Amended in Assembly April 9, 2013

California Legislature—2013–14 Regular Session

Assembly Bill No. 1215

Introduced by Assembly begin delete Member Hagman end delete begin insert Members Hagman and Holden end insert

February 22, 2013

An act to amend begin delete Section end delete begin insert Sections 1204 and end insert 1209 of the Business and Professions Code, relating to clinical laboratories.

LEGISLATIVE COUNSEL’S DIGEST

AB 1215, as amended, 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. begin insert Existing law defines “laboratory scientist” and authorizes a person licensed as a clinical laboratory scientist and qualified under CLIA to perform the duties and responsibilities of a technical consultant, clinical consultant, technical supervisor, and general supervisor, as specified under CLIA, in certain specialties. end insert

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 begin delete scientist. end delete begin insert scientist and a duly licensed limited clinical laboratory scientist. The bill would authorize a person licensed as a clinical laboratory scientist and qualified under CLIA to additionally perform the duties and responsibilities of a waived laboratory director, as specified under CLIA. end insert

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

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

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 1204 of the end insert begin insert Business and Professions
Code end insert begin insert is amended to read: end insert

1204.  

As used in this chapter, “clinical laboratory scientist”
means any person begin insert , end insert other than a licensed clinical laboratory
bioanalyst or trainee begin insert , end insert who is licensed under Sections 1261 and
1262 to engage in clinical laboratory practice under the overall
operation and administration of a laboratory director begin insert , unless serving
as a director of a waived laboratory as provided in Section 1209 end insert .
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 begin insert waived laboratory director, as specified under
CLIA, end insert 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. 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.

begin delete SECTION 1. end delete
begin insert SEC. 2. end insert   

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 a duly licensed physician and surgeon, or, only
for purposes of a clinical laboratory test or examination classified
as waived, is a duly licensed clinical laboratory scientist, begin insert a duly
licensed limited clinical laboratory scientist, end insert a duly licensed
naturopathic doctor, or a duly licensed optometrist serving as the
director of a laboratory which only performs clinical laboratory
tests authorized in paragraph (10) of subdivision (e) of Section
3041 that are classified as waived, or is licensed to direct a clinical
laboratory under this chapter and who substantially meets the
laboratory director qualifications under CLIA for the type and
complexity of tests being offered by the laboratory. 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) (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) 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) 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) 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 individual’s performance shall be reevaluated to
include the use of the new test methodology or instrumentation.

(f) 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) Subdivision (f) 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) 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.