Section 64816.10 - Suspension or Revocation of Accreditation(a) Reasons for suspending or revoking accreditation may include: (1) A laboratory fails to maintain a quality system in accordance with Section 64802.05;(2) A laboratory fails to comply with the analytical method(s) listed on the laboratory's certificate of accreditation;(3) A laboratory fails to complete Proficiency Testing studies in accordance with Section 64802.15;(4) A laboratory fails to complete an on-site assessment in accordance with Section 64802.20;(5) A laboratory fails to respond to an on-site assessment report with a Corrective Action Plan in accordance with Section 64802.20;(6) A laboratory fails to implement the corrective actions detailed in the Corrective Action Plan within the required timeframe in accordance with Section 64802.20;(7) If, during an on-site assessment, ELAP determines that Suspension is necessary to protect public interest, safety or welfare;(8) A laboratory denies entry during normal business hours for either an announced or unannounced on-site assessment;(9) A laboratory fails to pay fees in accordance with Section 64802.25;(10) A laboratory fails to notify ELAP of changes in key accreditation criteria referenced in Section 64808.15(d), (e), and (f);(11) A laboratory fails to employ staff that meet the personnel qualifications in accordance with Section 64812.00;(12) A laboratory makes consistent errors in analyses or erroneous reporting;(13) A laboratory knowingly makes any false statement or representation pertinent to receiving or maintaining accreditation;(14) A laboratory knowingly makes any false statement or representation in an application, record, or other document;(15) A laboratory fails to notify ELAP of a change in ownership; and/or(16) A laboratory fails to comply with any other provision of these regulations.(b) A laboratory issued a notice of Suspension or Revocation may request a hearing within twenty days of notice pursuant to Health and Safety Code Sections 100910 and 100915.(c) If a laboratory's accreditation for a Field(s) of Accreditation is suspended, the laboratory shall: (1) Cease all reporting of results for Regulatory Purposes for the Field(s) of Accreditation that were suspended; and(2) Notify all Clients of the Suspension status within three (3) days of receiving notice of Suspension from ELAP. Notification shall be made by registered mail, email with return receipt, or electronic signature document.(d) To reinstate a suspended Field(s) of Accreditation, a laboratory shall submit an amendment application in accordance with Section 64808.15.(e) If a laboratory's accreditation has been revoked, the laboratory shall: (1) Discontinue use of all catalogs, advertising, business solicitations, proposals, quotations, or materials that contain reference to their past accreditation status;(2) Return its certificate of accreditation to ELAP;(3) Cease all reporting of results for Regulatory Purposes;(4) Notify all Clients of the Revocation status within three (3) days of receiving notice of Revocation from ELAP. Notification shall be made by registered mail, email with return receipt, or electronic signature document;(5) Provide ELAP with a list of Clients affected by the Revocation; and(6) Discontinue use of subcontracting agreements for Regulatory Purposes with laboratories within seven (7) days of receiving notice of Revocation from ELAP.(f) To obtain accreditation after Revocation, the laboratory shall apply for initial accreditation, in accordance with Section 64808.00, as if it were a new laboratory.Cal. Code Regs. Tit. 22, § 64816.10
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.) Note: Authority cited: Section 100830, Health and Safety Code. Reference: Sections 100905, 100910 and 100915, Health and Safety Code.
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.)