BILL NUMBER: AB 1774 INTRODUCED
BILL TEXT
INTRODUCED BY Assembly Member Bonilla
FEBRUARY 3, 2016
An act to amend Sections 654.1, 655.5, 1206, 1206.6, 1220, 1244,
1246.5, 1271.1, 1272, 1300, 1301, and 1320 of, and to repeal Sections
1223, 1227, 1241.1, 1265, 1265.1, 1266, 1267, 1268, 1272.4, 1272.6,
1281, 1300.1, 1310, 1324, and 1325 of, the Business and Professions
Code, to amend Section 9272 of the Food and Agricultural Code, to
amend Sections 1206 and 1600.3 of the Health and Safety Code, and to
amend Section 14043.27 of the Welfare and Institutions Code, relating
to clinical laboratories.
LEGISLATIVE COUNSEL'S DIGEST
AB 1774, as introduced, Bonilla. Clinical laboratories: licensure.
Existing federal law, the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) requires the federal Centers for Medicare
and Medicaid Services to certify and regulate clinical laboratories
that perform testing on humans. Complaints against individual
laboratories are directed to the state.
Existing law provides for the licensure, registration, and
regulation of clinical laboratories and various clinical laboratory
personnel by the State Department of Public Health. Under existing
law the department inspects clinical laboratories and assesses a fee
for licensure of those facilities.
This bill would repeal the laws requiring a clinical laboratory to
be licensed and inspected by the department, including the licensing
fee. The bill would also make 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 654.1 of the Business and Professions Code is
amended to read:
654.1. (a) Persons
A person licensed under Chapter 4 (commencing with Section
1600) of this division or licensed under Chapter 5 (commencing with
Section 2000) of this division or licensed under any initiative act
referred to in this division relating to osteopaths may not refer
patients, clients, or customers to any a
clinical laboratory licensed under Section 1265
in which the licensee has any a
membership, proprietary interest, or coownership in any form,
or has any a profit-sharing
arrangement, unless the licensee at the time of making such
the referral discloses in writing such
the interest to the patient, client, or
customer. The written disclosure shall indicate that the patient may
choose any clinical laboratory for purposes of having any
laboratory work or assignment performed.
This
(b) This section
does shall not apply to persons who are members
of a medical group which that contracts
to provide medical care to members of a group practice prepayment
plan registered under the Knox-Keene Health Care Service Act of
1975, Chapter 1975 (Chapter 2.2
(commencing with Section 1340) of Division 2 of the Health and Safety
Code. Code).
This
(c) This section
does shall not apply to any
a referral to a clinical laboratory which
that is owned and operated by a health facility
licensed pursuant to Chapter 2 (commencing with Section 1250) of
Division 2 of the Health and Safety Code.
This
(d) This section does not
prohibit the acceptance of evaluation specimens for proficiency
testing or referral of specimens or such the
assignment from one clinical laboratory to another clinical
laboratory, either licensed or exempt under this chapter, providing
the report indicates clearly the laboratory performing the test.
"Proprietary
(e) "Proprietary interest" does
not include ownership of a building where space is leased to a
clinical laboratory at the prevailing rate under a straight lease
arrangement.
A
(f) A violation of this section
is a public offense and is punishable upon a first conviction by
imprisonment in a county jail for not more than one year, or by
imprisonment pursuant to subdivision (h) of Section 1170 of the Penal
Code, or by a fine not exceeding ten thousand dollars ($10,000), or
by both that imprisonment and fine. A second or subsequent conviction
shall be punishable by imprisonment pursuant to subdivision (h) of
Section 1170 of the Penal Code.
SEC. 2. Section 655.5 of the Business and Professions Code is
amended to read:
655.5. (a) It is unlawful for any a
person licensed under this division or under any
an initiative act referred to in this division, or
any a clinical laboratory, or
any a health facility when billing for a
clinical laboratory of the facility, to charge, bill, or otherwise
solicit payment from any a patient,
client, or customer for any a clinical
laboratory service not actually rendered by the person or clinical
laboratory or under his, her or its direct supervision unless the
patient, client, or customer is apprised at the first time of the
charge, billing, or solicitation of the name, address, and charges of
the clinical laboratory performing the service. The first
such written charge, bill, or other solicitation of payment
shall separately set forth the name, address, and charges of the
clinical laboratory concerned and shall clearly show whether or not
the charge is included in the total of the account, bill, or charge.
This subdivision shall be is satisfied
if the required disclosures are made to the third-party payer of the
patient, client, or customer. If the patient is responsible for
submitting the bill for the charges to the third-party payer, the
bill provided to the patient for that purpose shall include the
disclosures required by this section. This subdivision shall
does not apply to a clinical laboratory of a
health facility or a health facility when billing for a clinical
laboratory of the facility nor to a person licensed under this
division or under any initiative act referred to in this division if
the standardized billing form used by the facility or person requires
a summary entry for all clinical laboratory charges. For purposes of
this subdivision, "health facility" has the same meaning as defined
in Section 1250 of the Health and Safety Code.
(b) Commencing July 1, 1994, a A
clinical laboratory shall provide to each of its referring providers,
upon request, a schedule of fees for services provided to patients
of the referring provider. The schedule shall be provided within two
working days after the clinical laboratory receives the request. For
the purposes of this subdivision, a "referring provider" means
any a provider who has referred a
patient to the clinical laboratory in the preceding six-month period.
Commencing July 1, 1994, a A clinical
laboratory that provides a list of laboratory services to a referring
provider or to a potential referring provider shall include a
schedule of fees for the laboratory services listed.
(c) It is also unlawful for any a
person licensed under this division or under any initiative act
referred to in this division to charge additional charges for
any a clinical laboratory service that
is not actually rendered by the licensee to the patient and itemized
in the charge, bill, or other solicitation of payment. This section
shall not be construed to prohibit any of the following:
(1) Any An itemized charge for
any a service actually rendered to the
patient by the licensee.
(2) Any A summary charge for
services actually rendered to a patient by a health facility, as
defined in Section 1250 of the Health and Safety Code, or by a person
licensed under this division or under any initiative act referred to
in this division if the standardized billing form used by the
facility or person requires a summary entry for all clinical
laboratory charges.
(d) As used in this section, the term "any
"a person licensed under this division" includes a
person licensed under paragraph (1) of subdivision (a) of Section
1265, registered laboratory, as defined in Section
1206, all wholly owned subsidiaries of the person, a parent
company that wholly owns the person, and any subsidiaries wholly
owned by the same parent that wholly owns the person. "Wholly owned"
means ownership directly or through one or more subsidiaries. This
section shall not apply to billings by a person licensed
under paragraph (1) of subdivision (a) of Section 1265
registered laboratory when the person licensed under
paragraph (1) of subdivision (a) of Section 1265
registered laboratory bills for services performed by
any a laboratory owned or operated by the
person licensed under paragraph (1) of subdivision (a) of
Section 1265. registered laboratory.
(e) This section shall does not
apply to any a person or clinical
laboratory who or which contracts directly with a health care service
plan licensed pursuant to Section 1349 of the Health and Safety
Code, if the services are to be provided to members of the plan on a
prepaid basis and without additional charge or liability on account
thereof.
(f) A violation of this section is a public offense and is
punishable upon a first conviction by imprisonment in a county jail
for not more than one year, or by imprisonment pursuant to
subdivision (h) of Section 1170 of the Penal Code, or by a fine not
exceeding ten thousand dollars ($10,000), or by both that
imprisonment and fine. A second or subsequent conviction is
punishable by imprisonment pursuant to subdivision (h) of Section
1170 of the Penal Code.
