Cal. Code Regs. tit. 17 § 1066

Current through Register 2024 Notice Reg. No. 24, June 14, 2024

Section 1066 - Condition Level Requirements

(a) Any requirement specified in subsections (b) through (i) shall constitute a condition level requirement.

(b) Each clinical laboratory performing clinical laboratory tests or examinations classified as of moderate or of high complexity under CLIA shall obtain and maintain a valid clinical laboratory license issued pursuant to section 1265 of the Business and Professions Code.

(c) Each clinical laboratory shall employ:

(1) A sufficient number of laboratory personnel with the appropriate education and either experience or training to:

(A) Provide appropriate direction, supervision and consultation;

(B) Accurately perform tests; and

(C) Report test results.

(2) Laboratory personnel who meet the personnel qualifications, duties, and responsibilities required in CLIA and sections 1203, 1204, 1206.5, 1207, 1209, 1209.1, 1210, 1270 and 1271 of the Business and Professions Code.

(d) Each clinical laboratory shall:

(1) Enroll in a proficiency testing program approved by the department or by the United States Health Care Financing Administration if required to enroll under Business and Professions Code section 1220(a)(2)(A); and if required to enroll, demonstrate successful participation, as defined under CLIA, for each specialty and subspecialty in which it performs clinical laboratory tests or examinations, to the same extent as required under CLIA,

(2) 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

(3) Authorize the release of proficiency tests results to the public to the same extent required by CLIA.

(e) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(A) shall establish and maintain a patient test management system that meets the standards of CLIA;

(f) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(B) shall:

(1) Establish and maintain a quality control program that meets the requirements of CLIA,

(2) Perform all clinical laboratory tests or examinations classified as waived under CLIA in conformity with the manufacturer's instructions.

(g) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(C) shall:

(1) Establish and maintain a comprehensive quality assurance program that meets the standards of CLIA,

(2) Maintain records, equipment, and facilities that are adequate and appropriate for the services rendered,

(3) Be conducted, maintained and operated without injury to the public health, and

(4) If providing cytology services and its licensee ceases operation, preserve

(A) Records,

(B) Reports,

(C) Cytology slides, and

(D) Cell blocks as prescribed in subdivision (g) of section 1271 and section 1274 of the Business and Professions Code.

(h) Each licensed or registered clinical laboratory shall submit to the inspections identified in Business and Professions Code section 1220, which inspections may be conducted by department employees or contractors, or the United States Health Care Financing Administration (HCFA), or HCFA agents. The department may conduct announced or unannounced inspections of any premises, building, equipment, materials, records, or information at any reasonable time to secure compliance with, or prevent a violation of chapter 3 of division 2 of the B&P Code. A clinical laboratory shall permit, as part of this inspection, the department or its contractors or agents to:

(1) Inspect, photograph, or copy any records, reports, test results, test specimens, or other information related to the requirements of chapter 3 of division 2 of the Business and Professions Code or the regulations adopted pursuant thereto. (The laboratory shall make all records and data accessible and retrievable within a reasonable time frame during the course of the inspection.);

(2) Secure any sample, photograph, or other evidence from any building or premises for the purpose of enforcing chapter 3 of division 2 of the Business and Professions Code or the regulations adopted pursuant thereto;

(3) Observe laboratory personnel performing tests (including proficiency testing), data analysis and reporting;

(4) Interview all personnel of the clinical laboratory concerning compliance with chapter 3 of division 2 of the Business and Professions Code and the regulations adopted thereunder;

(5) Upon request, review all information and data necessary to:

(A) Determine that testing is being performed or the laboratory is being operated in a manner that does not constitute an imminent and serious risk to public health;

(B) Evaluate complaints from the public; and

(C) Determine whether or not the laboratory is performing tests without a license or registration applicable to the category of tests or examinations being performed; and

(6) Provide copies to the department or its contractors or agents of all records and data required under chapter 3 of division 2 of the Business and Professions Code and the regulations adopted thereunder.

(i) Each laboratory shall comply with the requirements identified as "conditions" in subparts G through P of CLIA.

Cal. Code Regs. Tit. 17, § 1066

1. New section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.
2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, Chapter 510, Section 1. Reference: Statutes 1995, Chapter 510, Section 1; and Sections 1203, 1204, 1206.5, 1207, 1209, 1209.1, 1210, 1220, 1223, 1225 and 1265, Business and Professions Code.