AB 940, as amended, Ridley-Thomas. Clinical laboratories.
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 licensee’s 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 bioanalyst’s 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 applicant’s 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 forbegin delete the clinicalend deletebegin insert
thoseend insert 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 wouldbegin insert rename the license for clinical molecular biologist as the license for clinical genetic molecular biologist. The bill wouldend insert apply existing license renewal fees to persons renewing a clinical cytogeneticist’sbegin insert licenseend insert or clinicalbegin insert geneticend insert molecular biologist’s license.
Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.
The people of the State of California do enact as follows:
Section 1203 of the Business and Professions
2Code is amended to read:
As used in this chapter, “clinical laboratory bioanalyst”
4or “bioanalyst” means a person licensed under Section 1260 to
5engage in clinical laboratory practice and direction of a clinical
6laboratory.
7(a) A person licensed as a clinical laboratory bioanalyst or
8bioanalyst and qualified under CLIA, who is not the CLIA
9laboratory director, may perform clinical laboratory tests or
10examinations classified as of high complexity under CLIA and the
11duties and responsibilities of a laboratory director in the specialties
12of histocompatibility, microbiology, diagnostic immunology,
13chemistry, hematology, immunohematology, genetics, or other
14specialty or subspecialty specified in
regulations adopted by the
15department.
16(b) A person licensed as a clinical laboratory bioanalyst or
17bioanalyst and qualified under CLIA may perform the duties and
18responsibilities of a CLIA laboratory director, technical consultant,
19clinical consultant, technical supervisor, and general supervisor,
20as specified under CLIA, in the specialties of histocompatibility,
21microbiology, diagnostic immunology, chemistry, hematology,
22immunohematology, genetics, or other specialty or subspecialty
23specified in regulations adopted by the department.
24(c) A person licensed as a clinical laboratory bioanalyst or
25bioanalyst may perform any clinical laboratory test or examination
26classified as waived or of moderate complexity under CLIA.
Section 1209 of the Business and Professions Code is
28amended to read:
(a) As used in this chapter, “laboratory director” means
30any person who is any of the following:
31(1) A duly licensed physician and surgeon.
32(2) Only for purposes of a clinical laboratory test or examination
33classified as waived, is any of the following:
34(A) A duly licensed clinical laboratory scientist.
35(B) A duly licensed limited clinical laboratory scientist.
36(C) A duly licensed naturopathic doctor.
P4 1(D) A duly licensed optometrist serving as the director of a
2laboratory that only performs clinical laboratory tests authorized
3in paragraph (10) of subdivision (e) of Section 3041.
4(3) Licensed to direct a clinical laboratory under this chapter.
5(b) (1) A person defined in paragraph (1) or (3) of subdivision
6(a) who is identified as the CLIA laboratory director of a laboratory
7that performs clinical laboratory tests classified as moderate or
8high complexity shall also meet the laboratory director
9qualifications under CLIA for the type and complexity of tests
10being offered by the laboratory.
11(2) As used in this subdivision, “CLIA laboratory director”
12means the person identified as the laboratory
director on the CLIA
13certificate issued to the laboratory by the federal Centers for
14Medicare and Medicaid Services (CMS).
15(c) The laboratory director, if qualified under CLIA, may
16perform the duties of the technical consultant, technical supervisor,
17clinical consultant, general supervisor, and testing personnel, or
18delegate these responsibilities to persons qualified under CLIA.
19If the laboratory director reapportions performance of those
20responsibilities or duties, he or she shall remain responsible for
21ensuring that all those duties and responsibilities are properly
22performed.
23(d) (1) The laboratory director is responsible for the overall
24operation and administration of the clinical laboratory, including
25administering the technical and scientific
operation of a clinical
26laboratory, the selection and supervision of procedures, the
27reporting of results, and active participation in its operations to
28the extent necessary to ensure compliance with this act and CLIA.