(g) (1) Notwithstanding subdivision (f), a violation of this
section by a physician and surgeon for a first offense shall be
subject to the exclusive remedy of reprimand by the Medical Board of
California if the transaction that is the subject of the violation
involves a charge for a clinical laboratory service that is less than
the charge would have been if the clinical laboratory providing the
service billed a patient, client, or customer directly for the
clinical laboratory service, and if that clinical laboratory charge
is less than the charge listed in the clinical laboratory's schedule
of fees pursuant to subdivision (b).
(2) Nothing in this This subdivision
shall be construed to does not permit
a physician and surgeon to charge more than he or she was charged for
the laboratory service by the clinical laboratory providing the
service unless the additional charge is for service actually rendered
by the physician and surgeon to the patient.
SEC. 3. Section 1206 of the Business and Professions Code is
amended to read:
1206. (a) For the purposes of this chapter the following
definitions are applicable:
(1) "Analyte" means the substance or constituent being
measured measured, including, but not limited
to, glucose, sodium, or theophyline, or any substance or property
whose presence or absence, concentration, activity, intensity, or
other characteristics are to be determined.
(2) "Biological specimen" means any material that is derived from
the human body.
(3) "Blood electrolyte analysis" means the measurement of
electrolytes in a blood specimen by means of ion selective electrodes
on instruments specifically designed and manufactured for blood gas
and acid-base analysis.
(4) "Blood gas analysis" means a clinical laboratory test or
examination that deals with the uptake, transport, and
metabolism metabolization of oxygen and carbon
dioxide in the human body.
(5) "Clinical laboratory test or examination" means the detection,
identification, measurement, evaluation, correlation, monitoring,
and reporting of any particular analyte, entity, or substance within
a biological specimen for the purpose of obtaining scientific data
which that may be used as an aid to
ascertain the presence, progress, and source of a disease or
physiological condition in a human being, or used as an aid in the
prevention, prognosis, monitoring, or treatment of a physiological or
pathological condition in a human being, or for the performance of
nondiagnostic tests for assessing the health of an individual.
(6) "Clinical laboratory science" means any of the sciences or
scientific disciplines used to perform a clinical laboratory test or
examination.
(7) "Clinical laboratory practice" means the application of
clinical laboratory sciences or the use of any means that applies the
clinical laboratory sciences within or outside of a licensed or
registered clinical laboratory. Clinical laboratory practice includes
consultation, advisory, and other activities inherent to the
profession.
(8) "Clinical laboratory" means any a
place used, or any an
establishment or institution organized or operated, for the
performance of clinical laboratory tests or examinations or the
practical application of the clinical laboratory sciences. That
application may include any means that applies the clinical
laboratory sciences.
(9) "Direct and constant supervision" means personal observation
and critical evaluation of the activity of unlicensed laboratory
personnel by a physician and surgeon, or by a person licensed under
this chapter other than a trainee, during the entire time that the
unlicensed laboratory personnel are engaged in the duties specified
in Section 1269.
(10) "Direct and responsible supervision" means both of the
following:
(A) Personal observation and critical evaluation of the activity
of a trainee by a physician and surgeon, or by a person licensed
under this chapter other than a trainee, during the entire time that
the trainee is performing clinical laboratory tests or examinations.
(B) Personal review by the physician and surgeon or the licensed
person of all results of clinical laboratory testing or examination
performed by the trainee for accuracy, reliability, and validity
before the results are reported from the laboratory.
(11) "Licensed laboratory" means a clinical laboratory licensed
pursuant to paragraph (1) of subdivision (a) of Section
1265. pursuant to the federal Clinical Laboratory
Improvement Amendments of 1988 (CLIA).
(12) "Location" means either a street and city address, or a site
or place within a street and city address, where any of the clinical
laboratory sciences or scientific disciplines are practiced or
applied, or where any clinical laboratory tests or
examinations are performed.
(13) "Physician office laboratory" means a clinical laboratory
that is licensed or registered under Section 1265, and that
is either: (A) a clinical laboratory that is
owned and operated by a partnership or professional
corporation that performs clinical laboratory tests or examinations
only for patients of five or fewer physicians and surgeons or
podiatrists who are shareholders, partners, or employees of the
partnership or professional corporation that owns and operates the
clinical laboratory; or (B) a clinical laboratory that is
owned and operated by an individual licensed physician and
surgeon or a podiatrist, and that performs clinical laboratory tests
or examinations only for patients of the physician and surgeon or
podiatrist who owns and operates the clinical laboratory.
(14) "Point-of-care laboratory testing device" means a portable
laboratory testing instrument to which the following applies:
(A) It is used within the proximity of the patient for whom the
test or examination is being conducted.
(B) It is used in accordance with the patient test management
system, the quality control program, and the comprehensive quality
assurance program established and maintained by the laboratory
pursuant to paragraph (2) of subdivision (d) of Section 1220.
(C) It meets the following criteria:
(i) Performs clinical laboratory tests or examinations classified
as waived or of moderate complexity under the federal Clinical
Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec.
263a).
(ii) Performs clinical laboratory tests or examinations on
biological specimens that require no preparation after collection.
(iii) Provides clinical laboratory tests or examination results
without calculation or discretionary intervention by the testing
personnel.
(iv) Performs clinical laboratory tests or examinations without
the necessity for testing personnel to perform calibration or
maintenance, except resetting pursuant to the manufacturer's
instructions or basic cleaning.
(15) "Public health laboratory" means a laboratory that is
operated by a city or county in conformity with Article 5 (commencing
with Section 101150) of Chapter 2 of Part 3 of Division 101 of the
Health and Safety Code and the regulations adopted thereunder.
(16) "Registered laboratory" means a clinical laboratory
registered pursuant to paragraph (2) of subdivision (a) of Section
1265. that performs clinical laboratory te
sts or examinations subject to a certificate of waiver or a
certificate of provider-performed microscopy under CLIA.
(17) "Specialty" means histocompatibility, microbiology,
diagnostic immunology, chemistry, hematology, immunohematology,
pathology, genetics, or other specialty specified by regulation
adopted by the department.
(18) "Subspecialty" for purposes of microbiology, means
bacteriology, mycobacteriology, mycology, parasitology, virology,
molecular biology, and serology for diagnosis of infectious diseases,
or other subspecialty specified by regulation adopted by the
department; for purposes of diagnostic immunology, means syphilis
serology, general immunology, or other subspecialty specified by
regulation adopted by the department; for purposes of chemistry,
means routine chemistry, clinical microscopy, endocrinology,
toxicology, or other subspecialty specified by regulation adopted by
the department; for purposes of immunohematology, means ABO/Rh Type
and Group, antibody detection for transfusion, antibody detection
nontransfusion, antibody identification, compatibility, or other
subspecialty specified by regulation adopted by the department; for
pathology, means tissue pathology, oral pathology, diagnostic
cytology, or other subspecialty specified by regulation adopted by
the department; for purposes of genetics, means molecular biology
related to the diagnosis of human genetic abnormalities,
cytogenetics, or other subspecialty specified by regulation adopted
by the department.
(b) Nothing in this This chapter
shall do es not restrict,
limit, or prevent any a person licensed
to provide health care services under the laws of this state,
including, but not limited to, licensed physicians and surgeons and
registered nurses, from practicing the profession or occupation for
which he or she is licensed.
(c) Nothing in this This chapter
shall does not authorize any
a person to perform or order health care
services, or utilize the results of the clinical laboratory test or
examination, unless the person is otherwise authorized to provide
that care or utilize the results. The inclusion of a person in
Section 1206.5 for purposes of performing a clinical laboratory test
or examination shall not be interpreted to authorize a person, who is
not otherwise authorized, to perform venipuncture, arterial
puncture, or skin puncture.
SEC. 4. Section 1206.6 of the Business and Professions Code is
amended to read:
1206.6. Subdivision (a) of Section 1206.5 shall
does 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. 5. Section 1220 of the Business and Professions Code is
amended to read:
1220. (a) (1) Each clinical laboratory shall maintain records,
equipment, and facilities that are adequate and appropriate for the
services rendered.
