BILL NUMBER: AB 2436	CHAPTERED  09/10/04

	CHAPTER  450
	FILED WITH SECRETARY OF STATE  SEPTEMBER 10, 2004
	APPROVED BY GOVERNOR  SEPTEMBER 10, 2004
	PASSED THE ASSEMBLY  AUGUST 24, 2004
	PASSED THE SENATE  AUGUST 18, 2004
	AMENDED IN SENATE  AUGUST 16, 2004
	AMENDED IN ASSEMBLY  MARCH 31, 2004

INTRODUCED BY   Assembly Member Bates
   (Coauthors:  Assembly Members Shirley Horton and Pacheco)

                        FEBRUARY 19, 2004

   An act to amend Sections 1206.5, 1244, and 1246.5 of, and to add
Section 1214 to, the Business and Professions Code, relating to
clinical laboratories.



	LEGISLATIVE COUNSEL'S DIGEST


   AB 2436, Bates.  Clinical laboratory testing.
   Existing law provides for the regulation and licensure of clinical
laboratories and clinical laboratory personnel by the State
Department of Health Services and makes a violation of these
provisions a misdemeanor.  Under existing law, only designated health
care personnel are authorized to perform, under specified
conditions, clinical laboratory tests or examinations that are
classified as waived, moderate complexity, or high complexity under
federal law.  Existing law also specifies conditions for the
operation of a nondiagnostic general health assessment program.
   This bill would authorize a person performing a nondiagnostic
general health assessment to also perform, under specified
conditions, a clinical laboratory test or examination that is
classified as "waived."  The bill would also specify additional
conditions for the operation of a nondiagnostic general health
assessment program.  Because a violation of these additional
requirements would be a crime, 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.


