(a)The Legislature finds and declares that it is the public policy of the state to ensure that California’s 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
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(a)
The Legislature finds and declares that it is the public policy of the state to ensure that California’s 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 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)
The laboratory meets all of the following requirements:
(A)
Meets the accreditation standards of the private, nonprofit organization.
(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.
(C)
Pays the
applicable fees required under Section 1300.
(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.
(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.
(F)
Authorizes the private, nonprofit organization to give notice to the
department of any withdrawal of the laboratory’s accreditation.
(d)
If the private, nonprofit organization described in subdivision (c) has withdrawn or revoked its accreditation of a laboratory, the laboratory shall retain its certificate of deemed status issued pursuant to subdivision (c) for 45 days after the laboratory receives notice of the withdrawal or revocation of the accreditation, or the effective date of any action taken by the department, whichever is earlier.
(e)
A certificate of deemed status issued pursuant to subdivision (c) shall be renewed annually provided that the conditions for issuance specified in subdivision (c) are still met. Except as authorized
under subdivision (f), the department shall not conduct routine inspections of a laboratory issued a certificate of deemed status pursuant to subdivision (c). Each application for a certificate of deemed status issued under subdivision (c) and each request for renewal of that certificate shall be accompanied by the fees set forth in Section 1300. The total of those certificate application and renewal fees collected by the department shall be sufficient to cover the cost of issuing the certificate. If the department determines that those certificate fees do not fully support the costs of these activities, it shall report that determination to the Legislature.
(f)
Nothing in this section shall be construed to prohibit the exercise of the department’s authority to conduct complaint investigations, sample validation inspections, or require submission of proficiency testing results to the department to ensure compliance of any clinical laboratory
with state standards.