result collected at the entry point of a water distribution system exceeds the maximum contaminant level.
(2) Immediately within 48 hours, when the following results are confirmed:
(A) A perchlorate sample result exceeds the maximum contaminant level;
(B) A chlorine dioxide sample result exceeds the maximum residual disinfectant level; or
(C) A chlorite sample result exceeds the maximum contaminant level.
(d) If a laboratory is unable to make direct contact with a water supplier's designated contact person within 24 hours in accordance with subdivision (c)(1) above, or within 48 hours in accordance with subdivision (c)(2) above, the laboratory shall immediately notify the State Water Board. If requested by the State Water Board, the laboratory shall provide a record of the time and method of attempts to contact the water supplier.
(e) If a water supplier is requesting that the State Water Board invalidate bacteriological sample(s) due to laboratory accident or error, as described in Title 22, California Code of Regulations, Section 64425(a)(2), the laboratory shall provide the water supplier with the following:
(1) A letter from the laboratory Technical Manager to the water supplier confirming the laboratory accident or error and agreeing to the invalidation request;
(2) Complete sample identification, laboratory sample log number (if used), date and time of collection, date and time of receipt by the laboratory, and date and time of analysis for the sample(s) in question;
(3) Complete description of the error alleged to have invalidated the result(s);
(4) Copies of all analytical, operational, and quality assurance records pertaining to the incident in question;
(5) Any observations noted by the laboratory personnel when receiving or analyzing the sample(s) in question; and
(6) A Corrective Action Plan that contains a Root Cause Analysis of the laboratory accident or error, the corrective actions that will take place, and the date the finding(s) will be corrected.
(f) When a laboratory subcontracts work:
(1) The subcontracting laboratory shall comply with 2016 TNI Standard - Revision 2.1, Volume 1, Module 2, Section 4.5, herein incorporated by reference; or
(2) The subcontracting laboratory shall comply with the following requirements:
(A) The subcontracting laboratory shall inform the customer(s) of arrangement with subcontractor(s);
(B) The subcontracting laboratory shall maintain a register of all subcontractors that are used for analytical testing;
(C) The subcontractor shall be accredited by ELAP in the Field(s) of Accreditation for analyses being performed for Regulatory Purposes;
(D) The subcontracting laboratory shall include the original of any report(s) prepared by the subcontractor; and
(E) The subcontracting laboratory shall provide the required notification in accordance with subdivision (c), above, unless there is an arrangement in writing that the subcontractor will provide the required notification.
(g) Subsection (f)(2), above, will be invalid three (3) years from the effective date of these regulations, at which time laboratories will be required to comply with subdivision (f)(1), above.
(h) A laboratory shall report to Clients:
(1) In accordance with 2016 TNI Standard - Revision 2.1, Volume 1, Module 2, Section 5.10, herein incorporated by reference; or
(2) In accordance with the request for analysis, the full and complete results of all requested contaminants and pollutants from the analyses of the sample or components thereof.
(i) Subsection (h)(2), above, will be invalid three (3) years from the effective date of these regulations, at which time laboratories will be required to comply with subdivision (h)(1), above.
(j) A laboratory performing bacteriological analyses on drinking water samples shall submit a bacterial monitoring report with bacteriological results to the State Water Board in accordance with Title 22, California Code of Regulations, Section 64423.1(c)(2) and (c)(3).
(k) A laboratory performing chemical, radiological, and microbiological analyses on drinking water samples in accordance with Title 22, California Code of Regulations, Division 4, Chapter 15, Domestic Water Quality and Monitoring, shall report analytical results to the State Water Board by the 10th day of the month following the month in which the analyses were completed. The results for chemical and radiological analyses shall be reported electronically using subdivision (k)(1) and the results for microbiological analyses may only be mailed or emailed to the State Water Board. Once the State Water Board notifies the laboratory that method (k)(2) is to be used for chemical, radiological, or microbiological analyses, the laboratory will have three (3) months from the date of notification to fully implement the reporting under that subdivision.
(1) Electronic Deliverable Format as defined in The Electronic Deliverable Format [EDF] Version 1.2i Guidelines & Restrictions dated April 2001 and Data Dictionary dated April 2001; or
(2) The California Laboratory Intake Portal (CLIP) using the EQEDD CASWRCB DDW data format with quality control elements related to individual sample results in PDF or electronic format.
(l) A laboratory performing chemical analyses on drinking water samples in accordance with Title 22, California Code of Regulations, Division 4, Chapter 15.5, Disinfectant Residuals, Disinfection Byproducts, and Disinfection Byproduct Precursors, and Chapter 17.5, Lead and Copper, or other required monitoring shall report analytical results directly to the State Water Board by the 10th day of the month following the month in which the analyses were completed. If the State Water Board is unable to accept results for these specific analytes electronically as set forth in subdivision (k), above, the results shall be submitted by hard copy or as otherwise directed by the State Water Board.
(m) A laboratory accredited for the analysis of pesticide residue in food shall verify the identity and concentration of a pesticide residue before reporting the results.
(n) A laboratory shall establish and maintain a system to control records:
(1) In accordance with 2016 TNI Standard - Revision 2.1, Volume 1, Module 2, Section 4.13, herein incorporated by reference; or
(2) That allows the history of the sample and associated data to be readily understood through the documentation. This system shall produce unequivocal, accurate records that document all laboratory activities such as laboratory facilities, equipment, analytical methods, and related laboratory activities, such as sample receipt, sample preparation, or data verification, and inter-laboratory transfers of samples and/or extracts. Records shall be retained for a minimum of five (5) years from generation of the last entry in the records.
(o) Subsection (n)(2), above, will be invalid three (3) years from the effective date of these regulations, at which time laboratories will be required to comply with subdivision (n)(1), above.
Note: Authority cited: Section 100827, Health and Safety Code. Reference: Sections 100827, 100886 and 116385, Health and Safety Code.
HISTORY
1. Amendment of article heading, repealer of former article 6 (section 64813), new article 6 (sections 64814.00-64814.10) and new section filed 11-19-2020; operative 1-1-2021 (Register 2020, No. 47). (Filing deadline specified in Government Code section 11349.3(a) extended by 60 calendar days pursuant to Executive Order N-40-20.)
This database is current through 9/3/21 Register 2021, No. 36
22 CCR § 64814.00, 22 CA ADC § 64814.00
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