California Legislature—2015–16 Regular Session

Assembly Bill No. 940

Introduced by Assembly Member Ridley-Thomas

February 26, 2015

An act to amend Sections 1209, 1260, 1261.5, 1264, and 1300 of the Business and Professions Code, relating to healing arts.

LEGISLATIVE COUNSEL’S DIGEST

AB 940, as introduced, 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 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 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 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.

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

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

SECTION 1.  

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 begin delete a end delete begin insert any of the following: end insert

begin insert (1) end insert begin insert   end insert begin insert A end insert duly licensed physician and begin delete surgeon, or, only end delete begin insert surgeon. end insert

begin insert (2) end insert begin insert   end insert begin insert Only end insert for purposes of a clinical laboratory test or examination
classified as waived, is begin delete a end delete begin insert any of the following: end insert

begin insert (A) end insert begin insert   end insert begin insert A end insert duly licensed clinical laboratory begin delete scientist, a end delete begin insert scientist. end insert

begin insert (B) end insert begin insert   end insert begin insert A end insert duly licensed limited clinical laboratory begin delete scientist, a end delete
begin insert scientist. end insert

begin insert (C) end insert begin insert   end insert begin insert A end insert duly licensed naturopathic begin delete doctor, or a end delete begin insert doctor. end insert

begin insert (D) end insert begin insert   end insert begin insert A end insert duly licensed optometrist serving as the director of a
laboratory begin delete which end delete begin insert that end insert only performs clinical laboratory tests
authorized in paragraph (10) of subdivision (e) of Section begin delete 3041
that are classified as waived, or is licensed end delete begin insert 3041. end insert

begin insert (3) end insert begin insert   end insert begin insert Licensed end insert to direct a clinical laboratory under this begin delete chapter
and who substantially meets end delete begin insert chapter. end insert

begin insert (b) end insert begin insert   end insert begin insert (1) end insert begin insert   end insert begin insert 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 end insert the laboratory director
qualifications under CLIA for the type and complexity of tests
being offered by the laboratory. begin delete The end delete

begin insert

(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).

end insert

begin insert (c) end insert begin insert   end insert begin insert The end insert 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.

begin delete

(b)

end delete

begin insert (d) end insert  (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.

begin delete

(c)

end delete

begin insert (e) end insert  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.

begin delete

(d)

end delete

begin insert (f) end insert  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.

begin delete

(e)

end delete

begin insert (g) end insert  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.

begin delete

(f)

end delete

begin insert (h) end insert  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.

begin delete

(g)

end delete

begin insert (i) end insert  Subdivision begin delete (f) end delete begin insert (h) end insert 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.

begin delete

(h)

end delete

begin insert (j) end insert  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
bioanalyst’s 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 begin delete licensed end delete clinical laboratory scientist begin delete , end delete performing clinical
laboratory work embracing the various fields of clinical laboratory
activity in a clinical laboratory begin delete approved by the department end delete
begin insert certified under the CLIA end insert . 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
scientist’s licenses in chemistry, microbiology, toxicology,
histocompatibility, immunohematology, begin insert embroyology, biochemical
genetics, end insert 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 scientist’s 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 scientist’s 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, begin insert clinical embryologist, clinical
biochemical geneticist, end insert 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 applicant’s 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
director’s, clinical laboratory bioanalyst’s, clinical chemist’s,
clinical microbiologist’s, clinical laboratory toxicologist’s, begin insert clinical
embryologist’s, clinical biochemical geneticist’s, end insert clinical
cytogeneticist’s, or clinical molecular biologist’s license is
sixty-three dollars ($63) commencing on July 1, 1983.

(b) The annual renewal fee for a histocompatibility laboratory
director’s, clinical laboratory bioanalyst’s, clinical chemist’s,
clinical microbiologist’s, begin delete or end delete clinical laboratory toxicologist’s begin insert ,
clinical embryologist’s, clinical biochemical geneticist’s, clinical
cytogeneticist’s, or clinical molecular biologist’s end insert license is
sixty-three dollars ($63) commencing on July 1, 1983.

(c) The application fee for a clinical laboratory scientist’s or
limited clinical laboratory scientist’s license is thirty-eight dollars
($38) commencing on July 1, 1983.

(d) The application and annual renewal fee for a
cytotechnologist’s license is fifty dollars ($50) commencing on
January 1, 1991.

(e) The annual renewal fee for a clinical laboratory scientist’s
or limited clinical laboratory scientist’s 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 trainee’s license is thirteen dollars
($13) commencing on July 1, 1983.

(i) The annual renewal fee for a trainee’s 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.