(2) (A) Except for tests or examinations classified as waived
under CLIA, each clinical laboratory shall enroll, and demonstrate
successful participation, as defined under CLIA, for each specialty
and subspecialty in which it performs clinical laboratory tests or
examinations, in a proficiency testing program approved by the
department or by HCFA, CMS, to the same
extent as required by CLIA in Subpart H (commencing with Section
493.801) of Title 42 of the Code of Federal Regulations. This
requirement shall does not be
interpreted to prohibit a clinical laboratory from
performing clinical laboratory tests or examinations in a specialty
or subspecialty for which there is no department or HCFA
CMS approved proficiency testing program.
(B) Each clinical laboratory shall authorize its proficiency test
results to be reported to the department in an electronic format that
is compatible with the department's proficiency testing data
monitoring system and shall authorize the release of proficiency
tests results to the public to the same extent required by CLIA.
(b) Each clinical laboratory shall be conducted, maintained, and
operated without injury to the public health.
(c) (1) The department shall conduct inspections of licensed
clinical laboratories no less than once every two years. The
department shall maintain a record of those inspections and shall
ensure that every licensed clinical laboratory in California is
inspected at least that often.
(2) Registered clinical laboratories shall not be routinely
inspected by the department.
(3)
(c) The department shall conduct an investigation of
complaints received concerning any a
clinical laboratory, which laboratory that
may include an inspection of the laboratory.
(4) Each licensed or registered clinical laboratory shall be
subject to inspections by HCFA or HCFA agents, as defined by CLIA, as
a condition of licensure or registration.
(d) (1) Each clinical laboratory shall perform all clinical
laboratory tests or examinations classified as waived under CLIA in
conformity with the manufacturer's instructions.
(2) Except for those clinical laboratories performing only tests
or examinations classified as waived under CLIA, each clinical
laboratory shall establish and maintain all of the following:
(A) A patient test management system that meets the standards of
CLIA in Subpart J (commencing with Section 493.1100) of Title 42 of
the Code of Federal Regulations.
(B) A quality control program that meets the requirements of CLIA
in Subpart K (commencing with Section 493.1200) of Title 42 of the
Code of Federal Regulations as in effect on January 1, 2015, and that
may include the clinical laboratory's use of the following
alternative quality control testing procedures recognized
an Individualized Quality Control Plan, as incorporated into
Appendix C of the State Operations Manual adopted by the
federal Centers for Medicare and Medicaid Services (CMS):
(CMS).
(i) Until December 31, 2015, equivalent quality control
procedures.
(ii) Commencing January 1, 2016, an Individualized Quality Control
Plan, as incorporated in Appendix C of the State Operations Manual
adopted by CMS.
(C) A comprehensive quality assurance program that meets the
standards of CLIA in Subpart P (commencing with Section 493.1701) of
Title 42 of the Code of Federal Regulations.
SEC. 6. Section 1223 of the Business and Professions Code is
repealed.
1223. (a) The Legislature finds and declares that it is the
public policy of the state to ensure that California's laboratory
standards, including its laboratory personnel standards, be sustained
in order to provide accurate, reliable, and necessary test results.
The Legislature further finds that inspections are the most effective
means of furthering this policy. It is not the intent of the
Legislature to reduce in any way the resources available to the
department for inspections, but rather to provide the department with
the greatest flexibility to concentrate its resources where they can
be most effective. It is the intent of the Legislature to provide
for an inspection process that includes state-based inspection
components and that determines compliance with federal and state
requirements for clinical laboratories.
(b) The department shall employ, or contract for, inspectors,
special agents, and investigators, and provide any clerical and
technical assistance as necessary to administer this chapter and may
incur other expenses as necessary.
(c) Laboratories accredited by a private, nonprofit organization
shall be deemed by the department to meet state licensure or
registration requirements, and shall be issued a certificate of that
deemed status by the department, provided that both of the following
conditions are met:
(1) The private, nonprofit organization meets all of the following
requirements:
(A) Is approved by the federal Center for Medicare and Medicaid
Services as an accreditation body under CLIA and provides the
department with the following information:
(i) A detailed comparison of the individual accreditation or
approval requirements, with the comparable condition-level
requirements.
(ii) A detailed description of its inspection process, including
all of the following:
(I) Frequency of inspections.
(II) Copies of inspection forms.
(III) Instructions and guidelines.
(IV) A description of the review and decisionmaking process of
inspections.
(V) A statement concerning whether inspections are announced or
unannounced.
(VI) A description of the steps taken to monitor the correction of
deficiencies.
(iii) A description of the process for monitoring proficiency
testing performance, including action to be taken in response to
unsuccessful participation.
(iv) A list of all of its current California licensed or
registered laboratories and the expiration date of their
accreditation, licensure, or registration, as applicable.
(B) Is approved by the department as having accreditation
standards that are equal to, or more stringent than, state
requirements for licensure and registration.
(C) Conducts inspections of clinical laboratories in a manner that
will determine compliance with federal standards and California laws
to the extent that California laws provide greater protection to
residents, or are more stringent than federal standards, as
determined by the department. Notwithstanding any other provision of
law, the department may, without taking regulatory action pursuant to
Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3
of Title 2 of the Government Code, implement or interpret this
section by means of an All Clinical Laboratories Letter (ACLL). The
department shall post the ACLL on its Internet Web site so that any
person may observe which California laws are more
stringent than federal standards, and which
accreditation bodies have been approved to conduct inspections.
Public comment on the ACLL shall be accepted by the department for 30
days after posting and shall become final 45 days after the posting.
Comments received shall be considered by the department. Nothing in
this subdivision is intended to change existing statutory or
regulatory requirements governing the operation of clinical
laboratories or their personnel.
(D) Is approved by the department as meeting the requirements of
this paragraph. The department shall begin accepting applications for
approval, in a form and manner prescribed by the department, by
January 1, 2011. The department shall make a determination on an
application submitted pursuant to this subparagraph within 180 days
of receiving the application.
(2) The laboratory meets all of the following requirements:
(A) Meets the accreditation standards of the private, nonprofit
organization.
(B) Agrees to permit the private, nonprofit organization to
provide any records or other information to the department, its
agents, or contractors, as the department may require.
(C) Pays the applicable fees required under Section 1300.
(D) Authorizes its proficiency testing organization to furnish to
the department and the private, nonprofit organization the results of
the laboratory's participation in an approved proficiency testing
program, as defined in 42 C.F.R. 493.2, for the purpose of monitoring
the laboratory's proficiency testing, along with explanatory
information needed to interpret the proficiency testing results, upon
request of the department.
(E) Authorizes the private, nonprofit organization to release to
the department a notification of every violation of condition-level
requirements, including the actions taken by the organization as a
result of the violation, within 30 days of the initiation of the
action.
(F) Authorizes the private, nonprofit organization to give notice
to the department of any withdrawal of the laboratory's
accreditation.
(d) If the private, nonprofit organization described in
subdivision (c) has withdrawn or revoked its accreditation of a
laboratory, the laboratory shall retain its certificate of deemed
status issued pursuant to subdivision (c) for 45 days after the
laboratory receives notice of the withdrawal or revocation of the
accreditation, or the effective date of any action taken by the
department, whichever is earlier.
(e) A certificate of deemed status issued pursuant to subdivision
(c) shall be renewed annually provided that the conditions for
issuance specified in subdivision (c) are still met. Except as
authorized under subdivision (f), the department shall not conduct
routine inspections of a laboratory issued a certificate of deemed
status pursuant to subdivision (c). Each application for a
certificate of deemed status issued under subdivision (c) and each
request for renewal of that certificate shall be accompanied by the
fees set forth in Section 1300. The total of those certificate
application and renewal fees collected by the department shall be
sufficient to cover the cost of issuing the certificate. If the
department determines that those certificate fees do not fully
support the costs of these activities, it shall report that
determination to the Legislature.
