2005 California Business and Professions Code Sections 1220-1228 Article 2. Administration and RegulationBUSINESS AND PROFESSIONS CODE
1220. (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 493.1101) 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 493.1201) of Title 42 of the Code of Federal Regulations. (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. 1220.5. (a) The Department of Health Services shall develop, and provide to all licensed clinical laboratories, a form in triplicate to be used by employees, agents, and couriers of licensed clinical laboratories to give notice when a specimen storage container has been improperly secured pursuant to Section 681. (b) The three copies of the triplicate form shall each contain instructions so that one copy is to be attached to the unlocked specimen storage container, one copy is mailed to the Department of Consumer Affairs to be forwarded to the appropriate licensing entity pursuant to Section 1288.3, and one copy is kept by the licensed clinical laboratory for its records. (c) This form shall be provided to all licensed clinical laboratories on and after January 1, 2001. 1221. The department may employ special examiners, and may make regulations for the conduct of examinations under this chapter. 1222. The department may approve schools that are accredited by the National Accrediting Agency for Clinical Laboratory Sciences. 1222.5. The department may approve schools seeking to provide instruction in clinical laboratory technic which in the judgment of the department will provide instruction adequate to prepare individuals to meet the requirements for licensure or performance of duties under this chapter and regulations of the department. The department shall establish by regulation the ratio of licensed clinical laboratory scientists to licensed trainees on the staff of the laboratory approved as a school and the minimum requirements for training in any specialty or in the entire field of clinical laboratory science or practice. Application for approval shall be made on forms provided by the department. 1223. (a) 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. (b) 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 accreditation 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 HCFA as an accreditation body under CLIA. (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) Agrees to permit the department or its agents or contractors to conduct random inspections of clinical laboratories accredited by it in order to validate compliance with California law. (2) The laboratory meets both 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) A certificate of accreditation shall be renewed annually provided that the conditions for issuance specified in subdivision (b) are still met. Each application for a certificate of accreditation and each request for renewal shall be accompanied by the fees set forth in Section 1300. The total of certificate of accreditation application and renewal fees collected by the department shall be sufficient to cover the cost of issuing the certificate of accreditation, the collection of fees, the administrative costs associated with evaluating programs of private, nonprofit organizations, and the costs to conduct sample validation surveys of accredited laboratories. If the department determines that the certificate of accreditation fees do not fully support the costs of these activities, it shall report that determination to the Legislature. 1224. The department may, pursuant to Chapter 3.5 (commencing with Section 11340) of Division 3 of Title 2 of the Government Code, adopt, amend, or repeal any regulations necessary for the administration or enforcement of this chapter. 1224.5. The department shall conduct a study to determine whether the persons conducting tests in physician office laboratories under paragraph (12) of subdivision (b) of, and paragraph (10) of subdivision (c) of Section 1206.5, produce accurate, reliable, and necessary test results comparable to those produced by other persons performing moderate complexity or high complexity testing, or both. 1225. (a) In order to carry out this chapter, any duly authorized representative of the department may do any of the following: (1) Enter or inspect on an announced or unannounced basis any building, premise, equipment, materials, records, or information at any reasonable time to secure compliance with, or prevent a violation of this chapter or the regulations adopted pursuant thereto. (2) Inspect, photograph, or copy any records, reports, test results, test specimens, or other information related to the requirements of this chapter or the regulations adopted pursuant thereto. (3) Secure any sample, photograph, or other evidence from any building or premise for the purpose of enforcing this chapter or the regulations adopted pursuant thereto. (b) The department may cooperate with, or assist persons licensed under this chapter, or other qualified persons, in evaluating laboratory procedures and techniques necessary to achieve and maintain high quality performance in clinical laboratories. 1226. Annually the department may compile and may thereafter publish and sell a directory of persons within the state licensed under the provisions of this chapter who hold unsuspended, unforfeited and unrevoked licenses. The directory may also contain a copy of the provisions of this chapter and regulations relating thereto and such other information as the department may determine advisable. 1227. Every person or clinical laboratory licensed or registered under this chapter shall report to the department, within 30 days thereof, any change of name or address. 1228. The department shall appoint a multidisciplinary committee to assist, advise, and make recommendations for the establishment of rules and regulations necessary to insure proper administration and enforcement of the provisions of this chapter and to assist and advise the department in matters concerning examinations for licensees of this chapter. Appointments shall be made from lists of nominees solicited by the department and shall provide adequate and proper representation of all persons affected by this chapter. Subcommittees of the committee may be appointed consisting of committee members and consultants having particular knowledge in a subject area for the purpose of assisting the department on special administrative problems and in making recommendations to the committee for consideration in the establishment of rules and regulations. The terms of office of the members shall be determined by the department.
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