BILL NUMBER: AB 761	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Roger Hernández

                        FEBRUARY 17, 2011

   An act to amend Sections 1206.5 and 1209 of the Business and
Professions Code, relating to optometrists.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 761, as introduced, Roger Hernández. Optometrists.
   Existing law provides for the regulation and licensure of clinical
laboratories and 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
unless the test or examination is performed under the overall
operation and administration of a laboratory director, as defined,
and is performed by specified persons, including certain health care
personnel. Existing law provides for the licensure and regulation of
optometrists by the State Board of Optometry.
   This bill would expand the category of persons who may perform
clinical laboratory tests or examinations that are classified as
waived to include licensed optometrists if the results of the tests
can be lawfully utilized within their practice, and would provide
that a laboratory director may include a licensed optometrist, as
specified for purposes of waived examinations.
   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 1206.5 of the Business and Professions Code is
amended to read:
   1206.5.  (a) Notwithstanding subdivision (b) of Section 1206 and
except as otherwise provided in Section 1241, no person shall perform
a clinical laboratory test or examination classified as waived under
CLIA unless the clinical laboratory test or examination is performed
under the overall operation and administration of the laboratory
director, as described in Section 1209, including, but not limited
to, documentation by the laboratory director of the adequacy of the
qualifications and competency of the personnel, and the test is
performed by any of the following persons:
   (1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
   (2) A licensed podiatrist, a licensed dentist,  a licensed
optometrist,  or a licensed naturopathic doctor, if the results
of the tests can be lawfully utilized within his or her practice.
   (3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory.
   (4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code.
   (5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or 3535.
   (6) A person licensed under Chapter 6 (commencing with Section
2700).
   (7) A person licensed under Chapter 6.5 (commencing with Section
2840).
   (8) A perfusionist if authorized by and performed in compliance
with Section 2590.
   (9) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
   (10) A medical assistant, as defined in Section 2069, if the
waived test is performed pursuant to a specific authorization meeting
the requirements of Section 2069.
   (11) A pharmacist, as defined in Section 4036, if ordering drug
therapy-related laboratory tests in compliance with clause (ii) of
subparagraph (A) of paragraph (5) of, or subparagraph (B) of
paragraph (4) of, subdivision (a) of Section 4052, or if performing
skin puncture in the course of performing routine patient assessment
procedures in compliance with Section 4052.1.
   (12) A naturopathic assistant, as defined in Sections 3613 and
3640.2, if the waived test is performed pursuant to a specific
authorization meeting the requirements of Sections 3613 and 3640.2.
   (13) Other health care personnel providing direct patient care.
   (14) Any other person performing nondiagnostic testing pursuant to
Section 1244.
   (b) Notwithstanding subdivision (b) of Section 1206, no person
shall perform clinical laboratory tests or examinations classified as
of moderate complexity under CLIA unless the clinical laboratory
test or examination is performed under the overall operation and
administration of the laboratory director, as described in Section
1209, including, but not limited to, documentation by the laboratory
director of the adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following persons:

   (1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
   (2) A licensed podiatrist or a licensed dentist if the results of
the tests can be lawfully utilized within his or her practice.
   (3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory.
   (4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code.
   (5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or 3535.
   (6) A person licensed under Chapter 6 (commencing with Section
2700).
   (7) A perfusionist if authorized by and performed in compliance
with Section 2590.
   (8) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
   (9) A person performing nuclear medicine technology if authorized
by and performed in compliance with Article 6 (commencing with
Section 107150) of Chapter 4 of Part 1 of Division 104 of the Health
and Safety Code.
   (10) Any person if performing blood gas analysis in compliance
with Section 1245.
   (11) (A) A person certified or licensed as an "Emergency Medical
Technician II" or paramedic pursuant to Division 2.5 (commencing with
Section 1797) of the Health and Safety Code while providing
prehospital medical care, a person licensed as a psychiatric
technician under Chapter 10 (commencing with Section 4500) of
Division 2, as a vocational nurse pursuant to Chapter 6.5 (commencing
with Section 2840), or as a midwife licensed pursuant to Article 24
(commencing with Section 2505) of Chapter 5, or certified by the
department pursuant to Division 5 (commencing with Section 70001) of
Title 22 of the California Code of Regulations as a nurse assistant
or a home health aide, who provides direct patient care, if the
person is performing the test as an adjunct to the provision of
direct patient care by the person, is utilizing a point-of-care
laboratory testing device at a site for which a laboratory license or
registration has been issued, meets the minimum clinical laboratory
education, training, and experience requirements set forth in
regulations adopted by the department, and has demonstrated to the
satisfaction of the laboratory director that he or she is competent
in the operation of the point-of-care laboratory testing device for
each analyte to be reported.
   (B) Prior to being authorized by the laboratory director to
perform laboratory tests or examinations, testing personnel
identified in subparagraph (A) shall participate in a preceptor
program until they are able to perform the clinical laboratory tests
or examinations authorized in this section with results that are
deemed accurate and skills that are deemed competent by the
preceptor. For the purposes of this section, a "preceptor program"
means an organized system that meets regulatory requirements in which
a preceptor provides and documents personal observation and critical
evaluation, including review of accuracy, reliability, and validity,
of laboratory testing performed.
   (12) Any other person within a physician office laboratory if the
test is performed under the supervision of the patient's physician
and surgeon or podiatrist who shall be accessible to the laboratory
to provide onsite, telephone, or electronic consultation as needed,
and shall: (A) ensure that the person is performing test methods as
required for accurate and reliable tests; and (B) have personal
knowledge of the results of the clinical laboratory testing or
examination performed by that person before the test results are
reported from the laboratory.
   (13) A pharmacist, if ordering drug therapy-related laboratory
tests in compliance with clause (ii) of subparagraph (A) of paragraph
(5) of, or subparagraph (B) of paragraph (4) of, subdivision (a) of
Section 4052.
   (c) Notwithstanding subdivision (b) of Section 1206, no person
shall perform clinical laboratory tests or examinations classified as
of high complexity under CLIA unless the clinical laboratory test or
examination is performed under the overall operation and
administration of the laboratory director, as described in Section
1209, including, but not limited to, documentation by the laboratory
director of the adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following persons:

   (1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
   (2) A licensed podiatrist or a licensed dentist if the results of
the tests can be lawfully utilized within his or her practice.
   (3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory if the test or
examination is within a specialty or subspecialty authorized by the
person's licensure.
   (4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code if the test
or examination is within a specialty or subspecialty authorized by
the person's certification.
   (5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or 3535.
   (6) A perfusionist if authorized by and performed in compliance
with Section 2590.
   (7) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
   (8) A person performing nuclear medicine technology if authorized
by and performed in compliance with Article 6 (commencing with
Section 107150) of Chapter 4 of Part 1 of Division 104 of the Health
and Safety Code.
   (9) Any person if performing blood gas analysis in compliance with
Section 1245.
   (10) Any other person within a physician office laboratory if the
test is performed under the onsite supervision of the patient's
physician and surgeon or podiatrist who shall: (A) ensure that the
person is performing test methods as required for accurate and
reliable tests; and (B) have personal knowledge of the results of
clinical laboratory testing or examination performed by that person
before the test results are reported from the laboratory.
   (d) Clinical laboratory examinations classified as
provider-performed microscopy under CLIA may be personally performed
using a brightfield or phase/contrast microscope by one of the
following practitioners:
   (1) A licensed physician and surgeon using the microscope during
the patient's visit on a specimen obtained from his or her own
patient or from a patient of a group medical practice of which the
physician is a member or employee.
   (2) A nurse midwife holding a certificate as specified by Section
2746.5, a licensed nurse practitioner as specified in Section 2835.5,
or a licensed physician assistant acting under the supervision of a
physician pursuant to Section 3502 using the microscope during the
patient's visit on a specimen obtained from his or her own patient or
from the patient of a clinic, group medical practice, or other
health care provider of which the certified nurse midwife, licensed
nurse practitioner, or licensed physician assistant is an employee.
   (3) A licensed dentist using the microscope during the patient's
visit on a specimen obtained from his or her own patient or from a
patient of a group dental practice of which the dentist is a member
or an employee.
  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 a duly licensed physician and surgeon, or, only for
purposes of a clinical laboratory test or examination classified as
waived, is a duly licensed naturopathic doctor,  or a duly
licensed optometrist,  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.