29He or she shall be responsible for the proper performance of all
30laboratory work of all subordinates and shall employ a sufficient
31number of laboratory personnel with the appropriate education
32and either experience or training to provide appropriate
33consultation, properly supervise and accurately perform tests, and
34report test results in accordance with the personnel qualifications,
35duties, and responsibilities described in CLIA and this chapter.
36(2) Where a point-of-care laboratory testing device is utilized
37and provides results for more than one analyte, the testing
38personnel may perform and report the results of all tests
ordered
39for each analyte for which he or she has been found by the
40laboratory director to be competent to perform and report.
P5 1(e) As part of the overall operation and administration, the
2laboratory director of a registered laboratory shall document the
3adequacy of the qualifications (educational background, training,
4and experience) of the personnel directing and supervising the
5laboratory and performing the laboratory test procedures and
6examinations. In determining the adequacy of qualifications, the
7laboratory director shall comply with any regulations adopted by
8the department that specify the minimum qualifications for
9personnel, in addition to any CLIA requirements relative to the
10education or training of personnel.
11(f) As part of the overall operation and administration,
the
12laboratory director of a licensed laboratory shall do all of the
13following:
14(1) Ensure that all personnel, prior to testing biological
15specimens, have the appropriate education and experience, receive
16the appropriate training for the type and complexity of the services
17offered, and have demonstrated that they can perform all testing
18operations reliably to provide and report accurate results. In
19determining the adequacy of qualifications, the laboratory director
20shall comply with any regulations adopted by the department that
21specify the minimum qualifications for, and the type of procedures
22that may be performed by, personnel in addition to any CLIA
23requirements relative to the education or training of personnel.
24Any regulations adopted pursuant to this section that specify the
25type of procedure that may be performed by testing
personnel shall
26be based on the skills, knowledge, and tasks required to perform
27the type of procedure in question.
28(2) Ensure that policies and procedures are established for
29monitoring individuals who conduct preanalytical, analytical, and
30postanalytical phases of testing to ensure that they are competent
31and maintain their competency to process biological specimens,
32perform test procedures, and report test results promptly and
33proficiently, and, whenever necessary, identify needs for remedial
34training or continuing education to improve skills.
35(3) Specify in writing the responsibilities and duties of each
36individual engaged in the performance of the preanalytic, analytic,
37and postanalytic phases of clinical laboratory tests or examinations,
38including which clinical laboratory
tests or examinations the
39individual is authorized to perform, whether supervision is required
40for the individual to perform specimen processing, test
P6 1performance, or results reporting, and whether consultant,
2supervisor, or director review is required prior to the individual
3reporting patient test results.
4(g) The competency and performance of staff of a licensed
5laboratory shall be evaluated and documented by the laboratory
6director, or by a person who qualifies as a technical consultant or
7a technical supervisor under CLIA depending on the type and
8complexity of tests being offered by the laboratory.
9(1) The procedures for evaluating the competency of the staff
10shall include, but are not limited to, all of the following:
11(A) Direct observations of routine patient test performance,
12including patient preparation, if applicable, and specimen handling,
13processing, and testing.
14(B) Monitoring the recording and reporting of test results.
15(C) Review of intermediate test results or worksheets, quality
16control records, proficiency testing results, and preventive
17maintenance records.
18(D) Direct observation of performance of instrument
19maintenance and function checks.
20(E) Assessment of test performance through testing previously
21analyzed specimens, internal blind testing samples, or external
22proficiency testing samples.
23(F) Assessment of problem solving skills.
24(2) Evaluation and documentation of staff competency and
25performance shall occur at least semiannually during the first year
26an individual tests biological specimens. Thereafter, evaluations
27shall be performed at least annually unless test methodology or
28instrumentation changes, in which case, prior to reporting patient
29test results, the individual’s performance shall be reevaluated to
30include the use of the new test methodology or instrumentation.
31(h) The laboratory director of each clinical laboratory of an
32acute care hospital shall be a physician and surgeon who is a
33qualified pathologist, except as follows:
34(1) If a qualified pathologist is not available, a physician and
35surgeon
or a clinical laboratory bioanalyst qualified as a laboratory
36director under subdivision (a) may direct the laboratory. However,
37a qualified pathologist shall be available for consultation at suitable
38intervals to ensure high-quality service.
