BILL NUMBER: SB 1481 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY AUGUST 7, 2012
AMENDED IN ASSEMBLY JUNE 13, 2012
AMENDED IN ASSEMBLY JUNE 6, 2012
INTRODUCED BY Senator Negrete McLeod
FEBRUARY 24, 2012
An act to amend Sections 1241 1206.5,
1211, 1265, and 4052.4 of , and to add Section 1206.6 to,
the Business and Professions Code, relating to clinical
laboratories.
LEGISLATIVE COUNSEL'S DIGEST
SB 1481, as amended, Negrete McLeod. Clinical laboratories:
community pharmacies.
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). Existing law provides for the licensure ,
registration, and regulation of clinical laboratories and
various clinical laboratory personnel by the State Department of
Public Health, subject to certain exceptions , and makes a
license or registration valid for one year .
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). prohibits a person from performing a
clinical laboratory test classified as waived unless the test is
performed under the overall operation and administration of the
laborator y director who meets specified requirements and
the test is performed by certain persons, as specified.
This bill would exempt a community pharmacy that solely
provides eliminate that laboratory director
requirement with respect to certain tests classified as waived
under CLIA from the clinical laboratory regulations and
that are 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 and are performed by a
pharmacist at a community pharmacy upon customer request ,
provided that the tests are performed by a pharmacist, as
specified, the pharmacy obtains a CLIA certificate of
waiver and a registration from the State Department of Public
Health and complies with all other requirements under
CLIA, and the pharmacy notifies the public health officer of the
county in which the pharmacy is located that the pharmacy is
performing those tests governing clinical
laboratories, as specified. The bill would make a registration issued
to the community pharmacy valid for 2 years and would make other
related conforming changes .
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
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 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) Other health care personnel providing direct patient care.
(14) 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 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 1206.6 is added to the
Business and Professions Code , to read:
1206.6. Subdivision (a) of Section 1265 shall not apply to a
pharmacist at a community pharmacy who, upon customer request,
performs only blood glucose, hemoglobin A1c, or cholesterol tests
that are classified as waived under CLIA and are 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, provided
that all of the following requirements are satisfied:
(a) The pharmacy obtains a valid CLIA certificate of waiver and
complies with all other requirements for the performance of waived
clinical laboratory tests under applicable federal regulations. For
purposes of CLIA, the person identified as responsible for directing
and supervising testing oversight and decisionmaking shall be the
pharmacist-in-charge, as defined in Section 4036.5.
(b) The pharmacy obtains a registration from the department
pursuant to Section 1265 and complies with this chapter.
(c) The tests are performed only by a pharmacist, as defined in
Section 4036, in the course of performing routine patient assessment
procedures in compliance with Section 4052.4.
SEC. 3. Section 1211 of the Business
and Professions Code is amended to read:
1211. (a) As used in this chapter, "owner" means any person with
an ownership or control interest in a clinical laboratory.
(b) "Person with an ownership or control interest" means a person,
partnership, or corporation that meets any of the following
descriptions:
(1) Has an ownership interest totaling 5 percent or more in a
clinical laboratory.
(2) Has an indirect ownership interest equal to 5 percent or more
in a clinical laboratory.
(3) Has a combination of direct and indirect ownership interests
equal to 5 percent or more in a clinical laboratory.
(4) Owns an interest of 5 percent or more in any mortgage, deed of
trust, note, or other obligation secured by the clinical laboratory
if that interest equals at least 5 percent of the value of the
property or assets of the clinical laboratory.
(5) Is an officer or director of a clinical laboratory that is
organized as a corporation.
(6) Is a partner in a clinical laboratory that is organized as a
partnership with no more than 25 partners, general or limited.
(7) Is a partner who exercises any operational or managerial
control over a clinical laboratory organized as a partnership with
more than 25 partners, general or limited.
(c) As used in this chapter "ownership interest" means the
possession of equity in capital, stock, or profits.
(d) "Indirect ownership interest" means an ownership interest in
an entity that has an ownership interest in a clinical laboratory,
and includes an ownership interest in any entity that has an indirect
ownership interest in a clinical laboratory.
(e) "Change in ownership" means any change in the persons who are
owners.
(f) "Major change in ownership" means a change in ownership where
50 percent or more of the ownership interest is owned by persons
other than the owners to whom the current clinical laboratory license
or registration is issued.
(g) "Change in name" means any change in the name under which the
laboratory operates or is doing business.
(h) "Change in location" means any change in the street and city
address, or the site or place within the street and city address, for
which a license or registration is issued.