(f) Nothing in this section shall be construed to prohibit the
exercise of the department's authority to conduct complaint
investigations, sample validation inspections, or require submission
of proficiency testing results to the department to ensure compliance
of any clinical laboratory with state standards.
SEC. 7. Section 1227 of the Business and Professions Code is
repealed.
1227. Every person or clinical laboratory licensed or registered
under this chapter shall report to the department, within 30 days
thereof, any change of name or address.
SEC. 8. Section 1241.1 of the Business and Professions Code is
repealed.
1241.1. (a) A primary care clinic, licensed pursuant to
subdivision (a) of Section 1204 of the Health and Safety Code, that
is operating within a network of primary care clinics, may be issued
a license to operate a clinical laboratory pursuant to Section 1265,
which authorizes the conduct of clinical laboratory tests and
examinations from its network of primary care clinics, if all of the
following conditions are met:
(1) The central laboratory's sole purpose is performing moderate
or high complexity clinical laboratory tests and examinations, or
both, for the patients of the clinics in the network.
(2) Prior to performing any tests or examinations, the central
laboratory obtains a certificate under the federal Clinical
Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) (CLIA) and
a state laboratory license for the appropriate complexity level of
clinical laboratory testing pursuant to Section 1265.
(b) For purposes of this section, "network of primary care clinics"
means two or more primary care clinics operated by the same
nonprofit corporation with the same board of directors and the same
corporate officers, and operating under the same procedures and
protocols.
SEC. 9. Section 1244 of the Business and Professions Code is
amended to read:
1244. (a) Nothing
in this This chapter shall
does not 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
(10) (a) The
written protocols adopted by the supervisory committee shall be
maintained for at least one year following completion of the
assessment program 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 This chapter
shall be interpreted as prohibiting does not
prohibit 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. by federal law or is
operating with a waiver for the applicable procedures. 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
onsite 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. 10. Section 1246.5 of the Business and Professions Code is
amended to read:
1246.5. (a) Notwithstanding any other
provision of law, any a
person may request, and any a
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.
CLIA. 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
(b) 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. 11. Section 1265 of the Business and Professions Code is
repealed.
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. 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.
SEC. 12. Section 1265.1 of the Business and Professions Code is
repealed.
1265.1. (a) A primary care clinic that submits an application to
the State Department of Public Health for clinic licensure pursuant
to subdivision (a) of Section 1204 of the Health and Safety Code may
submit prior to that submission, or concurrent therewith, an
application for licensure or registration of a clinical laboratory to
be operated by the clinic.
(b) An application for licensure of a clinical laboratory
submitted pursuant to this section shall be subject to all applicable
laboratory
licensing laws and regulations, including, but not limited to, any
statutory or regulatory timelines and processes for review of a
clinical laboratory application.
SEC. 13. Section 1266 of the Business and Professions Code is
repealed.
1266. The clinical laboratory license and the license or current
renewal permit of each person performing tests shall be conspicuously
posted in the clinical laboratory.
SEC. 14. Section 1267 of the Business and Professions Code is
repealed.
1267. Any denial, suspension, or revocation of a license under
this chapter shall be conducted in compliance with Section 100171 of
the Health and Safety Code.
SEC. 15. Section 1268 of the Business and Professions Code is
repealed.
1268. Upon filing application therefor, containing such
information as the department may require, and the payment of the
license fee, the department shall issue to any person duly licensed
under this chapter a duplicate license for one previously issued or,
where there has been a change of name, another license in lieu of one
previously issued.
SEC. 16. Section 1271.1 of the Business and Professions Code is
amended to read:
1271.1. (a) Clinical laboratories which are licensed
pursuant to this chapter and provide A clinical
laboratory that provides cytology services shall, if the
licensee laboratory ceases operation,
preserve records, reports, cytology slides, and cell blocks as
prescribed in subdivision (g) of Section 1271 and Section 1274.
(b) Any A person injured
as a result of the licensee's laboratory's
abandonment of records may bring an action in any
a court of competent jurisdiction for the amount
of any damages suffered as a result. In
the event the licensee If the laboratory was a
corporation or partnership which that
has been dissolved, the person injured may bring an action against
that corporation's or partnership's principal officers of record at
the time of the dissolution.
(c) For purposes of this section, the following definitions shall
apply:
(1) "Abandonment of records" means violating subdivision (a) and
thereby leaving patients and physicians and surgeons without access
to information to which they are entitled pursuant to this chapter.
(2) "Principal officers" means:
(A) In the case of a partnership other than a limited partnership,
any partner.
(B) In the case of a limited partnership, any general partner, as
defined in subdivision (i) of Section
15611 15904.02 of the Corporations Code.
(C) In the case of a corporation, the chairperson of the board,
the chief executive officer, and the president of the corporation.
SEC. 17. Section 1272 of the Business and Professions Code is
amended to read:
1272. A clinical laboratory shall participate in a
state-approved CLIA-approved proficiency testing
program and demonstrate satisfactory performance in all of the
laboratory specialities that include tests performed in the
laboratory. Proficiency shall be tested in the following specialties:
microbiology, serology, clinical chemistry, hematology, cytology,
and immunohematology.
SEC. 18. Section 1272.4 of the Business and Professions Code is
repealed.
1272.4. The department shall establish standards for the
evaluation of cytologic slides, for reporting the adequacy of
cytologic slides, for a cytotechnologist competency program, and for
a proficiency testing program for clinical laboratories providing
cytology services.
SEC. 19. Section 1272.6 of the Business and Professions Code is
repealed.
1272.6. The department shall, on or before January 1, 1992,
develop or adopt a proficiency testing program for laboratories
providing cytology services which may be administered by the
department or by a proficiency testing service or program approved by
the department. The proficiency program established pursuant to this
section shall include announced and unannounced onsite proficiency
testing, with that testing to take place, to the extent practicable,
under normal working conditions.
SEC. 20. Section 1281 of the Business and Professions Code is
repealed.
1281. It is unlawful for any person to own, operate, maintain,
direct, or engage in the business of operating a clinical laboratory,
as defined in this chapter, unless he or she possesses a valid
clinical laboratory license issued by the department. In the event a
health facility does not perform clinical laboratory services, but
provides laboratory services to its patients under an agreement with
another person or entity that holds and is operating under a valid
clinical laboratory license, the health facility shall not be
required to obtain a clinical laboratory license.
SEC. 21. Section 1300 of the Business and Professions Code is
amended to read:
1300. The amount of application, registration,
application and license fees under this chapter shall be
as follows:
(a) The application fee for a histocompatibility laboratory
director's, clinical laboratory bioanalyst's, clinical chemist's,
clinical microbiologist's, clinical laboratory toxicologist's,
clinical cytogeneticist's, or clinical genetic molecular biologist's
license is sixty-three dollars ($63) commencing on July 1,
1983. ($63).
(b) The annual renewal fee for a histocompatibility laboratory
director's, clinical laboratory bioanalyst's, clinical chemist's,
clinical microbiologist's, clinical laboratory toxicologist's,
clinical cytogeneticist's, or clinical genetic molecular biologist's
license is sixty-three dollars ($63) commencing on July 1,
1983. ($63).
(c) The application fee for a clinical laboratory scientist's or
limited clinical laboratory scientist's license is thirty-eight
dollars ($38) commencing on July 1, 1983.
($38).
(d) The application and annual renewal fee for a cytotechnologist'
s license is fifty dollars ($50) commencing on January 1,
1991. ($50).
