Bill Text: CA AB940 | 2015-2016 | Regular Session | Chaptered
Bill Title: Clinical laboratories.
Spectrum: Bipartisan Bill
Status: (Passed) 2015-09-28 - Chaptered by Secretary of State - Chapter 341, Statutes of 2015. [AB940 Detail]
Download: California-2015-AB940-Chaptered.html
BILL NUMBER: AB 940 CHAPTERED
BILL TEXT
CHAPTER 341
FILED WITH SECRETARY OF STATE SEPTEMBER 28, 2015
APPROVED BY GOVERNOR SEPTEMBER 28, 2015
PASSED THE SENATE AUGUST 31, 2015
PASSED THE ASSEMBLY SEPTEMBER 2, 2015
AMENDED IN SENATE AUGUST 20, 2015
AMENDED IN SENATE JULY 14, 2015
AMENDED IN SENATE JULY 1, 2015
AMENDED IN ASSEMBLY APRIL 23, 2015
AMENDED IN ASSEMBLY MARCH 23, 2015
INTRODUCED BY Assembly Members Ridley-Thomas and Waldron
FEBRUARY 26, 2015
An act to amend Sections 1203, 1209, 1260, 1264, and 1300 of the
Business and Professions Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
AB 940, 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 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 cytogeneticist's license or clinical genetic
molecular biologist's license.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1203 of the Business and Professions Code is
amended to read:
1203. 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 individual's 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 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 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 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,
clinical cytogeneticist's, or clinical genetic 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, clinical laboratory toxicologist's,
clinical cytogeneticist's, or clinical genetic molecular biologist's
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.