(i) "Change in laboratory director" means any change in the
laboratory director or directors to whom the current license or
registration is issued.
(j) "Major change in laboratory directorship" means a change in
laboratory director or directors resulting in the situation where
less than 50 percent of the laboratory directors to whom the current
laboratory license or registration is issued remain after the change.
(k) For purposes of this section, in the case of a pharmacy that
applies for a registration pursuant to Section 1206.6, "laboratory
director" means the pharmacist-in-charge identified pursuant to
subdivision (a) of Section 1206.6.
SEC. 4. Section 1265 of the Business
and Professions Code is amended to read:
1265. (a) (1) A clinical laboratory performing clinical
laboratory tests or examinations classified as of moderate or of high
complexity under CLIA shall obtain a clinical laboratory license
pursuant to this chapter. The department shall issue a clinical
laboratory license to any person who has applied for the license on
forms provided by the department and who is found to be in compliance
with this chapter and the regulations pertaining thereto. No
clinical laboratory license shall be issued by the department unless
the clinical laboratory and its personnel meet the CLIA requirements
for laboratories performing tests or examinations classified as of
moderate or high complexity, or both.
(2) A clinical laboratory performing clinical laboratory tests or
examinations subject to a certificate of waiver or a certificate of
provider-performed microscopy under CLIA, shall register with the
department. The department shall issue a clinical laboratory
registration to any person who has applied for the registration on
forms provided by the department and is found to be in compliance
with this chapter, the regulations pertaining thereto, and the CLIA
requirements for either a certificate of waiver or a certificate of
provider-performed microscopy.
(b) An application for a clinical laboratory license or
registration shall include the name or names of the owner or the
owners, the name or names of the laboratory director or directors,
the name and location of the laboratory, a list of the clinical
laboratory tests or examinations performed by the laboratory by name
and total number of test procedures and examinations performed
annually (excluding tests the laboratory may run for quality control,
quality assurance, or proficiency testing purposes). The application
shall also include a list of the tests and the test kits,
methodologies, and laboratory equipment used, and the qualifications
(educational background, training, and experience) of the personnel
directing and supervising the laboratory and performing the
laboratory examinations and test procedures, and any other relevant
information as may be required by the department. If the laboratory
is performing tests subject to a provider-performed microscopy
certificate, the name of the provider or providers performing those
tests shall be included on the application. Application shall be made
by the owners of the laboratory and the laboratory directors prior
to its opening. A license or registration to conduct a clinical
laboratory if the owners are not the laboratory directors shall be
issued jointly to the owners and the laboratory directors and the
license or registration shall include any information as may be
required by the department. The owners and laboratory directors shall
be severally and jointly responsible to the department for the
maintenance and conduct thereof or for any violations of this chapter
and regulations pertaining thereto.
(c) The department shall not issue a license or registration until
it is satisfied that the clinical laboratory will be operated within
the spirit and intent of this chapter, that the owners and
laboratory directors are each of good moral character, and that the
granting of the license will not be in conflict with the interests of
public health.
(d) A separate license or registration shall be obtained for each
laboratory location, with the following exceptions:
(1) Laboratories that are not at a fixed location, that is,
laboratories that move from one testing site to another, such as
mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations, may apply for and obtain one
license or registration for the designated primary site or home base,
using the address of that primary site.
(2) Not-for-profit, or federal, state, or local government
laboratories that engage in limited (not more than a combination of
15 moderately complex or waived tests, as defined under CLIA, per
license) public health testing may apply for and obtain a single
license or registration.
(3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction, may file a
single application or multiple applications for a license or
registration of laboratory locations within the same campus or street
address.
(4) Locations within a single street and city address that are
under common ownership may apply for and obtain a single license or
registration or multiple licenses or registrations, at the discretion
of the owner or owners.
(e) (1) A license or registration shall be valid for one year
unless revoked or suspended , except that a registration issued
to a pharmacy described in Section 1206.6 shall be valid for two
years unless revoked or suspended . A clinical laboratory
license or registration shall be automatically revoked 30 days from a
major change of laboratory directorship or ownership. The clinical
laboratory shall be required to submit a completed application for a
new clinical laboratory license or registration within those 30 days
or cease engaging in clinical laboratory practice.
(2) If a clinical laboratory intends to continue to engage in
clinical laboratory practice during the 30 days after a major change
in directorship occurs and before the laboratory license or
registration is automatically revoked, the laboratory owner may
appoint an interim director who meets the requirements of this
chapter and CLIA. The interim director shall be appointed within five
business days of the major change of the directorship. Written
notice shall be provided to the department of the appointment of the
laboratory director pursuant to this paragraph within five business
days of the appointment.
