BILL NUMBER: SB 1481 INTRODUCED
BILL TEXT
INTRODUCED BY Senator Negrete McLeod
FEBRUARY 24, 2012
An act to amend Sections 1241 and 4052.4 of the Business and
Professions Code, relating to clinical laboratories.
LEGISLATIVE COUNSEL'S DIGEST
SB 1481, as introduced, Negrete McLeod. Clinical laboratories:
community pharmacies.
Existing law provides for the licensure and regulation of clinical
laboratories and various clinical laboratory personnel by the State
Department of Public Health, subject to certain exceptions. Existing
law, the Pharmacy Law, provides for the licensure and regulation of
pharmacists by the California State Board of Pharmacy and authorizes
a pharmacist to perform skin puncture in the course of performing
clinical laboratory tests classified as waived pursuant to the
federal Clinical Laboratory Improvement Amendments of 1988 (CLIA).
This bill would exempt a community pharmacy that solely provides
certain tests classified as waived under CLIA from the clinical
laboratory regulations, provided that the tests are performed by a
pharmacist, as specified, and the pharmacy obtains a certificate of
waiver and complies with all other requirements under CLIA.
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 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
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 and licensed
paramedics 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 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.
(9) A community pharmacy that is providing only those tests
identified in Section 1246.5, provided that both of the following
requirements are satisfied:
(A) The pharmacy obtains a valid certificate of waiver and
complies with all other requirements for the performance of waived
clinical laboratory tests under applicable federal regulations.
(B) The tests are performed by a pharmacist, as defined in Section
4036, in the course of performing routine patient assessment
procedures in compliance with Section 4052.4.
(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.
SEC. 2. Section 4052.4 of the Business and Professions Code is
amended to read:
4052.4. 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 or
paragraph (9) of subdivision (b) of Section 1241 . 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 or paragraph (9) of subdivision (b) of Section
1241 . 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.