(e) The annual renewal fee for a clinical laboratory scientist's
or limited clinical laboratory scientist's license is twenty-five
dollars ($25) commencing on July 1, 1983.
($25).
(f) A clinical laboratory applying for a license to perform tests
or examinations classified as of moderate or of high complexity under
CLIA and a clinical laboratory applying for certification under
subdivision (c) of Section 1223 shall pay an application fee for that
license or certification based on the number of tests it performs or
expects to perform in a year, as follows:
(1) Less than 2,001 tests: two hundred seventy dollars ($270).
(2) Between 2,001 and 10,000, inclusive, tests: eight hundred
twenty dollars ($820).
(3) Between 10,001 and 25,000, inclusive, tests: one thousand
three hundred fifteen dollars ($1,315).
(4) Between 25,001 and 50,000, inclusive, tests: one thousand five
hundred eighty dollars ($1,580).
(5) Between 50,001 and 75,000, inclusive, tests: one thousand nine
hundred sixty dollars ($1,960).
(6) Between 75,001 and 100,000, inclusive, tests: two thousand
three hundred forty dollars ($2,340).
(7) Between 100,001 and 500,000, inclusive, tests: two thousand
seven hundred forty dollars ($2,740).
(8) Between 500,001 and 1,000,000, inclusive, tests: four thousand
nine hundred ten dollars ($4,910).
(9) More than 1,000,000 tests: five thousand two hundred sixty
dollars ($5,260) plus three hundred fifty dollars ($350) for every
500,000 tests over 1,000,000, up to a maximum of 15,000,000 tests.
(g) A clinical laboratory performing tests or examinations
classified as of moderate or of high complexity under CLIA and a
clinical laboratory with a certificate issued under subdivision (c)
of Section 1223 shall pay an annual renewal fee based on the number
of tests it performed in the preceding calendar year, as follows:
(1) Less than 2,001 tests: one hundred seventy dollars ($170).
(2) Between 2,001 and 10,000, inclusive, tests: seven hundred
twenty dollars ($720).
(3) Between 10,001 and 25,000, inclusive, tests: one thousand one
hundred fifteen dollars ($1,115).
(4) Between 25,001 and 50,000, inclusive, tests: one thousand
three hundred eighty dollars ($1,380).
(5) Between 50,001 and 75,000, inclusive, tests: one thousand
seven hundred sixty dollars ($1,760).
(6) Between 75,001 and 100,000, inclusive, tests: two thousand
forty dollars ($2,040).
(7) Between 100,001 and 500,000, inclusive, tests: two thousand
four hundred forty dollars ($2,440).
(8) Between 500,001 and 1,000,000, inclusive, tests: four thousand
six hundred ten dollars ($4,610).
(9) More than 1,000,000 tests per year: four thousand nine hundred
sixty dollars ($4,960) plus three hundred fifty dollars ($350) for
every 500,000 tests over 1,000,000, up to a maximum of 15,000,000
tests.
(h)
(f) The application fee for a trainee's license is
thirteen dollars ($13) commencing on July 1, 1983.
($13).
(i)
(g) The annual renewal fee for a trainee's license is
eight dollars ($8) commencing on July 1, 1983.
($8).
(j)
(h) The application fee for a duplicate license is five
dollars ($5) commencing on July 1, 1983.
($5).
(k)
(i) The personnel licensing delinquency fee is equal to
the annual renewal fee.
(l)
(j) The director may establish a fee for examinations
required under this chapter. The fee shall not exceed the total cost
to the department in conducting the examination.
(m) A clinical laboratory subject to registration under paragraph
(2) of subdivision (a) of Section 1265 and performing only those
clinical laboratory tests or examinations considered waived under
CLIA shall pay an annual fee of one hundred dollars ($100). A
clinical laboratory subject to registration under paragraph (2) of
subdivision (a) of Section 1265 and performing only
provider-performed microscopy, as defined under CLIA, shall pay an
annual fee of one hundred fifty dollars ($150). A clinical laboratory
performing both waived and provider-performed microscopy shall pay
an annual registration fee of one hundred fifty dollars ($150).
(n) The costs of the department in conducting a complaint
investigation, imposing sanctions, or conducting a hearing under this
chapter shall be paid by the clinical laboratory. The fee shall be
no greater than the fee the laboratory would pay under CLIA for the
same type of activities and shall not be payable if the clinical
laboratory would not be required to pay those fees under CLIA.
(o)
(k) The state, a district, city, county, city and
county, or other political subdivision, or any
a public officer or body shall be subject to the payment
of fees established pursuant to this chapter or regulations adopted
thereunder.
(p) In addition to the payment of registration or licensure fees,
a clinical laboratory located outside the State of California shall
reimburse the department for travel and per diem to perform any
necessary onsite inspections at the clinical laboratory in order to
ensure compliance with this chapter.
(q)
(l) The department shall establish an application fee
and a renewal fee for a medical laboratory technician license, the
total fees collected not to exceed the costs of the department for
the implementation and operation of the program licensing and
regulating medical laboratory technicians pursuant to Section 1260.3.
(r) The costs of the department to conduct any reinspections to
ensure compliance of a laboratory applying for initial licensure
shall be paid by the laboratory. This additional cost for each visit
shall be equal to the initial application fee and shall be paid by
the laboratory prior to issuance of a license. The department shall
not charge a reinspection fee if the reinspection is due to error or
omission on the part of the department.
(s) A fee of twenty-five dollars ($25) shall be assessed for
approval of each additional location authorized by paragraph (2) of
subdivision (d) of Section 1265.
(t) On or before July 1, 2013, the department shall report to the
Legislature during the annual legislative budget hearing process the
extent to which the state oversight program meets or exceeds federal
oversight standards and the extent to which the federal Department of
Health and Human Services is accepting exemption applications and
the potential cost to the state for an exemption.
SEC. 22. Section 1300.1 of the Business and Professions Code is
repealed.
1300.1. The application and renewal fees for clinical laboratory
licenses specified in Section 1300 shall be adjusted annually in the
manner specified in Section 100450 of the Health and Safety Code. The
adjustments shall be rounded off to the nearest whole dollar amount.
SEC. 23. Section 1301 of the Business and Professions Code is
amended to read:
1301. (a) The annual renewal fee for a clinical
laboratory license or registration set under this chapter shall be
paid during the 30-day period before the expiration date of the
license or registration. If the license or registration is not
renewed before the expiration date, the licensee or registrant, as a
condition precedent to renewal, shall pay a delinquency fee equal to
25 percent of the annual renewal fee for up to 60 days after the
expiration date, in addition to the annual renewal fee in effect on
the last preceding regular renewal date. Failure to pay the annual
renewal fee in advance during the time the license or registration
remains in force shall, ipso facto, work a forfeiture of the license
or registration after a period of 60 days from the expiration date of
the license or registration.
(b) (1)
(a) The department shall
give written notice to all persons licensed pursuant to Section 1260,
1260.1, 1261, 1261.5, 1262, 1264, or 1270 at least 30
days in advance of the regular renewal date that a renewal fee has
not been paid. In addition, the department shall give written notice
to licensed clinical laboratory bioanalysts or doctoral degree
specialists and clinical laboratory scientists or limited clinical
laboratory scientists by registered or certified mail 90 days in
advance of the expiration of the fifth year that a renewal fee has
not been paid and and, if not paid
before the expiration of the fifth year of delinquency
delinquency, the licensee may be subject to
reexamination.
(2)
(b) If the renewal fee is not paid for five or more
years, the department may require an examination before reinstating
the license, except that no an
examination shall not be required as a condition for
reinstatement if the original license was issued without an
examination. No An examination shall
not be required for reinstatement if the license was
forfeited solely by reason of nonpayment of the renewal fee if the
nonpayment was for less than five years.
