AB 940: Clinical laboratories.
- Session Year: 2015-2016
- House: Assembly
- Latest Version Date: 2015-09-28
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of a laboratory director. Existing law defines laboratory director, for purposes of a clinical laboratory test or examination classified as waived, as any person who, among others, is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under CLIA.
This bill would delete the requirement that a laboratory director substantially meet the laboratory director qualifications under CLIA. The bill would instead limit the CLIA qualification requirements to a person serving as the CLIA laboratory director, as defined, in a laboratory that performs tests classified as moderate or high complexity.
Existing law authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, and other persons licensed in specified clinical specialties, to perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, within the area of the licensees specialty.
This bill would specify that this authorization extends to a person who is not the CLIA laboratory director under specified circumstances.
Existing law requires an applicant for a clinical laboratory bioanalysts license to meet specified requirements for education and experience, including that the applicant have a minimum of 4 years experience as a licensed clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the State Department of Public Health.
This bill would revise the application requirements to provide that an applicants minimum of 4 years experience be in a clinical laboratory certified under CLIA.
Existing law authorizes the State Department of Public Health to issue specified licenses, including limited clinical laboratory scientist licenses and clinical licenses in specified fields, and establishes application and annual renewal fees for those licenses. Existing law deposits those fees in the Clinical Laboratory Improvement Fund for use, upon appropriation by the Legislature, for regulatory purposes relating to clinical laboratories, blood banks, or clinical laboratory personnel, as provided.
This bill would rename the license for clinical molecular biologist as the license for clinical genetic molecular biologist. The bill would apply existing license renewal fees to persons renewing a clinical cytogeneticists license or clinical genetic molecular biologists license.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of a laboratory director. Existing law defines laboratory director, for purposes of a clinical laboratory test or examination classified as waived, as any person who, among others, is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under CLIA.
This bill would delete the requirement that a laboratory director substantially meet the laboratory director qualifications under CLIA. The bill would instead limit the CLIA qualification requirements to a person serving as the CLIA laboratory director, as defined, in a laboratory that performs tests classified as moderate or high complexity.
Existing law authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, and other persons licensed in specified clinical specialties, to perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, within the area of the licensees specialty.
This bill would specify that this authorization extends to a person who is not the CLIA laboratory director under specified circumstances.
Existing law requires an applicant for a clinical laboratory bioanalysts license to meet specified requirements for education and experience, including that the applicant have a minimum of 4 years experience as a licensed clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the State Department of Public Health.
This bill would revise the application requirements to provide that an applicants minimum of 4 years experience be in a clinical laboratory certified under CLIA.
Existing law authorizes the State Department of Public Health to issue specified licenses, including limited clinical laboratory scientist licenses and clinical licenses in specified fields, and establishes application and annual renewal fees for those licenses. Existing law deposits those fees in the Clinical Laboratory Improvement Fund for use, upon appropriation by the Legislature, for regulatory purposes relating to clinical laboratories, blood banks, or clinical laboratory personnel, as provided.
This bill would rename the license for clinical molecular biologist as the license for clinical genetic molecular biologist. The bill would apply existing license renewal fees to persons renewing a clinical cytogeneticists license or clinical genetic molecular biologists license.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of a laboratory director. Existing law defines laboratory director, for purposes of a clinical laboratory test or examination classified as waived, as any person who, among others, is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under CLIA.
This bill would delete the requirement that a laboratory director substantially meet the laboratory director qualifications under CLIA. The bill would instead limit the CLIA qualification requirements to a person serving as the CLIA laboratory director, as defined, in a laboratory that performs tests classified as moderate or high complexity.
Existing law authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, and other persons licensed in specified clinical specialties, to perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, within the area of the licensees specialty.
This bill would specify that this authorization extends to a person who is not the CLIA laboratory director under specified circumstances.
Existing law requires an applicant for a clinical laboratory bioanalysts license to meet specified requirements for education and experience, including that the applicant have a minimum of 4 years experience as a licensed clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the State Department of Public Health.
This bill would revise the application requirements to provide that an applicants minimum of 4 years experience be in a clinical laboratory certified under CLIA.
Existing law authorizes the State Department of Public Health to issue specified licenses, including limited clinical laboratory scientist licenses and clinical licenses in specified fields, and establishes application and annual renewal fees for the clinical those licenses. Existing law deposits those fees in the Clinical Laboratory Improvement Fund for use, upon appropriation by the Legislature, for regulatory purposes relating to clinical laboratories, blood banks, or clinical laboratory personnel, as provided.
This bill would rename the license for clinical molecular biologist as the license for clinical genetic molecular biologist. The bill would apply existing license renewal fees to persons renewing a clinical cytogeneticists license or clinical genetic molecular biologists license.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of a laboratory director. Existing law defines laboratory director, for purposes of a clinical laboratory test or examination classified as waived, as any person who, among others, is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under CLIA.
This bill would delete the requirement that a laboratory director substantially meet the laboratory director qualifications under CLIA. The bill would instead limit the CLIA qualification requirements to a person serving as the CLIA laboratory director, as defined, in a laboratory that performs tests classified as moderate or high complexity.
Existing law authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, and other persons licensed in specified clinical specialties, to perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, within the area of the licensees specialty.
This bill would specify that this authorization extends to a person who is not the CLIA laboratory director under specified circumstances.
Existing law defines a clinical laboratory scientist as any person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed, as specified, to engage in a clinical laboratory practice under the overall operation and administration of a laboratory director.
The bill would add reproductive biology to the list of specialties that a clinical laboratory scientist may perform. The bill would make conforming changes.
Existing law requires an applicant for a clinical laboratory bioanalysts license to meet specified requirements for education and experience, including that the applicant have a minimum of 4 years experience as a licensed clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the State Department of Public Health.
This bill would revise the application requirements to provide that an applicants minimum of 4 years experience be in a clinical laboratory certified under CLIA.
Existing law authorizes the State Department of Public Health to issue specified licenses, including limited clinical laboratory scientist licenses and clinical licenses in specified fields, and establishes application and annual renewal fees for the clinical licenses. Existing law deposits those fees in the Clinical Laboratory Improvement Fund for use, upon appropriation by the Legislature, for regulatory purposes relating to clinical laboratories, blood banks, or clinical laboratory personnel, as provided.
This bill would authorize the department to issue limited clinical laboratory scientist licenses and clinical licenses in reproductive biology and biochemical genetics, as provided, and would apply existing application and license renewal fees to persons applying for additional clinical licenses. renewing a clinical cytogeneticists or clinical molecular biologists license.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of a laboratory director. Existing law defines laboratory director, for purposes of a clinical laboratory test or examination classified as waived, as any person who, among others, is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under the CLIA.
This bill would delete the requirement that a laboratory director substantially meet the laboratory director qualifications under CLIA. The bill would instead limit the CLIA qualification requirements to a person serving as the CLIA laboratory director, as defined, in a laboratory that performs tests classified as moderate or high complexity.
Existing law authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, and other persons licensed in specified clinical specialties, to perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, within the area of the licensees specialty.
This bill would specify that this authorization extends to a person who is not the CLIA laboratory director under specified circumstances.
Existing law defines a clinical laboratory scientist as any person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed, as specified, to engage in a clinical laboratory practice under the overall operation and administration of a laboratory director.
The bill would add reproductive biology to the list of specialties that a clinical laboratory scientist may perform. The bill would make conforming changes.
Existing law requires an applicant for a clinical laboratory bioanalysts license to meet specified requirements for education and experience, including that the applicant have a minimum of 4 years experience as a licensed clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the State Department of Public Health.
This bill would revise the application requirements to provide that an applicants minimum of 4 years experience be in a clinical laboratory certified under the CLIA.
Existing law authorizes the State Department of Public Health to issue specified licenses, including limited clinical laboratory scientist licenses and clinical licenses in specified fields, and establishes application and annual renewal fees for the clinical licenses. Existing law deposits those fees in the Clinical Laboratory Improvement Fund for use, upon appropriation by the Legislature, for regulatory purposes relating to clinical laboratories, blood banks, or clinical laboratory personnel, as provided.
This bill would authorize the department to issue limited clinical laboratory scientist licenses and clinical licenses in reproductive biology and biochemical genetics, as provided, and would apply existing application and license renewal fees to persons applying for additional clinical licenses.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of a laboratory director. Existing law defines laboratory director, for purposes of a clinical laboratory test or examination classified as waived, as any person who, among others, is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under the CLIA.
This bill would delete the requirement that a laboratory director substantially meet the laboratory director qualifications under CLIA. The bill would instead limit the CLIA qualification requirements to a person serving as the CLIA laboratory director, as defined, in a laboratory that performs tests classified as moderate or high complexity.
Existing law authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, and other persons licensed in specified clinical specialties, to perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, within the area of the licensees specialty.
This bill would specify that this authorization extends to a person who is not the CLIA laboratory director under specified circumstances.
Existing law defines a clinical laboratory scientist as any person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed, as specified, to engage in a clinical laboratory practice under the overall operation and administration of a laboratory director.
The bill would add reproductive biology to the list of specialties that a clinical laboratory scientist may perform. The bill would make conforming changes.
Existing law requires an applicant for a clinical laboratory bioanalysts license to meet specified requirements for education and experience, including that the applicant have a minimum of 4 years experience as a licensed clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the State Department of Public Health.
This bill would revise the application requirements to provide that an applicants minimum of 4 years experience be in a clinical laboratory certified under the CLIA.
Existing law authorizes the State Department of Public Health to issue specified licenses, including limited clinical laboratory scientist licenses and clinical licenses in specified fields, and establishes application and annual renewal fees for the clinical licenses. Existing law deposits those fees in the Clinical Laboratory Improvement Fund for use, upon appropriation by the Legislature, for regulatory purposes relating to clinical laboratories, blood banks, or clinical laboratory personnel, as provided.
This bill would authorize the department to issue limited clinical laboratory scientist licenses and clinical licenses in reproductive biology and biochemical genetics, as provided, and would apply existing application and license renewal fees to persons applying for additional clinical licenses.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of a laboratory director. Existing law defines laboratory director, for purposes of a clinical laboratory test or examination classified as waived, as any person who, among others, is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under the CLIA.
This bill would remove delete the requirement that a laboratory director substantially meet the laboratory director qualifications under CLIA. The bill would instead limit the CLIA qualification requirements to a person serving as the CLIA laboratory director, as defined, in a laboratory that performs tests classified as moderate or high complexity.
Existing law defines a clinical laboratory scientist as any person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed, as specified, to engage in a clinical laboratory practice under the overall operation and administration of a laboratory director.
The bill would add reproductive biology to the list of specialties that a clinical laboratory scientist may perform. The bill would make conforming changes.
Existing law requires an applicant for a clinical laboratory bioanalysts license to meet specified requirements for education and experience, including that the applicant have a minimum of 4 years experience as a licensed clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the State Department of Public Health.
This bill would revise the application requirements to provide that an applicants minimum of 4 years experience be in a clinical laboratory certified under the CLIA.
Existing law authorizes the State Department of Public Health to issue specified licenses, including limited clinical laboratory scientist licenses and clinical licenses in specified fields, and establishes application and annual renewal fees for the clinical licenses. Existing law deposits those fees in the Clinical Laboratory Improvement Fund for use, upon appropriation by the Legislature, for regulatory purposes relating to clinical laboratories, blood banks, or clinical laboratory personnel, as provided.
This bill would authorize the department to issue limited clinical laboratory scientist licenses and clinical licenses in embryology reproductive biology and biochemical genetics, as provided, and would apply existing application and license renewal fees to persons applying for additional clinical licenses.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of a laboratory director. Existing law defines laboratory director, for purposes of a clinical laboratory test or examination classified as waived, as any person who, among others, is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under the CLIA.
This bill would remove the requirement that a laboratory director substantially meet the laboratory director qualifications under CLIA. The bill would instead limit the CLIA qualification requirements to a person serving as the CLIA laboratory director, as defined, in a laboratory that performs tests classified as moderate or high complexity.
Existing law requires an applicant for a clinical laboratory bioanalysts license to meet specified requirements for education and experience, including that the applicant have a minimum of 4 years experience as a licensed clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the State Department of Public Health.
This bill would revise the application requirements to provide that an applicants minimum of 4 years experience be in a clinical laboratory certified under the CLIA.
Existing law authorizes the State Department of Public Health to issue specified licenses, including limited clinical laboratory scientist licenses and clinical licenses in specified fields, and establishes application and annual renewal fees for the clinical licenses. Existing law deposits those fees in the Clinical Laboratory Improvement Fund for use, upon appropriation by the Legislature, for regulatory purposes relating to clinical laboratories, blood banks, or clinical laboratory personnel, as provided.
This bill would authorize the department to issue limited clinical laboratory scientist licenses and clinical licenses in embryology and biochemical genetics, as provided, and would apply existing application and license renewal fees to persons applying for additional clinical licenses.
As used in this chapter, clinical laboratory bioanalyst or bioanalyst means a person licensed under Section 1260 to engage in clinical laboratory practice and direction of a clinical laboratory.
(a)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, who is not the CLIA laboratory director, may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department.
(b)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA may perform the duties and responsibilities of a CLIA laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department.
(c)A person licensed as a clinical laboratory bioanalyst or bioanalyst may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
SEC. 2.Section 1209 of the Business and Professions Code is amended to read:1209.(a)As used in this chapter, laboratory director means any person who is any of the following:
(1)A duly licensed physician and surgeon.
(2)Only for purposes of a clinical laboratory test or examination classified as waived, is any of the following:
(A)A duly licensed clinical laboratory scientist.
(B)A duly licensed limited clinical laboratory scientist.
(C)A duly licensed naturopathic doctor.
(D)A duly licensed optometrist serving as the director of a laboratory that only performs clinical laboratory tests authorized in paragraph (10) of subdivision (e) of Section 3041.
(3)Licensed to direct a clinical laboratory under this chapter.
(b)(1)A person defined in paragraph (1) or (3) of subdivision (a) who is identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity shall also meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory.
(2)As used in this subdivision, CLIA laboratory director means the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
(c)The laboratory director, if qualified under CLIA, may perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to persons qualified under CLIA. If the laboratory director reapportions performance of those responsibilities or duties, he or she shall remain responsible for ensuring that all those duties and responsibilities are properly performed.
(d)(1)The laboratory director is responsible for the overall operation and administration of the clinical laboratory, including administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with this act and CLIA. He or she shall be responsible for the proper performance of all laboratory work of all subordinates and shall employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with the personnel qualifications, duties, and responsibilities described in CLIA and this chapter.
(2)Where a point-of-care laboratory testing device is utilized and provides results for more than one analyte, the testing personnel may perform and report the results of all tests ordered for each analyte for which he or she has been found by the laboratory director to be competent to perform and report.
(e)As part of the overall operation and administration, the laboratory director of a registered laboratory shall document the adequacy of the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory test procedures and examinations. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for personnel, in addition to any CLIA requirements relative to the education or training of personnel.
(f)As part of the overall operation and administration, the laboratory director of a licensed laboratory shall do all of the following:
(1)Ensure that all personnel, prior to testing biological specimens, have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for, and the type of procedures that may be performed by, personnel in addition to any CLIA requirements relative to the education or training of personnel. Any regulations adopted pursuant to this section that specify the type of procedure that may be performed by testing personnel shall be based on the skills, knowledge, and tasks required to perform the type of procedure in question.
(2)Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process biological specimens, perform test procedures, and report test results promptly and proficiently, and, whenever necessary, identify needs for remedial training or continuing education to improve skills.
(3)Specify in writing the responsibilities and duties of each individual engaged in the performance of the preanalytic, analytic, and postanalytic phases of clinical laboratory tests or examinations, including which clinical laboratory tests or examinations the individual is authorized to perform, whether supervision is required for the individual to perform specimen processing, test performance, or results reporting, and whether consultant, supervisor, or director review is required prior to the individual reporting patient test results.
(g)The competency and performance of staff of a licensed laboratory shall be evaluated and documented by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA depending on the type and complexity of tests being offered by the laboratory.
(1)The procedures for evaluating the competency of the staff shall include, but are not limited to, all of the following:
(A)Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen handling, processing, and testing.
(B)Monitoring the recording and reporting of test results.
(C)Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
(D)Direct observation of performance of instrument maintenance and function checks.
(E)Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.
(F)Assessment of problem solving skills.
(2)Evaluation and documentation of staff competency and performance shall occur at least semiannually during the first year an individual tests biological specimens. Thereafter, evaluations shall be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance shall be reevaluated to include the use of the new test methodology or instrumentation.
(h)The laboratory director of each clinical laboratory of an acute care hospital shall be a physician and surgeon who is a qualified pathologist, except as follows:
(1)If a qualified pathologist is not available, a physician and surgeon or a clinical laboratory bioanalyst qualified as a laboratory director under subdivision (a) may direct the laboratory. However, a qualified pathologist shall be available for consultation at suitable intervals to ensure high-quality service.
(2)If there are two or more clinical laboratories of an acute care hospital, those additional clinical laboratories that are limited to the performance of blood gas analysis, blood electrolyte analysis, or both, may be directed by a physician and surgeon qualified as a laboratory director under subdivision (a), irrespective of whether a pathologist is available.
As used in this subdivision, a qualified pathologist is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.
(i)Subdivision (h) does not apply to any director of a clinical laboratory of an acute care hospital acting in that capacity on or before January 1, 1988.
(j)A laboratory director may serve as the director of up to the maximum number of laboratories stipulated by CLIA, as defined under Section 1202.5.
SEC. 3.Section 1260 of the Business and Professions Code is amended to read:1260.The department shall issue a clinical laboratory bioanalysts license to each person who is a lawful holder of a degree of master of arts, master of science, or an equivalent or higher degree as determined by the department with a major in chemical, physical, biological, or clinical laboratory sciences. This education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the department. The applicant also shall have a minimum of four years experience as a clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory certified under CLIA. The quality and variety of this experience shall be satisfactory to the department and shall have been obtained within the six-year period immediately antecedent to admission to the examination. The applicant shall successfully pass a written examination and an oral examination conducted by the department or a committee designated by the department to conduct the examinations, indicating that the applicant is properly qualified. The department may issue a license without conducting a written examination to an applicant who has passed a written examination of a national accrediting board having requirements that are, in the determination of the department, equal to or greater than those required by this chapter and regulations adopted by the department. The department shall establish by regulation the required courses to be included in the college or university training.
SEC. 4.Section 1264 of the Business and Professions Code is amended to read:1264.The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical genetic molecular biologist, or clinical cytogeneticist license to each person who has applied for the license on forms provided by the department, who is a lawful holder of a master of science or doctoral degree in the specialty for which the applicant is seeking a license and who has met such additional reasonable qualifications of training, education, and experience as the department may establish by regulations. The department shall issue an oral and maxillofacial pathologist license to every applicant for licensure who has applied for the license on forms provided by the department, who is a registered Diplomate of the American Board of Oral and Maxillofacial Pathology, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulation.
(a)The graduate education shall have included 30 semester hours of coursework in the applicants specialty. Applicants possessing only a master of science degree shall have the equivalent of one year of full-time, directed study or training in procedures and principles involved in the development, modification or evaluation of laboratory methods, including training in complex methods applicable to diagnostic laboratory work. Each applicant must have had one year of training in his or her specialty in a clinical laboratory acceptable to the department and three years of experience in his or her specialty in a clinical laboratory, two years of which must have been at a supervisory level. The education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by an agency acceptable to the department. The department shall determine by examination that the applicant is properly qualified. Examinations, training, or experience requirements for specialty licenses shall cover only the specialty concerned.
(b)The department may issue licenses without examination to applicants who have passed examinations of other states or national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of other state requirements or requirements of national accrediting boards shall be carried out by the department with the assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by another state or national accrediting board prior to the establishment of requirements that are equal to or exceed those of this chapter or regulations of the department.
(c)The department may issue licenses without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to conform to this section.
SEC. 5.Section 1300 of the Business and Professions Code is amended to read:1300.The amount of application, registration, and license fees under this chapter shall be as follows:
(a)The application fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical cytogeneticists, or clinical genetic molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(b)The annual renewal fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical cytogeneticists, or clinical genetic molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(c)The application fee for a clinical laboratory scientists or limited clinical laboratory scientists license is thirty-eight dollars ($38) commencing on July 1, 1983.
(d)The application and annual renewal fee for a cytotechnologists license is fifty dollars ($50) commencing on January 1, 1991.
(e)The annual renewal fee for a clinical laboratory scientists or limited clinical laboratory scientists license is twenty-five dollars ($25) commencing on July 1, 1983.
(f)A clinical laboratory applying for a license to perform tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory applying for certification under subdivision (c) of Section 1223 shall pay an application fee for that license or certification based on the number of tests it performs or expects to perform in a year, as follows:
(1)Less than 2,001 tests: two hundred seventy dollars ($270).
(2)Between 2,001 and 10,000, inclusive, tests: eight hundred twenty dollars ($820).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand three hundred fifteen dollars ($1,315).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand five hundred eighty dollars ($1,580).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand nine hundred sixty dollars ($1,960).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand three hundred forty dollars ($2,340).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand seven hundred forty dollars ($2,740).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand nine hundred ten dollars ($4,910).
(9)More than 1,000,000 tests: five thousand two hundred sixty dollars ($5,260) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(g)A clinical laboratory performing tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory with a certificate issued under subdivision (c) of Section 1223 shall pay an annual renewal fee based on the number of tests it performed in the preceding calendar year, as follows:
(1)Less than 2,001 tests: one hundred seventy dollars ($170).
(2)Between 2,001 and 10,000, inclusive, tests: seven hundred twenty dollars ($720).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand one hundred fifteen dollars ($1,115).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand three hundred eighty dollars ($1,380).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand seven hundred sixty dollars ($1,760).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand forty dollars ($2,040).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand four hundred forty dollars ($2,440).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand six hundred ten dollars ($4,610).
(9)More than 1,000,000 tests per year: four thousand nine hundred sixty dollars ($4,960) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(h)The application fee for a trainees license is thirteen dollars ($13) commencing on July 1, 1983.
(i)The annual renewal fee for a trainees license is eight dollars ($8) commencing on July 1, 1983.
(j)The application fee for a duplicate license is five dollars ($5) commencing on July 1, 1983.
(k)The personnel licensing delinquency fee is equal to the annual renewal fee.
(l)The director may establish a fee for examinations required under this chapter. The fee shall not exceed the total cost to the department in conducting the examination.
(m)A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only those clinical laboratory tests or examinations considered waived under CLIA shall pay an annual fee of one hundred dollars ($100). A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only provider-performed microscopy, as defined under CLIA, shall pay an annual fee of one hundred fifty dollars ($150). A clinical laboratory performing both waived and provider-performed microscopy shall pay an annual registration fee of one hundred fifty dollars ($150).
(n)The costs of the department in conducting a complaint investigation, imposing sanctions, or conducting a hearing under this chapter shall be paid by the clinical laboratory. The fee shall be no greater than the fee the laboratory would pay under CLIA for the same type of activities and shall not be payable if the clinical laboratory would not be required to pay those fees under CLIA.
(o)The state, a district, city, county, city and county, or other political subdivision, or any public officer or body shall be subject to the payment of fees established pursuant to this chapter or regulations adopted thereunder.
(p)In addition to the payment of registration or licensure fees, a clinical laboratory located outside the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections at the clinical laboratory in order to ensure compliance with this chapter.
(q)The department shall establish an application fee and a renewal fee for a medical laboratory technician license, the total fees collected not to exceed the costs of the department for the implementation and operation of the program licensing and regulating medical laboratory technicians pursuant to Section 1260.3.
(r)The costs of the department to conduct any reinspections to ensure compliance of a laboratory applying for initial licensure shall be paid by the laboratory. This additional cost for each visit shall be equal to the initial application fee and shall be paid by the laboratory prior to issuance of a license. The department shall not charge a reinspection fee if the reinspection is due to error or omission on the part of the department.
(s)A fee of twenty-five dollars ($25) shall be assessed for approval of each additional location authorized by paragraph (2) of subdivision (d) of Section 1265.
(t)On or before July 1, 2013, the department shall report to the Legislature during the annual legislative budget hearing process the extent to which the state oversight program meets or exceeds federal oversight standards and the extent to which the federal Department of Health and Human Services is accepting exemption applications and the potential cost to the state for an exemption.
As used in this chapter, clinical laboratory bioanalyst or bioanalyst means a person licensed under Section 1260 to engage in clinical laboratory practice and direction of a clinical laboratory.
(a)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, who is not the CLIA laboratory director, may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department.
(b)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA may perform the duties and responsibilities of a CLIA laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department.
(c)A person licensed as a clinical laboratory bioanalyst or bioanalyst may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
SEC. 2.Section 1209 of the Business and Professions Code is amended to read:1209.(a)As used in this chapter, laboratory director means any person who is any of the following:
(1)A duly licensed physician and surgeon.
(2)Only for purposes of a clinical laboratory test or examination classified as waived, is any of the following:
(A)A duly licensed clinical laboratory scientist.
(B)A duly licensed limited clinical laboratory scientist.
(C)A duly licensed naturopathic doctor.
(D)A duly licensed optometrist serving as the director of a laboratory that only performs clinical laboratory tests authorized in paragraph (10) of subdivision (e) of Section 3041.
(3)Licensed to direct a clinical laboratory under this chapter.
(b)(1)A person defined in paragraph (1) or (3) of subdivision (a) who is identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity shall also meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory.
(2)As used in this subdivision, CLIA laboratory director means the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
(c)The laboratory director, if qualified under CLIA, may perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to persons qualified under CLIA. If the laboratory director reapportions performance of those responsibilities or duties, he or she shall remain responsible for ensuring that all those duties and responsibilities are properly performed.
(d)(1)The laboratory director is responsible for the overall operation and administration of the clinical laboratory, including administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with this act and CLIA. He or she shall be responsible for the proper performance of all laboratory work of all subordinates and shall employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with the personnel qualifications, duties, and responsibilities described in CLIA and this chapter.
(2)Where a point-of-care laboratory testing device is utilized and provides results for more than one analyte, the testing personnel may perform and report the results of all tests ordered for each analyte for which he or she has been found by the laboratory director to be competent to perform and report.
(e)As part of the overall operation and administration, the laboratory director of a registered laboratory shall document the adequacy of the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory test procedures and examinations. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for personnel, in addition to any CLIA requirements relative to the education or training of personnel.
(f)As part of the overall operation and administration, the laboratory director of a licensed laboratory shall do all of the following:
(1)Ensure that all personnel, prior to testing biological specimens, have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for, and the type of procedures that may be performed by, personnel in addition to any CLIA requirements relative to the education or training of personnel. Any regulations adopted pursuant to this section that specify the type of procedure that may be performed by testing personnel shall be based on the skills, knowledge, and tasks required to perform the type of procedure in question.
(2)Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process biological specimens, perform test procedures, and report test results promptly and proficiently, and, whenever necessary, identify needs for remedial training or continuing education to improve skills.
(3)Specify in writing the responsibilities and duties of each individual engaged in the performance of the preanalytic, analytic, and postanalytic phases of clinical laboratory tests or examinations, including which clinical laboratory tests or examinations the individual is authorized to perform, whether supervision is required for the individual to perform specimen processing, test performance, or results reporting, and whether consultant, supervisor, or director review is required prior to the individual reporting patient test results.