(f) If the department does not within 60 days after the date of
receipt of the application issue a license or registration, it shall
state the grounds and reasons for its refusal in writing, serving a
copy upon the applicant by certified mail addressed to the applicant
at his or her last known address.
(g) The department shall be notified in writing by the laboratory
owners or delegated representatives of the owners and the laboratory
directors of any change in ownership, directorship, name, or
location, including the addition or deletion of laboratory owners or
laboratory directors within 30 days. However, notice of change in
ownership shall be the responsibility of both the current and new
owners. Laboratory owners and directors to whom the current license
or registration is issued shall remain jointly and severally
responsible to the department for the operation, maintenance, and
conduct of the clinical laboratory and for any violations of this
chapter or the regulations adopted thereunder, including any failure
to provide the notifications required by this subdivision, until
proper notice is received by the department. In addition, failure of
the laboratory owners and directors to notify the department within
30 days of any change in laboratory directors, including any
additions or deletions, shall result in the automatic revocation of
the clinical laboratory's license or registration.
(h) The withdrawal of an application for a license or registration
or for a renewal of a license, or registration, issuable under this
chapter, shall not, after the application has been filed with the
department, deprive the department of its authority to institute or
continue a proceeding against the applicant for denial of the
license, registration, or renewal upon any ground provided by law or
to enter an order denying the license, registration, or renewal upon
any such ground, unless the department consents in writing to the
withdrawal.
(i) The suspension, expiration, or forfeiture by operation of law
of a license or registration issued under this chapter, or its
suspension, forfeiture, or cancellation by order of the department or
by order of a court of law, or its surrender without the written
consent of the department, shall not deprive the department of its
authority to institute or continue an action against a license or
registration issued under this chapter or against the laboratory
owner or laboratory director upon any ground provided by law or to
enter an order suspending or revoking the license or registration
issued under this chapter.
(j) (1) Whenever a clinical laboratory ceases operations, the
laboratory owners, or delegated representatives of the owners, and
the laboratory directors shall notify the department of this fact, in
writing, within 30 calendar days from the date a clinical laboratory
ceases operation. For purposes of this subdivision, a laboratory
ceases operations when it suspends the performance of all clinical
laboratory tests or examinations for 30 calendar days at the location
for which the clinical laboratory is licensed or registered.
(2) (A) Notwithstanding any other provision of law, owners and
laboratory directors of all clinical laboratories, including those
laboratories that cease operations, shall preserve medical records
and laboratory records, as defined in this section, for three years
from the date of testing, examination, or purchase, unless a longer
retention period is required pursuant to any other provision of law,
and shall maintain an ability to provide those records when requested
by the department or any duly authorized representative of the
department.
(B) For purposes of this subdivision, "medical records" means the
test requisition or test authorization, or the patient's chart or
medical record, if used as the test requisition, the final and
preliminary test or examination result, and the name of the person
contacted if the laboratory test or examination result indicated an
imminent life-threatening result or was of panic value.
(C) For purposes of this subdivision, "laboratory records" means
records showing compliance with CLIA and this chapter during a
laboratory's operation that are actual or true copies, either
photocopies or electronically reproducible copies, of records for
patient test management, quality control, quality assurance, and all
invoices documenting the purchase or lease of laboratory equipment
and test kits, reagents, or media.
(D) Information contained in medical records and laboratory
records shall be confidential, and shall be disclosed only to
authorized persons in accordance with federal, state, and local laws.
(3) The department or any person injured as a result of a
laboratory's abandonment or failure to retain records pursuant to
this section may bring an action in a court of proper jurisdiction
for any reasonable amount of damages suffered as a result thereof.
(k) For purposes of this section, in the case of a pharmacy that
applies for a registration pursuant to Section 1206.6, "laboratory
director" means the pharmacist-in-charge identified pursuant to
subdivision (a) of Section 1206.6.
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 Public Health
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 blood glucose,
hemoglobin A1c, or cholesterol tests classified as waived under CLIA
and 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, provided that all of the following requirements are
satisfied:
(A) The pharmacy obtains a valid CLIA 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) The pharmacy notifies the public health officer of the county
in which the pharmacy is located that the pharmacy is performing one
or more of the tests identified in this paragraph.
(c) Any place where blood glucose testing is performed pursuant to
paragraph (6) of subdivision (b) shall register by notifying the
State Department of Public Health 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 Public Health.
SEC. 2. SEC. 5. 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
1206.6 . 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
Section 1206.6 . 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.