California Legislature—2013–14 Regular Session

Assembly BillNo. 1215


Introduced by Assembly Member Hagman

February 22, 2013


An act to amend Section 1209 of the Business and Professions Code, relating to clinical laboratories.

LEGISLATIVE COUNSEL’S DIGEST

AB 1215, as introduced, Hagman. 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 an individual who, among others, is a duly licensed naturopathic doctor.

This bill would expand the definition of “laboratory director” for purposes of a clinical laboratory test or examination classified as waived to include a duly licensed clinical laboratory scientist.

Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.

The people of the State of California do enact as follows:

P1    1

SECTION 1.  

Section 1209 of the Business and Professions
2Code
is amended to read:

P2    1

1209.  

(a) As used in this chapter, “laboratory director” means
2any person who is a duly licensed physician and surgeon, or, only
3for purposes of a clinical laboratory test or examination classified
4as waived, isbegin insert a duly licensed clinical laboratory scientist,end insert a duly
5licensed naturopathic doctor, or a duly licensed optometrist serving
6as the director of a laboratory which only performs clinical
7laboratory tests authorized in paragraph (10) of subdivision (e) of
8Section 3041 that are classified as waived, or is licensed to direct
9a clinical laboratory under this chapter and who substantially meets
10the laboratory director qualifications under CLIA for the type and
11complexity of tests being offered by the laboratory. The laboratory
12 director, if qualified under CLIA, may perform the duties of the
13technical consultant, technical supervisor, clinical consultant,
14general supervisor, and testing personnel, or delegate these
15responsibilities to persons qualified under CLIA. If the laboratory
16director reapportions performance of those responsibilities or
17duties, he or she shall remain responsible for ensuring that all those
18duties and responsibilities are properly performed.

19(b) (1) The laboratory director is responsible for the overall
20operation and administration of the clinical laboratory, including
21administering the technical and scientific operation of a clinical
22laboratory, the selection and supervision of procedures, the
23reporting of results, and active participation in its operations to
24the extent necessary to ensure compliance with this act and CLIA.
25He or she shall be responsible for the proper performance of all
26laboratory work of all subordinates and shall employ a sufficient
27number of laboratory personnel with the appropriate education
28and either experience or training to provide appropriate
29consultation, properly supervise and accurately perform tests, and
30report test results in accordance with the personnel qualifications,
31duties, and responsibilities described in CLIA and this chapter.

32(2) Where a point-of-care laboratory testing device is utilized
33and provides results for more than one analyte, the testing
34personnel may perform and report the results of all tests ordered
35for each analyte for which he or she has been found by the
36laboratory director to be competent to perform and report.

37(c) As part of the overall operation and administration, the
38laboratory director of a registered laboratory shall document the
39adequacy of the qualifications (educational background, training,
40and experience) of the personnel directing and supervising the
P3    1laboratory and performing the laboratory test procedures and
2examinations. In determining the adequacy of qualifications, the
3laboratory director shall comply with any regulations adopted by
4the department that specify the minimum qualifications for
5personnel, in addition to any CLIA requirements relative to the
6education or training of personnel.

7(d) As part of the overall operation and administration, the
8laboratory director of a licensed laboratory shall do all of the
9following:

10(1) Ensure that all personnel, prior to testing biological
11specimens, have the appropriate education and experience, receive
12the appropriate training for the type and complexity of the services
13offered, and have demonstrated that they can perform all testing
14operations reliably to provide and report accurate results. In
15determining the adequacy of qualifications, the laboratory director
16shall comply with any regulations adopted by the department that
17specify the minimum qualifications for, and the type of procedures
18that may be performed by, personnel in addition to any CLIA
19requirements relative to the education or training of personnel.
20Any regulations adopted pursuant to this section that specify the
21type of procedure that may be performed by testing personnel shall
22be based on the skills, knowledge, and tasks required to perform
23the type of procedure in question.

24(2) Ensure that policies and procedures are established for
25monitoring individuals who conduct preanalytical, analytical, and
26postanalytical phases of testing to ensure that they are competent
27and maintain their competency to process biological specimens,
28perform test procedures, and report test results promptly and
29proficiently, and, whenever necessary, identify needs for remedial
30training or continuing education to improve skills.

31(3) Specify in writing the responsibilities and duties of each
32individual engaged in the performance of the preanalytic, analytic,
33and postanalytic phases of clinical laboratory tests or examinations,
34including which clinical laboratory tests or examinations the
35individual is authorized to perform, whether supervision is required
36for the individual to perform specimen processing, test
37performance, or results reporting, and whether consultant,
38supervisor, or director review is required prior to the individual
39reporting patient test results.

P4    1(e) The competency and performance of staff of a licensed
2laboratory shall be evaluated and documented by the laboratory
3director, or by a person who qualifies as a technical consultant or
4a technical supervisor under CLIA depending on the type and
5complexity of tests being offered by the laboratory.

6(1) The procedures for evaluating the competency of the staff
7shall include, but are not limited to, all of the following:

8(A) Direct observations of routine patient test performance,
9including patient preparation, if applicable, and specimen handling,
10processing, and testing.

11(B) Monitoring the recording and reporting of test results.

12(C) Review of intermediate test results or worksheets, quality
13control records, proficiency testing results, and preventive
14maintenance records.

15(D) Direct observation of performance of instrument
16maintenance and function checks.

17(E) Assessment of test performance through testing previously
18analyzed specimens, internal blind testing samples, or external
19proficiency testing samples.

20(F) Assessment of problem solving skills.

21(2) Evaluation and documentation of staff competency and
22performance shall occur at least semiannually during the first year
23an individual tests biological specimens. Thereafter, evaluations
24shall be performed at least annually unless test methodology or
25instrumentation changes, in which case, prior to reporting patient
26test results, the individual’s performance shall be reevaluated to
27include the use of the new test methodology or instrumentation.

28(f) The laboratory director of each clinical laboratory of an acute
29care hospital shall be a physician and surgeon who is a qualified
30pathologist, except as follows:

31(1) If a qualified pathologist is not available, a physician and
32surgeon or a clinical laboratory bioanalyst qualified as a laboratory
33director under subdivision (a) may direct the laboratory. However,
34a qualified pathologist shall be available for consultation at suitable
35intervals to ensure high quality service.

36(2) If there are two or more clinical laboratories of an acute care
37hospital, those additional clinical laboratories that are limited to
38the performance of blood gas analysis, blood electrolyte analysis,
39or both, may be directed by a physician and surgeon qualified as
P5    1a laboratory director under subdivision (a), irrespective of whether
2a pathologist is available.

3As used in this subdivision, a qualified pathologist is a physician
4and surgeon certified or eligible for certification in clinical or
5anatomical pathology by the American Board of Pathology or the
6American Osteopathic Board of Pathology.

7(g) Subdivision (f) does not apply to any director of a clinical
8laboratory of an acute care hospital acting in that capacity on or
9before January 1, 1988.

10(h) A laboratory director may serve as the director of up to the
11maximum number of laboratories stipulated by CLIA, as defined
12under Section 1202.5.



O

    99