(3)
(c) If the license is not renewed within 60 days after
its expiration, the licensee, as a condition precedent to renewal,
shall pay the delinquency fee identified in subdivision (k)
(i) of Section 1300, in addition to the renewal
fee in effect on the last preceding regular renewal date. Payment of
the delinquency fee will not be is not
necessary if if, within 60 days of the
license expiration date date, the
licensee files with the department an application
for inactive status.
SEC. 24. Section 1310 of the Business and Professions Code is
repealed.
1310. If the department determines that a laboratory that has
been issued a license or registration under this chapter, except for
a laboratory only performing tests or examinations classified as
waived under CLIA, no longer substantially meets the requirements of
this chapter or the regulations adopted thereunder, the department,
in lieu of, or in addition to, revocation or suspension of the
license or registration under Section 1320 or 1323, may impose any of
the following:
(a) Directed plans of correction, as defined under CLIA.
(b) Civil money penalties in an amount ranging from fifty dollars
($50) to three thousand dollars ($3,000) per day of noncompliance, or
per violation, for a condition-level deficiency that does not pose
immediate jeopardy, to an amount ranging from three thousand fifty
dollars ($3,050) to ten thousand dollars ($10,000) per day of
noncompliance, or per violation, for a condition-level deficiency
that poses immediate jeopardy, but only after notice and an
opportunity to respond in accordance with Section 100171 of the
Health and Safety Code, and consideration of facts enumerated in CLIA
in Section 493.1834 of Title 42 of the Code of Federal Regulations.
(c) Civil money penalties in an amount ranging from fifty dollars
($50) to three thousand dollars ($3,000) per day of noncompliance, or
per violation, for a violation of subdivision (t) of Section 1320,
for failure to comply with disease reporting requirements, but only
after notice and an opportunity to respond in accordance with Section
100171 of the Health and Safety Code.
(d) Onsite monitoring, as defined under CLIA, and payment for the
costs of onsite monitoring.
(e) Any combination of the actions described in subdivisions (a),
(b), (c), and (d).
SEC. 25. Section 1320 of the Business and Professions Code is
amended to read:
1320. The department may deny, suspend, or revoke any
a license or registration
issued under pursuant to this chapter
for any of the following reasons:
(a) Conduct involving moral turpitude or dishonest reporting of
tests.
(b) Violation by the applicant, licensee, or registrant
applicant or licensee of this chapter or
any a rule or regulation adopted
pursuant thereto.
(c) Aiding, abetting, or permitting the violation of this chapter,
the rules or regulations adopted under
pursuant to this chapter chapter,
or the Medical Practice Act, Chapter Act
(Chapter 5 (commencing with Section 2000) of Division
2. 2).
(d) Permitting a licensed trainee to perform tests or procure
specimens unless under the direct and responsible
supervision of a person duly licensed under this chapter or
physician and surgeon other than another licensed trainee.
supervision.
(e) Violation of any provision of this code governing the practice
of medicine and surgery.
(f) Proof that an applicant, licensee, or registrant
applicant or licensee has made false statements
in any material regard on the application for a license,
registration, license or renewal issued
under pursuant to this chapter.
(g) Conduct inimical to the public health, morals, welfare, or
safety of the people of the State of California in the
maintenance or operation of the premises or provision
of services for which a license or registration
is issued under pursuant to
this chapter.
(h) Proof that the applicant or licensee has used any
degree, or certificate, a degree or certificate
as a means of qualifying for licensure that has been purchased or
procured by barter or by any unlawful means or obtained from
any an institution that
that, at the time the degree, certificate, or title was
obtained obtained, was not recognized
or accredited by the department of education of the state where the
institution is or was located to give training in the field of study
in which the degree, certificate, or title is claimed.
(i) Violation of any of the prenatal laws or regulations
pertaining thereto in Chapter 2 (commencing with Section 120675) of
Part 3 of Division 105 of the Health and Safety Code and Article 1
(commencing with Section 1125) of Group 4 of Subchapter 1 of Chapter
2 of Part 1 of Title 17 of the California Code of Regulations.
(j) Knowingly accepting an assignment for clinical laboratory
tests or specimens from from, and the
rendering of a report thereon to to,
persons not authorized by law to submit those specimens or
assignments.
(k) Rendering a report on clinical laboratory work actually
performed in another clinical laboratory without designating clearly
the name and address of the laboratory in which the test was
performed.
( l ) Conviction of a felony or of any
misdemeanor involving moral turpitude under the laws of any
state or of the United States arising out of or in connection with
the practice of clinical laboratory technology. The record of
conviction or a certified copy thereof shall be conclusive evidence
of that conviction.
(m) Unprofessional conduct.
(n) The use of drugs or alcoholic beverages to the extent or in a
manner as to be dangerous to a person licensed under this chapter, or
any other person to the extent that that use
impairs the ability of the licensee to conduct
conduct, with safety to the public
public, the practice of clinical laboratory technology.
(o) Misrepresentation in obtaining a license or
registration. license.
(p) Performance of, or representation of the laboratory
as entitled to perform, of a clinical laboratory
test or examination or other procedure that is not within the
specialties or subspecialties, or category of laboratory procedures
authorized by the license or registration.
license.
(q) Refusal of a reasonable request of HCFA, a HCFA agent, the
department, or any employee, agent, or contractor of the department,
for permission to inspect, pursuant to this chapter, the laboratory
and its operations and pertinent records during the hours the
laboratory is in operation.
(r) Failure to comply with reasonable requests of the department
for any information, work, or materials that the department concludes
is necessary to determine the laboratory's continued eligibility for
its license or registration, or its continued compliance with this
chapter or the regulations adopted under this chapter.
(s) Failure to comply with a sanction imposed under Section 1310.
(t) Failure to comply with the disease reporting requirements
adopted pursuant to Section 120130 of the Health and Safety Code.
However, when a laboratory is not able to obtain complete information
for a patient within the reporting timeframes, it shall document
that it made a good faith effort to do so and it shall submit the
report with the available information within the required reporting
timeframes and, in that case, the laboratory shall not be subject to
sanctions for failure to submit complete patient information.
SEC. 26. Section 1324 of the Business and Professions Code is
repealed.
1324. Except for a person or entity whose license was revoked
automatically under Section 1265, no person or entity who has owned
or operated a clinical laboratory that had its license or
registration revoked may, within two years of the revocation of the
license or registration, own or operate a laboratory for which a
license or registration has been issued under this chapter.
SEC. 27. Section 1325 of the Business and Professions Code is
repealed.
1325. Notwithstanding Sections 1267 and 1322, the license or
registration of a clinical laboratory that has been excluded from
participation under the Medicare program (Title XVIII of the Social
Security Act (42 U.S.C. Sec. 1395 et seq.)), under the Medicaid
Program (Title XIX of the Social Security Act (42 U.S.C. Sec. 1396 et
seq.)), or that had its certificate revoked under CLIA, shall be
automatically suspended by the department for the period the
laboratory is so excluded or has its certificate revoked.
SEC. 28. Section 9272 of the Food and Agricultural Code is amended
to read:
9272. The provisions of this chapter shall not apply (1) to
facilities primarily engaged in the collection, preparation, testing,
processing, storage, or distribution of human blood or blood
products, provided such the facility is
licensed pursuant to Section 1601 or 1602
Chapter 4 (commencing with Section 1600) of Division 2 of the
Health and Safety Code and any biologic
biologic, as defined in Section 9203
9203, produced by such the
facility is sold or distributed only to an establishment licensed by
this chapter or (2) to clinical laboratories licensed
pursuant to Chapter 3 (commencing with Section 1200) of Division 2 of
the Business and Professions Code whose only biologics are
autogenous bacterins prepared at the request of licensed
veterinarians.