(g)The competency and performance of staff of a licensed laboratory shall be evaluated and documented by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA depending on the type and complexity of tests being offered by the laboratory.
(1)The procedures for evaluating the competency of the staff shall include, but are not limited to, all of the following:
(A)Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen handling, processing, and testing.
(B)Monitoring the recording and reporting of test results.
(C)Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
(D)Direct observation of performance of instrument maintenance and function checks.
(E)Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.
(F)Assessment of problem solving skills.
(2)Evaluation and documentation of staff competency and performance shall occur at least semiannually during the first year an individual tests biological specimens. Thereafter, evaluations shall be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance shall be reevaluated to include the use of the new test methodology or instrumentation.
(h)The laboratory director of each clinical laboratory of an acute care hospital shall be a physician and surgeon who is a qualified pathologist, except as follows:
(1)If a qualified pathologist is not available, a physician and surgeon or a clinical laboratory bioanalyst qualified as a laboratory director under subdivision (a) may direct the laboratory. However, a qualified pathologist shall be available for consultation at suitable intervals to ensure high-quality service.
(2)If there are two or more clinical laboratories of an acute care hospital, those additional clinical laboratories that are limited to the performance of blood gas analysis, blood electrolyte analysis, or both, may be directed by a physician and surgeon qualified as a laboratory director under subdivision (a), irrespective of whether a pathologist is available.
As used in this subdivision, a qualified pathologist is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.
(i)Subdivision (h) does not apply to any director of a clinical laboratory of an acute care hospital acting in that capacity on or before January 1, 1988.
(j)A laboratory director may serve as the director of up to the maximum number of laboratories stipulated by CLIA, as defined under Section 1202.5.
SEC. 3.Section 1260 of the Business and Professions Code is amended to read:1260.The department shall issue a clinical laboratory bioanalysts license to each person who is a lawful holder of a degree of master of arts, master of science, or an equivalent or higher degree as determined by the department with a major in chemical, physical, biological, or clinical laboratory sciences. This education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the department. The applicant also shall have a minimum of four years experience as a clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory certified under CLIA. The quality and variety of this experience shall be satisfactory to the department and shall have been obtained within the six-year period immediately antecedent to admission to the examination. The applicant shall successfully pass a written examination and an oral examination conducted by the department or a committee designated by the department to conduct the examinations, indicating that the applicant is properly qualified. The department may issue a license without conducting a written examination to an applicant who has passed a written examination of a national accrediting board having requirements that are, in the determination of the department, equal to or greater than those required by this chapter and regulations adopted by the department. The department shall establish by regulation the required courses to be included in the college or university training.
SEC. 4.Section 1264 of the Business and Professions Code is amended to read:1264.The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical genetic molecular biologist, or clinical cytogeneticist license to each person who has applied for the license on forms provided by the department, who is a lawful holder of a master of science or doctoral degree in the specialty for which the applicant is seeking a license and who has met such additional reasonable qualifications of training, education, and experience as the department may establish by regulations. The department shall issue an oral and maxillofacial pathologist license to every applicant for licensure who has applied for the license on forms provided by the department, who is a registered Diplomate of the American Board of Oral and Maxillofacial Pathology, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulation.
(a)The graduate education shall have included 30 semester hours of coursework in the applicants specialty. Applicants possessing only a master of science degree shall have the equivalent of one year of full-time, directed study or training in procedures and principles involved in the development, modification or evaluation of laboratory methods, including training in complex methods applicable to diagnostic laboratory work. Each applicant must have had one year of training in his or her specialty in a clinical laboratory acceptable to the department and three years of experience in his or her specialty in a clinical laboratory, two years of which must have been at a supervisory level. The education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by an agency acceptable to the department. The department shall determine by examination that the applicant is properly qualified. Examinations, training, or experience requirements for specialty licenses shall cover only the specialty concerned.
(b)The department may issue licenses without examination to applicants who have passed examinations of other states or national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of other state requirements or requirements of national accrediting boards shall be carried out by the department with the assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by another state or national accrediting board prior to the establishment of requirements that are equal to or exceed those of this chapter or regulations of the department.
(c)The department may issue licenses without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to conform to this section.
SEC. 5.Section 1300 of the Business and Professions Code is amended to read:1300.The amount of application, registration, and license fees under this chapter shall be as follows:
(a)The application fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical cytogeneticists, or clinical genetic molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(b)The annual renewal fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical cytogeneticists, or clinical genetic molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(c)The application fee for a clinical laboratory scientists or limited clinical laboratory scientists license is thirty-eight dollars ($38) commencing on July 1, 1983.
(d)The application and annual renewal fee for a cytotechnologists license is fifty dollars ($50) commencing on January 1, 1991.
(e)The annual renewal fee for a clinical laboratory scientists or limited clinical laboratory scientists license is twenty-five dollars ($25) commencing on July 1, 1983.
(f)A clinical laboratory applying for a license to perform tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory applying for certification under subdivision (c) of Section 1223 shall pay an application fee for that license or certification based on the number of tests it performs or expects to perform in a year, as follows:
(1)Less than 2,001 tests: two hundred seventy dollars ($270).
(2)Between 2,001 and 10,000, inclusive, tests: eight hundred twenty dollars ($820).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand three hundred fifteen dollars ($1,315).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand five hundred eighty dollars ($1,580).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand nine hundred sixty dollars ($1,960).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand three hundred forty dollars ($2,340).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand seven hundred forty dollars ($2,740).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand nine hundred ten dollars ($4,910).
(9)More than 1,000,000 tests: five thousand two hundred sixty dollars ($5,260) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(g)A clinical laboratory performing tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory with a certificate issued under subdivision (c) of Section 1223 shall pay an annual renewal fee based on the number of tests it performed in the preceding calendar year, as follows:
(1)Less than 2,001 tests: one hundred seventy dollars ($170).
(2)Between 2,001 and 10,000, inclusive, tests: seven hundred twenty dollars ($720).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand one hundred fifteen dollars ($1,115).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand three hundred eighty dollars ($1,380).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand seven hundred sixty dollars ($1,760).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand forty dollars ($2,040).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand four hundred forty dollars ($2,440).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand six hundred ten dollars ($4,610).
(9)More than 1,000,000 tests per year: four thousand nine hundred sixty dollars ($4,960) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(h)The application fee for a trainees license is thirteen dollars ($13) commencing on July 1, 1983.
(i)The annual renewal fee for a trainees license is eight dollars ($8) commencing on July 1, 1983.
(j)The application fee for a duplicate license is five dollars ($5) commencing on July 1, 1983.
(k)The personnel licensing delinquency fee is equal to the annual renewal fee.
(l)The director may establish a fee for examinations required under this chapter. The fee shall not exceed the total cost to the department in conducting the examination.
(m)A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only those clinical laboratory tests or examinations considered waived under CLIA shall pay an annual fee of one hundred dollars ($100). A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only provider-performed microscopy, as defined under CLIA, shall pay an annual fee of one hundred fifty dollars ($150). A clinical laboratory performing both waived and provider-performed microscopy shall pay an annual registration fee of one hundred fifty dollars ($150).
(n)The costs of the department in conducting a complaint investigation, imposing sanctions, or conducting a hearing under this chapter shall be paid by the clinical laboratory. The fee shall be no greater than the fee the laboratory would pay under CLIA for the same type of activities and shall not be payable if the clinical laboratory would not be required to pay those fees under CLIA.
(o)The state, a district, city, county, city and county, or other political subdivision, or any public officer or body shall be subject to the payment of fees established pursuant to this chapter or regulations adopted thereunder.
(p)In addition to the payment of registration or licensure fees, a clinical laboratory located outside the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections at the clinical laboratory in order to ensure compliance with this chapter.
(q)The department shall establish an application fee and a renewal fee for a medical laboratory technician license, the total fees collected not to exceed the costs of the department for the implementation and operation of the program licensing and regulating medical laboratory technicians pursuant to Section 1260.3.
(r)The costs of the department to conduct any reinspections to ensure compliance of a laboratory applying for initial licensure shall be paid by the laboratory. This additional cost for each visit shall be equal to the initial application fee and shall be paid by the laboratory prior to issuance of a license. The department shall not charge a reinspection fee if the reinspection is due to error or omission on the part of the department.
(s)A fee of twenty-five dollars ($25) shall be assessed for approval of each additional location authorized by paragraph (2) of subdivision (d) of Section 1265.
(t)On or before July 1, 2013, the department shall report to the Legislature during the annual legislative budget hearing process the extent to which the state oversight program meets or exceeds federal oversight standards and the extent to which the federal Department of Health and Human Services is accepting exemption applications and the potential cost to the state for an exemption.
As used in this chapter, clinical laboratory bioanalyst or bioanalyst means a person licensed under Section 1260 to engage in clinical laboratory practice and direction of a clinical laboratory.
(a)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, who is not the CLIA laboratory director, may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department.
(b)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA may perform the duties and responsibilities of a CLIA laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department.
(c)A person licensed as a clinical laboratory bioanalyst or bioanalyst may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
SEC. 2.Section 1209 of the Business and Professions Code is amended to read:1209.(a)As used in this chapter, laboratory director means any person who is any of the following:
(1)A duly licensed physician and surgeon.
(2)Only for purposes of a clinical laboratory test or examination classified as waived, is any of the following:
(A)A duly licensed clinical laboratory scientist.
(B)A duly licensed limited clinical laboratory scientist.
(C)A duly licensed naturopathic doctor.
(D)A duly licensed optometrist serving as the director of a laboratory that only performs clinical laboratory tests authorized in paragraph (10) of subdivision (e) of Section 3041.
(3)Licensed to direct a clinical laboratory under this chapter.
(b)(1)A person defined in paragraph (1) or (3) of subdivision (a) who is identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity shall also meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory.
(2)As used in this subdivision, CLIA laboratory director means the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
(c)The laboratory director, if qualified under CLIA, may perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to persons qualified under CLIA. If the laboratory director reapportions performance of those responsibilities or duties, he or she shall remain responsible for ensuring that all those duties and responsibilities are properly performed.
(d)(1)The laboratory director is responsible for the overall operation and administration of the clinical laboratory, including administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with this act and CLIA. He or she shall be responsible for the proper performance of all laboratory work of all subordinates and shall employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with the personnel qualifications, duties, and responsibilities described in CLIA and this chapter.
(2)Where a point-of-care laboratory testing device is utilized and provides results for more than one analyte, the testing personnel may perform and report the results of all tests ordered for each analyte for which he or she has been found by the laboratory director to be competent to perform and report.
(e)As part of the overall operation and administration, the laboratory director of a registered laboratory shall document the adequacy of the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory test procedures and examinations. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for personnel, in addition to any CLIA requirements relative to the education or training of personnel.
(f)As part of the overall operation and administration, the laboratory director of a licensed laboratory shall do all of the following:
(1)Ensure that all personnel, prior to testing biological specimens, have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for, and the type of procedures that may be performed by, personnel in addition to any CLIA requirements relative to the education or training of personnel. Any regulations adopted pursuant to this section that specify the type of procedure that may be performed by testing personnel shall be based on the skills, knowledge, and tasks required to perform the type of procedure in question.
(2)Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process biological specimens, perform test procedures, and report test results promptly and proficiently, and, whenever necessary, identify needs for remedial training or continuing education to improve skills.
(3)Specify in writing the responsibilities and duties of each individual engaged in the performance of the preanalytic, analytic, and postanalytic phases of clinical laboratory tests or examinations, including which clinical laboratory tests or examinations the individual is authorized to perform, whether supervision is required for the individual to perform specimen processing, test performance, or results reporting, and whether consultant, supervisor, or director review is required prior to the individual reporting patient test results.
(g)The competency and performance of staff of a licensed laboratory shall be evaluated and documented by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA depending on the type and complexity of tests being offered by the laboratory.
(1)The procedures for evaluating the competency of the staff shall include, but are not limited to, all of the following:
(A)Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen handling, processing, and testing.
(B)Monitoring the recording and reporting of test results.
(C)Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
(D)Direct observation of performance of instrument maintenance and function checks.
(E)Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.
(F)Assessment of problem solving skills.
(2)Evaluation and documentation of staff competency and performance shall occur at least semiannually during the first year an individual tests biological specimens. Thereafter, evaluations shall be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance shall be reevaluated to include the use of the new test methodology or instrumentation.
(h)The laboratory director of each clinical laboratory of an acute care hospital shall be a physician and surgeon who is a qualified pathologist, except as follows:
(1)If a qualified pathologist is not available, a physician and surgeon or a clinical laboratory bioanalyst qualified as a laboratory director under subdivision (a) may direct the laboratory. However, a qualified pathologist shall be available for consultation at suitable intervals to ensure high-quality service.
(2)If there are two or more clinical laboratories of an acute care hospital, those additional clinical laboratories that are limited to the performance of blood gas analysis, blood electrolyte analysis, or both, may be directed by a physician and surgeon qualified as a laboratory director under subdivision (a), irrespective of whether a pathologist is available.
As used in this subdivision, a qualified pathologist is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.
(i)Subdivision (h) does not apply to any director of a clinical laboratory of an acute care hospital acting in that capacity on or before January 1, 1988.
(j)A laboratory director may serve as the director of up to the maximum number of laboratories stipulated by CLIA, as defined under Section 1202.5.
SEC. 3.Section 1260 of the Business and Professions Code is amended to read:1260.The department shall issue a clinical laboratory bioanalysts license to each person who is a lawful holder of a degree of master of arts, master of science, or an equivalent or higher degree as determined by the department with a major in chemical, physical, biological, or clinical laboratory sciences. This education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the department. The applicant also shall have a minimum of four years experience as a clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory certified under CLIA. The quality and variety of this experience shall be satisfactory to the department and shall have been obtained within the six-year period immediately antecedent to admission to the examination. The applicant shall successfully pass a written examination and an oral examination conducted by the department or a committee designated by the department to conduct the examinations, indicating that the applicant is properly qualified. The department may issue a license without conducting a written examination to an applicant who has passed a written examination of a national accrediting board having requirements that are, in the determination of the department, equal to or greater than those required by this chapter and regulations adopted by the department. The department shall establish by regulation the required courses to be included in the college or university training.
SEC. 4.Section 1264 of the Business and Professions Code is amended to read:1264.The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical genetic molecular biologist, or clinical cytogeneticist license to each person who has applied for the license on forms provided by the department, who is a lawful holder of a master of science or doctoral degree in the specialty for which the applicant is seeking a license and who has met such additional reasonable qualifications of training, education, and experience as the department may establish by regulations. The department shall issue an oral and maxillofacial pathologist license to every applicant for licensure who has applied for the license on forms provided by the department, who is a registered Diplomate of the American Board of Oral and Maxillofacial Pathology, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulation.
(a)The graduate education shall have included 30 semester hours of coursework in the applicants specialty. Applicants possessing only a master of science degree shall have the equivalent of one year of full-time, directed study or training in procedures and principles involved in the development, modification or evaluation of laboratory methods, including training in complex methods applicable to diagnostic laboratory work. Each applicant must have had one year of training in his or her specialty in a clinical laboratory acceptable to the department and three years of experience in his or her specialty in a clinical laboratory, two years of which must have been at a supervisory level. The education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by an agency acceptable to the department. The department shall determine by examination that the applicant is properly qualified. Examinations, training, or experience requirements for specialty licenses shall cover only the specialty concerned.
(b)The department may issue licenses without examination to applicants who have passed examinations of other states or national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of other state requirements or requirements of national accrediting boards shall be carried out by the department with the assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by another state or national accrediting board prior to the establishment of requirements that are equal to or exceed those of this chapter or regulations of the department.
(c)The department may issue licenses without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to conform to this section.
SEC. 4.SEC. 5.Section 1300 of the Business and Professions Code is amended to read:1300.The amount of application, registration, and license fees under this chapter shall be as follows:
(a)The application fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical cytogeneticists, or clinical genetic molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(b)The annual renewal fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical cytogeneticists, or clinical genetic molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(c)The application fee for a clinical laboratory scientists or limited clinical laboratory scientists license is thirty-eight dollars ($38) commencing on July 1, 1983.
(d)The application and annual renewal fee for a cytotechnologists license is fifty dollars ($50) commencing on January 1, 1991.
(e)The annual renewal fee for a clinical laboratory scientists or limited clinical laboratory scientists license is twenty-five dollars ($25) commencing on July 1, 1983.
(f)A clinical laboratory applying for a license to perform tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory applying for certification under subdivision (c) of Section 1223 shall pay an application fee for that license or certification based on the number of tests it performs or expects to perform in a year, as follows:
(1)Less than 2,001 tests: two hundred seventy dollars ($270).
(2)Between 2,001 and 10,000, inclusive, tests: eight hundred twenty dollars ($820).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand three hundred fifteen dollars ($1,315).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand five hundred eighty dollars ($1,580).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand nine hundred sixty dollars ($1,960).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand three hundred forty dollars ($2,340).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand seven hundred forty dollars ($2,740).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand nine hundred ten dollars ($4,910).
(9)More than 1,000,000 tests: five thousand two hundred sixty dollars ($5,260) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(g)A clinical laboratory performing tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory with a certificate issued under subdivision (c) of Section 1223 shall pay an annual renewal fee based on the number of tests it performed in the preceding calendar year, as follows:
(1)Less than 2,001 tests: one hundred seventy dollars ($170).
(2)Between 2,001 and 10,000, inclusive, tests: seven hundred twenty dollars ($720).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand one hundred fifteen dollars ($1,115).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand three hundred eighty dollars ($1,380).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand seven hundred sixty dollars ($1,760).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand forty dollars ($2,040).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand four hundred forty dollars ($2,440).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand six hundred ten dollars ($4,610).
(9)More than 1,000,000 tests per year: four thousand nine hundred sixty dollars ($4,960) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(h)The application fee for a trainees license is thirteen dollars ($13) commencing on July 1, 1983.
(i)The annual renewal fee for a trainees license is eight dollars ($8) commencing on July 1, 1983.
(j)The application fee for a duplicate license is five dollars ($5) commencing on July 1, 1983.
(k)The personnel licensing delinquency fee is equal to the annual renewal fee.
(l)The director may establish a fee for examinations required under this chapter. The fee shall not exceed the total cost to the department in conducting the examination.
(m)A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only those clinical laboratory tests or examinations considered waived under CLIA shall pay an annual fee of one hundred dollars ($100). A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only provider-performed microscopy, as defined under CLIA, shall pay an annual fee of one hundred fifty dollars ($150). A clinical laboratory performing both waived and provider-performed microscopy shall pay an annual registration fee of one hundred fifty dollars ($150).
(n)The costs of the department in conducting a complaint investigation, imposing sanctions, or conducting a hearing under this chapter shall be paid by the clinical laboratory. The fee shall be no greater than the fee the laboratory would pay under CLIA for the same type of activities and shall not be payable if the clinical laboratory would not be required to pay those fees under CLIA.
(o)The state, a district, city, county, city and county, or other political subdivision, or any public officer or body shall be subject to the payment of fees established pursuant to this chapter or regulations adopted thereunder.
(p)In addition to the payment of registration or licensure fees, a clinical laboratory located outside the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections at the clinical laboratory in order to ensure compliance with this chapter.
(q)The department shall establish an application fee and a renewal fee for a medical laboratory technician license, the total fees collected not to exceed the costs of the department for the implementation and operation of the program licensing and regulating medical laboratory technicians pursuant to Section 1260.3.
(r)The costs of the department to conduct any reinspections to ensure compliance of a laboratory applying for initial licensure shall be paid by the laboratory. This additional cost for each visit shall be equal to the initial application fee and shall be paid by the laboratory prior to issuance of a license. The department shall not charge a reinspection fee if the reinspection is due to error or omission on the part of the department.
(s)A fee of twenty-five dollars ($25) shall be assessed for approval of each additional location authorized by paragraph (2) of subdivision (d) of Section 1265.
(t)On or before July 1, 2013, the department shall report to the Legislature during the annual legislative budget hearing process the extent to which the state oversight program meets or exceeds federal oversight standards and the extent to which the federal Department of Health and Human Services is accepting exemption applications and the potential cost to the state for an exemption.
As used in this chapter, clinical laboratory bioanalyst or bioanalyst means a person licensed under Section 1260 to engage in clinical laboratory practice and direction of a clinical laboratory.
(a)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, who is not the CLIA laboratory director, may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department.
(b)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA may perform the duties and responsibilities of a CLIA laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department.
(c)A person licensed as a clinical laboratory bioanalyst or bioanalyst may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
SEC. 2.Section 1204 of the Business and Professions Code is amended to read:1204.As used in this chapter, clinical laboratory scientist means any person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed under Sections 1261 and 1262 to engage in clinical laboratory practice under the overall operation and administration of a laboratory director, unless serving as a director of a waived laboratory as provided in Section 1209. A person licensed as a clinical laboratory scientist and qualified under CLIA may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a waived laboratory director, as specified under CLIA, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, reproductive biology, or other specialty or subspecialty specified by regulation adopted by the department. A person licensed as a clinical laboratory scientist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
SEC. 3.Section 1205 of the Business and Professions Code is amended to read:1205.As used in this chapter, trainee means any person licensed under this chapter for the purpose of receiving comprehensive practical experience and instruction in clinical laboratory procedures in one of the sciences or in general clinical laboratory science. The training provided to a trainee shall be provided under the direct and responsible supervision of any of the following individuals: a person authorized to direct a laboratory under the provisions of this chapter, a clinical laboratory scientist, clinical chemist scientist, clinical microbiologist scientist, clinical toxicologist scientist, clinical immunohematologist scientist, clinical genetic molecular biologist scientist, clinical cytogeneticist scientist, clinical biochemical geneticist scientist, clinical reproductive biologist scientist, clinical histocompatibility scientist, or other equivalent licensee in the science or specialty or subspecialty for which he or she is licensed in a clinical laboratory certified for this purpose by the department under this chapter.
SEC. 4.Section 1206 of the Business and Professions Code is amended to read:1206.(a)For the purposes of this chapter the following definitions are applicable:
(1)Analyte means the substance or constituent being measured, including, but not limited to, glucose, sodium, or theophylline, or any substance or property whose presence or absence, concentration, activity, intensity, or other characteristics are to be determined.
(2)Biological specimen means any material that is derived from the human body.
(3)Blood electrolyte analysis means the measurement of electrolytes in a blood specimen by means of ion selective electrodes on instruments specifically designed and manufactured for blood gas and acid-base analysis.
(4)Blood gas analysis means a clinical laboratory test or examination that deals with the uptake, transport, and metabolism of oxygen and carbon dioxide in the human body.
(5)Clinical laboratory test or examination means the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within a biological specimen for the purpose of obtaining scientific data which may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual.
(6)Clinical laboratory science means any of the sciences or scientific disciplines used to perform a clinical laboratory test or examination.
(7)Clinical laboratory practice means the application of clinical laboratory sciences or the use of any means that applies the clinical laboratory sciences within or outside of a licensed or registered clinical laboratory. Clinical laboratory practice includes consultation, advisory, and other activities inherent to the profession.
(8)Clinical laboratory means any place used, or any establishment or institution organized or operated, for the performance of clinical laboratory tests or examinations or the practical application of the clinical laboratory sciences. That application may include any means that applies the clinical laboratory sciences.
(9)Direct and constant supervision means personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the unlicensed laboratory personnel are engaged in the duties specified in Section 1269.
(10)Direct and responsible supervision means both of the following:
(A)Personal observation and critical evaluation of the activity of a trainee by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the trainee is performing clinical laboratory tests or examinations.
(B)Personal review by the physician and surgeon or the licensed person of all results of clinical laboratory testing or examination performed by the trainee for accuracy, reliability, and validity before the results are reported from the laboratory.
(11)Licensed laboratory means a clinical laboratory licensed pursuant to paragraph (1) of subdivision (a) of Section 1265.
(12)Location means either a street and city address, or a site or place within a street and city address, where any of the clinical laboratory sciences or scientific disciplines are practiced or applied, or where any clinical laboratory tests or examinations are performed.
(13)Physician office laboratory means a clinical laboratory that is licensed or registered under Section 1265, and that is either: (A) a clinical laboratory that is owned and operated by a partnership or professional corporation that performs clinical laboratory tests or examinations only for patients of five or fewer physicians and surgeons or podiatrists who are shareholders, partners, or employees of the partnership or professional corporation that owns and operates the clinical laboratory; or (B) a clinical laboratory that is owned and operated by an individual licensed physician and surgeon or a podiatrist, and that performs clinical laboratory tests or examinations only for patients of the physician and surgeon or podiatrist who owns and operates the clinical laboratory.
(14)Point-of-care laboratory testing device means a portable laboratory testing instrument to which the following applies:
(A)It is used within the proximity of the patient for whom the test or examination is being conducted.
(B)It is used in accordance with the patient test management system, the quality control program, and the comprehensive quality assurance program established and maintained by the laboratory pursuant to paragraph (2) of subdivision (d) of Section 1220.
(C)It meets the following criteria:
(i)Performs clinical laboratory tests or examinations classified as waived or of moderate complexity under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).
(ii)Performs clinical laboratory tests or examinations on biological specimens that require no preparation after collection.
(iii)Provides clinical laboratory tests or examination results without calculation or discretionary intervention by the testing personnel.
(iv)Performs clinical laboratory tests or examinations without the necessity for testing personnel to perform calibration or maintenance, except resetting pursuant to the manufacturers instructions or basic cleaning.
(15)Public health laboratory means a laboratory that is operated by a city or county in conformity with Article 5 (commencing with Section 101150) of Chapter 2 of Part 3 of Division 101 of the Health and Safety Code and the regulations adopted thereunder.
(16)Registered laboratory means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.
(17)Specialty means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.
(18)Subspecialty for purposes of microbiology, means bacteriology, mycobacteriology, mycology, parasitology, virology, molecular biology, and serology for diagnosis of infectious diseases, or other subspecialty specified by regulation adopted by the department; for purposes of diagnostic immunology, means syphilis serology, general immunology, or other subspecialty specified by regulation adopted by the department; for purposes of chemistry, means routine chemistry, clinical microscopy, endocrinology, toxicology, or other subspecialty specified by regulation adopted by the department; for purposes of immunohematology, means ABO/Rh Type and Group, antibody detection for transfusion, antibody detection nontransfusion, antibody identification, compatibility, or other subspecialty specified by regulation adopted by the department; for pathology, means tissue pathology, oral pathology, diagnostic cytology, or other subspecialty specified by regulation adopted by the department; for purposes of genetics, means molecular biology related to the diagnosis of human genetic abnormalities, cytogenetics, biochemical genetics, or other subspecialty specified by regulation adopted by the department.
(b)Nothing in this chapter shall restrict, limit, or prevent any person licensed to provide health care services under the laws of this state, including, but not limited to, licensed physicians and surgeons and registered nurses, from practicing the profession or occupation for which he or she is licensed.
(c)Nothing in this chapter shall authorize any person to perform or order health care services, or utilize the results of the clinical laboratory test or examination, unless the person is otherwise authorized to provide that care or utilize the results. The inclusion of a person in Section 1206.5 for purposes of performing a clinical laboratory test or examination shall not be interpreted to authorize a person, who is not otherwise authorized, to perform venipuncture, arterial puncture, or skin puncture.
