(a) The Legislature finds and declares that it is the public policy of the state to ensure that Californiaâs laboratory standards, including its laboratory personnel standards, be sustained in order to provide accurate, reliable, and necessary test results. The Legislature further finds that inspections are the most effective means of furthering this policy. It is not the intent of the Legislature to reduce in any way the resources available to the department for inspections, but rather to provide the department with the greatest flexibility to concentrate its resources where they can be most effective. It is the intent of the Legislature to provide for an inspection process that includes state-based inspection components and that determines compliance with federal and state requirements for clinical laboratories. (b) The department shall employ, or contract for, inspectors, special agents, and investigators, and provide any clerical and technical assistance as necessary to administer this chapter and may incur other expenses as necessary. (c) Laboratories accredited by a private, nonprofit organization shall be deemed by the department to meet state licensure or registration requirements, and shall be issued a certificate of that deemed status by the department, provided that both of the following conditions are met: (1) The private, nonprofit organization meets all of the following requirements: (A) Is approved by the federal Center for Medicare and Medicaid Services as an accreditation body under CLIA and provides the department with the following information: (i) A detailed comparison of the individual accreditation or approval requirements, with the comparable condition-level requirements. (ii) A detailed description of its inspection process, including all of the following: (I) Frequency of inspections. (II) Copies of inspection forms. (III) Instructions and guidelines. (IV) A description of the review and decisionmaking process of inspections. (V) A statement concerning whether inspections are announced or unannounced. (VI) A description of the steps taken to monitor the correction of deficiencies. (iii) A description of the process for monitoring proficiency testing performance, including action to be taken in response to unsuccessful participation. (iv) A list of all of its current California licensed or registered laboratories and the expiration date of their accreditation, licensure, or registration, as applicable. (B) Is approved by the department as having accreditation standards that are equal to, or more stringent than, state requirements for licensure and registration. (C) Conducts inspections of clinical laboratories in a manner that will determine compliance with federal standards and California laws to the extent that California laws provide greater protection to residents, or are more stringent than federal standards, as determined by the department. Notwithstanding any other provision of law, the department may, without taking regulatory action pursuant to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, implement or interpret this section by means of an All Clinical Laboratories Letter (ACLL). The department shall post the ACLL on its Internet Web site so that any person may observe which California laws are more stringent than federal standards, and which accreditation bodies have been approved to conduct inspections. Public comment on the ACLL shall be accepted by the department for 30 days after posting and shall become final 45 days after the posting. Comments received shall be considered by the department. Nothing in this subdivision is intended to change existing statutory or regulatory requirements governing the operation of clinical laboratories or their personnel. (D) Is approved by the department as meeting the requirements of this paragraph. The department shall begin accepting applications for approval, in a form and manner prescribed by
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