39(2) If there are two or more clinical laboratories of an acute care
40hospital, those additional clinical laboratories that are limited to
P7 1the performance of blood gas analysis, blood electrolyte analysis,
2or both, may be directed by a physician and surgeon qualified as
3a laboratory director under subdivision (a), irrespective of whether
4a pathologist is available.
5As used in this subdivision, a qualified pathologist is a physician
6and surgeon certified or eligible for certification in clinical or
7anatomical pathology by the American Board of Pathology or the
8American
Osteopathic Board of Pathology.
9(i) Subdivision (h) does not apply to any director of a clinical
10laboratory of an acute care hospital acting in that capacity on or
11before January 1, 1988.
12(j) A laboratory director may serve as the director of up to the
13maximum number of laboratories stipulated by CLIA, as defined
14under Section 1202.5.
Section 1260 of the Business and Professions Code is
16amended to read:
The department shall issue a clinical laboratory
18bioanalyst’s license to each person who is a lawful holder of a
19degree of master of arts, master of science, or an equivalent or
20higher degree as determined by the department with a major in
21chemical, physical, biological, or clinical laboratory sciences. This
22education shall have been obtained in one or more established and
23reputable institutions maintaining standards equivalent, as
24determined by the department, to those institutions accredited by
25the Western Association of Schools and Colleges or an essentially
26equivalent accrediting agency, as determined by the department.
27The applicant also shall have a minimum of four years’ experience
28as a clinical laboratory scientist performing
clinical laboratory
29work embracing the various fields of clinical laboratory activity
30in a clinical laboratory certified under CLIA. The quality and
31variety of this experience shall be satisfactory to the department
32and shall have been obtained within the six-year period
33immediately antecedent to admission to the examination. The
34applicant shall successfully pass a written examination and an oral
35examination conducted by the department or a committee
36designated by the department to conduct the examinations,
37indicating that the applicant is properly qualified. The department
38may issue a license without conducting a written examination to
39an applicant who has passed a written examination of a national
40accrediting board having requirements that are, in the determination
P8 1of the department, equal to or greater than those required by this
2chapter and regulations adopted by the department. The department
3shall
establish by regulation the required courses to be included
4in the college or university training.
begin insertSection 1264 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
6amended to read:end insert
The department shall issue a clinical chemist, clinical
8microbiologist, clinical toxicologist, clinicalbegin insert geneticend insert molecular
9biologist, or clinical cytogeneticist license to each person who has
10applied for the license on forms provided by the department, who
11is a lawful holder of a master of science or doctoral degree in the
12specialty for which the applicant is seeking a license and who has
13met such additional reasonable qualifications of training, education,
14and experience as the department may establish by regulations.
15The department shall issue an oral and maxillofacial pathologist
16license to every applicant for licensure who has applied for the
17license on forms provided by the department, who is a
registered
18Diplomate of the American Board of Oral and Maxillofacial
19Pathology, and who meets any additional and reasonable
20qualifications of training, education, and experience as the
21department may establish by regulation.
22(a) The graduate education shall have included 30 semester
23hours of coursework in the applicant’s specialty. Applicants
24possessing only a master of science degree shall have the equivalent
25of one year of full-time, directed study or training in procedures
26and principles involved in the development, modification or
27evaluation of laboratory methods, including training in complex
28methods applicable to diagnostic laboratory work. Each applicant
29must have had one year of training in his or her specialty in a
30clinical laboratory acceptable to the department and three years of
31experience in his or her specialty in a clinical laboratory, two years
32of which must have been at a supervisory level. The education
33shall have been
obtained in one or more established and reputable
34institutions maintaining standards equivalent, as determined by
35the department, to those institutions accredited by an agency
36acceptable to the department. The department shall determine by
37examination that the applicant is properly qualified. Examinations,
38training, or experience requirements for specialty licenses shall
39cover only the specialty concerned.