SEC. 5.Section 1207 of the Business and Professions Code is amended to read:1207.(a)(1)(A)As used in this chapter, clinical chemist, or clinical microbiologist, or clinical toxicologist, or clinical genetic molecular biologist, or clinical cytogeneticist, or clinical reproductive biologist, or clinical biochemical geneticist, or oral and maxillofacial pathologist means any person licensed by the department under Section 1264 to engage in, or supervise others engaged in, clinical laboratory practice limited to his or her area of specialization or to direct a clinical laboratory, or portion thereof, limited to his or her area of specialization.
(B)A person described in subparagraph (A) may perform the duties and responsibilities of a laboratory director, who is not the CLIA laboratory director, limited to his or her area of specialty or subspecialty as described in subdivision (b), and shall only direct a clinical laboratory providing service within those specialties or subspecialties.
(C)If a person described in subparagraph (A) is qualified under CLIA, he or she may perform clinical laboratory tests or examinations classified as of high complexity under CLIA, and the duties and responsibilities of a CLIA laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, limited to his or her area of specialty or subspecialty as described in subdivision (b), and shall only direct a clinical laboratory providing service within those specialties or subspecialties.
(2)A person licensed as a clinical chemist, or clinical microbiologist, or clinical toxicologist, or clinical genetic molecular biologist, or clinical cytogeneticist, or clinical reproductive biologist, or clinical biochemical geneticist, or oral and maxillofacial pathologist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
(b)The specialty or subspecialty for each of the limited license categories identified in subdivision (a), and the clinical laboratories that may be directed by persons licensed in each of those categories, are the following:
(1)For a person licensed under this chapter as a clinical chemist, the specialty of chemistry and the subspecialties of routine chemistry, endocrinology, clinical microscopy, toxicology, or other specialty or subspecialty specified by regulation adopted by the department.
(2)For a person licensed under this chapter as a clinical microbiologist, the specialty of microbiology and the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology, molecular biology, and serology for diagnosis of infectious diseases, or other specialty or subspecialty specified by regulation adopted by the department.
(3)For a person licensed under this chapter as a clinical toxicologist, the subspecialty of toxicology within the specialty of chemistry or other specialty or subspecialty specified by regulation adopted by the department.
(4)For a person licensed under this chapter as a clinical genetic molecular biologist, the subspecialty of molecular biology related to diagnosis of human genetic abnormalities within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(5)For a person licensed under this chapter as a clinical cytogeneticist, the subspecialty of cytogenetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(6)For a person licensed under this chapter as a clinical biochemical geneticist, the subspecialty of biochemical genetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(7)For a person licensed under this chapter as a clinical reproductive biologist, the specialty of reproductive biology or other specialty or subspecialty specified by regulation adopted by the department.
(8)For a person licensed under this chapter as an oral and maxillofacial pathologist, the subspecialty of oral pathology within the specialty of pathology or other specialty or subspecialty specified by regulation adopted by the department.
SEC. 6.SEC. 2.Section 1209 of the Business and Professions Code is amended to read:1209.(a)As used in this chapter, laboratory director means any person who is any of the following:
(1)A duly licensed physician and surgeon.
(2)Only for purposes of a clinical laboratory test or examination classified as waived, is any of the following:
(A)A duly licensed clinical laboratory scientist.
(B)A duly licensed limited clinical laboratory scientist.
(C)A duly licensed naturopathic doctor.
(D)A duly licensed optometrist serving as the director of a laboratory that only performs clinical laboratory tests authorized in paragraph (10) of subdivision (e) of Section 3041.
(3)Licensed to direct a clinical laboratory under this chapter.
(b)(1)A person defined in paragraph (1) or (3) of subdivision (a) who is identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity shall also meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory.
(2)As used in this subdivision, CLIA laboratory director means the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
(c)The laboratory director, if qualified under CLIA, may perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to persons qualified under CLIA. If the laboratory director reapportions performance of those responsibilities or duties, he or she shall remain responsible for ensuring that all those duties and responsibilities are properly performed.
(d)(1)The laboratory director is responsible for the overall operation and administration of the clinical laboratory, including administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with this act and CLIA. He or she shall be responsible for the proper performance of all laboratory work of all subordinates and shall employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with the personnel qualifications, duties, and responsibilities described in CLIA and this chapter.
(2)Where a point-of-care laboratory testing device is utilized and provides results for more than one analyte, the testing personnel may perform and report the results of all tests ordered for each analyte for which he or she has been found by the laboratory director to be competent to perform and report.
(e)As part of the overall operation and administration, the laboratory director of a registered laboratory shall document the adequacy of the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory test procedures and examinations. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for personnel, in addition to any CLIA requirements relative to the education or training of personnel.
(f)As part of the overall operation and administration, the laboratory director of a licensed laboratory shall do all of the following:
(1)Ensure that all personnel, prior to testing biological specimens, have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for, and the type of procedures that may be performed by, personnel in addition to any CLIA requirements relative to the education or training of personnel. Any regulations adopted pursuant to this section that specify the type of procedure that may be performed by testing personnel shall be based on the skills, knowledge, and tasks required to perform the type of procedure in question.
(2)Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process biological specimens, perform test procedures, and report test results promptly and proficiently, and, whenever necessary, identify needs for remedial training or continuing education to improve skills.
(3)Specify in writing the responsibilities and duties of each individual engaged in the performance of the preanalytic, analytic, and postanalytic phases of clinical laboratory tests or examinations, including which clinical laboratory tests or examinations the individual is authorized to perform, whether supervision is required for the individual to perform specimen processing, test performance, or results reporting, and whether consultant, supervisor, or director review is required prior to the individual reporting patient test results.
(g)The competency and performance of staff of a licensed laboratory shall be evaluated and documented by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA depending on the type and complexity of tests being offered by the laboratory.
(1)The procedures for evaluating the competency of the staff shall include, but are not limited to, all of the following:
(A)Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen handling, processing, and testing.
(B)Monitoring the recording and reporting of test results.
(C)Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
(D)Direct observation of performance of instrument maintenance and function checks.
(E)Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.
(F)Assessment of problem solving skills.
(2)Evaluation and documentation of staff competency and performance shall occur at least semiannually during the first year an individual tests biological specimens. Thereafter, evaluations shall be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance shall be reevaluated to include the use of the new test methodology or instrumentation.
(h)The laboratory director of each clinical laboratory of an acute care hospital shall be a physician and surgeon who is a qualified pathologist, except as follows:
(1)If a qualified pathologist is not available, a physician and surgeon or a clinical laboratory bioanalyst qualified as a laboratory director under subdivision (a) may direct the laboratory. However, a qualified pathologist shall be available for consultation at suitable intervals to ensure high-quality service.
(2)If there are two or more clinical laboratories of an acute care hospital, those additional clinical laboratories that are limited to the performance of blood gas analysis, blood electrolyte analysis, or both, may be directed by a physician and surgeon qualified as a laboratory director under subdivision (a), irrespective of whether a pathologist is available.
As used in this subdivision, a qualified pathologist is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.
(i)Subdivision (h) does not apply to any director of a clinical laboratory of an acute care hospital acting in that capacity on or before January 1, 1988.
(j)A laboratory director may serve as the director of up to the maximum number of laboratories stipulated by CLIA, as defined under Section 1202.5.
SEC. 7.Section 1210 of the Business and Professions Code is amended to read:1210.(a)As used in this chapter, clinical chemist scientist, clinical microbiologist scientist, clinical toxicologist scientist, clinical immunohematologist scientist, clinical genetic molecular biologist scientist, clinical biochemical geneticist scientist, clinical reproductive biologist scientist, clinical cytogeneticist scientist, and clinical histocompatibility scientist means any person, other than a person licensed to direct a clinical laboratory, or licensed as a clinical laboratory scientist or trainee, who is licensed under Sections 1261, 1261.5, and 1262 to engage in clinical laboratory practice. Such a licensed person who is qualified under CLIA may perform clinical laboratory tests classified as of high complexity under CLIA and the duties and responsibilities of a technical consultant, clinical consultant, technical supervisor, and general supervisor limited to the specialty or subspecialty as identified in subdivision (b) for which he or she is licensed by the department. A person licensed as a clinical chemist scientist, or clinical microbiologist scientist, or clinical toxicologist scientist, or clinical immunohematologist scientist, or clinical genetic molecular biologist scientist, or clinical biochemical geneticist scientist, or clinical reproductive biologist scientist, or clinical cytogeneticist scientist, or a clinical histocompatibility scientist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
(b)The specialties and subspecialties included in each of the license categories identified in subdivision (a), are the following:
(1)For a person licensed under this chapter as a clinical chemist scientist, the specialty of chemistry and the subspecialties of routine chemistry, endocrinology, clinical microscopy, toxicology, or other specialty or subspecialty specified by regulation adopted by the department.
(2)For a person licensed under this chapter as a clinical microbiologist scientist, the specialty of microbiology and the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology, or molecular biology and serology for diagnosis of infectious diseases, or other specialty or subspecialty specified by regulation adopted by the department.
(3)For a person licensed under this chapter as a clinical toxicologist scientist, the subspecialty of toxicology within the specialty of chemistry or other specialty or subspecialty specified by regulation adopted by the department.
(4)For a person licensed under this chapter as a clinical genetic molecular biologist scientist, the subspecialty of molecular biology related to the diagnosis of human genetic abnormalities within the specialty of genetics, or other specialty or subspecialty specified by regulation adopted by the department.
(5)For a person licensed under this chapter as a clinical cytogeneticist scientist, the subspecialty of cytogenetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(6)For a person licensed under this chapter as a clinical biochemical geneticist scientist, the subspecialty of biochemical genetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(7)For a person licensed under this chapter as a clinical reproductive biologist scientist, the specialty of reproductive biology, or other specialty or subspecialty specified by regulation adopted by the department.
(8)For a person licensed under this chapter as a clinical immunohematologist scientist, the specialty of immunohematology or other specialty or subspecialty specified by regulation adopted by the department.
(9)For a person licensed under this chapter as a clinical histocompatibility scientist, the specialty of histocompatibility or other specialty or subspecialty specified by regulation adopted by the department.
(c)Clinical chemist scientists, clinical microbiologist scientists, clinical toxicologist scientists, clinical immunohematologist scientists, clinical genetic molecular biologist scientists, clinical cytogeneticist scientists, and clinical histocompatibility scientists shall engage in clinical laboratory practice authorized by their licensure only under the overall operation and administration of a laboratory director.
SEC. 8.SEC. 3.Section 1260 of the Business and Professions Code is amended to read:1260.The department shall issue a clinical laboratory bioanalysts license to each person who is a lawful holder of a degree of master of arts, master of science, or an equivalent or higher degree as determined by the department with a major in chemical, physical, biological, or clinical laboratory sciences. This education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the department. The applicant also shall have a minimum of four years experience as a clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory certified under CLIA. The quality and variety of this experience shall be satisfactory to the department and shall have been obtained within the six-year period immediately antecedent to admission to the examination. The applicant shall successfully pass a written examination and an oral examination conducted by the department or a committee designated by the department to conduct the examinations, indicating that the applicant is properly qualified. The department may issue a license without conducting a written examination to an applicant who has passed a written examination of a national accrediting board having requirements that are, in the determination of the department, equal to or greater than those required by this chapter and regulations adopted by the department. The department shall establish by regulation the required courses to be included in the college or university training.
SEC. 9.Section 1261.5 of the Business and Professions Code is amended to read:1261.5.The department may issue limited clinical laboratory scientists licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, reproductive biology, biochemical genetics, genetic molecular biology, cytogenetics, or other areas of laboratory specialty or subspecialty when determined to be necessary by the department in order for licensure categories to keep abreast of changes in laboratory or scientific technology. Whenever the department determines that a new limited clinical laboratory scientist license category is necessary, it shall adopt regulations identifying the category and the areas of specialization included within the category.
To qualify for admission to the examination for a special clinical laboratory scientists license, an applicant shall have all the following:
(a)Have graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate or higher degree with a major appropriate to the field for which a license is being sought.
(b)Have one year of full-time postgraduate training or experience in the various areas of analysis in the field for which a license is being sought in a laboratory that has a license issued under this chapter or which the department determines is equivalent thereto.
(c)Whenever a limited clinical laboratory scientists license is established for a specific area of specialization, the department may issue the license without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to implement this section.
SEC. 10.Section 1264 of the Business and Professions Code is amended to read:1264.The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical reproductive biologist, clinical biochemical geneticist, clinical molecular biologist, or clinical cytogeneticist license to each person who has applied for the license on forms provided by the department, who is a lawful holder of a master of science or doctoral degree in the specialty for which the applicant is seeking a license and who has met such additional reasonable qualifications of training, education, and experience as the department may establish by regulations. The department shall issue an oral and maxillofacial pathologist license to every applicant for licensure who has applied for the license on forms provided by the department, who is a registered Diplomate of the American Board of Oral and Maxillofacial Pathology, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulation.
(a)The graduate education shall have included 30 semester hours of coursework in the applicants specialty. Applicants possessing only a master of science degree shall have the equivalent of one year of full-time, directed study or training in procedures and principles involved in the development, modification, or evaluation of laboratory methods, including training in complex methods applicable to diagnostic laboratory work. Each applicant must have had one year of training in his or her specialty in a clinical laboratory acceptable to the department and three years of experience in his or her specialty in a clinical laboratory, two years of which must have been at a supervisory level. The education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by an agency acceptable to the department. The department shall determine by examination that the applicant is properly qualified. Examinations, training, or experience requirements for specialty licenses shall cover only the specialty concerned.
(b)The department may issue licenses without examination to applicants who have passed examinations of other states or national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of other state requirements or requirements of national accrediting boards shall be carried out by the department with the assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by another state or national accrediting board prior to the establishment of requirements that are equal to or exceed those of this chapter or regulations of the department.
(c)The department may issue licenses without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to conform to this section.
SEC. 11.SEC. 4.Section 1300 of the Business and Professions Code is amended to read:1300.The amount of application, registration, and license fees under this chapter shall be as follows:
(a)The application fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical reproductive biologists, clinical biochemical geneticists, clinical cytogeneticists, or clinical molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(b)The annual renewal fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical reproductive biologists, clinical biochemical geneticists, clinical cytogeneticists, or clinical molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(c)The application fee for a clinical laboratory scientists or limited clinical laboratory scientists license is thirty-eight dollars ($38) commencing on July 1, 1983.
(d)The application and annual renewal fee for a cytotechnologists license is fifty dollars ($50) commencing on January 1, 1991.
(e)The annual renewal fee for a clinical laboratory scientists or limited clinical laboratory scientists license is twenty-five dollars ($25) commencing on July 1, 1983.
(f)A clinical laboratory applying for a license to perform tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory applying for certification under subdivision (c) of Section 1223 shall pay an application fee for that license or certification based on the number of tests it performs or expects to perform in a year, as follows:
(1)Less than 2,001 tests: two hundred seventy dollars ($270).
(2)Between 2,001 and 10,000, inclusive, tests: eight hundred twenty dollars ($820).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand three hundred fifteen dollars ($1,315).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand five hundred eighty dollars ($1,580).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand nine hundred sixty dollars ($1,960).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand three hundred forty dollars ($2,340).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand seven hundred forty dollars ($2,740).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand nine hundred ten dollars ($4,910).
(9)More than 1,000,000 tests: five thousand two hundred sixty dollars ($5,260) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(g)A clinical laboratory performing tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory with a certificate issued under subdivision (c) of Section 1223 shall pay an annual renewal fee based on the number of tests it performed in the preceding calendar year, as follows:
(1)Less than 2,001 tests: one hundred seventy dollars ($170).
(2)Between 2,001 and 10,000, inclusive, tests: seven hundred twenty dollars ($720).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand one hundred fifteen dollars ($1,115).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand three hundred eighty dollars ($1,380).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand seven hundred sixty dollars ($1,760).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand forty dollars ($2,040).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand four hundred forty dollars ($2,440).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand six hundred ten dollars ($4,610).
(9)More than 1,000,000 tests per year: four thousand nine hundred sixty dollars ($4,960) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(h)The application fee for a trainees license is thirteen dollars ($13) commencing on July 1, 1983.
(i)The annual renewal fee for a trainees license is eight dollars ($8) commencing on July 1, 1983.
(j)The application fee for a duplicate license is five dollars ($5) commencing on July 1, 1983.
(k)The personnel licensing delinquency fee is equal to the annual renewal fee.
(l)The director may establish a fee for examinations required under this chapter. The fee shall not exceed the total cost to the department in conducting the examination.
(m)A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only those clinical laboratory tests or examinations considered waived under CLIA shall pay an annual fee of one hundred dollars ($100). A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only provider-performed microscopy, as defined under CLIA, shall pay an annual fee of one hundred fifty dollars ($150). A clinical laboratory performing both waived and provider-performed microscopy shall pay an annual registration fee of one hundred fifty dollars ($150).
(n)The costs of the department in conducting a complaint investigation, imposing sanctions, or conducting a hearing under this chapter shall be paid by the clinical laboratory. The fee shall be no greater than the fee the laboratory would pay under CLIA for the same type of activities and shall not be payable if the clinical laboratory would not be required to pay those fees under CLIA.
(o)The state, a district, city, county, city and county, or other political subdivision, or any public officer or body shall be subject to the payment of fees established pursuant to this chapter or regulations adopted thereunder.
(p)In addition to the payment of registration or licensure fees, a clinical laboratory located outside the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections at the clinical laboratory in order to ensure compliance with this chapter.
(q)The department shall establish an application fee and a renewal fee for a medical laboratory technician license, the total fees collected not to exceed the costs of the department for the implementation and operation of the program licensing and regulating medical laboratory technicians pursuant to Section 1260.3.
(r)The costs of the department to conduct any reinspections to ensure compliance of a laboratory applying for initial licensure shall be paid by the laboratory. This additional cost for each visit shall be equal to the initial application fee and shall be paid by the laboratory prior to issuance of a license. The department shall not charge a reinspection fee if the reinspection is due to error or omission on the part of the department.
(s)A fee of twenty-five dollars ($25) shall be assessed for approval of each additional location authorized by paragraph (2) of subdivision (d) of Section 1265.
(t)On or before July 1, 2013, the department shall report to the Legislature during the annual legislative budget hearing process the extent to which the state oversight program meets or exceeds federal oversight standards and the extent to which the federal Department of Health and Human Services is accepting exemption applications and the potential cost to the state for an exemption.
As used in this chapter, clinical laboratory bioanalyst or bioanalyst means a person licensed under Section 1260 to engage in clinical laboratory practice and direction of a clinical laboratory.
(a)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA, who is not the CLIA laboratory director, may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department.
(b)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA may perform the duties and responsibilities of a CLIA laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department.
(c)A person licensed as a clinical laboratory bioanalyst or bioanalyst may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
SEC. 2.Section 1204 of the Business and Professions Code is amended to read:1204.As used in this chapter, clinical laboratory scientist means any person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed under Sections 1261 and 1262 to engage in clinical laboratory practice under the overall operation and administration of a laboratory director, unless serving as a director of a waived laboratory as provided in Section 1209. A person licensed as a clinical laboratory scientist and qualified under CLIA may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a waived laboratory director, as specified under CLIA, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, reproductive biology, or other specialty or subspecialty specified by regulation adopted by the department. A person licensed as a clinical laboratory scientist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
SEC. 3.Section 1205 of the Business and Professions Code is amended to read:1205.As used in this chapter, trainee means any person licensed under this chapter for the purpose of receiving comprehensive practical experience and instruction in clinical laboratory procedures in one of the sciences or in general clinical laboratory science science. The training provided to a trainee shall be provided under the direct and responsible supervision of any of the following individuals: a person authorized to direct a laboratory under the provisions of this chapter, a clinical laboratory scientist, clinical chemist scientist, clinical microbiologist scientist, clinical toxicologist scientist, clinical immunohematologist scientist, clinical genetic molecular biologist scientist, clinical cytogeneticist scientist, clinical biochemical geneticist scientist, clinical reproductive biologist scientist, clinical histocompatibility scientist, or other equivalent licensee in the science or specialty or subspecialty for which he or she is licensed in a clinical laboratory certified for this purpose by the department under this chapter.
SEC. 4.Section 1206 of the Business and Professions Code is amended to read:1206.(a)For the purposes of this chapter the following definitions are applicable:
(1)Analyte means the substance or constituent being measured measured, including, but not limited to, glucose, sodium, or theophyline, theophylline, or any substance or property whose presence or absence, concentration, activity, intensity, or other characteristics are to be determined.
(2)Biological specimen means any material that is derived from the human body.
(3)Blood electrolyte analysis means the measurement of electrolytes in a blood specimen by means of ion selective electrodes on instruments specifically designed and manufactured for blood gas and acid-base analysis.
(4)Blood gas analysis means a clinical laboratory test or examination that deals with the uptake, transport, and metabolism of oxygen and carbon dioxide in the human body.
(5)Clinical laboratory test or examination means the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within a biological specimen for the purpose of obtaining scientific data which may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual.
(6)Clinical laboratory science means any of the sciences or scientific disciplines used to perform a clinical laboratory test or examination.
(7)Clinical laboratory practice means the application of clinical laboratory sciences or the use of any means that applies the clinical laboratory sciences within or outside of a licensed or registered clinical laboratory. Clinical laboratory practice includes consultation, advisory, and other activities inherent to the profession.
(8)Clinical laboratory means any place used, or any establishment or institution organized or operated, for the performance of clinical laboratory tests or examinations or the practical application of the clinical laboratory sciences. That application may include any means that applies the clinical laboratory sciences.
(9)Direct and constant supervision means personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the unlicensed laboratory personnel are engaged in the duties specified in Section 1269.
(10)Direct and responsible supervision means both of the following:
(A)Personal observation and critical evaluation of the activity of a trainee by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the trainee is performing clinical laboratory tests or examinations.
(B)Personal review by the physician and surgeon or the licensed person of all results of clinical laboratory testing or examination performed by the trainee for accuracy, reliability, and validity before the results are reported from the laboratory.
(11)Licensed laboratory means a clinical laboratory licensed pursuant to paragraph (1) of subdivision (a) of Section 1265.
(12)Location means either a street and city address, or a site or place within a street and city address, where any of the clinical laboratory sciences or scientific disciplines are practiced or applied, or where any clinical laboratory tests or examinations are performed.
(13)Physician office laboratory means a clinical laboratory that is licensed or registered under Section 1265, and that is either: (A) a clinical laboratory that is owned and operated by a partnership or professional corporation that performs clinical laboratory tests or examinations only for patients of five or fewer physicians and surgeons or podiatrists who are shareholders, partners, or employees of the partnership or professional corporation that owns and operates the clinical laboratory; or (B) a clinical laboratory that is owned and operated by an individual licensed physician and surgeon or a podiatrist, and that performs clinical laboratory tests or examinations only for patients of the physician and surgeon or podiatrist who owns and operates the clinical laboratory.
(14)Point-of-care laboratory testing device means a portable laboratory testing instrument to which the following applies:
(A)It is used within the proximity of the patient for whom the test or examination is being conducted.
(B)It is used in accordance with the patient test management system, the quality control program, and the comprehensive quality assurance program established and maintained by the laboratory pursuant to paragraph (2) of subdivision (d) of Section 1220.
(C)It meets the following criteria:
(i)Performs clinical laboratory tests or examinations classified as waived or of moderate complexity under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).
(ii)Performs clinical laboratory tests or examinations on biological specimens that require no preparation after collection.
(iii)Provides clinical laboratory tests or examination results without calculation or discretionary intervention by the testing personnel.
(iv)Performs clinical laboratory tests or examinations without the necessity for testing personnel to perform calibration or maintenance, except resetting pursuant to the manufacturers instructions or basic cleaning.
(15)Public health laboratory means a laboratory that is operated by a city or county in conformity with Article 5 (commencing with Section 101150) of Chapter 2 of Part 3 of Division 101 of the Health and Safety Code and the regulations adopted thereunder.
(16)Registered laboratory means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.
(17)Specialty means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.
(18)Subspecialty for purposes of microbiology, means bacteriology, mycobacteriology, mycology, parasitology, virology, molecular biology, and serology for diagnosis of infectious diseases, or other subspecialty specified by regulation adopted by the department; for purposes of diagnostic immunology, means syphilis serology, general immunology, or other subspecialty specified by regulation adopted by the department; for purposes of chemistry, means routine chemistry, clinical microscopy, endocrinology, toxicology, or other subspecialty specified by regulation adopted by the department; for purposes of immunohematology, means ABO/Rh Type and Group, antibody detection for transfusion, antibody detection nontransfusion, antibody identification, compatibility, or other subspecialty specified by regulation adopted by the department; for pathology, means tissue pathology, oral pathology, diagnostic cytology, or other subspecialty specified by regulation adopted by the department; for purposes of genetics, means molecular biology related to the diagnosis of human genetic abnormalities, cytogenetics, biochemical genetics, or other subspecialty specified by regulation adopted by the department.
(b)Nothing in this chapter shall restrict, limit, or prevent any person licensed to provide health care services under the laws of this state, including, but not limited to, licensed physicians and surgeons and registered nurses, from practicing the profession or occupation for which he or she is licensed.
(c)Nothing in this chapter shall authorize any person to perform or order health care services, or utilize the results of the clinical laboratory test or examination, unless the person is otherwise authorized to provide that care or utilize the results. The inclusion of a person in Section 1206.5 for purposes of performing a clinical laboratory test or examination shall not be interpreted to authorize a person, who is not otherwise authorized, to perform venipuncture, arterial puncture, or skin puncture.
SEC. 5.Section 1207 of the Business and Professions Code is amended to read:1207.(a)(1)(A)As used in this chapter, clinical chemist, or clinical microbiologist, or clinical toxicologist, or clinical genetic molecular biologist, or clinical cytogeneticist, or clinical reproductive biologist, or clinical biochemical geneticist, or oral and maxillofacial pathologist means any person licensed by the department under Section 1264 to engage in, or supervise others engaged in, clinical laboratory practice limited to his or her area of specialization or to direct a clinical laboratory, or portion thereof, limited to his or her area of specialization.
(B)A person described in subparagraph (A) may perform the duties and responsibilities of a laboratory director, who is not the CLIA laboratory director, limited to his or her area of specialty or subspecialty as described in subdivision (b), and shall only direct a clinical laboratory providing service within those specialties or subspecialties.
(C)If a person described in subparagraph (A) is qualified under CLIA, he or she may perform clinical laboratory tests or examinations classified as of high complexity under CLIA, and the duties and responsibilities of a CLIA laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, limited to his or her area of specialty or subspecialty as described in subdivision (b), and shall only direct a clinical laboratory providing service within those specialties or subspecialties.
(2)A person licensed as a clinical chemist, or clinical microbiologist, or clinical toxicologist, or clinical genetic molecular biologist, or clinical cytogeneticist, or clinical reproductive biologist, or clinical biochemical geneticist, or oral and maxillofacial pathologist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
(b)The specialty or subspecialty for each of the limited license categories identified in subdivision (a), and the clinical laboratories that may be directed by persons licensed in each of those categories, are the following:
(1)For a person licensed under this chapter as a clinical chemist, the specialty of chemistry and the subspecialties of routine chemistry, endocrinology, clinical microscopy, toxicology, or other specialty or subspecialty specified by regulation adopted by the department.