SEC. 29. Section 1206 of the Health and Safety Code is amended to
read:
1206. This chapter does not apply to the following:
(a) Except with respect to the option provided with regard to
surgical clinics in paragraph (1) of subdivision (b) of Section 1204
and, further, with
respect to specialty clinics specified in paragraph (2) of
subdivision (b) of Section 1204, any a
place or establishment owned or leased and operated as a clinic or
office by one or more licensed health care practitioners and used as
an office for the practice of their profession, within the scope of
their license, regardless of the name used publicly to identify the
place or establishment.
(b) Any A clinic directly conducted,
maintained, or operated by the United States or by any of its
departments, officers, or agencies, and any primary care clinic
specified in subdivision (a) of Section 1204 that is directly
conducted, maintained, or operated by this state or by any of its
political subdivisions or districts, or by any city. Nothing in this
subdivision precludes the state department from
adopting regulations that utilize clinic licensing standards as
eligibility criteria for participation in programs funded wholly or
partially under Title XVIII or XIX of the federal Social Security
Act.
(c) (1) Any A clinic conducted,
maintained, or operated by a federally recognized Indian tribe or
tribal organization, as defined in Section 450 or 1603 of Title 25 of
the United States Code, that is located on land recognized as tribal
land by the federal government.
(2) Any A clinic conducted,
maintained, or operated by a federally recognized Indian tribe or
tribal organization, as defined in Section 450 or 1603 of Title 25 of
the United States Code, under a contract with the United States
pursuant to the Indian Self-Determination and Education Assistance
Act (Public Law 93-638), regardless of the location of the clinic,
except that if the clinic chooses to apply to the State Department of
Public Health for a state facility license, then the State
Department of Public Health will retain authority to regulate that
clinic as a primary care clinic as defined by subdivision (a) of
Section 1204.
(d) Clinics conducted, operated, or maintained as outpatient
departments of hospitals.
(e) Any A facility licensed as a
health facility under Chapter 2 (commencing with Section 1250).
(f) Any A freestanding
clinical or pathological laboratory licensed under Chapter 3
(commencing with Section 1200) of Division 2 of the Business and
Professions Code. laboratory.
(g) A clinic operated by, or affiliated with, any
an institution of learning that teaches a
recognized healing art and is approved by the state board or
commission vested with responsibility for regulation of the practice
of that healing art.
(h) A clinic that is operated by a primary care community or free
clinic and that is operated on separate premises from the licensed
clinic and is only open for limited services of no more than 30 hours
a week. An intermittent clinic clinic,
as described in this subdivision shall, however,
subdivision, shall meet all other requirements of law,
including administrative regulations and requirements, pertaining to
fire and life safety.
(i) The offices of physicians in group practice who provide a
preponderance of their services to members of a comprehensive group
practice prepayment health care service plan subject to Chapter 2.2
(commencing with Section 1340).
(j) Student health centers operated by public institutions of
higher education.
(k) Nonprofit speech and hearing centers, as defined in Section
1201.5. Any A nonprofit speech and
hearing clinic desiring an exemption under this subdivision shall
make application therefor apply to the
director, who shall grant the exemption to any facility meeting the
criteria of Section 1201.5. Notwithstanding the licensure exemption
contained in this subdivision, a nonprofit speech and hearing center
shall be deemed to be an organized outpatient clinic for purposes of
qualifying for reimbursement as a rehabilitation center under the
Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of
Division 9 of the Welfare and Institutions Code).
( l ) A clinic operated by a nonprofit corporation
exempt from federal income taxation under paragraph (3) of subsection
(c) of Section 501 of the Internal Revenue Code of 1954, as amended,
or a statutory successor thereof, that conducts medical research and
health education and provides health care to its patients through a
group of 40 or more physicians and surgeons, who are independent
contractors representing not less than 10 board-certified
specialties, and not less than two-thirds of whom practice on a
full-time basis at the clinic.
(m) Any A clinic, limited
to in vivo diagnostic services by magnetic resonance imaging
functions or radiological services under the direct and immediate
supervision of a physician and surgeon who is licensed to practice in
California. This shall not be construed to permit cardiac
catheterization or any treatment modality in these clinics.
(n) A clinic operated by an employer or jointly by two or more
employers for their employees only, or by a group of employees, or
jointly by employees and employers, without profit to the operators
thereof or to any other person, for the prevention and treatment of
accidental injuries to, and the care of the health of, the employees
comprising the group.
(o) A community mental health center, as defined in Section 5667
of the Welfare and Institutions Code.
(p) (1) A clinic operated by a nonprofit corporation exempt from
federal income taxation under paragraph (3) of subsection (c) of
Section 501 of the Internal Revenue Code of 1954, as amended, or a
statutory successor thereof, as an entity organized and operated
exclusively for scientific and charitable purposes and that satisfied
all of the following requirements on or before January 1, 2005:
(A) Commenced conducting medical research on or before January 1,
1982, and continues to conduct medical research.
(B) Conducted research in, among other areas, prostatic cancer,
cardiovascular disease, electronic neural prosthetic devices,
biological effects and medical uses of lasers, and human magnetic
resonance imaging and spectroscopy.
(C) Sponsored publication of at least 200 medical research
articles in peer-reviewed publications.
(D) Received grants and contracts from the National Institutes of
Health.
(E) Held and licensed patents on medical technology.
(F) Received charitable contributions and bequests totaling at
least five million dollars ($5,000,000).
(G) Provides health care services to patients only:
(i) In conjunction with research being conducted on procedures or
applications not approved or only partially approved for payment (I)
under the Medicare program pursuant to Section 1359y(a)(1)(A) of
Title 42 of the United States Code, or (II) by a health care service
plan registered under Chapter 2.2 (commencing with Section 1340), or
a disability insurer regulated under Chapter 1 (commencing with
Section 10110) of Part 2 of Division 2 of the Insurance Code;
provided that services may be provided by the clinic for an
additional period of up to three years following the approvals, but
only to the extent necessary to maintain clinical expertise in the
procedure or application for purposes of actively providing training
in the procedure or application for physicians and surgeons unrelated
to the clinic.
(ii) Through physicians and surgeons who, in the aggregate, devote
no more than 30 percent of their professional time for the entity
operating the clinic, on an annual basis, to direct patient care
activities for which charges for professional services are paid.
(H) Makes available to the public the general results of its
research activities on at least an annual basis, subject to good
faith protection of proprietary rights in its intellectual property.
(I) Is a freestanding clinic, whose operations under this
subdivision are not conducted in conjunction with any affiliated or
associated health clinic or facility defined under this division,
except a clinic exempt from licensure under subdivision (m). For
purposes of this subparagraph, a freestanding clinic is defined as
"affiliated" only if it directly, or indirectly through one or more
intermediaries, controls, or is controlled by, or is under common
control with, a clinic or health facility defined under this
division, except a clinic exempt from licensure under subdivision
(m). For purposes of this subparagraph, a freestanding clinic is
defined as "associated" only if more than 20 percent of the directors
or trustees of the clinic are also the directors or trustees of any
individual clinic or health facility defined under this division,
except a clinic exempt from licensure under subdivision (m). Any
activity by a clinic under this subdivision in connection with an
affiliated or associated entity shall fully comply with the
requirements of this subdivision. This subparagraph shall not apply
to agreements between a clinic and any entity for purposes of
coordinating medical research.
(2) By January 1, 2007, and every five years thereafter, the
Legislature shall receive a report from each clinic meeting the
criteria of this subdivision and any other interested party
concerning the operation of the clinic's activities. The report shall
include, but not be limited to, an evaluation of how the clinic
impacted competition in the relevant health care market, and a
detailed description of the clinic's research results and the level
of acceptance by the payer community of the procedures performed at
the clinic. The report shall also include a description of procedures
performed both in clinics governed by this subdivision and those
performed in other settings. The cost of preparing the reports shall
be borne by the clinics that are required to submit them to the
Legislature pursuant to this paragraph.
