BILL NUMBER: AB 761	CHAPTERED
	BILL TEXT

	CHAPTER  714
	FILED WITH SECRETARY OF STATE  SEPTEMBER 28, 2012
	APPROVED BY GOVERNOR  SEPTEMBER 28, 2012
	PASSED THE SENATE  AUGUST 28, 2012
	PASSED THE ASSEMBLY  AUGUST 29, 2012
	AMENDED IN SENATE  AUGUST 22, 2012
	AMENDED IN SENATE  AUGUST 16, 2012
	AMENDED IN SENATE  JUNE 4, 2012
	AMENDED IN ASSEMBLY  JANUARY 23, 2012
	AMENDED IN ASSEMBLY  JANUARY 12, 2012
	AMENDED IN ASSEMBLY  JANUARY 4, 2012

INTRODUCED BY   Assembly Member Roger Hernández

                        FEBRUARY 17, 2011

   An act to amend Sections 1206.5, 1209, and 3041 of the Business
and Professions Code, relating to optometrists.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 761, 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, and requires
certification by the board for a licensed optometrist to use
therapeutic pharmaceutical agents. Existing law authorizes a licensed
optometrist certified to use therapeutic pharmaceutical agents to
diagnose and treat specified conditions.
   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, and would provide that a
laboratory director may include a licensed optometrist serving as the
director of a laboratory which only performs specified clinical
laboratory testing, for purposes of waived examinations. The bill
would authorize a licensed optometrist certified to use therapeutic
pharmaceutical agents to additionally perform specified clinical
laboratory tests or examinations classified as waived that are
necessary for the diagnosis of conditions and diseases of the eye or
adnexa, which the bill would define to mean ocular adnexa.
   This bill would also incorporate changes to Section 1206.5 of the
Business and Professions Code proposed by SB 1481 that would become
operative only if SB 1481 and this bill are chaptered and become
effective on or before January 1, 2013, and this bill is chaptered
last.


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, 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) A licensed optometrist as authorized under Chapter 7
(commencing with Section 3000).
   (14) Other health care personnel providing direct patient care.
   (15) 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. 1.5.  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 Sections 1206.6 and 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, 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 paragraph (2) of
subdivision (a) of Section 4052.1 or paragraph (2) of subdivision (a)
of Section 4052.2, 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) A licensed optometrist as authorized under Chapter 7
(commencing with Section 3000).
   (14) Other health care personnel providing direct patient care.
   (15) 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 paragraph (2) of subdivision (a) of Section
4052.1 or paragraph (2) of subdivision (a) of Section 4052.2.
   (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 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.
  SEC. 3.  Section 3041 of the Business and Professions Code is
amended to read:
   3041.  (a) The practice of optometry includes the prevention and
diagnosis of disorders and dysfunctions of the visual system, and the
treatment and management of certain disorders and dysfunctions of
the visual system, as well as the provision of rehabilitative
optometric services, and is the doing of any or all of the following:

