(a) When a certificate of accreditation is amended, the period of accreditation shall be the time remaining on the certificate of accreditation from the date it was amended.
(b) To amend accreditation, a laboratory shall:
(1) Submit an amendment application package;
(2) Pay the required fee in accordance with Section 64802.25.
(c) A laboratory shall submit an amendment application package for the following reasons:
(1) Change in laboratory name, except if the change in laboratory name is in connection with a sale or transfer of ownership, then the laboratory shall comply with Section 64814.05;
(2) Change in laboratory location;
(3) Addition of a satellite laboratory or mobile laboratory to the existing accreditation; or
(4) Addition or reinstatement of Field(s) of Accreditation to the laboratory's current certificate of accreditation.
(d) Amendments to a laboratory's accreditation are not accepted in the renewal application package. A separate amendment application package shall be submitted to amend accreditation.
(e) A laboratory applying for a change in laboratory name shall submit an amendment application package that includes the following:
(1) Existing name of the laboratory;
(2) Certificate number of the laboratory;
(3) Address of the laboratory;
(4) Proposed new name of the laboratory;
(5) Signature of the laboratory Owner, Owner's Agent, or officer; and
(6) Signature date.
(f) A laboratory applying for a change in laboratory location shall:
(1) Within thirty (30) days prior to the change of location, submit a relocation plan to ELAP that includes the following laboratory identifying information:
(A) Name of the laboratory;
(B) Certificate number of the laboratory;
(C) Existing address of the laboratory;
(D) Address of the new location;
(E) Description of the new location;
(F) Timeline of the change in location;
(G) Signature of the laboratory Owner, Owner's Agent, or officer; and
(H) Signature date;
(2) During the change in location, the laboratory shall:
(A) Comply with quality system requirements at the new location, in accordance with Section 64802.05; and
(B) Cease reporting data for Regulatory Purposes at the old location once the new location is reporting data for Regulatory Purposes;
(3) Within ninety (90) days after the change of location, submit an amendment application package that includes the following:
(A) Laboratory identifying information, which includes:
(i) Name of the laboratory;
(ii) Certificate number of the laboratory;
(iii) Existing or previous address of the laboratory;
(iv) New address of the laboratory;
(v) Description of the new location;
(vi) Signature of the laboratory Owner, Owner's Agent, or officer; and
(vii) Signature date;
(B) A copy of the laboratory Quality Manual, with updates necessitated by the change of location;
(C) A copy of new or revised standard operating procedure(s) necessitated by the change of location;
(D) Proficiency Testing report(s) with Acceptable Scores for the Field(s) of Accreditation for which the laboratory is requesting accreditation, whereby analysis occurred at the new location; and
(E) A completed on-site assessment report from ELAP or a third-party Assessment Agency, including all findings and approved Corrective Action Plan for each Field of Accreditation for which accreditation is requested in accordance with Section 64802.20, whereby the assessment occurred at the new location;
(g) A laboratory applying to add a satellite or mobile laboratory to an existing accreditation shall:
(1) Prior to applying, ensure the laboratory meets the criteria for a satellite laboratory or mobile laboratory in accordance with Sections 64810.05 and 64810.10, respectively;
(2) Submit an amendment application package that includes the following:
(A) Laboratory identifying Information including:
(i) Name of the laboratory;
(ii) Details on the laboratory's type, size, location, business entity type, contact information and ownership;
(iii) Name and qualifications of the Technical Manager(s), including copies of applicable degrees and/or Laboratory Analyst/Water Quality Analyst Certificates from CWEA or CA-NV/AWWA;
(iv) Name of the Quality Manager, if applicable;
(v) Agreement to comply with applicable ELAP statutes and regulations;
(vi) Signature of the laboratory Owner, Owner's Agent, or officer; and
(vii) Signature date;
(B) Signed and populated Field(s) of Accreditation tables for which the satellite laboratory or mobile laboratory is requesting accreditation;
(C) Proficiency Testing report(s) with Acceptable Scores for each Field of Accreditation for which the satellite laboratory or mobile laboratory is requesting accreditation, whereby analysis occurred at the satellite or mobile laboratory; and
(D) A completed on-site assessment report from ELAP or a third-party Assessment Agency, including all findings and approved Corrective Action Plan for each Field of Accreditation for which accreditation is requested in accordance with Section 64802.20, whereby the assessment occurred at the new laboratory;
(3) Pay the required fee in accordance with section 64802.25.
(h) A laboratory applying to add or reinstate Field(s) of Accreditation shall submit an amendment application package that includes the following:
(1) Laboratory identification information including:
(A) Name of the laboratory;
(B) Certificate number of the laboratory; and
(C) Address of the laboratory;
(2) Signed and populated Field(s) of Accreditation tables for which accreditation is being amended;
(3) A copy of the laboratory Quality Manual, with updates necessitated by the addition of Field(s) of Accreditation;
(4) Proficiency Testing report(s) with Acceptable Scores for each Field of Accreditation for which the laboratory is requesting to add; and
(5) A completed on-site assessment report from ELAP or a third-party Assessment Agency, including all findings and approved Corrective Action Plan for each Field of Accreditation for which accreditation is requested in accordance with Section 64802.20.
(i) The on-site assessment requirement for an amendment accreditation package may be waived if ELAP determines the amendment to accreditation would not affect the quality of the data.
(j) A laboratory is not required to submit an amendment application to remove Field(s) of Accreditation but may request an amended certificate of accreditation to remove Field(s) of Accreditation by submitting a written request to ELAP. Once a laboratory requests an amended certificate of accreditation, the laboratory shall cease reporting results for Regulatory Purposes of all removed Field(s) of Accreditation.
Credits
Note: Authority cited: Sections 100829 and 100830, Health and Safety Code. Reference: Sections 100825, 100840, 100845, 100850 and 100870, Health and Safety Code.
History
1. 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 5/10/24 Register 2024, No. 19.