(2)For a person licensed under this chapter as a clinical microbiologist, the specialty of microbiology and the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology, molecular biology, and serology for diagnosis of infectious diseases, or other specialty or subspecialty specified by regulation adopted by the department.
(3)For a person licensed under this chapter as a clinical toxicologist, the subspecialty of toxicology within the specialty of chemistry or other specialty or subspecialty specified by regulation adopted by the department.
(4)For a person licensed under this chapter as a clinical genetic molecular biologist, the subspecialty of molecular biology related to diagnosis of human genetic abnormalities within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(5)For a person licensed under this chapter as a clinical cytogeneticist, the subspecialty of cytogenetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(6)For a person licensed under this chapter as a clinical biochemical geneticist, the subspecialty of biochemical genetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(7)For a person licensed under this chapter as a clinical reproductive biologist, the specialty of reproductive biology or other specialty or subspecialty specified by regulation adopted by the department.
(8)For a person licensed under this chapter as an oral and maxillofacial pathologist, the subspecialty of oral pathology within the specialty of pathology or other specialty or subspecialty specified by regulation adopted by the department.
SEC. 6.Section 1209 of the Business and Professions Code is amended to read:1209.(a)As used in this chapter, laboratory director means any person who is any of the following:
(1)A duly licensed physician and surgeon.
(2)Only for purposes of a clinical laboratory test or examination classified as waived, is any of the following:
(A)A duly licensed clinical laboratory scientist.
(B)A duly licensed limited clinical laboratory scientist.
(C)A duly licensed naturopathic doctor.
(D)A duly licensed optometrist serving as the director of a laboratory that only performs clinical laboratory tests authorized in paragraph (10) of subdivision (e) of Section 3041.
(3)Licensed to direct a clinical laboratory under this chapter.
(b)(1)A person defined in paragraph (1) or (3) of subdivision (a) who is identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity shall also meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory.
(2)As used in this subdivision, CLIA laboratory director means the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
(c)The laboratory director, if qualified under CLIA, may perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to persons qualified under CLIA. If the laboratory director reapportions performance of those responsibilities or duties, he or she shall remain responsible for ensuring that all those duties and responsibilities are properly performed.
(d)(1)The laboratory director is responsible for the overall operation and administration of the clinical laboratory, including administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with this act and CLIA. He or she shall be responsible for the proper performance of all laboratory work of all subordinates and shall employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with the personnel qualifications, duties, and responsibilities described in CLIA and this chapter.
(2)Where a point-of-care laboratory testing device is utilized and provides results for more than one analyte, the testing personnel may perform and report the results of all tests ordered for each analyte for which he or she has been found by the laboratory director to be competent to perform and report.
(e)As part of the overall operation and administration, the laboratory director of a registered laboratory shall document the adequacy of the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory test procedures and examinations. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for personnel, in addition to any CLIA requirements relative to the education or training of personnel.
(f)As part of the overall operation and administration, the laboratory director of a licensed laboratory shall do all of the following:
(1)Ensure that all personnel, prior to testing biological specimens, have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for, and the type of procedures that may be performed by, personnel in addition to any CLIA requirements relative to the education or training of personnel. Any regulations adopted pursuant to this section that specify the type of procedure that may be performed by testing personnel shall be based on the skills, knowledge, and tasks required to perform the type of procedure in question.
(2)Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process biological specimens, perform test procedures, and report test results promptly and proficiently, and, whenever necessary, identify needs for remedial training or continuing education to improve skills.
(3)Specify in writing the responsibilities and duties of each individual engaged in the performance of the preanalytic, analytic, and postanalytic phases of clinical laboratory tests or examinations, including which clinical laboratory tests or examinations the individual is authorized to perform, whether supervision is required for the individual to perform specimen processing, test performance, or results reporting, and whether consultant, supervisor, or director review is required prior to the individual reporting patient test results.
(g)The competency and performance of staff of a licensed laboratory shall be evaluated and documented by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA depending on the type and complexity of tests being offered by the laboratory.
(1)The procedures for evaluating the competency of the staff shall include, but are not limited to, all of the following:
(A)Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen handling, processing, and testing.
(B)Monitoring the recording and reporting of test results.
(C)Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
(D)Direct observation of performance of instrument maintenance and function checks.
(E)Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.
(F)Assessment of problem solving skills.
(2)Evaluation and documentation of staff competency and performance shall occur at least semiannually during the first year an individual tests biological specimens. Thereafter, evaluations shall be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance shall be reevaluated to include the use of the new test methodology or instrumentation.
(h)The laboratory director of each clinical laboratory of an acute care hospital shall be a physician and surgeon who is a qualified pathologist, except as follows:
(1)If a qualified pathologist is not available, a physician and surgeon or a clinical laboratory bioanalyst qualified as a laboratory director under subdivision (a) may direct the laboratory. However, a qualified pathologist shall be available for consultation at suitable intervals to ensure high-quality service.
(2)If there are two or more clinical laboratories of an acute care hospital, those additional clinical laboratories that are limited to the performance of blood gas analysis, blood electrolyte analysis, or both, may be directed by a physician and surgeon qualified as a laboratory director under subdivision (a), irrespective of whether a pathologist is available.
As used in this subdivision, a qualified pathologist is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.
(i)Subdivision (h) does not apply to any director of a clinical laboratory of an acute care hospital acting in that capacity on or before January 1, 1988.
(j)A laboratory director may serve as the director of up to the maximum number of laboratories stipulated by CLIA, as defined under Section 1202.5.
SEC. 7.Section 1210 of the Business and Professions Code is amended to read:1210.(a)As used in this chapter, clinical chemist scientist, clinical microbiologist scientist, clinical toxicologist scientist, clinical immunohematologist scientist, clinical genetic molecular biologist scientist, clinical biochemical geneticist scientist, clinical reproductive biologist scientist, clinical cytogeneticist scientist, and clinical histocompatibility scientist means any person, other than a person licensed to direct a clinical laboratory, or licensed as a clinical laboratory scientist or trainee, who is licensed under Sections 1261, 1261.5, and 1262 to engage in clinical laboratory practice. Such a licensed person who is qualified under CLIA may perform clinical laboratory tests classified as of high complexity under CLIA and the duties and responsibilities of a technical consultant, clinical consultant, technical supervisor, and general supervisor limited to the specialty or subspecialty as identified in subdivision (b) for which he or she is licensed by the department. A person licensed as a clinical chemist scientist, or clinical microbiologist scientist, or clinical toxicologist scientist, or clinical immunohematologist scientist, or clinical genetic molecular biologist scientist, or clinical biochemical geneticist scientist, or clinical reproductive biologist scientist, or clinical cytogeneticist scientist, or a clinical histocompatibility scientist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
(b)The specialties and subspecialties included in each of the license categories identified in subdivision (a), are the following:
(1)For a person licensed under this chapter as a clinical chemist scientist, the specialty of chemistry and the subspecialties of routine chemistry, endocrinology, clinical microscopy, toxicology, or other specialty or subspecialty specified by regulation adopted by the department.
(2)For a person licensed under this chapter as a clinical microbiologist scientist, the specialty of microbiology and the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology, or molecular biology and serology for diagnosis of infectious diseases, or other specialty or subspecialty specified by regulation adopted by the department.
(3)For a person licensed under this chapter as a clinical toxicologist scientist, the subspecialty of toxicology within the specialty of chemistry or other specialty or subspecialty specified by regulation adopted by the department.
(4)For a person licensed under this chapter as a clinical genetic molecular biologist scientist, the subspecialty of molecular biology related to the diagnosis of human genetic abnormalities within the specialty of genetics, or other specialty or subspecialty specified by regulation adopted by the department.
(5)For a person licensed under this chapter as a clinical cytogeneticist scientist, the subspecialty of cytogenetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(6)For a person licensed under this chapter as a clinical biochemical geneticist scientist, the subspecialty of biochemical genetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(7)For a person licensed under this chapter as a clinical reproductive biologist scientist, the specialty of reproductive biology, or other specialty or subspecialty specified by regulation adopted by the department.
(8)For a person licensed under this chapter as a clinical immunohematologist scientist, the specialty of immunohematology or other specialty or subspecialty specified by regulation adopted by the department.
(9)For a person licensed under this chapter as a clinical histocompatibility scientist, the specialty of histocompatibility or other specialty or subspecialty specified by regulation adopted by the department.
(c)Clinical chemist scientists, clinical microbiologist scientists, clinical toxicologist scientists, clinical immunohematologist scientists, clinical genetic molecular biologist scientists, clinical cytogeneticist scientists, and clinical histocompatibility scientists shall engage in clinical laboratory practice authorized by their licensure only under the overall operation and administration of a laboratory director.
SEC. 8.Section 1260 of the Business and Professions Code is amended to read:1260.The department shall issue a clinical laboratory bioanalysts license to each person who is a lawful holder of a degree of master of arts, master of science, or an equivalent or higher degree as determined by the department with a major in chemical, physical, biological, or clinical laboratory sciences. This education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the department. The applicant also shall have a minimum of four years experience as a clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory certified under CLIA. The quality and variety of this experience shall be satisfactory to the department and shall have been obtained within the six-year period immediately antecedent to admission to the examination. The applicant shall successfully pass a written examination and an oral examination conducted by the department or a committee designated by the department to conduct the examinations, indicating that the applicant is properly qualified. The department may issue a license without conducting a written examination to an applicant who has passed a written examination of a national accrediting board having requirements that are, in the determination of the department, equal to or greater than those required by this chapter and regulations adopted by the department. The department shall establish by regulation the required courses to be included in the college or university training.
SEC. 9.Section 1261.5 of the Business and Professions Code is amended to read:1261.5.The department may issue limited clinical laboratory scientists licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, reproductive biology, biochemical genetics, genetic molecular biology, cytogenetics, or other areas of laboratory specialty or subspecialty when determined to be necessary by the department in order for licensure categories to keep abreast of changes in laboratory or scientific technology. Whenever the department determines that a new limited clinical laboratory scientist license category is necessary, it shall adopt regulations identifying the category and the areas of specialization included within the category.
To qualify for admission to the examination for a special clinical laboratory scientists license, an applicant shall have all the following:
(a)Have graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate or higher degree with a major appropriate to the field for which a license is being sought.
(b)Have one year of full-time postgraduate training or experience in the various areas of analysis in the field for which a license is being sought in a laboratory that has a license issued under this chapter or which the department determines is equivalent thereto.
(c)Whenever a limited clinical laboratory scientists license is established for a specific area of specialization, the department may issue the license without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to implement this section.
SEC. 10.Section 1264 of the Business and Professions Code is amended to read:1264.The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical reproductive biologist, clinical biochemical geneticist, clinical molecular biologist, or clinical cytogeneticist license to each person who has applied for the license on forms provided by the department, who is a lawful holder of a master of science or doctoral degree in the specialty for which the applicant is seeking a license and who has met such additional reasonable qualifications of training, education, and experience as the department may establish by regulations. The department shall issue an oral and maxillofacial pathologist license to every applicant for licensure who has applied for the license on forms provided by the department, who is a registered Diplomate of the American Board of Oral and Maxillofacial Pathology, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulation.
(a)The graduate education shall have included 30 semester hours of coursework in the applicants specialty. Applicants possessing only a master of science degree shall have the equivalent of one year of full-time, directed study or training in procedures and principles involved in the development, modification, or evaluation of laboratory methods, including training in complex methods applicable to diagnostic laboratory work. Each applicant must have had one year of training in his or her specialty in a clinical laboratory acceptable to the department and three years of experience in his or her specialty in a clinical laboratory, two years of which must have been at a supervisory level. The education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by an agency acceptable to the department. The department shall determine by examination that the applicant is properly qualified. Examinations, training, or experience requirements for specialty licenses shall cover only the specialty concerned.
(b)The department may issue licenses without examination to applicants who have passed examinations of other states or national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of other state requirements or requirements of national accrediting boards shall be carried out by the department with the assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by another state or national accrediting board prior to the establishment of requirements that are equal to or exceed those of this chapter or regulations of the department.
(c)The department may issue licenses without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to conform to this section.
SEC. 11.Section 1300 of the Business and Professions Code is amended to read:1300.The amount of application, registration, and license fees under this chapter shall be as follows:
(a)The application fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical reproductive biologists, clinical biochemical geneticists, clinical cytogeneticists, or clinical molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(b)The annual renewal fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical reproductive biologists, clinical biochemical geneticists, clinical cytogeneticists, or clinical molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(c)The application fee for a clinical laboratory scientists or limited clinical laboratory scientists license is thirty-eight dollars ($38) commencing on July 1, 1983.
(d)The application and annual renewal fee for a cytotechnologists license is fifty dollars ($50) commencing on January 1, 1991.
(e)The annual renewal fee for a clinical laboratory scientists or limited clinical laboratory scientists license is twenty-five dollars ($25) commencing on July 1, 1983.
(f)A clinical laboratory applying for a license to perform tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory applying for certification under subdivision (c) of Section 1223 shall pay an application fee for that license or certification based on the number of tests it performs or expects to perform in a year, as follows:
(1)Less than 2,001 tests: two hundred seventy dollars ($270).
(2)Between 2,001 and 10,000, inclusive, tests: eight hundred twenty dollars ($820).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand three hundred fifteen dollars ($1,315).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand five hundred eighty dollars ($1,580).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand nine hundred sixty dollars ($1,960).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand three hundred forty dollars ($2,340).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand seven hundred forty dollars ($2,740).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand nine hundred ten dollars ($4,910).
(9)More than 1,000,000 tests: five thousand two hundred sixty dollars ($5,260) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(g)A clinical laboratory performing tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory with a certificate issued under subdivision (c) of Section 1223 shall pay an annual renewal fee based on the number of tests it performed in the preceding calendar year, as follows:
(1)Less than 2,001 tests: one hundred seventy dollars ($170).
(2)Between 2,001 and 10,000, inclusive, tests: seven hundred twenty dollars ($720).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand one hundred fifteen dollars ($1,115).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand three hundred eighty dollars ($1,380).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand seven hundred sixty dollars ($1,760).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand forty dollars ($2,040).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand four hundred forty dollars ($2,440).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand six hundred ten dollars ($4,610).
(9)More than 1,000,000 tests per year: four thousand nine hundred sixty dollars ($4,960) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(h)The application fee for a trainees license is thirteen dollars ($13) commencing on July 1, 1983.
(i)The annual renewal fee for a trainees license is eight dollars ($8) commencing on July 1, 1983.
(j)The application fee for a duplicate license is five dollars ($5) commencing on July 1, 1983.
(k)The personnel licensing delinquency fee is equal to the annual renewal fee.
(l)The director may establish a fee for examinations required under this chapter. The fee shall not exceed the total cost to the department in conducting the examination.
(m)A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only those clinical laboratory tests or examinations considered waived under CLIA shall pay an annual fee of one hundred dollars ($100). A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only provider-performed microscopy, as defined under CLIA, shall pay an annual fee of one hundred fifty dollars ($150). A clinical laboratory performing both waived and provider-performed microscopy shall pay an annual registration fee of one hundred fifty dollars ($150).
(n)The costs of the department in conducting a complaint investigation, imposing sanctions, or conducting a hearing under this chapter shall be paid by the clinical laboratory. The fee shall be no greater than the fee the laboratory would pay under CLIA for the same type of activities and shall not be payable if the clinical laboratory would not be required to pay those fees under CLIA.
(o)The state, a district, city, county, city and county, or other political subdivision, or any public officer or body shall be subject to the payment of fees established pursuant to this chapter or regulations adopted thereunder.
(p)In addition to the payment of registration or licensure fees, a clinical laboratory located outside the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections at the clinical laboratory in order to ensure compliance with this chapter.
(q)The department shall establish an application fee and a renewal fee for a medical laboratory technician license, the total fees collected not to exceed the costs of the department for the implementation and operation of the program licensing and regulating medical laboratory technicians pursuant to Section 1260.3.
(r)The costs of the department to conduct any reinspections to ensure compliance of a laboratory applying for initial licensure shall be paid by the laboratory. This additional cost for each visit shall be equal to the initial application fee and shall be paid by the laboratory prior to issuance of a license. The department shall not charge a reinspection fee if the reinspection is due to error or omission on the part of the department.
(s)A fee of twenty-five dollars ($25) shall be assessed for approval of each additional location authorized by paragraph (2) of subdivision (d) of Section 1265.
(t)On or before July 1, 2013, the department shall report to the Legislature during the annual legislative budget hearing process the extent to which the state oversight program meets or exceeds federal oversight standards and the extent to which the federal Department of Health and Human Services is accepting exemption applications and the potential cost to the state for an exemption.
As used in this chapter, clinical laboratory bioanalyst or bioanalyst means a person licensed under Section 1260 to engage in clinical laboratory practice and direction of a clinical laboratory. A
(a)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA CLIA, who is not the CLIA laboratory director, may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a laboratory director, director in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department.
(b)A person licensed as a clinical laboratory bioanalyst or bioanalyst and qualified under CLIA may perform the duties and responsibilities of a CLIA laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the department. A
(c)A person licensed as a clinical laboratory bioanalyst or bioanalyst may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
SECTION 1.SEC. 2.Section 1204 of the Business and Professions Code is amended to read:1204.As used in this chapter, clinical laboratory scientist means any person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed under Sections 1261 and 1262 to engage in clinical laboratory practice under the overall operation and administration of a laboratory director, unless serving as a director of a waived laboratory as provided in Section 1209. A person licensed as a clinical laboratory scientist and qualified under CLIA may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a waived laboratory director, as specified under CLIA, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, reproductive biology, or other specialty or subspecialty specified by regulation adopted by the department. A person licensed as a clinical laboratory scientist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
SEC. 2.SEC. 3.Section 1205 of the Business and Professions Code is amended to read:1205.As used in this chapter, trainee means any person licensed under this chapter for the purpose of receiving comprehensive practical experience and instruction in clinical laboratory procedures in one of the sciences or in general clinical laboratory science under the direct and responsible supervision of a person authorized to direct a laboratory under the provisions of this chapter, clinical laboratory scientist, clinical chemist scientist, clinical microbiologist scientist, clinical toxicologist scientist, clinical immunohematologist scientist, clinical genetic molecular biologist scientist, clinical cytogeneticist scientist, clinical biochemical geneticist scientist, clinical reproductive biologist scientist, clinical histocompatibility scientist, or other equivalent licensee in the science or specialty or subspecialty for which he or she is licensed in a clinical laboratory certified for this purpose by the department under this chapter.
SEC. 3.SEC. 4.Section 1206 of the Business and Professions Code is amended to read:1206.(a)For the purposes of this chapter the following definitions are applicable:
(1)Analyte means the substance or constituent being measured including, but not limited to, glucose, sodium, or theophyline, or any substance or property whose presence or absence, concentration, activity, intensity, or other characteristics are to be determined.
(2)Biological specimen means any material that is derived from the human body.
(3)Blood electrolyte analysis means the measurement of electrolytes in a blood specimen by means of ion selective electrodes on instruments specifically designed and manufactured for blood gas and acid-base analysis.
(4)Blood gas analysis means a clinical laboratory test or examination that deals with the uptake, transport, and metabolism of oxygen and carbon dioxide in the human body.
(5)Clinical laboratory test or examination means the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within a biological specimen for the purpose of obtaining scientific data which may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual.
(6)Clinical laboratory science means any of the sciences or scientific disciplines used to perform a clinical laboratory test or examination.
(7)Clinical laboratory practice means the application of clinical laboratory sciences or the use of any means that applies the clinical laboratory sciences within or outside of a licensed or registered clinical laboratory. Clinical laboratory practice includes consultation, advisory, and other activities inherent to the profession.
(8)Clinical laboratory means any place used, or any establishment or institution organized or operated, for the performance of clinical laboratory tests or examinations or the practical application of the clinical laboratory sciences. That application may include any means that applies the clinical laboratory sciences.
(9)Direct and constant supervision means personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the unlicensed laboratory personnel are engaged in the duties specified in Section 1269.
(10)Direct and responsible supervision means both of the following:
(A)Personal observation and critical evaluation of the activity of a trainee by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the trainee is performing clinical laboratory tests or examinations.
(B)Personal review by the physician and surgeon or the licensed person of all results of clinical laboratory testing or examination performed by the trainee for accuracy, reliability, and validity before the results are reported from the laboratory.
(11)Licensed laboratory means a clinical laboratory licensed pursuant to paragraph (1) of subdivision (a) of Section 1265.
(12)Location means either a street and city address, or a site or place within a street and city address, where any of the clinical laboratory sciences or scientific disciplines are practiced or applied, or where any clinical laboratory tests or examinations are performed.
(13)Physician office laboratory means a clinical laboratory that is licensed or registered under Section 1265, and that is either: (A) a clinical laboratory that is owned and operated by a partnership or professional corporation that performs clinical laboratory tests or examinations only for patients of five or fewer physicians and surgeons or podiatrists who are shareholders, partners, or employees of the partnership or professional corporation that owns and operates the clinical laboratory; or (B) a clinical laboratory that is owned and operated by an individual licensed physician and surgeon or a podiatrist, and that performs clinical laboratory tests or examinations only for patients of the physician and surgeon or podiatrist who owns and operates the clinical laboratory.
(14)Point-of-care laboratory testing device means a portable laboratory testing instrument to which the following applies:
(A)It is used within the proximity of the patient for whom the test or examination is being conducted.
(B)It is used in accordance with the patient test management system, the quality control program, and the comprehensive quality assurance program established and maintained by the laboratory pursuant to paragraph (2) of subdivision (d) of Section 1220.
(C)It meets the following criteria:
(i)Performs clinical laboratory tests or examinations classified as waived or of moderate complexity under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).
(ii)Performs clinical laboratory tests or examinations on biological specimens that require no preparation after collection.
(iii)Provides clinical laboratory tests or examination results without calculation or discretionary intervention by the testing personnel.
(iv)Performs clinical laboratory tests or examinations without the necessity for testing personnel to perform calibration or maintenance, except resetting pursuant to the manufacturers instructions or basic cleaning.
(15)Public health laboratory means a laboratory that is operated by a city or county in conformity with Article 5 (commencing with Section 101150) of Chapter 2 of Part 3 of Division 101 of the Health and Safety Code and the regulations adopted thereunder.
(16)Registered laboratory means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.
(17)Specialty means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.
(18)Subspecialty for purposes of microbiology, means bacteriology, mycobacteriology, mycology, parasitology, virology, molecular biology, and serology for diagnosis of infectious diseases, or other subspecialty specified by regulation adopted by the department; for purposes of diagnostic immunology, means syphilis serology, general immunology, or other subspecialty specified by regulation adopted by the department; for purposes of chemistry, means routine chemistry, clinical microscopy, endocrinology, toxicology, or other subspecialty specified by regulation adopted by the department; for purposes of immunohematology, means ABO/Rh Type and Group, antibody detection for transfusion, antibody detection nontransfusion, antibody identification, compatibility, or other subspecialty specified by regulation adopted by the department; for pathology, means tissue pathology, oral pathology, diagnostic cytology, or other subspecialty specified by regulation adopted by the department; for purposes of genetics, means molecular biology related to the diagnosis of human genetic abnormalities, cytogenetics, biochemical genetics, or other subspecialty specified by regulation adopted by the department.
(b)Nothing in this chapter shall restrict, limit, or prevent any person licensed to provide health care services under the laws of this state, including, but not limited to, licensed physicians and surgeons and registered nurses, from practicing the profession or occupation for which he or she is licensed.
(c)Nothing in this chapter shall authorize any person to perform or order health care services, or utilize the results of the clinical laboratory test or examination, unless the person is otherwise authorized to provide that care or utilize the results. The inclusion of a person in Section 1206.5 for purposes of performing a clinical laboratory test or examination shall not be interpreted to authorize a person, who is not otherwise authorized, to perform venipuncture, arterial puncture, or skin puncture.
SEC. 4.SEC. 5.Section 1207 of the Business and Professions Code is amended to read:1207.(a)(1)(A)As used in this chapter, clinical chemist, or clinical microbiologist, or clinical toxicologist, or clinical genetic molecular biologist, or clinical cytogeneticist, or clinical reproductive biologist, or clinical biochemical geneticist, or oral and maxillofacial pathologist means any person licensed by the department under Section 1264 to engage in, or supervise others engaged in, clinical laboratory practice limited to his or her area of specialization or to direct a clinical laboratory, or portion thereof, limited to his or her area of specialization. Such a licensed person who specialization.
(B)A person described in subparagraph (A) may perform the duties and responsibilities of a laboratory director, who is not the CLIA laboratory director, limited to his or her area of specialty or subspecialty as described in subdivision (b), and shall only direct a clinical laboratory providing service within those specialties or subspecialties.
(C)If a person described in subparagraph (A) is qualified under CLIA CLIA, he or she may perform clinical laboratory tests or examinations classified as of high complexity under CLIA, and the duties and responsibilities of a CLIA laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, limited to his or her area of specialty or subspecialty as described in subdivision (b), and shall only direct a clinical laboratory providing service within those specialties or subspecialties. A
(2)A person licensed as a clinical chemist, or clinical microbiologist, or clinical toxicologist, or clinical genetic molecular biologist, or clinical cytogeneticist, or clinical reproductive biologist, or clinical biochemical geneticist, or oral and maxillofacial pathologist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
(b)The specialty or subspecialty for each of the limited license categories identified in subdivision (a), and the clinical laboratories that may be directed by persons licensed in each of those categories, are the following:
(1)For a person licensed under this chapter as a clinical chemist, the specialty of chemistry and the subspecialties of routine chemistry, endocrinology, clinical microscopy, toxicology, or other specialty or subspecialty specified by regulation adopted by the department.
(2)For a person licensed under this chapter as a clinical microbiologist, the specialty of microbiology and the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology, molecular biology, and serology for diagnosis of infectious diseases, or other specialty or subspecialty specified by regulation adopted by the department.
(3)For a person licensed under this chapter as a clinical toxicologist, the subspecialty of toxicology within the specialty of chemistry or other specialty or subspecialty specified by regulation adopted by the department.
(4)For a person licensed under this chapter as a clinical genetic molecular biologist, the subspecialty of molecular biology related to diagnosis of human genetic abnormalities within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(5)For a person licensed under this chapter as a clinical cytogeneticist, the subspecialty of cytogenetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(6)For a person licensed under this chapter as a clinical biochemical geneticist, the subspecialty of biochemical genetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(7)For a person licensed under this chapter as a clinical reproductive biologist, the specialty of reproductive biology or other specialty or subspecialty specified by regulation adopted by the department.
(8)For a person licensed under this chapter as an oral and maxillofacial pathologist, the subspecialty of oral pathology within the specialty of pathology or other specialty or subspecialty specified by regulation adopted by the department.
SEC. 5.SEC. 6.Section 1209 of the Business and Professions Code is amended to read:1209.(a)As used in this chapter, laboratory director means any person who is any of the following:
(1)A duly licensed physician and surgeon.