   (1) The examination of the human eye or eyes, or its or their
appendages, and the analysis of the human vision system, either
subjectively or objectively.
   (2) The determination of the powers or range of human vision and
the accommodative and refractive states of the human eye or eyes,
including the scope of its or their functions and general condition.
   (3) The prescribing or directing the use of, or using, any optical
device in connection with ocular exercises, visual training, vision
training, or orthoptics.
   (4) The prescribing of contact and spectacle lenses for, or the
fitting or adaptation of contact and spectacle lenses to, the human
eye, including lenses that may be classified as drugs or devices by
any law of the United States or of this state.
   (5) The use of topical pharmaceutical agents for the purpose of
the examination of the human eye or eyes for any disease or
pathological condition.
   (b) (1) An optometrist who is certified to use therapeutic
pharmaceutical agents, pursuant to Section 3041.3, may also diagnose
and treat the human eye or eyes, or any of its or their appendages,
for all of the following conditions:
   (A) Through medical treatment, infections of the anterior segment
and adnexa, excluding the lacrimal gland, the lacrimal drainage
system, and the sclera in patients under 12 years of age.
   (B) Ocular allergies of the anterior segment and adnexa.
   (C) Ocular inflammation, nonsurgical in cause except when
comanaged with the treating physician and surgeon, limited to
inflammation resulting from traumatic iritis, peripheral corneal
inflammatory keratitis, episcleritis, and unilateral nonrecurrent
nongranulomatous idiopathic iritis in patients over 18 years of age.
Unilateral nongranulomatous idiopathic iritis recurring within one
year of the initial occurrence shall be referred to an
ophthalmologist. An optometrist shall consult with an ophthalmologist
or appropriate physician and surgeon if a patient has a recurrent
case of episcleritis within one year of the initial occurrence. An
optometrist shall consult with an ophthalmologist or appropriate
physician and surgeon if a patient has a recurrent case of peripheral
corneal inflammatory keratitis within one year of the initial
occurrence.
   (D) Traumatic or recurrent conjunctival or corneal abrasions and
erosions.
   (E) Corneal surface disease and dry eyes.
   (F) Ocular pain, nonsurgical in cause except when comanaged with
the treating physician and surgeon, associated with conditions
optometrists are authorized to treat.
   (G) Pursuant to subdivision (f), glaucoma in patients over 18
years of age, as described in subdivision (j).
   (2) For purposes of this section, "treat" means the use of
therapeutic pharmaceutical agents, as described in subdivision (c),
and the procedures described in subdivision (e).
   (c) In diagnosing and treating the conditions listed in
subdivision (b), an optometrist certified to use therapeutic
pharmaceutical agents pursuant to Section 3041.3 may use all of the
following therapeutic pharmaceutical agents:
   (1) Pharmaceutical agents as described in paragraph (5) of
subdivision (a), as well as topical miotics.
   (2) Topical lubricants.
   (3) Antiallergy agents. In using topical steroid medication for
the treatment of ocular allergies, an optometrist shall consult with
an ophthalmologist if the patient's condition worsens 21 days after
diagnosis.
   (4) Topical and oral anti-inflammatories. In using steroid
medication for:
   (A) Unilateral nonrecurrent nongranulomatous idiopathic iritis or
episcleritis, an optometrist shall consult with an ophthalmologist or
appropriate physician and surgeon if the patient's condition worsens
72 hours after the diagnosis, or if the patient's condition has not
resolved three weeks after diagnosis. If the patient is still
receiving medication for these conditions six weeks after diagnosis,
the optometrist shall refer the patient to an ophthalmologist or
appropriate physician and surgeon.
   (B) Peripheral corneal inflammatory keratitis, excluding Moorens
and Terriens diseases, an optometrist shall consult with an
ophthalmologist or appropriate physician and surgeon if the patient's
condition worsens 72 hours after diagnosis.
   (C) Traumatic iritis, an optometrist shall consult with an
ophthalmologist or appropriate physician and surgeon if the patient's
condition worsens 72 hours after diagnosis and shall refer the
patient to an ophthalmologist or appropriate physician and surgeon if
the patient's condition has not resolved one week after diagnosis.
   (5) Topical antibiotic agents.
   (6) Topical hyperosmotics.
   (7) Topical and oral antiglaucoma agents pursuant to the
certification process defined in subdivision (f).
   (A) The optometrist shall refer the patient to an ophthalmologist
if requested by the patient or if angle closure glaucoma develops.
   (B) If the glaucoma patient also has diabetes, the optometrist
shall consult with the physician treating the patient's diabetes in
developing the glaucoma treatment plan and shall inform the physician
in writing of any changes in the patient's glaucoma medication.
   (8) Nonprescription medications used for the rational treatment of
an ocular disorder.
   (9) Oral antihistamines.
   (10) Prescription oral nonsteroidal anti-inflammatory agents.
   (11) Oral antibiotics for medical treatment of ocular disease.
   (A) If the patient has been diagnosed with a central corneal ulcer
and the central corneal ulcer has not improved 48 hours after
diagnosis, the optometrist shall refer the patient to an
ophthalmologist.
   (B) If the patient has been diagnosed with preseptal cellulitis or
dacryocystitis and the condition has not improved 48 hours after
diagnosis, the optometrist shall refer the patient to an
ophthalmologist.
   (12) Topical and oral antiviral medication for the medical
treatment of the following: herpes simplex viral keratitis, herpes
simplex viral conjunctivitis, and periocular herpes simplex viral
dermatitis; and varicella zoster viral keratitis, varicella zoster
viral conjunctivitis, and periocular varicella zoster viral
dermatitis.
   (A) If the patient has been diagnosed with herpes simplex
keratitis or varicella zoster viral keratitis and the patient's
condition has not improved seven days after diagnosis, the
optometrist shall refer the patient to an ophthalmologist. If a
patient's condition has not resolved three weeks after diagnosis, the
optometrist shall refer the patient to an ophthalmologist.
   (B) If the patient has been diagnosed with herpes simplex viral
conjunctivitis, herpes simplex viral dermatitis, varicella zoster
viral conjunctivitis, or varicella zoster viral dermatitis, and if
the patient's condition worsens seven days after diagnosis, the
optometrist shall consult with an ophthalmologist. If the patient's
