BILL NUMBER: AB 586	CHAPTERED  10/04/01

	CHAPTER  501
	FILED WITH SECRETARY OF STATE  OCTOBER 4, 2001
	APPROVED BY GOVERNOR  OCTOBER 4, 2001
	PASSED THE SENATE  SEPTEMBER 13, 2001
	PASSED THE ASSEMBLY  SEPTEMBER 13, 2001
	AMENDED IN SENATE  SEPTEMBER 12, 2001
	AMENDED IN SENATE  JULY 3, 2001
	AMENDED IN ASSEMBLY  MAY 3, 2001

INTRODUCED BY   Assembly Member Nation

                        FEBRUARY 21, 2001

   An act to amend Section 1206.5 of, to add Section 4052.1 to, and
to repeal Section 4102 of, the Business and Professions Code,
relating to pharmacists.



	LEGISLATIVE COUNSEL'S DIGEST


   AB 586, Nation.  Pharmacists:  performance of routine patient
assessment procedures and skin puncture.
   Existing law prohibits the performance of a clinical laboratory
test or examination classified as waived or of moderate complexity
under the federal Clinical Laboratory Improvement Amendments of 1988
unless it is performed under the overall operation and administration
of the laboratory director, as specified, and is performed by a
designated healing arts practitioner, including a pharmacist.  The
Pharmacy Law regulates the practice of pharmacy and authorizes a
pharmacist to perform skin puncture in connection with routine
patient assessment procedures, defined as including waived or
moderate complexity tests, subject to the existing law provisions
governing the performance of those tests by a pharmacist.  Existing
law requires a pharmacist performing these functions to, at the
direction of the patient, report the results obtained from a blood
test to the patient and the patient's physician of choice.
   This bill would authorize a pharmacist to perform skin puncture in
the course of performing an examination classified as waived.  The
bill would also delete moderate complexity tests from the definition
of patient assessment procedures and would make the performance of
those procedures subject to the supervision of a laboratory director.
  The bill would require a pharmacist performing these functions to
report the results from any test to the patient and any physician
designated by the patient.
   A violation of the Pharmacy Law is a crime.  Because a violation
of this bill's requirements regarding disclosure of test results to
patients would be a misdemeanor, the bill would impose a
state-mandated local program.
  The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state.  Statutory provisions establish procedures for making that
reimbursement.
   This bill would provide that no reimbursement is required by this
act for a specified reason.
   This bill would incorporate additional changes in Section 1206.5
of the Business and Professions Code proposed by SB 1174, that would
become operative only if SB 1174 and this bill are both chaptered and
become effective on or before January 1, 2002, 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, 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 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 Section
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) Other health care personnel providing direct patient care.
   (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 Section
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 107115) 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 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) of Division 2,
or as a midwife licensed pursuant to Article 24 (commencing with
Section 2505) of Chapter 5 of Division 2, 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 Section
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 107115) 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 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 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 Section
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) Other health care personnel providing direct patient care.
   (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 Section
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 107115) 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) of Division 2, or as a midwife licensed pursuant
to Article 24 (commencing with Section 2505) of Chapter 5 of Division
2, 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 Section
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 107115) 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 4052.1 is added to the Business and Professions
Code, to read:
   4052.1.  Notwithstanding Section 2038 or any other provision of
law, a pharmacist may perform skin puncture in the course of
performing routine patient assessment procedures or in the course of
performing any procedure authorized under Section 1206.5.  For
purposes of this section, "routine patient assessment procedures"
means:  (a) procedures that a patient could, with or without a
prescription, perform for himself or herself, or (b) clinical
laboratory tests that are classified as waived pursuant to the
federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C.
Sec.  263a) and the regulations adopted thereunder by the federal
Health Care Financing Administration, as authorized by paragraph (11)
of subdivision (a) of Section 1206.5.  A pharmacist performing these
functions shall report the results obtained from a test to the
patient and any physician designated by the patient.  Any pharmacist
who performs the service authorized by this section shall not be in
violation of Section 2052.
  SEC. 3.  Section 4102 of the Business and Professions Code is
repealed.
  SEC. 4.  No reimbursement is required by this act pursuant to
Section 6 of Article XIIIB of the California Constitution because the
only costs that may be incurred by a local agency or school district
will be incurred because this act creates a new crime or infraction,
eliminates a crime or infraction, or changes the penalty for a crime
or infraction, within the meaning of Section 17556 of the Government
Code, or changes the definition of a crime within the meaning of
Section 6 of Article XIIIB of the California Constitution.
  SEC. 5.  Section 1.5 of this bill incorporates amendments to
Section 1206.5 of the Business and Professions Code proposed by both
this bill and SB 1174.  It shall only become operative if (1) both
bills are enacted and become effective on or before January 1, 2002,
(2) each bill amends Section 1206.5 of the Business and Professions
Code, and (3) this bill is enacted after SB 1174, in which case
Section 1 of this bill shall not become operative.