P9 1(b) The department may issue licenses without examination to
2applicants who have passed examinations of other states or national
3accrediting boards whose requirements are equal to or greater than
4those required by this chapter and regulations established by the
5department. The evaluation of other state requirements or
6requirements of national accrediting boards shall be carried out
7by the department with the assistance of representatives from the
8licensed groups. This section shall not apply to persons who have
9passed an examination by
another state or national accrediting
10board prior to the establishment of requirements that are equal to
11or exceed those of this chapter or regulations of the department.
12(c) The department may issue licenses without examination to
13applicants who had met standards of education and training, defined
14by regulations, prior to the date of the adoption of implementing
15regulations.
16(d) The department shall adopt regulations to conform to this
17section.
Section 1300 of the Business and Professions Code is
20amended to read:
The amount of application, registration, and license fees
22under this chapter shall be as follows:
23(a) The application fee for a histocompatibility laboratory
24director’s, clinical laboratory bioanalyst’s, clinical chemist’s,
25clinical microbiologist’s, clinical laboratory toxicologist’s, clinical
26cytogeneticist’s, or clinicalbegin insert geneticend insert molecular biologist’s license
27is sixty-three dollars ($63) commencing on July 1, 1983.
28(b) The annual renewal fee for a histocompatibility laboratory
29director’s, clinical laboratory bioanalyst’s, clinical chemist’s,
30clinical
microbiologist’s, clinical laboratory toxicologist’s, clinical
31cytogeneticist’s, or clinicalbegin insert geneticend insert molecular biologist’s license
32is sixty-three dollars ($63) commencing on July 1, 1983.
33(c) The application fee for a clinical laboratory scientist’s or
34limited clinical laboratory scientist’s license is thirty-eight dollars
35($38) commencing on July 1, 1983.
36(d) The application and annual renewal fee for a
37cytotechnologist’s license is fifty dollars ($50) commencing on
38January 1, 1991.
P10 1(e) The annual renewal fee for a clinical laboratory scientist’s
2or limited clinical laboratory scientist’s license is twenty-five
3dollars
($25) commencing on July 1, 1983.
4(f) A clinical laboratory applying for a license to perform tests
5or examinations classified as of moderate or of high complexity
6under CLIA and a clinical laboratory applying for certification
7under subdivision (c) of Section 1223 shall pay an application fee
8for that license or certification based on the number of tests it
9performs or expects to perform in a year, as follows:
10(1) Less than 2,001 tests: two hundred seventy dollars ($270).
11(2) Between 2,001 and 10,000, inclusive, tests: eight hundred
12twenty dollars ($820).
13(3) Between 10,001 and 25,000, inclusive, tests: one thousand
14three hundred fifteen dollars ($1,315).
15(4) Between 25,001 and 50,000, inclusive, tests: one thousand
16five hundred eighty dollars ($1,580).
17(5) Between 50,001 and 75,000, inclusive, tests: one thousand
18nine hundred sixty dollars ($1,960).
19(6) Between 75,001 and 100,000, inclusive, tests: two thousand
20three hundred forty dollars ($2,340).
21(7) Between 100,001 and 500,000, inclusive, tests: two thousand
22seven hundred forty dollars ($2,740).
23(8) Between 500,001 and 1,000,000, inclusive, tests: four
24thousand nine hundred ten dollars ($4,910).
25(9) More than 1,000,000 tests: five thousand
two hundred sixty
26dollars ($5,260) plus three hundred fifty dollars ($350) for every
27
500,000 tests over 1,000,000, up to a maximum of 15,000,000
28tests.
29(g) A clinical laboratory performing tests or examinations
30classified as of moderate or of high complexity under CLIA and
31a clinical laboratory with a certificate issued under subdivision (c)
32of Section 1223 shall pay an annual renewal fee based on the
33number of tests it performed in the preceding calendar year, as
34follows:
35(1) Less than 2,001 tests: one hundred seventy dollars ($170).
36(2) Between 2,001 and 10,000, inclusive, tests: seven hundred
37twenty dollars ($720).