(2)Only for purposes of a clinical laboratory test or examination classified as waived, is any of the following:
(A)A duly licensed clinical laboratory scientist.
(B)A duly licensed limited clinical laboratory scientist.
(C)A duly licensed naturopathic doctor.
(D)A duly licensed optometrist serving as the director of a laboratory that only performs clinical laboratory tests authorized in paragraph (10) of subdivision (e) of Section 3041.
(3)Licensed to direct a clinical laboratory under this chapter.
(b)(1)A person defined in paragraph (1) or (3) of subdivision (a) who is identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity shall also meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory.
(2)As used in this subdivision, CLIA laboratory director means the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
(c)The laboratory director, if qualified under CLIA, may perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to persons qualified under CLIA. If the laboratory director reapportions performance of those responsibilities or duties, he or she shall remain responsible for ensuring that all those duties and responsibilities are properly performed.
(d)(1)The laboratory director is responsible for the overall operation and administration of the clinical laboratory, including administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with this act and CLIA. He or she shall be responsible for the proper performance of all laboratory work of all subordinates and shall employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with the personnel qualifications, duties, and responsibilities described in CLIA and this chapter.
(2)Where a point-of-care laboratory testing device is utilized and provides results for more than one analyte, the testing personnel may perform and report the results of all tests ordered for each analyte for which he or she has been found by the laboratory director to be competent to perform and report.
(e)As part of the overall operation and administration, the laboratory director of a registered laboratory shall document the adequacy of the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory test procedures and examinations. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for personnel, in addition to any CLIA requirements relative to the education or training of personnel.
(f)As part of the overall operation and administration, the laboratory director of a licensed laboratory shall do all of the following:
(1)Ensure that all personnel, prior to testing biological specimens, have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for, and the type of procedures that may be performed by, personnel in addition to any CLIA requirements relative to the education or training of personnel. Any regulations adopted pursuant to this section that specify the type of procedure that may be performed by testing personnel shall be based on the skills, knowledge, and tasks required to perform the type of procedure in question.
(2)Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process biological specimens, perform test procedures, and report test results promptly and proficiently, and, whenever necessary, identify needs for remedial training or continuing education to improve skills.
(3)Specify in writing the responsibilities and duties of each individual engaged in the performance of the preanalytic, analytic, and postanalytic phases of clinical laboratory tests or examinations, including which clinical laboratory tests or examinations the individual is authorized to perform, whether supervision is required for the individual to perform specimen processing, test performance, or results reporting, and whether consultant, supervisor, or director review is required prior to the individual reporting patient test results.
(g)The competency and performance of staff of a licensed laboratory shall be evaluated and documented by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA depending on the type and complexity of tests being offered by the laboratory.
(1)The procedures for evaluating the competency of the staff shall include, but are not limited to, all of the following:
(A)Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen handling, processing, and testing.
(B)Monitoring the recording and reporting of test results.
(C)Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
(D)Direct observation of performance of instrument maintenance and function checks.
(E)Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.
(F)Assessment of problem solving skills.
(2)Evaluation and documentation of staff competency and performance shall occur at least semiannually during the first year an individual tests biological specimens. Thereafter, evaluations shall be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance shall be reevaluated to include the use of the new test methodology or instrumentation.
(h)The laboratory director of each clinical laboratory of an acute care hospital shall be a physician and surgeon who is a qualified pathologist, except as follows:
(1)If a qualified pathologist is not available, a physician and surgeon or a clinical laboratory bioanalyst qualified as a laboratory director under subdivision (a) may direct the laboratory. However, a qualified pathologist shall be available for consultation at suitable intervals to ensure high-quality service.
(2)If there are two or more clinical laboratories of an acute care hospital, those additional clinical laboratories that are limited to the performance of blood gas analysis, blood electrolyte analysis, or both, may be directed by a physician and surgeon qualified as a laboratory director under subdivision (a), irrespective of whether a pathologist is available.
As used in this subdivision, a qualified pathologist is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.
(i)Subdivision (h) does not apply to any director of a clinical laboratory of an acute care hospital acting in that capacity on or before January 1, 1988.
(j)A laboratory director may serve as the director of up to the maximum number of laboratories stipulated by CLIA, as defined under Section 1202.5.
SEC. 6.SEC. 7.Section 1210 of the Business and Professions Code is amended to read:1210.(a)As used in this chapter, clinical chemist scientist, clinical microbiologist scientist, clinical toxicologist scientist, clinical immunohematologist scientist, clinical genetic molecular biologist scientist, clinical biochemical geneticist scientist, clinical reproductive biologist scientist, clinical cytogeneticist scientist, and clinical histocompatibility scientist means any person, other than a person licensed to direct a clinical laboratory, or licensed as a clinical laboratory scientist or trainee, who is licensed under Sections 1261, 1261.5, and 1262 to engage in clinical laboratory practice. Such a licensed person who is qualified under CLIA may perform clinical laboratory tests classified as of high complexity under CLIA and the duties and responsibilities of a technical consultant, clinical consultant, technical supervisor, and general supervisor limited to the specialty or subspecialty as identified in subdivision (b) for which he or she is licensed by the department. A person licensed as a clinical chemist scientist, or clinical microbiologist scientist, or clinical toxicologist scientist, or clinical immunohematologist scientist, or clinical genetic molecular biologist scientist, or clinical biochemical geneticist scientist, or clinical reproductive biologist scientist, or clinical cytogeneticist scientist, or a clinical histocompatibility scientist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
(b)The specialties and subspecialties included in each of the license categories identified in subdivision (a), are the following:
(1)For a person licensed under this chapter as a clinical chemist scientist, the specialty of chemistry and the subspecialties of routine chemistry, endocrinology, clinical microscopy, toxicology, or other specialty or subspecialty specified by regulation adopted by the department.
(2)For a person licensed under this chapter as a clinical microbiologist scientist, the specialty of microbiology and the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology, or molecular biology and serology for diagnosis of infectious diseases, or other specialty or subspecialty specified by regulation adopted by the department.
(3)For a person licensed under this chapter as a clinical toxicologist scientist, the subspecialty of toxicology within the specialty of chemistry or other specialty or subspecialty specified by regulation adopted by the department.
(4)For a person licensed under this chapter as a clinical genetic molecular biologist scientist, the subspecialty of molecular biology related to the diagnosis of human genetic abnormalities within the specialty of genetics, or other specialty or subspecialty specified by regulation adopted by the department.
(5)For a person licensed under this chapter as a clinical cytogeneticist scientist, the subspecialty of cytogenetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(6)For a person licensed under this chapter as a clinical biochemical geneticist scientist, the subspecialty of biochemical genetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(7)For a person licensed under this chapter as a clinical reproductive biologist scientist, the specialty of reproductive biology, or other specialty or subspecialty specified by regulation adopted by the department.
(8)For a person licensed under this chapter as a clinical immunohematologist scientist, the specialty of immunohematology or other specialty or subspecialty specified by regulation adopted by the department.
(9)For a person licensed under this chapter as a clinical histocompatibility scientist, the specialty of histocompatibility or other specialty or subspecialty specified by regulation adopted by the department.
(c)Clinical chemist scientists, clinical microbiologist scientists, clinical toxicologist scientists, clinical immunohematologist scientists, clinical genetic molecular biologist scientists, clinical cytogeneticist scientists, and clinical histocompatibility scientists shall engage in clinical laboratory practice authorized by their licensure only under the overall operation and administration of a laboratory director.
SEC. 7.SEC. 8.Section 1260 of the Business and Professions Code is amended to read:1260.The department shall issue a clinical laboratory bioanalysts license to each person who is a lawful holder of a degree of master of arts, master of science, or an equivalent or higher degree as determined by the department with a major in chemical, physical, biological, or clinical laboratory sciences. This education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the department. The applicant also shall have a minimum of four years experience as a clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory certified under the CLIA. The quality and variety of this experience shall be satisfactory to the department and shall have been obtained within the six-year period immediately antecedent to admission to the examination. The applicant shall successfully pass a written examination and an oral examination conducted by the department or a committee designated by the department to conduct the examinations, indicating that the applicant is properly qualified. The department may issue a license without conducting a written examination to an applicant who has passed a written examination of a national accrediting board having requirements that are, in the determination of the department, equal to or greater than those required by this chapter and regulations adopted by the department. The department shall establish by regulation the required courses to be included in the college or university training.
SEC. 8.SEC. 9.Section 1261.5 of the Business and Professions Code is amended to read:1261.5.The department may issue limited clinical laboratory scientists licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, reproductive biology, biochemical genetics, genetic molecular biology, cytogenetics, or other areas of laboratory specialty or subspecialty when determined to be necessary by the department in order for licensure categories to keep abreast of changes in laboratory or scientific technology. Whenever the department determines that a new limited clinical laboratory scientist license category is necessary, it shall adopt regulations identifying the category and the areas of specialization included within the category.
To qualify for admission to the examination for a special clinical laboratory scientists license, an applicant shall have all the following:
(a)Have graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate or higher degree with a major appropriate to the field for which a license is being sought.
(b)Have one year of full-time postgraduate training or experience in the various areas of analysis in the field for which a license is being sought in a laboratory that has a license issued under this chapter or which the department determines is equivalent thereto.
(c)Whenever a limited clinical laboratory scientists license is established for a specific area of specialization, the department may issue the license without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to implement this section.
SEC. 9.SEC. 10.Section 1264 of the Business and Professions Code is amended to read:1264.The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical reproductive biologist, clinical biochemical geneticist, clinical molecular biologist, or clinical cytogeneticist license to each person who has applied for the license on forms provided by the department, who is a lawful holder of a master of science or doctoral degree in the specialty for which the applicant is seeking a license and who has met such additional reasonable qualifications of training, education, and experience as the department may establish by regulations. The department shall issue an oral and maxillofacial pathologist license to every applicant for licensure who has applied for the license on forms provided by the department, who is a registered Diplomate of the American Board of Oral and Maxillofacial Pathology, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulation.
(a)The graduate education shall have included 30 semester hours of coursework in the applicants specialty. Applicants possessing only a master of science degree shall have the equivalent of one year of full-time, directed study or training in procedures and principles involved in the development, modification modification, or evaluation of laboratory methods, including training in complex methods applicable to diagnostic laboratory work. Each applicant must have had one year of training in his or her specialty in a clinical laboratory acceptable to the department and three years of experience in his or her specialty in a clinical laboratory, two years of which must have been at a supervisory level. The education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by an agency acceptable to the department. The department shall determine by examination that the applicant is properly qualified. Examinations, training, or experience requirements for specialty licenses shall cover only the specialty concerned.
(b)The department may issue licenses without examination to applicants who have passed examinations of other states or national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of other state requirements or requirements of national accrediting boards shall be carried out by the department with the assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by another state or national accrediting board prior to the establishment of requirements that are equal to or exceed those of this chapter or regulations of the department.
(c)The department may issue licenses without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to conform to this section.
SEC. 10.SEC. 11.Section 1300 of the Business and Professions Code is amended to read:1300.The amount of application, registration, and license fees under this chapter shall be as follows:
(a)The application fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical reproductive biologists, clinical biochemical geneticists, clinical cytogeneticists, or clinical molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(b)The annual renewal fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical reproductive biologists, clinical biochemical geneticists, clinical cytogeneticists, or clinical molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(c)The application fee for a clinical laboratory scientists or limited clinical laboratory scientists license is thirty-eight dollars ($38) commencing on July 1, 1983.
(d)The application and annual renewal fee for a cytotechnologists license is fifty dollars ($50) commencing on January 1, 1991.
(e)The annual renewal fee for a clinical laboratory scientists or limited clinical laboratory scientists license is twenty-five dollars ($25) commencing on July 1, 1983.
(f)A clinical laboratory applying for a license to perform tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory applying for certification under subdivision (c) of Section 1223 shall pay an application fee for that license or certification based on the number of tests it performs or expects to perform in a year, as follows:
(1)Less than 2,001 tests: two hundred seventy dollars ($270).
(2)Between 2,001 and 10,000, inclusive, tests: eight hundred twenty dollars ($820).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand three hundred fifteen dollars ($1,315).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand five hundred eighty dollars ($1,580).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand nine hundred sixty dollars ($1,960).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand three hundred forty dollars ($2,340).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand seven hundred forty dollars ($2,740).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand nine hundred ten dollars ($4,910).
(9)More than 1,000,000 tests: five thousand two hundred sixty dollars ($5,260) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(g)A clinical laboratory performing tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory with a certificate issued under subdivision (c) of Section 1223 shall pay an annual renewal fee based on the number of tests it performed in the preceding calendar year, as follows:
(1)Less than 2,001 tests: one hundred seventy dollars ($170).
(2)Between 2,001 and 10,000, inclusive, tests: seven hundred twenty dollars ($720).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand one hundred fifteen dollars ($1,115).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand three hundred eighty dollars ($1,380).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand seven hundred sixty dollars ($1,760).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand forty dollars ($2,040).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand four hundred forty dollars ($2,440).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand six hundred ten dollars ($4,610).
(9)More than 1,000,000 tests per year: four thousand nine hundred sixty dollars ($4,960) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(h)The application fee for a trainees license is thirteen dollars ($13) commencing on July 1, 1983.
(i)The annual renewal fee for a trainees license is eight dollars ($8) commencing on July 1, 1983.
(j)The application fee for a duplicate license is five dollars ($5) commencing on July 1, 1983.
(k)The personnel licensing delinquency fee is equal to the annual renewal fee.
(l)The director may establish a fee for examinations required under this chapter. The fee shall not exceed the total cost to the department in conducting the examination.
(m)A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only those clinical laboratory tests or examinations considered waived under CLIA shall pay an annual fee of one hundred dollars ($100). A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only provider-performed microscopy, as defined under CLIA, shall pay an annual fee of one hundred fifty dollars ($150). A clinical laboratory performing both waived and provider-performed microscopy shall pay an annual registration fee of one hundred fifty dollars ($150).
(n)The costs of the department in conducting a complaint investigation, imposing sanctions, or conducting a hearing under this chapter shall be paid by the clinical laboratory. The fee shall be no greater than the fee the laboratory would pay under CLIA for the same type of activities and shall not be payable if the clinical laboratory would not be required to pay those fees under CLIA.
(o)The state, a district, city, county, city and county, or other political subdivision, or any public officer or body shall be subject to the payment of fees established pursuant to this chapter or regulations adopted thereunder.
(p)In addition to the payment of registration or licensure fees, a clinical laboratory located outside the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections at the clinical laboratory in order to ensure compliance with this chapter.
(q)The department shall establish an application fee and a renewal fee for a medical laboratory technician license, the total fees collected not to exceed the costs of the department for the implementation and operation of the program licensing and regulating medical laboratory technicians pursuant to Section 1260.3.
(r)The costs of the department to conduct any reinspections to ensure compliance of a laboratory applying for initial licensure shall be paid by the laboratory. This additional cost for each visit shall be equal to the initial application fee and shall be paid by the laboratory prior to issuance of a license. The department shall not charge a reinspection fee if the reinspection is due to error or omission on the part of the department.
(s)A fee of twenty-five dollars ($25) shall be assessed for approval of each additional location authorized by paragraph (2) of subdivision (d) of Section 1265.
(t)On or before July 1, 2013, the department shall report to the Legislature during the annual legislative budget hearing process the extent to which the state oversight program meets or exceeds federal oversight standards and the extent to which the federal Department of Health and Human Services is accepting exemption applications and the potential cost to the state for an exemption.
As used in this chapter, clinical laboratory scientist means any person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed under Sections 1261 and 1262 to engage in clinical laboratory practice under the overall operation and administration of a laboratory director, unless serving as a director of a waived laboratory as provided in Section 1209. A person licensed as a clinical laboratory scientist and qualified under CLIA may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a waived laboratory director, as specified under CLIA, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, reproductive biology, or other specialty or subspecialty specified by regulation adopted by the department. A person licensed as a clinical laboratory scientist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
SEC. 2.Section 1205 of the Business and Professions Code is amended to read:1205.As used in this chapter, trainee means any person licensed under this chapter for the purpose of receiving comprehensive practical experience and instruction in clinical laboratory procedures in one of the sciences or in general clinical laboratory science under the direct and responsible supervision of a person authorized to direct a laboratory under the provisions of this chapter, clinical laboratory scientist, clinical chemist scientist, clinical microbiologist scientist, clinical toxicologist scientist, clinical immunohematologist scientist, clinical genetic molecular biologist scientist, clinical cytogeneticist scientist, clinical biochemical geneticist scientist, clinical reproductive biologist scientist, clinical histocompatibility scientist, or other equivalent licensee in the science or specialty or subspecialty for which he or she is licensed in a clinical laboratory certified for this purpose by the department under this chapter.
SEC. 3.Section 1206 of the Business and Professions Code is amended to read:1206.(a)For the purposes of this chapter the following definitions are applicable:
(1)Analyte means the substance or constituent being measured including, but not limited to, glucose, sodium, or theophyline, or any substance or property whose presence or absence, concentration, activity, intensity, or other characteristics are to be determined.
(2)Biological specimen means any material that is derived from the human body.
(3)Blood electrolyte analysis means the measurement of electrolytes in a blood specimen by means of ion selective electrodes on instruments specifically designed and manufactured for blood gas and acid-base analysis.
(4)Blood gas analysis means a clinical laboratory test or examination that deals with the uptake, transport, and metabolism of oxygen and carbon dioxide in the human body.
(5)Clinical laboratory test or examination means the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within a biological specimen for the purpose of obtaining scientific data which may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual.
(6)Clinical laboratory science means any of the sciences or scientific disciplines used to perform a clinical laboratory test or examination.
(7)Clinical laboratory practice means the application of clinical laboratory sciences or the use of any means that applies the clinical laboratory sciences within or outside of a licensed or registered clinical laboratory. Clinical laboratory practice includes consultation, advisory, and other activities inherent to the profession.
(8)Clinical laboratory means any place used, or any establishment or institution organized or operated, for the performance of clinical laboratory tests or examinations or the practical application of the clinical laboratory sciences. That application may include any means that applies the clinical laboratory sciences.
(9)Direct and constant supervision means personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the unlicensed laboratory personnel are engaged in the duties specified in Section 1269.
(10)Direct and responsible supervision means both of the following:
(A)Personal observation and critical evaluation of the activity of a trainee by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the trainee is performing clinical laboratory tests or examinations.
(B)Personal review by the physician and surgeon or the licensed person of all results of clinical laboratory testing or examination performed by the trainee for accuracy, reliability, and validity before the results are reported from the laboratory.
(11)Licensed laboratory means a clinical laboratory licensed pursuant to paragraph (1) of subdivision (a) of Section 1265.
(12)Location means either a street and city address, or a site or place within a street and city address, where any of the clinical laboratory sciences or scientific disciplines are practiced or applied, or where any clinical laboratory tests or examinations are performed.
(13)Physician office laboratory means a clinical laboratory that is licensed or registered under Section 1265, and that is either: (A) a clinical laboratory that is owned and operated by a partnership or professional corporation that performs clinical laboratory tests or examinations only for patients of five or fewer physicians and surgeons or podiatrists who are shareholders, partners, or employees of the partnership or professional corporation that owns and operates the clinical laboratory; or (B) a clinical laboratory that is owned and operated by an individual licensed physician and surgeon or a podiatrist, and that performs clinical laboratory tests or examinations only for patients of the physician and surgeon or podiatrist who owns and operates the clinical laboratory.
(14)Point-of-care laboratory testing device means a portable laboratory testing instrument to which the following applies:
(A)It is used within the proximity of the patient for whom the test or examination is being conducted.
(B)It is used in accordance with the patient test management system, the quality control program, and the comprehensive quality assurance program established and maintained by the laboratory pursuant to paragraph (2) of subdivision (d) of Section 1220.
(C)It meets the following criteria:
(i)Performs clinical laboratory tests or examinations classified as waived or of moderate complexity under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).
(ii)Performs clinical laboratory tests or examinations on biological specimens that require no preparation after collection.
(iii)Provides clinical laboratory tests or examination results without calculation or discretionary intervention by the testing personnel.
(iv)Performs clinical laboratory tests or examinations without the necessity for testing personnel to perform calibration or maintenance, except resetting pursuant to the manufacturers instructions or basic cleaning.
(15)Public health laboratory means a laboratory that is operated by a city or county in conformity with Article 5 (commencing with Section 101150) of Chapter 2 of Part 3 of Division 101 of the Health and Safety Code and the regulations adopted thereunder.
(16)Registered laboratory means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.
(17)Specialty means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, reproductive biology, or other specialty specified by regulation adopted by the department.
(18)Subspecialty for purposes of microbiology, means bacteriology, mycobacteriology, mycology, parasitology, virology, molecular biology, and serology for diagnosis of infectious diseases, or other subspecialty specified by regulation adopted by the department; for purposes of diagnostic immunology, means syphilis serology, general immunology, or other subspecialty specified by regulation adopted by the department; for purposes of chemistry, means routine chemistry, clinical microscopy, endocrinology, toxicology, or other subspecialty specified by regulation adopted by the department; for purposes of immunohematology, means ABO/Rh Type and Group, antibody detection for transfusion, antibody detection nontransfusion, antibody identification, compatibility, or other subspecialty specified by regulation adopted by the department; for pathology, means tissue pathology, oral pathology, diagnostic cytology, or other subspecialty specified by regulation adopted by the department; for purposes of genetics, means molecular biology related to the diagnosis of human genetic abnormalities, cytogenetics, biochemical genetics, or other subspecialty specified by regulation adopted by the department.
(b)Nothing in this chapter shall restrict, limit, or prevent any person licensed to provide health care services under the laws of this state, including, but not limited to, licensed physicians and surgeons and registered nurses, from practicing the profession or occupation for which he or she is licensed.
(c)Nothing in this chapter shall authorize any person to perform or order health care services, or utilize the results of the clinical laboratory test or examination, unless the person is otherwise authorized to provide that care or utilize the results. The inclusion of a person in Section 1206.5 for purposes of performing a clinical laboratory test or examination shall not be interpreted to authorize a person, who is not otherwise authorized, to perform venipuncture, arterial puncture, or skin puncture.
SEC. 4.Section 1207 of the Business and Professions Code is amended to read:1207.(a)As used in this chapter, clinical chemist, or clinical microbiologist, or clinical toxicologist, or clinical genetic molecular biologist, or clinical cytogeneticist, or clinical reproductive biologist, or clinical biochemical geneticist, or oral and maxillofacial pathologist means any person licensed by the department under Section 1264 to engage in, or supervise others engaged in, clinical laboratory practice limited to his or her area of specialization or to direct a clinical laboratory, or portion thereof, limited to his or her area of specialization. Such a licensed person who is qualified under CLIA may perform clinical laboratory tests or examinations classified as of high complexity under CLIA, and the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, limited to his or her area of specialty or subspecialty as described in subdivision (b), and shall only direct a clinical laboratory providing service within those specialties or subspecialties. A person licensed as a clinical chemist, or clinical microbiologist, or clinical toxicologist, or clinical genetic molecular biologist, or clinical cytogeneticist, or clinical reproductive biologist, or clinical biochemical geneticist, or oral and maxillofacial pathologist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
(b)The specialty or subspecialty for each of the limited license categories identified in subdivision (a), and the clinical laboratories that may be directed by persons licensed in each of those categories, are the following:
(1)For a person licensed under this chapter as a clinical chemist, the specialty of chemistry and the subspecialties of routine chemistry, endocrinology, clinical microscopy, toxicology, or other specialty or subspecialty specified by regulation adopted by the department.
(2)For a person licensed under this chapter as a clinical microbiologist, the specialty of microbiology and the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology, molecular biology, and serology for diagnosis of infectious diseases, or other specialty or subspecialty specified by regulation adopted by the department.
(3)For a person licensed under this chapter as a clinical toxicologist, the subspecialty of toxicology within the specialty of chemistry or other specialty or subspecialty specified by regulation adopted by the department.
(4)For a person licensed under this chapter as a clinical genetic molecular biologist, the subspecialty of molecular biology related to diagnosis of human genetic abnormalities within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(5)For a person licensed under this chapter as a clinical cytogeneticist, the subspecialty of cytogenetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(6)For a person licensed under this chapter as a clinical biochemical geneticist, the subspecialty of biochemical genetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(7)For a person licensed under this chapter as a clinical reproductive biologist, the specialty of reproductive biology or other specialty or subspecialty specified by regulation adopted by the department.
(6)
(8)For a person licensed under this chapter as an oral and maxillofacial pathologist, the subspecialty of oral pathology within the specialty of pathology or other specialty or subspecialty specified by regulation adopted by the department.
SECTION 1.SEC. 5.Section 1209 of the Business and Professions Code is amended to read:1209.(a)As used in this chapter, laboratory director means any person who is any of the following:
(1)A duly licensed physician and surgeon.
(2)Only for purposes of a clinical laboratory test or examination classified as waived, is any of the following:
(A)A duly licensed clinical laboratory scientist.
(B)A duly licensed limited clinical laboratory scientist.
(C)A duly licensed naturopathic doctor.
(D)A duly licensed optometrist serving as the director of a laboratory that only performs clinical laboratory tests authorized in paragraph (10) of subdivision (e) of Section 3041.
(3)Licensed to direct a clinical laboratory under this chapter.
(b)(1)A person defined in paragraph (1) or (3) of subdivision (a) who is identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity shall also meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory.
(2)As used in this subdivision, CLIA laboratory director means the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
(c)The laboratory director, if qualified under CLIA, may perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to persons qualified under CLIA. If the laboratory director reapportions performance of those responsibilities or duties, he or she shall remain responsible for ensuring that all those duties and responsibilities are properly performed.
(d)(1)The laboratory director is responsible for the overall operation and administration of the clinical laboratory, including administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with this act and CLIA. He or she shall be responsible for the proper performance of all laboratory work of all subordinates and shall employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with the personnel qualifications, duties, and responsibilities described in CLIA and this chapter.
(2)Where a point-of-care laboratory testing device is utilized and provides results for more than one analyte, the testing personnel may perform and report the results of all tests ordered for each analyte for which he or she has been found by the laboratory director to be competent to perform and report.
(e)As part of the overall operation and administration, the laboratory director of a registered laboratory shall document the adequacy of the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory test procedures and examinations. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for personnel, in addition to any CLIA requirements relative to the education or training of personnel.
(f)As part of the overall operation and administration, the laboratory director of a licensed laboratory shall do all of the following:
(1)Ensure that all personnel, prior to testing biological specimens, have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for, and the type of procedures that may be performed by, personnel in addition to any CLIA requirements relative to the education or training of personnel. Any regulations adopted pursuant to this section that specify the type of procedure that may be performed by testing personnel shall be based on the skills, knowledge, and tasks required to perform the type of procedure in question.
(2)Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process biological specimens, perform test procedures, and report test results promptly and proficiently, and, whenever necessary, identify needs for remedial training or continuing education to improve skills.
(3)Specify in writing the responsibilities and duties of each individual engaged in the performance of the preanalytic, analytic, and postanalytic phases of clinical laboratory tests or examinations, including which clinical laboratory tests or examinations the individual is authorized to perform, whether supervision is required for the individual to perform specimen processing, test performance, or results reporting, and whether consultant, supervisor, or director review is required prior to the individual reporting patient test results.
