(a)
(1)Each clinical laboratory shall maintain records, equipment, and facilities that are adequate and appropriate for the services rendered.
(2)
(A)Except for tests or examinations classified as waived under CLIA, each clinical laboratory shall enroll, and demonstrate successful participation, as defined under CLIA, for each specialty and subspecialty in which it performs clinical laboratory tests or examinations, in a proficiency testing program approved by the department or by HCFA, to the same extent as required by CLIA in Subpart H (commencing with Section 493.801) of Title 42 of the Code of Federal Regulations. This requirement
shall not be interpreted to prohibit a clinical laboratory from performing clinical laboratory tests or examinations in a specialty or subspecialty f
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(a)
(1)
Each clinical laboratory shall maintain records, equipment, and facilities that are adequate and appropriate for the services rendered.
(2)
(A)
Except for tests or examinations classified as waived under CLIA, each clinical laboratory shall enroll, and demonstrate successful participation, as defined under CLIA, for each specialty and subspecialty in which it performs clinical laboratory tests or examinations, in a proficiency testing program approved by the department or by HCFA, to the same extent as required by CLIA in Subpart H (commencing with Section 493.801) of Title 42 of the Code of Federal Regulations. This requirement
shall not be interpreted to prohibit a clinical laboratory from performing clinical laboratory tests or examinations in a specialty or subspecialty for which there is no department or HCFA approved proficiency testing program.
(B)
Each clinical laboratory shall authorize its proficiency test results to be reported to the department in an electronic format that is compatible with the department’s proficiency testing data monitoring system and shall authorize the release of proficiency tests results to the public to the same extent required by CLIA.
(b)
Each clinical laboratory shall be conducted, maintained, and operated without injury to the public health.
(c)
(1)
The department shall conduct inspections of licensed clinical laboratories no less than once every two years. The department shall
maintain a record of those inspections and shall ensure that every licensed clinical laboratory in California is inspected at least that often.
(2)
Registered clinical laboratories shall not be routinely inspected by the department.
(3)
The department shall conduct an investigation of complaints received concerning any clinical laboratory, which may include an inspection of the laboratory.
(4)
Each licensed or registered clinical laboratory shall be subject to inspections by HCFA or HCFA agents, as defined by CLIA, as a condition of licensure or registration.
(d)
(1)
Each clinical laboratory shall perform all clinical laboratory tests or examinations classified as waived under CLIA in conformity with the manufacturer’s
instructions.
(2)
Except for those clinical laboratories performing only tests or examinations classified as waived under CLIA, each clinical laboratory shall establish and maintain all of the following:
(A)
A patient test management system that meets the standards of CLIA in Subpart J (commencing with Section 493.1100) of Title 42 of the Code of Federal Regulations.
(B)
A quality control program that meets the requirements of CLIA in Subpart K (commencing with Section 493.1200) of Title 42 of the Code of Federal Regulations as in effect on January 1, 2015, and that may include the clinical laboratory’s use of the following alternative quality control testing procedures recognized by the federal Centers for Medicare and Medicaid Services (CMS):
(i)
Until December 31, 2015, equivalent quality control procedures.
(ii)
Commencing January 1, 2016, an Individualized Quality Control Plan, as incorporated in Appendix C of the State Operations Manual adopted by CMS.
(C)
A comprehensive quality assurance program that meets the standards of CLIA in Subpart P (commencing with Section 493.1701) of Title 42 of the Code of Federal Regulations.