38(3) Between 10,001 and 25,000, inclusive, tests: one thousand
39one hundred fifteen dollars ($1,115).
P11 1(4) Between 25,001 and 50,000, inclusive, tests: one thousand
2three hundred eighty dollars ($1,380).
3(5) Between 50,001 and 75,000, inclusive, tests: one thousand
4seven hundred sixty dollars ($1,760).
5(6) Between 75,001 and 100,000, inclusive, tests: two thousand
6forty dollars ($2,040).
7(7) Between 100,001 and 500,000, inclusive, tests: two thousand
8four hundred forty dollars ($2,440).
9(8) Between 500,001 and 1,000,000, inclusive, tests: four
10thousand six hundred ten dollars ($4,610).
11(9) More than 1,000,000 tests per year: four thousand nine
12
hundred sixty dollars ($4,960) plus three hundred fifty dollars
13($350) for every 500,000 tests over 1,000,000, up to a maximum
14of 15,000,000 tests.
15(h) The application fee for a trainee’s license is thirteen dollars
16($13) commencing on July 1, 1983.
17(i) The annual renewal fee for a trainee’s license is eight dollars
18($8) commencing on July 1, 1983.
19(j) The application fee for a duplicate license is five dollars ($5)
20commencing on July 1, 1983.
21(k) The personnel licensing delinquency fee is equal to the
22annual renewal fee.
23(l) The director may establish a fee for examinations required
24under
this chapter. The fee shall not exceed the total cost to the
25department in conducting the examination.
26(m) A clinical laboratory subject to registration under paragraph
27(2) of subdivision (a) of Section 1265 and performing only those
28
clinical laboratory tests or examinations considered waived under
29CLIA shall pay an annual fee of one hundred dollars ($100). A
30clinical laboratory subject to registration under paragraph (2) of
31subdivision (a) of Section 1265 and performing only
32 provider-performed microscopy, as defined under CLIA, shall pay
33an annual fee of one hundred fifty dollars ($150). A clinical
34laboratory performing both waived and provider-performed
35microscopy shall pay an annual registration fee of one hundred
36fifty dollars ($150).
37(n) The costs of the department in conducting a complaint
38investigation, imposing sanctions, or conducting a hearing under
39this chapter shall be paid by the clinical laboratory. The fee shall
40be no greater than the fee the laboratory would pay under CLIA
P12 1for the same type of activities and shall not be payable if the
2clinical
laboratory would not be required to pay those fees under
3CLIA.
4(o) The state, a district, city, county, city and county, or other
5political subdivision, or any public officer or body shall be subject
6to the payment of fees established pursuant to this chapter or
7regulations adopted thereunder.
8(p) In addition to the payment of registration or licensure fees,
9a clinical laboratory located outside the State of California shall
10reimburse the department for travel and per diem to perform any
11necessary onsite inspections at the clinical laboratory in order to
12ensure compliance with this chapter.
13(q) The department shall establish an application fee and a
14renewal fee for a medical laboratory technician license, the total
15fees
collected not to exceed the costs of the department for the
16implementation and operation of the program licensing and
17regulating medical laboratory technicians pursuant to Section
181260.3.
19(r) The costs of the department to conduct any reinspections to
20ensure compliance of a laboratory applying for initial licensure
21shall be paid by the laboratory. This additional cost for each visit
22shall be equal to the initial application fee and shall be paid by the
23laboratory prior to issuance of a license. The department shall not
24charge a reinspection fee if the reinspection is due to error or
25omission on the part of the department.
26(s) A fee of twenty-five dollars ($25) shall be assessed for
27approval of each additional location authorized by paragraph (2)
28of subdivision (d) of Section
1265.
29(t) On or before July 1, 2013, the department shall report to the
30Legislature during the annual legislative budget hearing process
31the extent to which the state oversight program meets or exceeds
32federal oversight standards and the extent to which the federal
33Department of Health and Human Services is accepting exemption
34applications and the potential cost to the state for an exemption.
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