condition has not resolved three weeks after diagnosis, the
optometrist shall refer the patient to an ophthalmologist.
   (13) Oral analgesics that are not controlled substances.
   (14) Codeine with compounds and hydrocodone with compounds as
listed in the California Uniform Controlled Substances Act (Division
10 (commencing with Section 11000) of the Health and Safety Code) and
the United States Uniform Controlled Substances Act (21 U.S.C. Sec.
801 et seq.). The use of these agents shall be limited to three days,
with a referral to an ophthalmologist if the pain persists.
   (d) In any case where this chapter requires that an optometrist
consult with an ophthalmologist, the optometrist shall maintain a
written record in the patient's file of the information provided to
the ophthalmologist, the ophthalmologist's response, and any other
relevant information. Upon the consulting ophthalmologist's request
and with the patient's consent, the optometrist shall furnish a copy
of the record to the ophthalmologist.
   (e) An optometrist who is certified to use therapeutic
pharmaceutical agents pursuant to Section 3041.3 may also perform all
of the following:
   (1) Corneal scraping with cultures.
   (2) Debridement of corneal epithelia.
   (3) Mechanical epilation.
   (4) Venipuncture for testing patients suspected of having
diabetes.
   (5) Suture removal, with prior consultation with the treating
physician and surgeon.
   (6) Treatment or removal of sebaceous cysts by expression.
   (7) Administration of oral fluorescein to patients suspected as
having diabetic retinopathy.
   (8) Use of an auto-injector to counter anaphylaxis.
   (9) Ordering of smears, cultures, sensitivities, complete blood
count, mycobacterial culture, acid fast stain, urinalysis, tear fluid
analysis, and X-rays necessary for the diagnosis of conditions or
diseases of the eye or adnexa. An optometrist may order other types
of images subject to prior consultation with an ophthalmologist or
appropriate physician and surgeon.
   (10) A clinical laboratory test or examination classified as
waived under CLIA and designated as waived in paragraph (9) necessary
for the diagnosis of conditions and diseases of the eye or adnexa,
or if otherwise specifically authorized by this chapter.
   (11) Punctal occlusion by plugs, excluding laser, diathermy,
cryotherapy, or other means constituting surgery as defined in this
chapter.
   (12) The prescription of therapeutic contact lenses, including
lenses or devices that incorporate a medication or therapy the
optometrist is certified to prescribe or provide.
   (13) Removal of foreign bodies from the cornea, eyelid, and
conjunctiva with any appropriate instrument other than a scalpel or
needle. Corneal foreign bodies shall be nonperforating, be no deeper
than the midstroma, and require no surgical repair upon removal.
   (14) For patients over 12 years of age, lacrimal irrigation and
dilation, excluding probing of the nasal lacrimal tract. The board
shall certify any optometrist who graduated from an accredited school
of optometry before May 1, 2000, to perform this procedure after
submitting proof of satisfactory completion of 10 procedures under
the supervision of an ophthalmologist as confirmed by the
ophthalmologist. Any optometrist who graduated from an accredited
school of optometry on or after May 1, 2000, shall be exempt from the
certification requirement contained in this paragraph.
   (f) The board shall grant a certificate to an optometrist
certified pursuant to Section 3041.3 for the treatment of glaucoma,
as described in subdivision (j), in patients over 18 years of age
after the optometrist meets the following applicable requirements:
   (1) For licensees who graduated from an accredited school of
optometry on or after May 1, 2008, submission of proof of graduation
from that institution.
   (2) For licensees who were certified to treat glaucoma under this
section prior to January 1, 2009, submission of proof of completion
of that certification program.
   (3) For licensees who have substantially completed the
certification requirements pursuant to this section in effect between
January 1, 2001, and December 31, 2008, submission of proof of
completion of those requirements on or before December 31, 2009.
"Substantially completed" means both of the following:
   (A) Satisfactory completion of a didactic course of not less than
24 hours in the diagnosis, pharmacological, and other treatment and
management of glaucoma.
   (B) Treatment of 50 glaucoma patients with a collaborating
ophthalmologist for a period of two years for each patient that will
conclude on or before December 31, 2009.
   (4) For licensees who completed a didactic course of not less than
24 hours in the diagnosis, pharmacological, and other treatment and
management of glaucoma, submission of proof of satisfactory
completion of the case management requirements for certification
established by the board pursuant to Section 3041.10.
   (5) For licensees who graduated from an accredited school of
optometry on or before May 1, 2008, and not described in paragraph
(2), (3), or (4), submission of proof of satisfactory completion of
the requirements for certification established by the board pursuant
to Section 3041.10.
   (g) Other than for prescription ophthalmic devices described in
subdivision (b) of Section 2541, any dispensing of a therapeutic
pharmaceutical agent by an optometrist shall be without charge.
   (h) The practice of optometry does not include performing surgery.
"Surgery" means any procedure in which human tissue is cut, altered,
or otherwise infiltrated by mechanical or laser means. "Surgery"
does not include those procedures specified in subdivision (e).
Nothing in this section shall limit an optometrist's authority to
utilize diagnostic laser and ultrasound technology within his or her
scope of practice.
   (i) An optometrist licensed under this chapter is subject to the
provisions of Section 2290.5 for purposes of practicing telehealth.
   (j) For purposes of this chapter, "glaucoma" means either of the
following:
   (1) All primary open-angle glaucoma.
   (2) Exfoliation and pigmentary glaucoma.
   (k) For purposes of this chapter, "adnexa" means ocular adnexa.
   (l) In an emergency, an optometrist shall stabilize, if possible,
and immediately refer any patient who has an acute attack of angle
closure to an ophthalmologist.
  SEC. 4.  Section 1.5 of this bill incorporates amendments to
Section 1206.5 of the Business and Professions Code proposed by both
this bill and Senate Bill 1481. It shall only become operative if (1)
both bills are enacted and become effective on or before January 1,
2013, (2) each bill amends Section 1206.5 of the Business and
Professions Code, and (3) this bill is enacted after Senate Bill
1481, in which case Section 1 of this bill shall not become
operative.