SEC. 30. Section 1600.3 of the Health and Safety Code is amended
to read:
1600.3. "Blood bank depository" means any
a place other than a blood bank where human whole blood and
human whole blood derivatives specified by regulation are stored and
held for transfusion. Such blood Blood
bank depositories shall be clinical laboratories, licensed in
accordance with the provisions of Chapter 3 (commencing with
Section 1200), Division 2 of the Business and Professions Code,
federal law, or such other
places where services essentially equivalent are maintained, as
determined by the department.
SEC. 31. Section 14043.27 of the Welfare and Institutions Code is
amended to read:
14043.27. (a) If an applicant or provider is granted provisional
provider status or preferred provisional provider status pursuant to
Section 14043.26 and, if at any time during the provisional provider
status period or preferred provisional provider status period, the
department conducts any announced or unannounced visits or any
additional inspections or reviews pursuant to this chapter or Chapter
8 (commencing with Section 14200), or the regulations adopted
thereunder, or pursuant to Section 100185.5 of the Health and Safety
Code, and discovers or otherwise determines the existence of any
ground to deactivate the provider's number and business addresses or
suspend the provider from the Medi-Cal program pursuant to this
chapter or Chapter 8 (commencing with Section 14200), or the
regulations adopted thereunder, or pursuant to Section 100185.5 of
the Health and Safety Code, or if any of the circumstances listed in
subdivision (c) occur, the department shall terminate the provisional
provider status or preferred provisional provider status of the
provider, regardless of whether the period of time for which the
provisional provider status or preferred provisional provider status
was granted under Section 14043.26 has elapsed.
(b) Termination of provisional provider status or preferred
provisional provider status shall include deactivation of the
provider's number, including all business addresses used by the
provider to obtain reimbursement from the Medi-Cal program and
removal of the provider from enrollment in the Medi-Cal program,
except where the termination is based upon a ground related solely to
a specific location for which provisional provider status was
granted. Termination of provisional provider status based upon
grounds related solely to a specific location may include failure to
have an established place of business, failure to possess the
business or zoning permits or other approvals necessary to operate a
business, or failure to possess the appropriate licenses, permits, or
certificates necessary for the provider of service category or
subcategory identified by the provider in its application package.
Where the grounds relate solely to a specific location, the
termination of provisional provider status shall include only
deactivation of the specific locations that the grounds apply to and
shall include removal of the provider from enrollment in the Medi-Cal
program only if, after deactivation of the specific locations, the
provider does not have any business address that is not deactivated.
(c) The following circumstances are grounds for termination of
provisional provider status or preferred provisional provider status:
(1) The provider, persons with an ownership or control interest in
the provider, or persons who are directors, officers, or managing
employees of the provider have been convicted of any felony, or
convicted of any misdemeanor involving fraud or abuse in any
government program, related to neglect or abuse of a patient in
connection with the delivery of a health care item or service, or in
connection with the interference with, or obstruction of, any
investigation into health care related fraud or abuse, or have been
found liable for fraud or abuse in any civil proceeding, or have
entered into a settlement in lieu of conviction for fraud or abuse in
any government program within 10 years of the date of the
application package.
(2) There is a material discrepancy in the information provided to
the department, or with the requirements to be enrolled, that is
discovered after provisional provider status or preferred provisional
provider status has been granted and that cannot be corrected
because the discrepancy occurred in the past.
(3) The provider has provided material information that was false
or misleading at the time it was provided.
(4) The provider failed to have an established place of business
at the business address for which the application package was
submitted at the time of any onsite inspection, announced or
unannounced visit, or any additional inspection or review conducted
pursuant to this article or a statute or regulation governing the
Medi-Cal program, unless the practice of the provider's profession or
delivery of services, goods, supplies, or merchandise is such that
services, goods, supplies, or merchandise are rendered or delivered
at locations other than the business address and this practice or
delivery of services, goods, supplies, or merchandise has been
disclosed in the application package approved by the department when
the provisional provider status or preferred provisional provider
status was granted.
(5) The provider meets the definition of a clinic under Section
1200 of the Health and Safety Code, but is not licensed as a clinic
pursuant to Chapter 1 (commencing with Section 1200) of Division 2 of
the Health and Safety Code and fails to meet the requirements to
qualify for at least one exemption pursuant to Section 1206 or 1206.1
of the Health and Safety Code.
(6) The provider performs clinical laboratory tests or
examinations, but it or its personnel do not meet CLIA, and the
regulations adopted thereunder, and the state clinical
laboratory law, thereunder, do not possess valid
CLIA certificates and clinical laboratory registrations or
licenses pursuant to Chapter 3 (commencing with Section 1200) of
Division 2 of the Business and Professions Code,
certificates, or are not exempt from licensure as a
clinical laboratory under pursuant to Section
1241 of the Business and Professions Code.
(7) The provider fails to possess either of the following:
(A) The appropriate licenses, permits, certificates, or other
approvals needed to practice the profession or occupation, or provide
the services, goods, supplies, or merchandise the provider
identified in the application package approved by the department when
the provisional provider status or preferred provisional provider
status was granted and for the location for which the application was
submitted.
(B) The business or zoning permits or other approvals necessary to
operate a business at the location identified in its application
package approved by the department when the provisional provider
status or preferred provisional provider status was granted.
(8) The provider, or if the provider is a clinic, group,
partnership, corporation, or other association, any officer,
director, or shareholder with a 10 percent or greater interest in
that organization, commits two or more violations of the federal or
state statutes or regulations governing the Medi-Cal program, and the
violations demonstrate a pattern or practice of fraud, abuse, or
provision of unnecessary or substandard medical services.
(9) The provider commits any violation of a federal or state
statute or regulation governing the Medi-Cal program or of a statute
or regulation governing the provider's profession or occupation and
the violation represents a threat of immediate jeopardy or
significant harm to any Medi-Cal beneficiary or to the public
welfare.
(10) The provider submits claims for payment that subject a
provider to suspension under Section 14043.61.
(11) The provider submits claims for payment for services, goods,
supplies, or merchandise rendered at a location other than the
business address or addresses listed on the application for
enrollment, unless the practice of the provider's profession or
delivery of services, goods, supplies, or merchandise is such that
services, goods, supplies, or merchandise are rendered or delivered
at locations other than the business address and this practice or
delivery of services, goods, supplies, or merchandise has been
disclosed in the application package approved by the department when
the provisional provider status was granted.
(12) The provider has not paid its fine, or has a debt due and
owing, including overpayments and penalty assessments, to any
federal, state, or local government entity that relates to Medicare,
medicaid, Medi-Cal, or any other federal or state health care
program, and has not made satisfactory arrangements to fulfill the
obligation or otherwise been excused by legal process from fulfilling
the obligation.
(d) If, during a provisional provider status period or a preferred
provisional provider status period, the department conducts any
announced or unannounced visits or any additional inspections or
reviews pursuant to this chapter or Chapter 8 (commencing with
Section 14200), or the regulations adopted thereunder, and commences
an investigation for fraud or abuse, or discovers or otherwise
determines that the provider is under investigation for fraud or
abuse by any other state, local, or federal government law
enforcement agency, the provider shall be subject to termination of
provisional provider status or preferred provisional provider status,
regardless of whether the period of time for which the provisional
provider status or preferred provisional provider status was granted
under Section 14043.26 has elapsed.
(e) A provider whose provisional provider status or preferred
provisional provider status has been terminated pursuant to this
section may appeal the termination in accordance with Section
14043.65.
(f) Any department-recovered fine or debt due and owing, including
overpayments, that are subsequently determined to have been
erroneously collected shall be promptly refunded to the provider,
together with interest paid in accordance with subdivision (e) of
Section 14171 and Section 14172.5.