(g)The competency and performance of staff of a licensed laboratory shall be evaluated and documented by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA depending on the type and complexity of tests being offered by the laboratory.
(1)The procedures for evaluating the competency of the staff shall include, but are not limited to, all of the following:
(A)Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen handling, processing, and testing.
(B)Monitoring the recording and reporting of test results.
(C)Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
(D)Direct observation of performance of instrument maintenance and function checks.
(E)Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.
(F)Assessment of problem solving skills.
(2)Evaluation and documentation of staff competency and performance shall occur at least semiannually during the first year an individual tests biological specimens. Thereafter, evaluations shall be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance shall be reevaluated to include the use of the new test methodology or instrumentation.
(h)The laboratory director of each clinical laboratory of an acute care hospital shall be a physician and surgeon who is a qualified pathologist, except as follows:
(1)If a qualified pathologist is not available, a physician and surgeon or a clinical laboratory bioanalyst qualified as a laboratory director under subdivision (a) may direct the laboratory. However, a qualified pathologist shall be available for consultation at suitable intervals to ensure high-quality service.
(2)If there are two or more clinical laboratories of an acute care hospital, those additional clinical laboratories that are limited to the performance of blood gas analysis, blood electrolyte analysis, or both, may be directed by a physician and surgeon qualified as a laboratory director under subdivision (a), irrespective of whether a pathologist is available.
As used in this subdivision, a qualified pathologist is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.
(i)Subdivision (h) does not apply to any director of a clinical laboratory of an acute care hospital acting in that capacity on or before January 1, 1988.
(j)A laboratory director may serve as the director of up to the maximum number of laboratories stipulated by CLIA, as defined under Section 1202.5.
SEC. 6.Section 1210 of the Business and Professions Code is amended to read:1210.(a)As used in this chapter, clinical chemist scientist, clinical microbiologist scientist, clinical toxicologist scientist, clinical immunohematologist scientist, clinical genetic molecular biologist scientist, clinical cytogeneticist scientist, and clinical histocompatibility scientist means any person, other than a person licensed to direct a clinical laboratory, or licensed as a clinical laboratory scientist or trainee, who is licensed under Sections 1261, 1261.5, and 1262 to engage in clinical laboratory practice. Such a licensed person who is qualified under CLIA may perform clinical laboratory tests classified as of high complexity under CLIA and the duties and responsibilities of a technical consultant, clinical consultant, technical supervisor, and general supervisor limited to the specialty or subspecialty as identified in subdivision (b) for which he or she is licensed by the department. A person licensed as a clinical chemist scientist, or clinical microbiologist scientist, or clinical toxicologist scientist, or clinical immunohematologist scientist, or clinical genetic molecular biologist scientist, or clinical cytogeneticist scientist, or a clinical histocompatibility scientist may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
(b)The specialties and subspecialties included in each of the license categories identified in subdivision (a), are the following:
(1)For a person licensed under this chapter as a clinical chemist scientist, the specialty of chemistry and the subspecialties of routine chemistry, endocrinology, clinical microscopy, toxicology, or other specialty or subspecialty specified by regulation adopted by the department.
(2)For a person licensed under this chapter as a clinical microbiologist scientist, the specialty of microbiology and the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology, or molecular biology and serology for diagnosis of infectious diseases, or other specialty or subspecialty specified by regulation adopted by the department.
(3)For a person licensed under this chapter as a clinical toxicologist scientist, the subspecialty of toxicology within the specialty of chemistry or other specialty or subspecialty specified by regulation adopted by the department.
(4)For a person licensed under this chapter as a clinical genetic molecular biologist scientist, the subspecialty of molecular biology related to the diagnosis of human genetic abnormalities within the specialty of genetics, or other specialty or subspecialty specified by regulation adopted by the department.
(5)For a person licensed under this chapter as a clinical cytogeneticist scientist, the subspecialty of cytogenetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(6)For a person licensed under this chapter as a clinical biochemical geneticist scientist, the subspecialty of biochemical genetics within the specialty of genetics or other specialty or subspecialty specified by regulation adopted by the department.
(7)For a person licensed under this chapter as a clinical reproductive biologist scientist, the specialty of reproductive biology, or other specialty or subspecialty specified by regulation adopted by the department.
(6)
(8)For a person licensed under this chapter as a clinical immunohematologist scientist, the specialty of immunohematology or other specialty or subspecialty specified by regulation adopted by the department.
(7)
(9)For a person licensed under this chapter as a clinical histocompatibility scientist, the specialty of histocompatibility or other specialty or subspecialty specified by regulation adopted by the department.
(c)Clinical chemist scientists, clinical microbiologist scientists, clinical toxicologist scientists, clinical immunohematologist scientists, clinical genetic molecular biologist scientists, clinical cytogeneticist scientists, and clinical histocompatibility scientists shall engage in clinical laboratory practice authorized by their licensure only under the overall operation and administration of a laboratory director.
SEC. 2.SEC. 7.Section 1260 of the Business and Professions Code is amended to read:1260.The department shall issue a clinical laboratory bioanalysts license to each person who is a lawful holder of a degree of master of arts, master of science, or an equivalent or higher degree as determined by the department with a major in chemical, physical, biological, or clinical laboratory sciences. This education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the department. The applicant also shall have a minimum of four years experience as a clinical laboratory scientist performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory certified under the CLIA. The quality and variety of this experience shall be satisfactory to the department and shall have been obtained within the six-year period immediately antecedent to admission to the examination. The applicant shall successfully pass a written examination and an oral examination conducted by the department or a committee designated by the department to conduct the examinations, indicating that the applicant is properly qualified. The department may issue a license without conducting a written examination to an applicant who has passed a written examination of a national accrediting board having requirements that are, in the determination of the department, equal to or greater than those required by this chapter and regulations adopted by the department. The department shall establish by regulation the required courses to be included in the college or university training.
SEC. 3.SEC. 8.Section 1261.5 of the Business and Professions Code is amended to read:1261.5.The department may issue limited clinical laboratory scientists licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, embroyology, reproductive biology, biochemical genetics, genetic molecular biology, cytogenetics, or other areas of laboratory specialty or subspecialty when determined to be necessary by the department in order for licensure categories to keep abreast of changes in laboratory or scientific technology. Whenever the department determines that a new limited clinical laboratory scientist license category is necessary, it shall adopt regulations identifying the category and the areas of specialization included within the category.
To qualify for admission to the examination for a special clinical laboratory scientists license, an applicant shall have all the following:
(a)Have graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate or higher degree with a major appropriate to the field for which a license is being sought.
(b)Have one year of full-time postgraduate training or experience in the various areas of analysis in the field for which a license is being sought in a laboratory that has a license issued under this chapter or which the department determines is equivalent thereto.
(c)Whenever a limited clinical laboratory scientists license is established for a specific area of specialization, the department may issue the license without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to implement this section.
SEC. 4.SEC. 9.Section 1264 of the Business and Professions Code is amended to read:1264.The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical embryologist, clinical reproductive biologist, clinical biochemical geneticist, clinical molecular biologist, or clinical cytogeneticist license to each person who has applied for the license on forms provided by the department, who is a lawful holder of a master of science or doctoral degree in the specialty for which the applicant is seeking a license and who has met such additional reasonable qualifications of training, education, and experience as the department may establish by regulations. The department shall issue an oral and maxillofacial pathologist license to every applicant for licensure who has applied for the license on forms provided by the department, who is a registered Diplomate of the American Board of Oral and Maxillofacial Pathology, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulation.
(a)The graduate education shall have included 30 semester hours of coursework in the applicants specialty. Applicants possessing only a master of science degree shall have the equivalent of one year of full-time, directed study or training in procedures and principles involved in the development, modification or evaluation of laboratory methods, including training in complex methods applicable to diagnostic laboratory work. Each applicant must have had one year of training in his or her specialty in a clinical laboratory acceptable to the department and three years of experience in his or her specialty in a clinical laboratory, two years of which must have been at a supervisory level. The education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by an agency acceptable to the department. The department shall determine by examination that the applicant is properly qualified. Examinations, training, or experience requirements for specialty licenses shall cover only the specialty concerned.
(b)The department may issue licenses without examination to applicants who have passed examinations of other states or national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of other state requirements or requirements of national accrediting boards shall be carried out by the department with the assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by another state or national accrediting board prior to the establishment of requirements that are equal to or exceed those of this chapter or regulations of the department.
(c)The department may issue licenses without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to conform to this section.
SEC. 5.SEC. 10.Section 1300 of the Business and Professions Code is amended to read:1300.The amount of application, registration, and license fees under this chapter shall be as follows:
(a)The application fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical embryologists, clinical reproductive biologists, clinical biochemical geneticists, clinical cytogeneticists, or clinical molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(b)The annual renewal fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical embryologists, clinical reproductive biologists, clinical biochemical geneticists, clinical cytogeneticists, or clinical molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(c)The application fee for a clinical laboratory scientists or limited clinical laboratory scientists license is thirty-eight dollars ($38) commencing on July 1, 1983.
(d)The application and annual renewal fee for a cytotechnologists license is fifty dollars ($50) commencing on January 1, 1991.
(e)The annual renewal fee for a clinical laboratory scientists or limited clinical laboratory scientists license is twenty-five dollars ($25) commencing on July 1, 1983.
(f)A clinical laboratory applying for a license to perform tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory applying for certification under subdivision (c) of Section 1223 shall pay an application fee for that license or certification based on the number of tests it performs or expects to perform in a year, as follows:
(1)Less than 2,001 tests: two hundred seventy dollars ($270).
(2)Between 2,001 and 10,000, inclusive, tests: eight hundred twenty dollars ($820).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand three hundred fifteen dollars ($1,315).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand five hundred eighty dollars ($1,580).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand nine hundred sixty dollars ($1,960).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand three hundred forty dollars ($2,340).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand seven hundred forty dollars ($2,740).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand nine hundred ten dollars ($4,910).
(9)More than 1,000,000 tests: five thousand two hundred sixty dollars ($5,260) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(g)A clinical laboratory performing tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory with a certificate issued under subdivision (c) of Section 1223 shall pay an annual renewal fee based on the number of tests it performed in the preceding calendar year, as follows:
(1)Less than 2,001 tests: one hundred seventy dollars ($170).
(2)Between 2,001 and 10,000, inclusive, tests: seven hundred twenty dollars ($720).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand one hundred fifteen dollars ($1,115).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand three hundred eighty dollars ($1,380).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand seven hundred sixty dollars ($1,760).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand forty dollars ($2,040).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand four hundred forty dollars ($2,440).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand six hundred ten dollars ($4,610).
(9)More than 1,000,000 tests per year: four thousand nine hundred sixty dollars ($4,960) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(h)The application fee for a trainees license is thirteen dollars ($13) commencing on July 1, 1983.
(i)The annual renewal fee for a trainees license is eight dollars ($8) commencing on July 1, 1983.
(j)The application fee for a duplicate license is five dollars ($5) commencing on July 1, 1983.
(k)The personnel licensing delinquency fee is equal to the annual renewal fee.
(l)The director may establish a fee for examinations required under this chapter. The fee shall not exceed the total cost to the department in conducting the examination.
(m)A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only those clinical laboratory tests or examinations considered waived under CLIA shall pay an annual fee of one hundred dollars ($100). A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only provider-performed microscopy, as defined under CLIA, shall pay an annual fee of one hundred fifty dollars ($150). A clinical laboratory performing both waived and provider-performed microscopy shall pay an annual registration fee of one hundred fifty dollars ($150).
(n)The costs of the department in conducting a complaint investigation, imposing sanctions, or conducting a hearing under this chapter shall be paid by the clinical laboratory. The fee shall be no greater than the fee the laboratory would pay under CLIA for the same type of activities and shall not be payable if the clinical laboratory would not be required to pay those fees under CLIA.
(o)The state, a district, city, county, city and county, or other political subdivision, or any public officer or body shall be subject to the payment of fees established pursuant to this chapter or regulations adopted thereunder.
(p)In addition to the payment of registration or licensure fees, a clinical laboratory located outside the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections at the clinical laboratory in order to ensure compliance with this chapter.
(q)The department shall establish an application fee and a renewal fee for a medical laboratory technician license, the total fees collected not to exceed the costs of the department for the implementation and operation of the program licensing and regulating medical laboratory technicians pursuant to Section 1260.3.
(r)The costs of the department to conduct any reinspections to ensure compliance of a laboratory applying for initial licensure shall be paid by the laboratory. This additional cost for each visit shall be equal to the initial application fee and shall be paid by the laboratory prior to issuance of a license. The department shall not charge a reinspection fee if the reinspection is due to error or omission on the part of the department.
(s)A fee of twenty-five dollars ($25) shall be assessed for approval of each additional location authorized by paragraph (2) of subdivision (d) of Section 1265.
(t)On or before July 1, 2013, the department shall report to the Legislature during the annual legislative budget hearing process the extent to which the state oversight program meets or exceeds federal oversight standards and the extent to which the federal Department of Health and Human Services is accepting exemption applications and the potential cost to the state for an exemption.
(a)As used in this chapter, laboratory director means any person who is a any of the following:
(1)A duly licensed physician and surgeon, or, only surgeon.
(2)Only for purposes of a clinical laboratory test or examination classified as waived, is a any of the following:
(A)A duly licensed clinical laboratory scientist, a scientist.
(B)A duly licensed limited clinical laboratory scientist, a scientist.
(C)A duly licensed naturopathic doctor, or a doctor.
(D)A duly licensed optometrist serving as the director of a laboratory which that only performs clinical laboratory tests authorized in paragraph (10) of subdivision (e) of Section 3041 that are classified as waived, or is licensed 3041.
(3)Licensed to direct a clinical laboratory under this chapter and who substantially meets chapter.
(b)(1)A person defined in paragraph (1) or (3) of subdivision (a) who is identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity shall also meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory. The
(2)As used in this subdivision, CLIA laboratory director means the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
(c)The laboratory director, if qualified under CLIA, may perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to persons qualified under CLIA. If the laboratory director reapportions performance of those responsibilities or duties, he or she shall remain responsible for ensuring that all those duties and responsibilities are properly performed.
(b)
(d)(1)The laboratory director is responsible for the overall operation and administration of the clinical laboratory, including administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with this act and CLIA. He or she shall be responsible for the proper performance of all laboratory work of all subordinates and shall employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with the personnel qualifications, duties, and responsibilities described in CLIA and this chapter.
(2)Where a point-of-care laboratory testing device is utilized and provides results for more than one analyte, the testing personnel may perform and report the results of all tests ordered for each analyte for which he or she has been found by the laboratory director to be competent to perform and report.
(c)
(e)As part of the overall operation and administration, the laboratory director of a registered laboratory shall document the adequacy of the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory test procedures and examinations. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for personnel, in addition to any CLIA requirements relative to the education or training of personnel.
(d)
(f)As part of the overall operation and administration, the laboratory director of a licensed laboratory shall do all of the following:
(1)Ensure that all personnel, prior to testing biological specimens, have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for, and the type of procedures that may be performed by, personnel in addition to any CLIA requirements relative to the education or training of personnel. Any regulations adopted pursuant to this section that specify the type of procedure that may be performed by testing personnel shall be based on the skills, knowledge, and tasks required to perform the type of procedure in question.
(2)Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process biological specimens, perform test procedures, and report test results promptly and proficiently, and, whenever necessary, identify needs for remedial training or continuing education to improve skills.
(3)Specify in writing the responsibilities and duties of each individual engaged in the performance of the preanalytic, analytic, and postanalytic phases of clinical laboratory tests or examinations, including which clinical laboratory tests or examinations the individual is authorized to perform, whether supervision is required for the individual to perform specimen processing, test performance, or results reporting, and whether consultant, supervisor, or director review is required prior to the individual reporting patient test results.
(e)
(g)The competency and performance of staff of a licensed laboratory shall be evaluated and documented by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA depending on the type and complexity of tests being offered by the laboratory.
(1)The procedures for evaluating the competency of the staff shall include, but are not limited to, all of the following:
(A)Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen handling, processing, and testing.
(B)Monitoring the recording and reporting of test results.
(C)Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
(D)Direct observation of performance of instrument maintenance and function checks.
(E)Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.
(F)Assessment of problem solving skills.
(2)Evaluation and documentation of staff competency and performance shall occur at least semiannually during the first year an individual tests biological specimens. Thereafter, evaluations shall be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance shall be reevaluated to include the use of the new test methodology or instrumentation.
(f)
(h)The laboratory director of each clinical laboratory of an acute care hospital shall be a physician and surgeon who is a qualified pathologist, except as follows:
(1)If a qualified pathologist is not available, a physician and surgeon or a clinical laboratory bioanalyst qualified as a laboratory director under subdivision (a) may direct the laboratory. However, a qualified pathologist shall be available for consultation at suitable intervals to ensure high-quality service.
(2)If there are two or more clinical laboratories of an acute care hospital, those additional clinical laboratories that are limited to the performance of blood gas analysis, blood electrolyte analysis, or both, may be directed by a physician and surgeon qualified as a laboratory director under subdivision (a), irrespective of whether a pathologist is available.
As used in this subdivision, a qualified pathologist is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.
(g)
(i)Subdivision (f) (h) does not apply to any director of a clinical laboratory of an acute care hospital acting in that capacity on or before January 1, 1988.
(h)
(j)A laboratory director may serve as the director of up to the maximum number of laboratories stipulated by CLIA, as defined under Section 1202.5.
SEC. 2.Section 1260 of the Business and Professions Code is amended to read:1260.The department shall issue a clinical laboratory bioanalysts license to each person who is a lawful holder of a degree of master of arts, master of science, or an equivalent or higher degree as determined by the department with a major in chemical, physical, biological, or clinical laboratory sciences. This education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the department. The applicant also shall have a minimum of four years experience as a licensed clinical laboratory scientist, performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the department certified under the CLIA. The quality and variety of this experience shall be satisfactory to the department and shall have been obtained within the six-year period immediately antecedent to admission to the examination. The applicant shall successfully pass a written examination and an oral examination conducted by the department or a committee designated by the department to conduct the examinations, indicating that the applicant is properly qualified. The department may issue a license without conducting a written examination to an applicant who has passed a written examination of a national accrediting board having requirements that are, in the determination of the department, equal to or greater than those required by this chapter and regulations adopted by the department. The department shall establish by regulation the required courses to be included in the college or university training.
SEC. 3.Section 1261.5 of the Business and Professions Code is amended to read:1261.5.The department may issue limited clinical laboratory scientists licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, embroyology, biochemical genetics, genetic molecular biology, cytogenetics, or other areas of laboratory specialty or subspecialty when determined to be necessary by the department in order for licensure categories to keep abreast of changes in laboratory or scientific technology. Whenever the department determines that a new limited clinical laboratory scientist license category is necessary, it shall adopt regulations identifying the category and the areas of specialization included within the category.
To qualify for admission to the examination for a special clinical laboratory scientists license, an applicant shall have all the following:
(a)Have graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate or higher degree with a major appropriate to the field for which a license is being sought.
(b)Have one year of full-time postgraduate training or experience in the various areas of analysis in the field for which a license is being sought in a laboratory that has a license issued under this chapter or which the department determines is equivalent thereto.
(c)Whenever a limited clinical laboratory scientists license is established for a specific area of specialization, the department may issue the license without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to implement this section.
SEC. 4.Section 1264 of the Business and Professions Code is amended to read:1264.The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical embryologist, clinical biochemical geneticist, clinical molecular biologist, or clinical cytogeneticist license to each person who has applied for the license on forms provided by the department, who is a lawful holder of a master of science or doctoral degree in the specialty for which the applicant is seeking a license and who has met such additional reasonable qualifications of training, education, and experience as the department may establish by regulations. The department shall issue an oral and maxillofacial pathologist license to every applicant for licensure who has applied for the license on forms provided by the department, who is a registered Diplomate of the American Board of Oral and Maxillofacial Pathology, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulation.
(a)The graduate education shall have included 30 semester hours of coursework in the applicants specialty. Applicants possessing only a master of science degree shall have the equivalent of one year of full-time, directed study or training in procedures and principles involved in the development, modification or evaluation of laboratory methods, including training in complex methods applicable to diagnostic laboratory work. Each applicant must have had one year of training in his or her specialty in a clinical laboratory acceptable to the department and three years of experience in his or her specialty in a clinical laboratory, two years of which must have been at a supervisory level. The education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by an agency acceptable to the department. The department shall determine by examination that the applicant is properly qualified. Examinations, training, or experience requirements for specialty licenses shall cover only the specialty concerned.
(b)The department may issue licenses without examination to applicants who have passed examinations of other states or national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of other state requirements or requirements of national accrediting boards shall be carried out by the department with the assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by another state or national accrediting board prior to the establishment of requirements that are equal to or exceed those of this chapter or regulations of the department.
(c)The department may issue licenses without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations.
(d)The department shall adopt regulations to conform to this section.
SEC. 5.Section 1300 of the Business and Professions Code is amended to read:1300.The amount of application, registration, and license fees under this chapter shall be as follows:
(a)The application fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, clinical laboratory toxicologists, clinical embryologists, clinical biochemical geneticists, clinical cytogeneticists, or clinical molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(b)The annual renewal fee for a histocompatibility laboratory directors, clinical laboratory bioanalysts, clinical chemists, clinical microbiologists, or clinical laboratory toxicologists, clinical embryologists, clinical biochemical geneticists, clinical cytogeneticists, or clinical molecular biologists license is sixty-three dollars ($63) commencing on July 1, 1983.
(c)The application fee for a clinical laboratory scientists or limited clinical laboratory scientists license is thirty-eight dollars ($38) commencing on July 1, 1983.
(d)The application and annual renewal fee for a cytotechnologists license is fifty dollars ($50) commencing on January 1, 1991.
(e)The annual renewal fee for a clinical laboratory scientists or limited clinical laboratory scientists license is twenty-five dollars ($25) commencing on July 1, 1983.
(f)A clinical laboratory applying for a license to perform tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory applying for certification under subdivision (c) of Section 1223 shall pay an application fee for that license or certification based on the number of tests it performs or expects to perform in a year, as follows:
(1)Less than 2,001 tests: two hundred seventy dollars ($270).
(2)Between 2,001 and 10,000, inclusive, tests: eight hundred twenty dollars ($820).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand three hundred fifteen dollars ($1,315).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand five hundred eighty dollars ($1,580).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand nine hundred sixty dollars ($1,960).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand three hundred forty dollars ($2,340).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand seven hundred forty dollars ($2,740).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand nine hundred ten dollars ($4,910).
(9)More than 1,000,000 tests: five thousand two hundred sixty dollars ($5,260) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(g)A clinical laboratory performing tests or examinations classified as of moderate or of high complexity under CLIA and a clinical laboratory with a certificate issued under subdivision (c) of Section 1223 shall pay an annual renewal fee based on the number of tests it performed in the preceding calendar year, as follows:
(1)Less than 2,001 tests: one hundred seventy dollars ($170).
(2)Between 2,001 and 10,000, inclusive, tests: seven hundred twenty dollars ($720).
(3)Between 10,001 and 25,000, inclusive, tests: one thousand one hundred fifteen dollars ($1,115).
(4)Between 25,001 and 50,000, inclusive, tests: one thousand three hundred eighty dollars ($1,380).
(5)Between 50,001 and 75,000, inclusive, tests: one thousand seven hundred sixty dollars ($1,760).
(6)Between 75,001 and 100,000, inclusive, tests: two thousand forty dollars ($2,040).
(7)Between 100,001 and 500,000, inclusive, tests: two thousand four hundred forty dollars ($2,440).
(8)Between 500,001 and 1,000,000, inclusive, tests: four thousand six hundred ten dollars ($4,610).
(9)More than 1,000,000 tests per year: four thousand nine hundred sixty dollars ($4,960) plus three hundred fifty dollars ($350) for every 500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(h)The application fee for a trainees license is thirteen dollars ($13) commencing on July 1, 1983.
(i)The annual renewal fee for a trainees license is eight dollars ($8) commencing on July 1, 1983.
(j)The application fee for a duplicate license is five dollars ($5) commencing on July 1, 1983.
(k)The personnel licensing delinquency fee is equal to the annual renewal fee.
(l)The director may establish a fee for examinations required under this chapter. The fee shall not exceed the total cost to the department in conducting the examination.
(m)A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only those clinical laboratory tests or examinations considered waived under CLIA shall pay an annual fee of one hundred dollars ($100). A clinical laboratory subject to registration under paragraph (2) of subdivision (a) of Section 1265 and performing only provider-performed microscopy, as defined under CLIA, shall pay an annual fee of one hundred fifty dollars ($150). A clinical laboratory performing both waived and provider-performed microscopy shall pay an annual registration fee of one hundred fifty dollars ($150).
(n)The costs of the department in conducting a complaint investigation, imposing sanctions, or conducting a hearing under this chapter shall be paid by the clinical laboratory. The fee shall be no greater than the fee the laboratory would pay under CLIA for the same type of activities and shall not be payable if the clinical laboratory would not be required to pay those fees under CLIA.
(o)The state, a district, city, county, city and county, or other political subdivision, or any public officer or body shall be subject to the payment of fees established pursuant to this chapter or regulations adopted thereunder.
(p)In addition to the payment of registration or licensure fees, a clinical laboratory located outside the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections at the clinical laboratory in order to ensure compliance with this chapter.
(q)The department shall establish an application fee and a renewal fee for a medical laboratory technician license, the total fees collected not to exceed the costs of the department for the implementation and operation of the program licensing and regulating medical laboratory technicians pursuant to Section 1260.3.
(r)The costs of the department to conduct any reinspections to ensure compliance of a laboratory applying for initial licensure shall be paid by the laboratory. This additional cost for each visit shall be equal to the initial application fee and shall be paid by the laboratory prior to issuance of a license. The department shall not charge a reinspection fee if the reinspection is due to error or omission on the part of the department.
(s)A fee of twenty-five dollars ($25) shall be assessed for approval of each additional location authorized by paragraph (2) of subdivision (d) of Section 1265.
(t)On or before July 1, 2013, the department shall report to the Legislature during the annual legislative budget hearing process the extent to which the state oversight program meets or exceeds federal oversight standards and the extent to which the federal Department of Health and Human Services is accepting exemption applications and the potential cost to the state for an exemption.