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 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.
   (13) 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 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 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 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 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 1214 is added to the Business and Professions
Code, to read:
   1214.  As used in this chapter, "health fair" means a program of
health assessment procedures offered to the general public that may
include screening, self-ordered, or diagnostic clinical laboratory
tests or examinations performed by a clinical laboratory licensed or
registered under subdivision (a) of Section 1265 that meets all the
requirements of this chapter.
  SEC. 3.  Section 1244 of the Business and Professions Code is
amended to read:
   1244.  (a) Nothing in this chapter shall restrict, limit, or
prevent a program of nondiagnostic general health assessment provided
that:
   (1) The program meets the requirements of Section 1265 and
complies with the requirements of CLIA for waived testing.
   (2) The purpose of the program is to screen asymptomatic
individuals for chronic health disorders and to refer individuals to
licensed sources of care as indicated.
   (3) The program does not test for human immunodeficiency virus or
any reportable disease or condition identified in Section 120130 of
the Health and Safety Code or the regulations adopted under that
section.
   (4) The program utilizes only those devices that comply with all
of the following:
   (A) Meet all applicable state and federal performance standards
pursuant to Section 111245 of the Health and Safety Code.
   (B) Are not adulterated as specified in Article 2 (commencing with
Section 111250) of Chapter 6 of Part 5 of Division 104 of the Health
and Safety Code.
   (C) Are not misbranded as specified in Article 3 (commencing with
Section 111330) of Chapter 6 of Part 5 of Division 104 of the Health
and Safety Code.
   (D) Are not new devices unless they meet the requirements of
Section 111550 of the Health and Safety Code.
   (E) Are approved as waived tests and are used according to the
manufacturer's instructions.
   (5) Blood collection is performed by skin puncture only.
   (6) Testing of a urine specimen is performed by the dipstick
method only.
   (7) Testing is performed on site and reported directly to the
person requesting the test.
   (8) The program maintains a supervisory committee consisting of,
at a minimum, a licensed physician and surgeon and a clinical
laboratory scientist licensed pursuant to this  code.
   (9) The supervisory committee for the program adopts written
protocols that shall be followed in the program and that shall
contain all of the following:
   (A) Provision of written information to individuals to be assessed
that shall include, but not be limited to, the following:
   (i) The potential risks and benefits of assessment procedures to
be performed in the program.
   (ii) The limitations, including the nondiagnostic nature, of
assessment examinations of biological specimens performed in the
program.
   (iii) Information regarding the risk factors or markers targeted
by the program.
   (iv) The need for followup with licensed sources of care for
confirmation, diagnosis, and treatment as appropriate.
   (B) Proper use of each device utilized in the program including
the operation of analyzers, maintenance of equipment and supplies,
and performance of quality control procedures including the
determination of both accuracy and reproducibility of measurements in
accordance with instructions provided by the manufacturer of the
assessment device used.
   (C) Proper procedures to be employed when collecting blood, if
blood specimens are to be obtained.
   (D) Proper procedures to be employed in handling and disposing of
all biological specimens to be obtained and material contaminated by
those biological specimens.  These procedures shall comply with all
county and city ordinances for medical waste management and
blood-borne pathogen control that apply to the location where the
program operates.
   (E) Proper procedures to be employed in response to fainting,
excessive bleeding, or other medical emergencies.
   (F) Documentation that the testing personnel are following the
instructions of the instrument's manufacturer, are trained in the
performance of the test, and are competent to perform the testing
without supervision.
   (G) Reporting of assessment results to the individual being
assessed.
   (H) Referral and followup to licensed sources of care as
indicated.
   The written protocols adopted by the supervisory committee shall
be maintained for at least one year following completion of the
assessment program during which period they shall be subject to
review by department personnel and the local health officer or his or
her designee, including the public health laboratory director.
   (b) If skin puncture to obtain a blood specimen is to be performed
in a program of nondiagnostic general health assessment, the
individual performing the skin puncture shall be authorized to
perform skin puncture under this chapter.
   (c) A program of nondiagnostic general health assessment that
fails to meet the requirements set forth in subdivisions (a) and (b)
shall not operate.
   (d) For purposes of this section, "skin puncture" means the
collection of a blood specimen by the finger prick method only and
does not include venipuncture, arterial puncture, or any other
procedure for obtaining a blood specimen.
   (e) Nothing in this chapter shall be interpreted as prohibiting a
licensed clinical laboratory from operating a program of
nondiagnostic general health assessment provided that the clinical
laboratory complies with the requirements of this section.
   (f) A program for a health fair providing diagnostic or screening
tests is not a nondiagnostic general health assessment program if all
of the requirements of this chapter are met, and the laboratory
performing the testing is licensed or registered under subdivision
(a) of Section 1265.  For a test that is not authorized for
self-ordering pursuant to Section 1246.5 and that is not for a
nondiagnostic general health assessment pursuant to this section, the
licensed or registered clinical laboratory participating in the
health fair shall assure that the test is ordered on-site only by a
person licensed under this division who is authorized under his or
her scope of practice to order the test or by a person authorized by
that licensee.  The results of a test performed at a health fair
shall be provided to the test subject along with an explanation of
the results.
  SEC. 4.  Section 1246.5 of the Business and Professions Code is
amended to read:
   1246.5.  Notwithstanding any other provision of law, any person
may request, and any licensed clinical laboratory or public health
laboratory may perform, the laboratory tests specified in this
section.  A registered clinical laboratory may perform the laboratory
tests specified in this section if the test is subject to a
certificate of waiver under CLIA and the laboratory has registered
with the department under paragraph (2) of subdivision (a) of Section
1265. A program for nondiagnostic general health assessment that
includes a laboratory test specified in this section shall comply
with the provisions of Section 1244.  The results from any test may
be provided directly to the person requesting the test if the test is
on or for his or her own body.  These test results shall be provided
in a manner that presents clear information and that identifies
results indicating the need for referral to a physician and surgeon.

   The tests that may be conducted pursuant to this section are:
pregnancy, glucose level, cholesterol, occult blood, and any other
test for which there is a test for a particular analyte approved by
the federal Food and Drug Administration for sale to the public
without a prescription in the form of an over-the-counter test kit.
A test approved only as an over-the-counter collection device may not
be conducted pursuant to this section.
  SEC. 5.  No reimbursement is required by this act pursuant to
Section 6 of Article XIII B 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 XIII B of the California
Constitution.