(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. (1) The private, nonprofit organization meets all of the following requirements:

   1. (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:

      1. (i) A detailed comparison of the individual accreditation or approval requirements, with the comparable condition-level requirements.

      2. (ii) A detailed description of its inspection process, including all of the following:

         1. (I) Frequency of inspections.
         2. (II) Copies of inspection forms.
         3. (III) Instructions and guidelines.
         4. (IV) A description of the review and decisionmaking process of inspections.
         5. (V) A statement concerning whether inspections are announced or unannounced.
         6. (VI) A description of the steps taken to monitor the correction of deficiencies.
      3. (iii) A description of the process for monitoring proficiency testing performance, including action to be taken in response to unsuccessful participation.
      4. (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.
   2. (B) Is approved by the department as having accreditation standards that are equal to, or more stringent than, state requirements for licensure and registration.
   3. (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.
   4. (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 the department, by January 1, 2011. The department shall make a determination on an application submitted pursuant to this subparagraph within 180 days of receiving the application.

2. (2) The laboratory meets all of the following requirements:

   1. (A) Meets the accreditation standards of the private, nonprofit organization.
   2. (B) Agrees to permit the private, nonprofit organization to provide any records or other information to the department, its agents, or contractors, as the department may require.
   3. (C) Pays the applicable fees required under Section 1300.
   4. (D) Authorizes its proficiency testing organization to furnish to the department and the private, nonprofit organization the results of the laboratory’s participation in an approved proficiency testing program, as defined in 42 C.F.R. 493.2, for the purpose of monitoring the laboratory’s proficiency testing, along with explanatory information needed to interpret the proficiency testing results, upon request of the department.
   5. (E) Authorizes the private, nonprofit organization to release to the department a notification of every violation of condition-level requirements, including the actions taken by the organization as a result of the violation, within 30 days of the initiation of the action.
   6. (F) Authorizes the private, nonprofit organization to give notice to the department of any withdrawal of the laboratory’s accreditation.