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Status
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| Jun 30, 2015 | From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 8. Noes 0.) (June 29). |
| Sep 28, 2015 | Chaptered by Secretary of State - Chapter 341, Statutes of 2015. |
| Sep 28, 2015 | Approved by the Governor. |
| Sep 15, 2015 | Enrolled and presented to the Governor at 4 p.m. |
| Sep 2, 2015 | Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 80. Noes 0.). |
| Sep 2, 2015 | Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 80. Noes 0. Page 2772.). |
| Aug 31, 2015 | Read third time. Passed. Ordered to the Assembly. (Ayes 40. Noes 0. Page 2297.). |
| Aug 31, 2015 | Read third time. Passed. Ordered to the Assembly. |
| Aug 31, 2015 | In Assembly. Concurrence in Senate amendments pending. May be considered on or after September 2 pursuant to Assembly Rule 77. |
| Aug 24, 2015 | Read second time. Ordered to third reading. |
| Aug 20, 2015 | Read third time and amended. Ordered to second reading. |
| Aug 18, 2015 | Read second time. Ordered to third reading. |
| Aug 17, 2015 | From committee: Be placed on second reading file pursuant to Senate Rule 28.8. |
| Jul 14, 2015 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on APPR. |
| Jul 8, 2015 | In committee: Hearing postponed by committee. |
| Jul 1, 2015 | Read second time and amended. Re-referred to Com. on APPR. |
| Feb 26, 2015 | Read first time. To print. |
| Jun 11, 2015 | Referred to Com. on B., P. & E.D. |
| Jun 1, 2015 | Read third time. Passed. Ordered to the Senate. (Ayes 79. Noes 0. Page 1721.) |
| Jun 1, 2015 | Read third time. Passed. Ordered to the Senate. |
| Jun 1, 2015 | In Senate. Read first time. To Com. on RLS. for assignment. |
| May 28, 2015 | Read second time. Ordered to third reading. |
| May 28, 2015 | From committee: Do pass. (Ayes 17. Noes 0.) (May 28). |
| May 6, 2015 | In committee: Set, first hearing. Referred to APPR. suspense file. |
| Apr 27, 2015 | Re-referred to Com. on APPR. |
| Apr 23, 2015 | From committee chair, with author's amendments: Amend, and re-refer to Com. on APPR. Read second time and amended. |
| Apr 21, 2015 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 14. Noes 0.) (April 21). Re-referred to Com. on APPR. |
| Apr 7, 2015 | In committee: Hearing postponed by committee. |
| Mar 24, 2015 | Re-referred to Com. on B. & P. |
| Mar 23, 2015 | From committee chair, with author's amendments: Amend, and re-refer to Com. on B. & P. Read second time and amended. |
| Mar 16, 2015 | Referred to Com. on B. & P. |
| Feb 27, 2015 | From printer. May be heard in committee March 29. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Sep 2, 2015 | AB 940 RIDLEY-THOMAS Concurrence in Senate Amendments | Assembly Floor |
Passed |
|
| Aug 31, 2015 | Assembly 3rd Reading AB940 Ridley-Thomas By Bates | Senate Floor |
Passed |
|
| Jun 29, 2015 | Do pass as amended, but first amend, and re-refer to the Committee on [Appropriations] | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
|
| Jun 1, 2015 | AB 940 RIDLEY-THOMAS Assembly Third Reading | Assembly Floor |
Passed |
|
| May 28, 2015 | Do pass. | Assembly Standing Committee on Appropriations |
Passed |
|
| Apr 21, 2015 | Do pass and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Business and Professions |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| American Association of Bioanalysts | ** Support | Aug 31, 2015 |
| American Clinical Laboratory Association | ** Support | Aug 31, 2015 |
| California Association Of Bioanalysts | ** Support | Aug 31, 2015 |
| California Clinical Laboratory Association | ** Support | Aug 31, 2015 |
| California Society Of Pathologists | ** Support | Aug 31, 2015 |
| Laboratory Corporation Of America | ** Support | Aug 31, 2015 |
AB 940
Page 2
CONCURRENCE IN SENATE AMENDMENTS
AB 940
(Ridley-Thomas and Waldron)
As Amended August 20, 2015
Majority vote
ASSEMBLY: |
79-0 |
(June 1, 2015) |
SENATE: |
40- |
(August 31, 2015) |
Original Committee Reference: B. & P.
SUMMARY: Clarifies that a qualified licensed bioanalyst may act as a laboratory director, allows an applicant for a bioanalyst license to obtain four years of experience in any laboratory approved under the federal Clinical Laboratory Improvement Amendments (CLIA), and authorizes the California Department of Public Health (CDPH) to charge a renewal fee for specified licenses. Specifically, this bill:
Defines "CLIA laboratory director" as the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
Clarifies that the laboratory director on the laboratory's CLIA certificate must meet the qualifications under CLIA for the type and complexity of tests being offered by the laboratory.
Clarifies that a licensed bioanalyst may, if qualified under CLIA, act as the CLIA laboratory director or co-director of a laboratory performing high complexity tests.
Allows a clinical laboratory scientist that is not licensed in this state, who is applying for a bioanalyst license, to obtain four years of experience in a CLIA-approved laboratory, rather than a laboratory inspected by the CDPH.
Authorizes the CDPH to charge a renewal fee for the existing license categories of clinical cytogeneticist and clinical molecular biologist licenses.
Makes other conforming changes.
The Senate amendments:
Clarify that a licensed bioanalyst, if qualified under CLIA, may act as a CLIA laboratory director or as a co-laboratory director.
Delete the two new license categories of reproductive biology and biochemical genetics.
Rename the license for clinical molecular biologist to the license for clinical genetic molecular biologist.
Make conforming changes.
FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS:
Purpose. This bill is sponsored by the California Clinical Laboratory Association. According to the author, "[this bill] will reestablish a true career ladder in the California clinical laboratory field. Without this bill, the growing shortage of licensed clinical laboratory personnel in California will continue. To meet the healthcare demands of the California population, increased numbers of licensed clinical laboratory personnel are needed."
Background. Under federal law, all clinical laboratories must have a laboratory director that complies with the CLIA requirements. This bill will clarify the distinction between a CLIA laboratory director and a co-laboratory director. It will also allow a licensed bioanalyst who is qualified under CLIA to serve as either the CLIA laboratory director or the co-director.
Bioanalyst Experience Requirement. Under current law, bioanalysts must complete four years of training in a CDPH approved facility as a California licensed clinical laboratory scientist. When approving laboratories, CDPH performs an onsite survey and requires ownership information prior to issuing a laboratory a state license.
This bill will allow an applicant for a bioanalyst license to use experience acquired in CLIA-approved laboratories in other states, without being licensed as a clinical laboratory scientist in this state. California, New York, Florida, and about 10 other states have state personnel licensing schemes that are in addition to the federal CLIA requirements.
Workforce Shortages. At this time, it is unclear whether there is a current laboratory personnel shortage. However, California is behind the national average in clinical laboratory technologists. This bill seeks to increase employment in clinical laboratories by providing more career opportunities for personnel.
Clinical Genetic Molecular Biologist Name Change. Existing CDPH regulations describe the clinical molecular biologist license as the clinical genetic molecular biologist license (California Code of Regulations, Title 17, Section 1031.3). This bill amends the statute to match the regulations.
Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001552
AB 940
Page 6
|
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 |
THIRD READING
Bill No: AB 940
Author: Ridley-Thomas (D) and Waldron (R)
Amended: 8/20/15 in Senate
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 8-0, 6/29/15
AYES: Hill, Bates, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski
NO VOTE RECORDED: Berryhill
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 79-0, 6/1/15 (Consent) - See last page for vote
SUBJECT: Clinical laboratories
SOURCE: California Clinical Laboratory Association
DIGEST: This bill allows a master’s level clinical laboratory bioanalyst who is not the Clinical Laboratory Improvement Amendments (CLIA) lab director to be a laboratory director for a high-complexity lab, allows a bioanalyst to gain experience in a clinical laboratory certified by CLIA, and makes other modifications to existing law.
Senate Floor Amendments of 8/20/15 add the word “genetic” to “clinical genetic molecular biologist.” “Clinical genetic molecular biologist and “clinical molecular biologist” are often used interchangeably in code and statute, but have the same meaning.
ANALYSIS: Existing federal law establishes conditions that laboratories must meet to perform testing on human specimens for certification under CLIA. (Title 42, Code of Federal Regulations (CFR) § 493.1)
Existing state law:
Authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst to:
If qualified under CLIA, perform clinical laboratory tests or examinations classified as high complexity under CLIA.
Perform the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the Department of Public Health (DPH).
Perform any clinical laboratory test or examination classified as waived or moderate complexity under CLIA. (Business and Professions Code (BPC) § 1203)
Defines the term “laboratory director” to means any person who is:
A duly licensed physician and surgeon.
Only for purposes of a clinical laboratory test or examination classified as waived:
A licensed clinical laboratory scientist.
A licensed limited clinical laboratory scientist.
A licensed naturopathic doctor.
A licensed optometrist serving as the director of a laboratory which only performs specified clinical laboratory tests.
Licensed to direct a clinical laboratory under existing law and who substantially meets the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory. (BPC § 1209 (a))
Allows a clinical laboratory to have multiple laboratory directors. (BPC § 1265)
This
bill:
Authorizes a master’s level licensed clinical laboratory bioanalyst or bioanalyst who is not the CLIA lab director to perform all of the following:
Clinical laboratory tests or examinations classified as of high complexity under CLIA.
The duties and responsibilities of a laboratory director in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in DPH regulations.
Defines “CLIA laboratory director” as the person identified on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
Deletes requirements that specify a laboratory director must substantially meet the requirements under CLIA.
Requires that the following individuals who are identified as the CLIA laboratory director of a laboratory performing clinical laboratory tests classified as moderate or high complexity to meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory:
A duly licensed physician and surgeon.
A person licensed by DPH to direct a clinical laboratory.
Deletes the requirement that an applicant for a clinical bioanalyst license have four years’ experience as a “licensed” clinical laboratory scientist.
Requires an applicant for a clinical bioanalyst license have experience in a clinical laboratory certified under CLIA, rather than approved by the DPH.
Authorizes a renewal fee for a clinical laboratory toxicologist, clinical cytogeneticist, and clinical genetic molecular biologist.
Makes clarifying and technical changes.
Background
Laboratory Personnel Shortage. According to the Healthcare Laboratory Workforce Initiative, a collaboration of the Hospital Council of Northern and Central California in conjunction with the California Hospital Association, California is experiencing a serious shortage of laboratory personnel. It reports that the number of clinical laboratory scientists declined in California between 1999 and 2001 from 36,000 to 26,000, and, as of several years ago, California ranks among the seven lowest states in the ratio of clinical laboratory scientists per 100,000 people. The report further indicates that, “While these numbers appear small, in fact their impact on patient care and hospital operations is great. The average age of a CLS in California is above 50.”
Several factors contribute to the shrinking clinical laboratory workforce:
Low visibility of the profession, resulting in a lack of recognition and public understanding of laboratory careers.
The growth of industries such as biotech and laboratory manufacturers has increased the demand for skilled workers.
A lack of career development opportunities has discouraged potential recruits and made it difficult to retain qualified professionals.
This bill is designed to create more professional opportunities for individuals interested in a clinical laboratory career and make it easier for professionals in other states to meet California training requirements towards state licensure.
Bioanalysts.
The federal CLIA laws set the regulatory floor for laboratory
testing; states are free to develop higher standards, and
laboratories must follow whichever law is more stringent. In most
cases, California law is stricter than CLIA. However, CLIA has
higher requirements for a bioanalyst to become the director of a lab
conducting high complexity tests than California. CLIA requires the
lab director for high complexity testing to have, among other
qualifications, a medical or doctorate degree. California law
permits a lab directors to “substantially meet” CLIA
requirements.
According the author, the purpose of the
term “substantially” was to allow for variation in case
California sought full CLIA exemption, which it has not, nor does it
plan to. Inclusion of the word “substantially” was intended to
allow lesser-credentialed individuals to be lab directors for labs
conducting high complexity tests. However, the DPH has interpreted
“substantially” to mean “fully.” Therefore, under state
law, all laboratory directors must meet all CLIA
requirements.
This bill revises current law to allow a
master’s level bioanalyst to be a lab director for a high
complexity lab, contrary to CLIA requirements. The Author’s office
argues this is not in direct conflict with federal law because
California law allows for multiple lab directors, and CLIA requires
only one; as long as a lab has one CLIA lab director responsible for
the direction of the lab and personnel, there may be other lab
directors performing lab director duties, but without the full
responsibility and liability associated with the CLIA lab director.
DPH has not opined on validity of this proposal and whether using the
term “lab director” for both individuals who are, and are not
CLIA qualified would cause undue confusion.
This bill also
allows a bioanalyst to qualify for California licensure in facilities
that are not DPH approved, but rather CLIA certified. The author’s
office argues that this would allow more flexibility for bioanalysts
coming from out of state to qualify for state licensure.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No
California Clinical Laboratory Association (source)
American Association of Bioanalysts
American Clinical Laboratory Association
California Association of Bioanalysts
California Society of Pathologists
Laboratory Corporation of America
OPPOSITION: (Verified 8/19/15)
None received
ARGUMENTS
IN SUPPORT: The sponsor, California Clinical Laboratory
Association, the American Association of Bioanalysts, and the
California Association of Bioanalysts write, “This bill proposes to
re-establish a career ladder for clinical laboratory personnel….
AB 940 is necessary because the bill allows for California to
continue being a competitive state in the clinical laboratory
business that attracts new individuals in this field.”
California
Society of Pathologists writes, “Clinical laboratories still have
shortages of multiple types of personnel. We believe that AB 940
will help create a career ladder to allow lab personnel to enter and
provide services in these specialty areas with requisite training and
experience.”
ASSEMBLY FLOOR: 79-0, 6/1/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins
NO VOTE RECORDED: Brough
Prepared by: Sarah Huchel / B., P. & E.D. / (916) 651-4104
8/25/15 15:13:49
**** END ****
AB 940
Page 6
|
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 |
THIRD READING
Bill No: AB 940
Author: Ridley-Thomas (D) and Waldron (R)
Amended: 7/14/15 in Senate
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 8-0, 6/29/15
AYES: Hill, Bates, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski
NO VOTE RECORDED: Berryhill
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 79-0, 6/1/15 - See last page for vote
SUBJECT: Clinical laboratories
SOURCE: California Clinical Laboratory Association
DIGEST: This bill allows a master’s level clinical laboratory bioanalyst who is not the Clinical Laboratory Improvement Amendments (CLIA) lab director to be a laboratory director for a high-complexity lab, allows a bioanalyst to gain experience in a clinical laboratory certified by CLIA, and makes other modifications to existing law.
ANALYSIS: Existing federal law establishes conditions that laboratories must meet to perform testing on human specimens for certification under CLIA. (Title 42, Code of Federal Regulations (CFR) § 493.1)
Existing state law:
Authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst to:
If qualified under CLIA, to perform clinical laboratory tests or examinations classified as of high complexity under CLIA.
Perform the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the Department of Public Health (DPH).
To perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA. (Business and Professions Code (BPC) § 1203)
Defines the term “laboratory director” to means any person who is:
A duly licensed physician and surgeon.
Only for purposes of a clinical laboratory test or examination classified as waived:
A licensed clinical laboratory scientist.
A licensed limited clinical laboratory scientist.
A licensed naturopathic doctor.
A licensed optometrist serving as the director of a laboratory which only performs specified clinical laboratory tests.
Licensed to direct a clinical laboratory under existing law and who substantially meets the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory. (BPC § 1209 (a))
Allows a clinical laboratory to have multiple laboratory directors. (BPC § 1265)
This
bill:
Authorizes a master’s level licensed clinical laboratory bioanalyst or bioanalyst who is not the CLIA lab director to perform all of the following:
Clinical laboratory tests or examinations classified as of high complexity under CLIA.
The duties and responsibilities of a laboratory director in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in DPH regulations.
Defines “CLIA laboratory director” as the person identified on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
Deletes requirements that specify a laboratory director must substantially meet the requirements under CLIA.
Requires that the following individuals who are identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity to meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory:
A duly licensed physician and surgeon.
A person licensed by DPH to direct a clinical laboratory.
Strikes reference to the requirement that an applicant for a clinical bioanalyst license have four years’ experience as a “licensed” clinical laboratory scientist.
Replaces the requirement that an applicant for a clinical bioanalyst license have experience in a clinical laboratory approved by the DPH and is certified under CLIA.
Authorizes a renewal fee for a clinical laboratory toxicologist, clinical cytogeneticist, and clinical molecular biologist.
Makes clarifying and technical amendments.
Background
Laboratory Personnel Shortage. According to the Healthcare Laboratory Workforce Initiative, a collaboration of the Hospital Council of Northern and Central California in conjunction with the California Hospital Association, California is experiencing a serious shortage of laboratory personnel. It reports that the number of clinical laboratory scientists declined in California between 1999 and 2001 from 36,000 to 26,000, and, as of several years ago, California ranks among the seven lowest states in the ratio of clinical laboratory scientists per 100,000 people. The report further indicates that, “While these numbers appear small, in fact their impact on patient care and hospital operations is great. The average age of a CLS in California is above 50.”
Several factors contribute to the shrinking clinical laboratory workforce:
Low visibility of the profession, resulting in a lack of recognition and public understanding of laboratory careers.
The growth of industries such as biotech and laboratory manufacturers has increased the demand for skilled workers.
A lack of career development opportunities has discouraged potential recruits and made it difficult to retain qualified professionals.
This bill is designed to create more professional opportunities for individuals interested in a clinical laboratory career and make it easier for professionals in other states to meet California training requirements towards state licensure.
Bioanalysts.
The federal CLIA laws set the regulatory floor for laboratory
testing; states are free to develop higher standards, and
laboratories must follow whichever law is more stringent. In most
cases, California law is stricter than CLIA. However, CLIA has
higher requirements for a bioanalyst to become the director of a lab
conducting high complexity tests than California. CLIA requires the
lab director for high complexity testing to have, among other
qualifications, a medical or doctorate degree. California law
permits a lab directors to “substantially meet” CLIA
requirements.
According the author, the purpose of the
term “substantially” was to allow for variation in case
California sought full CLIA exemption, which it has not, nor does it
plan to. Inclusion of the word “substantially” was intended to
allow lesser-credentialed individuals to be lab directors for labs
conducting high complexity tests. However, the DPH has interpreted
“substantially” to mean “fully.” Therefore, under state
law, all laboratory directors must meet all CLIA requirements.
This
bill revises current law to allow a master’s level bioanalyst to be
a lab director for a high complexity lab, contrary to CLIA
requirements. The Author’s office argues this is not in direct
conflict with federal law because California law allows for multiple
lab directors, and CLIA requires only one; as long as a lab has one
CLIA lab director responsible for the direction of the lab and
personnel, there may be other lab directors performing lab director
duties, but without the full responsibility and liability associated
with the CLIA lab director. DPH has not opined on validity of this
proposal and whether using the term “lab director” for both
individuals who are, and are not CLIA qualified would cause undue
confusion.
This bill also allows a bioanalyst to qualify
for California licensure in facilities that are not California
Department of Public Health approved, but rather CLIA certified. The
author’s office argues that this would allow more flexibility for
bioanalysts coming from out of state to qualify for state licensure.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No
California Clinical Laboratory Association (source)
American Association of Bioanalysts
American Clinical Laboratory Association
California Association of Bioanalysts
California Society of Pathologists
Laboratory Corporation of America
OPPOSITION: (Verified 8/19/15)
None received
ARGUMENTS
IN SUPPORT: The sponsor, California Clinical Laboratory
Association, the American Association of Bioanalysts, and the
California Association of Bioanalysts write, “This bill proposes to
re-establish a career ladder for clinical laboratory personnel….
AB 940 is necessary because the bill allows for California to
continue being a competitive state in the clinical laboratory
business that attracts new individuals in this field.”
California
Society of Pathologists write, “Clinical laboratories still have
shortages of multiple types of personnel. We believe that AB 940
will help create a career ladder to allow lab personnel to enter and
provide services in these specialty areas with requisite training and
experience.”
ASSEMBLY FLOOR: 79-0, 6/1/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins
NO VOTE RECORDED: Brough
Prepared by: Sarah Huchel / B., P. & E.D. / (916) 651-4104
8/19/15 20:48:52
**** END ****
AB 940 (Ridley-Thomas) Page 8 of 8
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 940 Hearing Date: June 29, 2015
Author: |
Ridley-Thomas |
||
Version: |
April 23, 2015 |
||
Urgency: |
No |
Fiscal: |
Yes |
Consultant: |
Sarah Huchel |
||
Subject: Clinical laboratories.
SUMMARY:
Allows a master’s level bioanalyst to be a laboratory director for a high-complexity lab, creates licenses for a clinical reproductive biologist and clinical biochemical geneticist, and makes other modifications to existing law.
Existing state law:
Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the California Department of Public Health (DPH). (Business and Professions Code (BPC) §§ 1200-1327)
Defines a “clinical laboratory bioanalyst” or “bioanalyst” to mean a person licensed to engage in clinical laboratory practice and direction of a clinical laboratory. (BPC § 1203)
Authorizes a person licensed as a clinical laboratory bioanalyst or bioanalyst to:
If qualified under Clinical Laboratory Improvement Amendments (CLIA), to perform clinical laboratory tests or examinations classified as of high complexity under CLIA.
Perform the duties and responsibilities of a laboratory director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the DPH.
To perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA. (BPC § 1203)
Authorizes a person licensed to engage in clinical laboratory practice or to direct a clinical laboratory to perform high complexity CLIA tests if the test is performed under the overall operation and administration of the laboratory director, and if the test or examination is within a specialty or subspecialty authorized by the person’s licensure. (BPC § 1206.5 (c)(3))
Requires DPH, if it determines that a new category of license is necessary to direct a laboratory or to perform clinical laboratory tests or examinations in specific specialties or subspecialties, to adopt regulations identifying the license category or modification, the education, training, and examination necessary to obtain the license, and the specialty or subspecialty, or both, included within the new license category, or within the existing category as modified. (BPC § 1208 (a))
Defines the term “laboratory director” to means any person who is:
A duly licensed physician and surgeon.
Only for purposes of a clinical laboratory test or examination classified as waived:
A licensed clinical laboratory scientist.
A licensed limited clinical laboratory scientist.
A licensed naturopathic doctor.
A licensed optometrist serving as the director of a laboratory which only performs specified clinical laboratory tests.
Licensed to direct a clinical laboratory under existing law and who substantially meets the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory. (BPC § 1209 (a))
Allows a clinical laboratory to have multiple laboratory directors. (BPC § 1265)
Requires an applicant for a clinical laboratory bioanalyst license to obtain experience at a clinical laboratory approved by DPH. (BPC § 1260)
Existing federal law:
Establishes conditions that laboratories must meet to perform testing on human specimens for certification under CLIA. (Title 42, Code of Federal Regulations (CFR) § 493.1)
Classifies laboratory tests using three categories: “waived,” “moderate complexity,” or “high complexity.” (42 CFR § 493.5)
Requires the laboratory director to be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory, as specified.
Requires the laboratory director to possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and
Requires the laboratory director to:
Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and
Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or
Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and
Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution, and
Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director, as specified, on or before February 28, 1992; or
On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located. (42 CFR § 493.1443)
Requires the laboratory director to be responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. Among other duties, the laboratory director is required to:
Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with personnel responsibilities.
Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. (42 CFR § 493.1407)
This
bill:
Authorizes a master’s level licensed clinical laboratory bioanalyst or bioanalyst who is not the CLIA lab director to perform all of the following:
Clinical laboratory tests or examinations classified as of high complexity under
CLIA.
The duties and responsibilities of a laboratory director in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in DPH regulations.
Establishes the following for a “clinical reproductive biologist” and “clinical biochemical geneticist:”
Adds them to the list of persons authorized to be licensed by DPH to engage in, or supervise others engaged in, clinical laboratory practice, that is limited to his or her area of specialization.
Authorizes them to perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA.
Authorizes them to perform the duties and responsibilities of a laboratory director, who is not the CLIA laboratory director, limited to his or her area of specialty or subspecialty and are permitted only direct a clinical laboratory providing service within those specialties or subspecialties.
Authorizes them, if qualified under CLIA, to perform clinical laboratory tests or examinations classified as of high complexity under CLIA, and the duties and responsibilities of a CLIA lab director, technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified.
Authorizes them to direct clinical laboratories specializing in biochemical genetics within the specialty of genetics and reproductive biology, respectively, or other specialty or subspecialty specified by DPH in regulation.
Makes them eligible for a limited clinical laboratory scientist license.
Adds them to the list of individuals who may supervise a trainee for the purpose of receiving comprehensive practical experience and instruction in clinical laboratory procedures.
Defines “CLIA laboratory director” as the person identified on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
Deletes requirements that specify a laboratory director must substantially meet the requirements under CLIA.
Requires that the following individuals who are identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity to meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory:
A duly licensed physician and surgeon.
A person licensed by DPH to direct a clinical laboratory.
Strikes reference to the requirement that an applicant for a clinical bioanalyst license have four years’ experience as a “licensed” clinical laboratory scientist.
Replaces the requirement that an applicant for a clinical bioanalyst license have experience in a clinical laboratory approved by the DPH and is certified under CLIA.
Makes clarifying and technical amendments.
FISCAL EFFECT:
This bill is keyed “fiscal” by the Legislative Counsel. According to the Assembly Appropriations Committee analysis dated May 4, 2015, this bill will have the following impact to the Clinical Laboratory Improvement Fund:
One-time costs of in the range of $400,000 over two years. This includes modifying regulations, program development, creating forms and related implementation activities.
Ongoing costs of under $100,000 to oversee additional licenses.
Projected ongoing fee revenue of approximately $90,000 associated with new licensure categories
COMMENTS:
Purpose. This bill is sponsored by the California Clinical Laboratory Association. According to the Author’s office, “There is a critical and growing shortage of licensed clinical laboratory personnel in California. AB 940 will re-instate a true career ladder for laboratory personnel by allowing a Bioanalyst to serve as the co-director of a high complexity laboratory.” This bill will also permit experience toward a bioanalyst license to be obtained at a CLIA-certified laboratory, instead of just a DPH-approved laboratory, and creates licensure categories for clinical reproductive biologists and clinical biochemical geneticists.
Laboratory Personnel Shortage. According to the Healthcare Laboratory Workforce Initiative, a collaboration of the Hospital Council of Northern and Central California in conjunction with the California Hospital Association, California is experiencing a serious shortage of laboratory personnel. It reports that the number of clinical laboratory scientists declined in California between 1999 and 2001 from 36,000 to 26,000, and, as of several years ago, California ranks among the seven lowest states in the ratio of clinical laboratory scientists per 100,000 people. The report further indicates that, “While these numbers appear small, in fact their impact on patient care and hospital operations is great. The average age of a CLS in California is above 50.”
Several factors contribute to the shrinking clinical laboratory workforce:
Low visibility of the profession, resulting in a lack of recognition and public understanding of laboratory careers.
The growth of industries such as biotech and laboratory manufacturers has increased the demand for skilled workers.
A lack of career development opportunities has discouraged potential recruits and made it difficult to retain qualified professionals.
This bill is designed to create more professional opportunities for individuals interested in a clinical laboratory career and make it easier for professionals in other states to meet California training requirements towards state licensure.
Bioanalysts. The federal CLIA laws set the regulatory floor for laboratory testing; states are free to develop higher standards, and laboratories must follow whichever law is more stringent. In most cases, California law is stricter than CLIA. However, CLIA has higher requirements for a bioanalyst to become the director of a lab conducting high complexity tests than California. CLIA requires the lab director for high complexity testing to have, among other qualifications, a medical or doctorate degree. California law permits a lab directors to “substantially meet” CLIA requirements.
According the Author, the purpose of the term “substantially” was to allow for variation in case California sought full CLIA exemption, which it has not, nor does it plan to. Inclusion of the word “substantially” was intended to allow lesser-credentialed individuals to be lab directors for labs conducting high complexity tests. However, the DPH has interpreted “substantially” to mean “fully.” Therefore, under state law, all laboratory directors must meet all CLIA requirements.
