BILL NUMBER: SB 1174 INTRODUCED
BILL TEXT
INTRODUCED BY Senator Polanco
FEBRUARY 23, 2001
An act to amend Sections 1206.5 and 1241 of the Business and
Professions Code, relating to clinical laboratory technology.
LEGISLATIVE COUNSEL'S DIGEST
SB 1174, as introduced, Polanco. Clinical laboratory technology:
performance of blood glucose tests by certified emergency medical
technicians.
Existing law provides for the regulation by the State Department
of Health Services of clinical laboratories and of persons performing
clinical laboratory tests or examinations or engaging in clinical
laboratory practice, subject to designated exceptions.
This bill would exempt from this regulation certified medical
technicians providing basic life support services or advanced support
services who perform blood glucose tests.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1206.5 of the Business and Professions Code is
amended to read:
1206.5. (a) Notwithstanding subdivision (b) of Section 1206
and except as otherwise provided in Section 1241 , no person
shall perform a clinical laboratory test or examination classified as
waived under CLIA unless the clinical laboratory test or examination
is performed under the overall operation and administration of the
laboratory director, as described in Section 1209, including, but not
limited to, documentation by the laboratory director of the adequacy
of the qualifications and competency of the personnel, and the test
is performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
(2) A licensed podiatrist or a licensed dentist when
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 when 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 when if
authorized by and performed in compliance with Section 2590.
(9) A respiratory care practitioner when
if authorized by and performed in compliance with Chapter 8.3
(commencing with Section 3700).
(10) A medical assistant, as defined in Section 2069,
when if the waived test is performed pursuant to
a specific authorization meeting the requirements of Section 2069.
(11) A pharmacist, when if ordering
drug therapy-related laboratory tests in compliance with clause (ii)
of subparagraph (A) of paragraph (5) of subdivision (a) of
, or paragraph (6) subparagraph (B)
of paragraph (4) of , subdivision (a) of ,
Section 4052.
(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 when
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 when 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 when if
authorized by and performed in compliance with Section 2590.
(8) A respiratory care practitioner when
if authorized by and performed in compliance with Chapter 8.3
(commencing with Section 3700).
(9) A person performing nuclear medicine technology when
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 when 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, so
long as 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
when 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, when if ordering
drug therapy-related laboratory tests in compliance with clause (ii)
of subparagraph (A) of paragraph (5) of subdivision (a) of
, or paragraph (6) 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 when
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 when
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
when if the test or examination is within a
specialty or subspecialty authorized by the person's certification.
(5) A licensed physician assistant when if
authorized by a supervising physician and surgeon in accordance
with Section 3502 or Section 3535.
(6) A perfusionist when if
authorized by and performed in compliance with Section 2590.
(7) A respiratory care practitioner when
if authorized by and performed in compliance with Chapter 8.3
(commencing with Section 3700).
(8) A person performing nuclear medicine technology when
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 when if performing
blood gas analysis in compliance with Section 1245.
(10) Any other person within a physician office laboratory
when 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 1241 of the Business and Professions Code is
amended to read:
1241. (a) This chapter applies to all clinical laboratories in
California or receiving biological specimens originating in
California for the purpose of performing a clinical laboratory test
or examination, and to all persons performing clinical laboratory
tests or examinations or engaging in clinical laboratory practice in
California or on biological specimens originating in California,
except as provided in subdivision (b).
(b) This chapter shall not apply to any of the following clinical
laboratories, or to persons performing clinical laboratory tests or
examinations in any of the following clinical laboratories:
(1) Those owned and operated by the United States of America, or
any department, agency, or official thereof acting in his or her
official capacity to the extent that the Secretary of the federal
Department of Health and Human Services has modified the application
of CLIA requirements to those laboratories.
(2) Public health laboratories, as defined in Section 1206.
(3) Those that perform clinical laboratory tests or examinations
for forensic purposes only.
(4) Those that perform clinical laboratory tests or examinations
for research and teaching purposes only and do not report or use
patient-specific results for the diagnosis, prevention, or treatment
of any disease or impairment of, or for the assessment of the health
of, an individual.
(5) Those that perform clinical laboratory tests or examinations
certified by the National Institutes on Drug Abuse only for those
certified tests or examinations. However, all other clinical
laboratory tests or examinations conducted by the laboratory are
subject to this chapter.
(6) Those that register with the State Department of Health
Services pursuant to subdivision (c) to perform blood glucose testing
for the purposes of monitoring a minor child diagnosed with diabetes
when if the person performing the test
has been entrusted with the care and control of the child by the
child's parent or legal guardian and provided that all of the
following occur:
(A) The blood glucose monitoring test is performed with a blood
glucose monitoring instrument that has been approved by the federal
Food and Drug Administration for sale over the counter to the public
without a prescription.
(B) The person has been provided written instructions by the child'
s health care provider or an agent of the child's health care
provider in accordance with the manufacturer's instructions on the
proper use of the monitoring instrument and the handling of any
lancets, test strips, cotton balls, or other items used during the
process of conducting a blood glucose test.
(C) The person, receiving written authorization from the minor's
parent or legal guardian, complies with written instructions from the
child's health care provider, or an agent of the child's health care
provider, regarding the performance of the test and the operation of
the blood glucose monitoring instrument, including how to determine
if the results are within the normal or therapeutic range for the
child, and any restriction on activities or diet that may be
necessary.
(D) The person complies with specific written instructions from
the child's health care provider or an agent of the child's health
care provider regarding the identification of symptoms of
hypoglycemia or hyperglycemia, and actions to be taken when results
are not within the normal or therapeutic range for the child. The
instructions shall also contain the telephone number of the child's
health care provider and the telephone number of the child's parent
or legal guardian.
(E) The person records the results of the blood glucose tests and
provides them to the child's parent or legal guardian on a daily
basis.
(F) The person complies with universal precautions when performing
the testing and posts a list of the universal precautions in a
prominent place within the proximity where the test is conducted.
(7) Those individuals who perform clinical laboratory tests or
examinations, 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, on their own bodies or on their minor
children or legal wards.
(8) Those certified emergency medical technicians providing basic
life support services or advanced life support services as defined in
Section 1797.52 of the Health and Safety Code who perform only blood
glucose tests that are classified as waived clinical laboratory
tests under CLIA, if the provider of those ambulance services obtains
a valid certificate of waiver and complies with all other
requirements for the performance of waived clinical laboratory tests
under applicable federal regulations.
(c) Any place where blood glucose testing is performed pursuant to
paragraph (6) of subdivision (b) shall register by notifying the
State Department of Health Services in writing no later than 30 days
after testing has commenced. Registrants pursuant to this
subdivision shall not be required to pay any registration or renewal
fees nor shall they be subject to routine inspection by the State
Department of Health Services.