This bill revises current law to allow a master’s level bioanalyst to be a lab director for a high complexity lab, contrary to CLIA requirements. The Author’s office argues this is not in direct conflict with federal law because California law allows for multiple lab directors, and CLIA requires only one; as long as a lab has one CLIA lab director responsible for the direction of the lab and personnel, there may be other lab directors performing lab director duties, but without the full responsibility and liability associated with the CLIA lab director. DPH has not opined on validity of this proposal and whether using the term “lab director” for both individuals who are, and are not CLIA qualified would cause undue confusion.
This bill also allows a bioanalyst to qualify for California licensure in facilities that are not DPH approved, but rather CLIA certified. The Author’s office argues that this would allow more flexibility for bioanalysts coming from out of state to qualify for state licensure.
Reproductive Biology and Biochemical Genetics. Current law allows the DPH to issue licenses and limited licenses in various scientific specialties and subspecialties. Current law also requires DPH, if it determines that a new category of license is necessary, to direct a laboratory or to perform clinical laboratory tests or examinations in specific specialties or subspecialties; to adopt regulations identifying the license category, the education, training, and examination necessary to obtain the license, and the specialty or subspecialty, or both, included within the new license category, or within the existing category as modified.
It does not appear that DPH has begun the regulatory process to recognize the new specialties and licenses authorized in this bill; reproductive biology and clinical biochemical genetics. It is unclear whether DPH has determined that these categories are unnecessary or is failing to act to reflect market needs.
Related legislation this year. AB 757 (Gomez) of 2015, makes an exception to California law to allow an individual who meets standards equivalent to federally requirements to perform a particular type of total protein refractometer test in a licensed plasma collection facility. (Status: This bill is scheduled to be heard in this committee on June 29, 2015.)
AB 599 (Bonilla) of 2015, expands the scope of practice for a licensed cytotechnologist by authorizing the performance of all tests and procedures pertaining to cytology under the supervision of a laboratory director. (Status: This bill is pending on the Senate Floor.)
Prior related Legislation. AB 1215 (Hagman and Holden), Chapter 199, Statutes of 2013, expanded the definition of “laboratory director” to include a duly licensed clinical laboratory scientist and a duly licensed limited clinical laboratory scientist and authorizes these individuals to perform the duties and responsibilities of a waived laboratory director under CLIA.
AB 830 (Holden) of 2013, would have required CDPH to promulgate regulations by January 1, 2015, requiring any facility operating a clinical laboratory to provide specified training to CLSs, medical laboratory technicians, and any individuals who are charged with direct and responsible supervision of either a CLS or a medical laboratory technician. (Status: This bill was held in the Assembly Business and Professions Committee.)
AB 761 (Hernández), Chapter 714, Statutes of 2012, allowed optometrists to independently perform waived clinical laboratory tests necessary for the diagnosis of conditions and diseases of the eye.
SB 1481 (Negrete McLeod), Chapter 874, Statutes of 2012, eliminated the requirement that only allowed a laboratory director to perform CLIA waived tests and permitted pharmacists to administer certain tests that were approved by the federal Food and Drug Administration for sale to the public without a prescription in the form of an over-the-counter test kit upon customer request, provided that the pharmacy obtained a CLIA certificate of waiver and a registration from the DPH and comply with all other requirements governing clinical laboratories, as specified.
Arguments in Support. The sponsor, California Clinical Laboratory Association, the American Association of Bioanalysts, and the California Association of Bioanalysts write, “This bill proposes to re-establish a career ladder for clinical laboratory personnel…. AB 940 is necessary because the bill allows for California to continue being a competitive state in the clinical laboratory business that attracts new individuals in this field.”
California Society of Pathologists write, “Clinical laboratories still have shortages of multiple types of personnel. We believe that AB 940 will help create a career ladder to allow lab personnel to enter and provide services in these specialty areas with requisite training and experience.”
Recommended Technical Amendment. BPC 1205 is currently one continuous sentence and is not clear as to its purpose. The following amendment would clarify that the professions listed are those authorized to provide training to a trainee.
On page 4, line 18, place a period after “science” and insert “The training provided to a trainee shall be provided”
On page 4, line 19, insert “any of the following individuals” before “a person”
On page 4, line 20, insert “a” after “chapter,”
SUPPORT AND OPPOSITION:
Support:
California Clinical Laboratory Association (Sponsor)
American Association of Bioanalysts
American Clinical Laboratory Association
California Association of Bioanalysts
California Society of Pathologists
Laboratory Corporation of America
Opposition:
None on file as of June 23, 2015.
-- END --
AB 940
Page 2
ASSEMBLY THIRD READING
AB 940
(Ridley-Thomas and Waldron)
As Amended April 23, 2015
Majority vote
Committee |
Votes |
Ayes |
Noes |
Business & Professions |
14-0 |
Bonilla, Jones, Baker, Bloom, Campos, Chang, Dodd, Eggman, Gatto, Holden, Mullin, Ting, Wilk, Wood |
|
Appropriations |
17-0 |
Gomez, Bigelow, Bonta, Calderon, Chang, Daly, Eggman, Gallagher, Eduardo Garcia, Gordon, Holden, Jones, Quirk, Rendon, Wagner, Weber, Wood |
|
SUMMARY: Adds the specialty of reproductive biology and the subspecialty of biochemical genetics and makes conforming changes, removes the requirement that clinical laboratory co-directors substantially comply with federal Clinical Laboratory Improvement Amendments (CLIA) requirements, and makes other technical and conforming changes. Specifically, this bill:
Amends the definition of laboratory director to clarify that the laboratory director on the laboratory's CLIA certificate meets the qualifications under CLIA for the type and complexity of tests being offered by the laboratory.
Amends the definition of laboratory director to allow a scientist, licensed under state law to direct a laboratory performing high complexity tests, such as a bioanalyst, to become a co-director of a laboratory performing high complexity tests without having to meet the CLIA requirements.
Amends the requirement for a bioanalyst license to allow an applicant to obtain four years of experience as any kind of CLS in any CLIA-approved laboratory instead of four years of experience as a California-licensed CLS in laboratory approved by the California Department of Public Health (CDPH).
Adds two new license categories: a) the specialty of reproductive biology and b) the subspecialty of biochemical genetics and makes conforming changes.
Authorizes CDPH to charge a renewal fee for the existing license categories of clinical cytogeneticist and clinical molecular biologist licenses.
Makes conforming changes.
FISCAL EFFECT: According to the Assembly Appropriations Committee, this bill would result in the following costs and revenues to the Clinical Laboratory Improvement Fund:
One-time costs of in the range of $400,000 over two years. This includes modifying regulations, program development, creating forms and related implementation activities.
Ongoing costs of under $100,000 to oversee additional licenses.
Projected ongoing fee revenue of approximately $90,000 associated with new licensure categories
COMMENTS:
Purpose. This bill is sponsored by the California Clinical Laboratory Association. According to the author, "[this bill] will reestablish a true career ladder in the California clinical laboratory field. This bill will allow a Bioanalyst with a Master's Degree to serve as an additional laboratory director in a laboratory performing high complexity testing and will allow an applicant for a bioanalyst license to obtain the required four years of experience in an out of state CLIA-approved laboratory.
Without this bill, the growing shortage of licensed clinical laboratory personnel in California will continue. To meet the healthcare demands of the California population, increased numbers of licensed clinical laboratory personnel are needed."
Background. This bill seeks to address clinical laboratory workforce issues with two changes: 1) allowing qualified licensees without doctorate or medical degrees, such as a bioanalyst, to serve as laboratory co-directors and 2) providing more career opportunities within the clinical laboratory field.
Clinical Lab Directors. Under federal law, all clinical laboratories must have a laboratory director that complies with the CLIA requirements. Among other things, CLIA requires that laboratory directors for laboratories performing high complexity tests must have, among other things, a medical or doctorate degree. For medium complexity tests, the minimum requirement is a bachelor's degree and a specific level of training. This bill will allow a licensee without a medical or doctorate degree, who can already perform high complexity tests, to serve as the director of a clinical laboratory performing high complexity tests.
Clinical Laboratory Bioanalyst Requirements. Under current law, bioanalysts must complete four years of training in a CDPH approved facility. When approving laboratories, CDPH performs an onsite survey and requires ownership information prior to issuing a laboratory a state license.
This bill will allow an applicant for a bioanalyst license to use experience acquired in states other states. New York, Florida, California, and about 10 other states and United States territories have personnel licensing schemes that laboratories must meet.
Workforce Shortages. At this time, it is unclear whether there is a current laboratory personnel shortage. However, California is behind the national average in clinical laboratory technologists. This bill seeks to increase employment in clinical laboratories by providing more career opportunities for personnel.
Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0000683
AB 940
Page 1
Date of Hearing: May 6, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
AB 940
(Ridley-Thomas) – As Amended April 23, 2015
Policy Committee: |
Business and Professions |
Vote: |
14 - 0 |
|
|
|
|
|
|
|
|
Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill adds licensure categories for reproductive biology and for biochemical genetics to existing clinical lab science professions regulated by the California Department of Public Health (CDPH), and applies an existing fee to these new categories.
It also allows licensed bioanalysts to serve as an additional laboratory director for laboratories performing high-complexity tests, and allows bioanalyst license applicants to obtain required experience in an out-of-state CLIA-approved laboratory.
FISCAL EFFECT:
All costs and revenues would be Clinical Laboratory Improvement Fund (CLIF).
One-time costs of in the range of $400,000 over two years. This includes modifying regulations, program development, creating forms and related implementation activities.
Ongoing costs of under $100,000 to oversee additional licenses.
Projected ongoing fee revenue of approximately $90,000 associated with new licensure categories.
COMMENTS:
Purpose. This bill is sponsored by the California Clinical Laboratory Association to "reestablish a true career ladder in the California clinical laboratory field." The intent is to allow a bioanalyst to serve as an additional laboratory director in a laboratory performing high complexity testing, and to update licensure categories consistent with scientific advances.
Background. Federal and state law jointly govern the provision of laboratory services, and CDPH regulates laboratories on behalf of the state and federal government. The federal Clinical Laboratory Improvement Amendments statute (CLIA) is the federal framework for laboratory oversight. CDPH enforces CLIA in California, overseeing quality standards for clinical laboratories and personnel. Laboratory technology is changing rapidly and workforce shortages have been noted for qualified laboratory personnel.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
AB 940
Page 8
Date of Hearing: April 21, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
AB 940
(Ridley-Thomas and Waldron) – As Amended March 23, 2015
SUBJECT: Clinical laboratories.
SUMMARY: Adds the specialty of reproductive biology and the subspecialty of biochemical genetics and makes conforming changes, removes the requirement that clinical laboratory co-directors substantially comply with federal Clinical Laboratory Improvement Amendments (CLIA) requirements, and makes other substantive and non-substantive changes.
EXISTING LAW:
Federal Clinical Laboratory Improvement Act of 1988 (CLIA)
Requires clinical laboratories that perform tests on human specimens to apply for certification with the Centers for Medicaid and Medicare Services (CMS). (Title 42 of the Code of Federal Regulations (CFR) § 493.3)
Sets standards for facility administration, personnel qualifications, and quality control. The standards apply to all settings, including commercial, hospital or physician office laboratories. The standards vary depending on the complexity of the tests performed by the laboratory. (42 CFR §§ 493.15-493.1495)
Classifies the complexity of the tests performed by a laboratory as waived, moderate-complexity, or high-complexity. (42 CFR § 493.5)
Defines waived tests as simple laboratory examinations and procedures that are approved by the Food and Drug Administration (FDA) for home use, employ methodologies that are simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly. (42 CFR § 493)
Establishes a set of criteria to establish the complexity of lab tests. Each criteria is rated from 1-3, and a total score of less 12 is a moderate-complexity test, while higher than 12 is a high-complexity test. (42 CFR §493.17)
Requires a laboratory, as specified, to have a director who meets specified qualifications and provides overall management and direction. (42 CFR §§ 493.1403, 493.1441)
Requires a clinical laboratory director of a laboratory performing medium complexity tests to have a medical degree, a Ph.D., a master’s degree, or bachelor’s degree in a specified field. (42 CFR § 493.1405)
Requires clinical laboratory directors of laboratories performing high complexity tests to either have a medical degree or a Ph.D. in a specified field with varying amounts of experience. (42 CFR §493.1443)
State Law
Provides for the licensure and regulation of clinical laboratories and their personnel by the California Department of Public Health (CDPH) and requires clinical laboratories to be operated under the supervision of a laboratory director. (Business and Professions Code (BPC) § 1260-1327; Title 17 California Code of Regulations (CCR) § 950-1230)
Defines a “laboratory director" as any person who is a duly licensed physician and surgeon or is licensed to direct a clinical laboratory and who substantially meets the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory. (BPC § 1209)
Defines a “clinical laboratory bioanalyst” or “bioanalyst” as any person licensed by the CDPH to engage in clinical laboratory practice and direct a clinical laboratory. (BPC § 1203)
Specifies that a licensed bioanalyst that is qualified under CLIA may perform the duties and responsibilities of a laboratory director, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified in regulations adopted by the CDPH. (BPC § 1203)
A licensed bioanalyst may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA. (BPC § 1203)
Defines “clinical laboratory scientist" (CLS) as any person, other than a licensed clinical laboratory bioanalyst or trainee, who is licensed to engage in clinical laboratory practice under the supervision of a laboratory director. (BPC § 1204)
Specifies that a licensed CLS that is qualified under CLIA may perform clinical laboratory tests or examinations classified as of high complexity under CLIA and the duties and responsibilities of a technical consultant, clinical consultant, technical supervisor and general supervisor, as specified under CLIA, in the specialties of histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, genetics, or other specialty or subspecialty specified by regulation adopted by the department. (BPC § 1204)
Specifies that a licensed CLS may perform any clinical laboratory test or examination classified as waived or of moderate complexity under CLIA. (BPC § 1204)
THIS BILL:
Amends the definition of laboratory director to clarify that the laboratory director on the laboratory’s CLIA certificate meets the qualifications under CLIA for the type and complexity of tests being offered by the laboratory.
Amends the definition of laboratory director to allow a scientist, licensed under state law to direct a laboratory performing high complexity tests, such as a bioanalyst, to become a co-director of a laboratory performing high complexity tests without having to meet the CLIA requirements.
Amends the requirement for a bioanalyst license to allow an applicant to obtain four years of experience as any kind of CLS in any CLIA-approved laboratory instead of four years of experience as a California-licensed CLS in a CDPH-approved laboratory.
Adds two new license categories: 1) the specialty of reproductive biology and 2) the subspecialty of biochemical genetics and makes conforming changes, including:
Authorizes a licensed clinical reproductive biologist and a licensed clinical biochemical geneticist, limited to the new subspecialty, to: 1) work in laboratory practice; 2) supervise others; 3) and direct a clinical laboratory, or the portion limited to the subspecialty.
Authorizes a licensed CLS, under the additional subspecialty of reproductive biology, to perform: 1) laboratory tests classified as high complexity under CLIA; 2) the duties of a waived laboratory director; 3) the duties of technical consultant; 4) the duties of clinical consultant; 5) the duties of technical supervisor; and 6) the duties general supervisor.
Authorizes a licensed trainee, if licensed in the specialty or subspecialty, to work under the supervision of a biochemical geneticist scientist and clinical reproductive biologist scientist.
Authorizes CDPH to issue limited clinical laboratory scientist licenses for reproductive biology and biochemical genetics (which limits them to tests of their specialty).
Defines the subspecialty of a licensed biochemical geneticist scientist as biochemical genetics within the specialty of genetics.
Defines the specialty of a licensed reproductive biologist scientist as reproductive biology.
Allows CDPH to charge a fee for licensing and renewal of clinical reproductive biologists and clinical biochemical geneticists.
Authorizes CDPH to charge a renewal fee for the existing license categories of clinical cytogeneticist and clinical molecular biologist licenses.
Makes other technical changes.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.
COMMENTS:
Purpose. This bill is sponsored by the California Clinical Laboratory Association. According to the author, “[this bill] will reestablish a true career ladder in the California clinical laboratory field. This bill will allow a Bioanalyst with a Master’s Degree to serve as an additional laboratory director in a laboratory performing high complexity testing and will allow an applicant for a bioanalyst license to obtain the required four years of experience in an out of state CLIA-approved laboratory.
Without this bill, the growing shortage of licensed clinical laboratory personnel in California will continue. To meet the healthcare demands of the California population, increased numbers of licensed clinical laboratory personnel are needed.”
Background. This bill seeks to address clinical laboratory workforce issues with two changes: 1) allowing qualified licensees without doctorate or medical degrees, such as a bioanalyst, to serve as laboratory co-directors and 2) providing more career opportunities within the clinical laboratory field. At the federal level, unless the state obtained exemption, clinical laboratories that perform diagnostic and medical tests on human specimens must be CLIA certified. CLIA requires laboratories performing moderate and high complexity testing to meet certain procedural and personnel standards. For laboratories performing waived testing, the laboratories receive a certificate of waiver.
At the state level, the California Laboratory Field Services (LFS), under the CDPH, ensures compliance with state law and CLIA by performing bi-annual onsite inspections of laboratories to ensure accuracy and reliability of laboratory test results. The LFS performs routine inspections of over 800 laboratories each year.
Clinical Lab Directors. Under federal law, all clinical laboratories must have a laboratory director that complies with the CLIA requirements. Among other things, CLIA requires that laboratory directors for laboratories performing high complexity tests must have, among other things, a medical or doctorate degree. For medium complexity tests, the minimum requirement is a bachelor’s degree and a specific level of training. This bill will allow a licensee without a medical or doctorate degree, who can already perform high complexity tests, to serve as the director of a clinical laboratory performing high complexity tests.
In California, laboratories are permitted to have more than one lab director and all laboratory directors must “substantially meet” CLIA requirements. However, the CDPH has not promulgated rules defining “substantially.” According the CDPH, the purpose of the term “substantially” was to allow for variation in case CDPH sought CLIA exemption, which it has not. Therefore, under state law, all laboratory directors must meet all CLIA requirements.
Because at least one laboratory director must meet CLIA, the removal of the term “substantially” would remove the requirement that the co-directors meet CLIA requirements. Instead, there will be one CLIA identified laboratory director, and the co-directors will only need to meet the CDPH licensing requirements (master’s degree). It is unclear how the supervision of laboratories is divided up between laboratory directors.
According to the sponsor, there is no need for all laboratory directors of laboratories performing high complexity tests to have a medical or doctorate degree, particularly since there will always be a CLIA identified laboratory director that has either a medical degree or doctorate degree. In support, the sponsor cites two studies commissioned by the U.S. Department of Health and Human Services (HHS) and one doctoral dissertation:
Kenney, Michael L., "Laboratory Quality and Director Qualifications: An Empirical Assessment of the Medicare Requirement that Directors of Independent Clinical Laboratories Possess Earned Doctorates," Ph.D. dissertation, University of California, Berkeley, 1984.
Kenney, Michael L., "Laboratory Performance and Regulatory Requirements: An Empirical Assessment of the Quality Assurance Effects of Selected Regulatory Requirements on the Performance of Clinical Laboratories," prepared for Technology, Evaluation and Assistance Division, Laboratory Program Office, Centers for Disease Control, United States Department of Health and Human Services, 1985.
Kenney, Michael L. and Greenberg, Don P., "Final Report on Assessment of Clinical Laboratory Regulations," prepared for Office of Assistant Secretary for Planning and Education, United States Department of Health and Human Services, 1986.
While useful, it is important to note that the studies are approximately 30 years old and may not take into account the new changes in technology and medicine. Further, they were all written by the same author so it is difficult to confirm a lack of bias. However, there are also no studies indicating otherwise.
Clinical Laboratory Bioanalyst Requirements. Under current law, bioanalysts must complete four years of training in a CDPH approved facility. When approving laboratories, CDPH performs an onsite survey and requires ownership information prior to issuing a laboratory a state license.
For laboratory approval, CLIA recognizes the personnel requirements of states that have licensing schemes personnel, such as New York, Florida, California, and about 10 other states and US territories, and requires that laboratories meet the state’s personnel license requirements.
By amending the state requirements, this bill will allow an applicant for a bioanalyst license to obtain the required experience out of state.
Workforce Shortages. In 2005, the federal Health Resources and Services Administration (HRSA), working with the University of California, San Francisco and the American Society for Clinical Pathology (ASCP) published a clinical lab scientist and technician workforce study. The study was done in response to growing concerns over laboratory personnel shortages.
The study utilized data from the 2002 federal Bureau of Labor Statistics workforce study, which was used to make comparisons between states (California was 76 percent lower than the national average). The study also cited data from a 2002 ASCP wage and vacancy survey. In the end, the study found conflicting evidence and methodological variables and was unable to conclude that there was a national workforce shortage.
More recent statistics from the Bureau of Labor Statistics show that, for clinical lab technicians (entry level clinical lab personnel), California has stayed close to the national average, between 91-93 percent from 2010 to 2014. For clinical lab technologists (higher level, such as scientists and bioanalysts), California has declined from 64 to 56 percent of the national average from 2010 to 2014.
The Bureau also projects that California’s employment of clinical lab technicians will increase 28% between 2012 and 2022, while nationally it will grow 30%. Clinical lab technologists will increase 12% between 2012 and 2022, while nationally it will grow 14%. As of 2014, California employs approximately 15,750 clinical lab technicians, and approximately 10,210 clinical lab technologists.
The most recent vacancy survey (2012) by the ASCP, the same survey used in the HRSA study, suggested that laboratory vacancy rates have decreased since 2010, a 2% decrease in laboratory staff and supervisor vacancies, except for the field of cytology. However, ASCP noted, based on the data it collected, it expects that there may be a future shortage.
Both the ASCP 2012 survey and the 2011 California Hospital Association Allied Workforce report point to an aging workforce; limitations on courses offered by colleges and universities; laboratory training program closures resulting in limited space in existing train programs; and, low professional salaries for graduates as possible contributors to a national shortage of qualified clinical laboratory scientists and other laboratory personnel.
In addition, a 2014 Advance Healthcare Network survey indicates that approximately 35% of laboratory workers are 50-59 years old, with approximately 17% over the age of 60. Based on the above data, it is currently unclear whether there is a current laboratory personnel shortage. However, California is behind the national average in clinical laboratory technologists. This bill seeks to increase employment in clinical laboratories by providing more career opportunities for personnel.
Reproductive Biology and Biochemical Genetics. Current law allows the CDPH to issue licenses and limited licenses in various scientific specialties and subspecialties. It does not currently allow licenses for reproductive biology or biochemical genetics.
According to the Johns Hopkins Bloomberg School of Public Health, reproductive biology is the study of the biochemistry, physiology, endocrinology, cell biology, genetics, and molecular biology of a wide range of biological processes involved in reproduction.
According to the Mayo Clinic, clinical biochemical genetics deals with the evaluation and diagnosis of patients and families with inherited metabolic disease, monitoring of treatment, and distinguishing heterozygous carriers from non-carriers by metabolite and enzymatic analysis of physiological fluids and tissues. This bill will allow the CDPH to issue licenses in the two fields.
Previous Legislation. AB 1215 (Hagman and Holden), Chapter 199, Statutes of 2013, expanded the definition of “laboratory director” to include a duly licensed clinical laboratory scientist and a duly licensed limited clinical laboratory scientist and authorizes these individuals to perform the duties and responsibilities of a waived laboratory director under CLIA.
AB 830 (Holden) of 2013, would have required CDPH to promulgate regulations by January 1, 2015, requiring any facility operating a clinical laboratory to provide specified training to CLSs, medical laboratory technicians, and any individuals who are charged with direct and responsible supervision of either a CLS or a medical laboratory technician. NOTE: This bill was held in the Assembly Business and Professions Committee.
AB 761 (Hernández), Chapter 714, Statutes of 2012, allowed optometrists to independently perform waived clinical laboratory tests necessary for the diagnosis of conditions and diseases of the eye.
SB 1481 (Negrete McLeod), Chapter 874, Statutes of 2012, eliminated the requirement that only allowed a laboratory director to perform CLIA waived tests and permitted pharmacists to administer certain tests that were approved by the federal Food and Drug Administration for sale to the public without a prescription in the form of an over-the-counter test kit upon customer request, provided that the pharmacy obtained a CLIA certificate of waiver and a registration from the CDPH and comply with all other requirements governing clinical laboratories, as specified.
SB 1246 (Negrete McLeod), Chapter 523, Statutes of 2010, included naturopathic doctors in the list of health care practitioners who can perform a clinical laboratory test or examination classified as waived under CLIA and designated naturopathic doctors as clinical laboratory directors for CLIA-waived tests only.
AB 1442 (Feuer) of 2007, would have required clinical laboratories that perform tests to screen for human immunodeficiency virus that are classified as waived under CLIA to enroll in a proficiency testing program and to obtain the appropriate license or registration from DPH, as specified. NOTE: This bill failed passage on the Assembly Floor.
AB 185 (Dymally) of 2007, would have expanded the duties that unlicensed personnel are authorized to perform in a clinical laboratory and would have revised the level of supervision required when unlicensed personnel perform them. NOTE: AB 185 failed passage in the Assembly Committee on Business and Professions.
AB 1370 (Matthews) of 2005, would have included a pharmacist within the definition of laboratory director if the clinical laboratory test or examination is a routine patient assessment procedure, as defined. NOTE: AB 1370 failed passage in the Assembly Committee on Business and Professions.
AB 433 (Nava) of 2005, would have exempted physician office laboratories from licensure and regulatory requirements governing clinical laboratories and their personnel by the Department of Health Services. NOTE: AB 433 failed passage in the Assembly Health Committee.
ARGUMENTS IN SUPPORT:
According to the sponsor, “AB 940 is necessary because the bill allows for California to continue being a competitive state in the clinical laboratory business that attracts new individuals in this field. For these reasons, we thank you for authoring AB 940 (Ridley-Thomas).”
ARGUMENTS IN OPPOSITION:
None on file.
IMPLEMENTATION ISSUES:
According to CDPH, “substantially meets CLIA” in BPC § 1209 is in conflict with another provision of law, BPC § 1207, states that a person licensed under BPC § 1264, and who supervises others engaged in specified laboratory duties, must be also qualified under CLIA. It is also in conflict with the provisions of BPC §1209.1, which states that, in order to perform high complexity tests, a histocompatibility laboratory director needs to both be licensed under BPC §1260.1 and qualify under CLIA. Therefore, these professions would need to meet CLIA requirements regardless.
Because of the possible conflicts between the new laboratory director definition this bill would create and the individual sections defining the licensees and their requirements (such as the bioanalyst in BPC § 1203), the author may wish to amend the individual licensing provisions to make conforming changes.
REGISTERED SUPPORT:
California Clinical Laboratories Association (sponsor)
California Association of Bioanalysts
LabCorp
American Association of Bioanalysts
American Clinical Laboratory Association
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301
Discussed in Hearing
54SEC
Assembly Floor
2MIN
Senate Floor
2MIN
Senate Standing Committee on Business, Professions and Economic Development
1MIN
Assembly Floor
1MIN
Assembly Standing Committee on Business and Professions
Bill Co-Author(s):